(77 days)
Not Found
No
The device description and intended use clearly describe a physical, non-electronic device used for manual sizing, with no mention of computational analysis, algorithms, or data processing that would indicate AI/ML.
No
The device is used to determine the correct weight for an implantable therapeutic device, but it is not itself implanted or directly used for treatment. It is a sizing tool.
Yes
The device is used by a physician to "determine the correct gold eyelid weight to be implanted." This determination is a form of diagnosis, as it identifies the appropriate treatment parameter for the patient's condition.
No
The device is described as physical weights made of tantalum, which are affixed to the eyelid. There is no mention of software in the description.
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.
- Device Function: The Labtician Lid Load External Eyelid Sizing Weights are physical weights applied externally to the eyelid. Their purpose is to help a physician determine the appropriate weight for an implantable device based on the physical response of the eyelid muscle.
- No Sample Analysis: The device does not analyze any biological samples from the patient. It is a tool used in a physical assessment.
Therefore, the device falls outside the scope of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Labtician Lid Load External Eyelid Sizing Weights are used by the physician to determine the correct gold eyelid weight to be implanted in the treatment of lagophthalmos.
Labtician Lid Load External Eyelid Sizing Weights are used by the physician who affixes a succession of external eyelid weights to the outer surface of the eyelid using until the proper eyelid closure is attained. Because the levator muscle seems to strengthen after the weight is added, the optimal weight for implantation is ususally that which holds lid about 1.0 mm lower than the normal lid as the patient looks straight ahead.
The corresponding implantable gold eyelid weight is then prescribed for implantation.
Sizing weights are not designed to be implanted, and are provided nonsterile and are re-usable following cleaning with soap and water and/or alcohol and rinsing with tap water.
Product codes (comma separated list FDA assigned to the subject device)
86 MML
Device Description
Labtician Lid Load External Eyelid Sizing Weights are spherically radiused strips of pure tantalum (99.5%), constructed in twelve sizes ranging from 0.6 grams to 2.8 grams in 0.2 gram increments.
A Labtician Lid Load External Eyelid Sizing Weight is attached to the outer skin of the upper eyelid with a double coated adhesive tape strip or other suitable adhesive.
The physical specifications and materials used in the construction of Labtician Iid Load External Eyelid Sizing Weights are identical to the EyeClose External Eyelid Weights, with the exception that Labtician Lid Load External Eyelid Sizing Weights are unpainted.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
outer surface of the eyelid
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician
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
4/9/99
510(k) Summary of Safety and Effectiveness 8. In accordance with CFR 807.92 (April 26, 1992), the following information is submitted:
- Labtician Ophthalmics. Inc. 1. Name: 2140 Winston Park Dr. Unit #6 Address: Oakville, ON L6H 5V5 Canada
Telephone: 905 829-0055 905 829-0056 Fax
R. David Sculati Contact:
Date of Summary Preparation: January 22, 1999
- Labtician Lid Load™ External Eyelid 2. Name of Device: Sizina Weights External Eyelid Sizing Weights Common Name: None known Classification Name:
- Predicate Device: EyeClose External Eyelid Weights, K940974. 3.
- Device Description: 4.
Labtician Lid Load External Eyelid Sizing Weights are spherically radiused strips of pure tantalum (99.5%), constructed in twelve sizes ranging from 0.6 grams to 2.8 grams in 0.2 gram increments.
A Labtician Lid Load External Eyelid Sizing Weight is attached to the outer skin of the upper eyelid with a double coated adhesive tape strip or other suitable adhesive.
The physical specifications and materials used in the construction of Labtician Iid Load External Eyelid Sizing Weights are identical to the EyeClose External Eyelid Weights, with the exception that Labtician Lid Load External Eyelid Sizing Weights are unpainted.
- ട. Intended Use:
Sizing weights are used to determine the correct gold eyelid weight to be implanted in the treatment of lagophthalmos. The sizing weights are used by the physician who affixes a succession of external eyelid weights to the outer surface of the eyelid until the proper evelid closure is attained. The corresponding implantable gold eyelid weight is then prescribed for implantation.
Today, the most commonly used and successful surgical treatment of lagophthalmos is implantation of the gold evelid load weight. This device is used to allow the upper lid to close by force of gravity when the levator palpebrae muscle is relaxed.
1
-
- Technological Characteristics of the Device: Labtician Lid Load External Eyelid Sizing Weights are produced to the same specifications as the EyeClose External Weights with the exception that the Labtician Lid Load External Sizing Weights are unpainted.
Labtician Lid Load External Eyelid Sizing Weights are constructed of pure tantalum (99.5%). 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.
- Technological Characteristics of the Device: Labtician Lid Load External Eyelid Sizing Weights are produced to the same specifications as the EyeClose External Weights with the exception that the Labtician Lid Load External Sizing Weights are unpainted.
SUBSTANTIAL EQUIVALENCE COMPARISON
| Labtician Lid Load | Med Dev |
|---|---|
| Extenal Eyelid | EyeClose External |
| Sizing Weight | Eyelid Weight |
| Indications for Use | Same* | Same** |
|---|---|---|
| Target Population | Same | Same |
| Design | Same | Same |
| Materials | Same*** | Same** |
| Performance | Same | Same |
| Sterility (non sterile) | Same | Same |
| Biocompatibility | Same | Same |
| Mechanical Safety | Same | Same |
| Anatomical Site | Same | Same |
| Human Factors | Same | Same |
★ affixed externally-used for determining the correct size gold weight to be implanted in treatment of lagophthalmos.
** affixed externally-used for treatment of lagophthalmos
***pure tantalum-unpainted ****pure tantalum-painted on outer surface
2
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 stylized caduceus symbol, which is a staff with two snakes coiled around it, representing medicine and healing. The caduceus is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in capital letters. The text is arranged to follow the curve of the circle, with the department name at the bottom and "USA" at the top.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 2 1999
R. David Sculati Vice President & General Manager Labtician Ophthalmics, Inc. 2140 Winston Park Drive, Unit 6 Oakville, Ontario, Canada, L6H 5V5
Re: K990224 Trade Name: Labtician Lid Load™ External Eyelid Sizing Weight Set Regulatory Class: Unclassified Product Code: 86 MML Dated: January 22, 1999 Received: January 25, 1999
Dear Mr. Sculati:
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 .
3
Page 2 - Mr. David Sculati
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,
ARoepl Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
| Page | of |
|---|---|
| 510(k) Number (if known): | K990224 |
| Device Name: | Labtician Lid Load External Sizing Weights |
| Indications For Use: |
Statement of Indications for Use
Labtician Lid Load External Eyelid Sizing Weights are used by the physician to determine the correct gold eyelid weight to be implanted in the treatment of lagophthalmos.
Labtician Lid Load External Eyelid Sizing Weights are used by the physician who affixes a succession of external eyelid weights to the outer surface of the eyelid using until the proper eyelid closure is attained. Because the levator muscle seems to strengthen after the weight is added, the optimal weight for implantation is ususally that which holds lid about 1.0 mm lower than the normal lid as the patient looks straight ahead.
The corresponding implantable gold eyelid weight is then prescribed for implantation.
Sizing weights are not designed to be implanted, and are provided nonsterile and are re-usable following cleaning with soap and water and/or alcohol and rinsing with tap water.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Youzé
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use_
(Optional Format 1-2-96)
Adiley Boudreaux for DEC
(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number K990224
R