(422 days)
The Aptiva™ v2.13U is a multifunctional transcutaneous electrical nerve stimulator (TENS) equipped with a surface electromyography and electroneurography.
Aptiva™ is indicated for symptomatic relief and management of chronic pain, intractable pain and/or as an adjunctive treatment for the management of post-traumatic pain.
The dynamic surface electromyography and electroneurography system is used for biofeedback, relaxation training, and muscle re-education as well as monitoring and display of bioelectric signals produced by muscles, stimulate peripheral nerves, and monitor and display the electrical activity produced by nerves.
The Aptiva™ v2.13U consists of a console on a mobile floor stand, power cord, battery charger, patient remote control, cables, and Manuals (User and Application). The Aptiva™ v2.13U is provided in four functional models (Ballet, Flamenco, Hip-Hop, and Jazz). EMG features are provided in the Ballet and Hip Hop models. One version of the Ballet model (Option Etoile) includes electroneurography (ENG) functions and a printer. Aptiva™ v2.13U uses commercially available electrodes. Models designated "Light" versions do not include the full treatment databases.
The provided text describes a 510(k) summary for the Lorenz Biotech Aptiva™ v2.13U device. This document focuses on demonstrating substantial equivalence to predicate devices and detailing the device's intended use and technological characteristics.
Regarding your request for acceptance criteria and a study proving the device meets them, the provided text does NOT contain information about specific performance acceptance criteria for diagnostic accuracy, sensitivity, specificity, or other clinical performance metrics, nor does it detail a study that evaluates these metrics in a clinical context.
Instead, the "PERFORMANCE TESTING" section states: "Testing included in this premarket notification includes electrical safety, electromagnetic compatibility, and design verification and validation testing. No materials of the Aptiva™ v2.13U are in direct contact with treatment sites and therefore no biocompatibility testing was provided. Test results demonstrate that the Aptiva™ v2.13U fulfills the prospectively defined performance specifications."
This indicates that the performance testing focused on engineering and safety specifications, not clinical efficacy or diagnostic accuracy as would be assessed in a study with a test set, ground truth, and expert readers. The 510(k) process for this type of device often relies on demonstrating substantial equivalence to legally marketed predicate devices based on technological characteristics and intended use, rather than conducting new clinical effectiveness studies for each submission.
Therefore, I cannot fulfill most of your request based on the provided text.
Here's what I can provide based on the information given, and where most of your requested points cannot be answered:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Type | Reported Device Performance/Testing |
|---|---|
| Clinical Performance (e.g., diagnostic accuracy, sensitivity, specificity) | Not reported. The document does not provide clinical performance metrics. The submission focuses on substantial equivalence based on intended use, indications for use, operational characteristics, and fundamental technological characteristics, and safety/engineering testing. |
| Electrical Safety | "Test results demonstrate that the Aptiva™ v2.13U fulfills the prospectively defined performance specifications." (Specific criteria and results not detailed in the summary.) |
| Electromagnetic Compatibility | "Test results demonstrate that the Aptiva™ v2.13U fulfills the prospectively defined performance specifications." (Specific criteria and results not detailed in the summary.) |
| Design Verification & Validation | "Test results demonstrate that the Aptiva™ v2.13U fulfills the prospectively defined performance specifications." (Specific criteria and results not detailed in the summary. This likely refers to engineering design and functional testing against internal specifications, not clinical performance.) |
| Biocompatibility | "No biocompatibility testing was provided." (Justified by no direct patient contact with materials.) |
The following information cannot be provided as it is not present in the given text:
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Adjudication method (e.g. 2+1, 3+1, none) for the test set
- 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
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The sample size for the training set
- How the ground truth for the training set was established
The Aptiva™ v2.13U is a Transcutaneous Electrical Nerve Stimulator (TENS) and EMG/ENG device, which are typically cleared through 510(k) based on established safety and performance standards for electrical devices and substantial equivalence, rather than extensive clinical studies for diagnostic accuracy that would involve a "test set" and "ground truth" in the way described for, for example, an AI imaging device.
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510(k) Summary Lorenz Biotech S.p.A Aptiva™ v2.13U
1. SPONSOR
AUG 2 4 2007
Lorenz Biotech S.p.A. Via Statale 12, 109/B/C 41036 Medolla Italy
| Contact Person: | Mr. Riccardo Isani |
|---|---|
| Email address: | Riccardo.isani@lorenzbiotech.it |
| Date Prepared: | August 6, 2007 |
2. DEVICE NAME
| Proprietary Name: | Aptiva™ v2.13U |
|---|---|
| Common/Usual Name: | Transcutaneous nerve stimulator (TENS)Biofeedback deviceElectromyography device (EMG)Nerve conduction velocity measurement device |
| Classification Name: | Transcutaneous nerve stimulator (TENS)Biofeedback deviceElectromyography device (EMG)Nerve conduction velocity measurement device |
3. PREDICATE DEVICES
| Functionality | Predicate Device |
|---|---|
| TENS | • Apex Medical Digital TENS (K021755) |
| • GEMS-HV TENS (K032994) | |
| • Bioscope SD TENS (K970249) | |
| • Promax TENS (K022405) | |
| • NeuroTrain III (K003433) | |
| Electromyography (EMG)/Biofeedback | • EMG Retrainer Dual Channel (K972487) |
| • MES-9000/EMG System (K013399) | |
| • Synergy System (K981405) | |
| Nerve conduction velocity (ENG) | Brevio (K010269) |
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4. DEVICE DESCRIPTION
The Aptiva™ v2.13U consists of a console on a mobile floor stand, power cord, battery charger, patient remote control, cables, and Manuals (User and Application). The Aptiva™ v2.13U is provided in four functional models (Ballet, Flamenco, Hip-Hop, and Jazz). EMG features are provided in the Ballet and Hip Hop models. One version of the Ballet model (Option Etoile) includes electroneurography (ENG) functions and a printer. Aptiva™ v2.13U uses commercially available electrodes. Models designated "Light" versions do not include the full treatment databases.
5. INTENDED USE
The AptivaTM is a multifunctional transcutaneous electrical nerve stimulator (TENS) equipped with a surface electromyography and electroneurography.
AptivaTM is indicated for symptomatic relief and management of chronic pain. intractable pain and/or as an adjunctive treatment for the management of posttraumatic pain.
The dynamic surface electromyography and electroneurography system is used for biofeedback, relaxation training, and muscle re-education as well as monitoring and display of bioelectric signals produced by muscles, stimulate peripheral nerves, and monitor and display the electrical activity produced by nerves.
6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
The Aptiva™ v2.13U is substantially equivalent to specified predicate devices based on intended use, indications for use, operational characteristics, and fundamental technological characteristics. Detailed side-by-side comparisons of the Aptiva™ v2.13U with cited predicate devices were included in the premarket notification and associated amendments.
7. PERFORMANCE TESTING
Testing included in this premarket notification includes electrical safety, electromagnetic compatibility, and design verification and validation testing. No materials of the Aptiva™ v2.13U are in direct contact with treatment sites and therefore no biocompatibility testing was provided. Test results demonstrate that the Aptiva™ v2.13U fulfills the prospectively defined performance specifications.
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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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 4 2007
Lorenz Biotech S.P.A. C/O Rosina Robinson, RN, MEd, RAC Medical Device Consultants, Inc. 49 Plain Street North Attleboro, MA 02760
Re: K061828
Trade Name: Aptiva 10 v2.13 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: GZJ, HCC, IKN, JXE Dated: August 6, 2007 Received: August 7, 2007
Dear Ms. Robinson:
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
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Page 2 - Rosina Robinson, RN, MEd, RAC
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. 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 N. Melkerson, M.S.
Mark N. Melkerson, M.S 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
510(k) Number (if known): K061828
Device Name: Lorenz Biotech Aptiva™ v2.13U
Indications for Use:
The Aptiva™ v2.13U is a multifunctional transcutaneous electrical nerve stimulator (TENS) equipped with a surface electromyography and electroneurography.
Aptiva™ is indicated for symptomatic relief and management of chronic pain, intractable pain and/or as an adjunctive treatment for the management of post-traumatic pain.
The dynamic surface electromyography and electroneurography system is used for biofeedback, relaxation training, and muscle re-education as well as monitoring and display of bioelectric signals produced by muscles, stimulate peripheral nerves, and monitor and display the electrical activity produced by nerves.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
sion Sign-Off Division of General. Restorative. and Neurological Devices
510(k) Number K061828
§ 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).