(334 days)
Not Found
No
The device description and performance studies focus solely on the physical characteristics, materials, and sterilization of acupuncture needles. There is no mention of any computational or analytical capabilities, let alone AI or ML.
Yes.
The device is intended to pierce the skin in the practice of acupuncture, which is a therapeutic intervention aimed at stimulating specific points for various health benefits.
No
Explanation: The device description states that the acupuncture needles are used to pierce the skin for the practice of acupuncture, which is a treatment method. There is no mention of the device being used for diagnosis or identifying a disease or condition.
No
The device description clearly details physical components made of stainless steel, copper, and aluminum, and the performance studies focus on material properties and sterilization, indicating it is a hardware device.
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 a sample taken from the body to diagnose a condition.
- Device Description: The description details a physical needle for insertion into the skin. There is no mention of reagents, samples (like blood, urine, etc.), or any process for analyzing biological specimens.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease or other conditions. This device does not fit this definition.
The device is a medical device, but it falls under a different category than IVDs.
N/A
Intended Use / Indications for Use
Our acupuncture needles are devices used by licensed practitioners and are intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.
Product codes (comma separated list FDA assigned to the subject device)
MQX
Device Description
The acupuncture needles are sterile, thin needles which are inserted into specific points on the skin called "acupuncture points." The Acupuncture Needles are manufactured from stainless steel and sterilized with ethylene oxide gas. Acupuncture is the stimulation of specific acupuncture points along the skin of the body involving various methods such as penetration by thin needles. The skin is sterilized, such as with alcohol, and the needles are inserted, frequently with a plastic guide tube for the user. Needles may be manipulated in various ways including spinning, flicking, or moving up and down relative to the skin. The Acuzone Acupuncture Needles and KSC DB Plus Acupuncture Needles are made of surgical stainless steel, a handle consisting of a flexible coiled copper handle with nickel plated for protection, or a surgical stainless steel or aluminum tube handle and may be provided with a plastic guide tube. (10pcs/pack, 1000pcs/box).
Acuzone press tack needles (with micropore tape) are made with surgical stainless steel (10pcs/ pack, 100pcs/box). AcuZone Intradermal Needles are made with surgical stainless steel (5pcs/pack, 100pcs/box).
Press tack and intradermal needles have same purpose for ear acupuncture point.
The Acupuncture needles are available in nine diameters (0.12 ~ 0.35mm), five needle lengths (15 ~ 60mm), and tube lengths (30mm, 45mm, 55mm, 65mm and 75mm).
Acuzone press tack needle is available in one diameter (0.20mm x 2mm x length (1mm). AcuZone Intradermal Needles is available in one diameter (0.12mm), one length (5mm).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin, specifically "acupuncture points" and "ear acupuncture point".
Indicated Patient Age Range
Not Found
Intended User / Care Setting
licensed practitioners, 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)
Non-clinical Performance Data:
Performance testing was conducted to evaluate and characterize the performance of the Acuzone and KSC DB Plus. Non-clinical data included dimensional conformance evaluation, visual inspections, and design verification to confirm biocompatibility testing based on the applicable elements of ISO 10993 series, which included the Material Mediated Pyrogen Testing using ISO 10993-11 and the EO and ECH Residuals Testing in accordance with ISO10993-7.
The EO Sterilization Validation, Sterility Testing, Bacterial Endotoxin Testing, Validation, and Long-Term Stability Testing were also performed.
Microscopic examination and mechanical testing:
The acupuncture needle, as well as two predicate devices, Asia-med Special + Needle (K031716) and Asia-med Press Tack (K042063), were examined microscopically and mechanically tested to evaluate pull-out and elasticity properties. Specifically, the surfaces of the subject and predicate devices were found to be smooth and free of visible defects at 100X or higher magnification. Also the pull-out force of Acupuncture Needle was quantified and fell within the average values reported for the predicate devices. Finally, the elasticity properties of the subject device were found to be substantially equivalent to the two predicate devices, as after cantilever-type loading all devices returned to their original shape showing no permanent deformation.
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are simple and abstract, with only the outlines of the faces visible.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 25, 2015
K. S. Choi Corporation Mr. Kak Soo Choi President 179 W 39th Street Los Angeles, California 90037-1015
Re: K142760
Trade/Device Name: AcuZone Acupuncture Needles, KSC DB Plus Acupuncture Needles, AcuZone Press Tack Needles, and AcuZone Intradermal Needles Regulation Number: 21 CFR 880.5580 Regulation Name: Acupuncture needle Regulatory Class: II Product Code: MQX Dated: May 8, 2015 Received: July 20, 2015
Dear Mr. Choi:
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) K142760
Device Name
AcuZone Acupuncture Needles, KSC DB Plus Acupuncture Needles, AcuZone Press Tack Needles, and AcuZone Intradermal Needles
Indications for Use (Describe)
Our acupuncture needles are devices used by licensed practitioners and are intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.
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)
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3
510(k) SUMMARY Traditional 510(k) (As required by 21CFR 807.92)
August 24, 2015
Applicant: 807.92(a)
K. S. Choi Corporation 179 W. 39th St. Los Angeles, CA 90037 Phone: 323-232-1600 Fax: 323-232-2747 Contact: Kak Soo Choi
Date Prepared: August 24, 2015
Device Name: AcuZone Acupuncture Needles. KSC DB Plus Acupuncture Needles. AcuZone Press Tack Needles, and AcuZone Intradermal Needles Common Name: Acupuncture Needle Classification Name: Acupuncture needle, Single Use Product Code: MQX Medical Specialty: General Hospital Device Class: II 510(k) Number: K142760 Regulation Number: 880.5580
Predicate Device: 807.92(a)
The summary identifies the legally marketed device to which your firm is claiming equivalence: (1) Asia-med : Asia-med Special + Needle (K031716) and (K042063)
Description of the Device 807.92(a) :
The acupuncture needles are sterile, thin needles which are inserted into specific points on the skin called "acupuncture points." The Acupuncture Needles are manufactured from stainless steel and sterilized with ethylene oxide gas. Acupuncture is the stimulation of specific acupuncture points along the skin of the body involving various methods such as penetration by thin needles. The skin is sterilized, such as with alcohol, and the needles are inserted, frequently with a plastic guide tube for the user. Needles may be manipulated in various ways including spinning, flicking, or moving up and down relative to the skin. The Acuzone Acupuncture Needles and KSC DB Plus Acupuncture Needles are made of surgical stainless steel, a handle consisting of a flexible coiled copper handle with nickel plated for protection, or a surgical stainless steel or aluminum tube handle and may be provided with a plastic guide tube. (10pcs/pack, 1000pcs/box).
Acuzone press tack needles (with micropore tape) are made with surgical stainless steel (10pcs/ pack, 100pcs/box). AcuZone Intradermal Needles are made with surgical stainless steel (5pcs/pack, 100pcs/box).
Press tack and intradermal needles have same purpose for ear acupuncture point.
4
The Acupuncture needles are available in nine diameters (0.12 ~ 0.35mm), five needle lengths (15 ~ 60mm), and tube lengths (30mm, 45mm, 55mm, 65mm and 75mm).
| Gauge | Diameter | Lengths | ||||
|---|---|---|---|---|---|---|
| (#) | ||||||
| 44 | .12mm | 15mm | 30mm | 40mm | ||
| 42 | .14mm | 15mm | 30mm | 40mm | ||
| 40 | .16mm | 15mm | 30mm | 40mm | ||
| 38 | .18mm | 15mm | 30mm | 40mm | 50mm | |
| 36 | .20mm | 15mm | 30mm | 40mm | 50mm | 60mm |
| 34 | .22mm | 15mm | 30mm | 40mm | 50mm | 60mm |
| 32 | .25mm | 15mm | 30mm | 40mm | 50mm | 60mm |
| 30 | .30mm | 15mm | 30mm | 40mm | 50mm | 60mm |
| 28 | .35mm | 15mm | 30mm | 40mm | 50mm | 60mm |
Acuzone press tack needle is available in one diameter (0.20mm x 2mm x length (1mm). AcuZone Intradermal Needles is available in one diameter (0.12mm), one length (5mm).
Intended Use of Device 807.92(a) :
Our acupuncture needles are devices used by licensed practitioners and are intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.
Summary of the technological characteristics of the device compared to the predicate devices 807.92(a)
The acupuncture needle, as well as two predicate devices, Asia-med Special + Needle (K031716) and Asia-med Press Tack (K042063), were examined microscopically and mechanically tested to evaluate pull-out and elasticity properties. Specifically, the surfaces of the subject and predicate devices were found to be smooth and free of visible defects at 100X or higher magnification. Also the pull-out force of Acupuncture Needle was quantified and fell within the average values reported for the predicate devices. Finally, the elasticity properties of the subject device were found to be substantially equivalent to the two predicate devices, as after cantilever-type loading all devices returned to their original shape showing no permanent deformation.
Table 1: Comparison of Acuzone Acupuncture Needles, KSC DB Plus Acupuncture Needle, and Asia-med Special + Needle (K031716)
| Device | AcuZone and KSC DB Plus
Acupuncture Needle | Asia-med Special + Needle
510(k) #K031716 |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Indication
for use | Intended to pierce the skin in the
practice of acupuncture by qualified
practitioners of acupuncture as
determined by the states. | Intended to pierce the skin in the
practice of acupuncture by qualified
practitioners of acupuncture as
determined by the states. |
| Needle tip
shape | Arrow | Arrow |
5
| Design | Stainless steel needle with a steel,
aluminum or copper handle and a
plastic guide tube for user | Stainless steel needle (+ silicon
layer) with a copper handle and a
copolymer (PET) guide tube. |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Materials | Needle: surgical stainless steel
Handle: metal (steel or aluminum
tube or copper wire) | Needle: surgical stainless steel (+
silicon layer)
Handle: copper |
| Sterility | Sterilized with ethylene oxide gas
with residuals at a validated dose
level | Sterilized with radiation at a
validated dose level. |
| Needle
(invasive) | Surgical stainless steel | Surgical stainless steel |
| Guide tube
(non-invasiv
e) | Polypropylene or PROVISTATM
Copolymer (PET) | PROVISTA™ Copolymer (PET) |
| Labeling | • Indication for use
• Manufactured for or Distributed
by
• Product name
• Acupuncture needles
• Quantity
• Size
• Lot number
• Expiration date
• "Sterilized by ethylene oxide
gas"
• "For single use"
• Discard any unused needle in the
package after treatment session
is completed.
• "Made in China" | • Manufacturer's name and address
• Product name
• Acupuncture needles
• Quantity
• Size
• Lot number
• "Sterile"
• Expiration date
• "Sterilized by gamma radiation"
• "For single use"
• Rx statement
• "Do not store at extreme
temperatures and humidity"
• "Do not use if package is previously
opened or damaged"
• "Made in Germany" |
| Available in
Needle
Diameters | 0.12 mm, 0.14 mm, 0.16 mm,
0.18 mm, 0.20 mm, 0.22 mm, 0.25
mm, 0.30 mm, and 0.35 mm | 0.20 mm, 0.25 mm, and 0.30 mm |
| Available in
Needle
Lengths | 15 mm, 30 mm, 40 mm, 50 mm,
and 60 mm | 15 mm, 30 mm, and 40 mm |
Table 2: Comparison of AcuZone Press Tack Needles, AcuZone Intradermal Needles, and Asia-med Press Tack (K042063)
| Device | AcuZone Press Tack Needles
and AcuZone Intradermal
Needles K142760 | Asia-med Press Tack
K042063 |
| -------- | -------------------------------------------------------------------------- | -------------------------------- |
|---|
6
| Indication for
use | Intended to pierce the skin in the
practice of acupuncture by
qualified practitioners of
acupuncture as determined by the
states. | Intended to pierce the skin in the
practice of acupuncture by qualified
practitioners of acupuncture as
determined by the states. |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Needle tip shape | Arrow | Arrow |
| Design | Image: acupuncture needles
With or without tape for user | Image: acupuncture needles |
| Materials | Surgical stainless steel | Surgical stainless steel |
| Sterility | Sterilized | Sterilized |
| Available in
Needle
Diameters | Intradermal: 0.12 mm
Press Tack: 0.20 mm | 0.22 ~ 0.26 mm |
| Available in
Needle Lengths | Intradermal: 5 mm
Press Tack: 1 mm | 1.6 ~ 1.8 mm |
Our acupuncture needles are as safe and effective as the predicate, and are substantially equivalent to the predicate devices listed in this 510(k) submission; that is, the acupuncture needle has the same intended use (i.e., indications for use) and is similar, and in some cases the same, in both design (e.g., materials, sizes) and performance. The only difference is the quality of the product; for instance, the sharpness and the smoothness of the needle. Any differences in technological characteristics between the acupuncture needle and the predicate devices do not raise new issues of safety and effectiveness.
Non-clinical Performance Data 807.92(b)
Performance testing was conducted to evaluate and characterize the performance of the Acuzone and KSC DB Plus. Non-clinical data included dimensional conformance evaluation, visual inspections, and design verification to confirm biocompatibility testing based on the applicable elements of ISO 10993 series, which included the Material Mediated Pyrogen Testing using ISO 10993-11 and the EO and ECH Residuals Testing in accordance with ISO10993-7.
The EO Sterilization Validation, Sterility Testing, Bacterial Endotoxin Testing, Validation, and Long-Term Stability Testing were also performed.
Clinical Data 807.92(b)
Does not apply for these devices
Conclusion 807.92(b)
Biocompatibility tests and performance tests show that the device meets the requirements of those standards. Comparison with the predicate device shows that the device has similar specification and performance. Thus,
7
we conclude that Acuzone Acupuncture Needles, KSC DB Plus Acupuncture Needles, Acuzone Press Tack Needles, and Acuzone Intradermal Needles are substantially equivalent to the predicate device.
Kakeeco cheai
08/24/15
Kak Soo Choi, President
Date