(73 days)
Intended 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 approval letter for acupuncture needles. It does not contain information about acceptance criteria or a study proving device performance against such criteria. The letter primarily states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices and outlines regulatory compliance requirements.
Therefore, I cannot extract the requested information (acceptance criteria table, sample sizes, expert details, adjudication methods, MRMC study, standalone performance, ground truth types, or training set details) from the provided document.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 4 2005
ASIA-MED GMBH AND CO KG C/O Mr. Kevin Walls Regulatory Insight, Incorporated 13 Red Fox Lane Littleton, Colorado 80127
Re: K052085
Trade/Device Name: STANDARD, SPECIAL, S/NEEDLE B-TYPE AND S/ NEEDLE J-TYPE Regulation Number: 21 CFR 880.5580 Regulation Name: ACUPUNCTURE NEEDLE Regulatory Class: II Product Code: MQX Dated: September 23, 2005 Received: September 26, 2005
Dear Mr. Walls:
We have reviewed your Section 510(k) premarket notification of intent to market the device we mave rottowed your 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 mendments, or to devices that have been reclassified in accordance with the provisions of Amendinens, of to de rood and Cosmetic Act (Act) that do not require approval of a premarket the I cuclar I out, Drag, and Commay, therefore, market the device, subject to the general approvin application (1 the Act. The general controls provisions of the Act include controls providents of a 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 (1 Mrs), it may of bund in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device can be rouncements concerning your device in the Federal Register.
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Page 2 - Mr. Walls
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that I Dr 3 lobalites or that your device complies with other requirements mean that IDA has made a deceminations administered by other Federal agencies. of the Act of ally I cochal statutes and registered to together to: registration You mast comply with an the Fee b roquitements (21 CFR Part 801); good manufacturing practice and listing (21 CFR Pat 607), laceming (21 cms (QS) regulation (21 CFR Part 820); and if requirements as Set form in the quality brovisions (Sections 531-542 of the Act); applicable, the cleculome product railabow you to begin marketing your device as described 21 CFR 1000-1030. This letter will and in Jour of substantial equivalence III your Section 510(x) premainer is a legice results in a classification for your of your device to a regions your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), If you desire specific advice for your de at (240) 276-0115. Also, please note the regulation please contact une Other or Ochiphanes are =================================================================================================================================== 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 Division of Binas-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Louise Y. Michael Oms.
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): K052085
Standard Acupuncture Needle Device Name: Special Acupuncture Needle Special+ Acupuncture Needle sineedle B-Type Acupuncture Needle s|needle J-Type Acupuncture Needle
Indications for Use:
Intended 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 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
$\int$ b.m.
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number:_
Page 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.