VENTURI PHACO PACK

K033653 · Bausch & Lomb, Inc. · HQC · Dec 17, 2003 · Ophthalmic

Device Facts

• Record ID: K033653
• Device Name: VENTURI PHACO PACK
• Applicant: Bausch & Lomb, Inc.
• Product Code: HQC · Ophthalmic
• Decision Date: Dec 17, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 886.4670
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Venturi Phaco Packs are disposable accessory kits for Bausch & Lomb Millennium, Premiere, and Protege microsurgical systems. Used during cataract surgery, these packs facilitate phacoemulsification—the ultrasonic disintegration of opacified crystalline lenses. The system uses an electronically driven handpiece to emulsify the lens, irrigate the anterior chamber, and aspirate emulsified material and irrigant. The pack includes a collection cassette, I/A tube set, test chamber, irrigation sleeve, needle wrench, filter irrigation administration set, tray support cover, auxiliary drape, cassette stopper/cap, and remote control drape. The device is used in an operating room setting by ophthalmic surgeons. The disposable components ensure sterility and proper fluidics management during the procedure, supporting the surgeon's control over the phacoemulsification process to safely remove cataracts.

Clinical Evidence

No clinical data. Substantial equivalence is based on bench testing and comparison of technological characteristics to legally marketed predicate devices.

Technological Characteristics

Disposable phacoemulsification accessory kit. Components include collection cassette, I/A tubing, irrigation sleeves, and drapes. Sterilized via gamma radiation to a sterility assurance level of 10^-6. Single-use. Designed for integration with Bausch & Lomb Millennium, Premiere, and Protege microsurgical systems.

Indications for Use

Indicated for patients undergoing anterior segment surgery requiring phacoemulsification of an opacified crystalline lens (cataract).

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.

Predicate Devices

• DP4310 (K955901)
• DP4330 (K952259)
• DP4345 (K952259)

Submission Summary (Full Text)

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# DEC 1 7 2003

K033653

#### Venturi Phaco Packs

## 510(k) SUMMARY (per 21 CFR §807.92)

| Submitter's Name:<br>Address: | Bausch & Lomb<br>3365 Tree Court Industrial Blvd.<br>St. Louis, MO 63122 |
|-----------------------------------|--------------------------------------------------------------------------|
| Telephone #:<br>Fax #: | [phone]<br>[phone] |
| Official Correspondent: | Dennis Pozzo<br>Regulatory Affairs Specialist |
| Date Summary Prepared: | November 13, 2003 |
| Device Name/<br>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 Marketed<br>DP4310 Pack | Currently Marketed<br>DP4330 & DP4345<br>Pack | Proposed DP4310<br>Pack | Proposed DP4305<br>Pack |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 Irrigation<br>Administration Set | X | X | X | X |
| Tray Support Cover | X | X | X | X |
| Auxiliary Drape | X | X | X | X |
| Cassette Stopper and<br>Cap | X | X | X | X |
| Remote Control Drape | X | X | X | X |
| Instructions<br>(Directions for Use) | X | X | X | X |
| Phaco Needle | | X | | |
| 2.5mm Slit Knife | | X | | |
| Components | Currently Marketed<br>DP4310 Pack | Currently Marketed<br>DP4330 & DP4345<br>Pack | Proposed DP4310<br>Pack | Proposed DP4305<br>Pack |
| Intended Use | Phaco packs used for<br>anterior segment<br>surgery with Bausch<br>and Lomb<br>Microsurgical<br>Systems, such as the<br>Millennium, Protégé,<br>and Premiere. | Phaco packs used for<br>anterior segment<br>surgery with Bausch<br>and Lomb<br>Microsurgical<br>Systems, such as the<br>Millennium, Protégé,<br>and Premiere. | Phaco packs used for<br>anterior segment<br>surgery with Bausch<br>and Lomb<br>Microsurgical<br>Systems, such as the<br>Millennium, Protégé,<br>and Premiere. | Phaco packs used for<br>anterior segment<br>surgery with Bausch<br>and Lomb<br>Microsurgical<br>Systems, such as the<br>Millennium, Protégé,<br>and Premiere. |
| Sterilization<br>Method | Gamma | Gamma | Gamma | Gamma |
| Sterility Assurance<br>Level | $10^{-6}$ | $10^{-6}$ | $10^{-6}$ | $10^{-6}$ |
| 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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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 [phone]. 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 [phone] or [phone] 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:

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.

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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 |
|---------------|------|
|---------------|------|

K033653

| Bausch & Lomb Surgical | 510(k) Number |
|------------------------|---------------|
|------------------------|---------------|