The Venturi Phaco Packs are intended for use with a Bausch & Lomb Millennium, Protegé or Premiere microsurgical system for the phacoemulsification of an opacified crystalline lens during anterior segment surgery.

Device Description

The Bausch & Lomb (B&L) Phacoemulification Disposable Packs are an accessory to the Millennium, Premiere and Protege Microsurgical Systems for use in performing phacoemulification procedures. Phacoemulsification involves the ultrasonic disintegration of the opacified crystalline lens (cataract) from the eye. This process is accomplished by means of an electronically driven handpiece which: 1) emulsifies the lens, 2) facilitates the irrigation of the anterior chamber and 3) facilitates the aspiration of the emulsified lens material and irrigant from the eve

AI/ML Overview

The provided text describes a 510(k) summary for Venturi Phaco Packs, which are accessories for microsurgical systems used in phacoemulsification procedures. This document aims to demonstrate substantial equivalence to previously marketed devices rather than presenting a study to prove performance against specific acceptance criteria for a new, distinct device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and comparative effectiveness studies is not available in the provided text.

The document primarily focuses on:

Product Description: Venturi Phaco Packs are accessories for Bausch & Lomb microsurgical systems, used for ultrasonic disintegration of cataracts.
Substantial Equivalence Claim: The redesigned DP4310 and new DP4305 Venturi Phaco Packs are claimed to be substantially equivalent to existing DP4310, DP4330, and DP4345 packs.
Comparison Matrix: This table details component similarities (e.g., collection cassette, I/A tube set, sterilization method, intended use, sterility assurance level, single-use nature) between the currently marketed and proposed packs. The key differences noted are the quantity of some components (e.g., Test Chamber, Irrigation Sleeve) and the inclusion/exclusion of Phaco Needle and 2.5mm Slit Knife in specific packs.
Intended Use: "The Venturi Phaco Packs are intended for use with a Bausch & Lomb Millennium, Protegé or Premiere microsurgical system for the phacoemulsification of an opacified crystalline lens during anterior segment surgery."
Regulatory Clearance: The document includes the FDA's 510(k) clearance letter, indicating that the device is substantially equivalent to legally marketed predicate devices.

In summary, the provided text does not contain the detailed study information requested, as it is a 510(k) submission for substantial equivalence based on component comparison and intended use, rather than a de novo clinical performance study against specified acceptance criteria.

Summary

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DEC 1 7 2003

K033653

Venturi Phaco Packs

510(k) SUMMARY (per 21 CFR §807.92)

Submitter's Name:Address:	Bausch & Lomb3365 Tree Court Industrial Blvd.St. Louis, MO 63122
Telephone #:Fax #:	(636) 226-3183(636) 226-3245
Official Correspondent:	Dennis PozzoRegulatory Affairs Specialist
Date Summary Prepared:	November 13, 2003
Device Name/Proprietary name:	Venturi Phaco Packs
Classification/Common Name	Phaco Packs
Class:	II
Panel:	Ophthalmic
Product Code:	HQC

The marketed device(s) to which substantial equivalence is claimed: Venturi Phaco Packs

PRODUCT DESCRIPTION:

The Bausch & Lomb (B&L) Phacoemulification Disposable Packs are an accessory to the Millennium, Premiere and Protege Microsurgical Systems for use in performing phacoemulsification procedures. Phacoemulsification involves the ultrasonic disintegration of the opacified crystalline lens (cataract) from the eye. This process is accomplished by means of an electronically driven handpiece which: 1) emulsifies the lens, 2) facilitates the irrigation of the anterior chamber and 3) facilitates the aspiration of the emulsified lens material and irrigant from the eve

Substantial Equivalent Basis

The modified DP4310 and new DP4305 Venturi Phaco Packs are substantially equivalent to the existing DP4310 (K955901) and DP4330 and DP4345 (combination K952259). See Comparison Matrix.

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Comparison Matrix

Components	Currently MarketedDP4310 Pack	Currently MarketedDP4330 & DP4345Pack	Proposed DP4310Pack	Proposed DP4305Pack
Collection Cassette	X	X	X	X
I/A Tube Set	X	X	X	X
Test Chamber	X (2ea)	X (2ea)	X (1ea)	X (1ea)
Irrigation Sleeve	X (2ea.)	X (2ea.)	X (2ea.)	X (1ea.)
Needle Wrench	X	X	X	X
Filter IrrigationAdministration Set	X	X	X	X
Tray Support Cover	X	X	X	X
Auxiliary Drape	X	X	X	X
Cassette Stopper andCap	X	X	X	X
Remote Control Drape	X	X	X	X
Instructions(Directions for Use)	X	X	X	X
Phaco Needle		X
2.5mm Slit Knife		X
Components	Currently MarketedDP4310 Pack	Currently MarketedDP4330 & DP4345Pack	Proposed DP4310Pack	Proposed DP4305Pack
Intended Use	Phaco packs used foranterior segmentsurgery with Bauschand LombMicrosurgicalSystems, such as theMillennium, Protégé,and Premiere.	Phaco packs used foranterior segmentsurgery with Bauschand LombMicrosurgicalSystems, such as theMillennium, Protégé,and Premiere.	Phaco packs used foranterior segmentsurgery with Bauschand LombMicrosurgicalSystems, such as theMillennium, Protégé,and Premiere.	Phaco packs used foranterior segmentsurgery with Bauschand LombMicrosurgicalSystems, such as theMillennium, Protégé,and Premiere.
SterilizationMethod	Gamma	Gamma	Gamma	Gamma
Sterility AssuranceLevel	$10^{-6}$	$10^{-6}$	$10^{-6}$	$10^{-6}$
Single Use	Yes	Yes	Yes	Yes

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Statement of Indications for Use

The Venturi Phaco Packs are intended for use with a Bausch & Lomb Millennium, Protege or Premiere microsurgical system for the phacoemulsification of an opacified crystalline lens during anterior segment surgery.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three wing-like shapes above a wavy line, representing water or movement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 7 2003

Bausch & Lomb, Inc. c/o Mr. Dennis Pozzo Regulatory Affairs Specialist 3365 Tree Court Industrial Blvd. St. Louis, MO 63122

Re: K033653

Trade/Device Name: Venturi Phaco Pack Regulation Number: 21 CFR 886.4670 Regulation Name: Phacofragmentation system Regulatory Class: Class II Product Code: HQC Dated: November 18, 2003 Received: November 21, 2003

Dear Mr. Pozzo:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be four d in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Dennis Pozzo

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

A Ralph Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(K) Number – K033653

Device Name: Venturi Phaco Pack

Indications for Use:

(Please do not write below this line - continue on another Page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	X
	OR Over-the-Counter Use

(Division Sign-Off)	Clay R. Buttemere
	(Division Sign Off)
	Division of Ophthalmic Ear, Nose and Throat Cavities

510(k) Number	K033
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K033653

Bausch & Lomb Surgical	510(k) Number
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Regulation Number and Section

§ 886.4670 Phacofragmentation system.

(a)
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.(b)
Classification. Class II.