(156 days)
The Aesculap-Meditec Phacolase™ Er:YAG laser is intended for cutting, incision, excision, vaporization, and ablation of soft tissue in ophthalmology: Anterior capsulotomy Soft tissue surrounding the orbit of the eye
The Aesculap-Meditec Phacolase™ Er: YAG laser emits a beam of coherent light at 2.94 microns.
The provided text is a 510(k) summary for the Aesculap-Meditec Phacolase™ Er:YAG laser. This document describes the device's intended use and claims substantial equivalence to predicate devices based on preclinical and clinical testing. However, it does not contain detailed acceptance criteria, specific performance metrics, sample sizes for test or training sets, information about expert adjudication, or discussions of multi-reader multi-case studies or standalone algorithm performance.
Therefore, many of your requested details cannot be extracted from this specific document.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- This information is not available in the provided text. The document states "The results of a preclinical and clinical testing were submitted in support of the claim for incision and fragmentation of cataractous lenses during cataract surgery," but no specific performance metrics or acceptance criteria are listed.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- This information is not available in the provided text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This information is not available in the provided text. The device is a laser for surgical procedures, so "ground truth" in the context of diagnostic AI is not directly applicable. For a surgical device, performance would typically be evaluated based on surgical outcomes, safety, and efficacy during the procedure itself.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not applicable/not available. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in diagnostic studies involving multiple human readers, not for evaluating the performance of a surgical laser device based on preclinical and clinical testing.
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
- This information is not applicable/not available. An MRMC study is relevant for AI-assisted diagnostic tools. This document describes a surgical laser, not an AI diagnostic system. Therefore, it does not involve "human readers" in the sense of interpreting medical images with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- This information is not applicable/not available. This is a surgical laser, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For a surgical laser, "ground truth" would generally refer to outcomes observed during preclinical (e.g., in-vitro, animal) and clinical (human) studies, such as successful incision, vaporization, absence of adverse events, and achievement of the surgical goal. However, the specific type of ground truth (e.g., detailed pathological findings, specific surgical outcome metrics) used in the submitted testing is not detailed in this summary. It only broadly mentions "preclinical and clinical testing."
8. The sample size for the training set
- This information is not applicable/not available. "Training set" is a term used in machine learning for AI development. This document is about a medical device (laser), not an AI algorithm.
9. How the ground truth for the training set was established
- This information is not applicable/not available. As above, "training set" is not relevant to this device type.
In summary, the provided 510(k) summary for the Aesculap-Meditec Phacolase™ Er:YAG laser confirms that preclinical and clinical testing were performed to demonstrate substantial equivalence for its intended indications. However, it lacks the detailed methodology and performance metrics typically found in a study report for a diagnostic AI device.
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NOV 1 7 1999
1 991993
APPENDIX F Rev. Oct. 1999
510(k) SUMMARY AESCULAP-MEDITEC PHACOLASE™ ER:YAG LASER
This 510(k) summary of safety and effectiveness for the Phacolase™ Er:Y AG laser is submitted in accordance with the requirements of SMDA 1990 and follows Office of Device Evaluation guidance concerning the organization and content of a 510(k) summary.
Applicant: Aesculap-Meditec
Address: 2525 McGaw Avenue Irvine, CA 92623-9791
Manufacturer: Aesculap-Meditec GmbH Prussingstrasse 41 D-07745 Jena Germany (011) +49/3641/653223 (011) +49/3641/652121
Contact Person: Mr. William T. Kelley
Telephone: 949-660-2770 949-660-2760 (Fax)
Preparation Date: November 1999 (of the Summary)
Phacolase™ Er: YAG laser Device Name:
Common Name: Er:YAG laser
Classification Laser surgical instrument for use in general and plastic surgery and in Name: dermatology (see: 21 CFR 878.4810). Product Code: GEX Panel: 79
The Aesculap-Meditec Phacolase™ Er: YAG laser emits a beam of coherent Description: light at 2.94 microns.
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- The Aesculap-Meditec Phacolase™ Er:YAG laser is intended for cutting, incision, Indications: excision, vaporization, and ablation of soft tissue in ophthalmology:
Anterior capsulotomy Soft tissue surrounding the orbit of the eye
Aesculap-Meditec proposes that the Phacolase™ Er:YAG laser be labeled; "CAUTION: Federal (US) law restricts the use of this device to licensed professionals."
- The Aesculap-Meditec Phacolase™ Er:YAG laser was compared to predicate Comparisons lasers with the cited indications.
- Performance Data: The results of a preciinical and clinical testing were submitted in support of the claim for incision and fragmentation of cataractous lenses during cataract surgery.
- CONCLUSION: Based on the preclinical and clinical testing and on comparisons of specifications and other descriptive information the Aesculap-Meditec Phacolase™ Er: YAG laser is substantially equivalent for its claimed indications for use.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles a stylized caduceus or a representation of human profiles.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 17 1999
Mr. William T. Kelley General Manager Aesculap-Meditec 2525 McGaw Avenue Irvine, California 92623-9791
K991993 Re: Trade Name: Phacolase™ Er:YAG Regulatory Class: II Product Code: GEX Dated: September 13, 1999 Received: September 21, 1999
Dear Mr. Kelley:
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 current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) 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 affect 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 – Mr. William T. Kelley
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) 594-4595. 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,
Stypt Rhodes
James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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APPENDIX B2 Rev. Nov. 1999
INDICATIONS FOR USE STATEMENT
510(K) Number (if known): # # 99 / 2 9 3
Device Name: Aesculap-Meditec Phacolase™ Er:YAG laser
Indications For Use Statement:
The Aesculap-Meditec Phacolase™ Er:YAG laser is intended for cutting, incision, excision, vaporization, and ablation of soft tissue in ophthalmology:
Anterior capsulotomy Soft tissue surrounding the orbit of the eye
Aesculap-Meditec proposes that the Phacolase™ Er.YAG laser be labeled: "CAUTION: Federal (US) law restricts the use of this device to licensed professionals."
This labeling will be included in the final printing of the manuals and on literature relating to the device.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR Over-The
that Rivels
(Division Sign-Off) Division of General Restorative Devices K991993 Sluk, Number
Over-The-Counter Use
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.