DN ACUPUNTURE NEEDLES

K983800 · Sedatelec · MQX · Aug 27, 1999 · General Hospital

Device Facts

• Record ID: K983800
• Device Name: DN ACUPUNTURE NEEDLES
• Applicant: Sedatelec
• Product Code: MQX · General Hospital
• Decision Date: Aug 27, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5580
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

To pierce the skin in the practice of acupuncture by qualified practitioners as determined by the states.

Device Story

DN Acupuncture Needles consist of solid 302 grade stainless steel needles with copper wire handles; designed to facilitate needle manipulation and placement during acupuncture therapy. Used by qualified practitioners in clinical settings to pierce skin. Sterile, single-use devices; supplied in various lengths and diameters. Benefit includes providing a tool for acupuncture treatment. No lubricant used.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Materials: 302 grade stainless steel (ASTM F899-84) needle, copper wire handle. Dimensions: 18-47mm invasive length, 0.25-0.40mm diameter. Sterilization: Gamma radiation (25kGy) per ISO 11137 and EN552. Clean room manufacturing per FED STD 209 E. No software or electronic components.

Indications for Use

Indicated for use by qualified practitioners to pierce the skin in acupuncture therapy.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Carbo Microclean acupuncture needle (K961339)

Submission Summary (Full Text)

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K983800

AUG 27 1999

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| 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 : [phone] Fax : [phone]

## 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)<br>mm | D (diameter)<br>inch | L (total length)<br>mm | L (total length)<br>inch | I (invasive length)<br>mm | I (invasive length)<br>inch |
|-------------|--------------------------------------------------------|--------------------|----------------------|------------------------|--------------------------|---------------------------|-----------------------------|
| DN 34.25 | 6321 (box of 100 needles)<br>6323 (box of 400 needles) | 0,25 | .0098 | 34 | 1.34 | 18 | .708 |
| DN 34.30 | 6331(box of 100 needles)<br>6333(box of 400 needles) | 0,30 | .0118 | 34 | 1.34 | 18 | .708 |
| DN 34.40 | 6341(box of 100 needles)<br>6343 (box of 400 needles) | 0,40 | .0157 | 34 | 1.34 | 18 | .708 |
| DN 52.25 | 6521 (box of 100 needles)<br>6523 (box of 400 needles) | 0,25 | .0098 | 52 | 2.05 | 30 | 1.18 |
| DN 52.30 | 6531 (box of 100 needles)<br>6533 (box of 400 needles) | 0,30 | .0118 | 52 | 2.05 | 30 | 1.18 |
| DN 62.25 | 6621 (box of 100 needles)<br>6623 (box of 400 needles) | 0,25 | .0098 | 62 | 2.44 | 39 | 1.53 |
| DN 62.30 | 6631(box of 100 needles)<br>6633 (box of 400 needles) | 0,30 | .0118 | 62 | 2.44 | 39 | 1.53 |
| DN 72.30 | 6731 (box of 100 needies)<br>6733 (box of 400 needles) | 0,30 | .0118 | 72 | 2.83 | 47 | 1.85 |
| DN 72.40 | 6741 (box of 100 needles)<br>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.

| Equivalency<br>Comparison<br>Feature | SEDATELEC<br>DN acupuncture needle | CARBO MicroClean acupuncture<br>needle |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Type: | DN - Type | DN Equivalent |
| 510(k) number | K961339 | K961339 |
| Intended use: | Intended to pierce the skin in the practice of acupuncture by qualified<br>practitioners of acupuncture as determined by the states | |
| Invasive Length<br>(mm) | From 18 to 47mm | From 13 to 75mm |
| Gauge (diameter<br>in 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<br>(Standard specifications for stainless<br>steel billet, bar, and wire for surgical<br>instruments F899-84) | Same |
| Materials | needle : surgical stainless steel<br>handle : copper | needle : surgical stainless steel<br>handle : silver plated metal |
| Labeling | IDENTIFICATION<br>Manufacturer name<br>and address<br>Product name<br>Acupuncture needles<br>Gauge, length<br>Quantity<br>Lot Number | IDENTIFICATION<br>Manufacturer name and address<br>Product name<br>Acupuncture needles<br>Gauge, length<br>Quantity<br>Lot Number<br><br>STATEMENTS<br>"STERILE"<br>"Sterile until"<br>"Ethylene oxide gas sterilization"<br>"For one time use only"<br>"Rx" statement<br>"keep away from high temperature and<br>humidity"<br>"Do not use if needle package is<br>broken"<br><br>"Made in China" |
| | STATEMENTS<br>"STERILE"<br>"Use before"<br>"Sterilized by gamma radiation"<br>"For single use"<br>"Do not reuse<br>"Rx" statement<br>"Do not store at extreme temperatures<br>and humidity"<br>"Do not use if external package has<br>been damaged or blisters previously<br>opened"<br><br>"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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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:

- 1. 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