Each proposed intended use description will have the letter (A ) which represents any of the family of AccuProbe® devices, the AccuProbe® 450, AccuProbe® 550/530 and the AccuProbe® 600 Series inclusive.

Urology

system may be used to ablate prostatic tissue. The (A) .
(A) system may be used for the ablation of prostate . The tissue in cases of prostate cancer and benign prostatic hyperplasia. 1

Oncology

system may be used for ablation of cancerous or ● The (A) malignant tissue.
system may be used for ablation of benign tumors. . The (A)
The (A) system may be used for palliative intervention.

Dermatology

. The (A) system may be used for the ablation or freezing of skin cancers and other cutaneous disorders.
Gynecology
The ● (A) system may be used for the ablation of malignant neoplasia or benign dysplasia of the female genitalia.

General Surgery

system may be used for the ablation of ● The (A) leukoplakia of mouth, angiomas, sebaceous hyperpalsia, basal cell tumors of the eyelid or canthus area, ulcerated basal cell tumors, dermatofibromas, small hemangiomas, mucocele cysts, multiple warts, plantar warts, hemorthoids, anal fissures, perianal condylomata, pilonidal cysts, actinic and sebortheic keratoses , cavernous hemangiomas, recurrent cancerous lesions.
system may be used for the destruction of warts The (A) . or lesions.
system may be used for the palliation of tumors ● (A) The of the oral cavity, rectum, breast, and skin.

Thoracic Surgery

system may be used for the ablation of . The (A) arthythmic cardiac tissue.
system may be used for the ablation of . The (A) cancerous lesions.

Proctology

system may be used for the ablation of benign or . The (A) malignant growths of the anus and rectum
systems may be used for the ablation of . (A) The hemorrhoids.

Device Description

Cryosurgical Units, Cryogenic Surgical Device. Console with multiple ports and spray/closed probes.

AI/ML Overview

This is a 510(k) premarket notification for a Class II medical device, the Cryomedical Sciences (CMS) AccuProbe cryosurgical unit. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than on providing extensive clinical performance data showing a device meets specific numeric acceptance criteria.

The 510(k) summary provided does not contain the kind of detailed acceptance criteria and performance study data typically found in clinical trials for novel devices with specific performance metrics (e.g., sensitivity, specificity, accuracy). Instead, it focuses on comparing the proposed device's intended use and characteristics to existing, legally marketed predicate devices. Therefore, many of the requested elements for acceptance criteria and study design are not applicable in this context.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission asserting substantial equivalence, there isn't a table of discrete, pre-defined quantitative acceptance criteria and corresponding reported performance metrics (e.g., sensitivity > 90%). The "acceptance criteria" for a 510(k) is primarily the demonstration of substantial equivalence in terms of intended use, technological characteristics, and safety/effectiveness as compared to predicate devices.

The document states: "The company believes that its CMS AccuProbe® device's original predicate devices and other legally marketed cryosurgical devices... are substantially equivalent for intended use and advertisement."

The "performance" is implicitly demonstrated through the device's technological characteristics (Console with multiple ports and spray/closed probes, Liquid nitrogen cryogen) being comparable to the listed predicate devices in Section {1}. The "intended use" is also compared through specific predicate device citations for each proposed use (e.g., Urology, Oncology, Dermatology, etc.) in Sections {2}, {3}, {4}, {7}, and {8}.

The FDA's decision in Section {5} confirms this: "We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..."

Key "Acceptance Criterion" Implicit in a 510(k): The device must be deemed "substantially equivalent" to one or more predicate devices as defined by the Federal Food, Drug, and Cosmetic Act.

Reported Device Performance: Not applicable in the sense of quantitative metrics from a performance study. The performance is implied to be equivalent to that of the predicate devices for their respective indications.

2. Sample size used for the test set and the data provenance

Not Applicable. This 510(k) submission does not include a performance study on a test set in the traditional sense of evaluating diagnostic accuracy or clinical outcomes with a specific sample size. The submission focuses on comparing the device's design and intended uses to predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. No ground truth was established by experts for a test set in this submission. The "ground truth" for the substantial equivalence claim relies on the legal marketing and established safety/effectiveness of the predicate devices.

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

Not Applicable. There was no test set requiring adjudication in this submission.

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

Not Applicable. This device is a cryosurgical unit, not an AI-assisted diagnostic or imaging device, and therefore, an MRMC study is irrelevant to this submission.

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

Not Applicable. This is a hardware cryosurgical device, not a standalone algorithm.

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

Implicit Ground Truth: The "ground truth" for this 510(k) submission is the established safety and effectiveness of the legally marketed predicate devices for their respective indications. The applicant is asserting that their device is sufficiently similar to these predicates that it can be considered equally safe and effective for the same indications.

8. The sample size for the training set

Not Applicable. This is not a machine learning or AI device that requires a training set.

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

Not Applicable. As there is no training set for this type of device, this question is not relevant.

Summary of the 510(k) Process Reflected in the Document:

The provided document describes a 510(k) submission for a cryosurgical device. The primary "study" involved here is a comparison study where the applicant details the technological characteristics and proposed indications for use of their AccuProbe device family against those of legally marketed predicate cryosurgical devices.

The acceptance (clearance) decision by the FDA is based on the determination that the AccuProbe devices are substantially equivalent to the identified predicate devices, particularly regarding their intended uses in Urology, Oncology, Dermatology, Gynecology, General Surgery, Thoracic Surgery, and Proctology.

A notable point in the "Dear Dr. Reinhart" letter (Section {5} and {6}) is that the FDA did not accept an indication for "cryoablation of the endometrium," stating it "raises new types of safety and effectiveness questions" and would require a Premarket Approval Application (PMA). This highlights that even in a 510(k), if an indication is deemed to significantly differ from predicates or raise new questions, substantial equivalence may not be found.

Summary

{0}------------------------------------------------

K973190 NOV 2 | 1997

510(k) SUMMARY

August 19, 1997

Submitted by:

Cryomedical Sciences, Inc. 1300 Piccard Drive Suite L105 Rockville, Maryland 20850 (301) 417-7070 Fax (310) 417-7077

Contact:

Richard J. Reinhart, Ph.D. President and CEO or Susan Hayes Regulatory Affairs

Proprietary name: CMS AccuProbe® Models 450, 550/530 and 600 Series

Common name: Cryosurgical Units, Cryogenic Surgical Device

Cryosurgical units with Liquid Nitrogen, Class II [2] CFR § Classification: 878.4350(a).

The sole purpose of this submission is to augment the labeling and advertisements which describe intended use of the CMS AccuProbe device family, the AccuProbe® 450, the AccuProbe® 550/530 and the AccuProbe® 600 Series.

The company believes that its CMS AccuProbe® device's original predicate devices and other legally marketed cryosurgical devices, listed below, are substantially equivalent for intended use and advertisement.

{1}------------------------------------------------

CMS Cryosurgical Device Family Comparison With Other Cryosurgical Devices

Cryosurgical Device	Type of System	Cryogen Used
CMS AccuProbe® Systems	Console with multiple ports andspray/closed probes	Liquid nitrogen
Frigitronics Model ZacarianC-21and Cryo-Surg	Hand-held body with spray probes only forC-21 and spray and closed probes for theCryo-Surg	Liquid nitrogen
Frigitronics ModelsCM-73 and CT -82	Hand-held body andclosed probes	Nitrous oxide
Frigitronics Model CE-4G*	Console with single port and closed probes	Liquid nitrogen
Frigitronics ModelsCS-76 and CE-8	Console with single port and closed andspray probes	Liquid nitrogen
ERBE Erbokryo*	Console and single probe	Liquid nitrogen
Candela Cryotech ModelsLCS 2000 and 3000	Console with multiple ports and spray andclosed probes	Liquid nitrogen
Brymill CorporationKryospray	Hand-held spray	Liquid nitrogen
Physicians Products, Inc.	Spray container	Liquid nitrogen
Spembly Medical 130Cryounit	Console with single port and spray andclosed probes	Liquid nitrogen
Cabot Medical's ModelsMT-700, MT750, FT-350and MC-8000	Hand-held system with single probe port	Nitrous oxide withchoice of N20 andCO2 in Model MT750

*Original predicate device to the CMS AccuProbe® device family

{2}------------------------------------------------

The following is the purposed intended use statements with predicate device citations noted:

Urology

system may be used to ablate prostatic tissue. The (A) .
system may be used for the ablation of prostate . The (A) tissue in cases of prostate cancer and benign prostatic hyperplasia.

(Candela/Cryotech LCS 3000 at Tab F)

(ERBE Erbokryo models NL, PS, PSC(T) and PSC Super at Tab E*)

(Candela Press Release dated April 8, 1996 at Tab F)

Oncology

system may be used for ablation of cancerous or The (A) . malignant tissue.
system may be used for ablation of benign The (A) = . tumors.
system may be used for palliative intervention. . The (A)

(Candela/Cryotech LCS 3000 at Tab F)

(Spembly Medical 130 Cryounit at Tab I)

Dermatology

system may be used for the ablation or freezing of . The (A) skin cancers and other cutaneous disorders.
(ERBE Erbokryo models NL, PS, PSC(T) and PSC Super at Tab E*)

(Frigitronics Cryo-Surg at Tab J )

(Spembly Medical 130 Cryounit at Tab I)

Page 3 of 5

{3}------------------------------------------------

Gynecology

system may be used for the ablation of . The (A) malignant neoplasia or benign dysplasia of the female genitalia.
(ERBE Erbokryo models NL, PS, PSC(T) and PSC Super at Tab E*)

General Surgery

(A) system may be used for the ablation of . The leukoplakia of mouth, anaiomas, sebaceous hyperpalsia, basal cell tumors of the eyelid or canthus area, ulcerated basal cell tumors, dermatofibromas, small hemangiomas, mucocele cysts, multiple warts, plantar warts, hemorrhoids, anal fissures, peri-anal condylomata, pilonidal cysts, actinic and seborrheic keratoses , cavernous hemanaiomas, recurrent cancerous lesions.
system may be used for the destruction of warts . The (A) or lesions.
system may be used for the palliation of turnors . The The (A) of the oral cavity, rectum, breast, and skin.

(Brymil Corporation at Tab H)

Thoracic Surgery

. The (A) system may be used for the ablation of arrhythmic cardiac tissue.

(Cooper Surgical Cardiovascular cryosurgical system CCS-1at Tab L)

{4}------------------------------------------------

Proctology

system may be used for the ablation of benign or The . (A) malignant growths of the anus and rectum
systems may be used for the ablation of . (A) The hemorrhoids.

(ERBE Erbokryo m models NL, PS, PSC(T) and PSC Super at Tab E*)

(Frigitronics/CooperVision Systems at Tab J)

- Original predicate of CMS AccuProbe device family.

{5}------------------------------------------------

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure, represented by three overlapping profiles, with a flowing, ribbon-like design below them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Richard J. Reinhart, Ph.D. President and CEO Cryomedical Sciences, Incorporated 1300 Piccard Drive, Suite L105 Rockville, Marvland 20850

NOV 2 1 1997

Re: K973190

Trade Name: AccuProbe® 450, AccuProbe® 550/530 and The AccuProbe® 600 Series Regulatory Class: II Product Code: GEI Dated: August 19, 1997 Received: August 25, 1997

Dear Dr. Reinhart:

We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are 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 devices, 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.

Please be advised that this substantial equivalence determination does not include an indication for cryoablation of the endometrium. The use of cryosurgery for endometrial ablation raises new types of safety and effectiveness questions when compared to currently identified predicate devices used for this purpose and therefore will require submission of a premarket approval application (PMA) to market for this indication.

Since, no data has been developed to establish the safety and effectiveness of this cryosurgical device for endometrial ablation, you may not market or promote such use until you have submitted such data and received clearance or approval for this claim.

{6}------------------------------------------------

Page 2 - Richard J. Reinhart, Ph.D.

If your devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices 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 requirements , as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. In addition, FDA may publish further announcements concerning your devices in the Federal Register. Please note: this response to your premarket notification submissions 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.

This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.

If you desire specific advice for your devices 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 devices, 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

{7}------------------------------------------------

Indications for Use

Urology

system may be used to ablate prostatic tissue. The (A) .
(A) system may be used for the ablation of prostate . The tissue in cases of prostate cancer and benign prostatic hyperplasia. 1

Oncology

system may be used for ablation of cancerous or ● The (A) malignant tissue.
system may be used for ablation of benign tumors. . The (A)
The (A) system may be used for palliative intervention.

Dermatology

. The (A) system may be used for the ablation or freezing of skin cancers and other cutaneous disorders.

Gynecology

The ● (A) system may be used for the ablation of malignant neoplasia or benign dysplasia of the female genitalia.
Prescription Use
(Per 21 CFR 801.109)

Division Sign-Off

(Division Sign-Off) (Division of General Restorative Devices 510(k) Number

{8}------------------------------------------------

Indications for Use

(continued for CMS AccuProbe® device family)

General Surgery

system may be used for the ablation of ● The (A) leukoplakia of mouth, angiomas, sebaceous hyperpalsia, basal cell tumors of the eyelid or canthus area, ulcerated basal cell tumors, dermatofibromas, small hemangiomas, mucocele cysts, multiple warts, plantar warts, hemorthoids, anal fissures, perianal condylomata, pilonidal cysts, actinic and sebortheic keratoses , cavernous hemangiomas, recurrent cancerous lesions.
system may be used for the destruction of warts The (A) . or lesions.
system may be used for the palliation of tumors ● (A) The of the oral cavity, rectum, breast, and skin.

Thoracic Surgery

system may be used for the ablation of . The (A) arthythmic cardiac tissue.
system may be used for the ablation of . The (A) cancerous lesions.

Proctology

system may be used for the ablation of benign or . The (A) malignant growths of the anus and rectum
systems may be used for the ablation of . (A) The hemorrhoids.

Prescription Use
(Per 21 CFR 801.109)

(Division Sign-Off)
Division of General Restorative Devices
blumber
14973190

510(k) Number .

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.