(303 days)
Not Found
No
The device description and intended use are purely mechanical and do not mention any computational or analytical capabilities. The "Mentions AI, DNN, or ML" field is explicitly "Not Found".
Yes
The device is described as an "acupuncture needle" used to "facilitate the delivery of acupuncture treatment." Acupuncture is a therapeutic modality, making the device used for this purpose a therapeutic device.
No
The device description and intended use indicate it is an acupuncture needle for treatment, not for diagnosing conditions.
No
The device description clearly describes a physical needle and injector, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics 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 Function: The described device is an acupuncture needle used to pierce the skin for therapeutic purposes. It does not analyze any biological specimens.
- Intended Use: The intended use is for "piercing the skin in the practice of acupuncture," which is a treatment modality, not a diagnostic process.
Therefore, based on the provided information, this device clearly falls outside the definition and function of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
"To pierce the skin in the practice of acupuncture by qualified practitioners as determined by the states."
Product codes
MQX
Device Description
"ASP Type needles consists of a short "tack-like" solid stainless steel needle contained in a plastic injector to introduce the needle in the epidermis, to facilitate the delivery of acupuncture treatment. ASP needles are sterile devices for single use only. The "ASP Gold needle" is an "ASP needle" which has been gold plated (an intermediate laver of copper is added between stainless steel and gold). The ASP needles are offered in a single size."
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"
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)
K970254 (SEIRIN - S, SEIRIN - PIONEX acupuncture needles)
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
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| 1. | Device Name(s): | ASP - Acupuncture Needles |
|---|---|---|
| Common Name: | Acupuncture Needles | |
| Classification Name: | Needle, Acupuncture |
-
- Establishment Name & Registration Number: SEDATELEC Name: Number: 8020802
-
- Classification: 21 CFR, § 880.5580 Device Class: Class II Classification Panel: General Hospital Product Code: MQX
Company Contact: 4.
Miss Tonia Courant SEDATELEC Tel : (+33) 4 72 66 33 22 Fax : (+33) 4 78 50 89 03
Submission Correspondent:
Mr. David W. Schlerf Buckman Company, Inc. 200 Gregory Lane, Suite C-100 Pleasant Hill, CA 94523-3389 925.356.2640 - 925.356.2654 - fax
5. Special Controls:
Special controls for this device type do not exist.
8. Substantially Equivalent Device(s):
Seirin - S & Seirin - Pionex acupuncture needles.
7. Device Description:
ASP Type needles consists of a short "tack-like" solid stainless steel needle contained in a plastic injector to introduce the needle in the epidermis, to facilitate the delivery of acupuncture treatment. ASP needles are sterile devices for single use only. The "ASP Gold needle" is an "ASP needle" which has been gold plated (an intermediate laver of copper is added between stainless steel and gold). The ASP needles are offered in a single size.
Intended Use: To pierce the skin in the practice of acupuncture by qualified practitioners as determined by the states.
Manufacturing Facility: ASP acupuncture needles are manufactured by SEDATELEC a registered, ISO compliant medical device manufacturing facility located in France.
1
Sterllization/Re-sterilization: 8.
The ASP needle are cleaned/disinfected and manufactured in a clean room meeting FED STD 209 E requirements) in accordance with the US GMP requirements (QSR). The devices are supplied sterile and are single use only. No attempt should be made to resterilize the product.
Sterilization method: ASP needles are sterilized by Gamma radiation at a validated dose level of 25kGv (kiloGray). The sterilization process is applied on finished devices following final packaging. The sterilization process is applied in accordance with EN552 and ISO 11137 standards by a qualified sterilizers are registered by the FDA with a Drug Master File type I. Visual indicators and dosimeters are used to verify product sterility. The radiation dose has been validated to get the sterility assurance level of 10° in accordance with the ISO 11737-1 standard.
| Equivalency
Comparison
Feature | SEDATELEC
ASP & ASP Gold acupuncture
needles | SEIRIN - S
SEIRIN - PIONEX acupuncture needles |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Type: | Tack | Tack |
| 510(k) number | | K970254 |
| Intended use: | Intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states | Intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states |
| Invasive Length (mm) | 2.1mm | From 15 to 50mm
From 1.5 to 1.8 mm |
| Gauge (diameter in mm) | 0 to 0.7 mm | From 0.22 to 0.26mm
From 0.20 to 0.35mm |
| Needle Tip Shape | Taper | Taper |
| Needle shape | Harpoon shape | Stylet
Thumbtack shape |
| Biocompatibility | ASTM 430F surgical stainless steel (Standard specifications for stainless steel billet, bar, and wire for surgical instruments F899-84) | Same |
| Materials | needle: surgical
stainless steel (+ a copper layer and a gold
layer for ASP Gold) | needle : surgical stainless steel
handle : plastic |
| Labeling | IDENTIFICATION
Manufacturer name and address
Product name
Acupuncture needles
Quantity
Lot Number
STATEMENTS
"STERILE"
"Use before"
"Sterilized by gamma radiation"
"For single use"
"Do not reuse"
"Rx" statement
"Do not store at extreme temperatures and
humidity"
"Do not use if external package has been
damaged or blisters previously opened"
"Made in France" | IDENTIFICATION
Manufacturer name and address
Product name
Acupuncture needles
Gauge, length
Quantity
Lot Number
STATEMENTS
"STERILE"
"EXPIRY"
"Sterilized with Ethylene oxide gas"
"For single use only"
"Rx" statement
"Do not store at extreme temperatures and
humidity"
"Do not use if package is previously opened or
damaged
"Made in Japan" |
9. Equivalency Comparison Table:
Based on the design, function, intended use and materials of the DN Needles, substantial equivalence is evident. The referenced CARBO brand needles are functionally identical. The anticipated safety and effectiveness of both devices is or may be expected to be the same.
SEDATELEC ASP Needles
2
Public Health Service
Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The text is in all capital letters and is in a sans-serif font.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 27 1999
SEDATELEC C/O Mr. David W. Schlerf Buckman Company, Incorporated 200 Gregory Lane, Suite C-100 94523-3389 Pleasant Hill, Caliornia
Re : K983798 ASP Acupuncture Needles Trade Name: Requlatory Class: II Product Code: MQX Dated: July 8, 1999 Received: July 12, 1999
Dear Mr. Schlerf
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of
3
Page 2 - Mr. Schlerf
the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 markeed problems, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on compriation and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to che regulation chereida, "MaxPanding II" other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
Page 1 of of 1 ---------
K 983798
Device Name(s):
:510(k) Number:
ASP - Acupuncture Needles
Indications for Use:
To pierce the skin in the practice of acupuncture by qualified practitioners as determined by the states.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY Concurrence of CDRH, Office of Device Evaluation (ODE)
Pallace Crescenti
Division Sign Off
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 4983798 510(k) Number _
| Prescription Use | ✓ |
|---|---|
| (Per 21 CFR 801.109) |
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (Optional format 1-2-96)
SEDATELEC ASP Needles