(133 days)
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Not Found
No
The provided 510(k) summary does not contain any mention of AI, ML, or related concepts like DNN, image processing, or training/test sets, which are typically associated with AI/ML-powered devices. The description focuses solely on the intended use and indications for a nerve and muscle stimulator.
Yes
The device is described as stimulating peripheral and motor nerves for pain relief and muscle rehabilitation, which falls under therapeutic uses.
No
The "Intended Use / Indications for Use" section describes the device's function as providing pain relief and muscle rehabilitation, which are therapeutic applications, not diagnostic ones.
Unknown
The provided text only includes the Intended Use/Indications for Use. Without a Device Description, it is 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/Indications for Use: The intended use clearly describes stimulating peripheral and motor nerves for pain relief and muscle rehabilitation. These are therapeutic applications performed on the patient's body.
- Definition of IVD: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This device does not involve the analysis of such specimens.
The device described is a type of neuromuscular electrical stimulator (NMES) or transcutaneous electrical nerve stimulator (TENS), which are external therapeutic devices, not IVDs.
N/A
Intended Use / Indications for Use
Stimulate peripheral nerves for the purpose of providing pain relief and to stimulate motor nerves for the purpose of muscle rehabilitation.
PAIN MANAGEMENT
- For adjunctive treatment of post-traumatic pain syndromes .
- For management and symptomatic relief of chronic (long-term) intractable . pain and inflammation
- As an adjunctive treatment the management of post-surgical pain . problems
MUSCLE STIMULATION
- Relaxation of Muscle Spasms ●
- Prevention or Retardation of Tissue Atrophy .
- Increasing Local Blood Circulation ●
- Muscle Re-education ●
- Immediate Post-Surgical Stimulation of Calf Muscles to prevent venous . thrombosis
- Maintaining or increasing range of motion .
Product codes
IPF, LIH and GXY
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(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 features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, U.S.A." is arranged in a circle around the caduceus symbol. The logo is black and white.
Public Health Service
JUL 2 8 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. James J. Gibson Axiom Worldwide, Inc. 9423 Corporate Lake Drive Tampa, FL 33634
Re: K050687
Trade/Device Name: Axiom EPS8000 with accessory electrodes Regulation Number: CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF, LIH and GXY Dated: July 22, 2005 Received: July 25, 2005
Dear Mr. Gibson:
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 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) 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 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.
1
Page 2 -- Mr. James J. Gibson
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), please contact the Office of Compliance at (240) 276-_. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Hypt Ruvdu
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known): K050687
Device Name: Axiom EPS8000
INDICATIONS FOR USE
Stimulate peripheral nerves for the purpose of providing pain relief and to stimulate motor nerves for the purpose of muscle rehabilitation.
PAIN MANAGEMENT
- For adjunctive treatment of post-traumatic pain syndromes .
- For management and symptomatic relief of chronic (long-term) intractable . pain and inflammation
- As an adjunctive treatment the management of post-surgical pain . problems
MUSCLE STIMULATION
510(k) Number_
- Relaxation of Muscle Spasms ●
- Prevention or Retardation of Tissue Atrophy .
- Increasing Local Blood Circulation ●
- Muscle Re-education ●
- Immediate Post-Surgical Stimulation of Calf Muscles to prevent venous . thrombosis
- Maintaining or increasing range of motion .
| Prescription Use
| (Part 21 CFR 801 Subpart D) | X |
|---|---|
| ------------------------------------------------- | --- |
AND/OR
| Over-The-Counter Use
| (21 CFR 801 Subpart C) | |
|---|---|
| ------------------------------------------------ | -- |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
DRH Office of Device Evaluation (ODE) (Division Sign-Off) Page 1 of Division of General, Restorative, ano > arological Devices