SURGIN KIT

K980849 · Surgin Surgical Instrumentation, Inc. · MSR · Jul 9, 1998 · Ophthalmic

Device Facts

• Record ID: K980849
• Device Name: SURGIN KIT
• Applicant: Surgin Surgical Instrumentation, Inc.
• Product Code: MSR · Ophthalmic
• Decision Date: Jul 9, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This product is indicated for use with the Alcon Series 20,000 Legacy Phacoemulsifier. It may be utilized in phaco procedures in which either combined or segregated automated irrigation and aspiration is deemed appropriate.

Device Story

Surgin Kit is an ophthalmic surgical accessory kit designed for use with the Alcon Series 20,000 Legacy Phacoemulsifier. The kit provides necessary components for automated irrigation and aspiration during phacoemulsification procedures. It is intended for use by ophthalmic surgeons in a clinical or surgical setting. The device functions as a fluidics management system, facilitating the delivery of irrigation fluid to the eye and the aspiration of lens material during cataract surgery. By maintaining anterior chamber stability through controlled irrigation and aspiration, the kit supports the surgeon in performing phacoemulsification, potentially improving surgical efficiency and patient outcomes.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Ophthalmic surgical kit containing components for irrigation and aspiration. Designed for compatibility with the Alcon Series 20,000 Legacy Phacoemulsifier. Mechanical fluidics system; no electronic or software components.

Indications for Use

Indicated for patients undergoing phacoemulsification procedures requiring automated irrigation and aspiration, specifically for use with the Alcon Series 20,000 Legacy Phacoemulsifier.

Regulatory Classification

Identification

A vitreous aspiration and cutting instrument is an electrically powered device, which may use ultrasound, intended to remove vitreous matter from the vitreous cavity or remove a crystalline lens.

Special Controls

*Classification.* Class II (special controls). The device, when it is phacofragmentation unit replacement tubing, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

Reference Devices

• Alcon Series 20,000 Legacy Phacoemulsifier

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

TUT - a 1998

Don W. Haar QA/RA Manager Surgin Inc. 14762 Bentley Circle Tustin, CA 92680

Re: K980849 Trade Name: Surgin Kit Regulatory Class: II Product Code: 86 MSR Dated: June 22, 1998 Received: June 24, 1998

Dear Mr. Haar:

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. Don W. Haar

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 Roerl lorentbal

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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## Surgin, Inc

14762 Bentley Circle Tustin, CA 92680 Tel: [phone]

## INDICATIONS FOR USE STATEMENT

510(k) Number (11known): N / A

Device Name: OPHTHALMIC KIT

## Indications For Use:

This product is indicated for use with the Alcon Series 20,000 Legacy Phacoemulsifier. It may be utilized in phaco procedures in which either combined or segregated automated irrigation and aspiration is deemed appropriate.

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Concurrance of CDRH, Office of Device Evaluation (ODE)

| | <img alt="Signature" src="signature.jpg"/> <div>(Division Sign-Off)</div> <div>Division of Ophthalmic Devices</div> <div>510(k) Number K980849</div> |
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| Prescription Use (Per 21 CFR 801.109) | <img alt="Checkmark" src="checkmark.jpg"/> | OR | Over-The-Counter Use |
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(Optional Format 1-2-96)