(272 days)
Not Found
No
The device description and performance studies focus on the physical properties and mechanical performance of acupuncture needles, with no mention of AI or ML.
No.
A therapeutic device is one that treats or alleviates a disease, injury, or other medical condition. The provided information indicates the device is used for piercing the skin in acupuncture, but does not describe any direct therapeutic action or outcome from the device itself. While acupuncture may be used therapeutically, the needle itself is an instrument for the procedure, not the therapy.
No
The device is described as an "Acupuncture Needle" intended to "pierce the skin in the practice of acupuncture." Its function is therapeutic rather than diagnostic, as it is used for treatment by inserting needles into specific points.
No
The device description clearly states it is a physical acupuncture needle made of stainless steel, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the body (in vitro).
- Device Description and Intended Use: The provided information clearly states that the device is an acupuncture needle intended to "pierce the skin in the practice of acupuncture." This is a procedure performed on the body (in vivo) and does not involve testing samples taken from the body.
The device is a therapeutic device used for a medical procedure, not a diagnostic device used for testing samples.
N/A
Intended Use / Indications for Use
This acupuncture needle is intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.
Product codes (comma separated list FDA assigned to the subject device)
MQX
Device Description
The Acupuncture Needles are sterile, hair thin needles 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 eleven diameters (0.14 to 0.50 mm), nine needle lengths (15-60mm), two stick lengths (20 and 30 mm), and nine tube lengths (30-145 mm).
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)
The Acupuncture Needle, as well as two of the predicate devices (Dong Bang Acupuncture Needle, K972659 and C & G Acupuncture Needle, K043277), were 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 two predicate devices, as after cantilever-type loading all three devices returned to their original shape showing no permanent deformation.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
KOS2240
510(k) Summary (per 21 CFR 807.92(c))
1. Applicant
APR 2 1 2010
HaengLim SeoWon Medical Co. #954-30, Gwanyang Dong, Dongan-Ku Anyang-City, Kyonggi-Do Korea (431-060)
Sang Don Kim, Director Tel: 82-31-421-4333 Fax: 82-31-421-5425 E-mail: shahn0525@naver.com
Date Prepared: April 13, 2010
-
- Device Name
Acupuncture needle Trade Name: Common/ Usual Name: needle, acupuncture, single use Acupuncture needle Classification Name: Regulation Number: 880.5580 MQX Product Code: Classification: ll Panel: General Hospital
- Device Name
3. Predicate Devices
The Acupuncture Needle is substantially equivalent to the following devices:
| 510(k)
| Number | Device | Applicant |
|---|---|---|
| K972659 | Dong Bang Acupuncture Needle | Dong Bang, U.S.A. |
| K043277 | C & G Acupuncture Needle | Helio Medical Supplies, |
| Incorporated | ||
| K052731 | Kangsheng Brand/Kangnian Brand/Unilink | |
| Brand /Huazhong Brand Acupuncture Needle | Daxin Li | |
| c/o | ||
| Lee & Xiao Attorneys |
1
4. Intended Use
This acupuncture needle is intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.
5. Description of the Device
The Acupuncture Needles are sterile, hair thin needles 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 eleven diameters (0.14 to 0.50 mm), nine needle lengths (15-60mm), two stick lengths (20 and 30 mm), and nine tube lengths (30-145 mm).
Summary of the Technical Characteristics 6.
The Acupuncture Needle, as well as two of the predicate devices (Dong Bang Acupuncture Needle, K972659 and C & G Acupuncture Needle, K043277), were 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 two predicate devices, as after cantilever-type loading all three devices returned to their original shape showing no permanent deformation.
7. 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.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Haenglim Seowon Medical Company C/O Ms. Jean Asquith APR 2 1 2010 Senior Regulatory Affairs Consultant Emergo Group, Incorporated 1705 South Capital of Texas Highway, Suite 500 Austin, Texas 78746
Re: K092240
Trade/Device Name: Acupuncture Needles Regulation Number: 21CFR 880.5580 Regulation Name: Acupuncture Needle Regulatory Class: II Product Code: MQX Dated: March 31, 2010 Received: April 2, 2010
Dear Ms. Asquith:
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.
3
Page 2- Ms. Asquith
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/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
h for
Anthony 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
4
Indications for Use
510(k) Number (if known):
Device Name: Acupuncture Needles
Indications for Use:
The device is 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)
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K092240