(29 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) clearance letter from the FDA for a device called "Lyra Acupuncture Needles." It does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert evaluations.
The document primarily focuses on:
- Confirming that the device is substantially equivalent to legally marketed predicate devices.
- Outlining the regulatory requirements the manufacturer must adhere to (e.g., registration, labeling, good manufacturing practice).
- Stating the intended "Indications For Use" for the device, which is "To pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the States."
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided text.
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Image /page/0/Picture/2 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus-like symbol, which is a staff with a snake entwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the symbol in a circular fashion. The seal is black and white.
SEP 2 0 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Eric Cheng Senior Quality System Engineer Helio Medical Supplies, Incorporated 606 Charcot Avenue San Jose, California 95131
Re: K062448
Trade/Device Name: Lyra Acupuncture Needles Regulation Number: 21 CFR 880.5580 Regulation Name: Acupuncture Needle Regulatory Class: II Product Code: MQX Dated: August 15, 2006 Received: August 22, 2006
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 Federal 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.
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.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Qur
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
510(k) Number (if known): _ K 062948
Lyra Acupuncture Needle 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)
Oliver
an Sign-Ctr) on of Anesthesiology, General Hospital, Control, Dental Devices
Number: K062448
C-1
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.