(88 days)
Frigitonics CCS 100, CMS AccuProbe
Not Found
No
The summary describes a standard cryotherapy system and does not mention any AI or ML components or functionalities.
Yes
The device is intended for "surgical ablation of tissue" which is a therapeutic intervention, and the manufacturer highlights its "safety and effectiveness" which are common claims for therapeutic devices.
No
The device is described as a cryo-therapy system intended for the surgical ablation or destruction of tissue by applying extreme cold, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states it is a "system" that includes a "console" and a "reusable cryoprobe," indicating hardware components are integral to its function.
Based on the provided information, the Soprano™ Cryo-Therapy System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "surgical ablation of tissue by the application of extreme cold". This describes a procedure performed directly on a patient's body (in vivo) to destroy tissue.
- Device Description: The description reinforces this by stating it's a "general use cryotherapy system for the destruction or cryoablation of tissue" and involves a cryorefrigerant circulating to a cryoprobe. This is a physical intervention on the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples taken from the body (like blood, urine, tissue samples) or providing information about a patient's health status based on such analysis. IVDs are designed to be used in vitro (outside the body) to diagnose, monitor, or screen for diseases or conditions.
Therefore, the Soprano™ Cryo-Therapy System is a therapeutic device used for surgical intervention, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
GEI
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.
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)
The results from the nonclinical tests indicate the Cryo-Therapy System is equivalent to the predicate devices in terms of safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Frigitonics CCS 100, CMS AccuProbe
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
1 1098 MAY
Premarket Notification Soprano™M FemRx Inc.
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))
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.
Intended Use (21 CFR 807.92 (a)(5))
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.
1
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.
.
2
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.
3
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
4
INDICATIONS FOR USE
510(K) Number (if known) K980393
Device Name: Cryosurgical Unit and Accessories
Indications for Use:
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.
Prescription Use
(Per 21 CFR 801.109)
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