(232 days)
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Not Found
No
The description details a physical, molded device with no mention of software, algorithms, or data processing, which are typically associated with AI/ML.
Yes
The device is used to prevent closure or adhesion during the healing process after eye surgery, which directly contributes to the restoration or maintenance of the eye's function and health.
No
The device prevents closure or adhesion during the healing process, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a physical, molded device made of polymethyl methacrylate, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to be used post eye surgery to prevent closure or adhesion during the healing process. This is a physical, mechanical function performed in vivo (within the body).
- Device Description: The description details a physical, molded device that is placed between the orbit and the eyelid to cause separation. This is a physical intervention, not a test performed on a sample in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in a sample
- Providing diagnostic information about a disease or condition
IVDs are devices used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This ophthalmic conformer does not fit that description.
N/A
Intended Use / Indications for Use
The ophthalmic conformer is intended to be used as a post eye surgery device to prevent closure or adhesion during the healing process.
Product codes
86 HQN
Device Description
An ophthalmic conformer is used after surgery on the eye to prevent closure or adhesion. It is a cup shaped device that is slipped between the orbit and the eye lid to cause separation. Its inner surface is formed to approximate the outer curvature of the eye.
The ophthalmic conformer of this 510(k) is molded of Class VI. medical grade polymethyl methacrylate. It is sold in three sizes and it is sold non-sterile
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
eye
Indicated Patient Age Range
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
Not Found
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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
K9712034
Image /page/0/Picture/1 description: The image shows the logo for Porex Surgical Inc. The logo consists of a square grid pattern with a circle in the center on the left side. To the right of the grid is the word "POREX" in large, bold letters, with the words "SURGICAL INC." in smaller letters underneath.
4715 Roosevelt Highway, College Park, GA 30349-2417 USA (404) 969-8145 · (800) 521-7321 · Fax: (404) 969-8045
JAN 20 1998
510(k) SUMMARY
Manufacturer and Submitter
Porex Surgical, Inc. 4715 Roosevelt Highway College Park, GA 30349
Tel: (770) 969-8145 Fax: (770) 969-8045
Contact: Howard Mercer, Ph.D.
Date: Mav 30. 1997
Trade Name: MEDPOR® Ocular Conformer Classification Name: Ophthalmic Conformer - Class II Device
Substantially equivalent to: A) Ophthalmic Conformer marketed by Wilson Ophthalmic Corp.
Device description:
An ophthalmic conformer is used after surgery on the eye to prevent closure or adhesion. It is a cup shaped device that is slipped between the orbit and the eye lid to cause separation. Its inner surface is formed to approximate the outer curvature of the eye.
The ophthalmic conformer of this 510(k) is molded of Class VI. medical grade polymethyl methacrylate. It is sold in three sizes and it is sold non-sterile
Comparison with predicate device
The device of this submission is identical to the predicate device in all aspects except for minor dimensional changes
1
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" around the top half of the circle. In the center of the logo is a stylized image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 20 1998
Howard A. Mercer, Ph.D. c/o Porex Technologies 500 Bohannon Road Fairburn, GA 30213-2828
Re: K972034 Trade Name: Medpor Ocular Conformer Regulatory Class: II Product Code: 86 HQN Dated: November 7, 1997 Received: November 10, 1997
Dear Dr. Mercer: . . .
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. Howard Mercer
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 forenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number : K972034
Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications for Use:
The ophthalmic conformer is intended to be used as a post eye surgery device to prevent closure or adhesion during the healing process.
(PLEASE DO NOT WRITE BELOW THIS LINE)
Daine R. Lochner.
(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number K972034
Prescription Use: X
(Per 21CFR801.109_
OR
Over the Counter Use: ________________________________________________________________________________________________________________________________________________________