(39 days)
Not Found
No
The device description and intended use are purely mechanical/optical, and there is no mention of AI, ML, or image processing.
Yes.
The "Intended Use / Indications for Use" section explicitly states that the device is used "for the laser therapy of intraocular abnormalities." The "Device Description" also mentions "therapy of intraocular abnormalities" and "Those used with laser radiation for therapy of ocular abnormalities."
Yes
The "Intended Use / Indications for Use" states that the device is a "diagnostic and therapeutic contact lenses used in the examination of the eye fundus, retina and irido-corneal angle". The "Device Description" also refers to "HS Contact Glasses used in diagnostic procedures".
No
The device description explicitly states it is a family of contact lenses made of materials like aluminum and acrylic plastic, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device function: The Haag-Streit Contact Glasses are used for direct examination and therapy of the eye itself. They are applied directly to the eye's surface to facilitate visualization and laser treatment of internal ocular structures.
- No specimen analysis: The device does not involve the collection or analysis of any biological specimens from the patient.
Therefore, the function and application of the Haag-Streit Contact Glasses fall outside the scope of In Vitro Diagnostics. They are considered medical devices used for direct examination and treatment of the eye.
N/A
Intended Use / Indications for Use
The Haag-Streit Contact Glasses are a family of diagnostic and therapeutic contact lenses for the examination of eye fundus, retina and irido-corneal angle, and for the laser therapy of intraocular abnormalities.
Product codes (comma separated list FDA assigned to the subject device)
HJK
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.
The HS Contact Glass typically consists of an aluminum housing, one or 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
eye fundus, retina, irido-corneal angle, intraocular abnormalities.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 886.1385 Polymethylmethacrylate (PMMA) diagnostic contact lens.
(a)
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.(b)
Classification. Class II.
0
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: 301.838.3182
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
1
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
2
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
3
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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 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
4
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 |
|---|---|
| --------------- | --------- |