SPRAYGENIX CRYO ABLATION SYSTEM

K060555 · Crymed Technologies, Inc. · GEH · Apr 21, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K060555
• Device Name: SPRAYGENIX CRYO ABLATION SYSTEM
• Applicant: Crymed Technologies, Inc.
• Product Code: GEH · General, Plastic Surgery
• Decision Date: Apr 21, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SprayGenix™ Cryo 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.

Device Story

SprayGenix™ Cryo Ablation System is a cryosurgical device used to destroy unwanted tissue via extreme cold. System components include an electronic console, cryo-catheter, nasal/oral gastric tube, and a liquid nitrogen cryogen delivery system. The operator positions the cryo-catheter at the target site under visual observation; liquid nitrogen is then propelled through the catheter to freeze and ablate the tissue. Used in clinical settings for endoscopic procedures. The device provides a therapeutic alternative to surgical resection for patients where resection is not indicated. Healthcare providers utilize the system to perform targeted tissue destruction, potentially reducing the need for invasive surgery.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, materials, and principles of operation consistent with predicate devices.

Technological Characteristics

Cryosurgical unit utilizing liquid nitrogen as the cryogen. System comprises an electronic console, cryo-catheter, and delivery tubing. Operates via controlled application of extreme cold to tissue. Class II device under 21 CFR 878.4350.

Indications for Use

Indicated for the destruction of unwanted tissue in general surgery, specifically for endoscopic applications where surgical resection is not indicated or as an alternative to resection.

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

• CryMed Cryo-Ablator (K040809)
• Wallach Surgical Devices WA1000 (K813024)
• Figitronics Cryo-Plus ™ (K811390)
• Figitronics Cryo-Surg™ System 5900 (K840536)
• Wallach Surgical Devices UltraFreeze (K935010)
• Cortex Technology's Cryopro Maxi and Cryopro Mini (K982280)
• CMS Cryolite (K970995)

Submission Summary (Full Text)

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## 510(k) Safety Summary

KOGOSSS

February 2006 Submitted by:

CryMed Technologies, Inc. CryMed Technologies, Inc. Emerging Technology Center 3225 Ellerslie Ave., Third Floor - #6311 Baltimore, MD 21218 0: 443.921.8053 Contact Person: Tim Askew, President CryMed Technologies, Inc.

Name of Device

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

Predicate Devices

| Device | Premarket Notification |
|------------------------------------------------------|------------------------|
| CryMed Cryo-Ablator | K040809 |
| Wallach Surgical Devices WA1000 | K813024 |
| Figitronics Cryo-Plus ™ | K811390 |
| Figitronics Cryo-Surg™ System 5900 | K840536 |
| Wallach Surgical Devices UltraFreeze | K935010 |
| Cortex Technology's Cryopro Maxi<br>and Cryopro Mini | K982280 |
| CMS Cryolite | K970995 |

Device Description

The SprayGenix™ Cryo Ablation System is a cryosurgical device. consisting of an electronic console, cryo-catheter, nasal/oral gastric tube and cryogen delivery system.

The SprayGenix™ Cryo 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 cryo-catheter to perform the cryo-ablation procedure. The catheter is placed in the appropriate position through the use of visual observation. The cryo-catheter applies the cryogen to a selected area and freezes the unwanted tissue. Cryosurgical procedures are

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used when surgical resection is not indicated, and may also provide an alternative to typical resection in certain cases.

Indications for Use
The SprayGenix™ Cryo 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.

# Technical Characteristics

The technology used by CryMed Technologies, Inc. is substantially equivalent to those of the above listed predicate devices.

### Summary

Based on the principles of operation, design, materials and intended use, the SprayGenix™ Cryo Ablation, design, matchans and in equillivant to devices currently marketed in the United States.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 1 2006

CryMed Technologies, Inc. c/o Mr. Tim Askew President Emerging Technology Center 3225 Ellerslie Avenue Third Floor - #B311 Baltimore, Maryland 21218

Re: K060555

Trade/Device Name: SprayGenix" Cryo Ablation Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical unit and accessories Regulatory Class: II Product Code: GEH Dated: February 24, 2006 Received: March 2. 2006

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 recicetions 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 Forte. Or to 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 TTT (The general controls provisions of the Act include requirements for annual registretiren. Until gol 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 devise can be found in the Code of Federal Regulations. Title 21, Parts 800 to 898. In addition, 127 max 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. Noumunst comply with all the Act's requirements, including, but not limited to: registrest and fitsting (21

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# Page 2 - Mr. Tim Askew

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. This letter will allow you to begin 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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsmamain.html

Sincerely yours.

elamae

Mar
Dir

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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# Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

DEVICE NAME: SprayGenix™ Cryo Ablation

CryMed Technologies, Inc.

INDICATIONS FOR USE:

The SprayGenix™ Cryo 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)

or Prescrition Use __X__ (per 21 CFR 801.109)

Over-The-Counter Use_

ell

(Division Sign-O Division of General, Restorative. and Neurological Devices

KOGOSS S 510(k) Number