(244 days)
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Not Found
No
The summary describes a physical implant (Lid Chain Eyelid Weight Implant) and makes no mention of AI, ML, image processing, or any software-driven analytical capabilities.
Yes
The device is used to restore lid closure in paralytic lagophthalmos, which indicates a therapeutic purpose.
No
This device is a therapeutic implant designed to restore lid closure, not to diagnose a condition.
No
The device description explicitly states "Lid Chain Eyelid Weight Implant," indicating a physical implant, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Restoration of dynamic lid closure in paralytic lagophthalmos due to facial nerve paralysis." This describes a therapeutic intervention performed on the patient's body to address a physical condition.
- Device Description: The device is a "Lid Chain Eyelid Weight Implant." This is a physical implant designed to be placed in the eyelid.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any such activity.
Therefore, this device is a medical device, but it falls under a different category than IVDs.
N/A
Intended Use / Indications for Use
This indication for use for the 'Lid Chain Eyelid Weight Implant' is for the "Restoration of dynamic lid closure in paralytic lagophthalmos due to facial nerve paralysis"
Product codes
MML
Device Description
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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
Eyelid
Indicated Patient Age Range
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Intended User / Care Setting
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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
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.)
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Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 886.5700 Eyelid weight.
(a)
Identification. An eyelid weight is a prescription device made of gold, tantalum, platinum, iridium, or surgical grade stainless steel that is rectangular in shape and contoured to the shape of the eye. The device is intended for the gravity assisted treatment of lagophthalmos (incomplete eyelid closure).(1) The external eyelid weight is adhered to the outer skin of the upper eyelid.
(2) The implantable eyelid weight is implanted into the upper eyelid.
(b)
Classification. (1) Class II (special controls) for the external eyelid weight. The external eyelid weight is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9. The special controls for the external eyelid weight are:(i) Testing demonstrating the biocompatibility of the device; and
(ii) Labeling must include the following information:
(A) Specific instructions regarding the proper placement, sizing, and removal of the device; and
(B) A warning stating that the patient should be instructed to remove the device prior to entering a magnetic resonance environment.
(2) Class II (special controls) for the implantable eyelid weight. The special controls for the implantable eyelid weight are:
(i) Testing demonstrating the biocompatibility of the device;
(ii) Testing demonstrating the sterility and shelf life of the device;
(iii) Nonclinical testing evaluating the compatibility of the device in a magnetic resonance environment.
(iv) Patient labeling to convey information regarding the safety and compatibility of the device in a magnetic resonance environment, the conditions under which a patient with the device can be safely scanned, and a mechanism for a healthcare provider to obtain detailed information about magnetic resonance safety and compatibility if needed.
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized human figure or a bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 7 2003
JEDMED Instrument Company c/o Craig R. Parks Regulatory Affairs Manager 5416 Jedmed Court St. Louis, MO 63129-2221
Re: K021750
Trade/Device Name: Lid Chain Eyelid Weight Implant Regulatory Class: Unclassified Product Code: MML Dated: November 4, 2002 Received: November 5, 2002
Dear Mr. Parks:
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 application (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 such 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 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Craig R. Parks
This letter will allow you to begin 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 (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
A kalpi korenthal
A. Ralph Rosenthal, M.D Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K021750
Device Name: Lid Chain Eyelid Weight
Indications for Use:
This indication for use for the 'Lid Chain Eyelid Weight Implant' is for the
"Restoration of dynamic lid closure in paralytic lagophthalmos due to facial nerve paralysis"
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Duwa R. Voorhies
(Division Sign-Off) Division of Ophthalmic Ear. Nose and Throat Devises
510(k) Number K021750
(Optional Format 3-10-98)
c:\parks\fdactitionm