(25 days)
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No
The summary describes contact lenses for vision correction and contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No.
The contact lenses are indicated for the correction of visual acuity, which is a functional improvement rather than the treatment or prevention of a disease or condition. They are a corrective device for vision.
No
Explanation: The device is indicated for correction of visual acuity, not for diagnosis of a disease or condition.
No
The device description clearly identifies the device as "SOFT CONTACT LENSES," which are physical medical devices, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for the "correction of visual acuity" in the eyes. This is a therapeutic or corrective function, not a diagnostic one.
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. This device does not involve testing samples from the body.
- Anatomical Site: The device is applied directly to the eyes, which is an in-vivo application, not in-vitro.
Therefore, the PROMED 38 SOFBLU contact lenses are medical devices, but they fall under a different classification than IVDs.
N/A
Intended Use / Indications for Use
The PROMED 38 SOFBLU (Toric) (polymacon) SOFT CONTACT LENSES for daily wear are indicated for the correction of visual acuity in not aphakic persons with non-diseased eyes with myopia or hyperopia and refractive astigmatism not exceeding 10 Diopters.
The PROMED 38 SOFBLU (Spherical) (polymacon) SOFT CONTACT LENSES for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit reffactive astigmatism of 1.50 diopters or less where the astigmatism does not interfere with visual acuity.
Product codes
86 LPL
Device Description
PROMED 38 SOFBLU (POLYMACON) Soft (Spherical and Toric) Daily Wear Contact Lens (Visibility Tinted, Lathe-cut from Lens Blank)
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 886.5925 Soft (hydrophilic) contact lens.
(a)
Identification. A soft (hydrophilic) contact lens is a device intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct vision conditions or act as a therapeutic bandage. The device is made of various polymer materials the main polymer molecules of which absorb or attract a certain volume (percentage) of water.(b)
Classification. (1) Class II if the device is intended for daily wear only.(2) Class III if the device is intended for extended wear.
(c)
Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before a device described in paragraph (b)(2) of this section may be commercially distributed. See § 886.3.
0
Image /page/0/Picture/1 description: The image shows a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "SERVICES - USA" are written above the eagle. The words "DEPARTMENT OF HEALTH & HUM" are written on the left side of the logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 0 1997
Mr. Martin Dalsing Consultant for Biomed Devices Corporation 623 Glacier Drive Grand Junction, CO 81503 · · ·
Re: K971515
Trade Name: PROMED 38 SOFBLU (POLYMACON) Soft (Spherical and Toric) Daily Wear Contact Lens (Visibility Tinted, Lathe-cut from Lens Blank)
Regulatory Class: II Product Code: 86 LPL Dated: April 23, 1997 Received: April 25, 1997
Dear Mr. Dalsing:
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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21-CFR Part 820) and that, through periodic GMP 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 sublish 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. Martin Dalsing
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, permics 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 at (301) 443-6597.
Sincerely yours,
Alberl Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
BIOMED DEVICES CORPORATION 510(K) Premarket Noufication
INDICATIONS FOR USE STATEMENT
Device Name:
Promed 38 SOFBLU (polymacon) Soft (Spherical & Toric) Daily Wear Contact Lens
INDICATIONS FOR USE:
The PROMED 38 SOFBLU (Toric) (polymacon) SOFT CONTACT LENSES for daily wear are indicated for the correction of visual acuity in not aphakic persons with non-diseased eyes with myopia or hyperopia and refractive astigmatism not exceeding 10 Diopters.
The PROMED 38 SOFBLU (Spherical) (polymacon) SOFT CONTACT LENSES for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit reffactive astigmatism of 1.50 diopters or less where the astigmatism does not interfere with visual acuity.
(PLEASE DO OT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Vickie W.L. Winston
(Division Sign-Off)
Division of Ophthalmic Devices
Prescription Use V (Per 21 CFR 801.109)
Division of Ophthalmic Devices
510(k) Number K971515
Over-The-Counter Use
(Optional Format 1-2-96)
PROMED 38 SOFBLU (Polyment) Soft (Spherical & Torio) Delly Wear Contact Lanz (Tistod, Lather-QF Even Land Bluel)
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