The CMS AccuProbe® 800 Series (all models depicted as A) has the same indications for use as its predicate device, the AccuProbe® 600 Series [510(k) number K973190 cleared November 21, 1997].

Urology

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

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

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

Gynecology

system may be used for the ablation of malignant . The (A) neoplasia or benign dysplasia of the female genitalia.

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, perianal condylomata, pilonidal cysts, actinic and seborrheic keratoses , cavernous hemanaiomas recurrent cancerous lesions.
. The (A) system may be used for the destruction of warts or lesions.
. The (A) system may be used for the palliation of tumors of the oral cavity, rectum, and skin.

Thoracic Surgery

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

Proctology

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

Device Description

The CMS AccuProbe® 800 Series consists of eight models, each of which has two components: i) a console with a pumping mechanism to compress and pressurize the cryogen and ii) one to eight (models 810 through 880) cryoprobes with tips extending from the console. The may include an optional on-board computer which is as redundant display system and archival system to store information about the procedure. The computer does not control or affect the operation of the cryoprobes in any fashion. The cryoprobes consist of interchangeable tips of various materials, sizes and shapes which are used a necessary.

The AccuProbe® 800 Series is used to destroy unwanted tissue by the application of extreme cold to the selected site. Liquid nitrogen is forced through the cryoprobes under pressure. The cryoprobe, having been placed in the appropriate position through the used of utlrasound or other imaging device, then becomes cold and freezes the unwanted tissue. The procedure may be monitored in real-time through the use of imaging modes such as ultrasound, Once the freezing is completed (approximately 20 minutes), the cryoprobe will be heated using warming gas in order to facilitate thawing and removal of the cryoprobe from the frozen tissue.

AI/ML Overview

This 510(k) submission describes a cryosurgical unit, the CMS AccuProbe® 800 Series, and states its substantial equivalence to a previously cleared device, the AccuProbe® 600 Series. The provided document focuses on comparing the features of the new device to the predicate device and listing its indications for use.

No information regarding acceptance criteria, device performance metrics, or study design (including sample size, ground truth establishment, expert qualifications, or adjudication methods) is present in the provided text. The 510(k) process for this type of device typically relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring new clinical performance studies with predefined acceptance criteria.

Therefore, I cannot provide the requested information from the given text.

Here's what can be extracted based on the document's content:

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

Not provided. The document does not define acceptance criteria or report specific performance metrics for the CMS AccuProbe® 800 Series against such criteria. It instead focuses on comparing features to a predicate device.

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

Not provided. No test set or corresponding data provenance is mentioned as part of this 510(k) submission.

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 provided. No ground truth establishment experts are mentioned.

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

Not provided. No adjudication method is mentioned.

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-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study with AI assistance is not relevant.

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

Not applicable. This device is a cryosurgical unit, not a standalone algorithm.

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

Not provided. No specific ground truth related to performance evaluation is mentioned. The submission relies on substantial equivalence to a predicate device for its safety and effectiveness claims.

8. The sample size for the training set

Not applicable / Not provided. As this is a physical medical device (cryosurgical unit) and not an AI/software algorithm requiring a training set, the concept of a "training set sample size" does not apply in this context.

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

Not applicable / Not provided. As there is no training set mentioned, there is no discussion of how ground truth was established for it.

Summary

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

8 1998 SEb

K982055

510(k) SUMMARY

June 11, 1998 Submitted by:

ﻤﺼﻨﻌﺔ

Contact:

Richard J. Reinhart, Ph.D. President and CEO

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

Proprietary name: CMS AccuProbe® Models 810, 820, 830, 840, 850, 860, 870, and 880

Common name: Cryosurgical units and accessories

Cryosuraical units with Liquid Nitrogen, Nitrous Oxide, Carbon Classification: Dioxide, Class II, under CFR § 878.4350. Under CFR § 882.4250 a cryogenic surgical device also is classified in Class II.

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

monitored in real-time through the use of imaging modes such as ultrasound, ﻤﺴﺴﺴﺴﺴﺴﺴﺴ Once the freezing is completed (approximately 20 minutes), the cryoprobe will be heated using warming gas in order to facilitate thawing and removal of the cryoprobe from the frozen tissue.

Image /page/1/Figure/1 description: The image shows the text "Page 2 of 3". This indicates that the image is a page from a document, specifically page 2 of a 3-page document. The text is written in a simple, clear font and is likely a page number indicator.

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

COMPARISON OF FEATURES BETWEEN THE AccuProbe® 600 Series [CLEARED 510(k) (K964336)] AND THE AccuProbe® 800 SERIES

FEATURES	AccuProbe® 600 Series	AccuProbe® 800 SERIES
Liquid NitrogenCapacity(Dewar size)	Model 610 15 litersModel 620 25 litersModel 630 40 litersModel 640 55 litersModel 650 70 litersModel 660 85 litersModel 670 100 litersModel 680 115 liters	Model 810 25 litersModel 820 25 litersModel 830 25 litersModel 840 35 litersModel 850 35 litersModel 860 45 litersModel 870 45 litersModel 880 45 liters
Normal OperatingPressure	65psi	65psi
Regen/recirculatingtime	Two minutes	Less than 10 seconds
Regen mode	Depressurizes the supplydewar and pressurizes thereturn dewar (this allowscapture of LN2 to flow fromthe return dewar through thecryoprobe and back to thesupply dewar)	The LN2 return line from thecryoprobe feeds directly intothe LN2 supply
Dimensions	Model 610 45"x24"x29"Model 620 49"x24"x29"Model 630 52"x24"x29"Model 640 52"x24"x29"Model 650 54"x28"x32"Model 660 54"x30"x34"Model 670 54"x32"x34"Model 680 54"x32"x34"	Model 810 38"x24"x24"Model 820 38"x24"x24"Model 830 38"x24"x24"Model 840 38"x24"x24"Model 850 38"x26"x26"Model 860 38"x26"x26"Model 870 38"x26"x26"Model 880 38"x26"x26"
Operation	Uses a three dewar system	Uses a one dewar system
Warming Gas	Nitrogen Gas	Nitrogen Gas

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with flowing lines, representing a sense of movement or progress. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

FEB 2 1 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Cryomedical Sciences, Inc. c/o Mr. Richard J. Reinhart, Ph.D President and CEO 1300 Piccard Drive, Suite L105 Rockville, MD 20850

Re: K982055

Trade Name: Accuprobe 800 Series Model Numbers: 810, 820, 830, 840, 850, 860, 870 and 880 Regulatory Class: II (two) Product Code: OCL. GEH Dated: June 11, 1998 Received: June 11, 1998

Dear Dr. Reinhart:

This letter corrects our substantially equivalent letter of September 8, 1998.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval (PMA). 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to continue marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

eempe.

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Indications For Use

The CMS AccuProbe® 800 Series (all models depicted as A) has the same indications for use as its predicate device, the AccuProbe® 600 Series [510(k) number K973190 cleared November 21, 1997].

Urology

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

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

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

Gynecology

system may be used for the ablation of malignant . The (A) neoplasia or benign dysplasia of the female genitalia.
ccer

Prescription Use
(Per 21 CFR 801.109)

(Division Sign-Off
Division of General Restorative Devices K982055
510(k) Number

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

Indications for Use

(continued for CMS AccuProbe® device family)

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, perianal condylomata, pilonidal cysts, actinic and seborrheic keratoses , cavernous hemanaiomas recurrent cancerous lesions.
. The (A) system may be used for the destruction of warts or lesions.
. The (A) system may be used for the palliation of tumors of the oral cavity, rectum, and skin.

Thoracic Surgery

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

Proctology

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

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K982655

Prescription Use
(Per 21 CFR 801.109)

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.