CRYOSPRAY ABLATION SYSTEM, MODEL CC2-NAM

K072651 · CSA Medical, Inc. · GEH · Dec 7, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K072651
• Device Name: CRYOSPRAY ABLATION SYSTEM, MODEL CC2-NAM
• Applicant: CSA Medical, Inc.
• Product Code: GEH · General, Plastic Surgery
• Decision Date: Dec 7, 2007
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 878.4350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CryoSpray Ablation™ System is intended to be used as a cryosurgical tool for destruction of unwanted tissue in the field of qeneral surgery, specifically for endoscopic applications.

Device Story

CryoSpray Ablation System destroys unwanted tissue via extreme cold application. Liquid nitrogen stored in tank; propelled through cryocatheter to target site. System includes Nasal/Oral Gastric Tube for suction/venting. Physician performs procedure endoscopically under visual observation. Modified gastric tube features dual lumen design: one for active suction, one for passive venting. Device intended for general surgery applications. Benefits include precise tissue destruction via cryo-ablation.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Cryosurgical unit using liquid nitrogen. Accessory includes a dual-lumen Nasal/Oral Gastric Tube (active suction and passive venting). Operates via cryo-ablation (extreme cold). No software or electronic algorithms described.

Indications for Use

Indicated for destruction of unwanted tissue in general surgery, specifically endoscopic applications.

Regulatory Classification

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.

Predicate Devices

• SprayGenix™ Cryo Ablation System (K060555)
• CryoSpray Ablation System (K070893)
• CryMed Cryo-Ablator (K040809)

Submission Summary (Full Text)

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K072651

100 2

CryoSpray "Ablation System Abbreviated 510(k) Submission

DEC - 7 2007

## 510(k) Safety Summary

September 2007 Submitted by:

CSA Medical, Inc. Emerging Technology Center 1101 E. 33rd, Third Floor - #E305 Baltimore, MD 21218 O: 443.921.8053 Contact Person: Jennifer Cartledge, VP Development, CSA Medical, Inc. (Direct Contact Number 864.506.0097)

Name of Device

- . Trade Name: CryoSpray Ablation System
- Common Name: Cryosurgical Unit, Cryogenic Surgical Device .
- Cryosurgical unit with Liquid Nitrogen, Class II Classification: . [21 CFR § 878.4350(a)].
- Establishment Registration Number: � 9062377

Predicate Devices Device

## Premarket Notification

| SprayGenix™ Cryo Ablation System | K060555 |
|----------------------------------|---------|
| CryoSpray Ablation System | K070893 |
| CryMed Cryo-Ablator | K040809 |

Company History:

CSA Medical, Inc., formerly CryMed Technologies, Inc., received market clearance for the SprayGenix™ Cryo Ablation System (K060555). The name for the SprayGenix™ Cryo Ablation System was changed to the CryoSpray Ablation™ System as documented in the letter to file dated March 12, 2007.

Device Modification Description:

The CryoSpray Ablation™ System is used to destroy unwanted tissue by application of extreme cold to a selected site. Liquid Nitrogen is stored in a tank and then propelled through a cryocatheter to perform the cryo-ablation procedure. The catheter, an accessory component of the CSA System, is placed in the

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CryoSpray TM Ablation System Abbreviated 510(k) Submission

appropriate position through the use of visual observation. The cryo-catheter applies the cryogen to a selected area and freezes the unwanted tissue. The Nasal/Oral Gastric Tube detailed in the K060555 and K070893 submission is of a single lumen design, with suction ports spanning the distal 15 inches of the tube, allowing ports to be positioned in the esophagus and stomach simultaneously.

The only device modification presented in this Abbreviated 510(k) submission involves a tubing configuration modification for the Nasal/Oral Gastric Tube. The modified Nasal/Oral Gastric Tube is a dual lumen product with the addition of a vent lumen for the gastric section of the tube. While identical materials are used as compared to the Nasal/Oral Gastric Tube listed in submission K060555 and K070893, the dual lumen tubing allows one lumen to provide active suction while the second lumen provides passive venting in the gastric section. Refer to Attachments A.

Indications for Use:

The CryoSpray Ablation™ System is intended to be used as a cryosurgical tool for destruction of unwanted tissue in the field of qeneral surgery, specifically for endoscopic applications.

The intended use of the Nasal/Oral Gastric Tube, as described in its labeling, has not changed as a result of the configuration modification. Refer to Attachment C.

Technical Characteristics:

The modification to the Nasal/Oral Gastric Tube does not change the operating principals or mechanism of action for the CryoSpray Ablation System and it is substantially equivalent to the above listed predicate devices.

Summary:

Based on the principles of operation, design, materials and intended use, the modification to the Nasal/Oral Gastric Tube results in a CryoSpray Ablation™ System that is substantially equivalent to devices currently marketed in the United States.

Certification of Conformance Standard: Refer to Attachment 2.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

CSA Medical, Inc. % Mr. Tim Askew President & CEO 1101 E. 33rd Street, #E305 Baltimore, Maryland 21218

DEC - 7 2007

Re: K072651

Trade/Device Name: CryoSpray Ablation™ System Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical unit and accessories Regulatory Class: II Product Code: GEH Dated: November 8, 2007 Received: November 20, 2007

Dear Mr. Askew:

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 application (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 such 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.

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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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## Page 2 - Mr. Tim Askew

This letter will allow you to begin marketing your device as described in your Section 510(k) rms loter will and my your e FDA finding of substantial equivalence of your device to a legally promated 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark M Millican

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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CryoSpray TM Ablation System Abbreviated 510(k) Submission

## Indications for Use

510(k) Number (if known): __

DEVICE NAME: CryoSpray Ablation™ System

CSA Medical, Inc.

INDICATIONS FOR USE: The CryoSpray Ablation™ System is intended to be used as a cryosurgical tool for destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _X (per 21 CFR 801.109

Over-The-Counter Use***_***_

Sign-Ol Division of General, Restorative, and Neurological De

**510(k) Number** 1672657

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