BAUSCH & LOMB D4600A AIR EXCHANGE LINE PACK

K082132 · Bausch & Lomb, Inc. · HQC · Aug 28, 2008 · Ophthalmic

Device Facts

• Record ID: K082132
• Device Name: BAUSCH & LOMB D4600A AIR EXCHANGE LINE PACK
• Applicant: Bausch & Lomb, Inc.
• Product Code: HQC · Ophthalmic
• Decision Date: Aug 28, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 886.4670
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Bausch & Lomb™ D4600A Air Exchange Line Pack is intended to be used as an accessory to the Bausch & Lomb STELLARIS® and Bausch & Lomb MILLENNIUM®, Microsurgical Systems for use in air and fluid exchange during posterior segment ophthalmic procedures.

Device Story

The Bausch & Lomb D4600A Air Exchange Line Pack is a sterile, single-patient-use accessory for the Stellaris and Millennium microsurgical systems. It functions as a conduit to deliver air from the microsurgical system into the posterior chamber of the eye during posterior segment ophthalmic surgery. The device is operated by a surgeon or surgical staff in an operating room setting. By providing the initial pathway for air, it facilitates air-fluid exchange, assisting the surgeon in managing the intraocular environment during complex eye procedures. The device is provided sterile via gamma irradiation.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Sterile, single-use accessory pack. Materials include Tyvek and PET/PE pouch packaging. Sterilization via gamma irradiation (Cobalt). Functions as a passive fluid/air delivery line for microsurgical systems.

Indications for Use

Indicated for use in air and fluid exchange during posterior segment ophthalmic surgical procedures in patients undergoing such procedures.

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

• Storz D4600 (K962131)

Reference Devices

• Bausch & Lomb Stellaris Microsurgical System (K063331)
• Bausch & Lomb MILLENNIUM Microsurgical System (K961310)
• Bausch & Lomb PREMIERE Microsurgical System

Submission Summary (Full Text)

{0}------------------------------------------------

K082132

Image /page/0/Picture/1 description: The image shows the logo for Bausch & Lomb. The logo consists of the company name, "Bausch & Lomb", in a serif font. Above the name is a geometric design, possibly representing a lens or other optical element, rendered in a halftone pattern.

AUG 2 8 2008

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

The following information is provided in accordance with requirements of 21CFR 807.92:

| Contact Person: | Ned Luce<br>Director Regulatory Affairs<br>Global Surgical Devices |
|----------------------|--------------------------------------------------------------------------------|
| Date Prepared: | July 24, 2008 |
| Proprietary Name: | Bausch & Lomb D4600A Air Exchange Line Pack |
| Common/Usual Name: | Ophthalmic surgical system accessory pack for<br>posterior segment procedures. |
| Classification Name: | System, Phacofragmentation (86 HQC) |

## Device Description/Intended Use

The Bausch & Lomb D4600A Air Exchange Line Pack is intended to be used as an accessory to the Bausch & Lomb Stellaris (K063331) Microsugrical System. The device is for use as an air exchange system during posterior segment ophthalmic surgical procedures. The D4600A Air Exchange Line provides the initial pathway through which air generated by the microsurgical system is routed into the posterior chamber of the eye.

Predicate Device: The proposed Bausch & Lomb D4600A Air Exchange Line Pack is substantially equivalent to the existing Bausch & Lomb D4600 Air Exchange Line Pack (K962131) for use with the Bausch & Lomb MILLENNIUM® Microsurgical System (K961310). The subject device may be used with each of these systems.

Predicate Comparison: A chart comparing the Bausch & Lomb D4600A to the predicate Bausch & Lomb D4600 device demonstrates substantial equivalence is attached.

{1}------------------------------------------------

# DEVICE COMPARISON CHART Bausch & Lomb D4600A Air Exchange Line Pack

| DEVICE | Bausch & Lomb<br>D4600A<br>Subject Device | Storz D4600<br>K962131 |
|----------------------------------|------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| Intended Use | To deliver air to the<br>eye during posterior<br>surgical procedures | To deliver air to the<br>eye during posterior<br>ophthalmic surgical<br>procedures |
| Recommended System | Bausch & Lomb<br>STELLARIS® or<br>MILLENNIUM®<br>Microsurgical Systems | Bausch & Lomb<br>PREMIERE®<br>Microsurgical System |
| Instructions for Use<br>Included | Yes | Yes |
| Single Patient Use? | Yes | Yes |
| Provided Sterile? | Yes | Yes |
| Sterilization Method | Gamma Irradiation<br>(Cobalt) | Gamma Irradiation |
| Packaging | Singly in Tyvek® and<br>PET/PE Pouch<br>6 pouches per Box | Singly in Tyvek® and<br>PET/PE Pouch<br>10 pouches per Box |

.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Bausch & Lomb, Inc. c/o Ned Luce Director Regulatory Affairs Global Surgical Devices 1400 North Goodman Street Rochester, NY 14609

AUG 2 8 2008

Re: K082132

Trade/Device Name: Bausch & Lomb™ D4600A Air Exchange Line Pack Regulation Number: 21 CFR 886.4670 Regulation Name: Phacofragmentation System Regulatory Class: II Product Code: HQC Dated: July 24, 2008 Received: July 29, 2008

Dear Mr. Luce:

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 found 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.

{3}------------------------------------------------

#### Page 2 - Ned Luce

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/industry/support/index.html.

Sincerely yours,

Malvina B. Egleston, und

Malvina B, Eydelman, M.I Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

# 082132

### Indications for Use

510(k) Number (if known):

K082132

Device Name:

Bausch & Lomb D4600A Air Exchange Line Pack

Indications for Use:

The Bausch & Lomb™ D4600A Air Exchange Line Pack is intended to be used as an accessory to the Bausch & Lomb STELLARIS® and Bausch & Lomb MILLENNIUM®, Microsurgical Systems for use in air and fluid exchange during posterior segment ophthalmic procedures.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use ( 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Bruce Drum

vision of Ophthalmic Ear Nose and Throat De

510(k) Number K082132