SMC ACUPUNCTURE NEEDLE is intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.

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 and/or ethylene oxide.

The Acupuncture Needles are available in nine needle diameters (0.16 to 0.70 mm), ten needle lengths (15-135 mm), and ten tube lengths (30-160 mm).

AI/ML Overview

This document is a 510(k) Premarket Notification for the SMC Acupuncture Needle, comparing it to a predicate device, the WOOJEON ACUPUNCTURE NEEDLE (K111392). The information provided focuses on demonstrating substantial equivalence rather than a detailed study proving the device meets strict acceptance criteria in the way a clinical trial for a novel, complex diagnostic or therapeutic AI device would.

Therefore, many of the requested categories (e.g., sample size for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth) are not applicable or not provided in this type of regulatory submission, as it's for a relatively simple medical device (acupuncture needle) and relies on demonstrating equivalence to an already marketed device.

However, I can extract the relevant information regarding performance and "acceptance criteria" as implied by the comparison to the predicate device and the non-clinical testing.

Here's the breakdown of the available information:

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

The acceptance criteria are implicitly defined by the characteristics of the predicate device and relevant international standards (like ISO 10993 for biocompatibility) as well as general performance expectations for acupuncture needles. The comparison table below highlights how the new device's attributes align with or expand upon the predicate.

Attribute	Acceptance Criteria (Predicate: WOOJEON ACUPUNCTURE NEEDLE K111392)	Reported Device Performance (SMC ACUPUNCTURE NEEDLE)
Indications for Use	Intended to pierce the skin in the practice of acupuncture by qualified practitioners.	Intended to pierce the skin in the practice of acupuncture by qualified practitioners.
Available Needle Diameters	0.16 to 0.50 mm	0.16 to 0.70 mm (Wider range, but includes predicate's range)
Available Needle Lengths	15-60 mm	15-135 mm (Wider range, but includes predicate's range)
Available Tube Lengths	30-145 mm	30-160 mm (Wider range, but includes predicate's range)
Material (needle body)	304 stainless steel	304 stainless steel (Identical)
Coating	Polydimethylsiloxane	Polydimethylsiloxane (Identical)
Sterilization Method	Radiation (Gamma) for Pouch	Radiation (Gamma) for Pouch and/or Ethylene oxide of Blister (Includes predicate's method, with additional option)
Dimensional Conformance	Implied to meet accepted standards/predicate's performance	Tested (performance testing conducted included dimensional conformance evaluation)
Visual Inspections	Implied to meet accepted standards/predicate's performance	Tested (visual inspections conducted)
Design Verification	Airway passage equivalency (specific to predicate device context)	Tested (design verification to confirm airway passage equivalency - This wording seems slightly mismatched for an acupuncture needle, but it's directly from the text)
Biocompatibility	Compliant with applicable elements of ISO 10993 series	Tested based on the applicable elements of ISO 10993 series (stated as met requirements)

Study Details:

The primary "study" described is a non-clinical performance and comparison study to demonstrate substantial equivalence to a predicate device, not a human clinical trial against specific acceptance criteria for diagnostic accuracy or treatment efficacy.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not specified in terms of a "test set" for performance metrics like sensitivity/specificity. The testing involved dimensional conformance, visual inspections, design verification, and biocompatibility on representative samples of the device. The exact number of units or samples for each test is not provided.
Data Provenance: Not applicable in the context of clinical data provenance (country, retrospective/prospective) for this type of device and submission. The non-clinical tests were likely conducted by the manufacturer, SMC, or their designated testing laboratories.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is not applicable. The "ground truth" for this device relates to its physical and biological safety characteristics, which are assessed through engineering tests and biocompatibility standards, not expert consensus on medical images or patient outcomes.

4. Adjudication method for the test set

This is not applicable. Adjudication methods (like 2+1, 3+1) are common in studies involving human interpretation or subjective assessments, which are not relevant for the non-clinical testing of an acupuncture needle.

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 is not applicable. An acupuncture needle is a physical tool, not an AI-powered diagnostic or assistive device. Therefore, MRMC studies and AI assistance metrics are irrelevant.

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

This is not applicable. This device is not an algorithm.

7. The type of ground truth used

The "ground truth" for this submission is based on:
- Predicate Device Characteristics: The established safety and effectiveness profile of the legally marketed WOOJEON ACUPUNCTURE NEEDLE (K111392).
- International Standards: Compliance with relevant standards like ISO 10993 series for biocompatibility.
- Engineering Specifications: Conformance to pre-defined dimensional, material, and manufacturing specifications for acupuncture needles.

8. The sample size for the training set

This is not applicable. There is no "training set" in the context of an AI/machine learning device. For manufacturing, routine quality control involves statistical process control, but this is not what is typically meant by a "training set" in medical device studies that involve algorithms.

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

This is not applicable as there is no training set.

Summary

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

August 1, 2014

SMC Mr. Jong-man Lee President (Jisan It Venture Center 601) 15 Beotkkot-ro 120gil Geumcheon-gu Seoul 153-829 KOREA

Re: K141473

Trade/Device Name: SMC Acupuncture Needle Regulation Number: 21 CFR 880.5580 Regulation Name: Acupuncture needle Regulatory Class: II Product Code: MQX Dated: June 10, 2014 Received: June 12, 2014

Dear Mr. Lee:

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. Lee

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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 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,

Mary S. Runner -S

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K141473

Device Name SMC ACUPUNCTURE NEEDLE

Indications for Use (Describe)

SMC ACUPUNCTURE NEEDLE is intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

] Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Digitally signed by Richard C. Chapman -S Date: 2014.08.01 11:19:39 -04'00'

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510(k) Summary 807.92(c)

Submitter's Name, address, telephone number, a contact person and date the summary was prepared: 807.92(a)(1)

Submitter's Name:	SMC.
Submitter's Address:	(Jisan IT Venture Center 601) 15, Beotkkot-ro 12-gil,Geumcheon-gu, Seoul, 153-829, Korea
Submitter's Telephone:	82-2-803-5800
Submitter's Fax:	82-2-803-5900
Submitter's Contact:	Jong-man Lee
Date 510(k) summary prepared:	March 04, 2014

Name of the device, including the trade or proprietary name if applicable, the common or usual name and the classification name, if known: 807.92(a)(2)

Proprietary Name:	SMC ACUPUNCTURE NEEDLE
Common or Usual Name:	needle, acupuncture, single use
Classification Name:	Acupuncture needle
Regulation Number:	21 CFR 880.5580
Review Panel:	General Hospital
Product Code:	MQX
Classification Code:	2
Type of 510(k) submission:	Traditional

Predicate Device:

807.92(a)(3)

The summary identifies the legally marketed device to which your firm is claiming equivalence;

WOOJEON ACUPUNCTURE NEEDLE - K111392 (1) Woojeon Co.

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Description of the Device

The Acupuncture Needles are available in nine needle diameters (0.16 to 0.70 mm), ten needle lengths (15-135 mm), and ten tube lengths (30-160 mm).

Statement of the 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.

Summary of the technological characteristics of the device compared to the predicate devices 807.92(a)(6)

The SMC ACUPUNCTURE NEEDLE is substantially equivalent to WOOJEON ACUPUNCTURE NEEDLE. Table 1 summarizes the technological characteristics of the SMC ACUPUNCTURE NEEDLE vs. the predicate device.

Table 1:

Comparison of SMC ACUPUNCTURE NEEDLE and WOOJEON ACUPUNCTURE NEEDLE

Attribute	SMC ACUPUNCTURENEEDLEK-	WOOJEON ACUPUNCTURENEEDLEK111392
Indications for Use	This acupuncture needle isintended to pierce the skin in thepractice of acupuncture byqualified practitioners ofacupuncture as determined bythe states.	This acupuncture needle isintended to pierce the skin in thepractice of acupuncture byqualified practitioners ofacupuncture as determined bythe states.
Available in needlediameters	0.16 to 0.70 mm	0.16 to 0.50 mm
Available in needlelengths	15-135 mm	15-60 mm
Available in tube	30-160 mm	30-145 mm
Material(part of needle body)	304 stainless steel	304 stainless steel
Coating	Polydimethylsiloxane	Polydimethylsiloxane

807.92(a)(4)

807.92(a)(5)

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Attribute	SMC ACUPUNCTURENEEDLEK-	WOOJEON ACUPUNCTURENEEDLEK111392
Sterilization method	Radiation (Gamma) for Pouchand/or Ethylene oxide of Blister	Radiation (Gamma) for Pouch

Non-clinical Performance Data

Performance testing was conducted to evaluate and characterize the performance of the SMC Preclinical testing conducted included dimensional conformance evaluation, visual inspections, and design verification to confirm airway passage equivalency and biocompatibility testing based on the applicable elements of ISO 10993 series.

Clinical Data

Comparison with the predicate indicates they are similar in functions and efficiency, and the post market experience proves that it is substantially equivalent.

Conclusion

Biocompatibility tests and performance tests show that the device meets the requirements of those standards. Literatures and post market experience show that the device is substantially equivalent. Comparison with the predicate device shows that the device has similar specification and performance. Thus, we conclude that WOOJEON ACUPUNCTURE NEEDLE is substantially equivalent to the predicate device.

807.92(b)(1)

807.92(b)(3)

807.92(b)(2)

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.