PHACO CHOP NEEDLES

K041998 · Bausch & Lomb, Inc. · HQC · Aug 16, 2004 · Ophthalmic

Device Facts

• Record ID: K041998
• Device Name: PHACO CHOP NEEDLES
• Applicant: Bausch & Lomb, Inc.
• Product Code: HQC · Ophthalmic
• Decision Date: Aug 16, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 886.4670
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Phaco Needles are intended for use with a Bausch & Lomb Millennium, Protegé or Premiere Microsurgical System for the emulsification of an opacified crystalline lens.

Device Story

Phaco Chop Needle is a cylindrical metal tip for phacoemulsification handpieces; used in anterior segment surgery. Device connects to distal end of ultrasonic handpiece; contacts and fragments cataractous crystalline lens. Irrigation fluid flows around needle exterior; emulsified lens material and irrigant aspirated through needle lumen. Designed for reusable use; internal restriction located deeper within needle bore compared to predicate needles. Operated by ophthalmologists in clinical/surgical settings. Output is physical fragmentation of lens material; assists surgeon in cataract removal; benefits patient by facilitating lens emulsification.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Cylindrical metal phacoemulsification needle; reusable; 30 and 45-degree tip angles; 0.042 inch outer diameter; 0.036 inch inner diameter. Connects to Bausch & Lomb Millennium, Protegé, or Premiere Microsurgical Systems. Ultrasonic energy source.

Indications for Use

Indicated for patients undergoing anterior segment surgery requiring emulsification of an opacified crystalline lens using Bausch & Lomb microsurgical systems.

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

• Bausch & Lomb Standard Phaco Needle
• Bausch & Lomb MicroFlow Phaco Needle
• Bausch & Lomb MicroFlow+ Phaco Needle

Submission Summary (Full Text)

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# (041998

## AUG 1 6 2004

## Phaco Chop Needle

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

| Submitter's Name: | Bausch & Lomb |
|-----------------------------------|-------------------------------------------------------|
| Address: | 3365 Tree Court Industrial Blvd. St. Louis, MO 63122 |
| Telephone #: | [phone] |
| Fax #: | [phone] |
| Official Correspondent: | Dennis Pozzo<br>Regulatory Affairs Specialist |
| Date Summary Prepared: | May 25, 2004 |
| Device Name/<br>Proprietary name: | Phaco Chop Needle |
| Classification/Common Name | Phaco Needles |
| Class: | II |
| Panel: | Ophthalmic |
| Product Code: | HQC |

The marketed device(s) to which substantial equivalence is claimed: Bausch & Lomb Phaco Needles

## PRODUCT DESCRIPTION:

The phacoemulsification (phaco) needle is the cylindrical, metal tip which is connected to the distal end of a phaco handpiece. The needle is the component of a phaco system which, as driven by the ultrasonic handpiece, contacts and fragments the cataractous crystalline lens. Irrigation fliud flows around the external surface of the needle into the eye. The emulsified lens material and irrigant are aspirated from the eye through the phaco needle lumen. The proposed Phaco Chop Needle has the same external and internal tip design as Bausch & Lomb's currently marketed MicroFlow and MicroFlow Plus Needles. However, the internal restriction is deeper within the needle bore

#### Substantial Equivalent Basis

The proposed Phaco Chop Needle is substantially equivalent to the reusable Phaco Needles currently offered by Bausch & Lomb. They are the Standard Phaco Needle, MicroFlow Phaco Needle, MicroFlow+ Phaco Needle

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## Comparison Matrix

| Components | Currently Marketed<br>Standard Phaco<br>Needle | Currently Marketed<br>MicroFlow Needle | Currently Marketed<br>MicroFlow Plus<br>Needle | Proposed Phaco<br>Chop Needle |
|---------------------|---------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| Intended Use | Phaco needles are<br>used for anterior<br>segment surgery with<br>Bausch and Lomb<br>Microsurgical<br>Systems | Phaco needles are<br>used for anterior<br>segment surgery with<br>Bausch and Lomb<br>Microsurgical<br>Systems. | Phaco needles are<br>used for anterior<br>segment surgerv<br>with Bausch and<br>Lomb Microsurgical<br>Systems. | Phaco needles are<br>used for anterior<br>segment surgery with<br>Bausch and Lomb<br>Microsurgical<br>Systems |
| Sterile/Non-Sterile | Sterile & Non-Sterile | Sterile & Non-Sterile | Sterile & Non-Sterile | Non-Sterile only |
| Single Use/Reusable | Single Use & Reusable | Single Use & Reusable | Single Use & Reusable | Reusable only |
| Tip Angle (degrees) | 15, 30 & 45 | 0, 15, 30 & 45 | 0, 15, 30 & 45 | 30 & 45 |
| Needle Tip OD (in.) | 0.042 | 0.042 | 0.046 | 0.042 |
| Needle Tip ID (in.) | 0.036 | 0.036 | 0.036 | 0.036 |

## Statement of Indications for Use

The Phaco Needles are intended for use with a Bausch & Lomb Millennium, Protegé or Premiere Microsurgical System for the emulsification of an opacified crystalline lens.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 6 2004

Bauch & Lomb, Inc. c/o Dennis Pozzo 3365 Tree Ct. Industrial Blvd. St. Louis, MO 63122-6694

Re: K041998

Trade/Device Name: Phaco Chop Needles Regulation Number: 21 CFR 886.4670 Regulation Name: Phacoemulsification Needles Regulatory Class: Class II Product Code: HQC Dated: July 22, 2004 Received: July 26, 2004

Dear Mr. Pozzo:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 910(t) presidentially equivalent (for the indications felerenced above and nave determined in marketed predicate devices marketed in interstate for use stated in the encrosule) to regars nearment date of the Medical Device American be of Draw commerce private to May 20, 1976, the encordance with the provisions of the Federal Food, Drug. devices that have occh recuired in access approval of a premarket approval application (PMA). and Costlience Act (Act) that to not require apt to the general controls provisions of the Act. The You may, merefore, manse the device, belyer to the one of the series for annual registration, listing of general controls provisions of the rest 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 If your device is classified (see above) ins. Existing major regulations affecting your device can Inay oc subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Ood of reants concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease be advised that I Driseantes over device complies with other requirements of the Act that I DA has made a determinations administered by other Federal agencies. You must of ally rederal statutes and regalations annualing, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFR Part 807), adomig (21 CFR Part 820); and if applicable, the electronic form in the quality by techno (Sections 531-542 of the Act); 21 CFR 1000-1050.

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#### Page 2 - Dennis Pozzo

This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter will and anyon your e FDA finding of substantial equivalence of your device to a legally premainted predicated 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 halpi korenthal

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

Device Name: Phaco Chop Needle

## Indications for Use:

The Phaco Needles are intended for use with a Bausch & Lomb Millennium, Protegé or Premiere Microsurgical System for the emulsification of an opacified crystalline lens.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR Over-the-Counter Use Prescription Use __ V

(Division Sign-Off)

Division of Ophthalmic Ear, Nose and Throat Devises

510(k) Number_ K 041998

510(k) Number k 041998

Bausch & Lomb Surgical