(133 days)
As an NMES device, indications are for the following conditions:
- Retarding or preventing disuse atrophy
- Maintaining or increasing range of motion
- Re-educating muscles
- Relaxation of muscle spasms
- Increasing local blood circulation
- Prevention of venous thrombosis of the calf muscles immediately after surgery
As a TENS device, indications are for the following conditions:
- Symptomatic relief and management of chronic, intractable pain
- Adjunctive treatment for post-surgical and post-trauma acute pain
- Relief of pain associated with arthritis
As a Pulsed Current device, indications are for the following conditions:
- Reduction of edema (under negative electrode)
- Reduction of muscle spasm
- Influencing local blood circulation (under negative electrode)
- Retardation or prevention of disuse atrophy
- Facilitation of voluntary motor function
- Maintenance of increase of range of motion
As an FES device, the indications for the following condition:
- Stimulation of the leg and ankle muscles of partially paralyzed patients to provide flexation of the foot, thus improving the patient's GAIT.
Not Found
The provided text is a 510(k) summary for the Empi Continuum device, a powered muscle stimulator. It details the device's indications for use, classification, and substantial equivalence to predicate devices, along with regulatory compliance information. However, it does not contain information about any specific study that proves the device meets acceptance criteria related to its performance characteristics.
The document focuses on regulatory compliance and substantial equivalence, which is a key aspect of the 510(k) process. Substantial equivalence generally means that the new device is as safe and effective as a legally marketed predicate device. This often involves demonstrating that the new device has the same intended use and technological characteristics as the predicate, or that any differences do not raise new questions of safety and effectiveness.
Here's an breakdown of the requested information based on the provided text, and where the text is lacking:
Acceptance Criteria and Device Performance Study Information
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (Specific metrics, thresholds) | Reported Device Performance (Measurements, results) |
|---|---|---|
| Electrical Safety | Compliance with UL 60601-1: 2003, 1st Edition | Complies with UL 60601-1: 2003, 1st Edition |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2: 2001 +Amendment 1:2004, 2nd Edition | Complies with IEC 60601-1-2: 2001 +Amendment 1:2004, 2nd Edition |
| Nerve and Muscle Stimulator Safety | Compliance with IEC 60601-2-10: 1987 +Amendment 1:2001 | Complies with IEC 60601-2-10: 1987 +Amendment 1:2001 |
| Clinical Performance (e.g., efficacy for pain relief, muscle re-education, etc.) | Not provided in the document. | Not provided in the document, as no clinical performance study results are detailed. |
2. Sample size used for the test set and the data provenance
- Not provided. The document does not describe a clinical test set or the use of human subjects to evaluate device performance against specific clinical outcomes. The compliance mentioned relates to recognized consensus standards for safety and EMC, which typically involve laboratory testing, not human subject testing in the context of efficacy claims for de novo devices. For 510(k) submissions based on substantial equivalence, clinical data might not always be required if technological characteristics are sufficiently similar to predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not provided. No clinical test set requiring expert ground truth establishment is described in this document.
4. Adjudication method for the test set
- Not applicable/Not provided. No clinical test set is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable/Not provided. This device is a muscle stimulator, not an imaging device or an AI-powered diagnostic tool, so an MRMC study and AI assistance are not relevant to its stated functionalities.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not provided. This device is not an algorithm or an AI product; it's a physical medical device. Performance would be assessed based on its electrical output characteristics and clinical outcomes when applied to a patient, not through standalone algorithm performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable/Not provided for clinical claims. For the compliance declarations, the "ground truth" is defined by the technical specifications and test methodologies within the cited consensus standards (UL 60601-1, IEC 60601-1-2, IEC 60601-2-10). These standards themselves specify test conditions and acceptable ranges for various parameters (e.g., leakage current, electromagnetic emissions, output accuracy).
8. The sample size for the training set
- Not applicable/Not provided. As there is no AI/machine learning component described, there is no training set.
9. How the ground truth for the training set was established
- Not applicable/Not provided. As there is no AI/machine learning component described, there is no training set or ground truth for it.
Summary of Device Acceptance:
The acceptance of the Empi Continuum device, as described in this 510(k) summary, is primarily based on demonstrating substantial equivalence to legally marketed predicate devices and conformity to recognized safety and electromagnetic compatibility consensus standards. The document states:
- "The Empi Continuum devices comply with the following FDA recognized Consensus Standards:" followed by a list of UL and IEC standards for medical electrical equipment safety and EMC. This compliance is the "study" demonstrating that the device meets safety and compatibility "acceptance criteria" as defined by these standards.
- The FDA's review resulted in a determination that the device is "substantially equivalent... to legally marketed predicate devices." This substantial equivalence finding implies that the device's intended use and technological characteristics (including performance) are considered safe and effective in comparison to the predicates, and therefore acceptable for marketing. No specific clinical performance studies showing efficacy against distinct acceptance criteria are detailed, which is common for devices cleared through the 510(k) pathway leveraging substantial equivalence to well-established predicate technologies.
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510 (k) : K093324
MAR - 5 2010
Section 4: 510(k) Summary per 21 CFR 807.92
SUBMITTER:
Empi Inc. 205 Hwy 22 East Clear Lake, SD 57226
ESTABLISHMENT REGISTRATION: 1721293
CONTACT: Virginia L. Conger, Director of Quality and Regulatory
PROPRIETARY NAME: Empi Continuum
CLASSIFICATION: Class II
PRODUCT CODES: IPF, Powered muscle stimulator GZI, External functional neuromuscular GZJ, Transcutaneous electrical nerve LIH, Interferential current therapy NYN, Stimulator, electrical, transcutaneous, for arthritis
REGULATION NUMBER: 21 CFR 890.5850
PANEL:
Physical Medicine
Indications for Use:
As an NMES device, indications are for the following conditions:
- · Retarding or preventing disuse atrophy
- · Maintaining or increasing range of motion
- Re-educating muscles
- · Relaxation of muscle spasms
- Increasing local blood circulation
- Prevention of venous thrombosis of the calf muscles immediately after surgery
{1}------------------------------------------------
As a TENS device, indications are for the following conditions:
- Symptomatic relief and management of chronic, intractable pain
- Adjunctive treatment for post-surgical and post-trauma acute pain
- Relief of pain associated with arthritis
- As a Pulsed Current device, indications are for the following conditions:
- · Reduction of edema (under negative electrode)
- Reduction of muscle spasm
- Influencing local blood circulation (under negative electrode)
- · Retardation or prevention of disuse atrophy
- Facilitation of voluntary motor function
- · Maintenance of increase of range of motion
As an FES device, the indications for the following condition:
- Stimulation of the leg and ankle muscles of partially paralyzed patients to provide flexation of the foot, thus improving the patient's GAIT.
Substantially Equivalent Predicate Devices
| Predicate device(s): | 300PV Complete Electrotherapy System |
|---|---|
| 510(k) number: | K021100 |
| Date: | June 18, 2002 |
Additional Predicate Devices:
| Predicate device(s): | Empi SELECT TENS System |
|---|---|
| 510(k) number: | K061650 |
| Date: | February 22, 2007 |
| Predicate device(s): | REHABILICARE IF 3 WAVE INTERFERENTIAL STIMULATORSYSTEM |
|---|---|
| 510(k) number: | K050046 |
| Date: | April 13, 2005 |
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Declarations of Conformity
The Empi Continuum devices comply with the following FDA recognized Consensus Standards:
- UL 60601-1: 2003, Standards for Medical Equipment Part 1: General . Requirements for Safety, 1st Edition
- IEC 60601-1-2: 2001 +Amendment 1:2004, Medical Electrical Equipment Part . 1 – 2: General requirements for Safety - Collateral Standard, Electromagnetic Compatibility - Requirements and Tests, 2nd Edition
- IEC 60601-2-10: 1987 +Amendment 1:2001, Medical Electrical Equipment -. Part 2-10: Particular Requirements for the safety of nerve and muscle stimulator
Truthful and Accurate Statement
A statement attesting to the truthfulness and accuracy of the information was included in the premarket submission.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Empi, Inc. c/o Mr. Jo P. Chiu, MS, MBA Senior Regulatory Affairs Specialist Chattanooga Group 4717 Adams Road Hixson, TN 37343
MAR - 5 2010
Re: K093324
Trade/Device Name: EMPI Continuum Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF Dated: February 19, 2010 Received: February 24, 2010
Dear Mr. Chiu:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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Page 2 - Mr. Jo P. Chiu, MS, MBA
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Eile. Then, m k
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number: Ko93334
Device Name: Empi Continuum
Indications for Use:
As an NMES device, indications are for the following conditions:
- · Retarding or preventing disuse atrophy
- · Maintaining or increasing range of motion
- · Re-educating muscles
- · Relaxation of muscle spasms
- Increasing local blood circulation
- · Prevention of venous thrombosis of the calf muscles immediately after surgery
As a TENS device, indications are for the following conditions:
- · Symptomatic relief and management of chronic, intractable pain
- · Adjunctive treatment for post-surgical and post-trauma acute pain
- · Relief of pain associated with arthritis
As a Pulsed Current device, indications are for the following conditions:
- · Reduction of edema (under negative electrode)
- · Reduction of muscle spasm
- · Influencing local blood circulation (under negative electrode)
- · Retardation or prevention of disuse atrophy
- · Facilitation of voluntary motor function
- · Maintenance of increase of range of motion
- As an FES device, the indications for the following condition:
• Stimulation of the leg and ankle muscles of partially paralyzed patients to provide flexation of the foot, thus improving the patient's GAIT.
| Prescription Use(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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Tan L. Kawa
(Division Sign-Off) (Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K093324
§ 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).