Our acupuncture needles are devices used by licensed practitioners and are 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, 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 ethylene oxide gas. Acupuncture is the stimulation of specific acupuncture points along the skin of the body involving various methods such as penetration by thin needles. The skin is sterilized, such as with alcohol, and the needles are inserted, frequently with a plastic guide tube for the user. Needles may be manipulated in various ways including spinning, flicking, or moving up and down relative to the skin. The Acuzone Acupuncture Needles and KSC DB Plus Acupuncture Needles are made of surgical stainless steel, a handle consisting of a flexible coiled copper handle with nickel plated for protection, or a surgical stainless steel or aluminum tube handle and may be provided with a plastic guide tube. (10pcs/pack, 1000pcs/box). Acuzone press tack needles (with micropore tape) are made with surgical stainless steel (10pcs/ pack, 100pcs/box). AcuZone Intradermal Needles are made with surgical stainless steel (5pcs/pack, 100pcs/box). Press tack and intradermal needles have same purpose for ear acupuncture point. The Acupuncture needles are available in nine diameters (0.12 ~ 0.35mm), five needle lengths (15 ~ 60mm), and tube lengths (30mm, 45mm, 55mm, 65mm and 75mm). Acuzone press tack needle is available in one diameter (0.20mm x 2mm x length (1mm). AcuZone Intradermal Needles is available in one diameter (0.12mm), one length (5mm).

AI/ML Overview

This document is a 510(k) Summary for AcuZone Acupuncture Needles, KSC DB Plus Acupuncture Needles, AcuZone Press Tack Needles, and AcuZone Intradermal Needles. It describes the device, its intended use, and compares it to predicate devices to demonstrate substantial equivalence.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative, measurable way for the performance tests. Instead, it refers to the outcomes of tests as meeting "requirements of those standards" or being "substantially equivalent" to predicate devices. The performance data presented focuses on comparisons with predicate devices and compliance with relevant ISO standards.

Criterion Type	Acceptance Criteria (Implied/Stated)	Reported Device Performance
Visual	Smooth and free of visible defects (at 100X or higher magnification)	Surfaces of subject device (AcuZone and KSC DB Plus Acupuncture Needles) found to be smooth and free of visible defects at 100X or higher magnification.
Pull-out Force	Fell within average values reported for predicate devices	Pull-out force of Acupuncture Needle was quantified and fell within the average values reported for the predicate devices.
Elasticity	Returned to original shape showing no permanent deformation	Elasticity properties of the subject device were found to be substantially equivalent to the two predicate devices, as after cantilever-type loading all devices returned to their original shape showing no permanent deformation.
Biocompatibility	Met requirements of applicable ISO 10993 series	Biocompatibility testing based on applicable elements of ISO 10993 series (including Material Mediated Pyrogen Testing using ISO 10993-11 and EO and ECH Residuals Testing in accordance with ISO 10993-7) was conducted and device met requirements.
Sterilization	Met requirements of relevant validation/testing	EO Sterilization Validation, Sterility Testing, Bacterial Endotoxin Testing, Validation, and Long-Term Stability Testing were performed, indicating compliance. (The document doesn't specify if specific standards were met, but "Validation" implies meeting predefined acceptance criteria for these processes).
Dimensional Conformance	Conformance to specified dimensions	Dimensional conformance evaluation was conducted. (Assumed to be successful, as it contributes to the overall conclusion of substantial equivalence).

2. Sample Size Used for the Test Set and the Data Provenance

The document does not provide specific sample sizes for the performance tests (visual inspections, pull-out force, elasticity, biocompatibility, sterilization, dimensional conformance). It generally refers to "the Acupuncture Needle" or "all devices" when discussing testing.

Data Provenance: The data appears to be prospective as it describes testing conducted specifically for this 510(k) submission. The country of origin of the data is not explicitly stated, but the testing was conducted to support a submission by a U.S. corporation (K. S. Choi Corporation in Los Angeles, California) to the U.S. FDA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not provided in the document. The testing described (mechanical, visual, biocompatibility, sterilization) would typically be performed by laboratory technicians or engineers following established protocols, not by medical experts establishing "ground truth" in the clinical sense.

4. Adjudication Method for the Test Set

This information is not applicable to the type of testing described (physical and chemical properties, sterilization) for acupuncture needles. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or image interpretation where human expert consensus is required for complex decisions.

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

An MRMC comparative effectiveness study was not done. This document describes the substantial equivalence of an acupuncture needle, which is a physical device, not an AI-powered diagnostic or assistive tool for human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not relevant here.

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

This is not applicable. The device is an acupuncture needle, a physical medical instrument, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is established through physical and chemical characterization, and compliance with recognized standards. This includes:

Microscopic examination for surface quality.
Mechanical testing (pull-out force, elasticity) against quantifiable parameters.
Biocompatibility testing against ISO 10993 series standards.
Sterilization validation against established protocols (e.g., for EO sterilization and residuals).
Dimensional conformance to specifications.
Comparison to the performance of legally marketed predicate devices.

8. The Sample Size for the Training Set

This is not applicable. The device is an acupuncture needle, not a machine-learning algorithm; therefore, there is no "training set" in the context of AI.

9. How the Ground Truth for the Training Set Was Established

This is not applicable as there is no training set mentioned or implied for an acupuncture needle.

Summary

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

August 25, 2015

K. S. Choi Corporation Mr. Kak Soo Choi President 179 W 39th Street Los Angeles, California 90037-1015

Re: K142760

Trade/Device Name: AcuZone Acupuncture Needles, KSC DB Plus Acupuncture Needles, AcuZone Press Tack Needles, and AcuZone Intradermal Needles Regulation Number: 21 CFR 880.5580 Regulation Name: Acupuncture needle Regulatory Class: II Product Code: MQX Dated: May 8, 2015 Received: July 20, 2015

Dear Mr. Choi:

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) K142760

Device Name

AcuZone Acupuncture Needles, KSC DB Plus Acupuncture Needles, AcuZone Press Tack Needles, and AcuZone Intradermal Needles

Indications for Use (Describe)

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)

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510(k) SUMMARY Traditional 510(k) (As required by 21CFR 807.92)

August 24, 2015

Applicant: 807.92(a)

K. S. Choi Corporation 179 W. 39th St. Los Angeles, CA 90037 Phone: 323-232-1600 Fax: 323-232-2747 Contact: Kak Soo Choi

Date Prepared: August 24, 2015

Device Name: AcuZone Acupuncture Needles. KSC DB Plus Acupuncture Needles. AcuZone Press Tack Needles, and AcuZone Intradermal Needles Common Name: Acupuncture Needle Classification Name: Acupuncture needle, Single Use Product Code: MQX Medical Specialty: General Hospital Device Class: II 510(k) Number: K142760 Regulation Number: 880.5580

Predicate Device: 807.92(a)

The summary identifies the legally marketed device to which your firm is claiming equivalence: (1) Asia-med : Asia-med Special + Needle (K031716) and (K042063)

Description of the Device 807.92(a) :

Acuzone press tack needles (with micropore tape) are made with surgical stainless steel (10pcs/ pack, 100pcs/box). AcuZone Intradermal Needles are made with surgical stainless steel (5pcs/pack, 100pcs/box).

Press tack and intradermal needles have same purpose for ear acupuncture point.

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The Acupuncture needles are available in nine diameters (0.12 ~ 0.35mm), five needle lengths (15 ~ 60mm), and tube lengths (30mm, 45mm, 55mm, 65mm and 75mm).

Gauge	Diameter	Lengths
(#)
44	.12mm	15mm	30mm	40mm
42	.14mm	15mm	30mm	40mm
40	.16mm	15mm	30mm	40mm
38	.18mm	15mm	30mm	40mm	50mm
36	.20mm	15mm	30mm	40mm	50mm	60mm
34	.22mm	15mm	30mm	40mm	50mm	60mm
32	.25mm	15mm	30mm	40mm	50mm	60mm
30	.30mm	15mm	30mm	40mm	50mm	60mm
28	.35mm	15mm	30mm	40mm	50mm	60mm

Acuzone press tack needle is available in one diameter (0.20mm x 2mm x length (1mm). AcuZone Intradermal Needles is available in one diameter (0.12mm), one length (5mm).

Intended Use of Device 807.92(a) :

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

The acupuncture needle, as well as two predicate devices, Asia-med Special + Needle (K031716) and Asia-med Press Tack (K042063), 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 100X or higher magnification. Also the pull-out force of 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 devices returned to their original shape showing no permanent deformation.

Table 1: Comparison of Acuzone Acupuncture Needles, KSC DB Plus Acupuncture Needle, and Asia-med Special + Needle (K031716)

Device	AcuZone and KSC DB PlusAcupuncture Needle	Asia-med Special + Needle510(k) #K031716
Indicationfor use	Intended to pierce the skin in thepractice of acupuncture by qualifiedpractitioners of acupuncture asdetermined by the states.	Intended to pierce the skin in thepractice of acupuncture by qualifiedpractitioners of acupuncture asdetermined by the states.
Needle tipshape	Arrow	Arrow

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Design	Stainless steel needle with a steel,aluminum or copper handle and aplastic guide tube for user	Stainless steel needle (+ siliconlayer) with a copper handle and acopolymer (PET) guide tube.
Materials	Needle: surgical stainless steelHandle: metal (steel or aluminumtube or copper wire)	Needle: surgical stainless steel (+silicon layer)Handle: copper
Sterility	Sterilized with ethylene oxide gaswith residuals at a validated doselevel	Sterilized with radiation at avalidated dose level.
Needle(invasive)	Surgical stainless steel	Surgical stainless steel
Guide tube(non-invasive)	Polypropylene or PROVISTATMCopolymer (PET)	PROVISTA™ Copolymer (PET)
Labeling	• Indication for use• Manufactured for or Distributedby• Product name• Acupuncture needles• Quantity• Size• Lot number• Expiration date• "Sterilized by ethylene oxidegas"• "For single use"• Discard any unused needle in thepackage after treatment sessionis completed.• "Made in China"	• Manufacturer's name and address• Product name• Acupuncture needles• Quantity• Size• Lot number• "Sterile"• Expiration date• "Sterilized by gamma radiation"• "For single use"• Rx statement• "Do not store at extremetemperatures and humidity"• "Do not use if package is previouslyopened or damaged"• "Made in Germany"
Available inNeedleDiameters	0.12 mm, 0.14 mm, 0.16 mm,0.18 mm, 0.20 mm, 0.22 mm, 0.25mm, 0.30 mm, and 0.35 mm	0.20 mm, 0.25 mm, and 0.30 mm
Available inNeedleLengths	15 mm, 30 mm, 40 mm, 50 mm,and 60 mm	15 mm, 30 mm, and 40 mm

Table 2: Comparison of AcuZone Press Tack Needles, AcuZone Intradermal Needles, and Asia-med Press Tack (K042063)

Device	AcuZone Press Tack Needlesand AcuZone IntradermalNeedles K142760	Asia-med Press TackK042063
--------	--------------------------------------------------------------------------	--------------------------------

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Indication foruse	Intended to pierce the skin in thepractice of acupuncture byqualified practitioners ofacupuncture as determined by thestates.	Intended to pierce the skin in thepractice of acupuncture by qualifiedpractitioners of acupuncture asdetermined by the states.
Needle tip shape	Arrow	Arrow
Design	Image: acupuncture needlesWith or without tape for user	Image: acupuncture needles
Materials	Surgical stainless steel	Surgical stainless steel
Sterility	Sterilized	Sterilized
Available inNeedleDiameters	Intradermal: 0.12 mmPress Tack: 0.20 mm	0.22 ~ 0.26 mm
Available inNeedle Lengths	Intradermal: 5 mmPress Tack: 1 mm	1.6 ~ 1.8 mm

Our acupuncture needles are as safe and effective as the predicate, and are 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. The only difference is the quality of the product; for instance, the sharpness and the smoothness of the needle. Any differences in technological characteristics between the acupuncture needle and the predicate devices do not raise new issues of safety and effectiveness.

Non-clinical Performance Data 807.92(b)

Performance testing was conducted to evaluate and characterize the performance of the Acuzone and KSC DB Plus. Non-clinical data included dimensional conformance evaluation, visual inspections, and design verification to confirm biocompatibility testing based on the applicable elements of ISO 10993 series, which included the Material Mediated Pyrogen Testing using ISO 10993-11 and the EO and ECH Residuals Testing in accordance with ISO10993-7.

The EO Sterilization Validation, Sterility Testing, Bacterial Endotoxin Testing, Validation, and Long-Term Stability Testing were also performed.

Clinical Data 807.92(b)

Does not apply for these devices

Conclusion 807.92(b)

Biocompatibility tests and performance tests show that the device meets the requirements of those standards. Comparison with the predicate device shows that the device has similar specification and performance. Thus,

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we conclude that Acuzone Acupuncture Needles, KSC DB Plus Acupuncture Needles, Acuzone Press Tack Needles, and Acuzone Intradermal Needles are substantially equivalent to the predicate device.

Kakeeco cheai

08/24/15

Kak Soo Choi, President

Date

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.