(170 days)
WOOJEON ACUPUNCTURE NEEDLES is intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states
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)
The "WOOJEON ACUPUNCTURE NEEDLE" 510(k) submission [K111392] provides information about the device's technical characteristics and claims of substantial equivalence but does not describe a study that establishes acceptance criteria or proves the device meets specific performance thresholds in a clinical or standalone evaluation.
Instead, the submission relies on demonstrating substantial equivalence to a predicate device (ASIA-MED Single use, Acupuncture Needle, K052085) based on technical characteristics and intended use.
Here's an analysis of the information provided, addressing your specific points where applicable, and highlighting what is not present in the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Microscopic Examination (Surface Defects) | "The surfaces of the subject and predicate devices were found to be smooth and free of visible defects at 200-300X magnification." (Implies an unstated acceptance criterion of "smooth and free of visible defects," which the device met.) |
| Pull-out Force | "Also, the pull-out force of the Acupuncture Needle was quantified and fell within the average values reported for the predicate devices." (Implies an unstated acceptance criterion related to "average values of predicate devices," which the device met.) |
| Elasticity Properties | "Finally, the elasticity properties of the subject device were found to be substantially equivalent to the predicate devices." (Implies an unstated acceptance criterion of "substantial equivalence to predicate devices," which the device met.) |
Note: The document does not define specific numerical acceptance criteria (e.g., "pull-out force greater than X Newtons") but rather compares the device's performance to that of the predicate device or general observations.
2. Sample Size Used for the Test Set and Data Provenance
The document does not report a specific "test set" in the context of a clinical performance study. The listed evaluations (microscopic, pull-out, elasticity) are likely laboratory-based tests on samples of the manufactured needles. The sample size for these manufacturing tests is not specified.
Data provenance (country of origin, retrospective/prospective) is not applicable as there is no clinical study described. The manufacturer is based in South Korea, so the device manufacturing and testing would presumably be conducted there.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not Applicable. The described evaluations are technical/mechanical tests (microscopic, pull-out, elasticity) performed on the device itself, not clinical assessments requiring expert ground truth for interpretation of patient data.
4. Adjudication Method for the Test Set
Not Applicable. There is no clinical test set or subjective assessment requiring an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The submission does not describe any study involving human readers or assessing improvement with AI assistance (as it is a physical medical device, not an AI-enabled diagnostic tool).
6. If a Standalone Study Was Done
The "studies" mentioned are laboratory tests of the device's physical properties:
- Microscopic examination of surfaces (smoothness and defects)
- Quantification of pull-out force
- Evaluation of elasticity properties
These are standalone technical evaluations of the device's characteristics against its predicate, but they are not a clinical standalone performance study in the typical sense (e.g., evaluating diagnostic accuracy or clinical outcomes). The document states these tests were performed to establish substantial equivalence.
7. The Type of Ground Truth Used
For the technical characteristics evaluated:
- Microscopic Examination: Ground truth is visually determined by inspection against a standard of "smooth and free of visible defects."
- Pull-out Force: Ground truth is the quantitative measurement of force, compared against the "average values reported for the predicate devices."
- Elasticity Properties: Ground truth is the measured elastic behavior, compared for "substantial equivalence" to the predicate.
These are engineering/material property ground truths derived from direct measurement and comparison, not clinical outcomes, pathology, or expert consensus on patient data.
8. The Sample Size for the Training Set
Not Applicable. This is a physical medical device. There is no AI model or "training set" in the context of machine learning. The manufacturing process of acupuncture needles is the "training" for consistent quality, not data training.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. As there is no training set as understood in AI/machine learning, this question does not apply.
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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
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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.
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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
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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
Page 1 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.