DBC Dongbang Acupuncture Needles have been used for "the general practice of acupuncture without any other specific use or treatment" in the United States. These single-use-only acupuncture needles 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 manufactured by Dong Bang Medical Co., LTD in Korea have been imported and sold through interstate commerce in the USA since 1988 under the FDA labeling restrictions of "Caution: Federal law restricts this device to sale by or on the order of qualified practitioners as determined by the State." The subject of this 510(k) application, "DBC, Dong Bang Acupuncture Needles," is a y-ray or EOG sterile, non-pyrogen, stainless, and single use only acupuncture needle and is identical to the DBC brand needles, 510(k) K963300. The DBC, Dong Bang acupuncture needles have various type (pipe or spring) needle handles, and are packaged by bulk or single sealed blister.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (DBC, Dong Bang Acupuncture Needles) seeking substantial equivalence to a predicate device. It is not a study report demonstrating the device meets specific acceptance criteria based on performance data.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment are not present in this type of pre-market notification. The 510(k) process focuses on demonstrating equivalence to a previously cleared device, not necessarily on new studies proving specific performance metrics beyond what's implied by the predicate.

Here's an analysis based on the information available within the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not present in the 510(k) summary. A 510(k) summary for substantial equivalence primarily focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than presenting a table of acceptance criteria with measured performance against those criteria. The "acceptance criteria" here are inherent to the substantial equivalence determination process itself.

The key "performance" reported is:

"Since 1988, no accidents or device failure claims have been reported as a result of using the acupuncture needles supplied by Dong Bang Medical Co., LTD in the U.S.A."
"Sterile, stainless, single use only acupuncture needles offer greater safety."
"The proposed DBC, Dong Bang acupuncture needles meet the general specifications and criterion for acupuncture needles and are effective for the practice of acupuncture."
The device is "identical to the DBC brand needles, 510(k) K963300."

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

Not applicable/Not provided. This is not a performance study as typically understood for new algorithms or diagnostic devices. The submission relies on the established safety and effectiveness of the predicate device and the assertion that the new device is identical.

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

Not applicable/Not provided. No "test set" or ground truth establishment by experts for specific performance metrics (e.g., accuracy, sensitivity) is described. The "ground truth" for substantial equivalence is the predicate device and its established market history.

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

Not applicable/Not provided. No expert adjudication process for a test set is described.

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

No. This is not an AI/diagnostic device, and no MRMC study was conducted or required. The device is a physical acupuncture needle.

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

No. This is not an algorithmic device.

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

The "ground truth" in this 510(k) application is the predicate device (DBC Acupuncture Needles, 510(k) K963300) and its established history of safe and effective use in the market. The applicant's primary argument is that the proposed device is "identical" to this legally marketed predicate. The lack of reported accidents or device failures for the manufacturer's products since 1988 also serves as supportive "outcomes data" for the predicate device.

8. The sample size for the training set

Not applicable/Not provided. There is no "training set" as this is not a learning algorithm.

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

Not applicable/Not provided. There is no "training set."

Summary of Device Acceptance:

The device's acceptance is based on the criteria for substantial equivalence under the 510(k) pathway, not on an independent study demonstrating novel performance metrics.

The "Study" (or rather, the basis for clearance):

The "study" that proves the device meets acceptance criteria is essentially the comparison to a legally marketed predicate device (K963300). The applicant asserts that the new device is "identical" to this predicate.

Key arguments for substantial equivalence presented by the applicant:

Identicality: The proposed "DBC, Dong Bang Acupuncture Needles" are stated to be "identical to the DBC brand needles, 510(k) K963300." Both are manufactured by the same company (Dong Bang Medical Co., LTD).
Intended Use: The proposed device has the "same intended use" as the predicate – "to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture."
Technological Characteristics: The devices share fundamental scientific technology (sterile, non-pyrogen, stainless, single-use only acupuncture needles).
Safety Record: No accidents or device failure claims reported related to the manufacturer's acupuncture needles in the U.S. since 1988.
Predicate Acceptance: The predicate device (K963300) was already cleared by the FDA.

The FDA reviewed these claims and determined that the device is "substantially equivalent" to the predicate, allowing it to be marketed. This regulatory determination serves as the "proof" the device meets the acceptance criteria for a 510(k) marketing clearance.

Summary

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K990328

PRE-MARKET NOTIFICATION 510(K) SUMMARY {As Requested by 21 CFR 807. 929 (c)}

Submitter: Ae-Hoe Kwon (President of Morning Star/Staff of Dong Bang Medical Co., LTD) Morning Star, Dong Bang Acupuncture U.S.A., Inc. 1429 Lyndon St. S. Pasadena, CA 91030-3381 Tel: 626) 403-5959, Fax: 626) 403-0128, E-mail: DBCacup@aol.com

Issued Date: January 28, 1999

Trade name: DBC, Dong Bang Acupuncture Needles, 510(k) Number: K990328 Classification: II Common name: Acupuncture Needles Product code: MQX Classification name: Needle, Acupuncture, Single Use The Legally Marketed Device: DBC Acupuncture Needles, 510(k) K963300

Description of Device:

Intended Use:

Acupuncture needles are defined as devices "intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the States." Single use only acupuncture needles have been used for "the general practice of acupuncture" in the United States. The proposed DBC, Dong Bang Acupuncture Needles have the same intended use as the DBC Acupuncture Needles which are currently being marketed through interstate distribution (K963300), because the two devices are manufactured by a same company.

Safety, Effectiveness, and Fundamental Scientific Technology:

Since 1988, no accidents or device failure claims have been reported as a result of using the acupuncture needles supplied by Dong Bang Medical Co., LTD in the U.S.A. Sterile, stainless, single use only acupuncture needles offer greater safety. The proposed DBC, Dong Bang acupuncture needles meet the general specifications and criterion for acupuncture needles and are effective for the practice of acupuncture. The differences in trade and distributor names in labeling do not alter safety, effectiveness, or device's fundamental scientific technology.

Substantial Equivalence:

In conclusion, based on the information provided with this 510(k) application, the DBC, Dong Bang brand acupuncture needle meets the criterion for 510 (k) acceptance. The subject of this application is the same safe and effective DBC acupuncture needle which has been legally marketed in commercial distribution. For this DBC, Dong Bang acupuncture needle is identical to the legally marketed DBC acupuncture needle, 510(k) K963300 submitted by an other importer (Lhasa Medical, Inc.) of Dong Bang Medical Co., LTD. The differences in trade and distributor names in labeling do not affect the device's intended use or alter the device's

fundamental scientific technology.

Ae-Hoe Kwon, contact person Date 1/24/99

1429 Lyndon St.

Pasadena,
CA 91030-3381

: (626) 403-5959
: 403-0128

ਤੇ

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Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized image of an eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is simple and recognizable, representing the department's mission to protect the health of all Americans.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

4 1999 MAY

Mr. Ae-Hoe Kwon President Morning Star, Dong Bang Acupuncture U.S.A., Incorporated 1429 Lyndon Street South Pasadena, California 91030-3381

Re : K990328 DBC, Dong Bang Acupuncture Needles Trade Name: Regulatory Class: II Product Code: MQX Dated: March 4, 1999 Received: March 8, 1999

Dear Mr. Ae-Hoe Kwon

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. ਸ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Ae-Hoe Kwon

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA debering of substantial equivalence of your device to a legally marketed predicate device results in a classification for your markets 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note ene Ories Or Compland, "Misbranding by reference to the regulacion encretica, "Mibbianding by Coronoveral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K990328

510(K) NUMBER (IF KNOWN): K990328 DEVICE NAME: DBC DONGBANG ACUPUNCTURE NEEDLES

INDICATIONS FOR USE

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRIH, Office of Device Evaluation (ODE)
(Division Sign-Off) Patricia Cucente
Division of Dental, Infection Control,
and General Hospital Devices

510(k) Number	K990328
Prescription Use(Per 21 CFR 801.109)	OR Over-The-Counter-Use(Optional Format 1-2)

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.