(246 days)
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No
The summary describes a device that generates and controls stimulation impulses according to a "stored program," which is typical of traditional medical devices and does not indicate the use of AI or ML. There are no mentions of AI, ML, or related concepts like training or test sets.
Yes
The device is indicated for "symptomatic relief of chronic, intractable pain, post-surgical and posttraumatic acute pain," which describes a therapeutic purpose.
No
The document states that the device is indicated for "Symptomatic relief of chronic, intractable pain, post-surgical and posttraumatic acute pain," and describes it as generating "Stimulation impulses ... to provide pain relief." This indicates a therapeutic function, not a diagnostic one.
No
The device description explicitly states it is a "multi-channel device" that "allows simultaneous treatment of a number of pain sites" and generates "stimulation impulses," indicating it is a hardware device that delivers electrical stimulation, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "Symptomatic relief of chronic, intractable pain, post-surgical and posttraumatic acute pain," and other types of acute and post-operative pain. This describes a therapeutic intervention applied to the patient's body, not a test performed on a sample taken from the body to diagnose or monitor a condition.
- Device Description: The description mentions "Stimulation impulses are generated and controlled according to a stored program to provide pain relief." This further reinforces that it's a device that interacts with the patient's nervous system for therapeutic purposes.
- Lack of IVD characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests in vitro (outside the body), or providing diagnostic information.
Therefore, the Scrambler Therapy MC-5A Device is a therapeutic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Scrambler Therapy MC-5A Device is indicated for:
- Symptomatic relief of chronic, intractable pain, post-surgical and posttraumatic acute pain.
- Symptomatic relief of acute pain.
- Symptomatic relief of post-operative pain.
Product codes (comma separated list FDA assigned to the subject device)
GZJ
Device Description
The Scrambler Therapy MC-5A Device is a multi-channel device which allows simultaneous treatment of a number of pain sites. Stimulation impulses are generated and controlled according to a stored program to provide pain relief.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Testing of the Scrambler Therapy MC-5A Device demonstrates that the device meets design and performance specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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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).
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§ 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).
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing right, with flowing lines above and below them. The profiles are stacked, creating a sense of depth and unity.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 22, 2015
Delta international Service & Logistics S.r.l. Ms. Mariella Giorgieri CEO Piazza Adriana 4 00193 Roma Italy
Re: K142666
Trade/Device Name: Scrambler Therapy MC-5A Device Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: GZJ Dated: May 6, 2015 Received: May 11, 2015
Dear Ms. Giorgieri:
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.
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
1
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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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.
Felipe Aquel -S
Carlos Peña, PhD, MS for Director Division and Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| 510(k) | Scrambler Therapy MC-5A | |
|---|---|---|
| -- | -------- | ------------------------- |
INDICATION FOR USE STATEMENT
| 510(k) Number (if you know): | K142666 |
|---|---|
| Device Name: | SCRAMBLER THERAPY MC-5A DEVICE |
Indication for Use:
The Scrambler Therapy MC-5A Device is indicated for:
- Symptomatic relief of chronic, intractable pain, post-surgical and posttraumatic acute pain.
- Symptomatic relief of acute pain.
- Symptomatic relief of post-operative pain.
| Prescription Use X
(Part 21 CFR 801 Subpart D) | AND / OR | Over-The-Counter Use ______
(Part 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)
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510(k)
510(K) SUMMARY
1. SUBMITTER/510(K) HOLDER:
| Company Name: | Delta International Services & Logistics S.r.l. |
|---|---|
| Company Address: | Piazza Adriana 4 |
| 00193, Roma - Italy | |
| Company Phone: | 039- 3921603399 |
| Company Fax: | 039-063215142 |
| Company e-mail: | ceo@st-team.eu |
| Contact person: | Ms. Mariella Giorgieri |
| CEO | |
| Delta International Services & Logistics S.r.l. | |
| Date Summary Prepared: | May 13, 2015 |
2. DEVICE IDENTIFICATION
| Common Usual Name: | Electrical Nerve Stimulator |
|---|---|
| Trade/Proprietary Name: | Scrambler Therapy MC-5A Device |
| Classification: | Class II |
| Product Code: | GZJ |
| Classification Panel: | 882 Neurological Devices |
| Regulation Number: | 882.5890 |
3. PREDICATED DEVICES
| Predicate device | 510 (k) Holder | 510 (k) No |
|---|---|---|
| SCRAMBLER MC-5A TENS | ||
| DEVICE | COMPETITIVE TECHNOLOGIES, | |
| INC. | K081255 |
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4. DEVICE DESCRIPTION
The Scrambler Therapy MC-5A Device is a multi-channel device which allows simultaneous treatment of a number of pain sites. Stimulation impulses are generated and controlled according to a stored program to provide pain relief.
5. INTENDED USE
The Scrambler Therapy MC-5A Device is indicated for:
- · Symptomatic relief of chronic, intractable pain, post-surgical and posttraumatic acute pain.
- · Symptomatic relief of acute pain.
- · Symptomatic relief of post-operative pain.
6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
Delta International Services & Logistics s.r.l. claims substantial equivalence of the Scrambler Therapy MC-5A Device to the predicate devices based on the intended use, fundamental technology, and operation characteristics. A side-by-side comparison of the Scrambler Therapy MC-5A Device and the cited predicate device is included in the 510(k).
7. PERFORMANCE TESTING
Testing of the Scrambler Therapy MC-5A Device demonstrates that the device meets design and performance specifications.
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