(562 days)
Therapeutic Ultrasound:
- Pain relief
- Reduction of muscle spasm
- Localized increase of blood flow
- Increase range of motion of contracted joints using heat and stretch techniques.
Neuromuscular Stimulation:
- Symptomatic relief of chronic intractable pain, acute post traumatic pain or acute surgical pain
- Temporary relaxation of muscle spasm
- Prevention of post-surgical phlebo-thrombosis through immediate stimulation of calf muscles
- Increase of blood flow in the treatment area.
- Prevention or retardation of disuse atrophy in post-injury type conditions
- Muscle re-education
- Maintaining or increasing range of motion
The BRH-A2 CUSEFS is comprised of the following main components:
- A system console including software and control electrodes; ●
- A control and display panel
- Specially designed cart
- User-friendly touch screen
. The BRH-A2 CUSEFS is powered by standard one phase 120 or 230 V power supply.
The BRH-A2 CUSEFS is a two-channel combination unit for therapeutic ultrasound and 4-Pole Interferential Current therapy folded into a specially designed cart. The microprocessor controlled BRH-A2 CUSEFS provides 4-Pole Interferential Current therapy alternating current with enhanced reliability and user friendly interface. The BRH-A2 CUSEFS offer 1 and 3 MHz ultrasound treatment modes.
There is a user-friendly touch screen interface. The screen provides operator information about operation mode and signal intersities. Large control knobs on the touch screen make adjusting power for ultrasound and muscle stimulation.
The BRH-A2 CUSEFS can provide 4-Pole Interferential Current therapy only and ultrasound treatment only.
The provided document is a 510(k) Premarket Notification from the FDA for a medical device called the BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS) system. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a standalone clinical study involving an AI algorithm and human readers.
Therefore, many of the requested elements (e.g., sample size for test set, number of experts, adjudication method, MRMC study, how ground truth was established, training set size) are not applicable as this document does not describe such a study.
The acceptance criteria here are implicitly defined by the FDA-recognized standards for the safety and effectiveness of ultrasonic physiotherapy equipment and nerve and muscle stimulators, and the device's performance is demonstrated through bench testing and non-clinical testing to meet these standards.
Here's a breakdown of the information that can be extracted from the document, tailored to the context of a 510(k) submission for substantial equivalence:
1. Table of Acceptance Criteria (Implicit) and Reported Device Performance
The acceptance criteria for this 510(k) submission are the requirements outlined in the referenced FDA-recognized standards for medical electrical equipment and the device's ability to demonstrate similar performance and safety characteristics to the predicate devices. The reported device performance is that it "Passed all testing requirements" for these standards.
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| Safety and Essential Performance: | |
| ANSI/AAMI ES60601-1:2005/(R) 2012 and A1:2012, C1:2009/(R) 2012 and A2:2010/(R) 2012 (Consolidated Text) "Medical electrical equipment. Part 1: General requirements for safety and essential performance" | Passed all testing requirements |
| IEC 60601-2-5:2009 "Medical electrical equipment. Part 2-5: Particular requirements for the safety of ultrasonic-physiotherapy equipment" | Passed all testing requirements |
| IEC 60601-2-10 Edition 2.0 2012-06 "Medical electrical equipment. Part 2-10 Particular requirements for the safety and essential performance of nerve and muscle stimulators." | Passed all testing requirements |
| Risk Management: | |
| ISO 14971:2007 "Medical devices – Application of risk management to medical devices” including residual risks evaluation. | Passed all testing requirements |
| Usability: | |
| IEC 60601-1-6 Edition 3.1 2013-10 "Medical electrical equipment. Part 1-6: General requirements for basic safety and essential performance – Collateral Standard: Usability" | Passed all testing requirements |
| Alarm Systems: | |
| IEC 60601-1-8:2006 & A1:2012 "Medical electrical equipment. Part 1-8: General requirements for basic safety and essential performance– Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems" | Passed all testing requirements |
| Electromagnetic Compatibility: | |
| IEC 60601-1-2: 2007 /AC: 2010 “Medical electrical equipment. Part 1-2: Electromagnetic compatibility – Requirements and tests" | Passed all testing requirements |
| Software Development: | |
| IEC 62304 Edition 1.1 2015-06 "Medical Device Software Development" | Passed all testing requirements |
| Quality Management Systems: | |
| ISO 13485:2016 Medical devices -- Quality management systems -- Requirements for regulatory purposes | Passed all testing requirements |
| Substantial Equivalence: | |
| Similar indications for use and technological characteristics to predicate devices (Sonicator Plus 930 and DU857), with no new questions of safety or effectiveness raised by differences. | The device has similar indications for use and technological characteristics resulting in substantial equivalence. |
2. Sample Size Used for the Test Set and the Data Provenance:
The document does not describe a clinical study with a test set of human subjects or patient data. The testing mentioned refers to bench testing and non-clinical testing of the device itself against established engineering and safety standards. Therefore, "sample size for the test set" and "data provenance" in the context of patient data are not applicable.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
Not applicable, as this is not a study assessing an AI algorithm's performance against human readers or a clinical ground truth. The "ground truth" here is compliance with engineering and safety standards, which is assessed through instrument calibration, performance measurements, and risk analyses according to the specified international standards.
4. Adjudication Method for the Test Set:
Not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
No. The document explicitly states that bench testing and non-clinical testing were conducted to demonstrate safety, effectiveness, and substantial equivalence. It does not mention any MRMC study or AI assistance to human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
Not applicable. The device is a physical therapeutic ultrasound and electrical stimulation unit, not a standalone algorithm.
7. The Type of Ground Truth Used:
The "ground truth" in this context is the compliance with recognized international standards for medical device safety and performance, such as IEC 60601 series, ISO 14971, IEC 62304, and ISO 13485. This is established through documented testing procedures and results, as well as comparison to predicate devices' known characteristics.
8. The Sample Size for the Training Set:
Not applicable. This is not an AI/machine learning device that would require training data.
9. How the Ground Truth for the Training Set Was Established:
Not applicable.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is written in a simple, sans-serif font.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 25, 2017
BRH Medical Ltd. % Susan D. Goldstein-Falk Vice President - FDA Compliance mdi Consultants, Inc. 55 Northern Blvd. Suite 200 Great Neck. New York 11021
Re: K160378
Trade/Device Name: BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS) Regulation Number: 21 CFR 890.5300 Regulation Name: Ultrasonic Diathermy Regulatory Class: Class II Product Code: IMI, IPF, LIH, IMG Dated: July 27, 2017 Received: July 28, 2017
Dear Ms. Goldstein-Falk:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
{1}------------------------------------------------
the quality systems (OS) 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" (21 CFR 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,
Michael J. Hoffmann -S
Carlos L. Peña, PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K160378
Device Name
BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS)
Indications for Use (Describe)
Therapeutic Ultrasound:
-
- Pain relief
-
- Reduction of muscle spasm
-
- Localized increase of blood flow
-
- Increase range of motion of contracted joints using heat and stretch techniques.
Neuromuscular Stimulation:
-
- Symptomatic relief of chronic intractable pain, acute post traumatic pain or acute surgical pain
-
- Temporary relaxation of muscle spasm
-
- Prevention of post-surgical phlebo-thrombosis through immediate stimulation of calf muscles
-
- Increase of blood flow in the treatment area.
-
- Prevention or retardation of disuse atrophy in post-injury type conditions
-
- Muscle re-education
-
- Maintaining or increasing range of motion
TARGET POPULATION Adult patients
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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Image /page/3/Picture/0 description: The image shows the logo for BRK Medical. The logo features the letters "BR" in gray, with the letter "K" stylized as a teal human figure with outstretched arms. Below the letters "BR" is the word "medical" in teal, written in a smaller, sans-serif font. The overall design is clean and modern, suggesting a company focused on health and well-being.
K160378 510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with 21 CFR 807.92.
General Information:
| Applicant: | BRH Medical Ltd. The Jerusalem Technological Gardens Building A, 1st Floor Jerusalem, 96951, Israel Tel: + 02-6483519 |
|---|---|
| Contact Persons: | |
| CEO | Motti Oderberg Tel: ++ 972 (0)54-6772277 E-mail: Motti@026430010.co.il |
| СТО | ILAN Feferberg Tel: ++972 (0)54-6678330 E-mail: imft@zahav.net.il |
| Date Prepared: | August 24, 2017 |
| Device Trade Name: | BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS) |
| Common or Usual Name: | Ultrasonic diathermy for Use in Applying Therapeutic Deep Heat |
| Classification Name: | Ultrasonic Diathermy (21 CFR 890.5300) |
| Regulatory Class: | Class II |
| Product Code: | IMI |
| Common or Usual Name: | Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat |
| Classification Name: | Ultrasound and muscle stimulator (21 CFR 890.5860) |
| Regulatory Class: | Class II |
| Product Code: | IMG |
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Image /page/4/Picture/0 description: The image shows a logo for BRK medical. The letters "BR" are in gray, and the letter "K" is stylized in blue with a figure of a person with their arms raised above their head. The word "medical" is written in blue below the letters "BR".
Common or Usual Name: Classification Name: Regulatory Class: Product Code:
Common or Usual Name: Classification Name:
Regulatory Class: Product Code:
The Jerusalem Technological Garden Building A' Floor 1 Jerusalem -96591- Israel Tel ++972-2-6483519 Fax ++972-2-6483541
Stimulator, Muscle, Powered Powered muscle stimulator (21 CFR 890.5850) Class II IPF
Interferential Current Therapy Transcutaneous electrical nerve stimulator for pain relief (21 CFR 882.5890) Class II LIH
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Image /page/5/Picture/0 description: The image contains a logo for BRK medical. The letters 'BR' are in gray, with 'K' in teal and a stick figure with arms raised incorporated into the 'K'. Below the letters is the word 'medical' in teal. The logo is simple and modern, using a clean font and a limited color palette.
| Primary Predicate Device: | Trade Name Sonicator® Plus 930(Combination ultrasound and muscle stimulator) Mettler ElectronicCorp.K013192 |
|---|---|
| Secondary Predicate Device: | Trade Name The DU857 Dual Frequency Ultrasound Therapyand Muscle Stimulator SystemAlfa Tech Medical Systems Ltd.K052340 |
Device Description:
The BRH-A2 CUSEFS is comprised of the following main components:
- A system console including software and control electrodes; ●
- A control and display panel
- Specially designed cart
- User-friendly touch screen
- . The BRH-A2 CUSEFS is powered by standard one phase 120 or 230 V power supply.
The BRH-A2 CUSEFS is a two-channel combination unit for therapeutic ultrasound and 4-Pole Interferential Current therapy folded into a specially designed cart. The microprocessor controlled BRH-A2 CUSEFS provides 4-Pole Interferential Current therapy alternating current with enhanced reliability and user friendly interface. The BRH-A2 CUSEFS offer 1 and 3 MHz ultrasound treatment modes.
There is a user-friendly touch screen interface. The screen provides operator information about operation mode and signal intersities. Large control knobs on the touch screen make adjusting power for ultrasound and muscle stimulation.
The BRH-A2 CUSEFS can provide 4-Pole Interferential Current therapy only and ultrasound treatment only.
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Image /page/6/Picture/0 description: The image shows the logo for BRK medical. The letters "BR" are in gray, with the "R" slightly overlapping the "B". To the right of the letters is a stylized figure of a person in teal. The word "medical" is in teal below the letters "BR".
Indications for Use:
The BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS) is intended for ultrasound and neuromuscular stimulation
Therapeutic Ultrasound:
-
- Pain relief
-
- Reduction of muscle spasm
-
- Localized increase of blood flow
-
- Increase range of motion of contracted joints using heat and stretch techniques.
Neuromuscular Stimulation
-
- Symptomatic relief of chronic intractable pain, acute post traumatic pain or acute surgical pain
-
- Temporary relaxation of muscle spasm
-
- Prevention of post-surgical phlebo-thrombosis through immediate stimulation of calf muscles
-
- Increase of blood flow in the treatment area.
-
- Prevention or retardation of disuse atrophy in post-injury type conditions
-
- Muscle re-education
-
- Maintaining or increasing range of motion
TARGET POPULATION
Adult patients
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Image /page/7/Picture/0 description: The image contains the logo for BRK medical. The logo has the letters "BR" in gray, with the letter "K" in teal. The "K" is stylized to look like a person with their arms raised. Below the letters is the word "medical" in teal.
Substantial Equivalence Comparison of Subject Device to Predicate Devices
| Parameter | BRH-A2 Combined Ultrasoundand Electric Field Stimulation(CUSEFS) K160378 | Primary PredicateSonicator Plus 930K013192 | Secondary PredicateDU857 K052340 |
|---|---|---|---|
| Trade Name | BRH-A2 Combined Ultrasound andElectric Field Stimulation (CUSEFS) | Sonicator Plus 930 | DU857 |
| 510(k) number | K160378 | K013192 | K052340 |
| ClassificationName | Ultrasonic Diathermy for Use inApplying Therapeutic Deep Heat,Stimulator, Ultrasound AndMuscle, For Use In ApplyingTherapeutic Deep Heat,Stimulator, Muscle, Powered andInterferential Current Therapy | Ultrasonic Diathermy,Powered MuscleStimulator, TranscutaneousElectrical Nerve Stimulatorfor Pain relief andInterferential CurrentTherapy. | Ultrasound and MuscleStimulator |
| Model Number | BRH-A2 | ME930 | DU857 |
| Product Code | IMI, IMG, IPF, LIH | IMI, GZJ, IPF, LIH | IMI, IMG, IPF, LIH |
| Manufacturer | BRH Medical Ltd. | Mettler Electronics | Alfa Tech MedicalSystems Ltd |
| Indications foruse | Therapeutic Ultrasound:1. Pain relief2. Reduction of musclespasm3. Localized increase ofblood flow4. Increase range of motionof contracted joints usingheat and stretchtechniques.Neuromuscular Stimulation1. Symptomatic relief ofchronic intractable pain,acute post traumatic painor acute surgical pain2. Temporary relaxation ofmuscle spasm3. Prevention of post-surgical phlebo-thrombosis throughimmediate stimulation ofcalf musclesIncrease of blood flow in4. | Therapeutic Ultrasound:1. Pain relief2. Reduction ofmuscle spasm3. Localized increaseof blood flow4. Increase range ofmotion ofcontracted jointsusing heat andstretchtechniques.Neuromuscular Stimulation1. Symptomatic reliefof chronicintractable pain,acute posttraumatic pain oracute surgical pain(Interferential andPre-modulatedwaveforms)2. Temporary | Therapeutic Ultrasound:1. Pain relief2. Reduction ofmuscle spasm3. Localizedincrease ofblood flow4. Increase rangeof motion ofcontractedjoints usingheat andstretchtechniques.NeuromuscularStimulation1. Symptomaticrelief of chronicintractablepain, acutepost traumaticpain or acutesurgical pain |
| the treatment area.5. Prevention or retardationof disuse atrophy in post-injury type conditions6. Muscle re-education7. Maintaining or increasingrange of motionTARGET POPULATION | relaxation ofmuscle spasm(allwaveforms)3. Prevention ofpost-surgicalphlebo-thrombosisthroughimmediatestimulation of calfmuscles(allwaveforms)4. Increase of bloodflow in thetreatment area(allwaveforms)5. Prevention orretardation ofdisuse atrophy inpost-injury typeconditions(allwaveforms)6. Muscle re-education(allwaveforms)7. Maintaining orincreasing range ofmotion(allwaveforms) | 2. Temporaryrelaxation ofmuscle spasm3. Prevention ofpost-surgicalphlebo-thrombosisthroughimmediatestimulation ofcalf muscles4. Increase ofblood flow inthe treatmentarea.5. Prevention orretardation ofdisuse atrophyin post-injurytype conditions6. Muscle re-education7. Maintaining orincreasingrange ofmotion | |
| Adult patients | |||
| Design andAppearance | Image: BRH MEDICAL device | Image: Device with buttons and screen | |
| Size (HxWxD) | 22 x 16.5 x 12 in | 6 x 12 x 12 in | 67 X 26 X 35 in |
| Weight | 22 pounds | 10 pounds | 165 pounds |
| Design | The concept is to combine twokinds of therapeutic methods in a | The concept is to combinetwo kinds of therapeutic | The concept is tocombine two kinds of |
| compact unit. | methods in one device | therapeutic methods in one device | |
| Overall designdifference | Separate touch screen controlsboth ultrasound & neuromuscularstimulation | A membrane panel and atouch screen to set uptreatments | A membrane panel anda touch screen to set uptreatments |
| Materials | Metal enclosure | Metal enclosure | Metal enclosure |
| Housingmaterials | Folded into a box shape andseams welded & ground flush anda stylized ABS cover screwed ontometal box | Folded into a box shapeand seams welded &ground flush and a stylizedABS cover screwed ontometal box | Aluminum chassis |
| Performance | Use friendly interface, easy tooperate | Use friendly interface, easyto operate | Use friendly interface,easy to operate |
| Targetpopulation | Adult patients | Patients who needTherapeutic Ultrasound andor Electrotherapytreatments | Patients who needphysiotherapytreatment |
| Environment(s)of use | Physical therapy clinics; hospitals | Physical therapy clinics;hospitals | Physical therapy clinics;hospitals |
| BASIC UNIT CHARACTERISTICS | |||
| Power source | AC Line | AC Line | AC Line |
| Power input | 90-264 VAC, 50-60 Hz | 90-240VAC, 50-60Hz | 90-132VAC, 50-60Hz,4A;207-264VAC, 50Hz, 2A |
| Method Linecurrent isolation | YesIsolation transformer | Yes | Yes |
| Operatingtemperature | +50°F to +104°F | +50°F to +104°F | +50°F to +86°F |
| Humidity | Operating, 30% to 75% RH (notcondensed)Storage, 20% to 80% RH (notcondensed) | Operating, 30% to 75%Relative Humidity (RH) at104°FStorage, 5% to 95% RH (notcondensed) | Operating, 30% to 75%Relative Humidity at86°FNon operating, 20 to80% Relative Humidity,noncondensing |
| Storagetemperature | 40°F to 167°F | 40°F to 167°F | 32°F to 113°F0°C to 45°C |
| Indicator display | Yes | Yes | Yes |
| On/off status | |||
| Treatmenttimer | Treatment time counts down tozero when time is set | Treatment time countsdown to zero when time isset | Treatment time countsdown to zero when atime is set, or up to 30minutes when no time isset. The digital timerindicates the remainingor elapsed treatmenttime during the "Hold" |
| Timer Accuracy | |||
| ± 0.5 seconds for all times range | ±0.5 minutes for times lessthan 5 minutestl 0% for times from 5 to 10minutes±1.0 minute for timesgreater than 10 minutes | ± 5 seconds for all timesrange | |
| Number of channels | 2 | 2 | 2 |
| Software control | Yes | Yes | Yes |
| Automatic overload trip | Yes | Yes | Yes |
| Insulation | BF | BF | BF |
| Patient override control | Yes | Yes | Yes |
| Maximum Treatment Time | 30 minutes - ultrasound therapy30 minutes - neuromuscularstimulation | 30 minutes - ultrasoundtherapy60 minutes -neuromuscular stimulation | 30 minutes - ultrasoundtherapy30 minutes - neuromuscular stimulation |
| Treatment Timer | Treatment time counts down tozero when time is set, or up to 30minutes when no time is set. Thedigital timer indicates theremaining or elapsed treatmenttime during the 'Hold' period. | Treatment time countsdown to zero when time isset, or up to 60 or 30minutes when no time isset. The digital timerindicates the remaining orelapsed treatment timeduring the 'Hold' period | Treatment time countsdown to zero when timeis set, or up to 60 or 30minutes when no time isset. The digital timerindicates the remainingor elapsed treatmenttime during the 'Hold'period |
| Power Indicator | Yes | Yes | Yes |
| Operational Indicator | Yes | Yes | Yes |
| THERAPEUTIC ULTRASOUND | |||
| Transducer | 4 cm2 transducer | 5 cm2 transducer | 5 cm2 transducer |
| Frequencies | 1.0 MHz ± 5% to 3.0 MHz ± 5% | 1.0 MHz ± 5% to 3.0 MHz ±5% | 1.0 MHz ± 5% to 3.0MHz ± 5% |
| Modes | Continuous | ContinuousPulsed - 20% duty cyclePulsed - 50% duty cycle | Continuous |
| Pulse repetition rate | Not applicable | 100 Hz ± 20% | Unknown |
| Pulse duration | Not applicable | 2 msec±20%, 20% dutycycle | Unknown |
| Temporal peak /averageintensity ratio | Not applicable | 5:1±20%, 20% duty cycle | Unknown |
| Maximum | 8 W with at 4 cm2 applicator | 11 W with a5 cm2 | 7W with a5 cm2 |
| output power | (Ma-11cb) | applicator, (ME 1513) | applicator, |
| Maximum intensity | $2.0 W/cm^2$ | $2.2 W/cm^2$ | $1.5 W/cm^2$ |
| Indication Accuracy | ±20% (for any level above 10% of maximum) | ±20% (for any level above 10% of maximum) | ±20% (for any level above 10% of maximum) |
| Fixed treatment head placement | Not Applicable | Not Applicable | Unknown |
| Treatment head weight | 0.250 KG | Unknown | Unknown |
| Leakage current | $0.003 \mu A$ | Unknown | Unknown |
| Crystal material | PZT807 | Unknown | Unknown |
| Technology of ultrasound generation (e.g., piezoelectric, magnetostrictive) | Piezoelectric | Piezoelectric | Piezoelectric |
| Beam maximum intensity and accuracy (W/cm2) | 2 W/cm2±5% | Unknown | Unknown |
| THERAPEUTIC ULTRASONIC APPLICATOR SPECIFICATIONS | |||
| Applicator Part Number | Ma-11cb | ME7513 | |
| Treatment head dimensions | D4.5x 15.5cm | D5.5x 17cm | Unknown |
| Transducer contact face Biological evaluation | 303 stainless steel | 303 stainless steel | The output transducer utilizes a barium titanate disc with a specially coated face |
| Contact Monitor | Light on transducer | Light on transducer | Light on transducer |
| Frequency | 1.0 MHz ± 5% to 3.0 MHz ± 5% | 1.0 MHz ± 5% to 3.0 MHz ± 5% | 1.0 MHz ± 5% to 3.0 MHz ± 5% |
| Beam type | Collimated | Collimated or divergent | Collimated |
| Effective Radiating Area ERA | $4 cm^2$ ±10% | $5 cm^2$ ±10% | $5 cm^2$ ±10% |
| Maximum Beam Non Uniformity Ratio BNR | <5 | 6:1 | 6:1 |
| Peak | N/A | N/A | Unknown |
| rise vs. time andtissue depth to | |||
| Maximumtreatment time(for fixedtreatment headplacement) (°C) | N/A | N/A | |
| Maximumpatient contactsurfacetemperature oftreatment headunder simulated | Continually operated formaximum treatment time - 32.1°CUnder simulated use conditions | Unknown | Unknown |
| UltrasoundTimer range | 0 - 30 min | 0 - 30 min | 0 - 30 min |
| Automatic shutoff | Yes | Yes | Yes |
| power levelindicator display | Yes | Yes | Yes |
| ContactMonitor | Yes | Yes | Yes |
| UltrasoundPower Display | Yes | Yes | Unknown |
| NEUROMUSCULAR STIMULATION | |||
| Outputwaveforms | InterferentialNot applicableNot applicable | InterferentialMedium FrequencyBiphasic | Interferential |
| Treatmenttimer | 1-30 minutes±1% | 1-60 minutes±1% | 1-30 minutes±1% |
| Automatic shutoff | Yes | Yes | Yes |
| Current levelindicator display | Yes | Yes | Yes |
| Number ofoutput modes | 1 | 3 | 1 |
| Channel(s) | 2 | 2 | 2 |
| Synchronous oralternatingoutput channels | Synchronous | Synchronous | Synchronous |
| Max OutputCurrent (mA) | Interferential0-65±10% mA RMS, max$500\Omega$ - 65mA$2K\Omega$ - 27mA | Interferential0-65±10% mA RMS, max1Kohm load | Interferential0-35±10% mA RMS, max1Kohm load |
| N/A | Premodulated and mediumfrequency modes0-50±10% mA RMS, max1Kohm load | ||
| N/A | Biphasic mode0-99±10% mA peak, max1Kohm load | ||
| N/A | High volt mode0-2500±10% mA peak, max1Kohm load | ||
| N/A | Microamp mode10-990±10 μA peak, 1Kohmload | ||
| Max outputVoltage (V) | Interferential0-65v ±10% volts RMS500Ω - 42.6V2KΩ - 56V10KΩ - 14.8V | Interferential0-65±10% volts RMS,1Kohm loadPremodulated and mediumfrequency modes0-50±10% voltsRMS,1Kohm loadBiphasic mode99±10% volts peak, 1KohmloadHigh volt mode0-500±10% voltspeak,1Kohm loadMicroamp mode1.0±10% volt peak, 1Kohmload | Interferential0-36±30% volts RMS,1Kohm load |
| Regulatedcurrent orregulatedvoltage | Regulated current | Regulated current | Regulated current |
| Electrode size | Round, 2 inch diameter | Round, 1.5, 2, and 3 inchdiameter | Round 2 inch diameter |
| Maximumcurrent density(2 inch dia) | 3.2 mA/cm² at 500Ω3.2 mA/cm² at 1kΩ1.33 mA/cm² at 2kΩ0.08 mA/cm² at 10kΩ | Unknown3.2 mA/cm² at 1kΩUnknownUnknown | UnknownUnknownUnknownUnknown |
| Maximumpower density | 0.195 W/cm2 at 500kΩ ≤ 0.25W/cm²0.208 W/cm² at 1kΩ ≤ 0.25W/cm²0.074 W/cm2 at 2kΩ ≤ 0.25W/cm²0.0012 W/cm2 at 10kΩ ≤ 0.25W/cm² | Unknown0.208 W/cm² at 1kΩ ≤ 0.25W/cm²Unknown | UnknownUnknownUnknown |
| Compliancewith 21 CFR 898 | Yes | Yes | Yes |
| ElectrodeHousingmaterials andconstruction | No | No | No |
| Carrierfrequency | 4000 Hz | 4000 Hz | 4800 Hz |
| InterferentialFrequencyrange | Channel 1=4000HzChannel 2=4000 Hz to 4250 Hz ±1%(Interferential mode) | Channel 1=4000HzChannel 2=4000 Hz to 4250 Hz ±1%(Interferential mode) | Channel 1=4800HzChannel 2=4800Hz to 5050 Hz ±1%(Interferential mode) |
| Interferentialbeat frequencyPPS | 1-250 Hz in 5Hz increments | 1-250 Hz depending onselected program | 1-250 Hz depending onselected program |
| All Channels | InterferentialN/AN/A | InterferentialMedium FrequencyBiphasic | Interferential |
| Output Displays | Two simultaneously, amberchannel active indicators | Two simultaneously, amberchannel active indicators | Two simultaneously,amber channel activeindicators |
| ChannelIsolation | YesTransformer isolated | Yes | Yes |
| Automatic NoLoad Trip | Yes | Yes | Yes |
| Control Method | On/Off | On/Off or hold | On/Off or hold |
| Max LeakageCurrent (μA) | Chassis <100Electrodes <100 | Chassis <100Electrodes <100 | Chassis <100Electrodes <100 |
| Patient leakagecurrent (µA) | Normal condition – 0.004 μASingle fault condition - 0.014 μA | Unknown | Unknown |
| IndicatorDisplay UnitFunctioning | Yes | Yes | Yes |
| Low BatteryIndicator | N/A | N/A | N/A |
| 500 Ω (if zero,state method ofachieving zeronet charge) | |||
| Maximumphase charge(μC) at 500 Ω | 8.9 μC | Unknown | Unknown |
| ON time | 5 sec | 5 sec 10 sec | Unknown |
| OFF time | 30 sec | 5 ,10, 30 ,50 sec | 30 sec |
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Image /page/8/Picture/0 description: The image shows a logo for "BRK medical". The letters "BR" are in gray, with "medical" in teal below the letters. To the right of the letters is a teal figure with arms raised.
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Image /page/9/Picture/0 description: The image contains the logo for BRK medical. The logo has the letters "BR" in gray, with the word "medical" in blue underneath. To the right of the letters is a blue figure of a person with their arms raised.
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Image /page/10/Picture/0 description: The image shows a logo for "BRK medical". The letters "BR" are in gray, and the word "medical" is in a teal color. To the right of the letters "BR" is a teal-colored figure of a person with their arms raised.
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Image /page/11/Picture/0 description: The image shows the logo for BRK Medical. The logo features the letters 'BR' in a bold, gray font, stacked on top of the word 'medical' in a smaller, teal font. To the right of the letters 'BR' is a stylized figure of a person with their arms raised, also in teal, which forms the 'K' in 'BRK'.
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Image /page/12/Picture/0 description: The image shows the logo for BRK medical. The logo consists of the letters "BR" in gray, with the word "medical" in blue underneath. To the right of the letters is a blue figure of a person with their arms raised.
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Image /page/13/Picture/0 description: The image shows the logo for BRK medical. The letters "BR" are in gray, and the letter "K" is a stylized figure in teal. The word "medical" is in teal and is located below the letters "BRK".
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Image /page/14/Picture/0 description: The image shows a logo for BRK medical. The letters "BR" are in gray, and the word "medical" is in blue below the letters. To the right of the letters is a blue figure of a person with their arms raised. The figure is stylized and simple, with a circle for the head and lines for the body and limbs.
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Image /page/15/Picture/0 description: The image shows the logo for BRK medical. The logo consists of the letters "BR" in gray, with the word "medical" in blue underneath. To the right of the letters is a blue figure of a person with their arms raised.
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Image /page/16/Picture/0 description: The image contains a logo for "BRK medical". The logo has the letters "BR" in gray, with the letter "K" stylized as a blue figure with outstretched arms. Below the letters is the word "medical" in blue.
Discussion of Similarities and Differences between Subject BRH-A2 and Sonicator Plus 930 Predicate Device:
Based on aforementioned comparison chart the subject device is substantially equivalent to predicate device. Although there are differences in appearance, the Sonicator plus 930 and the BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS) system are comparable in what it provides in terms of treatment.
The following parameters are similar:
- User friendly interface, easy to operate
- Indicator Display Unit Functioning
- Operating and Storage Temperature and Humidity
- Ultrasound Frequencies ●
- Ultrasound mode (Continuous)
- Ultrasound Contact Monitor
- Ultrasound Beam type (Collimated)
- Ultrasound Timer range and automatic shut off
- Interferential waveform output parameters
- Power level indicator display
The following parameters are different:
- External appearance (Size and Weight)
- Ultrasound Maximum intensity ●
- Ultrasound Pulse mode ●
- Ultrasound treatment head dimensions
- Electrotherapy number of Output Waveforms
- Electrode size
The BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS) System has the same intended use and similar characteristics as the predicate device, the Sonicator Plus ® 930.
Moreover, bench testing and non-clinical testing documentation supplied in this submission demonstrates that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. Thus, the BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS) System are substantially equivalent to the predicate devices.
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Image /page/17/Picture/0 description: The image contains the logo for BRK medical. The logo has the letters "BR" in gray, with the word "medical" in blue underneath. To the right of the letters is a blue figure of a person with their arms raised.
Discussion of Similarities and Differences between Subject BRH-A2 and DU857 Predicate Device:
Based on aforementioned comparison chart the subject device is substantially equivalent to reference predicate device. Although there are differences in appearance, the DU857 and the BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS) system are comparable in what it provides in terms of treatment.
The following parameters are similar:
- 4-pole interferential current therapy using a quadpolar electrode configuration
- User friendly interface, easy to operate
- Indicator Display Unit Functioning
- Ultrasound Frequencies ●
- Ultrasound mode (Continuous)
- Ultrasound Contact Monitor .
The following parameters are different:
- Housing Materials
- . Operating Temperature
- External appearance (Size and Weight) .
- Humidity
- Storage Temperature
- Treatment Timer
- Transducer
- Maximum Output Power for Ultrasound
- Maximum Intensity for Ultrasound
The BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS) System has the same intended use and similar characteristics as the reference predicate device, the DU857. Moreover, bench testing and non-clinical testing documentation supplied in this submission demonstrates that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. Thus, the BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS) System are substantially equivalent to the reference predicate devices.
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Image /page/18/Picture/0 description: The image shows the logo for BRK medical. The letters "BR" are in gray, and the letter "K" is stylized to look like a person with their arms raised. The word "medical" is written in blue below the letters "BRK". The logo is simple and modern, and it is likely used to represent a medical company or organization.
Performance testing:
Testing information demonstrating performance of BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS) device in the intended environment of use is supported by testing that was conducted in accordance with FDA recognized standards as follows:
The following testing was conducted to prove safety and effectiveness as well as Substantial equivalence to the predicate devices:
| Item | Test Name | Results |
|---|---|---|
| 1 | ANSI/AAMI ES60601-1:2005/(R) 2012 and A1:2012, C1:2009/(R) 2012 andA2:2010/(R) 2012 (Consolidated Text) "Medical electrical equipment. Part1: General requirements for safety and essential performance" | Passed all testingrequirements |
| 2 | IEC 60601-2-5:2009 Medical electrical equipment. Part 2-5: Particularrequirements for the safety of ultrasonic-physiotherapy equipment" | Passed all testingrequirements |
| 3 | IEC 60601-2-10 Edition 2.0 2012-06 “Medical electrical equipment. Part 2-10 Particular requirements for the safety and essential performance ofnerve and muscle stimulators. | Passed all testingrequirements |
| 4 | ISO 14971:2007 "Medical devices – Application of risk management tomedical devices” including residual risks evaluation. | Passed all testingrequirements |
| 5 | IEC 60601-1-6 Edition 3.1 2013-10 "Medical electrical equipment. Part 1-6:General requirements for basic safety and essential performance –Collateral Standard: Usability" | Passed all testingrequirements |
| 6 | IEC 60601-1-8:2006 & A1:2012 "Medical electrical equipment. Part 1-8:General requirements for basic safety and essential performance–Collateral Standard: General requirements, tests and guidance for alarmsystems in medical electrical equipment and medical electrical systems" | Passed all testingrequirements |
| 7 | IEC 60601-1-2: 2007 /AC: 2010 “Medical electrical equipment. Part 1-2:Electromagnetic compatibility – Requirements and tests" | Passed all testingrequirements |
| 8 | IEC 62304 Edition 1.1 2015-06 "Medical Device Software Development" | Passed all testingrequirements |
| 9 | ISO 13485:2016 Medical devices -- Quality management systems --Requirements for regulatory purposes | Passed all testingrequirements |
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Image /page/19/Picture/0 description: The image shows the logo for BRK medical. The letters "BR" are in gray, and the letter "K" is stylized in teal to resemble a person with their arms raised. Below the letters, the word "medical" is written in teal.
Conclusion:
The BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS) has similar indications for use to the Sonicator predicate device and identical indications for use to the DU857 predicate with similar technological characteristics to both predicate devices. Any differences in the predicates' technological characteristics do not raise any new questions of safety or effectiveness. Thus, the BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS) System is substantially equivalent to the predicate devices
§ 890.5300 Ultrasonic diathermy.
(a)
Ultrasonic diathermy for use in applying therapeutic deep heat for selected medical conditions —(1)Identification. An ultrasonic diathermy for use in applying therapeutic deep heat for selected medical conditions is a device that applies to specific areas of the body ultrasonic energy at a frequency beyond 20 kilohertz and that is intended to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies.(2)
Classification. Class II (performance standards).(b)
Ultrasonic diathermy for all other uses —(1)Identification. An ultrasonic diathermy for all other uses except for the treatment of malignancies is a device that applies to the body ultrasonic energy at a frequency beyond 20 kilohertz and that is intended for the treatment of medical conditions by means other than the generation of deep heat within body tissues as described in paragraph (a) of this section.(2)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP for a device described in paragraph (b) of this section is required to be filed with the Food and Drug Administration on or before July 13, 1999, for any ultrasonic diathermy described in paragraph (b) of this section that was in commercial distribution before May 28, 1976, or that has, on or before July 13, 1999, been found to be substantially equivalent to an ultrasonic diathermy described in paragraph (b) of this section that was in commercial distribution before May 28, 1976. Any other ultrasonic diathermy described in paragraph (b) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.