(41 days)
EVLT kits and Diomed D15plus and D30plus Diode Lasers are indicated for the treatment of varicose veins and varicosities associated with superficial reflux of the Greater Saphenous Vein
Not Found
The provided document is a 510(k) substantial equivalence letter from the FDA for a medical device: "EVLT Kit and D15Plus and D30Plus Diode Lasers."
This type of document primarily confirms that a new device is "substantially equivalent" to an already legally marketed predicate device, meaning it has the same intended use and technological characteristics, or different technological characteristics that do not raise new questions of safety and effectiveness.
Crucially, a 510(k) does not typically contain detailed acceptance criteria, device performance tables, sample sizes for studies, ground truth establishment, or information about AI/MRMC studies as would be expected for a novel device or a clinical trial submission. The focus is on demonstrating equivalence to an existing device.
Therefore, most of the information requested in the prompt cannot be extracted from the provided text.
Here's a breakdown of what can be inferred or what is explicitly missing:
1. A table of acceptance criteria and the reported device performance
- Not Available: The document does not provide specific acceptance criteria or detailed performance data for the EVLT Kit and Diode Lasers. Substantial equivalence relies on demonstrating that the new device is as safe and effective as a predicate device, but specific performance metrics against pre-defined acceptance criteria are not typically part of this public summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Available: This information would be found in detailed study reports, which are not included in this FDA 510(k) letter.
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)
- Not Available: This information pertains to the underlying data and ground truth establishment for a clinical trial or performance study, which is not detailed in this 510(k) letter.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Available: As above, this level of detail regarding study methodology is not present.
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
- Not Applicable: The device is a laser surgical instrument, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance would not be relevant in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This device is a laser surgical instrument, not an algorithm. Standalone algorithm performance studies are not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Available: Without detailed study reports, the type of ground truth used for any underlying data supporting the predicate comparison cannot be determined from this document. However, for a surgical device for varicose veins, ground truth would likely involve clinical outcomes, imaging confirmation of treatment success (e.g., ultrasound demonstrating vein closure), and expert clinical assessment.
8. The sample size for the training set
- Not Available: This information would be part of detailed study reports, which are not provided here. Also, for a device like this, the concept of a "training set" as understood in machine learning/AI is not applicable. The device's safety and effectiveness are established through engineering design, bench testing, and potentially clinical studies, rather than a machine learning training paradigm.
9. How the ground truth for the training set was established
- Not Applicable / Not Available: As mentioned, the concept of a "training set" doesn't directly apply here in the AI/ML sense. For traditional medical devices, the "ground truth" for design validation and clinical evidence would be established through a combination of engineering principles, established medical knowledge, clinical observations, and potentially clinical trial results compared to standard-of-care. The specific methods are not detailed in this 510(k) letter.
In summary, the provided document is a regulatory clearance letter, not a detailed technical or clinical study report. It focuses on the legal determination of substantial equivalence, not the granular details of performance studies.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three curved lines forming its body and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 0 2 2002
Mr. Samuel D. Wade Director, Regulatory and Quality Affairs Diomed, Inc. One Dundee Park, Suites 5 & 6 P.O. Box 97 Andover, Massachusetts 01810
Re: K023543
Trade/Device Name: EVLT Kit and D15Plus and D30Plus Diode Lasers Regulation Numbers: 21 CFR 878.4810 Regulation Names: Laser Surgical Instrument for Use in General and Plastic Surgery and in Dermatology Regulatory Class: II Product Code: GEX Dated: October 3, 2002 Received: October 22, 2002
Dear Mr. Wade:
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. Ilsting 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
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Page 2 -- Mr. Samuel D. Wade
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. 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) 594-4659. 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,
Miriam C. Provost
Calia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K023543
Device Name: Lasers Lasers - - - -
Indications for Use:
EVLT kits and Diomed D15plus and D30plus Diode Lasers are indicated for the treatment of varicose veins and varicosities associated with superficial reflux of the Greater Saphenous Vein
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Muriam C. Provost
Division Sign-Off) Division of General, Restorative and Neurological Devices
- 510(k) Number: K023543
§ 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.