SINGER ACUPUNCTURE NEEDLES

K974616 · Lorac, Inc. · MQX · Feb 5, 1998 · General Hospital

Device Facts

• Record ID: K974616
• Device Name: SINGER ACUPUNCTURE NEEDLES
• Applicant: Lorac, Inc.
• Product Code: MQX · General Hospital
• Decision Date: Feb 5, 1998
• 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 of acupuncture as determined by the states.

Device Story

Singer Acupuncture Needles are sterile, single-use devices designed for acupuncture therapy. The device consists of a stainless steel shaft and a color-coded polystyrol handle. Used by qualified acupuncture practitioners in clinical settings to pierce the skin. The device functions as a manual instrument; no electronic or automated components are involved. The needles are intended to provide a safe, sterile method for acupuncture, minimizing risks associated with reuse. Clinical benefit is derived from the practitioner's ability to perform acupuncture procedures with a sterile, single-use tool.

Clinical Evidence

Bench testing and user testing were performed to verify safety and effectiveness. No clinical trial data was required or provided.

Technological Characteristics

Materials: Stainless steel shaft, polystyrol handle. Form factor: Color-coded needle. Energy source: None (manual). Sterilization: Sterile, single-use.

Indications for Use

Indicated for use by qualified acupuncture practitioners to pierce the skin for 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

• Seirin Acupuncture needles (K962809)
• Lhasa Acupuncture needles (K962916)

Submission Summary (Full Text)

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K 974616

## EXHIBIT 2

- 5 1998

Lorac, Inc. 134 North Washington Naperville, IL 60540 Tel 1+630-548-4456 Fax 1+630-548-4457 Contact: Sandra Sobczak, President November 26, 1997

## 510(k) Summary of Safety and Effectiveness as required by 21 CFR 807.93

- 1. Identification of the Device: Proprietary-Trade Name: Singer Acupuncture Needles, Single Use, Sterile. Classification Name: NEEDLE, ACUPUNCTURE, SINGLE USE Common/Usual Name:, ACUPUNCTURE NEEDLE, SINGLE USE
- 2. Equivalent legally marketed devices: These products are similar in design and function to: Seirin Acupuncture needles, K962809 and Lhasa Acupuncture needles, K962916.
- 3. Indications for Use (intended use): To pierce the skin the practice of acupuncture by qualified practitioners as determined by the states.
- 4. Description of the Device: The needles are sterile, for single use only. They have a stainless steel shaft and a polystyrol handles are color coded for size.
- 5. Safety and Effectiveness, comparison to predicate device. The results of bench and user testing indicates that the new devices are as safe and effective as the predicate devices. Materials used in their manufacture are the same as used by predicate devices. The needles are equivalent to those which were in distribution in the United States prior to 1976, but are now sterile and for single use only. In the 30+ years that acupuncture needles have been in use in the United States, we are not aware of any serious or life-threatening accidents involving acupuncture needles.

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Image /page/1/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 5 1998

Ms. Sandra Sobczak President Lorac, Incorporated 134 North Washington Street Naperville, Illinois 60540

Re : K974616 Singer Acupuncture Needles Trade Name: Requlatory Class: II Product Code: MOX Dated: December 5, 1997 December 11, 1997 Received:

Dear Ms. Sobczak:

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 Title 21, Parts 800 to 895. Federal Requlations, ਉ substantially equivalent determination assumes_compliance with_ the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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

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Page 2 - Ms. Sobczak

through 542 of the Act for devices under the Electronic enroduct Radiation Control provisions, or other Federal laws or requlations.

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 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.fdp.gov/cdrh/dsmamain.html".

Sincerely yours

Timothy A. Ulatowski

Directo Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K9746/6

i) Indications for Use

510(k) Number__K974616

Device Name: Singer Acupuncture Needles (single use, sterile)

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Der and General Ha 510(k) Numb Over the Counter Use_ OR Prescription Use_ (Per 21 CFR 801.109)