(199 days)
Not Found
Not Found
No
The provided 510(k) summary contains no mention of AI, ML, image processing, or any other terms typically associated with AI/ML technology in medical devices.
Yes
The Intended Use section clearly states that the device is for "surgical intervention to reattach the retina and preserve/reserve the patient's vision," which describes a therapeutic action.
No
The intended use describes a surgical intervention to reattach the retina, which is a treatment, not a diagnostic process.
Unknown
The provided 510(k) summary lacks a device description, which is crucial for determining if the device is software-only or includes hardware components.
Based on the information provided, it is highly unlikely that this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Retinal detachment requiring surgical intervention to reattach the retina and preserve/reserve the patient's vision." This describes a surgical procedure and its goal, not a diagnostic test performed on samples taken from the body.
- Lack of IVD Indicators: The provided information lacks any of the typical characteristics of an IVD:
- No mention of samples: IVDs analyze biological samples (blood, urine, tissue, etc.). There is no mention of samples here.
- No mention of diagnostic testing: The focus is on surgical intervention and preserving vision, not on diagnosing the condition itself (which would likely be done prior to considering this device).
- No mention of analytical or clinical performance metrics relevant to diagnostics: Metrics like sensitivity, specificity, AUC, etc., are crucial for evaluating the performance of diagnostic tests. These are listed as "Not Found."
Conclusion:
The intended use and the absence of any information related to sample analysis or diagnostic testing strongly suggest that this device is a surgical device or instrument used during or for the surgical treatment of retinal detachment, rather than a device used to diagnose retinal detachment.
Therefore, it is not an IVD.
N/A
Intended Use / Indications for Use
Retinal detachment requiring surgical intervention to reattach the retina and preserve/reserve the patient's vision
Product codes
86 HQX
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Retina
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three tail feathers. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 8 1998
Ms. Anne Bohsack Vice President, General Manager FCI Ophthalmics, INC. P.O. Box 465 Marshfield Hills, MA 02051
K980816 Re: Trade Name: Retinal Detachment Implants Regulatory Class: II Product Code: 86 HQX Dated: July 31, 1998 Received: August 3, 1998
Dear Ms. Bohsack:
We have reviewed your Section 510(k) notification of intent to market the device referenced We have reviewed your Section 310(ts) noticelly equivalent (for the indications for above and we have determined the ocvice is seed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been the enactment unte of the Medical Device 11.1.6 Easy of Food, Drug, and Cosmetic Act reclassified in accordance with the provisions on the general controls provisions of the (Act). You may, therefore, market the actives requirements for annual registration,
Act. The general controls provisions of the Act include requirements for annual mishanding Act. I he general controls provisions of ractice, 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 (I remarket reproval), it they be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Farls 600 to 0731 11 Jacouning Practice requirements, as set forth in the Quality System Current Good Hamanaceaning Frices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such periodio Q . Inspections 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.
1
Page 2 - Ms. Anne Bohsack
This letter will allow you to hegin 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. lorenttal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
K980816 . 510(k) Number (if known): _ Retinal Detachment Implants - :: Device Name:
Indications For Use:
Retinal detachment requiring surgical intervention to reattach the retina and preserve/reserve the patient's vision
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Ophthalmic Devices | |
| 510(k) Number | K980816 |
| Prescription Use
| (Per 21 CFR 801.109) | X | OR | Over-The-Counter Use |
|---|---|---|---|
| ------------------------------------------ | ------------------------------------------ | ---- | ---------------------- |
(Optional Format 1-2-96)3