(78 days)
Gold Evelid Implants, EyeClose External Eyelid Weights
Not Found
No
The description focuses on the physical properties and mechanism of action (gravity) of the eyelid weights, with no mention of AI or ML.
Yes
The device is used to restore a functional blink mechanism and correct or avoid conditions like inadequate eyelid closure, corneal exposure, and serious keratopathy, which are medical treatments.
No
The device, Blink External Eyelid Weights, is used to restore a functional blink mechanism for patients with lagophthalmos, which is a treatment not a diagnosis.
No
The device description clearly states the device is constructed of physical materials (tantalum strips) and is attached to the eyelid with adhesive, indicating it is a hardware device, not software-only.
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 Blink External Eyelid Weights are a physical device applied externally to the eyelid. Their function is mechanical – using gravity to assist with eyelid closure. They do not analyze or test any biological samples.
- Intended Use: The intended use clearly describes a mechanical intervention to address a physical problem (lagophthalmos) and its consequences. It does not involve any diagnostic testing.
Therefore, the Blink External Eyelid Weights fall under the category of a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Blink External Eyelid Weights, attached to the outer skin of the upper eyelid with an adhesive, work by gravity to restore a functional blink mechanism to the patient who suffers from lagophthalmos resulting from temporary or permanent facial paralysis, specifically the orbicularis oculi muscle. This paralysis may be the result of Bell's palsy or from surgical trauma to the facial nerve.
Functional defects which may be corrected or avoided with the use of Blink External Eyelid Weights include inadequate evelid closure, corneal exposure, serious keratopathy such as ocular irritation, keratitis, corneal abrasion or ulceration. These conditions may result in decreased vision.
Blink External Eyelid Weight are attached with an adhesive tape or gum to the outer surface of the upper eyelid. This weight acts by gravity to restore a functional blink mechanism to the patient who is afflicted with lagophthalmos. Usually the adhesive is changed daily after bathing.
The patient with lagophthalmos is unable to close the eyelid completely because of partial or complete paralysis to the facial nerve. This paralysis may be the result of Bell's palsy or from surgical trauma to the facial nerve. The condition of paralysis can be either permanent or transient.
Product codes
86 MML
Device Description
The Blink External Evelid Weights are spherically radiused strips of pure tantalum, constructed in twelve sizes ranging from 0.6 grams to 2.8 grams in 0.2 gram increments.
The Blink External Weight is attached to the outer skin of the upper eyelid with a double coated adhesive tape strip or with mastisol.
Blink External Eyelid Weights are offered in four flesh tone colors: White. Tan. Medium Brown and Dark Brown
Only the top surface of the weight is painted. The underneath surface is bare tantalum metal.
The physical specifications and materials used in the construction of the Blink External Eyelid Weights are identical to the EyeClose External Eyelid Weights.
Blink External Eyelid Weights are produced to the same specifications as the EyeClose External Weights.
Blink External Eyelid Weights are constructed of pure tantalum. The weights are designed in a rectangular shape with a spherical radius of curvature of 12.7 mm which conforms to the shape of the eye. All edges are smoothly rounded.
The top surface is painted with a Polane 2.8 T Plus polyurethane enamel paint. The material safety data sheet is enclosed in appendix 4.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
outer skin of the upper 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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Gold Evelid Implants, EyeClose External Eyelid Weights
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
CONFIDENTIAL DOCUMENT JUN 2 0 1997
510(k) Summary of Safety and Effectiveness 8.
In accordance with CFR 807.92 (April 26, 1992), the following information is submitted:
lpax, Inc. Name: 2109 West Amherst Address: Englewood, CO 80110
303-781-2444 Telephone: 303-781-2505 Fax
Phillip Pennell Contact:
Date of Summary Preparation: March 30, 1997
- Name of Device: Blink ™ External Eyelid Weights 2. Common Name: External Eyelid Weights Classification Name: None known
- Predicate Device: Gold Evelid Implants, EyeClose External 3. Eyelid Weights, preamendment and equivalent devices, respectively.
4. Device Description:
The Blink External Evelid Weights are spherically radiused strips of pure tantalum, constructed in twelve sizes ranging from 0.6 grams to 2.8 grams in 0.2 gram increments.
The Blink External Weight is attached to the outer skin of the upper eyelid with a double coated adhesive tape strip or with mastisol.
Blink External Eyelid Weights are offered in four flesh tone colors: White. Tan. Medium Brown and Dark Brown
Only the top surface of the weight is painted. The underneath surface is bare tantalum metal.
The physical specifications and materials used in the construction of the Blink External Eyelid Weights are identical to the EyeClose External Eyelid Weights.
- ട്. Intended Use:
Blink External Eyelid Weights, attached to the outer skin of the upper eyelid with an adhesive, work by gravity to restore a functional blink mechanism to the patient who suffers from lagophthalmos resulting from temporary or permanent facial paralysis, specifically the orbicularis oculi muscle. This paralysis may be the result of Bell's palsy or from surgical trauma to the facial nerve.
�
1
K971245
CONFIDENTIAL DOCUMENT
Functional defects which may be corrected or avoided with the use of Blink External Eyelid Weights include inadequate evelid closure, corneal exposure, serious keratopathy such as ocular irritation, keratitis, corneal abrasion or ulceration. These conditions may result in decreased vision.
- Technological Characteristics of the Device: 6. Blink External Eyelid Weights are produced to the same specifications as the EyeClose External Weights.
Blink External Eyelid Weights are constructed of pure tantalum. The weights are designed in a rectangular shape with a spherical radius of curvature of 12.7 mm which conforms to the shape of the eye. All edges are smoothly rounded.
The top surface is painted with a Polane 2.8 T Plus polyurethane enamel paint. The material safety data sheet is enclosed in appendix 4.
SUBSTANTIAL EQUIVALENCE COMPARISON
| | Blink External
Eyelid Weight
(Ipax) | Series 1000 External
Eyelid Weight
(MedDev) |
|---------------------|-------------------------------------------|---------------------------------------------------|
| Indications for Use | Same | Same |
| Target Population | Same | Same |
| Design | Same | Same |
| Materials | Same | Same |
| Performance | Same | Same |
| Sterility | Same | Same |
| Biocompatibility | Same | Same |
| Mechanical Safety | Same | Same |
| Anatomical Site | Same | Same |
| Human Factors | Same | Same |
| Where Used | Same | Same |
73
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the symbol. The logo is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 20 1997
Mr. Phil Pennell IPAX, Inc. 2109 West Amherst Ave. -------------------------------------------------------------------------------------------------------------------------------------------------------Englewood, CO 80110
Re: K971245
Trade Name: Blink™ External Eyelid Weight Regulatory Class: I Product Code: 86 MML Dated: March 30, 1997 Received: April 3, 1997
Dear Mr. Pennell:
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 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.
3
Page 2 - Mr. Phil Pennell
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, 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 yours,
A Roerl Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Statement of Indications for Use
Blink External Eyelid Weight are attached with an adhesive tape or gum to the outer surface of the upper eyelid. This weight acts by gravity to restore a functional blink mechanism to the patient who is afflicted with lagophthalmos. Usually the adhesive is changed daily after bathing.
The patient with lagophthalmos is unable to close the eyelid completely --------because of partial or complete paralysis to the facial nerve. This paralysis may be the result of Bell's palsy or from surgical trauma to the facial nerve. The condition of paralysis can be either permanent or transient.
Susan Sougé KYA for DRL
(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number K971245
Prescription Use Susan Sougé
(Per 21 CFR 801.109)
14