INFINITECH BULLET ENDO ILLUMINATED PICK MANIPULATOR

K972506 · Infinitech, Inc. · HJM · Oct 1, 1997 · Ophthalmic

Device Facts

• Record ID: K972506
• Device Name: INFINITECH BULLET ENDO ILLUMINATED PICK MANIPULATOR
• Applicant: Infinitech, Inc.
• Product Code: HJM · Ophthalmic
• Decision Date: Oct 1, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1945
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Hand-held manual surgical instrument; combines pick manipulator with wide-angle fiber optic light. Used by ophthalmic surgeons during surgery to manipulate tissue and delaminate membranes. Provides illumination and mechanical manipulation capability in a single tool. Constructed of 304 stainless steel, acrylic, and fluoropolymer. Device is sterile, single-use, and intended for prescription use.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Manual surgical instrument. Materials: 304 stainless steel, acrylic, fluoropolymer. Fiber optic illumination. Validated EtO sterilization. Validated heat-sealed Tyvek packaging.

Indications for Use

Indicated for use in ophthalmic surgery for tissue manipulation and membrane delamination. No contraindications.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Peregrine Surgical Ltd. Peregrine Wide Angle Light Pipe (K940393)
• Peregrine Pic Manipulator (K940392)

Submission Summary (Full Text)

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#### Premarket Notification

OCT - 1 1997

### Infinitech. Inc. 750 Goddard Avenue Chesterfield, MO 63005 [phone]: [phone] 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<br>Characteristic | Peregrine<br>Wide Angle Light Pipe | Peregrine<br>Pic Manipulator | Infinitech<br>Wide Angle Pick Manipulator |
|--------------------------------|-----------------------------------------|------------------------------|---------------------------------------------------------|
| Device Type | Manual Wide Angle<br>Fiber Optic Light | Manual Manipulator | Manual Manipulator With<br>Wide Angle Fiber Optic Light |
| Indications for<br>Use | Ophthalmic Surgery | Ophthalmic Surgery | Ophthalmic Surgery |
| Patient Contact<br>Materials | Surgical Steel<br>Surgical Fiber Optics | Surgical Steel | 304 Stainless Steel<br>Acrylic & Fluoropolymer |
| Sterilization<br>Method | Not Known | Not Known | Validated EtO |
| Packaging | Not Known | Not Known | Validated Heat Sealed Tyvek |
| Labeling per<br>21CRF 801.109? | Not Known | Not Known | YES |

ోనేని

మూలాలు
మూలాలు

تراب بين وا

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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