(160 days)
Conformer, is fabricated for the needs of a specific patient. Each is uniquely designed, fabricated, and fitted past-enucleation surgery, to maintain correct eye lid/socket configuration. In the other cases, to correct deformities of the eyelids, and/or socket. They are also fitted in a necessarily, sequential, increasing size, for infants afflicted with anophthalmia, or micro-ophthalmia, or in infants previous to the trauma or other socket and eyelid anomalies. Proper expansion therapy, with the use of sequential, increasing size conformers, is essential in eyelid development in infants and children.
Not Found
This document is a 510(k) clearance letter from the FDA for an "Ocular Conformer" device, dated July 7, 1997. It explicitly states that the FDA has determined the device is "substantially equivalent" to predicate devices marketed prior to May 28, 1976.
Based on the content, this letter does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria. The 510(k) clearance process for this type of device typically focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials with specific performance metrics and acceptance criteria as would be expected for novel devices or those undergoing PMA.
Therefore, I cannot provide the requested table and study details. This document simply indicates market clearance based on substantial equivalence.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Daniel M. Wenske Southwest Artificial Eyes 4640 Centerview -San Antonio, TX 78229
JUL - 7 1097
K970318 Re:
Trade Name: Ocular Conformer Regulatory Class: II Product Code: 86 HQN Dated: April 15, 1997 Received: April 21, 1997
Dear Mr. Wenske:
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.
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Page 2 - Mr. Daniel M. Wenske
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. Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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5 10(k) Number (il known): K970318
Ocular Conformer Ocvice Name:
Indications I-or Use:
Conformer, is fabricated for the needs of a The Custom specific patient. Each is uniquely designed, fabricated, and Specific past-enucleation surgery, to maintain correct eye lid/socket configuration. In the other cases, to correct deformities of the eyelids, and/or socket. They are also fitted in a necessarily, sequential, increasing size, for infants afflicted with anophthalmia, or micro-ophthalmia, rol inrants arrivous no the trauma or other socket and eyelid anomalies. Proper expansion therapy, with the use of anomatics. proper expansion checapyress, is essential in
sequential, increasing size conformers, and evelop sequential, increasing size conformers) is occided on eyelid development in infants and children.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED!
Concurrence of CORH, Office of Device Evaluation (ODE)
intessiption lise 1Pcc 21 CFR 201 1031
门:
Over The Counter Use
(Optional Formal 1.2-90)
Dame (Schner Division Sign-Off) vision of Ophthalmic Devices
Number K970318
§ 886.3130 Ophthalmic conformer.
(a)
Identification. An ophthalmic conformer is a device usually made of molded plastic intended to be inserted temporarily between the eyeball and eyelid to maintain space in the orbital cavity and prevent closure or adhesions during the healing process following surgery. ](b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9.