ULTRA-FINE DIATHERMY LOOP AND COAGULATION BALLS by ROCKET MEDICAL PLC

Large Loop Excision of the Transformation zone in the Diagnosis and treatment of some Cervical Intraepithelial Neoplasias (CIN I, III) and Cervical Dysplasia
Extrenal Anogenital Lesions.
Cervical Conizations.
Large Vaginal Intraepithelial Neoplastic (VAIN) Lesions.

Device Description

Ultra-Fine™ Diathermy loops and Coagulation Balls

AI/ML Overview

This document describes a 510(k) submission for Rocket Medical's Ultra-Fine™ Diathermy Loops and Coagulation Balls. This is a notification of intent to market a medical device, which seeks to demonstrate substantial equivalence to legally marketed predicate devices, rather than establishing new safety and effectiveness through clinical trials with acceptance criteria.

Therefore, the provided text does not contain information about:

Acceptance criteria tables or reported device performance against such criteria.
Sample sizes for test sets or their data provenance.
Number or qualifications of experts for ground truth establishment.
Adjudication methods.
Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or their effect sizes.
Standalone algorithm performance studies.
Types of ground truth used (expert consensus, pathology, outcomes data).
Sample size for training sets.
How ground truth for training sets was established.

Instead, the document states the following pertinent information:

Device: Ultra-Fine™ Diathermy Loops and Coagulation Balls.
Manufacturer: Rocket Medical.
Regulatory Classification: Class II (Procode: 85 KNF).
Claim of Safety and Effectiveness: The manufacturer "believe[s] [the devices] are safe and effective for the application for which they are intended, having been subjected to full design evaluation. They have been on sale and in commercial distribution within the UK and many other countries for more than 8 years and have during this period been found to be safe and effective."
Substantial Equivalence: The submission asserts that these devices "are substantially equivalent to a great many medical devices which are currently in commerce and have been submitted to the FDA."
FDA Determination: The FDA reviewed the 510(k) notification and "determined the device is substantially equivalent for the indications for use stated in interstate in interstate commerce prior to May 28, 1976." This allows the device to be marketed.
Indications for Use:
- Large Loop Excision of the Transformation zone in the Diagnosis and treatment of some Cervical Intraepithelial Neoplasias (CIN I, III) and Cervical Dysplasia.
- External Anogenital Lesions.
- Cervical Conizations.
- Large Vaginal Intraepithelial Neoplastic (VAIN) Lesions.

Summary

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Rocket Medical - New 510(k) Notification Ultra-Fine™ Diathermy loops and Coagulation Balls

$\frac{P}{K972856}$

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Rocketmedical

FEB 11 1998

Summary of Safety and Effectiveness

Ultra-Fine™ Diathermy Electrodes

Rocket (Establishment number: devices. registered by These are class II 8010022/9610632). These devices are substantially equivalent to a great many medical devices which are currently in commerce and have been submitted to the FDA.

The devices we believe are safe and effective for the application for which they are intended, having been subjected to full design evaluation. They have been on sale and in commercial distribution within the UK and many other countries for more than 8 years and have during this period been found to be safe and effective.

Rocket Medical will, however, continue to search all appropriate sources for information relating to safety and effectiveness and maintains an in-house reporting system to identify adverse safety and effectiveness information and as such, applicable data will be recorded for this product.

CERTIFICATION

I hereby certify that this Summary of Safety and Effectiveness applies for the above indicated device.

21 July '97
Date

TZM

Signed by Leslie Todd Quality Assurance Manager Rocket Medical Wear Industrial Estate, Washington Tyne & Wear, England. NE37 1NE

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Image /page/1/Picture/2 description: The image shows a logo for the Department of Health. The logo features a stylized depiction of a human head in profile, with three overlapping lines forming the face. The words "DEPARTMENT OF HE" are written vertically along the left side of the logo.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 11 100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000

Rocket Medical PLC c/o Mr. Richard Keen Compliance Consultants 1151 Hope Street Stamford, CT 06907District 6 Re: K972856 Ultra-Fine™ Diathermy Loops and Coagulation Balls Dated: November 12, 1997 Received: December 4, 1997 Regulatory Class: II 21 CFR 884.4160/Procode: 85 KNF

Dear Mr. Keen:

We have reviewed your Section 510(k) notification of intent to market the device and we have determined the device is substantially equivalent for the indications for use stated in interstate in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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 III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question 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" (2) CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

h.7. liau lfi

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal. Ear, Nose and Throat. and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K972856

Page 1 of 1

Device Name: Ultra-Fine™ Diathermy loops and Coagulation Balls

Indications for Use:

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Large Loop Excision of the Transformation zone in the Diagnosis and treatment of some ● Cervical Intraepithelial Neoplasias (CIN I, III) and Cervical Dysplasia
Extrenal Anogenital Lesions. .
Cervical Conizations. ●
Large Vaginal Intraepithelial Neoplastic (VAIN) Lesions. ●

signature

Signed L. Todd QA and Regulatory Affairs Manager Rocket Medical Plc

11th July 1997

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDHR, Office of Device Evaluation (ODE)

Robert D. Rätting

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number K912856

Prescription use

Over-The -Counter Use

(Optional Format 1-2-96)

Rocketmedical

Regulation Number and Section

§ 884.4160 Unipolar endoscopic coagulator-cutter and accessories.

(a)
Identification. A unipolar endoscopic coagulator-cutter is a device designed to destroy tissue with high temperatures by directing a high frequency electrical current through the tissue between an energized probe and a grounding plate. It is used in female sterilization and in other operative procedures under endoscopic observation. This generic type of device may include the following accessories: an electrical generator, probes and electrical cables, and a patient grounding plate. This generic type of device does not include devices used to perform female sterilization under hysteroscopic observation.(b)
Classification. Class II (performance standards).