(52 days)
K85195, K01166
None
No
The device description and intended use describe a purely mechanical and electrical device for polypectomy. There is no mention of any software, image processing, or AI/ML terms.
Yes
Explanation: The device is described as a "monopolar electrosurgical device used with an electrical unit for endoscopic polypectomy," which indicates it is used to perform a medical procedure (polypectomy), fitting the definition of a therapeutic device.
No
The device description and intended use indicate it is an electrosurgical device for polypectomy, a therapeutic procedure, not a diagnostic one.
No
The device description clearly outlines physical components like a catheter, handle, wire, and lumen, 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 "for endoscopic polypectomy." This is a surgical procedure performed on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The description details a physical device used for a surgical procedure (a snare for removing polyps). It doesn't describe a device used to analyze biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information based on sample analysis
In summary, the Sonnet TM Polypectomy Snare is a surgical tool used for a therapeutic procedure, not a diagnostic test performed on a sample.
N/A
Intended Use / Indications for Use
The Sonnet TM Polypectorny Snare is a monopolar electrosurgical device used with an electrical unit for endoscopic polypectomy.
Product codes
FDI
Device Description
The Sonnet™ Polypectomy Snare consists of a 240cm catheter attached to a handle at the proximal end and incorporates a braided stainless steel wire in a loop configuration that is attached to a stainless steel drive-wire and is extendable and retractable with respect to the catheter distal tip. The handle provides an active cord connection. The catheter has a single lumen.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Tests include electrical testing
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K85195, K01166
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
COOK®
MAR 3 1 2005
Cook Ireland Ltd.
O'Halloran Road, National Technology Park, Limerick, IRELAND Phone: +353 61 334440 Fax: +353 61 334441 www.cookgroup.com
Pg 1 of 2
510(k) Summary
Submitted By:
Cook Ireland Ltd. O'Halloran Road, National Technology Park, Limerick, Ireland
Contact Information:
Emmett Devereux QA/RA Manager Cook Ireland Limited O'Halloran Road National Technology Park Limerick, Ireland Phone: +353-61-334440 Fax: +353-61-334441 Email: edevereux@cook.ie April Lavender Cook Incorporated 750 Daniels Way Bloomington, IN 47401 U.S.A Phone: 812-339-2235 Fax: 812-332-0281 Email: LAVENDER@COOK.INC.COM
Date Prepared:
February 3, 2005
510(k) #:
Device:
Trade Name: Common/Usual Name: Class: Product Code:
Sonnet TM Polypectomy Snare Snare Class II FDI
Intended Use:
The Sonnet TM Polypectorny Snare is a monopolar electrosurgical device used with an electrical unit for endoscopic polypectomy.
1
COOL
Pg 2 of 2
Device Description:
The Sonnet™ Polypectomy Snare consists of a 240cm catheter attached to a handle at the proximal end and incorporates a braided stainless steel wire in a loop configuration that is attached to a stainless steel drive-wire and is extendable and retractable with respect to the catheter distal tip. The handle provides an active cord connection. The catheter has a single lumen.
Test Data:
Tests include electrical testing
Substantial Equivalence:
The subject device is similar with respect to intended use and/or design features to the predicate devices in terms of section 510(k) substantial equivalence. The subject device is safe and effective and is substantially equivalent to the predicate devices.
| Manufacturer | Device | 510(k) |
|---|---|---|
| Wilson-Cook | Wilson-Cook Snare | K85195 |
| Horizons International Corp. | Horizons Polypectomy Snare | K01166 |
2
Image /page/2/Picture/2 description: The image shows a logo with a stylized bird in flight. The bird is facing left, and its body is represented by three curved lines. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES". The logo is black and white.
MAR 3 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MO 20850
Mr. Emmett Devereux QA/RA Manager Cook® Ireland Limited O'Halloran Road National Technology Park LIMERICK IRELAND
Re: K050294
Trade/Device Name: Sonnet™ Polypectomy Snare Regulation Number: 21 CFR §876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: II Product Code: FDI Dated: February 3, 2005 Received: February 7, 2005
Dear Mr. Devereux:
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 the cheroped of 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 recaussition in acoroval of a premarket approval application (PMA). You may, therefore, market the do not require approvate or a controls provisions of the Act. The general controls provisions of the Act as not regurements 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 (Premarket 11 your ab room be subject to such additional controls. Existing major regulations affecting your Applorary, It ifaly 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 I rease of a determination that your device complies with other requirements of the Act or any I Drivas mades and regulations administered by other Federal agencies. You must comply with all the r cacial starses and registration and 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) (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter witi anow you to begin maneting your and equivalence of your device to a legally premarket notheation. The PDA mainly of saosannal vice 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 If you desire specific advice tor your do 1706 of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, prease note the regulation entired, consibilities under the Act from the 807.97). Tou may obtain other general missance at its toll-free number (800) DVVSlon of 301) 443-6597 or at its Internet address http://www.fda.gov/cdrb/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
4
510(k) Number (if known): _K 05 c 3 94
Device Name: Sonnet™ Polypectomy Snare
Indications for Use:
The Sonnet ™ Polypectomy Snare is a monopolar electrosurgical device used with an electrical unit for endoscopic polypectomy.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use Only
Counter
(Per 21 CFR § 801.109
OR
Over-the-
Nancy C Brazdon
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number K050294