VINCO BRAND ACUPUNCTURE NEEDLE by HELIO MEDICAL SUPPLIES, INC.

The provided document is a 510(k) clearance letter from the FDA for a medical device: the Vinco Brand Acupuncture Needle. This type of document primarily confirms that a new device is "substantially equivalent" to a legally marketed predicate device, rather than detailing a comprehensive scientific study evaluating its performance against specific acceptance criteria.

Therefore, many of the requested points regarding acceptance criteria and a study proving device performance cannot be found within this document. The FDA clearance is based on a demonstration of equivalence in design, materials, and intended use to a pre-existing device, not necessarily extensive new clinical trial data.

Based on the provided text, here's what can be extracted and what cannot:

1. Table of acceptance criteria and the reported device performance

Not explicitly available. The document does not list specific performance criteria (e.g., tensile strength, sharpness, sterility levels) or corresponding test results for the Vinco Brand Acupuncture Needle. The clearance is based on substantial equivalence to a predicate device.

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

Not available. The document does not describe any specific "test set" or studies of this nature. Given it's a 510(k) for an acupuncture needle, any testing would likely be bench testing related to safety and manufacturing, not clinical trials with human subjects in the typical sense.

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/available. This refers to clinical studies where expert consensus defines ground truth, which is not described here.

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

Not applicable/available. This refers to clinical studies where expert consensus defines ground truth, which is not described here.

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. This type of study is relevant for AI-powered diagnostic tools, not for an acupuncture needle.

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

Not applicable. This is for AI algorithms, not for a physical medical device like an acupuncture needle.

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

Not applicable/available. Ground truth is a concept for diagnostic or predictive models; for a physical device like this, compliance with manufacturing standards and safety profiles are key.

8. The sample size for the training set

Not applicable. This refers to AI algorithms, not a physical medical device.

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

Not applicable. This refers to AI algorithms, not a physical medical device.

Summary from the document:

Device Name: Vinco Brand Acupuncture Needle
Regulation Number: 880.5580
Regulation Name: Acupuncture Needle
Regulatory Class: II
Product Code: MQX
Indication for Use: To pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the States.
Basis for Clearance: Substantial equivalence to legally marketed predicate devices, meaning it has essentially the same intended use, technological characteristics, and safety/effectiveness profile as a device already on the market. The document implies that the device meets the general controls provisions of the Act (e.g., annual registration, listing, good manufacturing practice, labeling, prohibitions against misbranding and adulteration) and any additional Class II special controls, though these specific controls are not detailed in this letter.

Summary

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 4 2003

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

Re: K024207

Trade/Device Name: Vinco Brand Acupuncture Needle Regulation Number: 880.5580 Regulation Name: Acupuncture Needle Regulatory Class: II Product Code: MQX Dated: March 7, 2003 Received: March 10, 2003

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 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 - 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 (301) 594-4618. 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/dsma/dsmamain.html

Sincerely yours,

Simen Russo

Susan Runner, DDS, MA Interim 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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K024207

510(k) Number (if known):

Device Name: Vinco Brand Acupuncture Needle

Indication for Use:

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)

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter-Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Patricia Caserite

(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital, Division of Anesthosions of Anestion Control, Devices

510(k) Number: K024207

ฯ

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.