OCULOSTAT

K981235 · Laser Center Dev. Corp. · HNC · Jul 15, 1998 · Ophthalmic

Device Facts

• Record ID: K981235
• Device Name: OCULOSTAT
• Applicant: Laser Center Dev. Corp.
• Product Code: HNC · Ophthalmic
• Decision Date: Jul 15, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4350
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The Oculostat, by Laser Center Development Corporation, is intended to reduce eye movement and stabilize the eye in any procedure in which the globe needs to be immobilized. The device is provided sterile and it is disposable for single use only.

Device Story

Oculostat is a sterile, single-use ophthalmic speculum combined with a scleral vacuum suction ring. Used by clinicians to stabilize the eye during procedures requiring globe immobilization. Operation involves retracting eyelids into the speculum and applying low vacuum (≤30mm Hg) to the sclera via a pump or spring-loaded syringe. The combination of eyelid-speculum friction and scleral vacuum holds the eye steady against extraocular muscle activity. The device provides a stable surgical field, potentially improving procedural precision and patient safety.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Medical quality plastic ophthalmic speculum integrated with a scleral vacuum suction ring. Operates via low vacuum (≤30mm Hg) generated by a pump or spring-loaded syringe. Sterile, single-use, disposable device.

Indications for Use

Indicated for patients undergoing procedures requiring globe immobilization to reduce eye movement and stabilize the eye.

Regulatory Classification

Identification

A manual ophthalmic surgical instrument is a nonpowered, handheld device intended to aid or perform ophthalmic surgical procedures. This generic type of device includes the manual corneal burr, ophthalmic caliper, ophthalmic cannula, eyelid clamp, ophthalmic muscle clamp, iris retractor clip, orbital compressor, ophthalmic curette, cystotome, orbital depressor, lachrymal dilator, erisophake, expressor, ophthalmic forcep, ophthalmic hook, sphere introducer, ophthalmic knife, ophthalmic suturing needle, lachrymal probe, trabeculotomy probe, cornea-sclera punch, ophthalmic retractor, ophthalmic ring (Flieringa), lachrymal sac rongeur, ophthalmic scissors, enucleating snare, ophthalmic spatula, ophthalmic specula, ophthalmic spoon, ophthalmic spud, trabeculotome or ophthalmic manual trephine.

Predicate Devices

• Eye Fixation Speculum (K964289)

Submission Summary (Full Text)

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JUL 1 5 1898

# K981235 Oculostat

0 . J . J . J . J . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

P.16

## 510(k) Summary

#### SUBMITTED:

#### Submitted on behalf of:

TEL :

Company Name: Address:

Phone: Fax:

Laser Center Develonment Corporation 709 The Hamptons Lane Town & Country, MO 63017 314-514-1478 314-434-7030

## CONTACT PERSON:

Francis E. O'Donnell, Jr., M.D.

# OFFICIAL CORRESPONDENT:

Firm Name: Address:

Phone: Fax:

Francis E. O'Donnell, Jr., M.D. Laser Center Development Corporation 709 The Hamptons Lanc Town & Country, MO 63017 314-514-1478 314-434-7030

DATE SUMMARY PREPARED:

TRADE NAME:

COMMON NAME:

Ophthalmic speculum

May 27, 1998

Oculostat

SUBSTANTIALLY EQUIVALENT TO: The Oculostat™ by Laser Center Development Corporation is substantially equivalent to the Eye Fixation Speculum, by eyeFix, Inc., which was determined by FDA to be marketable per K964289.

DESCRIPTION OF THE DEVICE: The Oculostat by Laser Center Development Corporation consists of a scleral vacuum suction ring attached to a medical quality plastic ophihalmic speculum. After retracting the eyelids and inserting the lid margins into the speculum portion of the Oculostat, the suction-vacuum ring is attached to the sclera by sequentially contering, depressing, and enguing low vacuum (30mm Hg or less) by pump or spring-loaded syringe. The frictional forces between the eyelids and speculum, together with the vacuum ring, hold the eye steady despite extraocular muscle activity.

INDICATIONS FOR USE: The Oculostat, by Laser Center Development Corporation, is intended to reduce eye movement and stabilize the eye in any procedure in which the globe needs to be immobilized. The device is provided sterile and it is disposable for single use only.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 5 1998

Francis E. O'Donnell, Jr., M.D. President Laser Center Development Corp. 1028 S. Kirkwood Road, Suite A Kirkwood, MO 63122-7222

Re: K981235 Trade Name: Oculostat Speculum Regulatory Class: I Product Code: 86 HNC Dated: May 27, 1998 Received: May 29, 1998

Dear Dr. O'Donnell :

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations .

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This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

A. Roerl. Rosenthal

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

Enclosure

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# Page 1 of 1

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ K981235

Oculostat Device Name: __

Indications For Use:

Oculostat is intended to reduce eye movement and stabilize the eye in any procedure in which the globe needs to be immobilized.

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

#### Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109) OR Over-The-Counter Use

(Optional Format 1-2-96)

Amwilliams
(Division Sign-Off)
Division of Ophthalmic Device
510(k) Number K981235