ACCUPROBE 450, ACCUPROBE 550/530 AND THE ACCUPROBE 600 SERIES

K973190 · Cryomedical Sciences, Inc. · GEI · Nov 21, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K973190
• Device Name: ACCUPROBE 450, ACCUPROBE 550/530 AND THE ACCUPROBE 600 SERIES
• Applicant: Cryomedical Sciences, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Nov 21, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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. The (A) system may be used for ablation of cancerous or malignant tissue. The (A) system may be used for ablation of benign tumors. The (A) system may be used for palliative intervention. The (A) system may be used for the ablation or freezing of skin cancers and other cutaneous disorders. The (A) system may be used for the ablation of malignant neoplasia or benign dysplasia of the female genitalia. The (A) system may be used for the ablation of 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, hemorrhoids, anal fissures, perianal condylomata, pilonidal cysts, actinic and seborrheic keratoses, cavernous hemangiomas, 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, breast, and skin. The (A) system may be used for the ablation of arrhythmic cardiac tissue. The (A) system may be used for the ablation of cancerous lesions. The (A) system may be used for the ablation of benign or malignant growths of the anus and rectum. The (A) system may be used for the ablation of hemorrhoids.

Device Story

CMS AccuProbe® (Models 450, 550/530, 600) are cryosurgical units utilizing liquid nitrogen as a cryogen. Systems consist of a console with multiple ports supporting spray or closed probes. Operated by physicians in clinical settings to achieve tissue ablation via extreme cold. Device delivers cryogen to target site; freezing causes cellular destruction of malignant or benign tissue. Output is physical tissue necrosis; healthcare providers monitor procedure to control depth/extent of ablation. Benefits include minimally invasive destruction of lesions, tumors, or arrhythmic cardiac tissue.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on comparison of intended use, technological characteristics, and design to legally marketed predicate devices.

Technological Characteristics

Cryosurgical console system; liquid nitrogen cryogen; multiple ports; spray and closed probe configurations. Class II device per 21 CFR 878.4350(a).

Indications for Use

Indicated for patients requiring cryoablation of benign or malignant tissues across urology (prostate cancer, BPH), oncology (tumors), dermatology (skin cancers, cutaneous disorders), gynecology (genital neoplasia/dysplasia), general surgery (various lesions, warts, cysts, hemorrhoids), thoracic surgery (arrhythmic cardiac tissue, cancerous lesions), and proctology (anal/rectal growths, hemorrhoids). Prescription use only.

Regulatory Classification

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.

Predicate Devices

• ERBE Erbokryo models NL, PS, PSC(T) and PSC Super (K973190)
• Frigitronics Model CE-4G (K973190)

Reference Devices

• Frigitronics Model Zacarian C-21
• Frigitronics Cryo-Surg
• Frigitronics Models CM-73 and CT-82
• Frigitronics Models CS-76 and CE-8
• Candela Cryotech Models LCS 2000 and 3000
• Brymill Corporation Kryospray
• Physicians Products, Inc. Spray container
• Spembly Medical 130 Cryounit
• Cabot Medical Models MT-700, MT750, FT-350 and MC-8000
• Cooper Surgical Cardiovascular cryosurgical system CCS-1

Submission Summary (Full Text)

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

# K973190 NOV 2 | 1997

# 510(k) SUMMARY

August 19, 1997

#### Submitted by:

Cryomedical Sciences, Inc. 1300 Piccard Drive Suite L105 Rockville, Maryland 20850 [phone] Fax [phone]

#### 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 and<br>spray/closed probes | Liquid nitrogen |
| Frigitronics Model Zacarian<br>C-21and Cryo-Surg | Hand-held body with spray probes only for<br>C-21 and spray and closed probes for the<br>Cryo-Surg | Liquid nitrogen |
| Frigitronics Models<br>CM-73 and CT -82 | Hand-held body and<br>closed probes | Nitrous oxide |
| Frigitronics Model CE-4G* | Console with single port and closed probes | Liquid nitrogen |
| Frigitronics Models<br>CS-76 and CE-8 | Console with single port and closed and<br>spray probes | Liquid nitrogen |
| ERBE Erbokryo* | Console and single probe | Liquid nitrogen |
| Candela Cryotech Models<br>LCS 2000 and 3000 | Console with multiple ports and spray and<br>closed probes | Liquid nitrogen |
| Brymill Corporation<br>Kryospray | Hand-held spray | Liquid nitrogen |
| Physicians Products, Inc. | Spray container | Liquid nitrogen |
| Spembly Medical 130<br>Cryounit | Console with single port and spray and<br>closed probes | Liquid nitrogen |
| Cabot Medical's Models<br>MT-700, MT750, FT-350<br>and MC-8000 | Hand-held system with single probe port | Nitrous oxide with<br>choice of N20 and<br>CO2 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 [phone]. Additionally, for questions on the promotion and advertising of your devices, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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.
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 .