(91 days)
No
The document describes a standard acupuncture needle and makes no mention of AI or ML technology.
Yes
The device is intended for the practice of acupuncture, which is a therapeutic intervention aimed at treating various conditions.
No
The device is described as intended to "pierce the skin in the practice of acupuncture" and its predicate device is also an acupuncture needle. There is no mention of it being used to diagnose conditions.
No
The device description clearly states it is an acupuncture needle, which is a physical, hardware device. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "pierce the skin in the practice of acupuncture." This is a physical intervention on the body, not a test performed on samples taken from the body (like blood, urine, or tissue).
- Device Description: The description details a physical needle used for acupuncture. There is no mention of reagents, test strips, or any components used for analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Providing information about a patient's health status based on sample analysis.
- Using reagents or test kits.
In summary, the DBC Dongbang Acupuncture Needles are a medical device used for a therapeutic procedure (acupuncture), not for diagnostic testing of samples.
N/A
Intended Use / Indications for 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.
Product codes
MQX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified practitioners of acupuncture as determined by the States.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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:
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.
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
1
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.
2
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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510(K) NUMBER (IF KNOWN): K990328 DEVICE NAME: DBC DONGBANG ACUPUNCTURE NEEDLES
INDICATIONS FOR USE
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."
(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) |