(90 days)
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.
Hand-held illuminated pick and membrane delamination instrument for ophthalmic surgery.
The Infinitech Bullet® Endo Illuminated Pick Manipulator is a manual tool intended for ophthalmic surgery, specifically for tissue manipulation and membrane delamination. The provided 510(k) summary does not include a detailed study proving the device meets specific acceptance criteria in terms of performance metrics like sensitivity, specificity, or any quantitative measure of effectiveness.
Instead, the submission focuses on demonstrating substantial equivalence to predicate devices based on device type, intended use, patient contact materials, and manufacturing/sterilization processes. The concept of "effectiveness" mentioned in the summary is broad and stated as: "The instrument is constructed of commonly used materials for ophthalmic surgical instruments and is configured in a common tool geometry." This implies that its effectiveness is assumed based on its similarity to existing, legally marketed devices.
Therefore, many of the requested details about acceptance criteria, study design, and performance metrics cannot be found in the provided document because the 510(k) pathway for this device did not require such a study to demonstrate performance against explicit acceptance criteria.
Below is the information that can be extracted from the provided text:
1. A table of acceptance criteria and the reported device performance
Based on the provided document, there are no explicit quantitative acceptance criteria or detailed performance metrics reported for the Infinitech Bullet® Endo Illuminated Pick Manipulator. The "effectiveness" is stated qualitatively by comparing it to predicate devices. The acceptance was based on "substantial equivalence" to predicate devices.
| Acceptance Characteristic | Predicate Device Information | Infinitech Bullet® Endo Illuminated Pick Manipulator Reported Performance |
|---|---|---|
| Device Type | Peregrine Wide Angle Light Pipe: Manual Wide Angle Fiber Optic Light Peregrine Pic Manipulator: Manual Manipulator | Manual Manipulator With Wide Angle Fiber Optic Light |
| Indications for Use | Ophthalmic Surgery (for both predicate devices) | Ophthalmic Surgery (specifically tissue manipulation and membrane delamination) |
| Patient Contact Materials | Peregrine Wide Angle Light Pipe: Surgical Steel, Surgical Fiber Optics Peregrine Pic Manipulator: Surgical Steel | 304 Stainless Steel, Acrylic & Fluoropolymer |
| Sterilization Method | Not Known (for both predicate devices) | Validated EtO |
| Packaging | Not Known (for both predicate devices) | Validated Heat Sealed Tyvek |
| Labeling | Not Known (for both predicate devices) | YES (per 21CRF 801.109) |
| Safety | The predicate devices were legally marketed. | "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 predicate devices were legally marketed. | "The instrument is constructed of commonly used materials for ophthalmic surgical instruments and is configured in a common tool geometry." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No clinical or performance study involving a test set with human or patient data is described in the provided document for the purpose of demonstrating device performance against specific metrics. The device's substantial equivalence was based on a comparison of its design and intended use to existing predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No ground truth establishment by experts for a test set is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No adjudication method is mentioned as there was no test set in the context of device performance evaluation.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a manual surgical instrument, not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a manual surgical instrument and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No ground truth in the context of performance evaluation was used or described.
8. The sample size for the training set
Not applicable. This is a manual surgical instrument; there is no training set involved in the context of machine learning or algorithm development.
9. How the ground truth for the training set was established
Not applicable. As there is no training set mentioned, the establishment of ground truth for it is not relevant.
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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
| DeviceCharacteristic | PeregrineWide Angle Light Pipe | PeregrinePic Manipulator | InfinitechWide Angle Pick Manipulator |
|---|---|---|---|
| Device Type | Manual Wide AngleFiber Optic Light | Manual Manipulator | Manual Manipulator WithWide Angle Fiber Optic Light |
| Indications forUse | Ophthalmic Surgery | Ophthalmic Surgery | Ophthalmic Surgery |
| Patient ContactMaterials | Surgical SteelSurgical Fiber Optics | Surgical Steel | 304 Stainless SteelAcrylic & Fluoropolymer |
| SterilizationMethod | Not Known | Not Known | Validated EtO |
| Packaging | Not Known | Not Known | Validated Heat Sealed Tyvek |
| Labeling per21CRF 801.109? | Not Known | Not Known | YES |
ోనేని
మూలాలు
మూలాలు
تراب بين وا
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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
§ 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.