(36 days)
Not Found
Not Found
No
The device is a physical sponge for shielding the cornea and the description contains no mention of AI, ML, or related concepts like image processing or data analysis.
No
This device is intended to shield the retina from illumination during ophthalmic procedures, which is a protective function rather than a therapeutic one (e.g., treating or diagnosing an illness).
No
This device is a physical shield placed on the cornea to block light during ophthalmic procedures, not to diagnose a condition.
No
The device description clearly states it is a "sterile sponge" and a "physical shield" placed on the cornea, indicating it is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device function: The Corneal Light Shield is a physical device placed on the surface of the cornea during a procedure. It does not analyze any biological samples from the body. Its function is to physically shield the retina from light.
- Intended Use: The intended use clearly states it's for shielding the retina from illumination during ophthalmic procedures, not for diagnosing or analyzing biological samples.
Therefore, the Corneal Light Shield falls under the category of a medical device used in a procedure, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Corneal Light Shield is a sterile sponge that is not absorbable by the body. It is intended for short-term transient use by a physician to be placed on the surface of the cornea and shield the retina from illumination during ophthalmic procedures. The Corneal Light Shield is to be used once and discarded.
Product codes
86 HOZ
Device Description
The M-Pact Corneal Light Shield is designed to be placed on the surface of the cornea during ophthalmic procedures to shield the retina from excessive illumination. The Corneal Light Shield is transient to minimal short-term use only. The Shield is nonabrasive, and is formulated to resist tearing or shedding of fibers.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cornea, retina
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician; ophthalmic procedures
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)
Merocel Corneal Sponge
Reference Device(s)
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
§ 886.4790 Ophthalmic sponge.
(a)
Identification. An ophthalmic sponge is a device that is an absorbant sponge, pad, or spear made of folded gauze, cotton, cellulose, or other material intended to absorb fluids from the operative field in ophthalmic surgery.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
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DEC 2 1 1999
Image /page/0/Picture/1 description: The image shows a sequence of handwritten characters. The characters are 'K993883' and are written in a bold, black font. The characters appear to be handwritten, giving them a unique and slightly irregular appearance.
A - 510(k) SUMMARY OF SAFETY AND EFFICACY
DATE PREPARED:
SUBMITTER:
November 2, 1999
M-Pact Corp. 1040 OCL Parkway Eudora, KS 66025 PH: 785-542-2920 ext. 112 800-255-4152 Fax: 785-542-3608
CONTACT PERSON:
TRADE (PROPRIETARY) NAME:
M-Pact Corneal Light Shield
And Quality Assurance.
Corneal Light Shield
Class II
Merocel -
Al Boedeker, Manager of Regulatory Affairs
COMMON NAME:
DEVICE CLASSIFICATION:
PREDICATE DEVICE:
DESCRIPTION OF DEVICE:
The M-Pact Corneal Light Shield is designed to be placed on the surface of the cornea during ophthalmic procedures to shield the retina from excessive illumination. The Corneal Light Shield is transient to minimal short-term use only. The Shield is nonabrasive, and is formulated to resist tearing or shedding of fibers.
STATEMENT OF INTENDED USE:
The Corneal Light Shield is a sterile sponge that is not absprbable by the body. It is intended for short-term transient use by a physician to be placed on the surface of the cornea and shield the retina from illumination during ophthalmic procedures. The Corneal Light Shield is to be used once and discarded.
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TECHNOLOGICAL CHARACTERISTICS:
The M-Pact Corneal Light Shield has similar technological characteristics compared to the predicate device. The features are given in the Substantial Equivalence Table below.
SUBSTANTIAL EQUIVALENCE TABLE
| FEATURES | M-pact Corneal Light Shield | Merocel Corneal Sponge |
|---|---|---|
| Made of PVA Sponge | ||
| Bio-compatible and non-toxic | YES | YES |
| shields the retina from laser | ||
| illumination | YES | YES |
| Foam is compressed and | ||
| dried prior to packaging | YES | YES |
| Sterilized by Gamma or | ||
| e-beam irradiation | YES | YES |
| Stored with moisture barrier | ||
| packaging | YES | YES |
| Interconnected cell structure | ||
| that prevents loose particles | YES | YES |
| Tear resistant | YES | YES |
| Nonabrasive | YES | YES |
| Absorbs about 15 times its | ||
| weight in fluid | YES | YES |
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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 resembling three stylized human profiles or a triple-stranded helix, often referred to as the "Human Services Symbol."
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 1 1999
M-Pact Corporation Mr. Al Boedeker Manager of Regulatory Affairs and Quality Assurance 1040 OCL Parkway Eudora, KS 66025
Re: K993883 Trade Name: Corneal Light Shield (ophthalmic sponge) Regulatory Class: II Product Code: 86 HOZ Dated: November 11, 1999 Received: November 15, 1999
Dear Mr. Boedeker:
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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Page 2 - Mr. Al Boedeker
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 marked 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 (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" (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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely vours.
A. Ralph 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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510(k) Number (if known): __ K993883
CORNEAL LIGHT SHEILD Device Name:
INDICATIONS FOR USE:
The Corneal Light Shield is a sterile sponge that is not absorbable by the body. It is intended for short-term transient use by a physician to be placed on the surface of the cornea and shield the retina from illumination during ophthalmic procedures. The Corneal Light Shield is to be used once and discarded.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) vision Sign-Off) Division of Ophthalmic Devices 510(k) Number_K993883 Prescription Use OR Over-The Counter OR Over-The-Counter Use Prescription Use (Optional Format 1-2-96) (Per 21 CER 801.109)