(179 days)
Diomed 810 nm Surgical Lasers and EVLT Procedure Kit are intended for use in endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux.
Diomed 810 nm Surgical Lasers and EVLT Procedure Kit is a semiconductor diode lasers operating at 810 ± 20 microns and associated disposables.
The provided text describes a 510(k) summary for the Diomed 810 nm Surgical Lasers and EVLT Procedure Kit, which establishes substantial equivalence to a predicate device. However, it does not contain detailed acceptance criteria, specific study results, or the methodology used to generate performance data in the way a traditional study report would.
Here's an analysis of the information available based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table of acceptance criteria or specific quantitative performance metrics. It generally states:
"Clinical tests performed by Diomed have demonstrated the substantially equivalent performance of the Diomed 810 nm Surgical Lasers and EVLT Procedure Kit with the predicate device used for substantially equivalent indications."
2. Sample Size Used for the Test Set and Data Provenance
The document states "Clinical tests performed by Diomed," but it does not specify the sample size for any test set or the data provenance (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided in the document. The nature of the device (a surgical laser) suggests that "ground truth" would likely be related to clinical outcomes, rather than image interpretation requiring multiple expert readers.
4. Adjudication Method for the Test Set
This information is not provided in the document. Given the likely nature of the "clinical tests" (evaluating surgical outcomes), a formal adjudication method for a test set in the context of expert consensus may not be applicable in the same way as for diagnostic imaging.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not provided and is unlikely to be relevant for this type of device. MRMC studies are typically used for diagnostic devices where human readers interpret medical images. This device is a surgical laser, and its performance would be assessed through surgical outcomes.
6. Standalone Performance Study
The document states "Clinical tests performed by Diomed have demonstrated the substantially equivalent performance," implying a study was done on the device's performance. However, it does not explicitly state if this was a "standalone" study in the sense of an algorithm-only performance without human intervention, as the device is a surgical tool requiring human operation. The performance described would inherently involve human users.
7. Type of Ground Truth Used
The document implies that "clinical tests" were performed. For a surgical laser used for endovascular coagulation of veins, "ground truth" would most likely be established through clinical outcomes data, such as:
- Successful occlusion of the saphenous vein.
- Absence of reflux post-procedure.
- Adverse events (e.g., pain, bruising, nerve injury).
- Follow-up ultrasound findings.
The document does not explicitly state the type of ground truth, but clinical outcomes are the most logical.
8. Sample Size for the Training Set
This information is not provided. The concept of a "training set" is typically associated with machine learning algorithms. While clinical experience and data might inform the design and use of a medical device, the document does not suggest a formal machine learning training set was used for this laser device.
9. How Ground Truth for the Training Set Was Established
This information is not provided, as a formal "training set" in the context of machine learning is not mentioned or implied for this device.
In summary:
The 510(k) summary provided is for a surgical laser, and it focuses on establishing substantial equivalence to a legally marketed predicate device based on "clinical tests." It lacks the detailed quantitative performance metrics, study methodologies, and expert involvement descriptions that would be typical for an AI/ML-driven diagnostic device. The primary takeaway is that the device's performance was deemed "substantially equivalent" to the predicate, but the specifics of how that equivalence was determined (e.g., sample sizes, precise outcomes measured) are not included in this summary.
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510(K) SUMMARY Diomed 810 nm Surgical Lasers and EVLT Procedure Kit
This 510(k) summary of safety and effectiveness for the Diomed 810 nm Surgical Lasers and EVLT Procedure Kit 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: | Diomed, Inc. |
|---|---|
| Address: | One Dundee ParkSuite 5/6Andover, MA 01810 |
| Contact Person: | Peter KleinChief Executive Officer |
| Telephone: | 978-475-7771978-475-8488 (fax) |
| Preparation Date:(of the Summary) | January, 2002 |
| Device Name: | Diomed 810 nm Surgical Lasers and EVLT Procedure Kit |
| Common Name: | Surgical Laser: GaAlAs Semiconductor Diode Laser |
| ClassificationName: | Device, Electrosurgical, Cutting & Coagulation & Accessories(see: 21 CFR 878.4400). Product Code: GEI. Panel: 79 |
| Legally marketedpredicatedevice: | VNUS Closure System (K974521, K003092, K982816) |
| Description ofthe Device: | Diomed 810 nm Surgical Lasers and EVLT Procedure Kitis a semiconductor diode lasers operating at 810 ± 20 microns andassociated disposables. |
| Indications forUse: | Diomed 810 nm Surgical Lasers and EVLT Procedure Kit areintended for use in endovascular coagulation of the greatersaphenous vein of the thigh in patients with superficial vein reflux. |
| Comparison toPredicate Device: | The intended use, method of tissue interaction, specifications,clinical technique and clinical results of the Diomed 810 nmSurgical Lasers and EVLT Procedure Kit are the same or verysimilar to those of the claimed predicate. |
| Performance Data: | Clinical tests performed by Diomed have demonstrated thesubstantially equivalent performance of the Diomed 810 nmSurgical Lasers and EVLT Procedure Kit with the predicate deviceused for substantially equivalent indications. |
| Conclusion: | Based on the foregoing, Diomed believes that the Diomed 810 nmSurgical Lasers and EVLT Procedure Kit are substantiallyequivalent to legally marketed predicate devices. |
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Image /page/2/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human figures connected at the shoulders, forming a symbolic representation of people.
JAN 2 2 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Diomed, Ltd. c/o Ms. Maureen O'Connell 5 Timber Lane North Reading, Massachusetts 01864
Re: K012398
R012376
Trade/Device Name: Diomed 810 nm Surgical Lasers and EVLT Procedure Kit Regulation Number: 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: October 22, 2001 Received: October 24, 2001
Dear Mr. O'Connell:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreate) to stgmay to the Medical Device Amendments, or to commerce proc to rias 2011-11-11 in accordance with the provisions of the Federal Food, Drug, de neces that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The Four may, ateres, mains of the Act include requirements for annual registration, listing of general controls provisions of ractice, 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 If your device is elassinon (controls. Existing major regulations affecting your device can may or babyer 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 r read of a nove a determination that your device complies with other requirements of the Act that I Dr Has Intatutes 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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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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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,
Sincerely yours,
Celia 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): ____________________________________________________________________________________________________________________________________________________ K012398
Device Name: Diomed 810 nm Surgical Lasers and EVLT Procedure Kit
Indications For Use:
Diomed 810 nm Surgical Lasers and EVLT Procedure Kit are intended for use in Dromed of 0 mm burgiour Dasers and 24 saphenous vein of the thigh in patients with superficial vein reflux.
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ાર ounter Use Division Sign-Off
Division of General Restorative and Neurological L vices
510(k) Number K012-398
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Pcr 21 CFR 810.109)
§ 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.