(90 days)
No
The device description and intended use clearly define a simple, physical acupuncture needle with no mention of AI or ML capabilities.
Yes
The device is used to diagnose, cure, mitigate, treat, or prevent disease, as indicated by its intended use in acupuncture practice, which is a recognized treatment modality.
No
Explanation: The device description states its intended use is to "pierce the skin in the practice of acupuncture" and "for the practice of acupuncture". It is a treatment device, not a diagnostic one.
No
The device description explicitly states it is a solid, stainless steel needle with a handle, which are physical hardware components. The performance studies also focus on bench testing of these physical attributes (biocompatibility, sterility).
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 therapeutic procedure performed directly on the patient's body.
- Device Description: The description details a physical needle used for insertion into the skin.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to analyze samples taken from the body to provide diagnostic information. This acupuncture needle is a therapeutic device used for a medical procedure.
N/A
Intended Use / Indications for Use
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.
Product codes
MQX, MOX
Device Description
Hansol Acupuncture Needle consists of components commonly found on Single use, Acupuncture Needle.
The Hansol acupuncture needle is a sterile surgical stainless steel, single use only acupuncture needle. The Hansol acupuncture needle meets the general specification and criteria for an acupuncture needle 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
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Bench tests were performed.
Bench testing included biocompatibility, sterility testing.
The tests demonstrated that the device is as safe , as effective and performs in a substantially equivalent manner to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
510(k) Summary ನ.
See 510(k) Summary, below.
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- Trade Name: . Hansol Acupuncture Needle Common Name: Single use, Acupuncture Needle. Classification Name: Single use, Acupuncture Needle. Product Code: MQX Regulation: 880.5580 Class of device : ClassII.
JUN 300 2009
- Trade Name: . Hansol Acupuncture Needle Common Name: Single use, Acupuncture Needle. Classification Name: Single use, Acupuncture Needle. Product Code: MQX Regulation: 880.5580 Class of device : ClassII.
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- The legally marketed device to which we are claiming equivalence: ASIA-MED Single use, Acupuncture Needle. K052085
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- Description of device: Hansol Acupuncture Needle consists of components commonly found on Single use, Acupuncture Needle.
The Hansol acupuncture needle is a sterile surgical stainless steel, single use only acupuncture needle. The Hansol acupuncture needle meets the general specification and criteria for an acupuncture needle and is effective for the practice of acupuncture.
-
- Intended Use: 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.
- Technological Characteristics: Hansol Acupuncture Needle and the predicate device have identical technological characteristics and perform the same way as common acupuncture Needle They are sterilized
-
- Performance: Bench tests were performed.
Bench testing included biocompatibility, sterility testing.
The tests demonstrated that the device is as safe , as effective and performs in a substantially equivalent manner to the predicate device.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Public Health Service
JUN 30 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Hansol Medical Company C/O Mr. Peter Chun 300 Atwood Street Pittsburgh, Pennsylvania 15213
Re: K090910
Trade/Device Name: Hansol Acupuncture Needle Regulation Number: 21 CFR 880.5580 Regulation Name: Acupuncture Needle Regulatory Class: II Product Code: MOX Dated: June 9, 2009 Received: June 22, 2009
Dear Mr. Chun:
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 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- Mr. Chun
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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.
Anthony Q. anton for
Susan Runner, D.D.S., M.A.
Acting 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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510(k) Number (if known): _K0909 1 0 _________________________________________________________________________________________________________________________________________
Device Name: Single use, Acupuncture Needle
Indications For Use:
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.
Prescription Use X (Pr 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)
(Division Sign=Off) Division of Sign-Olly
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K090910
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