ASSOCIATE 2500 DUAL AND COMPACT SYSTEMS

K081877 · Dutch Ophthalmic Research Center International BV · HQC · Jan 5, 2009 · Ophthalmic

Device Facts

• Record ID: K081877
• Device Name: ASSOCIATE 2500 DUAL AND COMPACT SYSTEMS
• Applicant: Dutch Ophthalmic Research Center International BV
• Product Code: HQC · Ophthalmic
• Decision Date: Jan 5, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4670
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ASSOCIATE is intended for ophthalmic anterior and posterior segment surgery. It provides capabilities for phacoemulsification, phacofragmentation, diathermy coagulation, irrigation, vitrectomy, illumination, air/fluid exchange, silicone oil injection and extraction.

Device Story

The Associate is a medical electrical system for ophthalmic anterior and posterior segment surgery. It performs phacoemulsification, phacofragmentation, diathermy coagulation, irrigation/aspiration, vitrectomy, illumination, air/fluid exchange, and silicone oil injection/extraction. The system includes a main console with a touchscreen display, a footswitch, and a remote control for surgeon operation. It can be mounted on a trolley and controls an automated infusion pole. The surgeon uses the interface to select and activate surgical functions. By providing precise control over fluidics and surgical tools, the device assists the surgeon in performing complex eye procedures, potentially improving surgical outcomes and patient safety.

Clinical Evidence

Bench testing only. Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-2-2, ISO 14971, ISO 11607-1, and ISO 11135-1 was demonstrated to support safety and performance.

Technological Characteristics

Medical electrical equipment; touchscreen interface; footswitch and remote control; automated infusion pole control. Standards: IEC 60601-1 (safety), IEC 60601-1-2 (EMC), IEC 60601-1-4 (programmable electrical medical systems), IEC 60601-2-2 (high frequency surgical equipment), ISO 14971 (risk management), ISO 11607-1 (packaging), ISO 11135-1 (EO sterilization).

Indications for Use

Indicated for patients undergoing ophthalmic anterior and posterior segment surgery.

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 & LombTM NGX Microsurgical System (K063331)
• AMO Ophthalmic Surgical System (K060366)
• Alcon InfinitiTM Cataract Extraction System (K021564)
• Storz Premiere II Microsurgical System (K961310)
• Alcon System 20000TM Legacy® Microsurgical System (K952213)

Submission Summary (Full Text)

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

# 510(k) Summary

# K081877 1. COMPANY NAME AND ADDRESS

Dutch Ophthalmic Research Center International bv Scheijdelveweg 2 3214 VN Zuidland The Netherlands

JAN - 5 2009

: Mr. Ger Vijfvinkel, President Contact Phone .: [phone] Fax : [phone] Date of summary : September 10, 2008

## 2. DEVICE NAME

| Trade Name | : ASSOCIATE |
|---------------------|-------------------------------------------------------------------------|
| Common Name | : Phacoemulsification/vitrectomy System |
| Classification Name | : Phacofragmentation system (21 CFR 886.4670,<br>Product Code HQC, HQE) |

#### 3. PREDICATE DEVICES

| 510(k) | Clearance<br>Date | Device Description |
|---------|-------------------|--------------------------------------------------------------------------------------------------------------------|
| K063331 | 12/19/2006 | Bausch & LombTM NGX Microsurgical System<br>(Marketed as the Bausch & Lomb Stellaris) |
| K060366 | 4/7/2006 | AMO Ophthalmic Surgical System<br>(Marketed as the AMO Signature) |
| K021564 | 7/2/2002 | Alcon InfinitiTM Cataract Extraction System |
| K961310 | 6/27/1996 | Storz Premiere II Microsurgical System<br>(Marketed as the Bausch & LombTM Millennium<br>Microsurgical System) |
| K952213 | 8/9/1995 | Alcon System 20000TM Legacy® Microsurgical<br>System<br>(Also marketed as the Alcon Accurus Ophthalmic<br>Systems) |

## 4. DEVICE DESCRIPTION

The Associate is medical electrical equipment to be used during eye surgery. The Associate is intended for ophthalmic anterior and posterior segment surgery.

Page 1 of 2

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

I. . I

It provides capabilities for phacoemulsification, phacofragmentation, diathermy coagulation, irrigation/ aspiration, vitrectorny, illumination, air/fluid exchange, silicone oil injection and extraction. The equipment has a display with touch screen for selecting and activating the functions. With the equipment a footswitch and a remote control are delivered for control by the surgeon. The equipment can be installed on a trolley and is able to control an automated infusion pole.

#### 5. INTENDED USE

ਸ

The ASSOCIATE is intended for ophthalmic anterior and posterior segment surgery. It provides capabilities for phacoemulsification, phacofragmentation, diathermy coagulation, irrigation, vitrectomy, illumination, air/fluid exchange, silicone oil injection and extraction.

#### 6. SUMMARY OF NON-CLINICAL TESTS

Prior to commercialization, safety tests of the ASSOCIATE have demonstrated compliance with applicable requirements of the following standards and the test reports have been filed as quality records for future review as required under 21CFR820.180.

| Standards | Standards Title |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 60601-1:1988,<br>A1:1991, A2:1995 | Medical electrical equipment<br>Part 1: General requirements for safety. |
| IEC 60601-1-2:2001,<br>A1:2006 | Medical electrical equipment<br>Part 1-2: General requirements for safety - Collateral standard:<br>Electromagnetic compatibility - Requirements and tests. |
| IEC 60601-1-4:1996,<br>A1:1999 | Medical electrical equipment<br>Part 1: General requirements for safety; 4. Collateral Standard:<br>Programmable electrical medical systems. |
| IEC 60601-2-2:1998 | Medical electrical equipment<br>Part 2-2: Particular requirements for the safety of high frequency<br>surgical equipment. |
| ISO 14971:2000,<br>A1:2003 | Medical devices - Application of Risk Management to Medical<br>Devices |
| ISO 11607-1:2006 | Packaging for terminally sterilized medical devices - Part 1:<br>Requirements for materials, sterile barrier systems and<br>packaging systems. |
| ISO 11135-1:2007 | Sterilization of health care products - Ethylene oxide - Part 1:<br>Requirements for the development, validation, and routine<br>control of a sterilization process for medical devices. |

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

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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 or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dutch Ophthalmic Research Center International BV c/o Ger Vijfvinkel. President Scheijdelveweg 2 Zuidland, NL-3214 VN JAN - 5 2009 The Netherlands

Re: K081877

Trade/Device Name: Associate 2500 Dual and Compact Systems Regulation Number: 21 CFR 886.4670 Regulation Name: Phacofragmentation system Regulatory Class: Class II Product Code: HOC Dated: December 19, 2008 Received: December 23, 2008

Dear Mr. Vijfvinkel:

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}------------------------------------------------

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.

M. B. Egleston, m.D.

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

Enclosure

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

## Indications for Use

510(k) Number (if known): K081877

Device Name: ASSOCIATE

Indications For Use:

The ASSOCIATE is intended for ophthalmic anterior and posterior segment surgery. It provides capabilities for phacoemulsification, phacofragmentation, diathermy coagulation, irrigation/aspiration, vitrectomy, illumination, air/fluid exchange and silicone oil injection & extraction.

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)

(Division Sign-Off) Division of Ophthalmic and Eas, Nose and Throat Devices

510(k) Number

Page 1 of