(239 days)
Not Found
No
The device description and performance studies focus solely on the physical characteristics, materials, sterilization, and biocompatibility of a sterile acupuncture needle. There is no mention of any software, algorithms, data processing, or AI/ML related terms.
Yes.
The device is used to "pierce the skin in the practice of acupuncture," which is a therapeutic intervention aimed at treating medical conditions.
No
The device is described as an acupuncture needle intended to pierce the skin for the practice of acupuncture, which is a therapeutic procedure, not a diagnostic one.
No
The device description explicitly states the device is manufactured from stainless steel and describes physical components like the needle handle and needle body. The performance studies also focus on material properties and physical performance, not software validation.
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 to diagnose or monitor a condition.
- Device Description: The description details a physical needle made of stainless steel for piercing the skin. It doesn't mention any components or functions related to analyzing biological samples.
- Lack of IVD Characteristics: The description and performance studies focus on the physical properties of the needle, sterilization, biocompatibility, and packaging. There is no mention of:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information based on sample analysis
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This acupuncture needle does not fit that description.
N/A
Intended Use / Indications for Use
The AIK Sterile Acupuncture Needles for Single Use 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 Acupuncture Needles are manufactured from stainless steel and sterilized with ethylene oxide gas. Acupuncture needle is made up of needle handle and needle body. The body of needle uses 304 stainless steel wire (06Cr19Ni10). The handle is a body coil with stainless steel wire, the spiral loop of which is arranged symmetrically without gaps.
The device can only be used by qualified practitioners of acupunctures. Qualified practitioners should already be knowledgeable on how to use the acupuncture needle and when not to use acupuncture in certain patient populations and medical conditions.
Handle of acupuncture needle is a plain handle. Types of acupuncture needle (sterile acupuncture needle for single use) are: acupuncture needle without a guide tube and acupuncture needle with a guide tube.
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
Performance testing was conducted to evaluate and characterize the performance of the AIK Sterile Acupuncture Needles. Non-clinical data included dimensional evaluation, and performance requirements evaluation per international standard, ISO 17218. Material performances are evaluated per international standard ISO 10993-1. In detail, the needle body needle handle, and guide tube were tested by tests of in vitro cytotoxicity, intracutaneous reactivity/irritation, skin sensitization and pyrogen. And the needle body were further tested by tests of hemodialysis study, and systemic toxicity study. All biocompatibility tests results show that the subject device is biocompatibility safe.
The primary package performance are evaluated per international standard ISO 11607. EO sterilization process are evaluated per international standard ISO 11135. And the EO and ECH Residuals Testing in accordance with ISO 10993-7.
The EO Sterilization Validation, Sterility Testing, Packaging Validation, and Long-Term Stability Testing were also performed per relevant standards.
All the test results demonstrate AIK Sterile Acupuncture Needles for Single Use meet the requirements of its pre-defined acceptance criteria and intended uses.
Key Metrics
- Appearance and cleanliness tests
- Drawing strength test
- Needle body hardness test
- Resistance to breakage of needle body test
- Intensity and puncture performance of needle tip test
- Sterile Test
- Resistance to corrosion test
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of a human figure, with three profiles overlapping to suggest community and support. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 11, 2017
CHANGCHUN AIK MEDICAL DEVICES CO., LTD Mr. Xingwang Li General Manager No. 25, Karen Industrial Park, Jiutai Economic Development Zone Changchun, Jilin 130507 CHINA
Re: K162566
Trade/Device Name: AIK Sterile Acupuncture Needles for Single Use Regulation Number: 21 CFR 880.5580 Regulation Name: Acupuncture needle Regulatory Class: Class II Product Code: MQX Dated: September 8, 2016 Received: April 10, 2017
Dear Mr. Xingwang Li:
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. Isting 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
Page 2 - Mr. Xingwang Li
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/ResourcesforYou/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,
Tina Kiang
-s
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Change Control Table, Change History
Change Control Table
| Version | Document Author | Document Approver | Date Approved |
|---|---|---|---|
| 1.00 | Name, Title, Office | Name, Title, Office | MM/DD/YYYY |
Complete Change Control Table (all versions) retained in SWIFT Docs.
3
Indications for Use
510(k) Number (if known) K162566
Device Name
AIK Sterile Acupuncture Needles for Single Use
Indications for Use (Describe)
The AIK Sterile Acupuncture Needles for Single Use is 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) | |
|---|---|
| --------------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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4
K162566
510(k) Summary
| Submitter: | CHANGCHUN AIK MEDICAL DEVICES CO., LTD
No. 25, Karen Industrial Park, Jiutai Economic Development Zone
Changchun, Jilin Province, 130507 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Mr. Li, Xingwang
General Manager
Phone: (86)-13364688867 /
(86)-18616806984
Email: aik2000@163.com |
| Date Prepared: | May, 4 2017 |
| Device Trade Name: | AIK Sterile Acupuncture Needles for Single Use |
| Device Common Name: | Acupuncture Needle |
| Classification Name: | Acupuncture Needle |
| Class: | II |
| Regulation Number: | 880.5580 |
| Panel: | General Hospital and Personal Use Devices |
| Product Code: | MQX |
1. Predicate Device:
| Device | Company | Product Code | 510(k) Number |
|---|---|---|---|
| SMC Acupuncture Needle | SMC. | MQX | K141473 |
3. Indications for Use:
The AIK Sterile Acupuncture Needles for Single Use is intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.
5
3. Product Description:
The Acupuncture Needles are manufactured from stainless steel and sterilized with ethylene oxide gas. Acupuncture needle is made up of needle handle and needle body. The body of needle uses 304 stainless steel wire (06Cr19Ni10). The handle is a body coil with stainless steel wire, the spiral loop of which is arranged symmetrically without gaps.
The device can only be used by qualified practitioners of acupunctures. Qualified practitioners should already be knowledgeable on how to use the acupuncture needle and when not to use acupuncture in certain patient populations and medical conditions.
Handle of acupuncture needle is a plain handle. Types of acupuncture needle (sterile acupuncture needle for single use) are: acupuncture needle without a guide tube and acupuncture needle with a guide tube.
Image /page/5/Figure/4 description: The image shows a diagram with labels. There are two sections, one with a straight line labeled with 'Φd' and 'l1', and another with a coiled line labeled with 'l2'. The entire diagram is labeled with 'L'.
Product Specification
Diameter specification of acupuncture needle: Ø 0.14mm-Ø 0.35mm; length specification of needle body: 13mm-75mm.
| Gauge (#) | Diameter | Lengths of needle body | |||||||
|---|---|---|---|---|---|---|---|---|---|
| 42G | 0.14mm | 13mm | 15mm | 25mm | |||||
| 40G | 0.16mm | 13mm | 15mm | 25mm | 30mm | ||||
| 38G | 0.18mm | 13mm | 15mm | 25mm | 30mm | 40mm | |||
| 36G | 0.20mm | 13mm | 15mm | 25mm | 30mm | 40mm | 50mm | ||
| 34G | 0.22mm | 13mm | 15mm | 25mm | 30mm | 40mm | 50mm | 60mm | |
| 32G | 0.25mm | 13mm | 15mm | 25mm | 30mm | 40mm | 50mm | 60mm | 75mm |
| 30G | 0.30mm | 13mm | 15mm | 25mm | 30mm | 40mm | 50mm | 60mm | 75mm |
| 28G | 0.35mm | 13mm | 15mm | 25mm | 30mm | 40mm | 50mm | 60mm | 75mm |
4. Non-Clinical Testing
Performance testing was conducted to evaluate and characterize the performance of the AIK Sterile Acupuncture Needles. Non-clinical data included dimensional evaluation, and performance requirements evaluation per international standard, ISO 17218. Material performances are evaluated per international standard ISO 10993-1. In detail, the needle body needle handle, and guide tube were tested by tests of in vitro cytotoxicity, intracutaneous reactivity/irritation, skin sensitization and pyrogen. And the needle body were further tested by tests of hemodialysis study, and systemic toxicity study. All biocompatibility tests results show that the subject device is biocompatibility safe.
6
The primary package performance are evaluated per international standard ISO 11607. EO sterilization process are evaluated per international standard ISO 11135. And the EO and ECH Residuals Testing in accordance with ISO10993-7.
The EO Sterilization Validation, Sterility Testing, Packaging Validation, and Long-Term Stability Testing were also performed per relevant standards.
All the test results demonstrate AIK Sterile Acupuncture Needles for Single Use meet the requirements of its pre-defined acceptance criteria and intended uses. For example, the function performance tests including:
- Appearance and cleanliness tests
- Drawing strength test
- Needle body hardness test
- Resistance to breakage of needle body test
- Intensity and puncture performance of needle tip test
- Sterile Test
- Resistance to corrosion test
5. Substantial Equivalence Determination
The indications for use and technology characteristics of the proposed AIK Sterile Acupuncture Needles for Single Use, and the substantial equivalence to the predicate devices have been demonstrated via data collected in design verifications. The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its indications for use. The subject device is substantial equivalent to the predicate device.
The comparison to predicate devices as below table.
| Item | Proposed Device
(AIK Sterile Acupuncture Needles for
Single Use) | Predicate Device
(SMC Acupuncture Needle) |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 |
| Applied types | Needle with/without plastic guide
tube | Needle with/without plastic guide
tube |
| Needle tip shape | Arrow | Arrow |
| Design | Stainless steel needle with a steel,
aluminum or copper handle and a
plastic guide tube for user | Stainless steel needle with a steel,
aluminum or copper handle and a
plastic guide tube for user |
| Materials | Needle: surgical stainless steel
(SUS304);
Handle: metal (steel);
Coating material:
Polydimethylsiloxane;
Guild Tube(not contact): PVC;
following ISO 10993-1 for
cytotoxicity test
| Needle: surgical stainless steel
(SUS304)
Handle: metal (steel or aluminum
tube or copper wire)
Coating material:
Polydimethylsiloxane;
Guild Tube(not contact): PVC;
following ISO 10993-1 for
cytotoxicity test |
Comparison to Predicate Devices
7
| | | intracutaneous reactivity test;
hemodialysis study;
systemic toxicity study;
Pyrogen and Endotoxins study; | sensitization test
and intracutaneous reactivity test |
|-------------------------------------|----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Sterility | | Sterilized with ethylene oxide gas
with residuals at a validated dose
level | Sterilized with ethylene oxide gas
and or / Sterilized by Gamma
Irradiation |
| Available in
Needle
Diameters | | 0.14 mm, 0.16 mm, 0.18 mm, 0.20
mm, 0.22 mm, 0.25 mm, 0.30 mm,
0.35 mm | 0.16 to 0.70 mm |
| Available in
Needle Lengths | | 13 mm, 15 mm, 25 mm, 30 mm, 40
mm, 50 mm, 60 mm, 75 mm | 15-135 mm |
| Labeling | | Comply to 21 CFR 801 | Comply to 21 CFR 801 |
| Performance Requirements | Appearance
and
Cleanliness | Examined under corrected-to-normal
vision, and x 10 magnification:
Comply to the requirements specified
is ISO 17218 | Examined under corrected-to-
normal vision, and x 10
magnification:
Comply to the requirements
specified is ISO 17218 |
| | Drawing
strength | Needle solidly joined after the test
following ISO 17218, clause 5.3.2 | Needle solidly joined after the test
following ISO 17218, clause 5.3.2 |
| | Hardness of
the needle
body | Hardness of needle body comply the
requirements specified in ISO 17218,
clause 5.3.3 | Hardness of needle body comply the
requirements specified in ISO 17218,
clause 5.3.3 |
| | Resistance
to breakage
of the
needle body | The body of the needle is sufficient
resistance to breakage after test
following ISO 17218, clause 5.3.4 | The body of the needle is sufficient
resistance to breakage after test
following ISO 17218, clause 5.3.4 |
| | Intensity
and
puncture
performance | The tip of the needle has good
intensity and puncture performance
following the tests specified in ISO
17218, clause 5.3.5 | The tip of the needle has good
intensity and puncture performance
following the tests specified in ISO
17218, clause 5.3.5 |
| | Resistance
to corrosion | No corrosion of the body of the
needle following the test specified in
ISO 17218, clause 5.3.6 | No corrosion of the body of the
needle following the test specified in
ISO 17218, clause 5.3.6 |
The subject device acupuncture needles are substantially equivalent to the predicate device 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. One difference is the available needle diameters and needle lengths. Another difference is that our acupuncture needle claims for EO sterilization only, and the predicate device claims for both EO sterilization and Gamma irradiation sterilization methods.
6. Conclusion
Based on the indications for use, technological characteristics and performance testing, the AIK Sterile Acupuncture Needles for Single Use has demonstrated to be substantially equivalent to the predicate device.