(170 days)
No
The device description and performance studies focus on the physical properties and manufacturing of acupuncture needles, with no mention of AI or ML technology.
Yes
The device is used to perform acupuncture, which is a therapeutic practice involving the insertion of needles into specific points on the skin to treat various conditions.
No
Explanation: The device, acupuncture needles, is used to pierce the skin for acupuncture, a treatment modality, and its description focuses on materials, sterilization, and mechanical properties, not on identifying or determining the nature or cause of a health condition.
No
The device description explicitly states the device is a physical acupuncture needle made of stainless steel, which is a hardware component.
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 device is a sterile needle for insertion into the skin.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health status, diagnose conditions, or monitor treatment. This device does not perform any such function.
Therefore, the WOOJEON ACUPUNCTURE NEEDLES are a medical device used for a therapeutic purpose, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
WOOJEON ACUPUNCTURE NEEDLES is intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states
Product codes
MQX
Device Description
The our needles are sterile which are inserted into specific points on the skin, called "acupuncture points." The Acupuncture Needles are manufactured from stainless steel and sterilized with gamma irradiation.
The Acupuncture Needles are available in 78 models as per diameters (0.16 to 0.40 mm) and 78 needle tube models as per lengths (8-60mm)
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
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)
The Acupuncture Needle is examined microscopically and mechanically tested to evaluate pull-out and elasticity properties. Specifically, the surfaces of the subject and predicate devices were found to be smooth and free of visible defects at 200-300X magnification. Also, the pull-out force of the Acupuncture Needle was quantified and fell within the average values reported for the predicate devices. Finally, the elasticity properties of the subject device were found to be substantially equivalent to the predicate devices
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
Woo_jeong 우정
ㄴ. 청구제
WOOJEON ACUPUNCTURE NEEDLE
510(k) Summary
1. Applicant
Wooieon Co. 364-4 Dangjeong-dong, Gunpo-si, Gyeonggi-do 435-832, Korea TEL. +82 (31) 456-5050 FAX. +82 (31) 455-2919 Date: Aug. 29th, 2011 2.Contact person
Peter Chung
–Tel 412-687-3976,Fax #: 412-687-3976 (Same with the home number)
-Mobil phone #: 412-512-8802)
-300 Atwood Street Pittsburgh, PA 15213 USA
3. Device Name
Trade Name: . WOOJEON ACUPUNCTURE NEEDLE
Common Name: Single use, Acupuncture Needle.
Classification Name: Single use, Acupuncture Needle.
Product Code: MOX
Requlation: 880.5580
Class of device : ClassII.
4. Predicate Devices
WOOJEON ACUPUNCTURE NEEDLE is similar with the legally marketed ASIA-MED Single use, Acupuncture Needle to have K052085.
5. Description of the Device
The our needles are sterile which are inserted into specific points on the skin, called "acupuncture points." The Acupuncture Needles are manufactured from stainless steel and sterilized with gamma irradiation.
The Acupuncture Needles are available in 78 models as per diameters (0.16 to 0.40 mm) and 78 needle tube models as per lengths (8-60mm)
6. Intended Use:
WOOJEON ACUPUNCTURE NEEDLES is intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states
7. Technical Characteristics
The Acupuncture Needle is examined microscopically and mechanically tested to evaluate pull-out and elasticity properties. Specifically, the surfaces of the subject and predicate devices were found to be smooth and free of visible defects at 200-300X magnification. Also, the pull-out force of the Acupuncture Needle was quantified and fell within the average values reported for the predicate devices. Finally, the elasticity properties of the subject device were found to be substantially equivalent to the predicate devices
8. Safety and Effectiveness
The Acupuncture Needle is a safe and effective device and is substantially equivalent to the predicate devices listed in this 510(k) submission; that is, the Acupuncture Needle has the same intended use (i.e., indications for use) and is similar, and in some cases the same, in both design (e.g., materials, sizes) and performance. Any differences in technological characteristics between the Acupuncture Needle and the predicate devices do not raise issues of safety and effectiveness.
NOV - 4 2011
11
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and features the department's emblem in the center. The emblem consists of a stylized caduceus-like symbol with three wavy lines emanating from a central point. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
NOV - 4 2011
Woojeon Company C/O Mr. Peter Chung 300 Atwood Street Pittsburgh, Pennsylvania 15213
Re: K111392
Trade/Device Name: Woojeon Acupuncture Needles Regulation Number: 21 CFR 880.5580 Regulation Name: Acupuncture Needle Regulatory Class: II Product Code: MQX Dated: September 29, 2011 Received: October 19, 2011
Dear Mr. Chung:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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. Chung
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/ucm 115809.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/MedicalDevices/Safety/ReportaProblem/default.htm 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Anthony D. Watson
Anthony D. Watson, B.S., M.S., M.B.A. 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):
Device Name: Woojeon Acupuncture Needles
Indications For Use:
WOOJEON ACUPUNCTURE NEEDLES is intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states
Prescription Use ×
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(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 Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K111392
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