(303 days)
To pierce the skin in the practice of acupuncture by qualified practitioners as determined by the states.
The DN needle consists of a solid stainless steel needle with a copper wire wrapped around the stainless steel needle shaft. The copper wire acts as a handle which facilitates the delivery of acupuncture treatment by making the needles easier to manipulate and place. DN needles are sterile devices for single use only. The needles are made from 302 grade stainless steel meeting ASTM F899-84 standards. No lubricant is used on the needles.
The provided document describes a 510(k) premarket notification for the SEDATELEC DN Acupuncture Needles (K983800). This submission aims to demonstrate substantial equivalence to a predicate device, the CARBO MicroClean acupuncture needle (K961339), rather than presenting a performance study against specific acceptance criteria. Therefore, the information requested in the prompt regarding acceptance criteria, device performance, and a study proving said performance is largely not applicable in the context of this 510(k) submission.
Here's an breakdown based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
Not applicable in this 510(k) submission. The submission's goal is to establish substantial equivalence to a predicate device, implying that if the DN Acupuncture Needles are sufficiently similar to the legally marketed CARBO MicroClean acupuncture needle, they are presumed to be safe and effective. There are no specific performance criteria or a study demonstrating achievement of those criteria detailed in this document.
2. Sample Size Used for the Test Set and Data Provenance:
Not applicable. This is not a performance study involving a test set. The submission relies on a comparison table of device features to demonstrate equivalence.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable. No ground truth establishment by experts for a test set is described.
4. Adjudication Method for the Test Set:
Not applicable. No test set requiring adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This is not a comparative effectiveness study involving human readers or AI assistance.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:
Not applicable. This device is an acupuncture needle, not an algorithm or AI system.
7. The type of ground truth used:
Not applicable. No ground truth in the context of a performance study is mentioned. The "ground truth" in a 510(k) submission is effectively the established safety and effectiveness of the predicate device.
8. The Sample Size for the Training Set:
Not applicable. There is no training set mentioned as this is not a study involving machine learning or similar methodologies.
9. How the Ground Truth for the Training Set was Established:
Not applicable. As there is no training set, there is no corresponding ground truth establishment process.
Summary of Relevant Information from the Document (if interpreted for "equivalence" as the "criterion"):
The submission argues for substantial equivalence to the CARBO MicroClean acupuncture needle (K961339) based on the following:
- Identical Intended Use: Both devices are "Intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states."
- Similar Design Features:
- Device Type: Both are considered "DN Type" (DN Equivalent for the predicate).
- Needle Tip Shape: Both are "Taper."
- Needle Shape: Both are "Stylet."
- Biocompatibility: Both use "ASTM 302 surgical stainless steel" (Standard specifications for stainless steel billet, bar, and wire for surgical instruments F899-84).
- Similar Materials: The needle material is surgical stainless steel for both. The handle material differs (copper for the SEDATELEC device vs. silver-plated metal for the CARBO device), but this difference is not presented as affecting equivalence for the intended use.
- Labeling: Both have comparable labeling requirements for identification and statements (e.g., sterile, single use, lot number, manufacturer, gauge, length, quantity).
- Sterilization: Both are sterilized devices. The SEDATELEC needles are sterilized by Gamma radiation at a validated dose level of 25kGy to achieve a sterility assurance level of 10^-6, in accordance with ISO 11737-1, EN552, and ISO 11137 standards. The predicate's sterilization method is listed as "Ethylene oxide gas sterilization" in its labeling, which is a different method but both are acceptable for sterilization.
- Dimensions: While there are differences in the range of invasive lengths (SEDATELEC: 18-47mm; CARBO: 13-75mm) and diameters (SEDATELEC: 0.25-0.40mm; CARBO: 0.20-0.30mm), these variations are considered within acceptable limits for acupuncture needles and do not preclude substantial equivalence.
Conclusion stated in the document: "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."
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AUG 27 1999
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| This and the offer and the cases of the first and a see a commendent and many a commended to a long and consistence and consistence and consistence and consistence and consisCompany of Children Children Company of Children Company of Children Comments of Children Comments of Children | CONTRACT CARRETT OF CHEARTH & FREE PROPERTY & PRODUCT OF CHARGE OF CHARGE OF CHARGE OF CHARGE OF CHARGE OF CHARGE OF CHARGE OF CHARGE OF CHARGE OF CHARGE OF CHARGE OF CHARGE | |
| 1. | Device Name(s): | DN Acupuncture Needles |
|---|---|---|
| Common Name: | Acupuncture Needles | |
| Classification Name: | Needle, Acupuncture |
Establishment Name & Registration Number: 2.
| Name: | SEDATELEC |
|---|---|
| Number: | 8020802 |
21 CFR, § 880.5580 3. Classification: Device Class: Class II Classification Panel: General Hospital Product Code: MQX
4. Company Contact:
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
ક. Special Controls:
Special controls for this device type do not exist.
8. Substantially Equivalent Device(s):
Carbo Microclean acupuncture needle
7. Device Description:
The DN needle consists of a solid stainless steel needle with a copper wire wrapped around the stainless steel needle shaft. The copper wire acts as a handle which facilitates the delivery of acupuncture treatment by making the needles easier to manipulate and place. DN needles are sterile devices for single use only. The needles are made from 302 grade stainless steel meeting ASTM F899-84 standards. No lubricant is used on the needles.
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| Designation | Reference | D (diameter)mm | D (diameter)inch | L (total length)mm | L (total length)inch | I (invasive length)mm | I (invasive length)inch |
|---|---|---|---|---|---|---|---|
| DN 34.25 | 6321 (box of 100 needles)6323 (box of 400 needles) | 0,25 | .0098 | 34 | 1.34 | 18 | .708 |
| DN 34.30 | 6331(box of 100 needles)6333(box of 400 needles) | 0,30 | .0118 | 34 | 1.34 | 18 | .708 |
| DN 34.40 | 6341(box of 100 needles)6343 (box of 400 needles) | 0,40 | .0157 | 34 | 1.34 | 18 | .708 |
| DN 52.25 | 6521 (box of 100 needles)6523 (box of 400 needles) | 0,25 | .0098 | 52 | 2.05 | 30 | 1.18 |
| DN 52.30 | 6531 (box of 100 needles)6533 (box of 400 needles) | 0,30 | .0118 | 52 | 2.05 | 30 | 1.18 |
| DN 62.25 | 6621 (box of 100 needles)6623 (box of 400 needles) | 0,25 | .0098 | 62 | 2.44 | 39 | 1.53 |
| DN 62.30 | 6631(box of 100 needles)6633 (box of 400 needles) | 0,30 | .0118 | 62 | 2.44 | 39 | 1.53 |
| DN 72.30 | 6731 (box of 100 needies)6733 (box of 400 needles) | 0,30 | .0118 | 72 | 2.83 | 47 | 1.85 |
| DN 72.40 | 6741 (box of 100 needles)6743 (box of 400 needles) | 0,40 | .0157 | 72 | 2.83 | 47 | 1.85 |
DN needles are available in a variety of lengths and diameters:
Intended Use: To pierce the skin in acupuncture therapy by qualified practitioners as determined by the states.
Manufacturing Facility: SEDATELEC brand acupuncture needles are manufactured by Manufacturing i addition compliant medical device manufacturing facility located in France.
Sterilization/Re-sterilization: 8.
The needles are cleaned/disinfected and manufactured in a clean room meeting FED STD 209 E The needless are clounce with the US GMP requirements (QSR). The devices are supplied roquiremently in access only. Do not attempt to resterilize product once the package has been opened.
Sterlization method: The needles are sterilized by Gamma radiation at a validated dose level of 25kGy (kiloGray). The sterilization process is applied on finished devices to the 11407 packaging. The sterilization process is applied in accordance with EN552 and ISO 11137 standards by a qualified sterilizer. All contract sterilizers are registered by the FDA with a Drug Master File type I. Visual indicators and dosimeters are used to verify product sterility.
Validation method used to validate sterilization cycle: The radiation dose level has been validated to get the sterility assurance level of 10 in accordance with the ISO 11737-1 standard.
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Equivalency Comparison Table: 9.
| EquivalencyComparisonFeature | SEDATELECDN acupuncture needle | CARBO MicroClean acupunctureneedle |
|---|---|---|
| Device Type: | DN - Type | DN Equivalent |
| 510(k) number | K961339 | K961339 |
| Intended use: | Intended to pierce the skin in the practice of acupuncture by qualifiedpractitioners of acupuncture as determined by the states | |
| Invasive Length(mm) | From 18 to 47mm | From 13 to 75mm |
| Gauge (diameterin mm) | From 0.25 to 0.40mm | From 0.20 to 0.30mm |
| Needle Tip | Taper | Taper |
| Shape | ||
| Needle shape | Stylet | Stylet |
| Biocompatibility | ASTM 302 surgical stainless steel(Standard specifications for stainlesssteel billet, bar, and wire for surgicalinstruments F899-84) | Same |
| Materials | needle : surgical stainless steelhandle : copper | needle : surgical stainless steelhandle : silver plated metal |
| Labeling | IDENTIFICATIONManufacturer nameand addressProduct nameAcupuncture needlesGauge, lengthQuantityLot Number | IDENTIFICATIONManufacturer name and addressProduct nameAcupuncture needlesGauge, lengthQuantityLot NumberSTATEMENTS"STERILE""Sterile until""Ethylene oxide gas sterilization""For one time use only""Rx" statement"keep away from high temperature andhumidity""Do not use if needle package isbroken""Made in China" |
| STATEMENTS"STERILE""Use before""Sterilized by gamma radiation""For single use""Do not reuse"Rx" statement"Do not store at extreme temperaturesand humidity""Do not use if external package hasbeen damaged or blisters previouslyopened""Made in France" |
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.
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Image /page/3/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 image of an eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
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 Pleasant Hill, Caliornia 94523-3389
Re: K983800 DN Acupuncture Needles Trade Name: Requlatory Class: II Product Code: MQX July 8, 1999 Dated: 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, qood 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations 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) regulation (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
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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 deborizonf 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 requlation (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 the promotion 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 premarket notification" (21 CFR 807.97). 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
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Indications for Use:
Page 1
K 983800
Device Name(s):
510(k) Number:
DN 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)
Pastoria Cucerite
(Division Sign Off)
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 1983800
510(k) Number __4
Prescription Use ✓
(Per 21 CFR 801.109)
。
OR
Over-The Counter Use _________________________________________________________________________________________________________________________________________________________ (Optional format 1-2-96)
SEDATELEC DN Acupuncture Needle
§ 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.