Instructions for Use
Intended Use / Indications for Use
The Sclerotherapy Needle is intended for endoscopic injection of approved sclerosing agents, vasoconstrictors, dyes, and other compatible solutions within the gastrointestinal tract.
The device is indicated for:
- Endoscopic treatment of esophageal and colonic varices.
- Injection of sclerosing agents for management of gastrointestinal bleeding.
- Submucosal injection during Endoscopic Mucosal Resection (EMR) procedures.
- Injection-assisted polypectomy procedures.
- Control of selected non-variceal gastrointestinal hemorrhage.
The device is supplied sterile and is intended for single-patient use only.
Device Description
The Sclerotherapy Needle is a sterile endoscopic injection device designed to facilitate controlled delivery of therapeutic solutions into gastrointestinal tissue.
The device consists of:
- Control handle with locking mechanism
- Luer-lock connector
- Flexible catheter assembly
- Inner and outer sheath
- Injection needle with beveled tip
The handle mechanism enables controlled advancement and retraction of the injection needle through thumb-actuated operation. A standard syringe may be connected to the luer-lock fitting for administration of injectable solutions.
The catheter design promotes smooth passage through the endoscope working channel while maintaining reliable needle deployment characteristics. The beveled needle tip is designed to facilitate tissue penetration and accurate delivery of injectates.
Technical Specifications
- Catheter Lengths: 180 cm, 200 cm, 230 cm
- Catheter Outer Diameter: 2.3 mm
- Needle Sizes: 21G and 23G
- Minimum Endoscope Working Channel: 2.8 mm
- Sterilization Method: Ethylene Oxide (EO)
- Intended Use: Single Use Only
Contraindications
The device should not be used in patients:
- With known hypersensitivity to the intended injectable agents.
- For lesions where injection therapy is clinically contraindicated.
- Where the treating physician determines injection therapy presents an unacceptable risk.
Potential Adverse Events
Potential complications associated with endoscopic injection procedures may include:
- Bleeding
- Perforation
- Infection
- Fever
- Sepsis
- Esophageal ulceration
- Esophageal stricture formation
The physician should evaluate all risks and benefits prior to treatment.
Warnings
- Read and understand all instructions prior to use.
- Use only by healthcare professionals trained in therapeutic endoscopy.
- Do not use if packaging is damaged or sterility is compromised.
- For single use only. Do not reuse, reprocess, or resterilize.
- Reuse may result in contamination, infection, device malfunction, patient injury, or death.
- Inspect the device before use and discard if damaged.
- Do not use beyond the expiration date shown on the package.
- The device must be used only for its intended purpose.
- If needle retraction failure occurs, remove the device together with the endoscope when clinically appropriate.
- Dispose of used devices in accordance with institutional and local regulations.
Precautions
- Review the complete Instructions for Use before beginning the procedure.
- Verify compatibility with the endoscope working channel.
- Ensure the needle is fully retracted before insertion, advancement, or withdrawal.
- Confirm that the protective sheath is securely positioned before handling the device.
- Exercise caution during manipulation to avoid damage to the endoscope or surrounding tissue.
- Maintain sterile technique throughout the procedure.
Instructions for Use
Device Preparation
- Open the sterile package using aseptic technique.
- Inspect the device for damage, bends, kinks, or loose components.
- Straighten the catheter carefully if required.
- Attach a pre-filled syringe to the luer-lock connector.
- Prime the system and remove air from the lumen.
- Verify proper needle movement by operating the handle mechanism.
Device Insertion
- Ensure the needle is fully retracted within the sheath.
- Introduce the catheter into the endoscope working channel.
- Advance the device until the distal tip is visible endoscopically.
- Position the device at the intended injection site.
Injection Procedure
- Extend the needle using the control handle.
- Penetrate the target tissue under direct visualization.
- Inject the required solution through the attached syringe.
- Monitor the treatment area throughout the injection process.
- Repeat injections as clinically required.
Device Removal
- Retract the needle completely into the sheath.
- Withdraw the device carefully through the endoscope channel.
- Inspect the device following removal.
- Dispose of the used device according to applicable regulations.
Change in Performance
If any change in device performance is observed or the device fails to perform its intended function, appropriate clinical action should be taken based on the patient’s condition and physician judgment.
Disposal
Following use, the device should be considered potentially biohazardous and disposed of according to hospital, local, state, and national regulations.
Storage Conditions
Store in a clean, dry, and well-ventilated environment.
Avoid exposure to:
- Excessive heat
- Moisture
- Direct sunlight
- Organic solvents
- Ionizing radiation
- Ultraviolet radiation
- Corrosive environments
Store within the conditions specified on the product labeling.
Limited Warranty
KINDMED DEVICES PRIVATE LIMITED warrants that this product has been manufactured in accordance with established quality control procedures and applicable manufacturing specifications.
Because product performance may be affected by storage conditions, handling practices, procedural techniques, and patient-specific factors beyond the manufacturer’s control, no warranty is provided regarding clinical outcomes.
The manufacturer’s liability is limited to replacement of defective products. KINDMED DEVICES PRIVATE LIMITED shall not be liable for incidental, indirect, special, or consequential damages arising from product use, misuse, modification, resterilization, or reuse.
Manufacturer:
KINDMED DEVICES PRIVATE LIMITED
1st Floor, Plot No. 175B
Dada Nagar Industrial Area
Kanpur Nagar, Uttar Pradesh – 208022, India
| Working length (mm) | Sheath O.D. (mm) | Needle gauge | Needle length (mm) | Sheath material | Metal cup (Y/N) |
| 2300 | 2.4 | 21 | 4 | PP | N |
| 2300 | 2.4 | 21 | 6 | PP | N |
| 2300 | 2.4 | 23 | 4 | PP | N |
| 2300 | 2.4 | 23 | 6 | PP | N |
| 2300 | 2.4 | 25 | 4 | PP | N |
| 2300 | 2.4 | 25 | 6 | PP | N |
| 2300 | 2.4 | 23 | 4 | Metal | Y |
| 2300 | 2.4 | 23 | 6 | Metal | Y |
| 2300 | 2.4 | 25 | 4 | Metal | Y |
| 2300 | 2.4 | 25 | 6 | Metal | Y |
| 2300 | 2.4 | 21 | 4 | PP | N |
| 2300 | 2.4 | 21 | 6 | PP | N |
| 2300 | 2.4 | 23 | 4 | PP | N |
| 2300 | 2.4 | 23 | 6 | PP | N |
| 2300 | 2.4 | 25 | 4 | PP | N |
| 2300 | 2.4 | 25 | 6 | PP | N |
