(90 days)
Not Found
No
The description focuses on the mechanical and electrical components of a standard electrosurgical snare and does not mention any AI/ML capabilities or related data/performance metrics.
Yes
The device is used to transect polyps in the gastrointestinal tract using electrocautery, which is a therapeutic intervention.
No
The device is intended for the electrocautery transection, capture, and retrieval of polyps for pathological analysis, which are interventional procedures, not diagnostic ones. Although the polyp is submitted for pathological analysis, the device itself performs a therapeutic (resection) and collection function, not a diagnostic one.
No
The device description clearly outlines physical components such as a handle, flexible sheath, cable, snare loop, and net, indicating it is a hardware device used for endoscopic procedures.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. They are used outside of the body.
- Device Function: This device is used inside the body (endoscopically) to remove polyps from the gastrointestinal tract. It uses electrocautery for transection and a snare/net for capture and retrieval.
- Purpose: The primary purpose is a surgical procedure (polyp removal), not a diagnostic test performed on a sample. While the retrieved polyp is submitted for pathological analysis (which is an IVD process), the device itself is the tool for removal, not the diagnostic test.
Therefore, this device falls under the category of a surgical or therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
These devices are intended to endoscopically transect polyps in the gastrointestinal tract (sessile or perdunctuated) using electrocautery. During the same maneuver the polyp is captured, retrieved and submitted for pathological analysis.
Product codes
78 FDI
Device Description
This disposable product consists of a handle equipped with a male plug for connection to a standard ESU, a flexible sheath and a cable to which a snare loop fitted with a net is attached distally. Upon resection, the device and scope is removed from the patient and the polyp removed from the net together in a continuous retrograde motion. The Snare II version is disposed after one use. The Snare III version may be reused with the same patient. The device is available with different loop sizes and the sheath/cable lengths to accommodate different polyp sizes and endoscope types.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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
JUN 1 7 2002
KO20891
Page 1 of 1
510(k) Summary of Safety and Effectiveness for the Nakao Snare II and Nakao Snare III:
- Granit Medical Innovations, Inc. 1.) Submitter: 992 Fifth Avenue New York City, NY 10028
- Naomi L. Nakao, MD 2). Contact Person:
- 3.) Summary Preparation Date: March 15, 2002
- Snare, Flexible 4.) Classification Name:
- Monopolar Polypectomy Snare Net Device 5.) Common Name:
- Nakao Snare II and Nakao Snare III 6.) Proprietary Name:
- 7.) Substantially Equivalent Device:
K926103 - U. S. Endoscopy Group Inc.
-
8.) Description of Subject Device:
This disposable product consists of a handle equipped with a male plug for connection to a standard ESU, a flexible sheath and a cable to which a snare loop fitted with a net is attached distally. Upon resection, the device and scope is removed from the patient and the polyp removed from the net together in a continuous retrograde motion. The Snare II version is disposed after one use. The Snare III version may be reused with the same patient. The device is available with different loop sizes and the sheath/cable lengths to accommodate different polyp sizes and endoscope types. -
9.) Intended Use:
These devices are intended to endoscopically transect polyps in the gastrointestinal tract (sessile or perdunctuated) using electrocautery. During the same maneuver the polyp is captured, retrieved and submitted for pathological analysis. -
10.) Technological Characteristics:
The subject device has the same technological characteristics, is composed of the same type of materials and is of a similar design to the predicate device.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three parallel lines forming its wings and body.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 7 2002
Naomi L. Nakao, M.D. President Granit Medical Innovations, Inc. 992 Fifth Avenue NEW YORK CITY NY 10028
Re: K020891
Trade/Device Name: Nakao Snare II and Nakao Snare III Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories
Regulatory Class: II Product Code: 78 FDI Dated: March 15, 2002 Received: March 19, 2002
Dear Dr. Nakao
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.
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): 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.
2
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
K020891
Page 1 of 1
K020891
Nakao Snare II and Nakao Snare III Proprietary Name:
Monopolar Polypectomy Snare Net Device Common Name:
Indication(s) for Use:
These devices are intended to endoscopically transect polyps in the These "devilose" and "internated) using electrocautery. During the gastromitootiful tract (coosn's captured, retrieved and submitted for pathological analysis.
Sarid G. Lynn
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
prescr-iption weker/