The Soprano™ Cryo-Therapy System is intended for use in the surgical ablation of tissue by the application of extreme cold in the fields of dermatology, general surgery, neurosurgery, thoracic surgery, E.N.T., gynecology, oncology, proctology and urology.

Device Description

The FemRx Soprano Cryo-Therapy System is designed to be a general use cryotherapy system for the destruction or cryoablation of tissue. The system allows the circulation of a cryorefrigerant from the console to the reusable cryoprobe.

AI/ML Overview

This document is a 510(k) summary for the Soprano™ Cryo-Therapy System, indicating that the device has been reviewed and found substantially equivalent to predicate devices. However, the provided text does not contain detailed performance data, acceptance criteria, or a description of a study that proves the device meets specific acceptance criteria in the manner requested by the prompt for AI/ML device evaluations.

It states: "The results from the nonclinical tests indicate the Cryo-Therapy System is equivalent to the predicate devices in terms of safety and effectiveness." This is a general statement and not a detailed account of performance results against specific acceptance criteria.

Therefore, the following information cannot be extracted from the provided text:

A table of acceptance criteria and the reported device performance: The document does not list specific acceptance criteria or quantitative performance metrics.
Sample sized used for the test set and the data provenance: No information on test set size or data origin is provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no expert-derived ground truth or test set is mentioned.
Adjudication method for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done: The document does not mention such a study.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable as this is a physical medical device, not an algorithm.
The type of ground truth used: Not applicable as no specific test data or ground truth establishment is described.
The sample size for the training set: Not applicable as no training set is mentioned for this type of device.
How the ground truth for the training set was established: Not applicable.

This 510(k) summary pertains to a physical cryo-therapy system and evaluates its substantial equivalence to predicate devices based on intended use, principle of operation, and control function, rather than the performance metrics typically associated with AI/ML-driven diagnostic devices.

Summary

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1 1098 MAY

Premarket Notification Soprano™M FemRx Inc.

K980393

510(k) SUMMARY

Submitter Information (21 CFR 807.92(a)(1))

FemRx, Inc. Submitter: 1221 Innsbruck Drive Sunnyvale, CA 94089 Ms. Jean La Douceur Contact: Vice President Product Assurance (408) 752-8580 x 104

January 30, 1998 Summary Date:

Name of Device and Classification (21 CFR 807.92(a)(2))

Soprano™ Name (trade):

Cryo-Therapy System Name (usual):

Class II, 21 CFR 878.4350, "cyrosurgical unit and accessories" Classification:

Predicate Device (21 CFR 807.92 (a)(3))

The Cryo-Therapy System (Soprano™) is substantially equivalent to the Frigitonics CCS 100 and CMS AccuProbe in terms of intended use, principle of operation, and control function.

Description of Device (21 CFR 807.92 (a)(4))

Intended Use (21 CFR 807.92 (a)(5))

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Premarket Notification Soprano™ FemRx Inc.

Performance Data - Conclusions (21 CFR 807.92 (b)(3))

The results from the nonclinical tests indicate the Cryo-Therapy System is equivalent to the predicate devices in terms of safety and effectiveness.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three heads facing to the right. The eagle is black and white, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

1 1098 MAY

George Savage, M.D. Chief Medical Officer FemRx Incorporated 1221 Innsbruck Drive 94089 Sunnyvale, California

Re: K980393 : Soprano Cyro-Therapy System Trade Name: Requlatory Class: II Product Code: GEI Dated: January 30, 1998 February 2, 1998 Received:

Dear Dr. Savage:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (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 requlation may result in regulatory In addition, FDA may publish further announcements action. 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 the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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Page 2 - Dr. Savage

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 diaqnostic devices), please contact the Office of Compliance at (301) 594-4595. 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 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,

Celia M. Witten, Ph.D., M.D.
Director

Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

510(K) Number (if known) K980393

Device Name: Cryosurgical Unit and Accessories

Indications for Use:

Prescription Use
(Per 21 CFR 801.109)

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Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.