SD-730 IF-SDS, PERFECT PULSE IF-SDS by SKYLARK DEVICE & SYSTEMS CO., LTD

The provided document is a 510(k) clearance letter from the FDA for a device named SD-730 IF-SDS (also known as Perfect Pulse IF-SDS). This letter indicates that the device has been found substantially equivalent to a predicate device, allowing it to be marketed.

However, the document does NOT contain information about acceptance criteria, specific device performance data from a study, sample sizes, expert qualifications, adjudication methods, details of comparative effectiveness studies (MRMC), standalone performance, types of ground truth used, or training set information.

The document is a regulatory approval letter, not a study report. It outlines the indications for use for which the device was cleared ("Symptomatic relief of chronic, intractable pain" and "Management of pain associated with post-traumatic or post-operative conditions") but does not present the data used to support these claims or demonstrate performance against specific criteria.

Therefore, I cannot provide the requested information based on the text provided.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around an emblem. The emblem is a stylized image of a human figure in profile, with three lines extending from the head, resembling a bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 3 2000

George K.C. Chen, Ph.D., M.D. Skylark Device & Systems Co., Ltd. 34 Chung Shan North Road 12th Floor, Section 3 Taipei, Taiwan China

K992652 Re:

Trade Name: SD-730 IF-SDS, Perfect Pulse IF-SDS Regulatory Class: Unclassified Product Code: LIH Dated: Undated Received: November 12, 1999

Dear Dr. Chen:

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 (OS) 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.

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

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Page 2 - George K.C. Chen, Ph.D., M.D.

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,

Mark N Milkeess

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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510(k) NUMBER (IF KNOWN): K 992652 DEVICE NAME: SD-730 IF-SDS

INDICATIONS FOR USE:

1.Symptomatic relief of chronic, intractable pain

2.Management of pain associated with post-traumatic or post-operative conditions

(PLEASE DO. NOT WRITE. BELOK THIS LLINE - CONTINUE - ON : ANGTHER - PAGE - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General Restorative Devices

510(k) Number	K992652
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Prescription Use	X	OR	Over-The-Counter-Use (Optional Format 1-2-96)
(Per 21 CFR 801.109)

Regulation Number and Section

§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.

(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).