(469 days)
K780987A
Not Found
No
The summary describes a physical implant made of silicone for retinal surgery and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes, it is a therapeutic device.
Used to "buckle" the sclera in retinal reattachment surgery.
No
The device is described as an implant used to "buckle" the sclera in retinal reattachment surgery, which indicates a therapeutic or surgical purpose rather than a diagnostic one.
No
The device description explicitly states it is a "molded extruded silicone device," indicating it is a physical hardware implant, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "buckle" the sclera in retinal reattachment surgery. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as molded extruded silicone implants used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze samples. This device is used in vivo (inside the body) during surgery.
N/A
Intended Use / Indications for Use
The intended use of the modified Solid Silicone and Silicone Sponge Implants is unchanged from the pre-amendment and cleared MIRA Solid Silicone and Silicone Sponge Implants. These devices are used to "buckle" the sclera in retinal reattachment surgery.
Product codes
Not Found
Device Description
Solid Silicone and Silicone Sponge Implants are molded extruded silicone devices, available in a wide variety of shapes and sizes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Non-clinical testing was performed to show that the new material used for the manufacture of MIRA Solid Silicone and Silicone Sponge Implants is not substantially different from that of the original Dow Corning material. Physical testing was performed by the material supplier with results provided in FDA Master Files.
Sterilized finished devices manufactured with new silicone material were tested for biocompatibility according to FDA "Tripartite Guidance" and according to "Table IV. Confirmatory Biological Testing" referenced in FDA "Guidance for Manufacturers of Silicone Devices Affected by Withdrawal of Dow Corning Silastic Materials. Testing demonstrated that the implants were non-toxic and biocompatible.
Key Metrics
Not Found
Predicate Device(s)
K780987A
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 886.3340 Extraocular orbital implant.
(a)
Identification. An extraocular orbital implant is a nonabsorbable device intended to be implanted during scleral surgery for buckling or building up the floor of the eye, usually in conjunction with retinal reattachment. Injectable substances are excluded.(b)
Classification. Class II.
0
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
Solid Silicone and Silicone Sponge Implants
JUN - 5 1996
1. APPLICANT
MIRA, Inc. 87 Rumford Avenue Waltham, MA 02154 Contact Person: Michael A. Warren 1-800-847-6472 (In MA, 617-894-2200) Telephone: Facsimile: 617-647-1855
Date of Summary Preparation: February 21, 1995
- DEVICE NAME 2.
| Proprietary Name: | Solid Silicone and Silicone Sponge Implants |
|---|---|
| Common/Usual Name: | Scleral Buckling Device |
| Classification Name: | Extraocular Orbital Implants |
PREDICATE DEVICE 3.
MIRA, Inc. claims substantial equivalence of the Solid Silicone and Silicone Sponge Implants to currently marketed Solid Silicone (preamendment) and Silicone Sponge Implants (K780987A) manufactured and marketed by MIRA, Inc.
DEVICE DESCRIPTION 4.
Solid Silicone and Silicone Sponge Implants are molded extruded silicone devices, available in a wide variety of shapes and sizes.
1
INTENDED USE 5.
The intended use of the modified Solid Silicone and Silicone Sponge Implants is unchanged from the pre-amendment and cleared MIRA Solid Silicone and Silicone Sponge Implants. These devices are used to "buckle" the sclera in retinal reattachment surgery.
Comparison of Technological Characteristics of this Device to the 6. PREDICATE
-
Operational Principles .
The general operational principles are identical. Buckling implants are used to occupy space and provide compression for retinal reattachment. The change in materials has no impact on the function of these implants. -
. Materials of Construction
1
The only difference between the modified Solid Silicone and Silicone Sponge Implants is the silicone material. This difference is minor and does not affect safety or effectiveness.
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. Models Available
The models of Solid Silicone and Silicone Sponge Implants is unchanged. -
Sterility Status ●
The Solid Silicone and Silicone Sponge Implants, like the currently marketed devices, are provided sterile. -
- TESTING
- . Non-clinical Testing
Non-clinical testing was performed to show that the new material used for the manufacture of MIRA Solid Silicone and Silicone Sponge Implants is not substantially
MIRA, Inc. 510(k) for Change in Silicone Material 2/21/95
2
different from that of the original Dow Corning material. Physical testing was performed by the material supplier with results provided in FDA Master Files.
Biocompatibility .
There is no change in biocompatibility. Sterilized finished devices manufactured with new silicone material were tested for biocompatibility according to FDA "Tripartite Guidance" and according to "Table IV. Confirmatory Biological Testing" referenced in FDA "Guidance for Manufacturers of Silicone Devices Affected by Withdrawal of Dow Corning Silastic Materials. Testing demonstrated that the implants were non-toxic and biocompatible.
MIRA, Inc. 510(k) for Change in Silicone Material
2/21/95