(99 days)
K-963300, K-962809
Not Found
No
The summary describes sterile, disposable acupuncture needles and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
Yes
Acupuncture needles are used in the practice of acupuncture, which is a traditional medical treatment aimed at restoring and maintaining health. This directly implies a therapeutic purpose.
No
The device is described as acupuncture needles used to pierce the skin for acupuncture practice, which is a treatment modality, not a diagnostic one.
No
The device description clearly states it is a physical acupuncture needle made of surgical stainless steel with plastic handles, indicating it is a hardware device.
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 samples taken from the body (like blood, urine, or tissue).
- Device Description: The description details a physical needle used for insertion into the skin.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting substances, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This acupuncture needle does not fit that definition.
N/A
Intended Use / Indications for Use
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
Nano Tech and Super Nano Acupuncture Needles are sterile disposable, surgical s/steel acupuncture needles with rigid pipe type plastic 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
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
Substantial equivalence is not based on an assessment of performance data.
Description of the test set, sample size, data source, and annotation protocol
Substantial equivalence is not based on an assessment of performance data.
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-963300, 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
JUL 1 1 2003
LHASA MEDICAL, INC.
234 Libbey Parkway, Weymouth, MA 02189 (781) 340-1071 fax: 781-659-9916 (or fax: 781-335-6296)
April 2, 2003
Page 6a
PRE-MARKET NOTIFICATION 510(k) SUMMARY (As Required by 21 CFR 807.92)
| (a)(1) | |
|---|---|
| Submitter: | Lhasa Medical, Inc |
| 234 Libbey Parkway | |
| Weymouth, MA 02189 | |
| Contact Person: | Kyung P. Riihimaki |
| Date Summary Prepared: | April 2, 2003 |
| (a)(2) | |
| Device Trade Name: | Nano Tech and Super Nano |
| Acupuncture Needles | |
| Common or Usual Name: | Acupuncture Needles |
| Device Classification Name: | Needle, Acupuncture, Single Use |
| Classification: | Class II |
| 510(k) Number: | K- |
(a)(3) Substantially Equivalent
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:
| DBC Acupuncture Needles | K-963300 (9/23/96) |
|---|---|
| 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)
April 2, 2003
Page 6b
PRE-MARKET NOTIFICATION 510(k) SUMMARY ..... continued from previous page
(a)(4) Description
Description of Nano Tech and Super Nano Acupuncture Needles. Nano Tech and Super Nano Acupuncture Needles are sterile disposable, surgical s/steel acupuncture needles with rigid pipe type plastic handles. These needles are supplied in individual blister or bulk packages, with or without polypropylene insertion tubes.
(a)(5) Indications for Use
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) Technological Characteristics
Nano Tech and Super Nano 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 design; and use the same 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.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the top half of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 1 2003
Ms. Kyung P. Riihimaki President Lhasa Medical. Incorporated 234 Libbey Parkway Weymouth, Massachusetts 02189
Re: K031060
Trade/Device Name: Nano Tech and Super Nano Acupuncture Needles Regulation Number: 880.5580 Regulation Name: Acupuncture needle Regulatory Class: II Product Code: MQX Dated: April 2, 2003 Received: May 12, 2003
Dear Ms. 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 - Ms. 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.
Suser Ruans
Susan Runner, DD, 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
K0310600
Page 4
510(k) Number (if known): K-
Device Name:
Nano Tech and Super Nano 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)
Patricia Ciuccute
(División Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number: K031060
or
Prescription Use _ (Per 21 CFR 801.109)
Over-The-Counter Use