AUTOMATED CHAMBER MAINTENANCE MODULE

K971795 · Paradigm Medical Industries, Inc. · HQC · Jul 14, 1997 · Ophthalmic

Device Facts

• Record ID: K971795
• Device Name: AUTOMATED CHAMBER MAINTENANCE MODULE
• Applicant: Paradigm Medical Industries, Inc.
• Product Code: HQC · Ophthalmic
• Decision Date: Jul 14, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4670
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ACM Module is an accessory device incorporated in the aspiration line behind the handpiece to neutralize vacuum surge during phacoemulsification.

Device Story

The Automated Chamber Maintenance (ACM) Module is an accessory device for phacoemulsification systems. It is installed in the aspiration line, positioned behind the handpiece. Its primary function is to neutralize vacuum surge during surgery, which helps maintain anterior chamber stability. The device is used in an ophthalmic surgical setting by a surgeon or surgical staff. By mitigating vacuum fluctuations, it aims to prevent chamber collapse, thereby improving safety and control during cataract extraction procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Accessory device for phacoemulsification aspiration lines. Mechanical design intended for vacuum surge neutralization. No specific materials, software, or energy sources described.

Indications for Use

Indicated for use as an accessory in the aspiration line during phacoemulsification procedures to neutralize vacuum surge.

Regulatory Classification

Identification

A phacofragmentation system is an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUL 1 4 1997

Mr. Richard Dirkson ------------Director of Regulatory/Quality Affairs Paradigm Medical Industries, Inc. 1772 West 2900 South Salt Lake City, UT 84119

Re: K971795 Trade Name: Automated Chamber Maintenance (ACM) Module Regulatory Class: II Product Code: 86 HQC Dated: May 13, 1997 Received: May 15, 1997

Dear Mr. Dirkson:

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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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. Richard Dirkson

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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K971795

## STATEMENT OF INDICATION FOR USE

510(K) Number: Unknown ACM Module Device Name:

Indications for use: The ACM Module is an accessory device incorporated in the aspiration line behind the handpiece to neutralize vacuum surge during phacoemulsification.

Emenetta T. Beene
Division Sign-Off

Division of Ophthalmic Devices
510(k) Number K971795

Prescription Use
(Per 21 CFR 801.109)

(Per 21 CFR 801.109)