ACUSTIM

K014273 · S.H.P. Intl. Pty., Ltd. · BWK · Jun 12, 2002 · NE

Device Facts

• Record ID: K014273
• Device Name: ACUSTIM
• Applicant: S.H.P. Intl. Pty., Ltd.
• Product Code: BWK · NE
• Decision Date: Jun 12, 2002
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Indications for Use

The intended use of the ACUSTIM is for use as an ELECTRO-ACUPUNCTURE DEVICE. It can be used by a Physician administering to his patients, or by a patient. It is a prescription device and should be used under continued medical supervision. It does not have curative value but stimulates appropriate auricular acupuncture points. It cannot be used transcerebrally, in the carotid sinus area or during pregnancy.

Device Story

ACUSTIM (also referred to as ACUSLIM) is a portable, battery-powered electro-acupuncture device. It delivers low-level electrical pulses to the outer ear via two electrodes: one gold electrode and one adhesive conductive electrode. The device is operated by a physician or a patient under medical supervision. The user adjusts pulse strength via a control button. The device functions by stimulating auricular acupuncture points to provide non-curative stimulation. It is intended for use in clinical or home settings under continued medical supervision.

Clinical Evidence

Clinical evidence includes a pilot study conducted in a medical practice environment and a double-blind study performed under the University of Adelaide General Practice Department. Bench testing was conducted according to AAMI Standard Transcutaneous Electrical Nerve Stimulators NS4-1985.

Technological Characteristics

Portable battery-powered device using four 1.5V batteries. Emits low-level electrical pulses with a rectangular waveform. Electrodes consist of one gold electrode and one adhesive conductive electrode. Complies with AAMI NS4-1985 standards for transcutaneous electrical nerve stimulators.

Indications for Use

Indicated for stimulation of auricular acupuncture points in patients under medical supervision. Contraindicated for transcerebral use, carotid sinus area, and during pregnancy.

Predicate Devices

• ACUPLUS (K954334)

Submission Summary (Full Text)

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JUN 1 2 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dr. Dean Richards S.H.P. International Pty. Ltd. 5/212 Glen Osmond Road Fullarton, S.A. Australia 5063

Re: K014273 Trade/Device Name: ACUSTIM Regulation Name: Electro-Acupuncture Regulatory Class: Unclassified Product Code: BWK Dated: March 18, 2002 Received: March 29, 2002

Dear Dr. Richards:

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 for abound in the 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.

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

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Page 2 - Dr. Dean Richards

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 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Sincerely yours,

Mark N. Millman

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page of

510(k) Number (if known): 长۵14273

Device Name:_

Indications For Use:

The intended use of the ACUSTIM is for use as an ELECTRO-ACUPUNCTURE DEVICE.

It can be used by a Physician administering to his patients, or by a patient.

It is a prescription device and should be used under continued medical supervision.

It does not have curative value but stimulates appropriate auricular acupuncture points.

It cannot be used transcerebrally, in the carotid sinus area or during pregnancy.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N. Millman

(Division Sign-Off) (Division of General, Restorative and Neurological Devices

510(k) Number

(Optional Format 3-10-98)

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ACUSLIM 510(k) Notification Page R

Koj4/273

## 510(K) SUMMARY

Submitters Information:

S.H.P. International Pty. Ltd 5/212 Glen Osmond Road Fullarton, S.A., 5064 Australia

6/12/02

Contact Person:

Dr. Dean Richards Telephone: [phone]

August 15, 2001

Device Name:

Date Summary Prepared:

Proprietary Name: Common or usual name: Classification name:

ACUSLIM

Portable transcutaneous electrical nerve stimulator. Transcutaneous electrical nerve stimulator, Class II, 882.5890.

Legally marketed device for substantial equivalence comparison: ACUPLUS K954 334.

## Description of the Device:

The device consists of a battery powered portable instrument, with a basic power pack which is connected by conducting wires to two electrodes which make contact with the skin of the outer ear of the patient.

Switching the unit on generates low level electrical pulses the strength of which are controlled by the treatment strength control button.

## Technological Characteristics:

ACUSLIM uses four 1.5 volt batteries as does the ACUPLUS. Both devices have similar electrical outputs and frequency and use a rectangular waveform.

Whereas the ACUPLUS has one gold electrode and a stainless steel grounding electrode, the ACUSLIM has a positive output from a gold electrode and a negative output from an adhesive conductive electrode using the same conductive adhesive gel as is common to most TENS devices.

## Performance Data:

Applicable performance testing criteria from the AAMI Standard Transcutaneous Electrical Nerve Stimulators NS4-1985, were applied.

Clinical testing results both as a pilot study in a medical practice environment, and a double blind study under the University of Adelaide General Practice Department are included in the 510k.

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