(29 days)
Not Found
No
The description focuses on the mechanical and electrical function of a polypectomy snare and does not mention any AI or ML components or capabilities.
Yes
The device is used for the removal and/or cauterization of polyps and tissue, which are therapeutic interventions.
No
The device is used for the removal and/or cauterization of polyps and tissue, which are therapeutic actions, not diagnostic. Its description focuses on mechanical and electrical functions for tissue manipulation and cauterization rather than information gathering for diagnosis.
No
The device description clearly outlines physical components (flexible wire cable, loop, outer sheath, handle) and a function involving delivering electrical current, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states the Polypectomy Snares are used endoscopically to remove and/or cauterize tissue from within the GI tract. This is a direct intervention on the patient's body, not an analysis of a specimen taken from the body.
- Intended Use: The intended use is for a surgical procedure (polyp removal and cauterization), not for analyzing a sample in a lab setting.
The device is a surgical instrument used during an endoscopic procedure.
N/A
Intended Use / Indications for Use
The Polypectomy Snares are used endoscopically in the removal and /or cauterization of diminutive polyps, sessile polyps, pedunculated polyps and tissue from within the GI tract.
Product codes
FDI, FGX
Device Description
The Polypectomy Snares consists of a flexible wire cable and loop which can be extended and retracted from the snare's flexible outer sheath using a three-ring handle. When passed through an endoscope the snare can be activated to deliver 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
GI 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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 Loop Extension Functionality, Loop Retraction Functionality, Cable to Handle Tensile, Active Cord Compatibility, Active Cord Attachment, Loop Width and Electrical Resistance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
SECTION 5 510(k) SUMMARY
JAN 2 4 2014
1. Submitter
Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 Telephone: 508-683-4560 Fax: 508-683-5939
Contact: Janis F. Taranto M.S., RAC Sr. Regulatory Affairs Specialist Date Prepared: December 24, 2013
2. Device
Trade Name: Single Use Polypectomy Snares
Captivator II, Single-Use Polypectomy Snares Common Name: Polypectomy Snare Classification Name: 1) Snare, Flexible, 2) Snare, Non-Electrical Regulation Number: 1) 876.4300, 2) 876.4730 Product Code: 1) FDI, 2) FGX Classification: Class II
3. Predicate Devices
Trade Name: Sensation Short Throw, Single-Use Polypectomy Snares Captiflex, Single-Use Polypectomy Snares Captivator, Single-Use Polypectomy Snares Captivator II, Single-Use Polypectomy Snares Profile, Single-Use Polypectomy Snares Manufacturer and Clearance Number: Boston Scientific Corporation, K131700 Classification Name: 1) Snare, Flexible, 2) Snare, Non-Electrical Regulation Number: 1) 876.4300, 2) 876.4730 Product Code: 1) FDI, 2) FGX
Classification: Class II
Trade Name: SnareMaster Manufacturer and Clearance Number: Olympus, K955650 Classification Name: 1) Snare, Flexible, 2) Electrode, electrosurgical, active, urological Regulation Number: 876.4300 Product Code: 1) FDI, 2) FAS Classification: II
1
4. Device Description
The Polypectomy Snares consists of a flexible wire cable and loop which can be extended and retracted from the snare's flexible outer sheath using a three-ring handle. When passed through an endoscope the snare can be activated to deliver a monopolar electrical current to cut and cauterize tissue with the loop.
5. Indication for Use:
The Polypectomy Snares are used endoscopically in the removal and for cauterization of diminutive polyps, sessile polyps, pedunculated polyps and tissue from within the GI tract.
6. Technological Characteristics:
This change is adding snare loop sizes to the current Polypectomy Snare Family and modifying the handle design. The proposed Polypectomy Snares are similar in design, materials, and manufacturing processes to the predicate Polypectomy Snares (K131700) and the Olympus SnareMaster (K955650).
7. Performance Data:
In-vitro testing has been performed and all components, subassemblics, and/or full devices met the required specifications for the completed tests. A summary of the test results has been provided for Loop Extension Functionality, Loop Retraction Functionality, Cable to Handle Tensile, Active Cord Compatibility, Active Cord Attachment, Loop Width and Electrical Resistance.
8. Conclusion:
Boston Scientific Corporation has demonstrated that the proposed Polypectomy Snares are substantially equivalent to Boston Scientific Corporation's currently marketed Polypectomy Snares (K131700) and the Olympus SnareMaster (K955650).
2
Public Health Service
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 24, 2014
Boston Scientific Corporation Janis F. Taranto, M.S., RAC Senior Regulatory Affairs Specialist 100 Boston Scientific Way Marlborough, MA 01752
Re: K133987
Trade/Device Name: Single Use Polypectomy Snares Captivator II, Single-Use Polypectomy Snares Regulation Number: 21 CFR§ 876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: II Product Code: FDI, FGX Dated: December 24, 2013 Received: December 26, 2013
Dear Janis F. Taranto,
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 adviteration. 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.
3
Page 2 - Janis F. Taranto, M.S., RAC
. . . . .
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Benjamin Fisher -S
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
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SECTION 4 INDICATIONS FOR USE STATEMENT
Indications for Use:
510(k) Number (if known): K133987
Device Name: Single Use Polypectomy Snares Captivator II, Single-Use Polypectomy Snares
Indications for Use:
The Polypectomy Snares are used endoscopically in the removal and /or cauterization of diminutive polyps, sessile polyps, pedunculated polyps and tissue from within the GI tract.
Prescription Use X (Part 21 CFR 801 Part D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Benjamin 2014.01 22