(154 days)
No
The description focuses on standard electro-stimulation technology and explicitly states the technological characteristics are the same as predicate devices that do not mention AI/ML. There is no mention of AI, ML, or related concepts like training/test sets or performance metrics associated with AI/ML models.
Yes
The device is intended for symptomatic relief and management of chronic and acute pain, which are therapeutic applications.
No
The device description states it is for symptomatic relief and management of pain, not for diagnosing conditions.
No
The device description explicitly states it is a "micro-current transcutaneous electro-stimulation device" and describes it as "handheld, easy-to-use battery operated portable devices," indicating it is a physical hardware device that delivers electrical stimulation.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description: The description clearly states this device is a "micro-current transcutaneous electro-stimulation device." It applies electrical stimulation to the body (transcutaneous means through the skin) for pain relief.
- Intended Use: The intended use is for "symptomatic relief and management of chronic, intractable pain, and adjunctive treatment in the management of post-surgical and posttraumatic acute pain." This is a therapeutic use, not a diagnostic one based on analyzing bodily specimens.
The device's function and intended use are entirely focused on treating pain by interacting with the body directly, not by analyzing samples taken from the body.
N/A
Intended Use / 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.
Product codes
GZJ
Device Description
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
home or clinic
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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
1
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
2
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
3
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
4
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 |
|---|---|
| --------------- | --------- |