(205 days)
Yes
The device description explicitly mentions "Five artificial neurons create 'packets' (strings) of information recognized as 'non pain', the content of which is controlled by a proprietary algorithm." This directly indicates the use of AI/ML concepts ("artificial neurons").
Yes
The device is described as an "electro-analgesia device" intended for "symptomatic relief of chronic, intractable pain, post-surgical and post-traumatic acute pain," and "post-operative pain," which are all therapeutic outcomes.
No
Explanation: The device is described as an "electro-analgesia device" intended for "symptomatic relief" of pain. Its function is to deliver electrical stimuli to reduce pain, not to diagnose a condition.
No
The device description explicitly mentions hardware components such as electrodes, microprocessors, and channels that deliver electrical stimuli, indicating it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The ST-5A device is described as an electro-analgesia device that delivers low-intensity electrical stimuli to the patient's body for pain relief. It does not analyze any biological specimens.
- Intended Use: The intended use is for symptomatic relief of pain, not for diagnosing or monitoring a condition based on in vitro analysis.
- Device Description: The description focuses on the electrical stimulation mechanism and electrode placement on the body, not on laboratory analysis of samples.
Therefore, the ST-5A device falls under the category of a therapeutic device, specifically for pain management, rather than an in vitro diagnostic device.
No
The provided text does not contain any explicit statements indicating that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device. The 'Control Plan Authorized (PCCP) and relevant text' section explicitly states 'Not Found'.
Intended Use / Indications for Use
Symptomatic relief of chronic, intractable pain, post-surgical and post-traumatic acute pain.
Symptomatic relief of acute pain.
Symptomatic relief of post-operative pain.
Product codes
GZJ
Device Description
The ST-5A is a patented non-invasive electro-analgesia device, with 5 chamels that deliver low-intensity stimuli (max. 5 mA) generated by a completely automated treatment program.
Five artificial neurons create "packets" (strings) of information recognized as "non pain", the content of which is controlled by a proprietary algorithm. This various information of "no pain" produces an immediate analgesic effect, capable of completely eliminating pain in real time. Up to 5 pairs of independent electrodes can be placed on the patient's body based on the need of the treatment.
Two microprocessors ensure the correct operation of the device by automatically establishing the optimal parameters of effectiveness and safety, which cannot be modified by the operator. In order to perform the treatment correctly, the operator only needs to position the electrodes and adjust the stimulation levels correctly. The placement of the electrodes requires scrupulous observance of the method of identifying the areas of pain treatment. If the treatment is performed correctly, normally the pain is zeroed (or reduced very close to zero) in real time regardless of the initial intensity and the pathology that generated it.
In this technology the concept of similarity that only considers of frequency, pulse width and intensity (used in other devices) is not applicable because they do not generate and do not characterize the specific information of "no pain" of the Scrambler Therapy®. In this sense any modification of the Scrambler Therapy® in the form and organization of the flows in time, is functionally equivalent to the modification of the chemical formula of a drug.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
The whole body excluding: areas near the heart with trans- thoracic stimulation, in the upper part of the throat, in the head, in the mouth, and in parts affected by skin diseases or wounds
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The ST-5A device has been designed for the pain therapy in hospital, outpatient facility and hospice by trained physicians or other trained healthcare personnel under physicians supervision.
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)
All the scientific literature referenced on Scrambler Therapy® is entirely applicable also to the Scrambler Therapy ® Technology ST-5A model, since there are no technological differences between the different generations of devices "MC-5A" that influence the efficacy and safety profile.
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
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 23, 2020
Delta International Services & Logistics S.r.l Mariella Giorgieri, CEO Piazza Adriana 4 Rome, 00193 Italy
Re: K201458
Trade/Device Name: Scrambler Therapy Technology (Model ST-5A) Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief Regulatory Class: Class II Product Code: GZJ Dated: November 23, 2020 Received: November 23, 2020
Dear Mariella 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Robert Kang, PharmD Acting Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K201458
Device Name
Scrambler Therapy® Technology (Model ST-5A)
Indications for Use (Describe)
General Indications for Use :
- · Symptomatic relief of chronic, intractable pain, post-surgical and post-traumatic acute pain.
- · Symptomatic relief of acute pain.
- · Symptomatic relief of post-operative pain.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Section 5. 510(k) Summary
5.0.1 Submitter/510(K) Holder
Company Name: Delta International Services & Logistics s.r.l. Company Address: Piazza Adriana 4, Rome, Italy, 00193 Company Phone: +39 392 160 3399 Company e-mail: ceo@st-team.eu
Contact person: Ms. Mariella Giorgieri, CEO Delta International Services & Logistics S.r.l
Date the summary was prepared: June 22, 2020 (K201458)
Name of the device: Scrambler Therapy® Technology ST-5A Trade name: Scrambler Therapy® Technology Proprietary name: Scrambler Therapy® Common or usual name: Scrambler Therapy® No prior submission
5.0.2 Predicate Device
Device Name: Scrambler Therapy® MC-5A Device (Manufactured in Korea by GEOMC Co., LTD under DIS&L license) Applicant: Delta International Services & Logistics S.r.1 (DIS&L) 510(k) Number: # K142666
Device Identification:
Scrambler Therapy® Technology Model ST-5A (Manufactured in Italy under DIS&L license)
The associated accessories include:
1 - Set of connection cables for standard ECG electrodes consisting of 5 cables with different identification color
-
- 1 spare gray cable.
- 1 Power cable
- 1 Instruction manual
5.0.3 Device Characteristics:
Software:
Version 3.1 of the ST-5A proprietary software is the same of firmware versions running on predecessor medical devices build under license with the same technology. All program units and waveform data are stored directly in the microcontroller onboard memory.
biologics: N/A drugs: N/A any patient-contacting materials: coatings: ABS additives: N/A single-use: N/A sterile: N/A sterilization method [specify] : N/A
Delta International Services & Logistics s.r.l. 510(k) – November 16, 2020 - CONFIDENTAL Scrambler Therapy® Technology ST-5A
4
5.0.4 Environment of Use:
Hospital, Healthcare Facility, Hospice
Image /page/4/Picture/2 description: The image is a logo that says "Rx only". The "Rx" is in a black circle on the left side of the logo. The word "only" is in black text on the right side of the logo. The logo is surrounded by a black border.
Federal law restricts this device to sale by or on the order of a physician
5.0.5 Brief Written Description of the Device:
The ST-5A is a patented non-invasive electro-analgesia device, with 5 chamels that deliver low-intensity stimuli (max. 5 mA) generated by a completely automated treatment program.
Five artificial neurons create "packets" (strings) of information recognized as "non pain", the content of which is controlled by a proprietary algorithm. This various information of "no pain" produces an immediate analgesic effect, capable of completely eliminating pain in real time. Up to 5 pairs of independent electrodes can be placed on the patient's body based on the need of the treatment.
Two microprocessors ensure the correct operation of the device by automatically establishing the optimal parameters of effectiveness and safety, which cannot be modified by the operator. In order to perform the treatment correctly, the operator only needs to position the electrodes and adjust the stimulation levels correctly. The placement of the electrodes requires scrupulous observance of the method of identifying the areas of pain treatment. If the treatment is performed correctly, normally the pain is zeroed (or reduced very close to zero) in real time regardless of the initial intensity and the pathology that generated it.
In this technology the concept of similarity that only considers of frequency, pulse width and intensity (used in other devices) is not applicable because they do not generate and do not characterize the specific information of "no pain" of the Scrambler Therapy®. In this sense any modification of the Scrambler Therapy® in the form and organization of the flows in time, is functionally equivalent to the modification of the chemical formula of a drug.
5.0.6 Mechanism of action
In the Scrambler Therapy®, the therapeutic approach is no longer to inhibit the transmission of pain, but to transform the information of pain into "non-pain" using the same pathways. In the Scrambler Therapy® model, information becomes the central point of control of the pain system, both in the genesis of chronicity (induced by endogenous information of pain repeated over time) and in its regression (induced by synthetic information of "no pain" repeated over time).
The result of this theoretical model applied in the Scrambler Therapy® medical device, is an immediate and complete analgesic effect in treatment, and the return to normal physiological response after one or more cycles of treatment.
In view of these specific approach, it is quite clear that the concept of similarity that only considers the parameters of frequency, pulse width and intensity (used in other devices) for this Technology is not applicable because they do not generate and do not characterize the specific information of "no pain" of the Scrambler Therapy®. In this sense any modification of the emissions of the Scrambler Therapy in the form and organization of the flows in time (i.e. the specific strings of "no pain" information), is functionally equivalent to the modification of the chemical formula of a drug.
5.0.7 Any necessary feature to determine SE or device performance
The new device has the same technological characteristics that do not raise different questions of safety and effectiveness than the identified Delta International Services & Logistics Scrambler Therapy®
Delta International Services & Logistics s.r.l. 510(k) – November 16, 2020 - CONFIDENTIAL Scrambler Therapy® Technology ST-5A
5
510(K) # K142666 predicate.
Energy source: Power Supply 100-120V / 200-240V / 50-60 Hz Materials of Use External Chassis: ABS Internal Chassis: Aluminum Patient: Standard pre-gelled ECG Electrodes (single-use).
Type of electrode to use with Scrambler Therapy® Technology ST-5A: Kendall H34LG FDA GUDID: https://accessgudid.nlm.nih.gov/devices/search?query=H34LG DEVICE: Kendall (20884527005069) Device Description: ECG Electrodes, H34LG, Foam, Wet Gel, Snap, Diagnostic, Stress
Image /page/5/Picture/3 description: The image shows two round, blue medical electrodes. The electrode on the left has a white center with a repeating pattern of blue squares and the word "COVIDIEN" printed on it. A small, silver metal button is in the center of the electrode. The electrode on the right has a white center with a blue gel-like substance visible through it.
Basic Product Information Shape / size Tear drop / 50 x 45 mm Total product surface (incl. grip) 1730 mm2 Gel area 346 mm2 Adhesive area 1312 mm2
Materials Information Backing material Polyethylene foam (PE), blue Adhesive characteristics Medical grade pressure sensitive stress adhesive Gel characteristics Wet gel Supporting / back label Polyethylene terephthalate (PET) white Release liner Polyethylene terephthalate (PET), one side siliconized Sensor Polymer Ag/AgC1 coated Adapter / connector Stainless steel
Biocompatibility Test acc. to DIN ISO 10993 passed LATEX content no
Environment Halogenated hydrocarbon content (e.g. PVC) no Phthalate derivatives content (e.g. DEHP) no RoHS directive in compliance
Delta International Services & Logistics s.r.l. 510(k) – November 16, 2020 - CONFIDENTIAL Scrambler Therapy® Technology ST-5A
6
5.0.8 Key Performance Specifications/Characteristics of the Device
Intended Use
The ST-5A device has been designed for the pain therapy in hospital, outpatient facility and hospice by trained physicians or other trained healthcare personnel under physicians supervision.
Indications for Use
General
- Symptomatic relief of chronic, intractable pain, post-surgical and post-traumatic acute pain. .
- o Symptomatic relief of acute pain.
- . Symptomatic relief of post-operative pain.
5.1.0 Side-by-Side Comparison of Scrambler Therapy® Technology ST-5A Device with Predicate Device
| Devices | Scrambler Therapy® Technology
ST-5A Device | Scrambler Therapy® MC-5A
Predicate Device |
|---------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K201458 | K142666 |
| Device Name, Model | Scrambler Therapy® Technology, ST-5A | Scrambler Therapy®, MC-5A |
| Manufacturer | Intellimed s.r.l.s. (Italy) | Geomc Co., Ltd. (Korea) |
| Power Source(s) | 100-120V / 200-240V / 50-60 Hz | 220 VAC |
| Number of Output Modes | one | one |
| Number of Output Channels | five | five |
| Method of Channel Isolation | transformer | transformer |
| Regulated Current or Regulated
Voltage? | current | current |
| Software/Firmware/Microprocessor
Control? | Yes (the same of the Predicate
Device MC-5A) | Yes |
| Automatic Overload Trip? | Yes | Yes |
| Automatic No-Load Trip? | Yes | Yes |
| Automatic Shut Off? | Yes | Yes |
| Patient Override Control? | Yes | Yes |
| Indicator Display: | | |
| - On/Off Status? | Yes | Yes |
| - Low Battery? | NA | NA |
| - Voltage/Current Level? | NA | NA |
| Timer Range (minutes) | 20 to 60 | 20 to 60 |
| Compliance with Voluntary Standards? | Yes | Yes |
| Compliance* with 21 CFR 898?
(*Becomes mandatory beginning May
9, 2000) | Yes | Yes |
| Maximum Output Voltage Available
(+/- 2 %) (with software calibration
correction) | 2.2 V, load 500 ohm
4.4 V, load 1 KΩ | 2.2 V, load 500 ohm
4.4 V, load 1 KΩ |
| Maximum Output Current
(+/-2 %) | Treatment mode: