(68 days)
Not Found
Not Found
No
The provided text does not contain any keywords or descriptions related to AI or ML technology.
No
The device is intended to aid in the guidance of injections, not to treat a disease or condition itself. Therapeutic devices provide treatment, while this device supports a therapeutic procedure.
No
The device is intended to aid in the guidance of injections, which is a therapeutic rather than a diagnostic function. It helps deliver treatment, not diagnose a condition.
Unknown
The provided 510(k) summary lacks a device description, making it impossible to determine if the device is software-only or includes hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "aid in the guidance of injections into the muscles." This describes a device used in vivo (within a living organism) to assist a medical procedure.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. The device described here does not perform such tests on samples.
The device's function is related to guiding injections, which is a procedure performed directly on the patient, not on a sample outside the body.
N/A
Intended Use / Indications for Use
The Signal Amplifier for BOTOX® is intended to aid in the guidance of injections into the muscles.
Product codes
GWL
Device Description
Signal Amplifier for BOTOX®
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
muscles
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.1835 Physiological signal amplifier.
(a)
Identification. A physiological signal amplifier is a general purpose device used to electrically amplify signals derived from various physiological sources (e.g., the electroencephalogram).(b)
Classification. Class II (performance standards).
0
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.
1
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 (800) 638-2041 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
2
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
Page 1 of 1
§10(k) Number K051852