(46 days)
To pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the States.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA to Helio Medical Supplies, Incorporated regarding their Press Tack/Intradermal Acupuncture Needles. This document is a regulatory approval letter and does not contain information about acceptance criteria or a study proving device performance as typically understood for medical device AI/algorithm submissions.
Therefore, I cannot extract the requested information from the provided text. The document primarily focuses on:
- Device Name: Press Tack/Intradermal Acupuncture Needles
- Regulatory Classification: Class II
- Product Code: MQX
- Submission Date and Receipt Date: February 3, 2005 / February 7, 2005
- FDA Determination: Substantially equivalent to a legally marketed predicate device.
- Indications for Use: To pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the States.
- Prescription Use status: Prescription Use.
To address your request, I would need a document that presents a clinical or performance study for a medical device, ideally one involving an AI or algorithmic component, which would then detail its acceptance criteria and the results of the study.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 5 2005
Mr. Eric Cheng Senior Quality System Engineer Helio Medical Supplies, Incorporated 606 Charcot Avenue San Jose, California 95131
Re: K050295
Trade/Device Name: Press Tack/Intradermal Acupuncture Needles Regulation Number: 880.5580 Regulation Name: Acupuncture Needle Regulatory Class: II Product Code: MQX Dated: February 3, 2005 Reccived: February 7, 2005
Dear Mr. Cheng:
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, 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 (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 Eederal Register.
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Page 2 - Mr. Cheng
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. or mo rot or any 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 und instille (s = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = roquirely, 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 (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.
Sincerely vours.
Seulite M.chiel Ond.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications For Use
| : 17 " | 7 ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ||
|---|---|---|---|
| 510(k) Number (if known): |
Press Tack/Intradermal Acupuncture Needles Device Name:
Indications For Use:
To pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the States.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use __ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Number. K054295
Page 1 of
§ 880.5580 Acupuncture needle.
(a)
Identification. An acupuncture needle is a device intended to pierce the skin in the practice of acupuncture. The device consists of a solid, stainless steel needle. The device may have a handle attached to the needle to facilitate the delivery of acupuncture treatment.(b)
Classification. Class II (special controls). The device, when it is an acupuncture point locator or a single use acupuncture needle, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9. Acupuncture needles must comply with the following special controls:(1) Labeling for single use only and conformance to the requirements for prescription devices set out in 21 CFR 801.109,
(2) Device material biocompatibility, and
(3) Device sterility.