(93 days)
K-003760, K-962809
Not Found
No
The 510(k) summary describes sterile, disposable acupuncture needles and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is used to perform acupuncture, which is a therapeutic practice aimed at treating various conditions and promoting health.
No
The device description states that the acupuncture needles are "used to pierce the skin in the practice of acupuncture." This describes a therapeutic or interventional use, not a diagnostic one. There is no mention of the device being used to identify, detect, or characterize a disease or condition.
No
The device description clearly states it is an acupuncture needle, which is a physical hardware device. There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the needles are used 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 (like blood, urine, or tissue).
- Device Description: The description details sterile, disposable needles for piercing the skin. This aligns with a surgical or therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
In summary, the device is an acupuncture needle, which is a therapeutic device used for a medical procedure, not a diagnostic test performed on a sample.
N/A
Intended Use / Indications for Use
These acupuncture needles are used 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
Tai-Chi and Master acupuncture needles are sterile disposable, surgical s/steel acupuncture needles with spiral wound spring or rigid pipe type handles. These needles are supplied in individual blister or bulk packages. with or without polypropylene insertion tubes.
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 as determined by the States.
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)
Substantial equivalence is not based on an assessment of performance data.
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.
K-003760, K-962809
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
LHASA MEDICAL, INC.
234 Libbey Parkway, Weymouth, MA 02189 (781) 340-1071 fax: 781-659-9916 (or fax: 781-335-6296)
February 13, 2003
Page 8a
PRE-MARKET NOTIFICATION 510(k) SUMMARY (As Required by 21 CFR 807.92)
(a)(1) Cubmitter
| Submitter: | Lhasa Medical, Inc
234 Libbey Parkway
Weymouth, MA 02189 |
|-----------------------------|--------------------------------------------------------------------------------|
| Contact Person: | Kyung P. Riihimaki |
| Date Summary Prepared: | February 13, 2003 |
| (a)(2) | |
| Device Trade Name: | Tai-Chi and Master Acupuncture Needles
(other trade names may also be used) |
| Common or Usual Name: | Acupuncture Needles |
| Device Classification Name: | Needle, Acupuncture, Single Use |
| Classification: | Class II |
| 510(k) Number: | K-023787 |
(a)(3)
This device is substantially equivalent in design and performance to other brands of acupuncture needles which were in commercial distribution in the USA prior to May 28, 1976. These acupuncture needles are also substantially equivalent to other acupuncture needles which have received approval through the 510(k) premarket notification process.
These include the following:
| Tai-Chi Acupuncture Needles | K-003760 (2/6/01) |
|---|---|
| SEIRIN Acupuncture Needles | K-962809 (8/16/92) |
1
LHASA MEDICAL, INC.
234 Libbey Parkway, Weymouth, MA 02189 (781) 340-1071 fax: 781-659-9916 (or fax: 781-335-6296)
November 11, 2002
Page 8b
PRE-MARKET NOTIFICATION 510(k) SUMMARY ..... continucd from previous page
(a)(4)
Description of Tai-Chi and Master Acupuncture Needles.
Tai-Chi and Master acupuncture needles are sterile disposable, surgical s/steel acupuncture needles with spiral wound spring or rigid pipe type handles. These needles are supplied in individual blister or bulk packages. with or without polypropylene insertion tubes.
(a)(5)
Acupuncture needles are used to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the States.
(a)(6)
Tai-Chi and Master acupuncture needles have the same technological characteristics as the predicate devices identified in paragraph (a)(3). These needles use the same needle body lengths and gauges (needle thickness); handle length and design; and packaging methods (single blister and bulk packaging) as these predicate devices. These needles also employ the same method of insertion, with or without polypropylene guide tubes.
(b)(1)(2)(3)
Substantial equivalence is not based on an assessment of performance data.
(c) This summary includes these 2 pages in total.
Hyry P. Büchrich.
February 13, 2003
Date
Kyung P. Riihimaki, President Premarket Notification (510(k) Number): K-023787
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird with three wing-like shapes extending upwards and to the right. Below the bird is a wavy line. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 4 2003
Mr. Kyung P. Riihimaki President Lhasa Medical, Incorporated 234 Libbey Parkway Weymouth, Massachusetts 02189
Re: K023787
Trade/Device Name: Tai-Chi and Master Acupuncture Needles Regulation Number: 880.5580 Regulation Name: Acupuncture Needle Regulatory Class: II Product Code: MQX Dated: January 17, 2003 Received: January 22, 2003
Dear Mr. Riihimaki:
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 Federal Register.
3
Page 2 - Mr. Riihimaki
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 (301) 594-4618. 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/dsma/dsmamain.html
Sincerely yours,
Susan Runner
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 6
K-023787 510(k) Number (if known):
Device Name:
Tai-Chi and Master Acupuncture Needles
Indications for Use
These acupuncture needles are used 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 Evaluations (ODE)
Prescription Use (Per 21 CFR 801.109)
Or
Over-The-Counter Use _
Patricia Cucurullo
510(k) Number. K023787