The Cryo-Mono Cryogenic System is intended for cryogenic destruction of tissues during surgical procedures. It is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurosurgery, thoracic surgery, ENT, gynecology, oncology, proctology, and urology for the ablation of tissue, including liver metastases, skin lesions, warts, and prostate tissues. Cryo-Mono with TUF probe is specifically indicated for the ablation of prostate tissue in cases of benign prostatic hyperplasia ("BPH").

Device Description

The Cryo-Mono is a modified version of Cryo-Hit. They have the same technological characteristics with several exceptions: The primary technological differences between the Cryo-Mono with TUF probe and the Cryo-Hit are: (1) Cryo-Mono with TUF accepts only one cryoprobe, the TUF probe, which is one of the options for the Cryo-Hit; (2) The Cryo-Mono with TUF probe is smaller than Cryo-Hit; (3) The Cryo-Mono with TUF probe has fewer gas cylinders; (4) The physician manually applies the Cryo-Mono's probe while with the Cryo-Hit, the physician has the option to use the "Stick" mode, which automatically adheres the probe to the tissue; (5) The Cryo-Mono with TUF probe has an optional foot pedal control; (6) The Cryo-Mono with TUF probe delivers preset amounts of argon for cooling while the Cryo-Hit adjusts the amount of argon delivered based on the tissue temperature measured by its thermocouples; (7) The Cryo-Mono with TUF probe's iceball size is monitored by transrectal ultrasound; the use of ultrasound, as well as external theromcouples, is optional with the Cryo-Hit; and (8) The Cryo-Mono's TUF probe is delivered transurethrally through a cystoscope rather than transperineally as with the Cryo-Hit. The only modification to the device' s software was the removal of the "stick" option mentioned above. The Cryo-Mono's single-use probes are within the range of probes that can be used with the Cryo-Hit, i.e. one to eight probes.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Cryo-Mono Cryogenic System with TUF probe. This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study with explicit acceptance criteria for device performance. Therefore, many of the requested elements (like sample size for test sets, ground truth establishment, MRMC studies, standalone performance studies, etc.) are not typically included or required in a 510(k) submission focused on substantial equivalence based on technological characteristics and intended use.

The performance data mentioned pertains primarily to biocompatibility and compliance with general safety standards, not a specific clinical performance study for a machine learning algorithm.

However, based on the information provided, here's what can be extracted and inferred:

1. A table of acceptance criteria and the reported device performance:

Since this is a 510(k) for substantial equivalence, the "acceptance criteria" are implicitly met by demonstrating that the device is as safe and effective as the predicate devices. There are no explicit performance metrics like "sensitivity" or "specificity" provided for an AI algorithm.

Acceptance Criteria (Implied by 510(k) process)	Reported Device Performance (from submission)
Biocompatibility	Components made of same materials as K980205 (Cryo-Hit) and Impra's Venaflo™ vascular graft, which have FDA premarket clearance.
Electrical Safety & EMC	Conformance with IEC 60601-1 and IEC 60601-1-2.
Material Safety	Conformance with ASTM F882-84.
Intended Use & Indication for Use	Same general intended use as Cryo-Hit. Specifically indicated for ablation of prostate tissue in BPH, similar to CryoCare™ and TUNA system.
Technological Characteristics	"Virtually identical technological characteristics" to Cryo-Hit, with minor differences not raising new safety/effectiveness questions (e.g., single probe, smaller size, fewer gas cylinders, no "stick" option, foot pedal, modified software, transurethral delivery for TUF probe).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable/Not provided. This submission relies on demonstrating substantial equivalence based on technological characteristics and prior clearances, not on a new clinical study with a test set of patient data to evaluate an algorithm's performance. The "performance data" refers to engineering and material compliance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable/Not provided. No clinical test set requiring expert ground truth was described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not provided. No clinical test set requiring adjudication was described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This device is a cryosurgical system, not an AI software/algorithm designed to assist human readers. Therefore, an MRMC study is not relevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

No. This device is a physical cryosurgical system, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable/Not provided pertaining to an algorithm's performance. For biocompatibility and safety, the "ground truth" is adherence to established standards (e.g., IEC, ASTM) and the FDA's prior clearances for the predicate materials and devices.

8. The sample size for the training set

Not applicable/Not provided. This submission does not describe an AI/machine learning component that would require a training set in the typical sense. The "modified software" mentioned simply involved removing a "stick" option, not a re-training of a predictive model.

9. How the ground truth for the training set was established

Not applicable/Not provided. As there is no described AI training set, there is no ground truth establishment method.

Summary

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K991792

510(k) Summary Influence, Inc.'s Cryo-Mono with TUF probe Cryogenic System 510(k) Number

Submitter's Name:

Peter A. Bick, M.D., President and CEO, Influence, Inc. 71 Stevenson Street, Suite 1120 San Francisco, California 94105 Telephone: 415-546-7700 / Fax: 415-546-7744

Trade Name:

Crvo-Mono Cryogenic System with TUF probe.

Classification Name:

Cryosurgical unit

Product Code:

GEH

Predicate Devices:

Galil Medical, Ltd.'s Cryo-Hit Cryogenic System, Endocare's CryoCare™ cryogenic system and Vidamed's TUNA system.

Intended Use and Indication for Use:

Influence, Inc.'s Cryo-Mono Cryogenic System and Galil Medical, Ltd.'s Cryo-Hit Cryogenic System are intended for cryogenic destruction of tissues during surgical procedures. They are indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurosurgery, thoracic surgery, ENT, gynecology, oncology, proctology, and urology for the ablation of tissue, including liver metastases, skin lesions, warts, and prostate tissues. Cryo-Mono with TUF probe is specifically indicated for the ablation of prostate tissue in cases of benign prostatic hyperplasia ("BPH").

Technological Characteristics:

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K991792

probe while with the Cryo-Hit, the physician has the option to use the "Stick" mode, which automatically adheres the probe to the tissue; (5) The Cryo-Mono with TUF probe has an optional foot pedal control; (6) The Cryo-Mono with TUF probe delivers preset amounts of argon for cooling while the Cryo-Hit adjusts the amount of argon delivered based on the tissue temperature measured by its thermocouples; (7) The Cryo-Mono with TUF probe's iceball size is monitored by transrectal ultrasound; the use of ultrasound, as well as external theromcouples, is optional with the Cryo-Hit; and (8) The Cryo-Mono's TUF probe is delivered transurethrally through a cystoscope rather than transperineally as with the Cryo-Hit.

The only modification to the device' s software was the removal of the "stick" option mentioned above.

The Cryo-Mono's single-use probes are within the range of probes that can be used with the Cryo-Hit, i.e. one to eight probes.

Performance Data:

The only component of the Cryo-Mono that comes into contact with the patient's body is its cryoprobe. The biocompatibility of the Cryo-Mono is based on FDA premarket clearance of the Cryo-Hit. Its components are made of the same materials, as the Cryo-Hit's probes and Impra's Venaflo™ vascular graft. Influence has certified to the Cryo-Mono's conformance with IEC 60601-1. IEC 60601-1-2 and ASTM F882-84.

Substantial Equivalence:

The Cryo-Mono has the same general intended use and virtually identical technological characteristics as the 510(k) cleared Cryo-Hit. The minor technological differences between these devices, namely, the Cryo-Mono smaller size, use of fewer probes, lack of a "stick" option, foot pedal, modified software, fewer gas cylinders and acceptance of a transurethral flexible probe do not raise any new questions of safety and effectiveness. Thus, the Cryo-Mono is substantially equivalent to a legally marketed cryosurgical device. The Cryo-Mono with TUF probe is substantially equivalent to EndoCare's CryoCare™ in terms of its technology and indication for use. The Cryo-Mono with TUF probe is substantially equivalent also to Vidamed's TUNA system in terms of its indication.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a symbol consisting of three stylized human profiles facing to the right, with flowing lines beneath them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1.2 1999

Influence, Inc. c/o Jonathan S. Kahan Hogan & Hartson 555 Thirteenth Street, N.W. Washington, D.C. 20004

Re: K991792

Trade Name: Cryo-Mono Cryogenic System with TUF Probe Regulatory Class: II Product Code: GEH Dated: May 23, 1999 Received: May 26, 1999

Dear Mr. Kahan:

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 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 (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 the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Jonathan S. Kahan

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 vour 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) 594-4595. 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 Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

Device Name:

Indications for Use:

Cryo-Mono Cryogenic System with TUF probe.

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

Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-off) Division of General and Restorative Devices

510(k) Number K991792

Prescription Use
(Per 21 CFR 801.109)

OR Over-The-Counter-Use

(Division Sign-Off) Division of General Re 510(k) Number

Regulation Number and Section

§ 878.4350 Cryosurgical unit and accessories.

(a)
Identification —(1)Cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories. A cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold.(2)
Cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories. A cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures, including urological applications, by applying extreme cold.(3)
Cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories. A cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold. The device is intended to treat disease conditions such as tumors, skin cancers, acne scars, or hemangiomas (benign tumors consisting of newly formed blood vessels) and various benign or malignant gynecological conditions affecting vulvar, vaginal, or cervical tissue. The device is not intended for urological applications.(b)
Classification. Class II.