SEVEN STAR NEEDLE by HELIO MEDICAL SUPPLIES, INC.

This document is a 510(k) premarket notification letter from the FDA regarding a medical device called "Seven Star Needle." It establishes substantial equivalence for the device for the stated indications for use.

Based on the provided text, the document does not contain the detailed acceptance criteria or a study that proves the device meets specific performance criteria in the way typically expected for AI/ML-based medical devices. This is a notification for an acupuncture needle, which is a traditional medical device, not a software-based or AI-driven diagnostic/prognostic tool. Therefore, many of the questions asked in the prompt, such as those related to AI performance, sample sizes for test/training sets, expert adjudication, or MRMC studies, are not applicable to the content of this document.

The document primarily focuses on:

Confirming the device's substantial equivalence to a legally marketed predicate device.
Stating the intended use of the device (to pierce the skin in the practice of acupuncture by qualified practitioners).
Regulatory classification (Class II, Product Code MQX).
General regulatory requirements for the manufacturer.

Since the prompt asks for information that is not present in the document for a device of this nature, I will explicitly state where the information is not provided.

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

Acceptance Criteria: Not provided in this document. For a traditional medical device like an acupuncture needle, acceptance criteria would typically relate to manufacturing specifications, material biocompatibility, sterility, needle sharpness, and structural integrity, rather than performance metrics like sensitivity or specificity. These details would be in the full 510(k) submission, not the FDA's final decision letter.
Reported Device Performance: Not provided in this document.

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

Not applicable/Not provided. This document pertains to a traditional medical device, not one that undergoes performance evaluation with a "test set" in the context of AI/ML.

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)

Not applicable/Not provided.

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

Not applicable/Not provided.

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

Not applicable/Not provided. This device is an acupuncture needle, not an AI-assisted diagnostic tool.

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

Not applicable/Not provided.

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

Not applicable/Not provided. Ground truth is not relevant for this type of device in the context of this document. The "ground truth" for an acupuncture needle would be its physical properties and functionality.

8. The sample size for the training set

Not applicable/Not provided.

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

Not applicable/Not provided.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN I 3 2006

Mr. Eric Cheng Senior Quality System Engineer Helio Medical Supplies, Incorporated 606 Charcot Avenue San Jose, California 95131

Re: K052723

Trade/Device Name: Seven Star Needle Regulation Number: 880.5580 Regulation Name: Acupuncture Needle Regulatory Class: II Product Code: MQX Dated: December 20, 2005 Received: January 3, 2006

Dear Mr. Cheng:

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 Ameradeents, 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 approvisions 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 - Mr. Cheng

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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sutte Y. Mchican Ond.

Chiú Lin, Ph.D. 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): $0522733

Seven Star Needle Device Name:

Indications For Use:

To pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the States.

Prescription Use
(Part 21 CFR 801 Subpart D)
✓

AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (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)

Anton D, m

12, Channi, Ph. -12 27 17 1 19 12

K453733

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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.