(17 days)
The Dignity™ Ophthalmic Surgical System is a Phacofragmentation device intended for use in cataract surgery to emulsify, and extract the cataract.
The Dignity™ Ophthalmic Surgical System is used by ophthalmic surgeons to perform cataract surgery. The system utilizes accessories connected to the console to perform the cataract surgery.
This document describes a 510(k) premarket notification for the Dignity™ Ophthalmic Surgical System, a phacofragmentation unit used in cataract surgery. The submission focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing.
Here's an analysis of the provided information regarding acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate devices for Phacoemulsification, Irrigation/Aspiration, Diathermy, and Vitrectomy in an in vitro model. This implies that the Dignity™ Ophthalmic Surgical System should perform similarly to the predicate devices in these functional areas within a controlled laboratory setting. | The performance tests conducted on the Dignity™ Ophthalmic Surgical System in an in vitro model demonstrated that it was substantially equivalent to the predicate devices with respect to Phacoemulsification, Irrigation/Aspiration, Diathermy and Vitrectomy. |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: The document does not specify a numerical sample size for the test set. It mentions "Performance tests were conducted," implying a set of tests were performed, but not the quantity of tests or specific materials used.
- Data Provenance: The study was an in vitro model. This means the testing was conducted in a controlled laboratory environment, likely using simulated cataract materials or experimental setups, rather than on live subjects or human tissues. No country of origin is explicitly stated for the testing itself, but the submission is for the US FDA. The study is non-clinical.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- This information is not applicable as the study was an in vitro performance test, not a study involving human interpretation or clinical data where expert ground truth would be established. The "ground truth" here is the measured performance against defined engineering or functional specifications, benchmarked against predicate devices.
4. Adjudication Method for the Test Set
- This information is not applicable for an in vitro performance test. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in studies involving human interpretation (e.g., image reading) or complex clinical endpoints.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, an MRMC comparative effectiveness study was not done. The device described is a surgical instrument (phacofragmentation unit), not an AI-assisted diagnostic or interpretation tool for human readers. Therefore, there's no mention of human readers or AI assistance in this context.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- This question is not directly applicable in the AI-sense. The "device" itself (the Dignity™ Ophthalmic Surgical System) performs its function (phacofragmentation, etc.) without human "in-the-loop" once the surgeon initiates and controls it. However, this is a mechanical/electronic device, not an "algorithm" in the AI sense. The performance tests were of the device's functional capabilities (Phacoemulsification, Irrigation/Aspiration, Diathermy, and Vitrectomy) in an in vitro setting, which can be considered "standalone" in that it measures the device's inherent performance.
7. The Type of Ground Truth Used
- The ground truth in this non-clinical study was the performance of the predicate devices, against which the Dignity™ Ophthalmic Surgical System was compared to establish substantial equivalence. The specific metrics for Phacoemulsification, Irrigation/Aspiration, Diathermy, and Vitrectomy (e.g., efficiency, flow rates, temperature control) would have been measured for both the new device and the predicates to demonstrate comparable function.
8. The Sample Size for the Training Set
- Not applicable. This submission describes a medical device clearance based on substantial equivalence through in vitro performance testing against predicate devices. There is no mention or implication of a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set for an AI/ML model, there is no ground truth established for one. The "ground truth" for the device's functional testing was its performance relative to established predicate devices.
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Premarket Notification, 510(k) Summary
Date: 5/2/03
Submitter Information: Jeff B. Paul Director. Quality Assurance and Requlatory Affairs Phacor Inc., A Santen Company 775 Fiero Lane San Luis Obispo, CA 93401 805-546-1815 805-546-1826 fax
Device Name:
Trade or Proprietary Name:
Dignity™ Ophthalmic Surgical System
Common or Usual Name:
Phacofragmentation unit
Classification Number:
21 CFR section 886.4670
Predicate Device Comparison:
The Dignity™ Ophthalmic Surgical System device that is the subject of this 510(k) is substantially equivalent to predicate devices marketed by Advanced Medical Optics Inc., Alcon Laboratories Inc. and Bausch & Lomb. The Advanced Medical Optics device most closely equivalent to the Phacor Inc. device is the Sovereign™, cleared for commercial distribution under 510(k) number K981116. The Alcon Laboratories device most closely equivalent to the Phacor Inc. device is the Legacy® Series 20000™, cleared for commercial distribution under 510(k) number K955789. The Bausch & Lomb device most closely equivalent to the Phacor Inc. device is the Millenium™, cleared for commercial distribution under 510(k) number K980488.
The significant differences between the Dignity™ Ophthalmic Surgical System and the three predicate devices, Sovereign™, Legacy™ and Millenium™ are listed below:
- t External and internal structural differences. The external differences are in size, weight, and configuration. Also the Graphical User Interface has a different navigational format.
- Software will facilitate a more user friendly format in coordination with the . footbedal and cassette/cartridge loading and unloading.
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Device Description:
The Dignity™ Ophthalmic Surgical System is used by ophthalmic surgeons to perform cataract surgery. The system utilizes accessories connected to the console to perform the cataract surgery.
Intended Use:
The Dignity™ Ophthalmic Surgical System is a Phacofragmentation device intended for use in cataract surgery to emulsify, and extract the cataract.
Summary of non-clinical tests:
Performance tests were conducted on the Dignity™ Ophthalmic Surgical System. The performance in an in vitro model was substantially equivalent to the predicate devices with respect to Phacoemulsification, Irrigation/Aspiration, Diathermy and Vitrectomy.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three lines extending from its head, symbolizing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
MAY 2 2 2003
Food and Drug Administration 9200 Corporate Boulevard · Rockville MD 20850
Phacor Inc., A Santen Company c/o Jeff B. Paul Director, Quality Assurance & Regulatory Affairs 775 Fiero Lane San Luis Obispo, CA 93401
Re: K031404
Trade/Device Name: Dignity™ Ophthalmic Surgical System Regulation Number: 21 CFR 886.4670 Regulation Name: Phacofragmentation system Regulatory Class: Class II Product Code: HQC Dated: May 2, 2003 Received: May 8, 2003
Dear Mr. Paul:
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.
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Page 2 - Jeff B. Paul
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 Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
A képi korentbol
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
Enclosure
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S10(k) Number (if known): K031404
Device Name: DignityTM Ophthalmic Surgical System
Indications for Use:
The Dignity™ Ophthalmic Surgical System is a Phacofragmentation device intended for use in cataract surgery to emulsify, and extract the cataract.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
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)
Denis L. McCarthy
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
510(k) Number K031404
§ 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.