(245 days)
Not Found
No
The device description and performance studies focus on the physical properties and sterility of a simple acupuncture needle, with no mention of AI or ML capabilities.
Yes
The device description states that the needles are "used by an acupuncture practioner in the treatment of various conditions." This indicates a therapeutic purpose.
No
Explanation: The device description states that acupuncture needles are used for "stimulation of specific acupuncture points" and "treatment of various conditions," not for diagnosing them.
No
The device description clearly states it is a physical acupuncture needle made of stainless steel, not software.
No, 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 a sample taken from the body to diagnose a condition.
- Device Description: The device is a "simple stainless steel pin" used for "penetration by thin needles." This describes a physical tool for a therapeutic procedure.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices that are used to perform tests on samples taken from the human body (such as blood, urine, or tissue) to provide information about a person's health, including diagnosis, monitoring, or screening.
This device is clearly a therapeutic device used for a physical treatment, not a diagnostic test performed on a sample.
N/A
Intended Use / Indications for Use
This KM Needles (Acupuncture Needle) is intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the state regulations.
Product codes (comma separated list FDA assigned to the subject device)
MQX
Device Description
The KM Needles (Acupuncture Needle) are simple stainless steel pins that are used by an acupuncture practioner in the treatment of various conditions. Acupuncture is the timulation of specific acupuncture points along the skin of the body involving various methods such as penetration by thin needles or the application of heat, pressure, or laser light. Clinical practice varies depending on the country. Traditional acupuncture involves needle insertion, moxibustion, and cupping therapy. It is a form of alternative medicine and a key component of traditional Chinese medicine (TCM).
The KM Needles (Acupuncture Needle) are constructed of stainless steel, with pin body diameters ranging from 0.16 to 0.70 mm and vary in length from 15 to 135 mm. Each acupuncture needle has a handle for the practioner to manipulate the needle. The handle is also made from stainless steel and range in length from 20-30 mm.
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)
Bench testing was performed to ensure the tensile strength of the stainless steel needle and Sterility testing (ISO10993-1 Biological evaluation of medical devices --Part 1: Evaluation and testing within a risk management process; ISO 10993-5 Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity, ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization, ISO 1137-2 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose, AAMI/ISO/ANSI 11737-1 Sterilization of medical devices - Microbiological methods Part 1: Determination of the population of microorganisms on product, 2ed. AAMI ANSI ISO 11607-1 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems, AAMI ANSI ISO 11607-2 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes, ASTM F1980-07 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices.) was performed. All test results were satisfactory.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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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 caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 10, 2015
K.M.S. Inc. c/o Mr. Charlie Mack International Regulatory Consulting 12226 Washington Lane Parker, Arizona 85344
Re: K142920
Trade/Device Name: KM Needles (Acupuncture Needle) Regulation Number: 21 CFR 880.5580 Regulation Name: Acupuncture Needle Regulatory Class: II Product Code: MQX Dated: April 29, 2015 Received: May 06, 2015
Dear Mr. Mack:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
1
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Tina
Kiang -S
for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K142920
Device Name KM Needles (Acupuncture Needle)
Indications for Use (Describe)
This KM Needles (Acupuncture Needle) is intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the state regulations.
| Type of Use (Select one or both, as applicable) | ||
|---|---|---|
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ||
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary
This summary of 510(k) substantial equivalence information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: May 29, 2015 510(k) Number: K142920
- Company and Correspondent making the submission:
Name - K.M.S Inc. Address - F2, 81-1 Haengjeong-ri, Gwangdeok-myeon, Dongnam-gu, Cheonansi, Chungcheongnam-do, Korea 330922 Tel: 82-41-5587785 Fax: 82-41-5587786 Contact - Mr. Chul Hui.Kim Executive Director Email - charliemack@irc-us.com
- Device :
Trade/proprietary name: KM Needles (Acupuncture Needle) Common Name : Acupuncture Needle Classification Name : needle, acupuncture, single use
-
- Predicate Devices : Dong Bang Acupuncture Needles, (K972659)
-
- Classifications Names & Citations : 21CFR 880.5580, MQX, Acupuncture Needle, Class 2
5. Description :
The KM Needles (Acupuncture Needle) are simple stainless steel pins that are used by an acupuncture practioner in the treatment of various conditions. Acupuncture is the timulation of specific acupuncture points along the skin of the body involving various methods such as penetration by thin needles or the application of heat, pressure, or laser light. Clinical practice varies depending on the country. Traditional acupuncture involves needle insertion, moxibustion, and cupping therapy. It is a form of alternative medicine and a key component of traditional Chinese medicine (TCM).
The KM Needles (Acupuncture Needle) are constructed of stainless steel, with pin body diameters ranging from 0.16 to 0.70 mm and vary in length from 15 to 135 mm. Each acupuncture needle has a handle for the practioner to manipulate the needle. The handle is also made from stainless steel and range in length from 20-30 mm.
4
-
- Indication for use :
This acupuncture needle is intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the state regulations.
- Indication for use :
-
- Comparison with predicate device :
K.M.S Inc. believes that the KM Needles (Acupuncture Needle) is substantially equivalent to the Dong Bang Acupuncture Needles (K972659).
- Comparison with predicate device :
The predicate device chosen is comprised of the same material and both are single use devices delivered in a sterile condition. The predicate uses EO as the sterilization method and the KM Needles (Acupuncture Needle) are sterilized using radiation. Please note the table below, which demonstrates the similarities of the K.M.S Inc. Acupuncture Needles and the predicate device.
| UV YIVV.
| Element of comparison | Subject Device | Claimed SE Device |
|---|---|---|
| Company | K.M.S Inc. | Dong Bang Acupuncture |
| Needle | ||
| FDA510(K) Number | N/A | K972659 |
| Device Name | KM Needles | |
| (Acupuncture Needle) | ACUPUNCTURE NEEDLES | |
| Intended Use | This acupuncture needle is | |
| intended to pierce the skin in | ||
| the practice of acupuncture by | ||
| qualified practitioners of | ||
| acupuncture as determined by | ||
| the state regulations. | This acupuncture needle is | |
| intended to pierce the skin in | ||
| the practice of acupuncture by | ||
| qualified practitioners of | ||
| acupuncture as determined by | ||
| the states. | ||
| Principle of operation | General and hand type | General and hand type |
| Material: | ||
| Needle body |
Handle
- | STS 304 | STS 304 |
| Specification:
Length
Diameter
- | Length: 15
135mm0.70mm | Length: 7
Diameter: 0.16150mm0.50mm |
Diameter: 0.16
| Tensile Strength of the
Acupuncture Needle | Diameter :
0.20 (723.3gf)
0.25 (726.6gf)
0.35 (733.3gf) | Diameter :
0.20 (709.6gf)
0.25 (673.6gf)
0.35 (686.3gf) |
| Biocompatibility | Conform to ISO10993-1 | Conform to ISO10993-1 |
| Design | Spring | Spring |
| Reuse | Disposable, single use | Disposable, single use |
| Sterility | Gamma radiation | Sterilized by EO; SAL=10-6 |
The table provides a comparison of the KM Needles (Acupuncture Needle) with the predicate device:
5
The submitted K.M.S Inc. device and the predicate device have undergone testing to validate the tensile strength of the materials and also testing to verify the sterilization process and the sterile properties of the device, as delivered. The testing performed demonstrated that the devices met all of the criteria in these standards and that the submitted devices are similar in construction and delivered in the same state as the predicate Dong Bang acupuncture needles.
8. Performance Data :
Bench testing was performed to ensure the tensile strength of the stainless steel needle and Sterility testing (ISO10993-1 Biological evaluation of medical devices --Part 1: Evaluation and testing within a risk management process; ISO 10993-5 Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity, ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization, ISO 1137-2 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose, AAMI/ISO/ANSI 11737-1 Sterilization of medical devices - Microbiological methods Part 1: Determination of the population of microorganisms on product, 2ed. AAMI ANSI ISO 11607-1 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems, AAMI ANSI ISO 11607-2 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes, ASTM F1980-07 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices.) was performed. All test results were satisfactory.
9. Conclusions:
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification K.M.S Inc. concludes that the KM Needles (Acupuncture Needle) are as safe and effective and substantially equivalent to predicate devices as described herein.
END