CRYOMATIC

K062412 · Keeler Instruments, Inc. · HRN · Nov 6, 2006 · Ophthalmic

Device Facts

• Record ID: K062412
• Device Name: CRYOMATIC
• Applicant: Keeler Instruments, Inc.
• Product Code: HRN · Ophthalmic
• Decision Date: Nov 6, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4170
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Keeler Cryomatic System and probes are for use in ophthalmic surgery in cryopexy procedures in retinal detachment, cataract extraction, cryo destruction of lash follicles, treatment of retinopathy of prematurity (ROP), and procedures in refractory glaucoma, extraction of fragments within the eye.

Device Story

Cryomatic System consists of console and probes; used in ophthalmic surgery. Device utilizes cryogenic technology to perform cryopexy, cataract extraction, and tissue destruction. Operated by ophthalmologists in clinical/surgical settings. Console controls gas flow to probes to achieve localized freezing temperatures for therapeutic tissue destruction or adhesion. Benefits include precise, controlled application of cold for various ophthalmic procedures. Output is physical cooling of probe tip applied directly to ocular tissue.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and technological similarity to legally marketed predicate devices.

Technological Characteristics

Cryogenic surgical system; console-based gas delivery to specialized probes. Class II device (21 CFR 886.4170).

Indications for Use

Indicated for ophthalmic surgery including cryopexy for retinal detachment, cataract extraction, cryo-destruction of lash follicles, treatment of retinopathy of prematurity (ROP), refractory glaucoma, and removal of intraocular fragments.

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

• Keeler Cryomaster and Probes (K992954)
• Keeler ACU 22 XT Ophthalmic Cryo unit (K874555)

Submission Summary (Full Text)

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

# K062412

## 510 (k) Summary Section 3

February 23rd 2006

NUW - 6 2006

#### 1 Submitter

Keeler Instruments Inc 456 Parkway Broomall PA. 19008 USA.

Contact: Mr. Eugene r. Van Arsdale Marketing Manager Tel: [phone] Fax: [phone] E.Mail: [e-mail]

#### 2 Name of Device

Proprietary Name: Cryomatic System and Probes comprising of:

- a) Cryomatic Console
- b) Cryomatic Probes

Common Name

- Ophthalmic Cryo. Systems and Probes
Device Classification: Cryogenic Surgical devices have been placed in Class II as per 21 CFR Regulation Number 886.4170 and assigned the Product Code 86HRN

#### 3 Predicate Devices

The components of the Cryomatic System are substantially equivalent to the following legally marketed devices:

- K992954 Keeler Cryomaster and Probes
K874555 Keeler ACU 22 XT Ophthalmic Cryo unit.

This statement is based on the similarity of the subject device to the predicate devices in intended use, materials, design and principles of operation.

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

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling a stylized caduceus symbol. The caduceus is represented by three abstract, wave-like lines, and the text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 6 2006

Keeler Instruments Inc. c/o Mr. Eugene R. Van Arsdale 456 Parkway Broomall, PA 19008

Re: K062412

Tradc/Device Name: Cryomatic System & Probes Regulation Number: 21 CFR 886.4170 Regulation Name: Cryophthalmic unit Regulatory Class: II Product Code: HRN Dated: October 18, 2006 Received: October 20, 2006

Dear Mr. Van Arsdale:

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 intestate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendmonts, or to devices that have been reclassified in accordance with the provisions of the Federal Fiond, Or to and Cosmetic Act (Act) that do not require approval of a premarket approval application (DMA), 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, isting of devices, good manufacturing practice, labeling, and prohibitions against misbrandi, ing 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, TDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination docs 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 seg forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 100-1000,

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

### Page 2 - Mr. Eugene R. Van Arsdale

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/industry/support/index.html.

Sincerely yours,

M.B. Egelston MD

Malvina B. Fydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Indications for Use

Page 1 of 1

KO62412 510(k) Number (if known):

Device Name: Cryomatic System & Probes

Indications for Use:

The Keeler Cryomatic System and probes are for use in ophthalmic surgery in cryopexy The Reeler Cryoniatic Bystem and procedures in refractory glaucoma, extraction of for remal detachinent, eyello destruction, cataract extraction, cryo destruction of lash follicles fragments within treatment of retinopathy of prematurity (ROP)

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Marsha L. Dimple Nicholas

(Division Sign-Off) Division of Ophthalmic Ear, Nose and Throat Devises

510(k) Number K062412