(158 days)
Not Found
No
The summary describes a physical implant and conformer made of hydroxyapatite and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes.
The device is described as an ocular implant and conformer intended to occupy space or maintain space in the orbital cavity following surgical removal of eyeball contents or other ocular procedures, indicating a therapeutic purpose in anatomical restoration and healing.
No
The device is an implant and conformer used to occupy space in the eye socket after removal of the eyeball contents, and to maintain space during healing, respectively. These are therapeutic and supportive devices, not diagnostic ones.
No
The device description clearly states the device is an "eye sphere implant manufactured of hydroxyapatite" and an "Ophthalmic Conformer," which are physical, implantable devices, not software.
Based on the provided text, 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 Bio-eye Hydroxyapatite Ocular Implant and Ophthalmic Conformer are physical implants and conformers intended to be surgically placed within the eye and orbital cavity. They are not used to analyze samples from the body.
- Intended Use: The intended use clearly states that the devices are for occupying space following removal of the eyeball contents and maintaining space during healing. This is a surgical and prosthetic function, not a diagnostic one.
- Device Description: The description focuses on the material (hydroxyapatite) and manufacturing process of the implants and conformer, not on any analytical or testing capabilities.
Therefore, the Bio-eye Hydroxyapatite Ocular Implant and Ophthalmic Conformer fall under the category of surgical implants and accessories, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Bio-eye Hydroxyapatite Ocular Implant is intended to be implanted in the eyeball to occupy space following removal of the contents of the eyeball. The Ophthalmic Conformer is intended to be inserted temporarily between the eyeball and eyelid to maintain space in the orbital cavity during the healing process following surgery.
Product codes
86 HPZ
Device Description
Both the Motility Orbital Implant and the Bio-eye Hydroxyapatite Ocular Implant are eye sphere implants manufactured of hydroxyapatite. The Bio-eve Hydroxyapatite Ocular Implant will now be provided sterile. The Ophthalmic Conformer is used in conjunction with the Ocular Implant for ocular prosthesis and will also be supplied sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Eyeball, orbital cavity
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 applicable.
Key Metrics
Not Found
Predicate Device(s)
Motility Orbital Implant K891137, Ophthalmic Conformer K945110, Interpore 200 Porous Hydroxyapatite K860983.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 886.3320 Eye sphere implant.
(a)
Identification. An eye sphere implant is a device intended to be implanted in the eyeball to occupy space following the removal of the contents of the eyeball with the sclera left intact.(b)
Classification. Class II (special controls). The device, when it is an ocular peg which is supplied sterile only, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
0
DEC 28 1998
Image /page/0/Picture/1 description: The image shows a logo with the letters "IDI" in a stylized, blocky font. The "D" in the center is formed by a semi-circular shape with a solid black circle in the middle, creating a unique design. The letters are bold and outlined, giving them a strong visual presence.
INTEGRATED ORBITAL IMPLANTS, INC.
510(k) SUMMARY as required by 807.92(c) Bio-eve® Hydroxyapatite Ocular Implant and Conformer
SUBMITTER'S NAME, ADDRESS, TELEPHONE AND FAX NUMBER: 1. Integrated Orbital Implants, Inc. 12526 High Bluff Dr., Suite 300 San Diego, CA 92130-2067 Telephone: 619-792-3565 Fax: 619-259-6277 CONTACT PERSON: Jeanne Dunham, President Bioserv Corporation Telephone: 619-450-3123 Fax: 619-450-0785 DATE SUMMARY PREPARED: July 10, 1998 2. NAME OF DEVICE: Bio-eye® Hydroxyapatite Ocular Implant and PROPRIETARY NAME: Conformer COMMON/USUAL NAME: Eye sphere implant Ophthalmic Conformer CLASSIFICATION NAME: Eye sphere implant, 21 CFR 886.3320, Class II Ophthalmic conformer, 21 CFR 886.3130, Class II PREDICATE DEVICE: Motility Orbital Implant K891137 3. Ophthalmic Conformer K945110 (510(k) exempt Federal Register 1-21-98) Interpore 200 Porous Hydroxyapatite K860983.
- DESCRIPTION OF DEVICE: Both the Motility Orbital Implant and the Bio-eye 4. Hydroxyapatite Ocular Implant are eye sphere implants manufactured of hydroxyapatite. The Bio-eve Hydroxyapatite Ocular Implant will now be provided sterile. The Ophthalmic Conformer is used in conjunction with the Ocular Implant for ocular prosthesis and will also be supplied sterile.
-
- INTENDED USE: The Bio-eye Hydroxyapatite Ocular Implant is intended to be implanted in the eyeball to occupy space following removal of the contents of the eyeball. The Ophthalmic Conformer is intended to be inserted temporarily between the eyeball and eyelid to maintain space in the orbital cavity during the healing process following surgery.
1
INTEGRATED ORBITAL IMPLANTS, INC.
Bio-eve® Hydroxvapatite Ocular Implant and Conformer 510(k) SUMMARY page 2 of 2
- TECHNOLOGICAL CHARACTERISTICS: The technological characteristics of the 6. Ocular Implant are the same as the predicate: Both Implants are manufactured of porous hydroxyapatite. It is a synthetic hydroxyapatite which is similar in composition to the mineral content of human bone. The implant material has a unique interconnected porous matrix derived from specific marine corals. A patented manufacturing process preserves the porous structure of the coral while the calcium carbonate skeleton undergoes a hydrothermal chemical conversion to hydroxyapatite. The Bio-eye Hydroxyapatite Ocular Implant will now be supplied sterile.
The Interpore 200 Porous Hydroxyapatite is identical to the Motility Orbital Implant described above. Interpore is the manufacturer and supplier of the Motility Orbital Implant. The Interpore 200 Porous Hydroxyapatite is sterilized by gamma radiation and is supplied sterile.
The Ophthalmic Conformer, which is now 510(k) exempt (Federal Register 1-21-98), will now be supplied sterile.
-
- SUMMARY OF PERFORMANCE DATA: Not applicable.
- CONCLUSIONS DRAWN FROM NONCLINICAL AND CLINICAL TESTS: Not 8. applicable.
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Image /page/2/Picture/2 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or bird-like figure, with its wings forming three curved lines.
DEC 28 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Integrated Orbital Implants, Inc. Ms. Jeanne Dunham President Bioserv Corporation 5340 Eastgate Mall San Diego, CA 92121
Re: K982562
Trade Name: Bio-eye ® Hydroxyapatite Ocular Implant and Conformer Regulatory Class: II Product Code: 86 HPZ Dated: November 3, 1998 Received: November 5, 1998
Dear Ms. Dunham:
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 (OS) 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 .
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Page 2 - Ms. Jeanne Dunham, President
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,
ARoeyl Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Bio-eye Hydroxyapatite Ocular Implant and Conformer Integrated Orbital Implants, Inc. July 1998
No 510(k) Number has been issued
Bio-eve® Hydroxyapatite Ocular Implant and Conformer Device Name:
Indications for Use:
The Bio-eye Hydroxyapatite Ocular Implant is indicated as a primary implant in cases of enucleation and evisceration, and as a secondary implant in cases of poor performance of a primary implant, such as in cases of poor motility, migration, extrusion, chronic infection, enophthalmos, and lid sag. The device is indicated in any situation where silicone, acrylic, polyethylene, glass, or other traditional ocular implants are used.
The Conformer is indicated in all cases in which an orbital implant is used.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Ophthalmic Devices
510(k) Number.
Prescription Use V
OR
Over-The-Counter Use _
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
Prescription Use . (Per 21 CFR 801.109)