(31 days)
No
The device description and intended use are for a simple, sterile acupuncture needle. There is no mention of any computational or analytical capabilities, let alone AI/ML. The "Not Found" entries for AI/ML mentions, image processing, training/test sets, and performance studies further confirm the absence of such technology.
Yes.
The device is used in the practice of acupuncture, which is a therapeutic modality for treating various conditions.
No.
The device is described as an acupuncture needle, intended to pierce skin for the practice of acupuncture. There is no mention of it being used to identify, detect, or monitor a disease, condition, or health status.
No
The device description clearly states it is a physical acupuncture needle made of stainless steel and aluminum alloy, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "pierce skin in the practice of acupuncture." This is a therapeutic procedure performed directly on the patient's body.
- IVD Definition: In Vitro Diagnostics (IVDs) are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description clearly states the needle is used for "the practice of acupuncture" and the handle is used to "control the insertion of the needle." This reinforces its use in a direct therapeutic intervention, not for analyzing samples outside the body.
The information provided aligns with a device used for a medical procedure performed in vivo (within the living body), not in vitro (in glass, or outside the body).
N/A
Intended Use / Indications for Use
Carbo/Optimed brand acupuncture needles are intended to be used to pierce the skin in the practice of acupuncture (by qualified practitioner of acupuncture) as determined by the States.
This device is intended to pierce skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.
Product codes
MQX
Device Description
Carbo/Optimed brand acupuncture needles are sterile disposable needle for one time use only. The needle shaft/body is made of surgical grade stainless steel (as per ASTM specifications) and is used for the practice of acupuncture as determined by state. The handle is made of aluminium alloy, which does not enter the human body, but is used to control the insertion of the needle.
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 practitioner 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)
Tai-Chi Acupuncture needles (K003760), Addiquip Acupuncture needles (K981272)
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
Carbo Trading Co. Inc.
FEB 2 1 2003 4500 Sheppard Avenue East, Unit 1 Toronto, ON. MIS 3R6 Toll-Free: 1-800-370-9077 Fax: (416) 299-7003 Phone: (416) 299-6643 www.carbotrading.com
January 16, 2003
PREMARKET NOTIFICATION [510(K)] SUMMARY [As required by CFR 21 807.92(c)]
Submitter:
Suzhou Sen Sen Medical Supplies Limited Wu Xian New Development Zone 38 Shi Hu Road East Suzhou, Jiangsu. 215128 China Tel: (86) (512) 6564-5122 Fax: (86) (512) 6528-4420
Applicant:
Kevin Liu Carbo Trading Co. Inc. 4500 Sheppard Avenuc East Unit #1 Scarborough, ON. MIS 3R6 Canada Tel: (416) 299-6643 Fax: (416) 299-7003
Device Summary (a)(2):
Carbo/Optimed brand Acupuncture Needle Trade Name: Common or Usual Name: Acupuncture Needle Classification Name: Acupuncture Needle, Single Use Medical Speciality: General Hospital Device Class II MQX Product Code: Regulation Number: 880.5580
Substantial Equivalence (a)(3):
Carbo/Optimed brand acupuncture needle is substantially equivalent to acupuncture needles sold in the US market. It's design and intended use is SE to the following brand of acupuncture needles available in the US market:
| Tai-Chi Acupuncture needles | (K003760) |
|---|---|
| Addiquip Acupuncture needles | (K981272) |
... ...... continued on next page
PRE-MARKET NOTIFICATION [510(K)] SUBMISSION
1
Image /page/1/Picture/0 description: The image shows a logo with a stylized letter 'C' at the top and the word 'CARBO' at the bottom. The 'C' is formed by a thick, curved line, and a vertical line extends from the top of the 'C', piercing through the center. The word 'CARBO' is written in bold, block letters directly below the 'C' symbol.
Carbo Trading Co. Inc. 4500 Sheppard Avenue East, Unit 1
Toronto, ON. MIS 3R6 Fax: (416) 299-7003 Toll-Free: 1-800-370-9077 Phone: (416) 299-6643 www.carbotrading.com
January 16, 2003
PREMARKET NOTIFICATION [510(K)] SUMMARY [As required by CFR 21 807.92(c)]
Description (a)(4):
Carbo/Optimed brand acupuncture needles are sterile disposable needle for one time use only. The needle shaft/body is made of surgical grade stainless steel (as per ASTM specifications) and is used for the practice of acupuncture as determined by state. The handle is made of aluminium alloy, which does not enter the human body, but is used to control the insertion of the needle.
Intended Use (a)(5):
Carbo/Optimed brand acupuncture needles are intended to be used to pierce the skin in the practice of acupuncture (by qualified practitioner of acupuncture) as determined by the States.
Technological Characteristics (a)(6):
A Carbo/Optimed brand acupuncture needle has the same technological characteristics as the predicated devices described in paragraph (a)(3). Carbo/Optimed brand needles also comes in bulk packaging with 5 needles in one tube with a total of 500 needles per box, which is SE to Tai-Chi Acupuncture needles (K003760).
Assessment and Performance Data (b)(1)(2)(3):
Substantial equivalence is not based on an assessment of performance data.
Kevin Liu, Sales Manager
January 16, 2002 Date
PRE-MARKET NOTIFICATION [510(K)] SUBMISSION
Page 12
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 features a stylized eagle or bird symbol with three curved lines forming its body and head. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 1 2003
Suzhou Sen Sen Medical Supplies Limited C/O Mr. Kevin Liu Carbo Trading Company, Incorporated 4500 Sheppard Avenue East, Unit #1 Scarborough, Ontario MIS 3R6 CANADA
Re: K030190
Trade/Device Name: Carbo/Optimed Brand Acupuncture Needle Regulation Number: 880.5580 Regulation Name: Acupuncture Needle Regulatory Class: II Product Code: MQX Dated: January 16, 2003 Received: January 21, 2003
Dear Mr. Liu:
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. Liu
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 vour 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 Runires
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
Carbo Trading Co. Inc.
Image /page/4/Picture/2 description: The image shows a logo with the word "CARBO" written in bold, sans-serif font. Above the word, there is a stylized graphic that resembles the letters "C" and "D" connected together. A vertical line extends downward from the top of the "D", intersecting with the horizontal line connecting the "C" and "D".
4500 Sheppard Avenue East, Unit 1 Toronto, ON. M1S 3R6 Toronio, ON: MTD 2Ro
Phone: (416) 299-6643 Fax: (416) 299-7003 Toll-Free: 1-800-370-9077 www.carbotrading.com
Indication for Use Statement
This device is intended to pierce skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.
Patruu Cescenti
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection of Ancolnestology, Gene
510(k) Number: _