(73 days)
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.
The subject 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.
Acceptance Criteria and Device Performance Study
The information provided describes a 510(k) premarket notification for modified AMO®Diplomax™ and AMO®Opsys® consoles. The study aims to demonstrate substantial equivalence to predicate devices, not necessarily to prove the device meets specific acceptance criteria as would be typical for a novel device. The "acceptance criteria" here are implicitly the performance characteristics of the predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The "acceptance criteria" for the modified consoles are based on their equivalence to the predicate devices. The study demonstrates that the modified consoles exhibit the "Same" performance or capability as the predicate devices in the listed categories.
| Characteristic | Acceptance Criteria (Predicate Performance) | Reported Device Performance (Modified Consoles) |
|---|---|---|
| Safety Specification | Meets UL 544 | Meets UL 544 |
| Vitrectomy Circuit Output | Same (as predicate) | Same |
| Diathermy Circuitry Output | Same (as predicate) | Same |
| Load Compensation | Yes (present in predicate) | Yes |
| Output Waveforms | Yes (present in predicate) | Yes |
| Phaco Output Energy | Yes (present in predicate) | Yes |
| Continuous Irrigation All Modes | Yes (present in predicate) | Yes |
| CAP VAC | Yes (present in predicate) | Yes |
| U/S I/S | Yes (present in predicate) | Yes |
| Phaco Mode Sound ASP, VAC, U/S | Yes (present in predicate) | Yes |
| Diathermy Sound | Yes (present in predicate) | Yes |
| I/A Sound | Yes (present in predicate) | Yes |
| Self Test | Yes (present in predicate) | Yes |
(Note: "Same" and "Yes" in the reported device performance column indicate that the modified device performs identically to or possesses the same feature as the predicate device, thereby meeting the implicit acceptance criteria of substantial equivalence.)
2. Sample Size and Data Provenance
- Test Set Sample Size: The document does not explicitly state the sample size for the performance testing. It mentions "Performance testing was conducted on the AMO®Diplomax™ console with the Enhanced Driver Board, Power Module PCB and modified software." This implies testing was done on a console, potentially a limited number of consoles, but a specific numerical sample size is not provided.
- Data Provenance: The study was conducted by Allergan, based in Irvine, California, USA. The data is retrospective in the sense that it evaluates modifications to existing devices against their predicate versions. However, the testing itself for the modified device would be prospective at the time of submission. The country of origin for the data is the USA.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. This is not a study that involves expert assessment for establishing ground truth, such as in image analysis or diagnosis. The study is a technical performance comparison against predicate devices.
4. Adjudication Method
Not applicable. As noted above, this is a technical performance study, not one requiring expert adjudication of results against a ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This is not an MRMC study. It is a technical comparison of an updated medical device against its predicate for substantial equivalence.
6. Standalone Performance Study
Yes, in a way. The performance testing described is of the device itself (the modified consoles) and its components (Enhanced Driver Board, Power Module PCB, modified software). The results 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." This directly assesses the standalone performance of the modified components within the console system. There isn't a "human-in-the-loop" aspect to this performance evaluation described.
7. Type of Ground Truth Used
The "ground truth" for this study is the performance characteristics of the legally marketed predicate devices, specifically the original AMO®Diplomax™ and AMO®Opsys® consoles. The goal is to demonstrate that the modified devices are substantially equivalent to these established, safe, and effective devices.
8. Sample Size for the Training Set
Not applicable. This is not a study involving a "training set" in the context of machine learning or AI. The modifications are to hardware and software components of a physical medical device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, there is no "training set" in the AI/ML sense. The ground truth for the comparison is the established performance of the predicate medical devices.
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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
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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
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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
| ModifiedAMO®Diplomax™ andAMO®Opsys® Consoles | PredicateAMO®Diplomax™Console | PredicateAMO®Opsys®Console | |
|---|---|---|---|
| Safety Specification | Meets UL 544 | Meets UL 544 | Meets UL 544 |
| Vitrectomy CircuitOutput | Same | Same | Same |
| Diathermy CircuitryOutput | Same | Same | Same |
| Load Compensation | Yes | Yes | Yes |
| Output Waveforms | Yes | Yes | Yes |
| Phaco Output Energy | Yes | Yes | Yes |
| Continuous Irrigation AllModes | 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
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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 |
|---|---|
| -------------------------------- | --------- |
§ 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.