(519 days)
relaxation of muscle spasms; prevention or retardation of disuse atrophy; increasing local blood circulation; muscle re-education; immediate post-surgical stimulation of calf muscles to prevent venous thrombosis; and maintaining or increasing range of motion.
The Unit ELECTROMEDICARIN 900 is a 3-channel electrostimulator of low and medium frequency currents. The 3 output channels makes possible to treat 3 patients at the same time or synchronize several muscle groups. The unit is controlled by a microprocessor which allows a wide variation of parameters in order to work with the optimal currents all the time and for each patient: pulse width, bursts, relaxation time, time of increasing and decreasing ramps, modulation frequency, vector type, ... See all types of waveforms in "Technical Characteristics". Also, the user can save his/her own parameters in non-volatile memory. The unit has a 320x240 pixels monochrome (white and blue) LCD of 9" and the Menu options and intensity are selected by means of endless encoders. The end of the treatment is notified with a melody or a sequence of beeps.
The provided text is a 510(k) summary for the ELECTROMEDICARIN 900 electrostimulator, dated February 10th, 2003. This document focuses on demonstrating substantial equivalence to a predicate device (Rich-Mar Corporation's Winner ST4 Stimulator, K000808), rather than presenting a study with specific acceptance criteria and performance data for the ELECTROMEDICARIN 900 itself.
Therefore, much of the requested information (acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone studies, and training set details) is not applicable or not available in this type of regulatory submission.
The 510(k) process for this device relies on showing that the new device has the same intended use and similar technological characteristics as a legally marketed predicate device. The "study" here is essentially the comparative analysis against the predicate device to demonstrate substantial equivalence, rather than a clinical trial measuring a specific outcome for the ELECTROMEDICARIN 900.
Here's a breakdown of the available and applicable information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) for substantial equivalence, formal "acceptance criteria" for a specific performance study of the ELECTROMEDICARIN 900 are not defined. Instead, the acceptance criteria are implicitly that the technological characteristics and indications for use are similar enough to the predicate device as deemed by the FDA. The reported "performance" for the ELECTROMEDICARIN 900 is presented by comparing its specifications to the predicate device.
| Characteristic | Acceptance Criteria (Similarity to Predicate) | ELECTROMEDICARIN 900 Performance (Claimed) | Predicate Device (Winner ST4) Performance |
|---|---|---|---|
| Indications for Use | Identical | Relaxation of muscle spasms; prevention or retardation of disuse atrophy; increasing local blood circulation; muscle re-education; immediate post-surgical stimulation of calf muscles to prevent venous thrombosis; and maintaining or increasing range of motion | Same as Electromedicarin 900 |
| Power Source | Similar (120VAC / 60Hz) | 120VAC / 60Hz | 120VAC / 60Hz |
| Patient Leakage Current | < 100 μA (normal); < 500 μA (single fault) | < 100 μA (normal); < 500 μA (single fault) | < 100 μA (normal); < 500 μA (single fault) |
| Output Modes | 1 (Regulated Current Mode) | 1 (Regulated Current Mode) | 1 (Regulated Current Mode) |
| Number of Channels | Similar (4 for predicate) | 3 | 4 |
| Software/Microprocessor Control | Yes | Yes | Yes |
| Automatic Overload Trip | Yes | Yes | Yes |
| Automatic No-Load Trip | Yes | Yes | Yes |
| Automatic Shut Off | No | No | No |
| Patient Override Control | No | No | No |
| Indicator Display (On/Off Status, V/C level) | Yes, Yes, 30 | Yes, Yes, 30 | Yes, Yes, 30 |
| Max Output Voltage (± 5%) | Similar (± 150V @ 500Ω, ± 150V @ 1000Ω) | ± 150V @ 500Ω, ± 150V @ 1000Ω | ± 150V @ 500Ω, ± 150V @ 1000Ω |
| Max Output Current (± 5%) (pulsed monophasic, biphasic, sinusoidal) | Similar (± 70 mA @ 500Ω, ± 70 mA @ 1000Ω) | ± 90 mA @ 500Ω, ± 90 mA @ 1000Ω | ± 70 mA @ 500Ω, ± 70 mA @ 1000Ω |
| Pulse Width (μs) | Similar (20 to 500) | 10 to 500 | 20 to 500 |
| Frequency (Hz) | Similar (1 to 200) | 0.3 to 1000 | 1 to 200 |
| Interferential Beat Frequency (Hz) | Similar (1 to 250) | Unknown | 1 to 250 |
| Multiphasic Waveforms | Yes | Yes | Yes |
| Symmetrical Phases | Similar (5 to 1000) | 1 to 3300 | 5 to 1000 |
| Net Charge (μC per pulse) | 0 (compensated pulse) | 0 (compensated pulse) | 0 (compensated pulse) |
| Max Phase Charge (μC) | 45 | 45 | 45 |
| Max Current Density (mA/cm²) | 2 | 2 | 2 |
| Burst Mode | Similar (1 to 25) | 5 - 10 | 1 to 25 |
| ON/OFF Time (seconds) | Similar (1 to 25) | 5 - 10 - 20 - 30 - 50 | 1 to 25 |
| Electrical Safety | Identical (IEC 60601-1) | Identical (IEC 60601-1) | Assumed compliant with relevant standards |
| Thermal Safety | Identical (Class I, Type BF) | Identical (Class I, Type BF) | Assumed compliant with relevant standards |
Comments on Discrepancies:
- Max Output Current: The ELECTROMEDICARIN 900 reports higher maximum output current (± 90 mA) than the predicate (± 70 mA). The FDA still deemed it substantially equivalent, suggesting this difference was not considered a significant safety or effectiveness concern in this context.
- Pulse Width & Frequency: The ELECTROMEDICARIN 900 offers a wider range for pulse width (10-500 μs vs 20-500 μs) and frequency (0.3-1000 Hz vs 1-200 Hz).
- Number of Channels: The ELECTROMEDICARIN 900 has 3 channels, while the predicate has 4.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable. This is not a study involving a test set of patient data, but a comparison of device specifications.
- Data Provenance: Not applicable. The data is a comparison of technical specifications from the applicant and the predicate device's existing 510(k) information.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set
- Adjudication Method: Not applicable.
5. 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
- MRMC Study: No. This device is an electrostimulator, not an AI diagnostic imaging tool or a system involving human readers in the way an MRMC study would apply.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Study: No. This device is an electrostimulator. Its "performance" is primarily defined by its electrical output characteristics and safety, not by an algorithm's diagnostic accuracy.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: Not applicable in the sense of clinical "ground truth." The "ground truth" for this submission is the established safety and effectiveness of the predicate device and compliance with relevant electrical and medical device standards (e.g., IEC 60601-1). The "proof" is that the new device's specifications meet or are substantially equivalent to those of the predicate and conform to pertinent standards.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. As this is not an AI/ML device, there is no "training set."
9. How the ground truth for the training set was established
- Ground Truth for Training Set Establishment: Not applicable.
{0}------------------------------------------------
K 020478
510(k) Summary As Required by 21 section 807.92 ( c )
1-Submitter Name: Electromedicarin, S.A.
- 2-Address: Poligono Industrial "Can Volart" C/Torre de Cellers, 6 - 08150 Partes del Vallés Barcelona / Spain +34 / 93 573 07 24 / 86 / 91 3-Phone: 4-Fax: +34 / 93 573 03 31
5-Contact Person: Mr Rafael Barba Trujillo (General Manager)
6-Date summary prepared: February 10th, 2003
7- Official Correspondent: Mansour Consulting
- 8- Address: 1308 Morningside Park Dr
- Alpharetta, GA 30022 USA
9- Phone:
-
(678) 908-8180 (425) 795-9341
10- Fax: -
10- Fax:
12-Device Trade or Proprietary Name: ELECTROMEDICARIN 900
13-Device Common or usual name: Electrostimulator
14-Device Classification Name: Stimulator, Muscle, Powered
15-Substantial Equivalency is claimed against the following device:
Rich-Mar Corporation's Winner ST4 Stimulator, 510k #K000808 (refer to Appendix 2 for FDA website printout) This notification for ELECTROMEDICARIN 900 is of the
ABBREVIATED type as per the declaration of conformity included
in this summary
16-Description of the Device:
The Unit ELECTROMEDICARIN 900 is a 3-channel electrostimulator of low and medium frequency currents.
The 3 output channels makes possible to treat 3 patients at the same time or synchronize several muscle groups. The unit is controlled by a microprocessor which allows a wide variation of parameters in order to work with the optimal currents all the time and for each patient: pulse width, bursts, relaxation time, time of increasing and decreasing ramps, modulation frequency, vector type, ... See all types of waveforms in "Technical Characteristics".
Also, the user can save his/her own parameters in non-volatile memory.
The unit has a 320x240 pixels monochrome (white and blue) LCD of 9" and the Menu options and intensity are selected by means of endless encoders. The end of the treatment is notified with a melody or a sequence of beeps.
17-Intended use of the device: (Indications for use typed on a separate FDA form)
This device is an electrically powered device intended for medical purposes to repeatdly contracts muscles by passing electrical currents through electrodes contacting the affected area (21 CFR 890.5850) for the following indications for use: relaxation of muscle spasms; prevention or retardation of disuse atrophy; increasing local blood circulation; muscle re-education; immediate post-surgical stimulation of calf muscles to prevent venous thrombosis; and maintaning or increasing range of motion
18-Safety and effectiveness of the device:
This device is safe and effective as the predicate device Winner ST4 Stimulator.
This is better expressed in the tabulated comparison (Paragraph 19 below)
{1}------------------------------------------------
Summary comparing technological characteristics with other predicate devi
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Please find below a tabulated comparison that BLECTROMEDICARIN 900 is substantially equivalent to other medical devices
commercial distribution. Also, Equivalency detailed ch
| FDA file reference number | Basic Unit Characteristics | Output Specifications | ||||
|---|---|---|---|---|---|---|
| Attachments inside notification submission file | 510k 000808510k summary print out | Comparison result | Pre-Mod IFCHi-VoltRussianMicrocurrent (0.3Hz to 1000Hz)Similar | PREDICATE DEVICE | Pre-Mod IFC (called Bipolar Interferentials)Hi-Volt (called Rectangular Pulses)Russian (called MEGAA current)Microcurrent (1Hz to 200Hz) | |
| TECHNOLOGICALCHARACTERISTICS | Characteristic | ELECTROMEDICARIN 900 | ||||
| Indications for use | Identical | Power Sorce | 120VAC / 60Hz | |||
| Target population | Identical | Method of Line Current Isolation | - unknown - | 120VAC / 60Hzisolation transformer | ||
| Materials | Similar | Patient Leakage Current- normal condition- single fault condition | < 100 μA< 500 μA | < 100 μA< 500 μA | ||
| PREDICATE DEVICEmetal cabinet with plastic panel | Number of Output Modes | 1 (Regulated Current Mode) | 1 (Regulated Current Mode) | |||
| Performance | Similar | Number of Output Channels- synchronous or alternating- method of channel isolation | 4synchronous- unknown - | 3synchronousisolation transformers | ||
| Sterility | Identical | Software/Microprocessor control | Yes | |||
| Biocompatibility | Identical | Automatic Overload Trip | Yes | Yes | ||
| Mechanical safety | Identical | Automatic No-Load Trip | Yes | Yes | ||
| Chemical safety | Identical | Automatic Shut Off | No | No | ||
| Anatomical sites | Identical | Patient Override Control | No | No | ||
| Human factors | Identical | Indicator Display- On/Off Status- Voltage/Current level | YesYes30 | |||
| Number of channels | Similar | Timer Range | YesYes30 | |||
| PREDICATE DEVICE4 | Compliance with Voluntary Standards? | - | Yes | |||
| Output Waveforms | SimilarPREDICATE DEVICEQuadpolar IFC | Compliance with 21CFR 898? | Yes | |||
| ELECTROMEDICARIN 900lower metallic chassis with plastic front cover | Weight | 9 lbs | 12 lbs | |||
| ELECTROMEDICARIN 9003 | Dimensions (inches) [W x H x D] | 15" x 5.5" x 9" | 17" x 5.9" x 14.3" | |||
| ELECTROMEDICARIN 900Quadpolar IFC (called Tetrapolar Interferentials) | Housing Materials and Construction | metal cabinet with plastic panel | lower metalic chassis with plastic front cover | |||
| Similar | PREDICATE DEVICE | |||||
| Characteristic | ELECTROMEDICARIN 900 | |||||
| Maximum Output Voltage (± 5%)(for all waveforms) | ± 150V @ 500Ω± 150V @ 1000Ω | ± 150V @ 500Ω± 150V @1000Ω |
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| Maximum Output Current (± 5%)- pulsed monphasic, biphasic andsinusoidal | ± 90 mA @ 500Ω± 90 mA @ 1000Ω | ± 70 mA @ 500Ω± 70 mA @ 1000Ω | |
|---|---|---|---|
| - exponentials and galvanic | - | - | |
| Pulse Width (μs) | 10 to 500 | 20 to 500 | |
| Frequency (Hz) | 0.3 to 1000 | 1 to 200 | |
| Interferential Beat Frequency (Hz) | unknown | 1 to 250 | |
| Multiphasic Waveforms | Yes | Yes | |
| - symmetrical phases | 1 to 3300 | 5 to 1000 | |
| - phase duration (ms) | 0 (compensated pulse) | 0 (compensated pulse) | |
| - net charge (μC per pulse) | 45 | 45 | |
| maximum phase charge (μC) | 2 | 2 | |
| Maximum current density (mA/cm²) | - | - | |
| Burst Mode | 5 - 10 | 1 to 25 | |
| - ON Time (seconds) | 5 - 10 - 20 - 30 - 50 | 1 to 25 | |
| Energy used and/or delivered | - OFF Time (seconds) | Similar (see Output Specifications) | - |
| Compatibility with environmentand other devices | Identical | - | - |
| Where used | Identical | - | - |
| Standards met | Identical | - | - |
| Electrical safety | Identical (IEC 60601-1: Safety of Medical Electrical Equipment) | - | - |
| Thermal safety | Identical (Class I, Type BF units) | - | - |
| Identical | - | - |
.
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510(k) "SUBSTANTIAL EQUIVALENCE" DECISION-MAKING PROCESS (DETAILED)
Image /page/4/Figure/1 description: This image is a flowchart with several steps. It starts with a question labeled "How Device is Compared to Marketed Device" and proceeds through a series of questions and decision points. The flowchart includes numbered steps from 3 to 11, and it uses "Yes" and "No" answers to guide the flow. The end result is a determination of "Substantially Equivalent" or a return to point A.
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*** Dala may be in the 510(k), ether SIO(k)s, the Center's classification files, or the lifes area,
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(10)
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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Public Health Service
JUL 17 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Jay Mansour Mansour Consulting, LLC Representing Electromedicarin, S.A. 1308 Morningside Park Drive Alpharetta, Georgia 30022
Re: K020478
Trade/Device Name: Electromedicarin 900 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Codes: IPF Dated: May 28, 2003 Received: June 2, 2003
Dear Mr. Mansour:
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 forth in the quality systems (QS) regulation (21 CFR Part 820); and if
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Page 2 - Mr. Jay Mansour
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 Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
l. Mark A. Millener
Celia M. Witten, M.D., Ph.D. Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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17
510(k) Number (if known): K020478
Device Name: ELECTROMEDICARIN 900
Indications for Use:
This device is an electrically powered device intended for medical purposes to repeatdly contracts muscles by passing electrical currents through electrodes contacting the affected area (21 CFR 890.5850) for the following indications for use: relaxation of muscle spasms; prevention or retardation of disuse atrophy; increasing local blood circulation; muscle re-education; immediate post-surgical stimulation of calf muscles to prevent venous thrombosis; and maintaning or increasing range of motion
for Mark N. Millman
(Divisi Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K020478
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) =============================================================================================================================================================================
Concurence of CDRH, Office of Device Evaulation (ODE)
(Optional Format 3-10-98)
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).