This KM Needles (Acupuncture Needle) is intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the state regulations.

Device Description

The KM Needles (Acupuncture Needle) are simple stainless steel pins that are used by an acupuncture practioner in the treatment of various conditions. Acupuncture is the timulation of specific acupuncture points along the skin of the body involving various methods such as penetration by thin needles or the application of heat, pressure, or laser light. Clinical practice varies depending on the country. Traditional acupuncture involves needle insertion, moxibustion, and cupping therapy. It is a form of alternative medicine and a key component of traditional Chinese medicine (TCM).

The KM Needles (Acupuncture Needle) are constructed of stainless steel, with pin body diameters ranging from 0.16 to 0.70 mm and vary in length from 15 to 135 mm. Each acupuncture needle has a handle for the practioner to manipulate the needle. The handle is also made from stainless steel and range in length from 20-30 mm.

AI/ML Overview

The manufacturer, K.M.S. Inc., states that the KM Needles (Acupuncture Needle) are substantially equivalent to the Dong Bang Acupuncture Needles (K972659). The performance data section describes bench testing for tensile strength and sterility testing.

Here's the breakdown of the information requested:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria / Test	Reported Device Performance
Tensile Strength of the Acupuncture Needle	Met criteria.
* Diameter 0.20 mm	723.3gf
* Diameter 0.25 mm	726.6gf
* Diameter 0.35 mm	733.3gf
Biocompatibility (e.g., cytotoxicity, irritation, sensitization)	Conform to ISO10993-1 (Biological evaluation of medical devices). Specifically: ISO 10993-5 (In Vitro cytotoxicity), ISO 10993-10 (irritation and skin sensitization). All test results were satisfactory.
Sterilization Dose (Gamma radiation)	Met criteria, established per ISO 1137-2. All test results were satisfactory.
Microbiological Methods (Bioburden)	Met criteria, performed per AAMI/ISO/ANSI 11737-1. All test results were satisfactory.
Packaging for Terminally Sterilized Medical Devices	Met criteria, performed per AAMI ANSI ISO 11607-1 (materials, sterile barrier systems, packaging systems) and AAMI ANSI ISO 11607-2 (validation requirements for forming, sealing and assembly processes). All test results were satisfactory.
Accelerated Aging of Sterile Barrier Systems	Met criteria, performed per ASTM F1980-07. All test results were satisfactory.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

The document does not explicitly state the sample sizes used for each of the bench tests (tensile strength, biocompatibility, sterilization, packaging, accelerated aging). It only mentions that "Bench testing was performed" and "Sterility testing was performed."

The data provenance is not specified beyond being generated by K.M.S. Inc. for the K.M.S Inc. device. There is no information regarding country of origin of data, or if it was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not applicable. The device is an acupuncture needle, and the testing involves physical and biological properties rather than diagnostic accuracy requiring expert interpretation of results. The "ground truth" for these tests would be established by validated scientific methods and international standards (e.g., ISO, AAMI, ASTM), rather than expert consensus on diagnostic imaging.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not applicable as the study involves bench testing of physical and biological properties, not a clinical study requiring adjudication of expert interpretations.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This information is not applicable. The device is a medical instrument (acupuncture needle), not an AI-powered diagnostic tool. Therefore, an MRMC study related to human reader performance with or without AI assistance would not be conducted.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

This information is not applicable as the device is not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

The "ground truth" for the performance claims of the KM Needles is based on established international standards and validated scientific testing methodologies. For example:

Tensile Strength: Objective measurement against specified physical limits.
Biocompatibility: Evaluation against the requirements of ISO 10993 series standards, which define acceptable biological responses.
Sterilization: Demonstration of a sterility assurance level (SAL) of $10^{-6}$ using validated methods like ISO 1137-2 concerning radiation sterilization.
Packaging: Compliance with AAMI ANSI ISO 11607 series standards for maintaining sterility.
Accelerated Aging: Compliance with ASTM F1980-07 for determining package integrity over time.

8. The sample size for the training set:

This information is not applicable. This is not a study involving machine learning or AI where a "training set" would be used. The testing described is verification and validation of a physical medical device.

9. How the ground truth for the training set was established:

This information is not applicable, as there is no training set for this device.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 10, 2015

K.M.S. Inc. c/o Mr. Charlie Mack International Regulatory Consulting 12226 Washington Lane Parker, Arizona 85344

Re: K142920

Trade/Device Name: KM Needles (Acupuncture Needle) Regulation Number: 21 CFR 880.5580 Regulation Name: Acupuncture Needle Regulatory Class: II Product Code: MQX Dated: April 29, 2015 Received: May 06, 2015

Dear Mr. Mack:

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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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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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 vours.

Tina
Kiang -S

for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, 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) K142920

Device Name KM Needles (Acupuncture Needle)

Indications for Use (Describe)

This KM Needles (Acupuncture Needle) is intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the state regulations.

Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C)	☒ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
☒ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

This summary of 510(k) substantial equivalence information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date: May 29, 2015 510(k) Number: K142920

Company and Correspondent making the submission:

Name - K.M.S Inc. Address - F2, 81-1 Haengjeong-ri, Gwangdeok-myeon, Dongnam-gu, Cheonansi, Chungcheongnam-do, Korea 330922 Tel: 82-41-5587785 Fax: 82-41-5587786 Contact - Mr. Chul Hui.Kim Executive Director Email - charliemack@irc-us.com

Device :

Trade/proprietary name: KM Needles (Acupuncture Needle) Common Name : Acupuncture Needle Classification Name : needle, acupuncture, single use

1. Predicate Devices : Dong Bang Acupuncture Needles, (K972659)
1. Classifications Names & Citations : 21CFR 880.5580, MQX, Acupuncture Needle, Class 2

5. Description :

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1. Indication 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 state regulations.
1. Comparison with predicate device :
  K.M.S Inc. believes that the KM Needles (Acupuncture Needle) is substantially equivalent to the Dong Bang Acupuncture Needles (K972659).

The predicate device chosen is comprised of the same material and both are single use devices delivered in a sterile condition. The predicate uses EO as the sterilization method and the KM Needles (Acupuncture Needle) are sterilized using radiation. Please note the table below, which demonstrates the similarities of the K.M.S Inc. Acupuncture Needles and the predicate device.

UV YIVV.Element of comparison	Subject Device	Claimed SE Device
Company	K.M.S Inc.	Dong Bang AcupunctureNeedle
FDA510(K) Number	N/A	K972659
Device Name	KM Needles(Acupuncture Needle)	ACUPUNCTURE NEEDLES
Intended Use	This acupuncture needle isintended to pierce the skin inthe practice of acupuncture byqualified practitioners ofacupuncture as determined bythe state regulations.	This acupuncture needle isintended to pierce the skin inthe practice of acupuncture byqualified practitioners ofacupuncture as determined bythe states.
Principle of operation	General and hand type	General and hand type
Material:Needle body-Handle-	STS 304	STS 304
Specification:Length-Diameter-	Length: 15~~135mmDiameter: 0.16~~0.70mm	Length: 7~~150mmDiameter: 0.16~~0.50mm
Tensile Strength of theAcupuncture Needle	Diameter :0.20 (723.3gf)0.25 (726.6gf)0.35 (733.3gf)	Diameter :0.20 (709.6gf)0.25 (673.6gf)0.35 (686.3gf)
Biocompatibility	Conform to ISO10993-1	Conform to ISO10993-1
Design	Spring	Spring
Reuse	Disposable, single use	Disposable, single use
Sterility	Gamma radiation	Sterilized by EO; SAL=10-6

The table provides a comparison of the KM Needles (Acupuncture Needle) with the predicate device:

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The submitted K.M.S Inc. device and the predicate device have undergone testing to validate the tensile strength of the materials and also testing to verify the sterilization process and the sterile properties of the device, as delivered. The testing performed demonstrated that the devices met all of the criteria in these standards and that the submitted devices are similar in construction and delivered in the same state as the predicate Dong Bang acupuncture needles.

8. Performance Data :

Bench testing was performed to ensure the tensile strength of the stainless steel needle and Sterility testing (ISO10993-1 Biological evaluation of medical devices --Part 1: Evaluation and testing within a risk management process; ISO 10993-5 Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity, ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization, ISO 1137-2 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose, AAMI/ISO/ANSI 11737-1 Sterilization of medical devices - Microbiological methods Part 1: Determination of the population of microorganisms on product, 2ed. AAMI ANSI ISO 11607-1 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems, AAMI ANSI ISO 11607-2 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes, ASTM F1980-07 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices.) was performed. All test results were satisfactory.

9. Conclusions:

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification K.M.S Inc. concludes that the KM Needles (Acupuncture Needle) are as safe and effective and substantially equivalent to predicate devices as described herein.

END

Regulation Number and Section

§ 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.