(187 days)
Not Found
No
The provided text describes a surgical system with various functionalities for ophthalmic surgery. There is no mention of AI, ML, image processing, or any data-driven decision-making or analysis capabilities that would indicate the presence of AI/ML. The control mechanisms described are traditional (touch screen, footswitch, remote control).
Yes
Explanation: The device is intended for ophthalmic surgery, providing capabilities like phacoemulsification and vitrectomy, which are medical treatments or procedures to restore health or alleviate symptoms in the eye.
No
The device is described as equipment for performing ophthalmic surgery, providing capabilities like phacoemulsification, vitrectomy, and irrigation/aspiration. It does not mention any function for diagnosing conditions or diseases.
No
The device description explicitly states it is "medical electrical equipment" and includes hardware components like a display with touch screen, footswitch, remote control, and the ability to control an automated infusion pole.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "ophthalmic anterior and posterior segment surgery." This involves performing surgical procedures directly on the eye.
- Device Description: The description details the surgical capabilities of the device (phacoemulsification, vitrectomy, etc.) and how it is used during surgery.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, tissue, or other body fluids) outside of the body to provide information for diagnosis, monitoring, or screening. IVDs are designed for testing samples in vitro.
The device described is a surgical system used in vivo (within the living body) during eye surgery.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
HQC, HQE
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ophthalmic anterior and posterior segment
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K063331, K060366, K021564, K961310, K952213
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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 .: +31 181 458080 Fax : +31 181 458090 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, |
| Product Code HQC, HQE) |
3. PREDICATE DEVICES
| 510(k) | Clearance
Date | Device Description |
|---------|-------------------|--------------------------------------------------------------------------------------------------------------------|
| K063331 | 12/19/2006 | Bausch & LombTM NGX Microsurgical System
(Marketed as the Bausch & Lomb Stellaris) |
| K060366 | 4/7/2006 | AMO Ophthalmic Surgical System
(Marketed as the AMO Signature) |
| K021564 | 7/2/2002 | Alcon InfinitiTM Cataract Extraction System |
| K961310 | 6/27/1996 | Storz Premiere II Microsurgical System
(Marketed as the Bausch & LombTM Millennium
Microsurgical System) |
| K952213 | 8/9/1995 | Alcon System 20000TM Legacy® Microsurgical
System
(Also marketed as the Alcon Accurus Ophthalmic
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.
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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, | |
| A1:1991, A2:1995 | Medical electrical equipment |
| Part 1: General requirements for safety. | |
| IEC 60601-1-2:2001, | |
| A1:2006 | Medical electrical equipment |
| Part 1-2: General requirements for safety - Collateral standard: | |
| Electromagnetic compatibility - Requirements and tests. | |
| IEC 60601-1-4:1996, | |
| A1:1999 | Medical electrical equipment |
| Part 1: General requirements for safety; 4. Collateral Standard: | |
| Programmable electrical medical systems. | |
| IEC 60601-2-2:1998 | Medical electrical equipment |
| Part 2-2: Particular requirements for the safety of high frequency | |
| surgical equipment. | |
| ISO 14971:2000, | |
| A1:2003 | Medical devices - Application of Risk Management to Medical |
| Devices | |
| ISO 11607-1:2006 | Packaging for terminally sterilized medical devices - Part 1: |
| Requirements for materials, sterile barrier systems and | |
| packaging systems. | |
| ISO 11135-1:2007 | Sterilization of health care products - Ethylene oxide - Part 1: |
| Requirements for the development, validation, and routine | |
| 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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 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
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