(236 days)
For symptomatic relief and management of chronic, intractable pain, and adjunctive treatment in the management of post-surgical and posttraumatic pain.
The four Avazzia Biofeedback Electro-Stimulation Technology (BEST) devices are biofeedback, micro-current transcutaneous electro-stimulation devices for symptomatic relief and management of chronic, intractable pain, and adjunctive treatment in the management of post-surgical and post-traumatic pain. They are easy-to-use, handheld, AA battery-operated portable devices for use in the home or clinic.
The provided text is a 510(k) Summary for TENS devices (Body-Stim™, Biomodulator™, BEST-RSI™, BEST-Pro1TM). It states that the technological characteristics of these devices are the same as their predicate device, InterX5000 (K042912). The summary highlights software verification according to FDA guidance and conformity with IEC 60601-1 and EMC:IEC 60601-1-2 international safety standards. It also mentions a CE Mark for the devices.
However, the 510(k) summary does not contain the specific information requested about acceptance criteria and a study proving the device meets those criteria.
Here's why and what's missing:
- Acceptance Criteria and Reported Device Performance: This type of document, a 510(k) Summary, primarily focuses on demonstrating substantial equivalence to a predicate device. It typically does not include a table of detailed performance acceptance criteria and their corresponding reported values from a specific clinical or technical study. Instead, it relies on demonstrating that the new device's technological characteristics are equivalent to the predicate, and safety standards are met.
- Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Set): The document refers to "verification and validation tests" but provides no details about them. It does not describe:
- The sample size of any test set.
- The provenance of any data (e.g., country of origin, retrospective/prospective).
- The number or qualifications of experts used for ground truth.
- Any adjudication methods.
- Whether an MRMC or standalone study was performed, or any effect sizes.
- The type of ground truth used (e.g., pathology, outcomes data).
- The sample size of a training set or how its ground truth was established.
Conclusion:
Based on the provided 510(k) summary, it is not possible to complete the requested table or answer the specific questions regarding acceptance criteria and the details of a study proving the device meets those criteria. The document states that "verification and validation tests contained in this submission demonstrate that the submitted models are equivalent to the safety and effectiveness as that of the cleared devices," but it does not present the data or methodology of those tests in this summary.
To obtain this information, one would typically need to review the full 510(k) submission, not just the summary.
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510(k) Summary
Submitter's Identifications
Manufacturer and Sponsor Avazzia, Inc. 13154 Coit Rd., Ste 200 Dallas. TX 75240 USA Establishment Registration # 3004839404 Official Contact Person: Catherine Tone Date of Summary Preparation: April 17, 2007
Trade Names of Devices Body-Stim™, Biomodulator™, BEST-RSI™, BEST-Pro1TM
Common Name
TENS device
Classification
TENS 882.5890 Class II
Information of the 510(k) Cleared Devices (Predicate Devices)
InterX5000, K042912, 17/May/2005
Description and Intended Use
The four Avazzia Biofeedback Electro-Stimulation Technology (BEST) devices are biofeedback, micro-current transcutaneous electro-stimulation devices for symptomatic relief and management of chronic, intractable pain, and adjunctive treatment in the management of post-surgical and post-traumatic pain. They are easy-to-use, handheld, AA battery-operated portable devices for use in the home or clinic.
The technological characteristics of these devices, including waveforms, outputs, and biofeedback are the same as the InterX5000.
The software verification has been conducted according to the Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices - Guidance for Industry and FDA Staff - May 11, 2005.
A vazzia has received a CB Test Certificate certifying that these four devices, all accessories and lead wires were tested and found to be in conformity with IEC 60601-1:1988 + A1:1991 + A2: 1995 and EMC:IEC 60601-1-2 (ed. 2) international safety standards for TENS devices. See certificate in TAB 8.
Additionally, Avazzia has received a CE Mark in the TENS category for the four devices, all accessories and lead wires in this submission certifying that we meet the EC-Directive 93/42/EEC (TAB 8).
APR 3 0 2007
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| BEST-AV1 DevicesK062641Avazzia, IncApril 17, 2007MANAGE AND COLLECT OF CLAST OF CLAST OF CLAST OF CLAST OF CLAST OF CLAST OF CLAST OF CLAST OF CLAST OF CLAST OF CLAST OF CLEASE OF CLAST OF CLAST OF CLASS OF CALL OF CLAST OFLAND - AND - ANNOL CL -- A + -- A -- A -- A -- A -- A -- A -- A -- A -- A -- A -- A -- A -- A -- A -- A -- A -- A -- A -- A -- A -- A -- A -- A -- A -- A -- A -- A -- A -- A | |
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| -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | -- |
Conclusions
The devices have intended uses and technological characteristics that are substantially equivalent to the predicate device InterX5000 (K042912). Moreover, verification and validation tests contained in this submission demonstrate that the submitted models are equivalent to the safety and effectiveness as that of the cleared devices.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, represented by three curved lines that suggest wings and a body. The logo is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Avazzia Inc % Ms. Catherine Tone 13154 Coit Rd. Suite 200 Dallas. Texas 75240
APR 3 0 2007
Re: K062641
Trade/Device Name: Body-Stim, Biomodulator, Best-RSI, Best Pro, Model Best-AV 1 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: II Product Code: GZJ Dated: April 24, 2007 Received: April 20, 2007
Dear Ms. Tone:
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. Ilsting 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.
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Page 2 - Ms. Catherine Tone
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 yours,
Mark Markerson, M.S.
Mark Melkerson. Division Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use – Biomodulator™ and each of its modes
510(k) Number K062641 Device name: Biomodulator Modes:
Assess Ten-8 Infinity Automatic
Indications for use:
For symptomatic relief and management of chronic, intractable pain, and adjunctive treatment in the management of post-surgical and posttraumatic pain.
| Prescription Use | X | AND/OR | Over-The-Counter Use |
|---|---|---|---|
| (Part 21 CFR 801 Subpart D) | (21 CFR 801 subpart C) |
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
| 510(k) Number | K062691 |
|---|---|
| --------------- | --------- |
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Indications for Use – Body Stim™ and each of its modes
510(k) Number K062641 Device name: Body-Stim Modes: Relax RSI VASO Acute Trauma
Indications for use:
For symptomatic relief and management of chronic, intractable pain, and adjunctive treatment in the management of post-surgical and posttraumatic pain.
Prescription Use _ X ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Indications for Use – BEST-RSI™ and each of its modes
| 510(k) Number | K062641 |
|---|---|
| Device name: | BEST-RSI |
| Modes: | |
| Relax | |
| Deep Stimulation | |
| RSI |
Acute
Indications for use:
For symptomatic relief and management of chronic, intractable pain, and adjunctive treatment in the management of post-surgical and posttraumatic pain.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Indications for Use -- BEST-Pro 1 ™ and each of its modes
510(k) Number K062641 Device name: BEST-Pro 1 Modes: Assess Stimulation
Deep Stimulation Acute
Indications for Use:
For symptomatic relief and management of chronic, intractable pain, and adjunctive treatment in the management of post-surgical and posttraumatic pain.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).