(53 days)
The DioScan Scanning Handpiece Accessory is indicated for incision, excision, vaporization, ablation, cutting, hemostasis, and coagulation of soft tissue in dermatology and plastic surgery, including aesthetic surgery.
The DioScan Scanning Handpiece is intended to allow the rapid treatment of a large area of skin by scanning a laser spot over a treatment area. The area treated allows the majority of the operator's time to be spent in treatment, with a small proportion of time spent in moving the scanner between areas. To minimize patient discomfort and reduce spent in moving the counter ous, the handpiece employs a cooled sapphire window in thermal contact with the skin during treatment.
The provided text is a 510(k) summary for the DioScan Scanning Handpiece Accessory. It explicitly states that no performance data or studies were required because the device's specifications and indications for use are "the same or very similar" to legally marketed predicate devices.
Therefore, the requested information regarding acceptance criteria and a study to prove they are met cannot be extracted from this document, as such a study was not performed for this submission.
Here's a breakdown based on the information provided:
1. Table of acceptance criteria and the reported device performance:
- Acceptance Criteria: None explicitly stated as performance data was not required. The implicit acceptance criterion for this 510(k) submission was "substantial equivalence" to predicate devices.
- Reported Device Performance: Not applicable, as performance data was not required or reported.
2. Sample size used for the test set and the data provenance:
- Not applicable, as no performance tests were conducted.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable, as no performance tests were conducted.
4. Adjudication method for the test set:
- Not applicable, as no performance tests were conducted.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size:
- No, an MRMC comparative effectiveness study was not done.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, a standalone performance study was not done. This device is a physical handpiece accessory, not an algorithm.
7. The type of ground truth used:
- Not applicable, as no performance tests were conducted.
8. The sample size for the training set:
- Not applicable, as no training set was used for this type of device submission.
9. How the ground truth for the training set was established:
- Not applicable, as no training set was used.
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2/26/95
996014
Appendix E
510(K) SUMMARY DIOSCAN SCANNING HANDPIECE ACCESSORY
This 510(k) summary of safety and effectiveness for the handpiece accessory is submitted in accordance I his 510(K) summaly of sacty and circultions office of Device Evaluation guidance concerning the organization and content of a 510(k) summary.
| Applicant: | Diomed, Inc. |
|---|---|
| ------------ | -------------- |
- 30-31 Union Wharf Address: Boston, MA 02109
- Contact Person: Adrian Grundy General Manager
- 617-723-6593 Telephone: 617-723-6598 (fax)
Preparation Date:December, 1998 (of the Summary)
DioScan Scanning Handpiece Accessory Device Name:
Common Name: Laser Handpiece Delivery System
Accessory to a laser surgical instrument for use in general and plastic surgery and in Classification dermatology Name: (see: 21 CFR 878.4810). Product Code: GEX. Panel: 79.
Legally marketed
| predicate | |
|---|---|
| device: | Lihtan Technologies, Inc. Hexascan HandpieceCool Laser Optics, Inc. CLO Contact Cooling System |
- The DioScan Scanning Handpiece is intended to allow the rapid treatment of a large Description of area of skin by scanning a laser spot over a treatment area. The area treated allows the the Device: majority of the operator's time to be spent in treatment, with a small proportion of time spent in moving the scanner between areas. To minimize patient discomfort and reduce spent in moving the counter ous, the handpiece employs a cooled sapphire window in thermal contact with the skin during treatment.
- The DioScan Scanning Handpiece Accessory is indicated for incision, excision, Indications for I he Diocoan. Obtaining sutting, hemostasis, and coagulation of soft tissue in dermatology use: and plastic surgery, including aesthetic surgery.
- The specifications of the DioScan Scanning Handpiece Accessory are the same or very Comparison to: similar to those of the claimed predicates.
41
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-
None. The specifications and indications for use of the DioScan Scanning Handpiece Performance Accessory are the same or very similar to those of the claimed predicate devices. The Data: DioScan Scanning Handpiece Accessory has similar indications for use for which the claimed predicates have been cleared.
Because of this, performance data were not required. -
Based on the foregoing, Diomed believes that the DioScan Scanning Handpiece Conclusion: Accessory is substantially equivalent 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 stylized eagle-like symbol with three curved lines representing wings or feathers. The symbol is enclosed within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in capital letters. The text is arranged around the circumference of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 26 1999
Mr. Adrian Grundy General Manager Diomed, Inc. 30-31 Union Wharf Boston, Massachusetts 02109
K990014 Re: Trade Name: DioScan Scanning Handpiece Accessory Regulatory Class: II Product Code: GEX Dated: December 30, 1998 Received: January 4, 1999
Dear Mr. Grundy:
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 (QS) 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. Adrian Grundy
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,
Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
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990014 510(K) Number (if known):
Device Name: DioScan Scanning Handpiece Accessory
Indications For Use:
The DioScan Scanning Handpiece Accessory is indicated for incision, excision, vaporization, The DioScan Scaming Hampico Accossery is marketed to consisted, "
ablation, cutting, hemostasis, and coagulation of soft tissue in dermatology and plastic surgery, including aesthetic surgery.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) OR Prescription Use Over-The-Counter Use (Per 21 CFR 810.109) 36
§ 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.