(73 days)
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No
The document describes a phacoemulsification system with hardware and software modifications, but there is no mention of AI or ML capabilities, image processing, or data sets typically associated with AI/ML development.
Yes
The device is a component of a phacofragmentation system used for cataract removal, which is a surgical procedure to treat a medical condition.
No
The device is a phacofragmentation system designed for cataract removal, which is a surgical procedure. It does not mention any function related to diagnosing a condition or disease.
No
The device description explicitly states that the subject of the 510(k) includes modified hardware components (driver controller board, power supply printed circuit board) in addition to software. Performance studies also mention testing these modified boards.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide surgical capabilities for cataract removal using phacofragmentation. This is a surgical procedure performed directly on the patient's eye.
- Device Description: The device is described as part of a phacoemulsification system used by ophthalmic surgeons during cataract surgery. It aids in breaking up and removing the cataract from the patient's eye.
- 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. This device does not perform such tests on biological samples.
The device is a surgical instrument used in vivo (within the living body) during a surgical procedure, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The AMO®Diplomax™ and AMO®Opsys® consoles are components of phacofragmentation systems designed to provide all the surgical capabilities desired by the Anterior Segment/Cataract Surgeon. Phacofragmentation, also known as phacoemulsification or "phaco," is a cataract removal technique. When utilizing this * technique, the surgeon makes a small incision in the eye and breaks up the cataract using ultrasonic vibration delivered by the tip of the handpiece inserted through the incision.
Product codes (comma separated list FDA assigned to the subject device)
86 HQC
Device Description
The subiect of this 510(k) is the AMO®Diplomax™ and AMO®Opsys® consoles with modified driver controller board, power supply printed circuit board and software. The consoles are part of the phacoemulsification system which is used by ophthalmic surgeons during cataract surgery. Accessories, which are connected to the consoles, aid the surgeon in breaking up and removing the cataract from the patient's eye.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
eye
Indicated Patient Age Range
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Intended User / Care Setting
Anterior Segment/Cataract Surgeon
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing was conducted on the AMO®Diplomax™ console with the Enhanced Driver Board, Power Module PCB and modified software.
The results of these tests indicate that the Enhanced Driver Board and Power Module PCB are compatible when incorporated into the AMO®Diplomax™ and AMO®Opsys® consoles and will not compromise system performance. The modifications incorporated into the modified boards and software do not affect the safety or effectiveness of the console. The overall function and intended use of the modified consoles are substantially equivalent to the predicate devices. Therefore, the consoles with the modified boards are substantially equivalent to the predicate consoles in commercial distribution.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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.
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ALLERGAN
Image /page/0/Picture/1 description: The image shows a handwritten string of characters. The string appears to be "K971186". The characters are written in black ink on a white background. The handwriting is somewhat messy and the characters are not perfectly formed.
Image /page/0/Picture/2 description: The image shows a stylized graphic of what appears to be a sun or a series of horizontal lines. The graphic consists of several horizontal bars of varying lengths, arranged in a stacked formation. The bars are thick and black, and they are slightly tapered at the ends, giving them a somewhat aerodynamic or streamlined appearance. The overall shape of the graphic is oval or elliptical, with the longest bar in the middle and the shorter bars above and below it.
2525 Dupont Drive, P.O. Box 19534, Irvine, CA 92623-9534 (714) 752-4500
-
JUN 1 3 1997
510(k) Summary Modified Consoles -
Submitter's name, address, telephone number, a contact person, and 1. · the date the summary was prepared:
- Allergan a. 2525 Dupont Drive P.O. Box 19534 Irvine, California 92623-9534 (800) 347-4500
- Monique M. Heyninck-Duran Contact Person: b.
- Date Summary Prepared: March 31, 1997 C.
Name of device, including trade name and classification name: 2.
- Name of Device: AMO®Diplomax™ and AMO®Opsys® a. Consoles
- Phacofragmentation or Phacoemulsification Common Name: b. System
- Classification Name: As per 21 CFR 886.4670, the product C. nomenclature is Phacofragmentation System.
- Identification of the predicate for legally marketed device or devices to 3. which substantial equivalence is being claimed:
- AMO®Diplomax™ console a.
- AMO®Opsys® console b.
- A description of the device that is the subject of the 510(k), including 4. an explanation of how the device functions, basic scientific concepts, significant physical and performance characteristics (design, material, physical properties).
The subiect of this 510(k) is the AMO®Diplomax™ and AMO®Opsys® consoles with modified driver controller board, power supply printed circuit board and software. The consoles are part of the phacoemulsification system which is used by ophthalmic surgeons during cataract surgery. Accessories, which are connected to the consoles, aid the surgeon in breaking up and removing the cataract from the patient's eye.
AMO Surgical Products
1
The design, materials and physical properties of the modified AMO®Diplomax™ and AMO®Opsys® consoles are substantially equivalent to the predicate devices.
Statement of intended use: 5.
The AMO®Diplomax™ and AMO®Opsys® consoles are designed to provide all the surgical capabilities desired by the Anterior Segment/Cataract Surgeon. Phacofragmentation, also known as phacoemulsification or "phaco," is a cataract removal technique. When utilizing this technique, the surgeon makes a small incision in the eye and breaks up the cataract using ultrasonic vibration delivered by the tip of the handpiece inserted through the incision.
- Statement of how the technological characteristics (i.e. design, 6. materials, chemical composition, energy source) compare to the predicate device:
COMPARISON OF THE SIMILARITIES AND DIFFERENCES BETWEEN THE MODIFIED AND PREDICATE CONSOLES OF THE AMO®DIPLOMAX™ AND AMO®OPSYS® PHACOEMULSIFICATION MACHINES
| | Modified
AMO®Diplomax™ and
AMO®Opsys® Consoles | Predicate
AMO®Diplomax™
Console | Predicate
AMO®Opsys®
Console |
|------------------------------------|------------------------------------------------------|---------------------------------------|------------------------------------|
| Safety Specification | Meets UL 544 | Meets UL 544 | Meets UL 544 |
| Vitrectomy Circuit
Output | Same | Same | Same |
| Diathermy Circuitry
Output | Same | Same | Same |
| Load Compensation | Yes | Yes | Yes |
| Output Waveforms | Yes | Yes | Yes |
| Phaco Output Energy | Yes | Yes | Yes |
| Continuous Irrigation All
Modes | Yes | Yes | Yes |
| CAP VAC | Yes | Yes | Yes |
| U/S I/S | Yes | Yes | Yes |
| Phaco Mode Sound ASP,
VAC, U/S | Yes | Yes | Yes |
| Diathermy Sound | Yes | Yes | Yes |
| I/A Sound | Yes | Yes | Yes |
| Self Test | Yes | Yes | Yes |
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Image /page/2/Picture/0 description: The image shows a series of handwritten numbers and a letter. The characters are K971186. The numbers are written in a bold, somewhat messy style, with thick strokes. The letter K is on the left.
7. Brief summary of nonclinical tests and results:
Performance testing was conducted on the AMO®Diplomax™ console with the Enhanced Driver Board, Power Module PCB and modified software.
The results of these tests indicate that the Enhanced Driver Board and Power Module PCB are compatible when incorporated into the AMO®Diplomax™ and AMO®Opsys® consoles and will not compromise system performance. The modifications incorporated into the modified boards and software do not affect the safety or effectiveness of the console. The overall function and intended use of the modified consoles are substantially equivalent to the predicate devices. Therefore, the consoles with the modified boards are substantially equivalent to the predicate consoles in commercial distribution.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 3 1997
Ms. Monique M. Heyninck-Duran Regulatory Affairs Analyst Allergan 2525 Dupont Drive P.O.,Box 19534 Irvine, CA 92623-9534
. Re: K971186 . Trade Name: AMO®Diplomax™ and AMO®Opsys® Phacoemulsification Consoles Regulatory Class: II Product Code: 86 HQC Dated: March 31, 1997 Received: April 1, 1997
Dear Ms. Heyninck-Duran:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not aftect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Monique M. Heyninck-Duran
This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
A Roerl lorentbal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): Unknown at this time
Device Name: AMO®Diplomax™ and AMO®Opsys® Phacoemulsification Consoles
Indications for Use:
The AMO®Diplomax™ and AMO®Opsys® consoles are components of phacofragmentation systems designed to provide all the surgical capabilities desired by the Anterior Segment/Cataract Surgeon. Phacofragmentation, also known as phacoemulsification or "phaco," is a cataract removal technique. When utilizing this * technique, the surgeon makes a small incision in the eye and breaks up the cataract using ultrasonic vibration delivered by the tip of the handpiece inserted through the incision.
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| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| -------------------------------------------------------- |
| Prescription Use (Per 21 CFR 801.109) | |
|---|---|
| OR | |
| Over-The-Counter Use (Optional Format 1-2-96) |
| (Division Sign-Off) | |
|---|---|
| Division of Ophthalmic Devices |
| ALLERGAN - CONFIDENTIAL Number | K971186 |
|---|---|
| -------------------------------- | --------- |