(125 days)
Not Found
No
The device description details a simple, physical acupuncture needle and its materials, with no mention of software, algorithms, or data processing capabilities that would indicate AI/ML.
No.
A therapeutic device actively treats a condition or disease. This device is an acupuncture needle, which is a tool used by a practitioner, but it does not independently perform a therapeutic action.
No
The device is an acupuncture needle, intended to pierce the skin for therapeutic purposes, not for diagnosing conditions.
No
The device description explicitly details a physical acupuncture needle made of stainless steel and other materials, which is a hardware component. There is no mention of any software functionality.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Intended Use: The intended use of this device is to "pierce the skin in the practice of acupuncture." This is a direct intervention on the body, not an examination of a specimen taken from the body.
- Device Description: The description details a physical needle designed for insertion into the skin. It does not mention any components or processes related to analyzing biological samples.
Therefore, based on the provided information, this device clearly falls outside the definition of an In Vitro Diagnostic. It is a medical device used for a therapeutic procedure (acupuncture).
N/A
Intended Use / Indications for Use
The device is intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.
Product codes
MQX
Device Description
The Device is defined as prescription device intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states. The Device consists of a solid stainless steel needle with handle attached to facilitate the delivery of acupunture treatment. The material for the Device is stainless steel wire 0Cr19Ni9, which complies with the Chinese National Standard GB2024-94 for acupuncture needles.
The handles of the Device are in flat, ring, flower or tube shape and are made of different materials including copper, stainless steel, aluminum, and plastic. The length of the Device conforms to GB2024-94, which meets the needs for depth of insertion and manipulation. The diameters of the needle come in 0.16mm, 0.18mm, 0.25mm, 0.30mm, 0.35mm, 0.40mm, and 0.45mm, depending on the needs. The point of the needle is round, straight, and smooth and complies with GB2024-94.
Each acupuncture needle is individually packaged, with or without a guide (insertion) tube. The Device is sterilized with Ethylene Oxide, whose residue on the surface of needle body meets clinical health requirements. The Device package is confirmed to remain stainless and aseptic in two years of shelf life at room temperature, normal pressure, and ≤80%RH
The Device is sterile, disposable, and for single use only. The material, sterility, and biocompatibility of the Device meet the general specifications and the criteria for single use acupuncture needle. In addition, the Device is designed such that it is compatible with the current acupuncture needles produced by other major acupuncture needle manufacturers.
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
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
page 1 of 2
-ER I 2006
510(k) Summary
1 Submitter's Identification:
Lee & Xiao 2600 Mission Street, Suite 100 San Marino, CA 91108 Tel: (626)799-0998 Fax: (626)799-1588
Contact Person: Yingchao Xiao, Esq.
Date: September 27, 2005
2. Device Name:
| Trade Name: | Kangsheng Brand/Kangnian Brand/Unilink Brand/
Huazhong Brand Acupuncture Needles |
|----------------------|-------------------------------------------------------------------------------------|
| Common Name: | Acupuncture Needle |
| Classification Name: | Needle, Acupuncture, Single Use |
3. Predicate Device Information:
Vinco Brand Acupuncture Needle (K024207) Acumaster Band Acupuncture Needle (K991508) Carbo Brand/Viva Brand Acupuncture Needles (K961339)
4. Device Description:
、 The Device is defined as prescription device intended to to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states. The Device consists of a solid stainless steel needle with handle attached to facilitate the delivery of acupunture treatment. The material for the Device is stainless steel wire 0Cr19Ni9, which complies with the Chinese National Standard GB2024-94 for acupuncture needles.
The handles of the Device are in flat, ring, flower or tube shape and are made of different materials including copper, stainless steel, aluminum, and plastic. The length of the Device conforms to GB2024-94, which meets the needs for depth of insertion and manipulation. The diameters of the needle come in 0.16mm, 0.18mm, 0.25mm, 0.30mm, 0.35mm, 0.40mm, and 0.45mm, depending on the needs. The point of the needle is round, straight, and smooth and complies with GB2024-94.
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K0527731 page 2 of 2
Each acupuncture needle is individually packaged, with or without a guide (insertion) tube. The Device is sterilized with Ethylene Oxide, whose residue on the surface of needle body meets clinical health requirements. The Device package is confirmed to remain stainless and aseptic in two years of shelf life at room temperature, normal pressure, and ≤80%RH
The Device is sterile, disposable, and for single use only. The material, sterility, and biocompatibility of the Device meet the general specifications and the criteria for single use acupuncture needle. In addition, the Device is designed such that it is compatible with the current acupuncture needles produced by other major acupuncture needle manufacturers.
5. Intended Use:
The device is intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states
6. Conclusion:
Kangsheng Brand, Kangnian Brand, Unilink Brand, and Huazhong Brand Acupuncture Needles are very similar to the Predicate Device in all areas of comparison. Where there is a difference in the subject device, the difference does not raise any question in terms of the subject device's safety and effectiveness. Therefore, Kangsheng Brand, Kangnian Brand, Unilink Brand, Huazhong Brand Acupuncture Needles are substantially equivalent to Vinco Brand, Acumaster Brand, Carbo Brand/Viva Brand acupuncture needles.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which features three abstract human figures in profile. The figures are arranged in a row, with each figure slightly overlapping the previous one. The logo is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA".
2006 FEB 1
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Daxin Li C/O Mr. Yingchao Xiao Lee & Xiao Attorneys 2600 Mission Street, Suite 100 San Marino, California 91108
Re: K052731
Trade/Device Name: Kangsheng Brand/Kangnian Brand/Unilink Brand/Huazhong Brand Acupuncture Needles Regulation Number: 21 CFR 880.5580 Regulation Name: Acupuncture Needle Regulatory Class: II Product Code: MQX Dated: January 9. 2006 Received: January 13, 2006
Dear Mr. Xiao:
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 Eederal Register.
3
Page 2 - Mr. Xiao
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) 276-0115. 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 vours,
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
4
K0527731
INDICATIONS FOR USE
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Kangsheng Brand/Kangnian Brand/Unilink Brand/Huazhong Brand Acupuncture Needles
Indications for Use:
The device is intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.
,
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
()ver-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)
Chr. Vintges
and they Caneral Hospital, n Chayel, Danial Davices
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