CRYOSUCCESS, MODEL C-SUC-01, C-SUC-02, C-DTS-02, C-DTS-03, C-GTS-13. C-CA-23

K091721 · New Medical Technologies GmbH · GEH · Oct 2, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K091721
• Device Name: CRYOSUCCESS, MODEL C-SUC-01, C-SUC-02, C-DTS-02, C-DTS-03, C-GTS-13. C-CA-23
• Applicant: New Medical Technologies GmbH
• Product Code: GEH · General, Plastic Surgery
• Decision Date: Oct 2, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4350
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

To destroy tissue during surgical procedures by applying extreme cold.

Device Story

Hand-held cryosurgical instrument; uses liquid nitrous oxide (N2O) stored in 23.5g cartridges at ~50 bar pressure. Operates by delivering liquid N2O through a capillary tube to a cryotip; phase transition causes evaporation at the treatment site, achieving a constant temperature of -89°C. Physician-operated; flow controlled by a manual lever. Used in clinical settings for tissue necrosis. Benefits include precise, controlled destruction of target tissue. Device body constructed of brass and stainless steel (gold-plated); cryotips made of borosilicate glass 3.3. No electronic components or software.

Clinical Evidence

Bench testing only. The device was evaluated against requirements in ASTM F 882-84 (2002) and manufacturer-specified performance criteria. No clinical data provided.

Technological Characteristics

Hand-held cryosurgical unit. Materials: brass, gold-plated stainless steel, borosilicate glass 3.3 (DURAN), thermoplastic rubber, PTFE, and acrylonitrile-butadiene-rubber seals. Energy source: pressurized N2O gas (50 bar). Principle: phase transition/evaporation of liquid N2O at -89°C. Connectivity: none. Sterilization: steam sterilization (134°C) for tips; alcohol-based disinfection for body. Mechanical operation only.

Indications for Use

Indicated for the destruction of tissue during surgical procedures via extreme cold application. Applicable to any patient regardless of age or gender. Must be performed by medically trained specialists.

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

• CryoProbe (K024009)

Submission Summary (Full Text)

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# 5 510(k) Summary

In accordance with 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.

## Submitter Information / Official Correspondent:

| Submitter name: | New Medical Technologies GmbH | |
|---------------------|-------------------------------|--------------|
| Responsible person: | Adrian B. Joss | OCT - 2 2009 |
| Phone: | [phone] | |
| Fax: | [phone] | |
| Mailto: | [e-mail] | |

#### US Agent:

| United States<br>contact address: | Premier Dental Products, 1710 Romano Drive, Plymouth Meeting,<br>PA 19462 U.S.A. |
|-----------------------------------|----------------------------------------------------------------------------------|
| United States<br>contact person: | Vince d'Alessandro |
| Phone: | [phone] |
| Fax: | [phone] |
| Mailto: | [e-mail] |
| Date prepared: | May 27, 2009 |

#### Device Name:

| Proprietary name: | CRYOSUCCESS |
|----------------------|------------------------------------------------------|
| 510(k) number: | K091721 |
| Common name: | cryosurgery unit |
| Classification name: | 878.4350 Unit, cryosurgery and accessories, Class II |
| Product code: | GEH |

#### Predicate Device:

Substantial Equivalence is claimed with the device, K024009 "CryoProbe", manufactured by H&O Equipments NV/SA on the basis of equivalent intended use / indications for use, technological characteristics and principle of operation.

#### Device Description:

The CRYOSUCCESS is a hand-held cryosurgical instrument for destroying tissue during surgical procedures by applying cold gas (nitrous oxide, N₂O). The device is based on direct application of nitrous oxide in the liquid phase to the selected treatment area. The N₂0 gas is delivered to the treatment site at -89° C to effect cellular destruction (necrosis).

CRYOSUCCES functions by means of heat evaporation upon phase transition, where liquid nitrous oxide (N₂O, laughing gas) is applied to the treatment area by means of a capillary tube at

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a constant temperature of -89°C (cold performance) followed by evaporation. The treatment may be invasive.

In general any person may be treated, irrespective of gender or age. The treatment must be performed by medically trained specialists.

#### Intended Use:

To destroy tissue during surgical procedures by applying extreme cold.

## Comparison of Technological Characteristics:

Table 05-1 provides a comparison of the predominant technical characteristics of the new device and the legally marketed predicate device. A more detailed comparison of the devices is presented in section 12-A.

| Characteristic | Predicate Device | Device Under Evaluation |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | CryoProbe | CRYOSUCCESS |
| Models | CryoProbe c, 1 micro-applicator<br>(information not clear) | Standard tip ( $Ø$ = 1mm) |
| | CryoProbe x, 3 micro-applicators | Standard tip ( $Ø$ = 2mm) |
| | | Standard tip ( $Ø$ = 3mm) |
| | | Standard tip ( $Ø$ = 4mm) |
| | | Gynecology tip |
| 510(k) Number | K024009 | K091721 |
| Cryogen | Nitrous oxide (N2O, laughing gas),<br>available in 8 g or 16 g cartridges | Nitrous oxide (N2O, laughing gas),<br>available in 23,5 g cartridge |
| | Cartridge Pressure: ~50 bar (725 psi) | Cartridge Pressure: 50 bar (725 psi) |
| | Shelf life: 2 years | Shelf life: 2 years |
| Shelf life<br>(device) | 2 years | 5 years (with 2 years warranty) |
| Treatment<br>temperature | Temperature: Depending on<br>distance of device to lesion,<br>minimum -89°C at contact to lesion | Temperature: constant temperature<br>of -89°C (-128° F) at contact to lesion |
| Materials | Housing: aluminum | Cryo unit (no housing): brass and<br>stainless steel, gold plated |
| | Micro-applicator: unknown | Cryotip: metal, gold plated, cryotip in<br>borosilicate glass 3.3 (such as<br>DURAN) |
| | Lock cap: unknown | Protective cap: thermoplastic rubber |
| | Filter: unknown | Filter: stainless steel |
| | O-rings: unknown | Seals: PTFE and acrylonitrile-<br>butadiene-rubber |
| | Cartridge: metal | Cartridge: metal |
| Operating<br>Principle | The patented principle of the<br>CryoProbe™ is based upon the direct<br>flow of N₂O in liquid phase for the<br>purpose of freezing with resulting<br>necrosis of tissue in the practice of<br>medicine. To achieve this<br>phenomena a economical gas<br>cartridge is used. The cartridge is<br>filled with liquid N₂O (83%) and the<br>rest with N₂O gas. The liquid N20 is<br>the refrigerant and the N₂O gas is<br>the propellant.<br>The innovation of the CryoProbe™ is<br>the ability to achieve a constant flow<br>of liquid N₂O out of the micro-<br>applicator tip. This is made possible<br>by maintaining the pressure level<br>within the instrument until the liquid<br>N₂O leaves the tip of the micro-<br>applicator, whereupon it will<br>immediately expand. | CRYOSUCCESS functions by means of<br>heat evaporation upon phase<br>transition, where liquid nitrous oxide<br>(N₂O, laughing gas) is applied to the<br>treatment area by means of a<br>capillary tube at a constant<br>temperature of -89°C (cold<br>performance) followed by<br>evaporation. This results in cellular<br>destruction (necrosis) in the<br>treatment area. The amount of gas<br>dispensed is controlled by the<br>medical specialist pressing the lever<br>of the device. |
| Cleaning /<br>Sterilization | All external parts can be wiped with<br>a cloth soaked in any non-corrosive<br>sterilization solution or alcohol /<br>Whole CryoProbe may be autoclaved | The unit body and cryotips can been<br>cleaned and disinfected with a<br>alcohol-based disinfectant or alcohol<br>/ Steam sterilize tips at 134° C<br>(273° F), according to the instruction<br>in the manual of your steam sterilizer<br>and according to the country specific<br>law |
| Storage | Store in a cool dry place and keep<br>out of the reach of children | Protect the unit against heat and<br>exposure to direct sunlight. The<br>storage temperature is between<br>-10° C and max. +45° C (14° F and<br>max. 113° F). |
| Maintenance | Change filter with each cartridge,<br>exchange o-rings after frequent<br>autoclaving | No maintenance required, repairs<br>may only be executed by a licensed<br>wholesaler / representative |

### Table 05-1: Comparison of Technological Characteristics

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## Summary of Testing:

The relevant requirements set forth in standard ASTM F 882-84 (2002) and the additional requirements specified by the manufacturer are sufficient to assure a safe and effective functioning of the CRYOSUCCESS cryosurgery device. The device has fulfilled the requirements detailed above. The results of the bench testing are summarized in the V&V Plan & Report CRYOSUCCESS enclosed.

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## Conclusion:

Based on equivalence of intended use / indications for use, technological characteristics and operational principle the applicant concludes, that substantial equivalence between the new and the predicate device has been demonstrated and that the new device, CRYOSUCCESS, is at least as safe and as effective as the legally marketed predicate device, CryoProbe (K024009).

Section 5: 510(k) Summary

.

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

New Medical Technologies, GmbH % Premier Dental Products Mr. Vince D'Alessandro 1710 Romano Drive Plymouth Meeting, Pennsylvania 19462

OCT - 2 2009 -

Re: K091721

Trade/Device Name: Cryosuccess Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical unit and accessories Regulatory Class: Class II Product Code: GEH Dated: May 27, 2009 Received: June 11, 2009

Dear Mr. D'Alessandro:

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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Vince D'Alessandro

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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,

incerely yours.

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

Enclosure

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## Indications for Use Statement

510(k) Number (if known): K091721

Device Name:

CRYOSUCCESS

Indications for Use:

To destroy tissue during surgical procedures by applying extreme cold.

Prescription Use _ × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nilpeal for men

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K091721