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 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.

AI/ML Overview

This is a 510(k) premarket notification for a medical device called the D.O.R.C. CryoStar Cryosurgical System. It claims substantial equivalence to predicate devices, and therefore no clinical study was performed.

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1. Table of Acceptance Criteria and Reported Device Performance

Feature/Acceptance Criteria (Implied)	D.O.R.C. CryoStar Cryosurgical System (Reported Performance)
Console Technology	Electro-mechanical
Software Content	Non-programmable firmware
Pressure Control	Manual
Temperature Measurement	Thermocouple (for some probes in range only)
Indicator Panel: Timer	Digital display
Indicator Panel: Pressure	LED array
Indicator Panel: Temperature	LED array
Power Source	Mains
Gas Inlet	Screw connection
Gas Outlet	Barbed fitting
Probe Connection	Screw fitting
Probes	Ophthalmic standard freeze and end-freeze, some with thermocouples. Re-usable when sterilized by autoclaving.
Probe Adaptor	Universal (suits probes with or without thermocouples)
Consumable Cryogen Gases (Nitrous Oxide)	Medical grade, vapour withdrawal gas
Consumable Cryogen Gases (Carbon Dioxide)	Medical grade, vapour withdrawal gas

Study Proving Device Meets Acceptance Criteria:

The provided document is a 510(k) submission, not a study report. The "study" that proves the device meets the acceptance criteria is a demonstration of substantial equivalence to predicate devices. This means the manufacturer presented evidence that the D.O.R.C. CryoStar Cryosurgical System has the same intended use and similar technological characteristics to previously cleared devices (D.O.R.C. Cryo 1500 and Keeler Cryo Master) and that any differences do not raise new questions of safety or effectiveness.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size for Test Set: Not applicable. This is not a clinical study involving a test set of data. The submission relies on a comparison of technical specifications and intended use.
Data Provenance: Not applicable. The data is descriptive information about the device itself and a comparison to predicate devices, not data collected from a clinical setting.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Not applicable. No ground truth was established by experts for a test set in this context. The determination of substantial equivalence is made by the FDA based on the provided technical information and comparison to predicate devices.

4. Adjudication Method for the Test Set:

Not applicable. There was no test set or adjudication process as part of a clinical study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a cryosurgical system, not an AI-powered diagnostic tool engaging human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a surgical instrument, not an algorithm or AI system.

7. The Type of Ground Truth Used:

Not applicable in the typical sense of a clinical study. The "ground truth" in this 510(k) submission is the established safety and effectiveness of the predicate devices (D.O.R.C. Cryo 1500 and Keeler Cryo Master) based on their prior FDA clearance. The new device is deemed substantially equivalent if it can demonstrate it performs safely and effectively like these predicate devices.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/machine learning study requiring a training set.

9. How the Ground Truth for the Training Set was Established:

Not applicable.

Summary

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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: 603-642-8468

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(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

റ് INTENDED USE

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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.

SignificantFeature	DORCCryoStar	DORCModel 1500	KeelerCryomaster
CONSOLE
Basic technology	Electro-mechanical	Electro-mechanical	Electro-mechanical
Software content	Non-programmablefirmware	None	Non-programmablefirmware
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 standardfreeze and end-freeze,some with thermocouplesRe-usable when sterilisedby autoclaving	Ophthalmic standardfreeze and end-freeze.some with thermocouples.Re-usable when sterilisedby autoclaving	Ophthalmic standardfreeze and end-freeze.some with thermocouples.Re-usable when sterilisedby autoclaving
ACCESSORIES

CRYOSTAR COMPARISON CHART

ACCESSORIES
Probe adaptor	Universal(suits probes with orwithout thermocouples)	None	One adaptor for probeswith thermocouples andone adaptor for thosewithout

CONSUMABLE CRYOGEN GASES
Nitrous oxide	Medical grade, vapourwithdrawal gas	Medical grade, vapourwithdrawal gas	Medical grade, vapourwithdrawal gas
Carbon dioxide	Medical grade, vapourwithdrawal gas	Medical grade, vapourwithdrawal gas	Medical grade, vapourwithdrawal gas

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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.

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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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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

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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.

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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

Regulation Number and Section

§ 886.4170 Cryophthalmic unit.

(a)
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.(b)
Classification. Class II.