(53 days)
To pierce the skin in the practice of acupuncture by qualified practitioners as determined by the States.
Marknew Products Acupuncture Needles
I apologize, but the provided text is a 510(k) clearance letter from the FDA for acupuncture needles. It does not contain any information about acceptance criteria for a device, a study proving device performance, or any of the specific details requested in your prompt (like sample sizes, ground truth establishment, or expert qualifications).
Therefore, I cannot fulfill your request based on the given input.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/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" around the perimeter. Inside the circle is a stylized eagle or bird-like symbol with three curved lines representing its wings or body.
FEB 1 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Marknew Products C/O Mr. Greg Holland Regulatory Consultant Regulatory Specialists, Incorporated 3722 Avenue Sausalito Irvine, California 92606
Re: K043506
Trade/Device Name: Marknew Products Acupuncture Needles Regulation Number: 880.5580 Regulation Name: Acupuncture Needle Regulatory Class: II Product Code: MQX Dated: December 13, 2994 Received: December 20, 2004
Dear Mr. Holland:
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 restrenced above and in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mendments, or to devices that have been reclassified in accordance with the provisions of / Infondinone, of to active Act (Act) that do not require approval of a premarket the Federal F 800; Drag) . You may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provisions on 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 If your device it enables to such additional controls. Existing major regulations affecting (1 writ), it hay be bacyse to the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device can or roublish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Holland
Please be advised that FDA's issuance of a substantial equivalence determination does not r least be auvrast that I Da determination that your device complies with other requirements moan that I DA mas made statutes and regulations administered by other Federal agencies. or the Act of all , I outh all the Act's requirements, including, but not limited to: registration 1 ou indisting (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and issuits (21 CF reful 067), as ality systems (QS) regulation (21 CFR Part 820); and if requirements as set form in ate quadiation 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) This letter will and my Jorle Finding of substantial equivalence of your device to a premaired 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), 11 you desire specific af 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 may obtain 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 yours,
Clus
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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KØ435Ø6
Premarket Notification Mar
Page 1 of 1
Indications for Use Statement
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: Marknew Products Acupuncture Needless
Indications For Use:
To pierce the skin in the practice of acupuncture by qualified practitioners as determined by the States.
X Prescription Use_ (Per 21 CFR 801.109)
Over-The-Counter Use_ OR (Optional Format 1-2-96)
(Please do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Antr Vme
vision Sinn-Off) UNIsion of Anesthesiology, General Hospital, Intection Control, Dental Devices
310(k) Number: K443546
§ 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.