(27 days)
Not Found
No
The device description and intended use are purely mechanical, describing a physical implant made of gold. There is no mention of software, algorithms, data processing, or any other component that would suggest the use of AI or ML.
Yes
The device is intended for the "gravity-assisted treatment of protracted or permanent lagophthalmos," indicating a therapeutic purpose.
No
Explanation: The device is described as an implantable gold weight intended for treatment of lagophthalmos, not for diagnosing a condition.
No
The device description clearly states the device is a physical implant made of gold, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description: The MedDev Contour Design Gold Eyelid Implants are physical implants made of gold that are surgically placed into the eyelid.
- Intended Use: The intended use is for the gravity-assisted treatment of lagophthalmos, which is a physical condition. This is a therapeutic intervention, not a diagnostic test performed on a specimen.
The device is a surgically implanted medical device, not an IVD.
N/A
Intended Use / Indications for Use
The MedDev Contour Design Gold Eyelid Implants intended use is for the gravity-assisted treatment of protracted or permanent lagophthalmos, usually resulting from facial paralysis.
Product codes (comma separated list FDA assigned to the subject device)
MML
Device Description
MedDev's Contour Design Gold Eyelid Implants are spherically radiused parts of gold (at McdDCV S Ource) which conform to the curvature of the eye globe. They are available in twelve sizes ranging from 0.6 grams in 0.2-grams in 0.2-gram increments. All product tworo olzoo ranging trone or substantially equivalent to the predicated devices mentioned Specifications are the barns of Suzen the predicated MedDev devices and the proposed above. The occasion Gold Eyelid Implants is that the devices will now be supplied sterile to end users.
MedDev's Contour Design Gold Eyelid Implants can be implanted into the eyelid using the Medical techniques depicted in the product brochure. This technique is the same or substantially equivalent to techniques used for the predicated devices.
Implants are made of 99.99% pure gold. They are Medbers Oonlour Doolyn Sola Lyona spherical radius of 12.7 mm to conform to the shape designed in a receinigular onapo with a opners and tapered, smooth edges. Suture holes are of the good. The implant, allowing the surgeon to secure the implant to the tarsus or orbital septum.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
eyelid
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
§ 886.5700 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
CONFIDENTIAL DOCUMENT
JUL = 2 2001
SPECIAL 510(K) SUMMARY
In accordance with CFR 807.92 the following information is submitted:
- MedDev Corporation 1. Submitter: 730 North Pastoria Avenue Tel .: (408) 730-9702 Fax: (408) 730-9732
Suzanne Brick, Operations Administrator Contact:
Registration Number: 2921577
Monday, June 18, 2001 Date of Summary:
- Contour™ Design Gold Eyelid Implants 2. Device Name:
Gold Evelid Weight Common Name:
Class II; Eyelid Weights, External Classification:
- MedDev Contour™ Design Gold Eyelid Implants, Predicated Devices: 3. preamendment devices Labtician Lid Load™ Gold Eyelid Weight Implants, 510(k) number K983607
Description of Modified Device: 4.
Description of Moullied Dovide.
MedDev's Contour Design Gold Eyelid Implants are spherically radiused parts of gold (at McdDCV S Ource) which conform to the curvature of the eye globe. They are available in twelve sizes ranging from 0.6 grams in 0.2-grams in 0.2-gram increments. All product tworo olzoo ranging trone or substantially equivalent to the predicated devices mentioned Specifications are the barns of Suzen the predicated MedDev devices and the proposed above. The occasion Gold Eyelid Implants is that the devices will now be supplied sterile to end users.
MedDev's Contour Design Gold Eyelid Implants can be implanted into the eyelid using the Medical techniques depicted in the product brochure. This technique is the same or substantially equivalent to techniques used for the predicated devices.
Indications for Use: 5.
Indications for Use of the proposed Contour Design Gold Eyelid Implants is exactly the The Indications for 600 of the preposign Gold Eyelid Implants. The broad indication for Sume as to the onginer Design Gold Eyelid Implants is for the gravity-assisted prosombing "ModDove" - Comos.
treatment of protracted or permanent lagophthalmos, usually resulting from facial paralysis.
730 North Pastoria Avenue Sunnyvale, California 94085-3522 Tel 408.730.9702 Fax 408.730.9732 www.meddev-corp.com
1
Conditions, which may damage the facial nerve, include Bell's palsy, facial nerve injury, Conditions, whiler may admage the natures, i.e. acoustic neuroma and parotidectorny.
-
Technical Specifications for the Device: 6.
Technical Specifications for the Borico. Implants are made of 99.99% pure gold. They are Medbers Oonlour Doolyn Sola Lyona spherical radius of 12.7 mm to conform to the shape designed in a receinigular onapo with a opners and tapered, smooth edges. Suture holes are of the good. The implant, allowing the surgeon to secure the implant to the tarsus or orbital septum. -
- Comparison and Substantial Equivalence:
Outhpanson and Gabotantan Ligaratoristics of the proposed Contour While Exception of Storilly, an Toolt Contour Design Gold Eyelid Implants and Labtician Design Ook Lyolid Implants are the same or substantially equivalent. The proposed Eld Coad Ook Eyelid Implants are the same implants as the predicated Contour Contour Design Oola Eyona Implants will be sold sterile. The proposed MedDev Contour Design Gold Eyelid Implants will be sterilized by steam using a validated sterilization cycle providing a Sterility Assurance Level of 1 x 10 6.
- Comparison and Substantial Equivalence:
| | Proposed MedDev
Contour Design Gold
Eyelid Implant | MedDev Contour
Design Gold Eyelid
Implants | Labtician Lid Load
Gold Eyelid Weight
Implants |
|---------------------|----------------------------------------------------------|--------------------------------------------------|------------------------------------------------------|
| Indications for Use | Same | Same | Same |
| Target Population | Same | Same | Same |
| Design | Same | Same | Same |
| Materials | Same | Same | Same |
| Performance | Same | Same | Same |
| Sterility | Sterile | Non-Sterile | Sterile |
| Biocompatibility | Same | Same | Same |
| Mechanical Safety | Same | Same | Same |
| Anatomical Site | Same | Same | Same |
| Human Factors | Same | Same | Same |
| Where Used | Same | Same | Same |
SUBSTANTIAL EQUIVALENCE COMPARISON
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized design of three human profiles facing right, with flowing lines suggesting movement or connection. The profiles are arranged in a row, with the first profile being the most defined and the subsequent profiles gradually fading into the background. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the design.
JUL - 2 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Suzanne Brick Operations Administrator MedDev Corporation 730 North Pastoria Avenue Sunnyvale, CA 94085-
K011740 Re: Contour™ Design Gold Eyelid Implants Unclassified Product Code: MML Dated: May 31, 2001 Received: June 5, 2001 Amended: June 22, 2001
Dear Ms. Brick:
We have reviewed your Section 510(k) notification of intent to market the device referenced above We have revewed your Secuent 700x7 notically equivalent (for the indications for use stated in and we have detellimited the devices is oase allerices marketed in interstate commerce prior to the enclosure) to legally marketed predical Device Amendments, or to devices that have been the Association Associated Ast Association Association Associated Association Asso May 26, 1976, the ellaculicit tare of the Federal Food, Drug, and Cosmetic Act (Act).
reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic A reclassified in accordance with the provisions of the general controls provisions of the Act. The You may, therefore, manet the device, subject to the games for annual registration, listing of devices, general collutors provisions of the free measonst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Prematker If your device is classified (see above) into clifted in (Existing major regulations affecting your Approval), if may be subject to sach additions, Title 21, Parts 800 to 895. A substantially device can be round in the Code of Pederal Regulance with the Current Good Manufacturing Practice equivalent detectimination assumes colinp.System Regulation (QS) for Medical Developed Developed Devel requirements, as set fortu in the Quality of techniques inspections, the Food and Drugs fegulation (FDA) will verify such asumptions. Failure to comply with the GMP regulation may Administration (FDA) will velify such assumptions further announcements concerning your result in regulatory action. In addition, I DA hist processed on the more of 10 at the Art for download device in the Federal Negister. Thease noter and sections 531 through 542 of the Act for devices does not affect any obligation you might have ander sources of other Federal laws or regulations.
3
Page 2 - Ms. Suzanne Brick
This letter will allow you to begin marketing your device as described in your 510(k) premarket I his letter will anow you to begal maintains of your device to a legally marketed noutication: "The PDF midning or rubstins 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 IT you desire specific advice for your dorices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please 574-4037. Numbiliary, 102 quest (301) 594-4639. Also, please note the regulation entitled, Contact are Stices of Schools of Scation" (21CFR 807.97). Other general information Misolanding by receience to premaired an an an a Division of Small Manufacturers on your responsibilities and its not 200 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
David M. Whijsole
Lee A. Ralph Rosenthal, M.D.
A. Ralph Rosenthal, M. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
CONFIDENTIAL DOCUMENT
Image /page/4/Picture/1 description: The image shows the logo for MedDev Corporation. The text "MedDev" is in a large, bold font on the top line. Below that, the word "CORPORATION" is in a smaller font.
730 North Pastoria Avenue Sunnyvale, California 94085-3522 Tel 408.730.9702 Fax 408.730.9732 www.meddev-corp.com
INDICATIONS FOR USE STATEMENT
- Preamendment Device 1. 510(k) Number:
- MedDev Contour Design Gold Eyelid Implants Device Name: 2.
-
- Indications for Use: Includions for Ose.
The MedDev Contour Design Gold Eyelid Implants intended use is for the gravity-assisted treatment of protracted or permanent lagophthalmos, usually resulting from facial paralysis.
- Indications for Use: Includions for Ose.
The intended use and indications for use of the proposed device have not changed at all.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
× Prescription Use (Per 21 CFR 801. 109) OR
Over-The-Counter Use_
Joel P. H
(Division Sign-Off)
Division of Ophthalmic Devices
011740
510(k) Nul