Jia Chen Acupuncture Needle will be used for "Intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the States."

Device Description

The Jia Chen Acupuncture Needles are defined as prescription devices intended to pierce the skin in the practice of acupuncture as determined by the States. The device consists of a solid stainless steel needle with handle attached to the needle to facilitate the delivery of acupuncture treatment. The material for Jia Chen Acupuncture needles is Austenitic stainless steel wire of ASMTF 899-94, type 304. The needle body is vacuum melted high purity stainless steel, with a good body tensile and spring, and the body surface finish has no visible defects under 100X magnifications. Jia Chen Acupuncture needle handles come in many different materials including copper, silver, plastic, steel tube and all stainless steel. The needle to handle bond strength is of at least 1 kilogram. The each single acupuncture needle is packed in plastic guide (insertion) tube. Jia Chen Acupuncture needles are sterilized with Ethylene Oxide GB 13098-98 and device sterility level (SAL) is at least 106. The ethylene oxide residue level in finished devices does not exceed EtO 25 ppm, Ethylene glycol 250 ppm, and ethylene chlorohydrin 25 ppm. Jia Chen Acupuncture needles are sterile, and for single use only.

AI/ML Overview

This is a 510(k) premarket notification for an acupuncture needle, which is a medical device. The document describes how the device is substantially equivalent to legally marketed predicate devices, rather than providing a study proving performance against acceptance criteria in the context of an AI/software device.

Acupuncture needles, as medical devices, generally have acceptance criteria related to material composition, sterility, biocompatibility, and physical properties (e.g., tensile strength, handle bond strength). The study described in this document is a demonstration of substantial equivalence to existing predicate devices, which is the regulatory pathway for this type of Class II medical device. It does not involve AI or software, and therefore, many of the requested points are not applicable.

Here's how the provided information relates to your questions, with N/A for non-applicable points:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document refers to "general specifications and criteria for single use acupuncture needle" rather than explicit numeric acceptance criteria in a table format. The performance is demonstrated through compliance with manufacturing standards and material specifications.

Acceptance Criteria Category	Specific Criteria (from document)	Reported Device Performance
Material	Austenitic stainless steel wire of ASMTF 899-94, type 304.	"Austenitic stainless steel wire of ASMTF 899-94, type 304, which holds Certificate of Quality Control Approvals issued by China Quality Certification Center for Import and Export Commodities and holds the Mill Certificate of Chemical Composition and Physical Properties of needle material." "The needle body is vacuum melted high purity stainless steel, with a good body tensile and spring, and the body surface finish has no visible defects under 100X magnifications."
Physical Properties	Needle to handle bond strength.	"The needle to handle bond strength is of at least 1 kilogram."
Sterility	Sterilized with Ethylene Oxide GB 13098-98; Sterility Assurance Level (SAL) at least 10-6; Ethylene oxide residue levels.	"Jia Chen Acupuncture needles are sterilized with Ethylene Oxide GB 13098-98 and device sterility level (SAL) is at least 10-6." "The ethylene oxide residue level in finished devices does not exceed EtO 25 ppm, Ethylene glycol 250 ppm, and ethylene chlorohydrin 25 ppm."
Biocompatibility	Meet general specifications and criteria for single use acupuncture needle.	"The material, sterility, and the biocompatibility of these acupuncture needles meet the general specifications and the criteria for single use acupuncture needle."
Intended Use	"Intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the States." "Sterile Acupuncture needles for single use only." "Federal Law restricts this device to sell by or on the order of a qualified practitioner of acupuncture as determined by the States."	The device is labeled for this intended use and is designed to be compatible with existing acupuncture needles.
Safety Record	No serious life-threatening accidents involving acupuncture needles (as per previous 510(k) approvals and market history).	"We have searched the Federal Consumer Information Center official website... and the U.S. Consumer Product Safety Commission official website... and have found no serious life threatening accidents involving acupuncture needles." (Referring to the class of device, not specifically this brand).

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

N/A. This submission is for a medical device (acupuncture needle), not a software/AI device. The "study" is a demonstration of substantial equivalence based on material specifications, manufacturing processes, and adherence to established standards for similar devices. There is no "test set" in the context of an algorithm's performance. The provenance of material quality control is from China (manufacturer Wujiang Jia Chen Acupuncture Devices Co., Ltd.).

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)

N/A. Ground truth in the context of expert consensus for AI/software is not relevant here. The ground truth for device safety and effectiveness relies on established engineering standards for medical devices (e.g., ASTM standards for materials, ISO/GB standards for sterilization, biocompatibility testing in accordance with general medical device requirements).

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

N/A. Not applicable for a physical medical device submission demonstrating substantial equivalence.

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

N/A. This is not an AI/software device. No MRMC study was conducted.

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

N/A. This is not an AI/software device. No standalone algorithm performance was assessed.

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

The "ground truth" for this device's safety and effectiveness is based on:
- Adherence to recognized standards: e.g., ASMTF 899-94 for stainless steel, GB 13098-98 for Ethylene Oxide sterilization.
- Biocompatibility testing: General medical device requirements for materials that contact the human body.
- Mechanical property testing: Such as bond strength.
- Clinical history of predicate devices: The fact that similar acupuncture needles have been safely marketed and used for decades without serious adverse events provides historical evidence of the device type's general safety and effectiveness.

8. The sample size for the training set

N/A. This is not an AI/software device. There is no training set.

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

N/A. This is not an AI/software device. There is no training set and thus no ground truth established for one.

Summary

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MANDALA HEALTH CARE, LLC

13740 Midway Rd., Suite 801 Phone: (972) 977-4180

Dallas, Texas 75244 Fax: (972) 404-4404

510(k) Number: K-023054

II. 510(k) Summary As required by Section 807.92(c)

Device Name:Classification Name:Regulation Number:Product Code:Regulatory Class:	Jia Chen Acupuncture NeedleNeedle, Acupuncture, Single Use880-5580MQXII
510(k) Applicant:	Mandala Health Care, LLC13740 Midway Rd., Suite 801Dallas, Texas 75244
Contact:	Dashima Dovchin, PresidentPhone: (972) 977-4180Fax: (972) 404-4404
510(k) Submitter:	Wujiang Jia Chen Acupuncture Devices Co., Ltd.Wujiang City, Jiangsu Province, China

Identification of predicate device(s):

Kangnian Brand Acupuncture Needle, Single Use Manufactured by Suzhou Kangnian Medical Devices Co., Ltd. 510(k) Number: K991507

Spirit Brand Acupuncture Needle, Single Use Manufactured by Wujiang Acupuncture Needle Factory 510(k) Number: K003010

Shen Ling Brand Acupuncture Needle, Single Use Manufactured by Shen Ling Medical Devices Co., Ltd. 510(k) Number: K002411

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Description of the Device:

The needle body is vacuum melted high purity stainless steel, with a good body tensile and spring, and the body surface finish has no visible defects under 100X magnifications. Jia Chen Acupuncture needle handles come in many different materials including copper, silver, plastic, steel tube and all stainless steel. The needle to handle bond strength is of at least 1 kilogram.

The each single acupuncture needle is packed in plastic guide (insertion) tube, which facilitates the delivery of needles in treatments and protects the healthcare worker's hand from accidental needle sticks.

Jia Chen Acupuncture needles are sterilized with Ethylene Oxide GB 13098-98 and device sterility level (SAL) is at least 106. The ethylene oxide residue level in finished devices does not exceed EtO 25 ppm, Ethylene glycol 250 ppm, and ethylene chlorohydrin 25 ppm.

Jia Chen Acupuncture needles are sterile, and for single use only. The material, sterility, and the biocompatibility of these acupuncture needles meet the general specifications and the criteria for single use acupuncture needle. In addition, the Jia Chen Acupuncture needles are designed such that they are compatible with the current acupuncture needles produced by the other major acupuncture needle manufacturers.

Indications for Use:

Jia Chen Brand Acupuncture needles will be used as directed: "Intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the States".

Jia Chen Acupuncture needles are labeled, "Sterile Acupuncture needles for single use only" and also have a prescription statement on the box, "Caution: Federal Law restricts this device to sell by or on the order of a qualified practitioner of acupuncture as determined by the States".

The Food and Drug Administration has issued 510(k)'s to over 50 different single use acupuncture needle brands and they are been used for general practice of acupuncture in the United States since 1996. We have searched the Federal Consumer Information Center official website (http://www.pubeblo.gsa.gov) and the U.S. Consumer Product Safety Commission official website (http://cpsc.gov) and have found no serious life threatening accidents involving acupuncture needles.

The subjects of this 510(k) application, The Jia Chen Brand Acupuncture needles, are sterile and are for single use only. The design, material, sterility, and the biocompatibility of these acupuncture needles meet the general specifications and the

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criteria for single use acupuncture needle and are effective for the practice of acupuncture.

Conclusion:

The Jia Chen Acupuncture needles have the same technological characteristics (design, material, sterility, and biocompatibility) and the same intended use as the predicate needle devices. Therefore, Jia Chen Acupuncture needles are substantially equivalent to the other acupuncture needles that are currently being marketed in interstate commerce. In conclusion, based on the information provided with this 510(k) Notification, Jia Chen Acupuncture needles meet the criteria for FDA 510(k) acceptance.

Mandala Health Ca e
MAANY
Doub
Dashima Doxchid, &esident
Mandala Health Care, LLC

Dashima D. Yochim, & President
Mandala Health Care, LLC
Limited Liability Co.

10-10-02.
Date Prepared

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized human figure with three faces in profile, suggesting a sense of community and care.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 3 2002

Ms. Dashima Dovchin President Mandala Health Care, LLC 13740 Midway Road, Suite 801 Dallas, Texas 75244

Re: K023054

Trade/Device Name: Jia Chen Acupuncture Needle Regulation Number: 880.5580 Regulation Name: Acupuncture Needle Regulatory Class: II Product Code: MQA Dated: October 21, 2002 Received: October 23, 2002

Dear Ms. Dovchin:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 - Ms. Dovchin

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Susan Runner

Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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K023054
III-1

III. Statement of Indications for Use

510(k) Number: K-023054

Jia Chen Acupuncture Needle Device Name:

Indications for Use:

Jia Chen Acupuncture Needle will be used for "Intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the States."

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Patrice Crescenti

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K023054

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter-Use (Optional Format 3-10-98)

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.