SINGLE AMPLIFIER FOR BOTOX

K051852 · Allergan, Inc. · GWL · Sep 14, 2005 · Neurology

Device Facts

• Record ID: K051852
• Device Name: SINGLE AMPLIFIER FOR BOTOX
• Applicant: Allergan, Inc.
• Product Code: GWL · Neurology
• Decision Date: Sep 14, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1835
• Device Class: Class 2

Intended Use

The Signal Amplifier for BOTOX® is intended to aid in the guidance of injections into the muscles.

Device Story

Signal Amplifier for BOTOX® functions as a physiological signal amplifier; aids clinicians in guiding intramuscular injections. Device detects electrical signals from muscles to assist in needle placement. Used in clinical settings by physicians or qualified healthcare providers. Output provides feedback to the clinician to facilitate accurate injection of BOTOX® into target muscles, potentially improving therapeutic outcomes and reducing procedural errors.

Clinical Evidence

No clinical data provided; device cleared based on technological characteristics and intended use as a physiological signal amplifier.

Technological Characteristics

Physiological signal amplifier; Class II device; 21 CFR 882.1835; Product Code GWL. Designed for signal acquisition and amplification to assist in intramuscular injection guidance.

Indications for Use

Indicated for aiding in the guidance of injections into muscles for patients requiring BOTOX® treatment.

Regulatory Classification

Identification

A physiological signal amplifier is a general purpose device used to electrically amplify signals derived from various physiological sources (e.g., the electroencephalogram).

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Public Health Service

SEP 1 4 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Susan O'Brien Manager, Regulatory Affairs Allergan, Inc. 2525 Dupont Drive T2 2A Irvine, California 92612

Re: K051852

Trade/Device Name: Signal Amplifier for BOTOX® Regulation Number: 21 CFR 882.1835 Regulation Name: Physiological signal amplifier Regulatory Class: II Product Code: GWL Dated: July 7, 2005 Received: July 19, 2005

Dear Ms. O'Brien:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your boctor b re(s) fe device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure/to regars annent date of the Medical Device Amendments, or to comments provided in accordance with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA). and Cosmette Act (71ct) market the device, subject to the general controls provisions of the Act. The You may, therefore, market the device, sologe requirements for annual registration, listing of general controls provisions of use tice, 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 If your device is clussified (600 a0010) als. Existing major regulations affecting your device can may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Overnments concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I least be advised that I DT brissants of rour device complies with other requirements of the Act that I DA has made a acted regulations administered by other Federal agencies. You must of any I cach stututed and regaraments, including, but not limited to: registration and listing (21 Comply with an the Hec oreans 801); good manufacturing practice requirements as set CI I art 6077, adoming (21 CFR Part 820); and if applicable, the electronic 1000 1050 form in the quart) by ovisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2- Ms. Susan O'Brien

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to oegin manicaling of substantial equivalence of your device to a legally premarket nothleadon: The PDF mailing of casion 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), please If you desire specific advice for your as not 100 more at 100 mease note the regulation entitled, contact the Office of Complance at (210) = 16 = 21 = 1 Part 807.97). You may obtain Misolalling by Icrerchec to prenanto no no responsibilities under the Act from the Division of Small other gelleral information on your respense Assistance at its toll-free number [phone] or Manufacturers, Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

sincerely yours,

Barbara Gueldus

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K05185-2

## Indications for Use

510(k) Number: K051852

Device Name: Signal Amplifier for BOTOX®

Indications for Use:

The Signal Amplifier for BOTOX® is intended to aid in the guidance of injections into the muscles.

Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use _ (21 CFR 801 Subpart C)

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

Baudare Buchurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

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§10(k) Number K051852