HAAG-STREIT CONTACT GLASSES STERY CUP, ACCESSORY

K051103 · Haag-Streit USA, Inc. · HJK · Jun 7, 2005 · Ophthalmic

Device Facts

• Record ID: K051103
• Device Name: HAAG-STREIT CONTACT GLASSES STERY CUP, ACCESSORY
• Applicant: Haag-Streit USA, Inc.
• Product Code: HJK · Ophthalmic
• Decision Date: Jun 7, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1385
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Haag-Streit Contact Glasses are a family of diagnostic / therapeutic contact lenses used for the examination of eye fundus, retina and irido-corneal angle and for the laser therapy of intraocular abnormalities.

Device Story

Haag-Streit Contact Glasses are diagnostic and therapeutic contact lenses used for eye examination and laser therapy of intraocular abnormalities. The device consists of an aluminum housing with plastic (PMMA) or mineral glass optical elements. When placed directly on the cornea, the lenses provide a binocular, stereoscopic view of ocular anatomical areas (fundus, vitreous, retina, irido-corneal angle) when used in conjunction with a slit-lamp. Some models are designed for use with laser radiation for therapeutic procedures. The device is operated by eye care professionals in a clinical setting. By providing clear visualization of the ocular interior, the lenses assist clinicians in diagnosing conditions and performing precise laser treatments, potentially improving patient outcomes for intraocular pathologies.

Clinical Evidence

bench testing only

Technological Characteristics

Materials: PMMA (acrylic) or mineral glass; aluminum housing. Design: Classic Goldmann-style contact lens geometry. Function: Binocular/stereoscopic visualization via slit-lamp integration. Energy: Passive optical device; some models compatible with laser radiation for therapy. Form factor: Contact lens for direct corneal application.

Indications for Use

Indicated for the examination of eye fundus, retina, and irido-corneal angle, and for laser therapy of intraocular abnormalities in patients requiring ophthalmic diagnostic or therapeutic procedures.

Regulatory Classification

Identification

A polymethylmethacrylate (PMMA) diagnostic contact lens is a device that is a curved shell of PMMA intended to be applied for a short period of time directly on the globe or cornea of the eye for diagnosis or therapy of intraocular abnormalities.

Predicate Devices

• Volk Optical Inc. Quadraspheric Fundus Lens (K943125)
• Volk Optical Inc. Quadraspheric Fundus Lens (K023221)
• Ocular Instruments Inc. Saurenghi Scan Laser Lens (K014170)

Submission Summary (Full Text)

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## JUN 7 - 2005

## 510k SUMMARY OF SAFETY AND EFFECTIVENESS

K 05//03

#### Date of Summary: 23 May 2005

## Submitter's Name:

Haag-Streit USA Inc. 5500 Courseview Drive Mason, Ohio 45040-2398

#### Contact Person:

Eduardo March Senior Consultant AAC Consulting Group Inc. 7361 Calhoun Place, Suite 500 Rockville, MD 20855

Phone- 301.838.3120 Fax: [phone]

#### Name of Devices:

Haag-Streit Contact Glasses

Classification Regulation Number: 21 CFR 886.1385 Regulation Name: Polymethylmethacrylate (PMMA) Diagnostic Contact . Lens Product Code: HJK Regulatory Class: II

## DEVICE DESCRIPTION

The HS Contact Glasses is a family of diagnostic and therapeutic contact lenses used for eye examination and therapy of intraocular abnormalities.

The HS Contact Glass family is designed around the classic Goldmann contact lenses. All HS Contact Glass models are of similar design, but provide different optical elements to provide excellent visualization of the ocular anatomical areas for the particular intended use. When used in conjunction with the HS 900 slit-lamp, the HS Contact Glasses provide a binocular and stereoscopic view of the specific optical region of the eye.

23 May 2005 Vers: Correction1

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The HS Contact Glass typically consists of an aluminum housing, one or The HS Contact Glass typically consists of plastic (acrylic) or mineral more mirror elements and a carved of time directly on the globe or cornea of the eye.

The HS contact glass family has two principal modes of use. Those The FIS contact grass family nto to thers used with laser radiation for therapy of ocular abnormalities.

HS Contact Glasses used in diagnostic procedures are made of acrylic HS Contact Glasses ason in Glaghood for the examination of the entire plastic (PMMA). These are doolgnou with slit-lamps, such as fundus, the vitreous and the may of HS diagnostic Contact Glasses have the Flaag Otreit Bookine by Goldmann: 59/ 66/ 73 degrees.

## Intended Uses:

The Haag-Streit Contact Glasses are a family of diagnostic / therapeutic The Haag-otroit Oontact Olassmination of eye fundus, retina and irido-Contact lenses assoc in the Chail for the laser therapy of intraocular abnormalities.

## Substantial Equivalence:

The diagnostic and laser therapy HS Contact Glass are equivalent to other The diagnootio and lace. The agency has previously cleared lenses described in Part 050.100 contact lenses constructed of PMMA and ulagnostic and laosi therapy at Glasses are substantially equivalent to diagnostic and laser therapy use lenses marketed by Volk Optical Inc. (Quadraspheric Fundus Lens- K943125 and K023221) and Ocular Instruments Inc. (Saurenghi Scan Laser Lens- K014170).

23 May 2005 Vers: Correction1

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Image /page/2/Picture/2 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" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, resembling a bird-like shape.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 7 2007

Haag-Streit USA, Inc c/o Lena Sattler Clinical Application Specialist 3535 Kings Mills Road Mason, OH 45040-2303

Re: K051103 Trade/Device Name: Haag-Streit Contact Glasses Regulation Number: 21 CFR 886.1385 Regulation Name: Polymethylmethacrylate (PMMA) Diagnostic Contact Lens Regulatory Class: II Product Code: HJK Dated: April 29, 2005 Received: May 4, 2005

Dear Ms. Sattler:

This letter corrects our substantially equivalent letter of June 7, 2005.

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 (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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21

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Page 2 - Ms. Lena Sattler

CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to continue 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" (21 CFR 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/dsma/dsmamain.html

Sincerely yours.

દ્વ

Evenetto Deens PhD

Malvina B. Eydelman, 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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# INDICATIONS FOR USE

K051103 510(K) NUMBER (If known):

Device Name:

Haag-Streit Contact Glasses

Indications for Use:

The Haag-Streit Contact Glasses are a family of diagnostic and therapeutic coutact lenses a The Haag-Stren Coulact Glasses are archarges and vitreous bodies and vitreous bodies and use in the examination of the of the of the organities.

(Please do not write below this line -- Continue on other page if necessary)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | x | OR | Over-the Counter Use | |
|----------------------|---|----|----------------------|--|
| (Per 21 CFR 801.109) | | | | |

Daniel W. Brown, Ph.D.

(Division Sign-Off)

Division of Ophthalmic Ear,

Nose and Throat Devises

| 510(k) Number | K051103 |
|---------------|---------|
|---------------|---------|