(154 days)
For symptomatic relief and management of chronic, intractable pain, and adjunctive treatment in the management of post-surgical and posttraumatic acute pain.
Delta Scanner devices are micro-current transcutaneous electro-stimulation devices for symptomatic relief and management of chronic, intractable pain, and as adjunctive treatment in the management of post-traumatic and post surgical pain. They are handheld, easy-to-use battery operated portable devices, for use in the home or clinic. The technological characteristics of these devices, including waveforms, outputs, and impedance sensing functions are the same as the InterX 5000™ and the Avazzia Best ProTM
The provided text is a 510(k) summary for the Med-Lectric Corporation's Delta Scanner devices. This type of submission focuses on demonstrating substantial equivalence to predicate devices rather than conducting new clinical trials with acceptance criteria and performance metrics described in the way a de novo or PMA submission would.
Therefore, the document does not contain the information requested regarding acceptance criteria and a specific study proving the device meets them, as it relates to performance benchmarks (e.g., sensitivity, specificity, accuracy).
Here's why the information is not present and what the document does state:
- Acceptance Criteria & Reported Device Performance: This information is not explicitly stated in the context of a performance study for the Delta Scanner devices. The submission claims substantial equivalence based on technological characteristics and intended use matching predicate devices. The document implies that the "acceptance criteria" are met if the new device's characteristics are similar enough to existing cleared devices.
- Study That Proves the Device Meets Acceptance Criteria: There is no specific clinical study described that proves the Delta Scanner devices meet quantitative performance acceptance criteria in terms of efficacy or safety beyond demonstrating substantial equivalence to predicate devices. The submission mentions "verification and validation tests" but provides no details on their methodology, results, or how they relate to specific performance metrics.
Breakdown of what can be extracted or inferred from the provided text, and what is explicitly missing:
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Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria (Inferred): Substantial equivalence to predicate devices (InterX5000™, K042912, K053626; Body-Stim™, Biomodulator™, Best-RSI™, Best Pro™, K062641). Specifically, "technological characteristics... including waveforms, outputs, and impedance sensing functions are the same as the InterX 5000™ and the Avazzia Best ProTM." Also, the "intended uses" are the same.
- Reported Device Performance: Not mentioned in terms of quantitative clinical outcomes or performance metrics (e.g., pain reduction percentage, adverse events rate, etc.) for the Delta Scanner itself, beyond the claim of substantial equivalence to predicate devices which are presumed to be safe and effective.
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Sample size used for the test set and the data provenance: Not applicable. No clinical test set or data provenance is detailed for this 510(k) submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment for a test set is detailed.
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Adjudication method for the test set: Not applicable.
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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. This device is a TENS device, not an AI-based imaging or diagnostic tool that involves human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a TENS device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to this type of submission. The "ground truth" for a 510(k) is the established safety and effectiveness of the predicate devices.
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The sample size for the training set: Not applicable. No training set is detailed.
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How the ground truth for the training set was established: Not applicable.
Conclusion from the document:
The 510(k) summary for the Delta Scanner devices relies on demonstrating "substantial equivalence" to already cleared devices. The "verification and validation tests" mentioned are general statements regarding software compliance and overall device equivalence, rather than detailed clinical performance studies with specific acceptance criteria and results for the new device itself.
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Med-Lectric Corporation
510 (k) Summary
Submitter's Identifications Manufacturer and Sponsor
Med-Lectric Corp. 1909 Lawrence Road # 100 Kemah, TX 77565 USA. Date of Summary Preparation: November 24, 2007 DEC 0 7 2007
Contact
M. Lee Gunter Telephone: 281-334-5166 Fax: 281-538-1463
Trade Name of Devices
Delta Scanner™, Delta Scanner Pro™, DS Low Back Pro™, DS Sports Pro™, DS Rehab™M
Common name
TENS device
Classification 21 CFR 882.5890, GZJ, Class II, Transcutaneous Electrical Nerve stimulator
Information of the 510(k) Cleared Devices (Predicate Devices)
InterX5000™, K042912, K053626 17/May/2005
Body-Stim™, Biomodulator™, Best-RSI™, Best Pro™, K062641, May 30, 2007
Description and Intended Use
Delta Scanner devices are micro-current transcutaneous electro-stimulation devices for symptomatic relief and management of chronic, intractable pain, and as adjunctive treatment in the management of post-traumatic and post surgical pain. They are handheld, easy-to-use battery operated portable devices, for use in the home or clinic.
The technological characteristics of these devices, including waveforms, outputs, and impedance sensing functions are the same as the InterX 5000™ and the Avazzia Best ProTM
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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.
Conclusions
The devices have intended uses and technological characteristics that are substantially equivalent to the predicate devices. 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 an abstract symbol resembling an eagle or bird in flight, composed of three curved lines representing the wings and a stylized head and tail.
DEC 0 7 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
M. Lee Gunter Med-Lectric Corporation 1909 Lawrence Road, #100 Kemah, Texas 77565
Re: K071878
Trade Name: Delta Scanner™, Delta Scanner Pro™, DS Low Back Pro™, DS Sports ProTM, DS Rehab™ Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: GZJ Dated: October 9, 2007 Received: October 17, 2007
Dear Mr. Gunter:
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
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Page 2 – Mr. M. Lee Gunter
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. Millerson
Mark N. Melkerson 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: K071878
Device name: Delta Scanner™, Delta Scanner Pro™, DS Low Back Pro™, DS Sports Pro™, and DS Rehab™
Indications for use:
For symptomatic relief and management of chronic, intractable pain, and adjunctive treatment in the management of post-surgical and posttraumatic acute pain.
| Prescription Use | X | AND/OR | Over-The-Counter Use |
|---|---|---|---|
| (Part 21 CFR 801 Subpart D) | (21 CFR 807 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
(Division Sign-Off)
Concurrence of Division of General, Restorative,
Office of Device Evaluation (ODE)
and Neurological Devices
| 510(k) Number | K071876 |
|---|---|
| --------------- | --------- |
§ 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).