(23 days)
No
The device description and performance studies focus on mechanical and electrical functionality, with no mention of AI or ML.
Yes
Explanation: The Rotatable Snare is described as being used for the removal and/or cauterization of polyps and tissue within the gastrointestinal tract, which directly addresses a disease condition (polyps) and involves a direct medical intervention (removal, cauterization) to improve patient health.
No
The device description and intended use clearly state that it is used for the removal and cauterization of polyps and tissue, which are therapeutic actions, not diagnostic ones.
No
The device description clearly outlines physical components such as a flexible wire cable, loop, outer sheath, and a three-ring handle, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is the removal and/or cauterization of polyps and tissue from within the gastrointestinal tract. This is a therapeutic and surgical procedure performed directly on the patient's body.
- Device Description: The device is a physical tool (snare) used to manipulate and treat tissue in vivo (within a living organism). It delivers electrical current for cutting and cauterization.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue samples) outside the body to provide information about a patient's health status. This device does not perform any such analysis of specimens.
The device described is a surgical instrument used for endoscopic procedures.
N/A
Intended Use / Indications for Use
The Rotatable Snare is used endoscopically in the removal and/or and cauterization of diminutive polyps, sessile polyps, pedunculated polyps and tissue from within the gastrointestinal tract.
Product codes
FDI, FGX
Device Description
The Rotatable Snare consists of a flexible wire cable (core wire) and loop which can be extended and retracted from the Snare's flexible outer sheath using a three-ring handle. The flexible cable and loop can also be rotated 360° using the rotation actuator on the handle. The inner diameter of the sheath is Polyglide™ coated to provide minimal friction during extension, rotation, and retraction of the loop from the sheath. When passed through an endoscope and activated, the Snare delivers a monopolar electrical current to cut and cauterize tissue with the loop.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrointestinal tract
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
In-vitro Testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests. A summary of the test results has been provided for Working Length, Tortuous Path Functionality, Rotation Capability, Handle to Core Wire Tensile Strength, Electrical Resistance, Electrical Safety, and Snare Actuation. The results of all testing were passing.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).
0
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 30, 2016
Boston Scientific Corporation Michael Secondini Senior Regulatory Affairs Specialist 100 Boston Scientific Way Marlborough, MA 01752
Re: K160637 Trade/Device Name: Rotatable Snares Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic Electrosurgical unit and accessories Regulatory Class: Class II Product Code: FDI, FGX Dated: March 4, 2016 Received: March 7, 2016
Dear Michael Secondini,
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
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for
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name Rotatable Snares
Indications for Use (Describe)
The Rotatable Snare is used endoscopically in the removal and/or and cauterization of diminutive polyps, sessile polyps, pedunculated polyps and tissue from within the gastrointestinal tract.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Section 5: 510(K) Summary
1. Submitter
Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752
| Contact: | Michael Secondini |
|---|---|
| Sr. Regulatory Affairs Specialist | |
| Email: | Michael.Secondini@bsci.com |
| Telephone: | (508) 683-6503 |
| Fax: | (508) 683-5939 |
Date Prepared: March 4, 2016
2. Device
| Trade Name: | Rotatable Snares |
|---|---|
| Common Name: | Rotatable Snares |
| Classification Name: | Snare, Flexible |
| Snare, Non-Electrical | |
| Regulation Number: | 876.4300 |
| 876.4730 | |
| Product Code: | FDI |
| FGX | |
| Classification: | Class II |
3. Predicate Device
| Trade Name: | Rotatable Snares |
|---|---|
| Common Name: | Rotatable Snares |
| Manufacturer: | Boston Scientific Corporation |
| Clearance Numbers: | K131700 |
| Classification Name: | Snare, Flexible |
| Snare, Non-Electrical | |
| Regulation Number: | 876.4300 |
| 876.4730 | |
| Product Code: | FDI |
| FGX | |
| Classification: | Class II |
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Special 510(k) Premarket Notification Rotatable Snares
4. Reference Device
Trade Name: Single Use Polypectomy Snares Captivator II, Single Use Polypectomy Snares Common Name: Polypectomy Snares Manufacturer: Boston Scientific Corporation K133987 Clearance Numbers: Classification Name: Snare, Flexible Snare, Non-Electrical 876.4300 Regulation Number: 876.4730 Product Code: FDI FGX Classification: Class II
5. Device Description
The Rotatable Snare consists of a flexible wire cable (core wire) and loop which can be extended and retracted from the Snare's flexible outer sheath using a three-ring handle. The flexible cable and loop can also be rotated 360° using the rotation actuator on the handle. The inner diameter of the sheath is Polyglide™ coated to provide minimal friction during extension, rotation, and retraction of the loop from the sheath. When passed through an endoscope and activated, the Snare delivers a monopolar electrical current to cut and cauterize tissue with the loop.
6. Indications for Use
The Rotatable Snare is used endoscopically in the removal and/or and cauterization of diminutive polyps, sessile polyps, pedunculated polyps and tissue from within the gastrointestinal tract.
7. Technological Characteristics
This change is modifying the design of the Rotatable Snare to improve ergonomics of the device handle by moving the rotation actuator of the snare to the handle from its current position along the main sheath. The proposed Rotatable Snares are similar in materials, design, and manufacturing process to the predicate Rotatable Snares (K131700) and will use many of the same components as the reference Captivator II Snares (K133987). There are no new patient contacting materials used on the proposed snares.
8. Performance Data
In-vitro Testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests. A summary of the test results has been provided for Working Length, Tortuous Path Functionality, Rotation Capability, Handle to Core
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Wire Tensile Strength, Electrical Resistance, Electrical Safety, and Snare Actuation. The results of all testing were passing.
9. Conclusion
Boston Scientific Corporation has demonstrated that the proposed Rotatable Snares are substantially equivalent to Boston Scientific Corporation's currently marketed Rotatable Snares (K131700).