D.O.R.C. CRYOSTAR CRYOSURGICAL SYSTEM

K012821 · Dutch Ophthalmic USA, Inc. · HRN · Oct 22, 2001 · Ophthalmic

Device Facts

• Record ID: K012821
• Device Name: D.O.R.C. CRYOSTAR CRYOSURGICAL SYSTEM
• Applicant: Dutch Ophthalmic USA, Inc.
• Product Code: HRN · Ophthalmic
• Decision Date: Oct 22, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4170
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The D.O.R.C. Harmony CryoStar Cryosurgical System is a surgical system for ophthalmic surgery intended for use in surgery of the posterior segment or anterior segment including cryopexy for retinal detachment, glaucoma, cataract extraction, trichiasis, and retinopathy of prematurity.

Device Story

D.O.R.C. CryoStar Cryosurgical System is an AC-powered ophthalmic cryosurgical unit. System components include a console, cryogen gas bottle (nitrous oxide or carbon dioxide), ophthalmic probe, and footswitch. Console controls gas delivery to the probe; processes footswitch signals to initiate freeze/defrost cycles. Used in clinical settings by ophthalmic surgeons for procedures including retinal detachment, glaucoma, cataract extraction, trichiasis, and retinopathy of prematurity. Provides digital timer, LED pressure, and temperature displays to assist surgeon monitoring. Enables controlled tissue freezing for therapeutic benefit.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and operational comparison to predicate devices.

Technological Characteristics

Electro-mechanical cryosurgical system. Powered by mains electricity. Uses medical-grade nitrous oxide or carbon dioxide. Features include manual pressure control, thermocouple-based temperature measurement, and LED array displays for pressure and temperature. Includes a digital timer. Probes are reusable and autoclavable. Non-programmable firmware controls system operation.

Indications for Use

Indicated for ophthalmic surgery, including posterior and anterior segment procedures such as cryopexy for retinal detachment, glaucoma, cataract extraction, trichiasis, and retinopathy of prematurity.

Regulatory Classification

Identification

A cryophthalmic unit is a device that is a probe with a small tip that becomes extremely cold through the controlled use of a refrigerant or gas. The device may be AC-powered. The device is intended to remove cataracts by the formation of an adherent ice ball in the lens, to freeze the eye and adjunct parts for surgical removal of scars, and to freeze tumors.

Predicate Devices

• D.O.R.C. Cryo 1500 (K940373)
• Keeler Cryo Master (K992954)

Submission Summary (Full Text)

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

# OCT 22 2001

510(k) Summary Dutch Ophthalmic, USA D.O.R.C. CryoStar Cryosurgical System (per 21 CFR 807.92)

012821

#### 1. SUBMITTER NAME AND ADDRESS

Dutch Ophthalmic, USA One Little River Road P.O. Box 968 Kingston, NH 03848

| Contact Person: | Mark W. Furlong, President |
|-----------------|----------------------------|
| | Telephone: [phone] |

Date Prepared: August 22, 2001

### 2. DEVICE NAME

| Proprietary Name: | D.O.R.C. CryoStar Cryosurgical System |
|----------------------|-----------------------------------------------------------|
| Common/Usual Name: | Cryosurgical System |
| Classification Name: | Unit, Cryophthalmic, AC-Powered<br>(HRN & 21CFR 886.4170) |

#### 3. PREDICATE DEVICES

| Manufacturer | Product Name | 510(k) Number |
|---------------------|--------------------|---------------|
| Spembly Medical Ltd | D.O.R.C. Cryo 1500 | K940373 |
| Spembly Medical Ltd | Keeler Cryo Master | K992954 |

#### 4. DEVICE DESCRIPTION

The D.O.R.C. CryoStar Cryosurgical System consists of a cryogen gas bottle, a console, an ophthalmic probe, a footswitch and necessary interconnections. The console controls delivery of the gas to the probe. It also processes signals from the footswitch, enabling the probe to freeze and defrost.

#### റ് INTENDED USE

The D.O.R.C. Harmony CryoStar Cryosurgical System is a surgical system for ophthalmic surgery intended for use in surgery of the posterior segment or anterior segment including cryopexy for retinal detachment, glaucoma, cataract extraction, trichiasis, and retinopathy of prematurity.

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

K 01282|

### BASIS FOR SUBSTANTIAL EQUIVALENCE 6.

Operational and technological characteristics form the basis for the determination of substantial equivalence of the D.O.R.C. CryoStar Cryosurgical System with legally marketed predicate devices. Information supplied in this premarket notification includes descriptive information about the intended use, operation and technological characteristics. The following table summarizes the technological characteristics of the D.O.R.C. CryoStar Cryosurgical System in comparison to the predicate devices.

| Significant<br>Feature | DORC<br>CryoStar | DORC<br>Model 1500 | Keeler<br>Cryomaster |
|------------------------|-------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| CONSOLE | | | |
| Basic technology | Electro-mechanical | Electro-mechanical | Electro-mechanical |
| Software content | Non-programmable<br>firmware | None | Non-programmable<br>firmware |
| Pressure control | Manual | Manual | Manual |
| Temperature | Thermocouple (for some | Thermocouple (for some | Thermocouple (for some |
| measurement | probes in range only) | probes in range only) | probes in range only) |
| Indicator panel: | | | |
| timer | Digital display | None | Digital display |
| pressure | LED array | Dial gauge | Digital display |
| temperature | LED array | LED array | Digital display |
| Power source | Mains | Battery | Mains |
| Gas inlet | Screw connection | Screw connection | Screw connection |
| Gas outlet | Barbed fitting | Barbed fitting | Barbed fitting |
| Probe connection | Screw fitting | Screw fitting | Bayonet fitting |
| PROBES | Ophthalmic standard<br>freeze and end-freeze,<br>some with thermocouples<br>Re-usable when sterilised<br>by autoclaving | Ophthalmic standard<br>freeze and end-freeze.<br>some with thermocouples.<br>Re-usable when sterilised<br>by autoclaving | Ophthalmic standard<br>freeze and end-freeze.<br>some with thermocouples.<br>Re-usable when sterilised<br>by autoclaving |
| ACCESSORIES | | | |

## CRYOSTAR COMPARISON CHART

| ACCESSORIES | | | |
|---------------|--------------------------------------------------------------|------|--------------------------------------------------------------------------------------|
| Probe adaptor | Universal<br>(suits probes with or<br>without thermocouples) | None | One adaptor for probes<br>with thermocouples and<br>one adaptor for those<br>without |

| CONSUMABLE CRYOGEN GASES | | | |
|--------------------------|-----------------------------------------|-----------------------------------------|-----------------------------------------|
| Nitrous oxide | Medical grade, vapour<br>withdrawal gas | Medical grade, vapour<br>withdrawal gas | Medical grade, vapour<br>withdrawal gas |
| Carbon dioxide | Medical grade, vapour<br>withdrawal gas | Medical grade, vapour<br>withdrawal gas | Medical grade, vapour<br>withdrawal gas |

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

Image /page/2/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 22 2001

Mr. Mark Furlong President Dutch Ophthalmic USA, Inc. One Little River Rd. P.O. Box 968 Kingston, NH 03848

Re: K012821

Trade/Device Name: D.O.R.C. CryoStar Cryosurgical System Regulation Number: 21 CFR 886.4170 Regulation Name: Cryophthalmic Unit Regulatory Class: Class II Product Code: HRN Dated: August 22, 2001 Received: August 23, 2001

Dear Mr. Furlong:

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.

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

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 and additionally 21 CFR Part 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 device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

A. Ralph Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

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

KO1282

510(k) Number (if known):

Device Name: _ D.O.R.C. CryoStar Cryosurgical System

Indications For Use:

The D.O.R.C. CryoStar Cryosurgical System is a surgical system for ophthalmic surgery intended for use in surgery of the posterior segment or ophicilanine surger y mosing for retinal detachment, glaucoma, cataract extraction, trichiasis and retinopathy of prematurity.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dexinder, 10-15-01

Division of Ophthalmic De 510(k) Number

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use