(90 days)
Not Found
No
The description clearly states it is a "manual tool" and there are no mentions of AI, ML, image processing, or data sets typically associated with AI/ML devices.
Yes
Explanation: The device is a manual tool used by surgeons during ophthalmic surgery for tissue manipulation and membrane delamination, which are therapeutic procedures.
No
The device description states it is a "manual tool for aiding the procedural needs of the surgeon during ophthalmic surgery, such as tissue manipulation and membrane delamination." This clearly indicates an interventional or surgical purpose, not a diagnostic one. There is no mention of identifying or characterizing diseases or conditions.
No
The device description explicitly states it is a "Hand-held illuminated pick and membrane delamination instrument," indicating it is a physical hardware tool, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "manual tool for aiding the procedural needs of the surgeon during ophthalmic surgery, such as tissue manipulation and membrane delamination." This describes a surgical instrument used on the patient during a procedure.
- Device Description: The description reinforces this, calling it a "Hand-held illuminated pick and membrane delamination instrument for ophthalmic surgery."
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue samples) outside the body to provide information for diagnosis, monitoring, or screening. This device does not perform any such function. It is a surgical tool used directly in the surgical field.
Therefore, the Pick Manipulator is a surgical instrument, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Pick Manipulator is a manual tool for aiding the procedural needs of the surgeon during ophthalmic surgery, such as tissue manipulation and membrane delamination.
There are no contraindications for the device.
Product codes
86HJM
Device Description
Hand-held illuminated pick and membrane delamination instrument for ophthalmic surgery.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 886.1945 Transilluminator.
(a)
Identification. A transilluminator is an AC-powered or battery-powered device that is a light source intended to transmit light through tissues to aid examination of patients.(b)
Classification. (1) Class I (general controls) for the battery-powered device. The battery-powered device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.(2) Class II (special controls) for the AC-powered device. The AC-powered device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
0
Premarket Notification
OCT - 1 1997
Infinitech. Inc. 750 Goddard Avenue Chesterfield, MO 63005 (314) 532-5667: (314) 532 8059 fax
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
The following information is submitted in accordance with the requirements of 21 CFR 807.92:
Contact Person: Alan T. Beckman, Vice President, RA/OA
Date Prepared: July 2, 1997
Proprietary Names: Infinitech Bullet® Endo Illuminated Pick Manipulator
Common/Usual Name; Illuminated ophthalmic surgical instrument
Classification Name: Transilluminator, Class II per 21 CFR §886.1945, Product Code 86HJM.
Device Description/Intended Use: Hand-held illuminated pick and membrane delamination instrument for ophthalmic surgery.
Safety: The instrument is constructed of commonly used materials for ophthalmic surgical instruments and is configured in a tool geometry familiar to surgeons. The patient contact materials raise no questions regarding toxicity or biocompatibility.
Effectiveness: The instrument is constructed of commonly used materials for ophthalmic surgical instruments and is configured in a common tool geometry.
Predicate Devices: Peregrine Surgical Ltd. Peregrine Wide Angle Light Pipe (K940393) and Peregrine Pic Manipulator (K940392).
Predicate Comparison: A chart comparing the Multi-Spot Adapter to the predicate devices, demonstrating substantial equivalence, is attached.
Submitted by:
Alan 7. Behrman
Alan T. Beckman
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Device Comparison Chart
| Device
Characteristic | Peregrine
Wide Angle Light Pipe | Peregrine
Pic Manipulator | Infinitech
Wide Angle Pick Manipulator |
|--------------------------------|-----------------------------------------|------------------------------|---------------------------------------------------------|
| Device Type | Manual Wide Angle
Fiber Optic Light | Manual Manipulator | Manual Manipulator With
Wide Angle Fiber Optic Light |
| Indications for
Use | Ophthalmic Surgery | Ophthalmic Surgery | Ophthalmic Surgery |
| Patient Contact
Materials | Surgical Steel
Surgical Fiber Optics | Surgical Steel | 304 Stainless Steel
Acrylic & Fluoropolymer |
| Sterilization
Method | Not Known | Not Known | Validated EtO |
| Packaging | Not Known | Not Known | Validated Heat Sealed Tyvek |
| Labeling per
21CRF 801.109? | Not Known | Not Known | YES |
ోనేని
మూలాలు
మూలాలు
تراب بين وا
--
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes extending from its back, representing the department's mission to promote health and well-being. 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
OCT - I 1997
Mr. Alan T. Beckman Vice President, RA/QA Infinitech, Inc. 750 Goddard Avenue Chesterfield, MO 63005
K972506 Re:
Trade Name: Infinitech Bullet Endo Illuminated Pick Manipulator Regulatory Class: II Product Code: 86 HJM Dated: July 2, 1997 Received: July 3, 1997
Dear Mr. Beckman:
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. Alan T. Beckman
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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Indications for Use
Infinitech Bullet® Endo Illuminated Pick Manipulator
The Pick Manipulator is a manual tool for aiding the procedural needs of the surgeon during ophthalmic surgery, such as tissue manipulation and membrane delamination.
There are no contraindications for the device.
Kassia K. Baski Nicholas
(Division Sign-Off) Division of Ophthalmic Devices 510(k) Number_K97250 G
Prescription Use
(Per 210 CFR 3901.109)
Marsha L. Dirklicktar