(50 days)
Not Found
No
The summary does not mention AI, ML, image processing, or any related concepts. The description focuses on the mechanical and functional aspects of the cataract extraction system.
Yes
The device is described as a "cataract extraction system" used by ophthalmologists during cataract surgery for "emulsification and removal of cataracts, as well as associated procedures such as vitreous aspiration and cutting along with bipolar coagulation," which are therapeutic procedures.
No
Explanation: The device description clearly states its purpose is for "emulsification and removal of cataracts, as well as associated procedures" and "simultaneous lens fragmentation, irrigation and aspiration, as well as ancillary functions". These are interventional/treatment procedures, not diagnostic ones.
No
The device description explicitly states it is a "cataract extraction system" and a "modification of the Alcon Series 20000 'Legacy' system," indicating it is a hardware system with associated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device is a "cataract extraction system" used during surgery to emulsify and remove cataracts, perform vitreous aspiration and cutting, and bipolar coagulation. These are all procedures performed directly on the patient's eye during surgery.
- Lack of Sample Analysis: There is no mention of the device analyzing any samples taken from the patient. Its function is to perform surgical actions.
Therefore, the Infiniti" system is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of the device is emulsification and removal of cataracts, as well as associated procedures such as vitreous aspiration and cutting along with bipolar coagulation.
Product codes (comma separated list FDA assigned to the subject device)
HOC, HOR, MLZ
Device Description
The Infiniti" is a cataract extraction system used by ophthalmologists during cataract surgery. It is designed for use in anterior segment procedures that require simultaneous lens fragmentation, irrigation and aspiration, as well as ancillary functions such as vitreous aspiration and cutting The Infiniti" system is a modification of the Alcon Series along with bipolar coagulation. 20000 " Legacy " system and is substantially equivalent to the predicate devices listed above.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
ophthalmologists
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)
Safety tests of the Infinitit" Cataract Extraction System will demonstrate its compliance with applicable requirements of the following standards:
IEC 60601-1: 1988 Medical Electrical Equipment, Part 1 - General Requirements for Safety.
IEC 60601-1: A1:1991-11 + A2:1995 -03 Amendment - Medical Electrical Equipment, Part 1 - General Requirements for Safety
IEC 60601-1-2 : 1993 Medical electrical equipment Part 1: General Requirements for Safety 2. Collateral Standard: ElectroMagnetic Compatibility - Requirements and tests.
UL 2601-1: 1997 Medical Electrical Equipment, Part 1 - General Requirements for Safety
Biocompatibility evaluations of materials coming in contact with the patient fluid path in the Infiniti" system will be performed to the following standards:
AAMI/ ANSI/ ISO 10993-1: 1997 Biological evaluation of medical devices, Part 1: Evaluation and Testing
AAMI/ ANSI/ ISO 10993-5: 1999 Biological evaluation of medical devices, Part 5: Test for cytotoxicity: in vitro methods.
AAMI/ ANSI/ ISO 10993-7: 1995 Biological evaluation of medical devices, Part 7: Ethylene oxide sterilization methods.
AMI/ ANSI/ ISO 10993-10: 1995 Biological evaluation of medical devices, Part 10: Tests for irritation and sensitization.
The Infiniti" consumable products are provided sterile and intended for single use only. These products will be EtO sterilized and the process will be validated per the standard: AAMI/ ISO 11135:1994: Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization. Reusable handpieces are not provided sterile. Validated reprocessing instructions for cleaning. sterilization and re-use will be provided in the Directions for Use of the product.
Technological characteristics affecting clinical performance are similar to that of predicate devices previously listed. The Infiniti" Cataract Extraction System will be developed and manufactured in compliance with FDA and ISO quality system requirements. Testing will demonstrate that the functional requirements have been met and that the system specifications are fulfilled prior to commercial product release.
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.
K911808, K981116, K961310, K980292, K925631
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
JUL - 2 2002
Premarket Notification 510(k) Summary
This summary document is being prepared in accordance with section 21 CFR 807.92(c).
The submitter of the 510(k) is:
Michael Buenger Associate Director, Regulatory Affairs Alcon Research, Inc. 6201 South Freeway Fort Worth, TX 76132 Phone: (817) 551-6810 Fax: (817) 551-4630
Date Summary Prepared: May, 1, 2002
Device Subject to this 510(k)
| Trade Name: | Infiniti ™ Cataract Extraction System |
|---|---|
| Common Name: | Phacofragmentation System |
| Classification Name: | Phacofragmentation System (per 21 CFR 886.4670) |
1. Predicate Devices:
The legally marketed devices(s) to which we are claiming equivalence to are:
| 510(k) Number | Device |
|---|---|
| K911808 | Gemini Ophthalmic Surgery System |
| (Marketed as the Series 20000® Legacy® (STTL) and Accurus®) | |
| K981116 | Sovereign* Cataract Extraction System |
| K961310 | Storz Premiere* II Microsurgical System |
| K980292 | Cataract Liquefracture Device (Marketed as AquaLase™) |
| K925631 | Phacotron Gold* Multifunction Ultrasonic (Tmesis*) Handpiece |
2. Device Description
The Infiniti" is a cataract extraction system used by ophthalmologists during cataract surgery. It is designed for use in anterior segment procedures that require simultaneous lens fragmentation, irrigation and aspiration, as well as ancillary functions such as vitreous aspiration and cutting The Infiniti" system is a modification of the Alcon Series along with bipolar coagulation. 20000 " Legacy " system and is substantially equivalent to the predicate devices listed above.
1
3. Indications for Use:
The intended use of the device is emulsification and removal of cataracts, as well as associated procedures such as vitreous aspiration and cutting along with bipolar coagulation.
4. Brief Summary of Nonclinical test and Results:
Safety tests of the Infinitit" Cataract Extraction System will demonstrate its compliance with applicable requirements of the following standards:
| IEC 60601-1: 1988 | Medical Electrical Equipment, Part 1 - General Requirements for
Safety. |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 60601-1:
A1:1991-11 +
A2:1995 -03 | Amendment - Medical Electrical Equipment, Part 1 - General
Requirements for Safety |
| IEC 60601-1-2 : 1993 | Medical electrical equipment Part 1: General Requirements for
Safety 2. Collateral Standard: ElectroMagnetic Compatibility -
Requirements and tests. |
| UL 2601-1: 1997 | Medical Electrical Equipment, Part 1 - General Requirements for
Safety |
Biocompatibility evaluations of materials coming in contact with the patient fluid path in the Infiniti" system will be performed to the following standards:
| AAMI/ ANSI/ ISO | Biological evaluation of medical devices, Part 1: Evaluation and |
|---|---|
| 10993-1: 1997 | Testing |
| AAMI/ ANSI/ ISO | Biological evaluation of medical devices, Part 5: Test for |
| 10993-5: 1999 | cytotoxicity: in vitro methods. |
| AAMI/ ANSI/ ISO | Biological evaluation of medical devices, Part 7: Ethylene oxide |
| 10993-7: 1995 | sterilization methods. |
| AMI/ ANSI/ ISO | Biological evaluation of medical devices, Part 10: Tests for irritation |
| 10993-10: 1995 | and sensitization. |
The Infiniti" consumable products are provided sterile and intended for single use only. These products will be EtO sterilized and the process will be validated per the standard: AAMI/ ISO 11135:1994: Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization. Reusable handpieces are not provided sterile. Validated reprocessing instructions for cleaning. sterilization and re-use will be provided in the Directions for Use of the product.
Technological characteristics affecting clinical performance are similar to that of predicate devices previously listed. The Infiniti" Cataract Extraction System will be developed and manufactured in compliance with FDA and ISO quality system requirements. Testing will demonstrate that the functional requirements have been met and that the system specifications are fulfilled prior to commercial product release.
2
Trademark References:
*PHACOTRON GOLD is a registered trademark of Chiron Corporation *PREMIERE is a registered trademark of Storz Ophthalmics, Inc. Corp. *SOVEREIGN is a registered trademark of Allergan, Inc. Corp. *TMESIS is a registered trademark of Azia Y. Anis *SYNERGIST is a registered trademark of Chiron Corporation
3
Image /page/3/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the top half of the circle. Inside the circle is a stylized graphic of three human profiles facing to the right, with flowing lines suggesting movement or connection.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL = 2 2002
Alcon Research, Ltd. c/o Mr. Michael Buenger Associate Director, Regulatory Affairs 6201 South Freeway Fort Worth, TX 76134-2099
Re: K021566
Trade/Device Name: Infiniti™ Cataract Extraction System Regulation Number: 21 CFR 886.4670 Regulation Name: Phacofragmentation System Regulatory Class: II Product Code: HOC: HOR: MLZ Dated: May 10, 2002 Received: May 13, 2002
Dear Mr. Buenger:
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.
4
Page 2 - Mr. Michael Buenger
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 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
5
Page 1 of 1
510(k) Number (if known): ¥021566
Device Name: _ Infiniti™ Cataract Extraction System___
Indications for Use:
The intended use of this device is emulsification and removal of cataracts, as well as associated procedures such as vitreous aspiration and cutting along with bipolar coagulation.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurence of CDRH, Office of Device Evaulation (ODE)
Donna L. Vedner, for DMW/ARR
(Division Sign Off)
ision of Ophthaln Nose and Throat De
510(k) Number K021566
(Optional Format 3-10-98)