(87 days)
K-970254
Not Found
No
The summary describes a simple, sterile, disposable acupuncture needle and explicitly states that AI, DNN, or ML were not found in the description.
Yes
A therapeutic device is one used for treatment or diagnosis. Acupuncture needles are used in the practice of acupuncture to treat various conditions, thus fitting the definition of a therapeutic device.
No
The device description and intended use indicate that these are acupuncture needles used to pierce the skin for therapeutic purposes in the practice of acupuncture. There is no mention of the device being used to identify, measure, or monitor a medical condition, disease, or injury.
No
The device description clearly states it is a physical acupuncture needle, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that these acupuncture 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 samples taken from the body (like blood, urine, or tissue).
- Device Description: The description details a physical needle used for insertion, not a reagent, instrument, or system intended for the examination of specimens.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Providing information about a patient's health status, diagnosis, or disease.
- Using reagents or analytical methods.
Based on the provided information, this device is a medical device used for a therapeutic procedure (acupuncture), not an in vitro diagnostic device.
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
MQX
Device Description
DBC Press Acupuncture Needles are small, sterile disposable, surgical s/steel, press type acupuncture needles. The 2.0 mm dia ring handle is continous with the 1.0 mm or 1.5 mm long needle body. These needles are supplied in sealed packages on polystyrene plastic holders.
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
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)
K-970254
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
JUL 15 2003
LHASA MEDICAL, INC.
234 Libbey Parkway, Weymouth, MA 02189 (or fax: 781-335-6296)
April 17, 2003
Page ба
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 17, 2003 |
| (a)(2) | |
| Device Trade Name: | DBC Press 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:
SEIRIN Pyonex Press Acupuncture Needles K-970254
....... continued on next page
1
LHASA MEDICAL, INC.
234 Libbey Parkway, Weymouth, MA 02189 (781) 340-1071 fax: 781-659-9916 (or fax: 781-335-6296)
April 17, 2003
Page 6b
PRE-MARKET NOTIFICATION 510(k) SUMMARY ..... continued from previous page
(a)(4) Description
Description of DBC Press Acupuncture Needles.
DBC Press Acupuncture Needles are small, sterile disposable, surgical s/steel, press type acupuncture needles. The 2.0 mm dia ring handle is continous with the 1.0 mm or 1.5 mm long needle body. These needles are supplied in sealed packages on polystyrene plastic holders.
(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
DBC Press Acupuncture Needles are used in the same manner and have the same technological characteristics as the predicate device(s) identified in paragraph (a)(3). These needles use the same needle body lengths and gauges (needle thickness); handle design; method of insertion; and use the same packaging methods as these predicate devices.
(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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the department's name encircling an abstract symbol. The symbol resembles an eagle or bird in flight, composed of three stylized human profiles. The text is arranged around the top half of the circle, with the bird symbol taking up the central space.
Public Health Service
JUL 1 5 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Kyung P. Riihimaki President LHASA MEDICAL, Incorporated 234 Libbey Parkway Weymouth, Massachusetts 02189
Re: K031250
Trade/Device Name: DBC Press Acupuncture Needles Regulation Number: 880:5580 Regulation Name: Acupuncture Needles Regulatory Class: II Product Code: MQX Dated: June 11, 2003 Received: June 13, 2003
Dear: 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 - 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 (OS) 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 vours.
Susan Rainier
Susan Runner, DDDS. 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
K03125Ω
510(k) Number (if known): K-
Device Name:
DBC Press 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)
Paltur Cucente
(Division Sign-On)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number. K031250
Or
Prescription Use _ (Per 21 CFR 801.109)
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________