(112 days)
For Russian, and High Volt:
- Relaxation of muscle spasms
- Prevention or retardation of disuse atrophy
- Increase local blood circulation
- Muscle re-education
- Maintaining or increasing range of motion
- Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis
For interferential and premodulated interferential:
- Symptomatic relief of chronic, intractable pain
- Management of pain associated with post-traumatic or post-operative conditions
For Ultrasound:
Application of therapeutic deep heat for the treatment of selected sub-chronic and chronic medical conditions such as:
- Pain Relief
- Reduction of muscle spasms
- Joint contractures
For TENS and EMS:
- Symptomatic relief and management of chronic intractable pain
- Adjunctive treatment in the management of post surgical and post traumatic acute pain condition
Ultrasound and Muscle Stimulator. Transcutaneous electrical nerve stimulator for pain relief, Powered muscle stimulator. Available as 2 channel stimulator, 4 channel stimulator, ultrasound, 2 channel stimulator with ultrasound, and 4 channel stimulator with ultrasound. Units are supplied with electrodes listed in 510(K) K050469, typically 2 x 2 inch. Units are supplied with a bottle of ultrasound coupling gel listed in 510(K) K012522, or similar gels already in the market.
Here's an analysis of the provided information regarding the acceptance criteria and study for the Sonic-Stim device:
Important Note: The provided document is a 510(k) summary and FDA clearance letter. These documents explicitly state "Non-clinical Testing: Not Applicable" and "Clinical Testing: Not Applicable." This means no specific clinical study was performed or required to demonstrate the device meets acceptance criteria in the traditional sense of a performance study with numerical endpoints. Instead, clearance was granted based on substantial equivalence to predicate devices.
Summary based on the provided document:
-
Table of Acceptance Criteria and Reported Device Performance:
Acceptance Criteria Reported Device Performance Comments Not specified in terms of numerical performance metrics. Not specified in terms of numerical performance metrics. The device was cleared based on substantial equivalence, implying its performance is considered comparable to existing legally marketed predicate devices (K031077 and K010749) for the stated indications for use. No specific quantifiable acceptance criteria (e.g., accuracy, sensitivity, specificity for a diagnostic device) or corresponding performance data are presented. -
Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not applicable. No clinical test set was used for performance evaluation in this 510(k) submission.
- Data Provenance: Not applicable.
-
Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable. No ground truth establishment by experts for a test set was conducted for this 510(k) submission.
-
Adjudication Method for the Test Set:
- Not applicable. No test set requiring adjudication was used.
-
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Was one done? No.
- Effect size: Not applicable.
-
Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study:
- Was one done? No. This device is a physical therapy device (ultrasound and stimulator), not an AI algorithm.
-
Type of Ground Truth Used:
- Not applicable. For a device like this, the "ground truth" for its function would typically be its ability to generate specific electrical stimulation waveforms and ultrasound frequencies/intensities, for which non-clinical engineering tests would be done. However, based on the document's explicit statement, these were also deemed "Not Applicable" for this 510(k) and likely covered by the predicate device's existing clearance or general safety and performance standards.
-
Sample Size for the Training Set:
- Not applicable. This is not an AI/machine learning device requiring a training set.
-
How the Ground Truth for the Training Set Was Established:
- Not applicable.
Explanation of the 510(k) Context:
This 510(k) submission for the Sonic-Stim device achieved clearance by demonstrating substantial equivalence to existing predicate devices (Chattanooga Group Vectra GENiSYS and Biomedical Life Science, QUADSTAR II). This means the FDA determined that the Sonic-Stim device has the same intended use and the same technological characteristics as the predicate devices, or if it has different technological characteristics, that the different characteristics do not raise different questions of safety and effectiveness, and that the device is as safe and effective as the predicate device.
Therefore, the "acceptance criteria" were met by showing:
- The same intended use as the predicates (e.g., relaxation of muscle spasms, pain relief, increased local blood circulation, etc.).
- Similar technological characteristics (Ultrasound and Muscle Stimulator).
- Compliance with general controls (e.g., manufacturing practices, labeling).
No de novo clinical or non-clinical performance studies were required for this specific 510(k) submission because the device was deemed to be substantially equivalent to devices already on the market with a long history of safe and effective use.
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K063135
Pag 1:2
5 2007
www.naimco.com
Plant: 888-549-4945 Fax: 423-648-7735
4120 South Creek F Chattanooga, TN 374
510(k) Summary
Submitter's Information:
Julie Creasman, Regulatory Affairs Manager NAlmco, Inc. 4120 South Creek Road Chattanooga, TN 37406
Ultrasound and Powered Muscle Stimulator
K031077 (Chattanooga Group Vectra GENiSYS) K010749 (Biomedical Life Science, QUADSTAR II)
890.5860 and 21 CFR 882.5890)
Ultrasound and Powered Muscle Stimulator (per 21 CFR
Phone: 888-549-4945 Fax: 423-648-7735
Date of Preparation:
Sonic-Stim
February 1, 2007
Common Name:
Proprietary Name:
Classification Name:
Predicate Device:
Description of Device:
Ultrasound and Muscle Stimulator. Transcutaneous electrical nerve stimulator for pain relief, Powered muscle stimulator. Available as 2 channel stimulator, 4 channel stimulator, ultrasound, 2 channel stimulator with ultrasound, and 4 channel stimulator with ultrasound.
Units are supplied with electrodes listed in 510(K) K050469, typically 2 x 2 inch.
Units are supplied with a bottle of ultrasound coupling gel listed in 510(K) K012522, or similar gels already in the market.
Intended Use:
For Russian, and High Volt
- Relaxation of muscle spasms ●
- Prevention or retardation of disuse atrophy .
- . Increase local blood circulation
- Muscle re-education .
- Maintaining or increasing range of motion ●
{1}------------------------------------------------
- Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis
For interferential and premodulated interferential
- Symptomatic relief of chronic, intractable pain ●
- Management of pain associated with post-traumatic or . post-operative conditions
Application of therapeutic deep heat for the treatment of selected sub-chronic and chronic medical conditions such as: Pain Relief . Reduction of muscle spasms . Joint contractures . For TENS and EMS Symptomatic relief and management of chronic . intractable pain . Adjunctive treatment in the management of post surgical and post traumatic acute pain condition Technological Comparison: Summary of the technological characteristics compare to the predicate devices. Labeling Comparison: Labeling of the device compares to that of predicate devices.
Non-clinical Testing: Not Applicable
.
For Ultrasound
- Clinical Testing: Not Applicable
- Conclusions: As provided in the Comparison and Standards sections, the Sonic-Stim device models have similar characteristics and are equivalent to models of the VECTRA GENISYS and the QUADSTAR II.
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Image /page/2/Picture/12 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and service. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", indicating the department's name and national affiliation. The seal is presented in black and white, emphasizing its official and formal nature.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
North American Industrial Manufacturing Company % Julie Creasman Regulatory Affairs Manager 4120 South Creek Road Chattanooga, TN 37406
್ನೆ ಮತ್ತು 5 2007
Re: K063135
Trade/Device Name: Sonic-Stim Regulation Number: 21 CFR 890.5860, 21 CFR 882.5890 Regulation Name: Ultrasound and muscle stimulator Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: IMG, GZJ, IPF, GZI. Dated: December 19, 2006 Received: December 28, 2006
Dear Ms. Creasman:
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
{3}------------------------------------------------
Page 2 - Ms. Julie Creasman
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), please contact the Office of Compliance at (240) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yo
full
Mark N. Melkerson, M.S. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Indications for Use
Image /page/4/Picture/1 description: The image shows a logo for "North American Industrial manufacturing company". The logo features the letters "NA" in a large, bold font, with a globe-like image above the letters. To the right of the letters "NA" are the letters "mco" in a smaller font.
4120 South Creek Chattanooga, TN 37 K063135
Device Name: Sonic-Stim
For Russian, and High Volt
- Relaxation of muscle spasms ●
- Prevention or retardation of disuse atrophy ●
- Increase local blood circulation .
- Muscle re-education .
- Maintaining or increasing range of motion ●
- Maintaining of incroacing range in the cles to prevent venous thrombosis
For interferential and premodulated interferential
- Symptomatic relief of chronic, intractable pain .
- Oymptomatio roller of essociated with post-traumatic or post-operative . conditions
For Ultrasound
Application of therapeutic deep heat for the treatment of selected sub-chronic and chronic medical conditions such as:
- Pain Relief .
- Reduction of muscle spasms .
- Joint contractures �
For TENS and EMS
- Symptomatic relief and management of chronic intractable pain .
- Adjunctive treatment in the management of post surgical and post . traumatic acute pain condition
| 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)
| Concurrence of CDRH, Office of Device Evaluation (QDE)Page 1 of ______ | (Division Sign-Off)Division of General, Restorative,and Neurological Devices |
|---|---|
| 510(k) Number | 1063136 |
§ 890.5860 Ultrasound and muscle stimulator.
(a)
Ultrasound and muscle stimulator for use in applying therapeutic deep heat for selected medical conditions —(1)Identification. An ultrasound and muscle stimulator for use in applying therapeutic deep heat for selected medical conditions is a device that applies to specific areas of the body ultrasonic energy at a frequency beyond 20 kilohertz and that is intended to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies. The device also passes electrical currents through the body area to stimulate or relax muscles.(2)
Classification. Class II (performance standards).(b)
Ultrasound and muscle stimulator for all other uses —(1)Identification. An ultrasound and muscle stimulator for all other uses except for the treatment of malignancies is a device that applies to the body ultrasonic energy at a frequency beyond 20 kilohertz and applies to the body electrical currents and that is intended for the treatment of medical conditions by means other than the generation of deep heat within body tissues and the stimulation or relaxation of muscles as described in paragraph (a) of this section.(2)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP for a device described in paragraph (b) of this section is required to be filed with the Food and Drug Administration on or before July 13, 1999 for any ultrasound and muscle stimulator described in paragraph (b) of this section that was in commercial distribution before May 28, 1976, or that has, on or before July 13, 1999, been found to be substantially equivalent to an ultrasound and muscle stimulator described in paragraph (b) of this section that was in commercial distribution before May 28, 1976. Any other ultrasound and muscle stimulator described in paragraph (b) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.