(174 days)
Not Found
Not Found
No
The summary describes a single-use acupuncture needle and does not mention any AI or ML capabilities.
Yes
The device is described as an "acupuncture needle," which is used in the practice of acupuncture. Acupuncture is a therapeutic treatment.
No
Explanation: The device is an acupuncture needle, intended to pierce the skin for therapeutic purposes, not for diagnosing a condition or disease.
No
The device description explicitly states it is a "SINGLE USE ACUPUNCTURE NEEDLE," which is a physical, 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 procedure performed directly on a patient's body.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. They are used outside of the body (in vitro).
This device is used on the body for a therapeutic purpose (acupuncture), not to analyze a specimen for diagnostic information.
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
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
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): 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.
Not Found
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).
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§ 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 seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized representation of an eagle with three lines forming its body and wings. The eagle is facing to the right.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 3 2003
Facilai Enterprise Limited C/O Dr. Ke- Min Jen Official Correspondent Roc-Chinese-Europe Industrial Research Society No. 58, Fu-Chiun Street Hsin-Chu City, CHINA (TAIWAN) 300
Re: K031818
K051618
Trade/Devicc Name: Facilai Various Models of Single Use Acupuncture Necdle Regulation Number: 880.5580 Regulation Name: Needle Acupuncture Regulatory Class: II Product Code: MQX Dated: October 28, 2003 Received: November 3, 2003
Dear Dr. Jen:
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 approvisions of the Act. The general controls provisions of the Act include controls providens of an 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 (1 wr y, it may of caefoot to the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device ear over bublish further announcements concerning your device in the Federal Register.
1
Page 2 - Dr. Jen
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 meall that FDA has made a autes and regulations administered by other Federal agencies. of the Act of ally I ederal bates and submitted to: requirements, including, but not limited to: registration 1 od mast comply with an the Heveling (21 CFR Part 801); good manufacturing practice allu listing (21 CFR Pat 007), laceiity systems (QS) regulation (21 CFR Part 820); and if requirements as sections 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) This letter whilanon. 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), If you desire specific at . of Compliance at (301) 594-4618. Also, please note the regulation entified, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain 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/dsma/dsmamain.html
Sincerely yours,
Susan Runos
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
Enclosure
2
4. INDICATIONS FOR USE STATEMENT
| Applicant : | FACILAI ENTERPRISE LTD. |
|---|---|
| 510(k) Number : | K031818 |
| Device Name : | FACILAI VARIOUS MODELS OF SINGLE USE |
| ACUPUNCTURE NEEDLE |
Indications for Use :
- e The device is 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-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH Office of Device Evaluation (ODE)
Prescription Use Per 21 CFR 801.109 OR
Over-The-Counter __ (Optional Format 1-2-96)
Palacie Crescenti
eneral Hospital
510(k) Number: K031818