(174 days)
Not Found
Not Found
No
The device description and intended use are for simple acupuncture needles, and there is no mention of AI, ML, or any computational processing.
Yes
Acupuncture is considered a therapeutic practice, and the device is intended for use in the practice of acupuncture.
No
The device description states its intended use is to "pierce the skin in the practice of acupuncture". This is a therapeutic or interventional function, not a diagnostic one. Diagnostic devices are used to identify or detect a disease or condition.
No
The device description explicitly states it is a sterile, single-use acupuncture needle, which is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "To pierce the skin in the practice of acupuncture". This is a physical intervention on the body, not a test performed on samples taken from the body to diagnose or monitor a condition.
- Device Description: The description details acupuncture needles, which are instruments used for physical treatment.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), reagents, or any diagnostic purpose.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly falls outside of that definition.
N/A
Intended Use / Indications for Use
To pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the States.
Product codes
MQX
Device Description
Precision Press Tack / Intraderm Needles, Precision Seven Star Needles, Präzision Acupuncture Needles, Alpha Acupuncture Needles, Fine Point Acupuncture Needles, Chi Acupuncture Needles, Zen Acupuncture Needles are sterile, single use only. The design, material used, sterility and biocompatibility of this acupuncture Needles meet the general specifications and criteria for an single use acupuncture Needles and is effective for the practice of acupuncture.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Qualified practitioners of acupuncture
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
October 10, 2006
PRE-MARKET NOTIFICATION 510 (K) SUMMARY
(As Required by 21 CFR 807.92)
Prime Herbs Co., 754 San Aleso Avenue Sunnyvale, CA 94085 Phone: 408-744-1077 Genevieve Hsia
NOV 2 2 2006
Device Name: Precision Press Tack / Intraderm Needle, Precision Seven Star Needle, Präzision Acupuncture Needle, Alpha Acupuncture Needle, Fine Point Acupuncture Needle, Chi Acupuncture Needle and Zen Acupuncture Needle Common Device Name: Acupuncture Needle, Signal Use Product Code: MQX Medical Specialty: General Hospital Device Class: II
Precision Press Tack / Intraderm Needles, Precision Seven Star Needles, Präzision I receision 11035 Tach / Alpha Acupuncture Needles, Fine Point Acupuncture Needles, Chi Acupuncture Needles, Inc. Zen Acupuncture Needles are defined as prescription devices intended to reapanetate rebates are tice of acupuncture by qualified practitioners of acupuncture as determined by the States.
FDA had issued 510(K)s to 47 different signal use acupuncture Needless brand and them have I DA had issued 9 ro(11)3 wire in the United States since 1996. We had searched Federal Consumer Information Center web site http://www.pueblo.gsa.gov and U.S. Consumer Product Safety Commission web site http://www.cpsc.gov and found no serious or We threatening accidents involving acupuncture Needless.
Precision Press Tack / Intraderm Needles, Precision Seven Star Needles, Präzision Acupuncture 1 (CUSTO) Fress Fack - The Point Acupuncture Needles, Chi Acupuncture Needles and Needes, Alpha Acupanedare sterile, single use only. The design, material used, sterility and hiocompatibility of this acupuncture Needles meet the general specifications and criteria for an single use acupuncture Needles and is effective for the practice of acupuncture.
In conclusion, based on the information provided with this 510(K) Notification, the Precision Press In conclusion, based on the Precision Seven Star Needles, Präzision Acupuncture Needles, Alpha Tack / Intraderin Necdles, Freehslon Soven Star Fronter Needles and Zen Acupuncture Acupunciale Necutes, I he Follo Reapanetane Press Tack / Intraderm Needles, Nectiles meet the or nerial 10. 910(1) issort Acupuncture Needles, Alpha Acupuncture Needles, Fine Point I recision Devell Star Procures Needles and Zen Acupuncture Needles are equivalent to other Acupuncture Needless which are currently being sold through interstate commerce.
Genevieve Hsia, President
Date
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The logo is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in capital letters.
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Genevieve Hsia President Prime Herbs Corporation 754 San Aleso Avenue Sunnyvale, California 94085
NOV 2 2 2006
Re: K061517
Trade/Device Name: Fine Point Acupuncture Needle, Alpha Acupuncture Needle, Prazision Acupuncture Needle, Zen Acupuncture Needle, Chi Acupuncture Needle, Precision Press Tack, Precision Intradermal Needle and Seven Star Needle Regulation Number: 880.5580 Regulation Name: Acupuncture Needle Regulatory Class: II Product Code: MOX Dated: October 19, 2006 Received: October 19, 2006
Dear Ms. Hsia:
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.
2
Page 2 - Ms. Hsia
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Soutte y. Michael Dms.
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
3
Indications for Use
510(k) Number (if known): K061517
- Device Name: Fine Point Acupuncture Needle, Alpha Acupuncture Needle, Prazision Acupuncture Needle, Zen Acupuncture Needle, Chi Acupuncture Needle, Precision Press Tack, Precision Intradermal Needle, & Seven Star Needle
- Indications For Use: To pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the States.
Prescription Use X AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Suytle Y. Michem MD
Page 1 of 1
utatiology, General Hospital,
won Contol, Denial Devices
K 061517