(146 days)
No
The device description and performance studies focus on the mechanical and electrical properties of a polypectomy snare, with no mention of AI or ML capabilities.
Yes
The device is used for the removal and/or cauterization of polyps and tissue from within the GI tract, indicating it is intended for treating medical conditions.
No
Explanation: The device is described as being used for the "removal and /or cauterization of diminutive polyps, sessile polyps, pedunculated polyps and tissue from within the GI tract" and delivers "a monopolar electrical current to cut and cauterize tissue". This indicates a therapeutic function, not a diagnostic one.
No
The device description clearly outlines physical components like a flexible wire cable, loop, outer sheath, and handle, indicating it is a hardware device, not software-only.
Based on the provided information, 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, tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Function: The description clearly states that the Polypectomy Snares and Rotatable Snares are used endoscopically to remove and/or cauterize tissue from within the GI tract. This is a procedure performed inside the body.
- Lack of Specimen Analysis: There is no mention of the device being used to analyze specimens or provide diagnostic information based on laboratory testing. Its function is the physical removal and cauterization of tissue during an endoscopic procedure.
Therefore, this device falls under the category of a surgical or therapeutic device used during an endoscopic procedure, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Polypectomy Snares and Rotatable 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 (comma separated list FDA assigned to the subject device)
FDI, FGX
Device Description
Both the rotatable and non-rotatable 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 and activated, the snare delivers a monopolar electrical current to cut and cauterize tissue with the loop. For the rotatable snares, the snare can be rotated by using the rotation actuator.
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.
Comparative testing was performed to assess similarities between the Boston Scientific Corporation Polypectorny Snares and Rotatable Snares and the Olympus SnareMaster.
Specifications tested included length, OD, loop width and shape, loop plane deflection and tensile strength.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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: June 10, 2013
NOV 0 4 2013
2. Device
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 Common Name: Polypectomy Snare Family 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: Rotatable Snare, Single-Use Polypectomy Snare Common Name: Rotatable Snare Classification Name: Snare, Flexible Regulation Number: 876.4300 Product Code: FDI Classification: Class II
3. Predicate Devices
Trade Name: Sensation Short Throw, Single-Use Polypectorny 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, K941750 Classification Name: Snare, Flexible Regulation Number: 876.4300 Product Code: FDI Classification: Class II
Premarket Notification, Polypectorny and Rotatable Snares: Tissue Resection
000072
1
Trade Name: Single-Use Rotatable Snare Manufacturer and Clearance Number: Boston Scientific Corporation, K992477 Classification Name: Snare, Flexible Regulation Number: 876.4300 Product Code: FDI Classification: 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
4. Device Description
Both the rotatable and non-rotatable 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 and activated, the snare delivers a monopolar electrical current to cut and cauterize tissue with the loop. For the rotatable snares, the snare can be rotated by using the rotation actuator.
5. Indication for Use:
The Polypectorny Snares and Rotatable 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 is a change to the device indication only. The proposed Polypectorny Snares and Rotatable Snares are identical in design, materials, and manufacturing processes to the predicate Polypectorny Snares and Rotatable Snares (K941750 and K992477). The proposed Polypectomy Snares and Rotatable Snares are similar in design to the Olympus SnareMaster (K955650).
7. Performance Data:
In-vitro testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests.
Comparative testing was performed to assess similarities between the Boston Scientific Corporation Polypectorny Snares and Rotatable Snares and the Olympus SnareMaster.
2
Specifications tested included length, OD, loop width and shape, loop plane deflection and tensile strength.
8. Conclusion:
Boston Scientific Corporation has demonstrated that the proposed Polypectomy Snares and Rotatable Snares are substantially equivalent to Boston Scientific Corporation's currently marketed Polypectomy Snares and Rotatable Snares (K941750 and K992477) and the Olympus SnareMaster (K955650).
Premarket Notification, Polypectorny and Rotatable Snares: Tissue Resection
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, and three horizontal bars above it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the caduceus symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 4, 2013
Boston Scientific Corporation Janis F. Taranto, M.S., RAC Senior Regulatory Affairs Specialist 100 Boston Scientific Way Marlborough, MA 01752
Re: K131700
Trade/Device Name: Single Use Polypectomy Snares and Rotatable Snares; 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; Rotatable Snare, Single-Use Polypectomy Snares Regulation Number: 21 CFR§ 876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: Il Product Code: FDI Dated: October 11, 2013 Received: October 15, 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. Ilsting 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.
4
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/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/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 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/ResourcesforYou/Industrv/default.htm.
Sincerely yours,
Image /page/4/Picture/7 description: The image shows the name "Benjamin R. Fisher -S" in a bold, sans-serif font. The letters "R" and "F" are stylized with a geometric pattern, creating a unique visual element within the name. The text is horizontally oriented and appears to be a signature or title. The overall impression is clean and professional, with a touch of artistic flair in the letter design.
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): 131700
Device Name: Single use Polypectomy Snares and Rotatable Snares 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 Rotatable Snare, Single-Use Polypectomy Snares
Indications for Use:
The Polypectomy Snares and Rotatable 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)
Beniamin 2013.1
Premarket Notification, Polypectomy and Rotatable Snares: Tissue Resection