JAS Pulse(TM) Ultrasonic Therapy

K161628 · Bonutti Research, Inc. · IMI · Nov 10, 2016 · Physical Medicine

Device Facts

• Record ID: K161628
• Device Name: JAS Pulse(TM) Ultrasonic Therapy
• Applicant: Bonutti Research, Inc.
• Product Code: IMI · Physical Medicine
• Decision Date: Nov 10, 2016
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 890.5300
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Application of therapeutic ultrasound for: · Pain. - · Pain relief, muscle spasms, and joint contractures. - · Relief of pain, muscle spasms, and joint contractures that may be associated with: - o Adhesive capsulitis. - o Bursitis with slight calcification, - o Myositis, - o Soft tissue injuries, and - o Shortened tendons due to past injuries and scar tissues. - · Relief of pain, muscle spasms, and joint contractures resulting from: - o Capsular tightness, and - o Capsular scarring. - · Localized increase in blood flow. - · Increased range of motion of contracted joints using heat and stretch techniques.

Device Story

JAS Pulse is a handheld ultrasonic diathermy device for physical medicine. Input: electrical power; Output: 1MHz high-frequency sound waves via handheld transducer. Operation: user selects power levels/time intervals on control unit; device delivers continuous or pulsed ultrasound to patient tissue using ultrasonic gel for coupling. Used in clinical settings by healthcare providers to treat pain, muscle spasms, and joint contractures. Benefits: deep heat application stimulates blood flow, reduces spasms, and facilitates stretching to improve joint range of motion. Provider uses output to manage musculoskeletal conditions.

Clinical Evidence

Bench testing only. No clinical data provided. Evidence consists of electrical safety and electromagnetic compatibility (EMC) testing per IEC 60601-1, IEC 60601-2-5, and IEC 60601-1-2, alongside software verification and validation.

Technological Characteristics

Handheld ultrasonic diathermy device; piezoelectric PZT crystal transducer; ABS/Ultem plastic construction; 1MHz operating frequency; continuous (1.4 W/cm2) and pulsed (0.7 W/cm2) modes; AC line powered (100-240V); collimated beam; software-controlled user interface for power/time selection; complies with IEC 60601-1, 60601-1-2, 60601-1-6, 60601-2-5, and AAMI 62366.

Indications for Use

Indicated for patients requiring therapeutic deep heat for pain relief, reduction of muscle spasms, and treatment of joint contractures associated with adhesive capsulitis, bursitis, myositis, soft tissue injuries, and shortened tendons/scar tissue. Also indicated for localized blood flow increase and range of motion improvement.

Regulatory Classification

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.

Predicate Devices

• Ito US-101L (K112520)
• IBRAMED Sonopulse Compact 1 MHz (K131309)
• Zimmer Soleo Sono (K121059)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 10, 2016

Bonutti Research, Inc. Patrick G. Balsmann Director, Regulatory/Clinical Affairs & OA P.O. Box 1367 Effingham, Illinois 62401

Re: K161628

Trade/Device Name: JAS Pulse™ Ultrasonic Therapy Regulation Number: 21 CFR 890.5300 Regulation Name: Ultrasonic Diathermy Regulatory Class: Class II Product Code: IMI Dated: October 6, 2016 Received: October 11, 2016

Dear Patrick G. Balsmann:

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

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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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Michael J. Hoffmann -A

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) K161628

Device Name JAS Pulse™ Ultrasonic Therapy

Indications for Use (Describe)

Application of therapeutic ultrasound for:

· Pain.

- · Pain relief, muscle spasms, and joint contractures.
- · Relief of pain, muscle spasms, and joint contractures that may be associated with:
- o Adhesive capsulitis.
- o Bursitis with slight calcification,
- o Myositis,
- o Soft tissue injuries, and
- o Shortened tendons due to past injuries and scar tissues.
- · Relief of pain, muscle spasms, and joint contractures resulting from:
- o Capsular tightness, and
- o Capsular scarring.
- · Localized increase in blood flow.
- · Increased range of motion of contracted joints using heat and stretch techniques.

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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# Bonutti Research, Inc. - JAS Pulse™ Ultrasonic Therapy

### November 9, 2016

# ABBREVIATED 510(k) SUMMARY

The following information is submitted in accordance with the requirements of 21 CFR 807.92:

#### I. SUBMITTER:

Bonutti Research, Inc., P.O. Box 1367 Effingham, Illinois 62401

## Contact Person:

Patrick Balsmann, MBA, MS, RAC Director, Regulatory/Clinical Affairs & QA Phone: [phone], ext. 5106 Fax: [phone]

### Date Prepared:

October 6, 2016

- II. DEVICE:
Name of Device: JAS Pulse™ (JAS Pulse) Ultrasonic Therapy Common Name: Therapeutic Ultrasound Classification Name: Ultrasonic diathermy. For Use In Applying Therapeutic Deep Heat (21 CFR 890.5300) Regulatory Class: II Product Code: IMI

#### III. PREDICATE DEVICE(S)

Ito US-101L (K112520) - Primary Predicate IBRAMED Sonopulse Compact 1 MHz (K131309) Zimmer Soleo Sono (K121059)

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### IV. DEVICE DESCRIPTION

The JAS Pulse is a physical medicine ultrasonic diathermy device. The JAS Pulse device consists of a handheld transducer that generates high frequency sound waves. These sound waves penetrate tissue and are used to treat injured or painful areas of the body in order to alleviate symptoms and to stimulate blood flow. The handheld device is intended to be single patient use and is used with ultrasonic gels to facilitate coupling to the patient's skin surface and to enhance ultrasonic penetration.

Components of the JAS Pulse device include the handheld electrical control unit with user interface to select treatment power levels and time intervals. The controller drives the handheld treatment applicator to provide continuous and pulsed 1MHz therapeutic ultrasound. Ultrasonic gels applied to the user's area of pain facilitate ultrasonic coupling and penetration to facilitate the therapeutic ultrasound.

### V. INDICATIONS FOR USE

Application of therapeutic ultrasound for:

- Pain.
- Pain relief, muscle spasms, and joint contractures.
- Relief of pain, muscle spasms, and joint contractures that may be associated . with:
- Adhesive capsulitis. O
- o Bursitis with slight calcification,
- Mvositis. о
- Soft tissue injuries, and O
- Shortened tendons due to past injuries and scar tissues. о
- Relief of pain, muscle spasms, and joint contractures resulting from: ●
- o Capsular tightness, and
- 0 Capsular scarring.
- Localized increase in blood flow. ●
- . Increased range of motion of contracted joint using heat and stretch techniques.

Comparisons of the JAS Pulse device to its predicate devices indications demonstrate its substantial equivalence as follows:

Identical to Ito US-101L (K112520) - Primary Predicate: (1) Relief of pain, muscle spasms, & joint contractures.

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Identical to Zimmer Soleo Sono (K121059):

- Relief of pain, muscle spasms, & joint contractures. (1)
- Relief of pain, muscle spasms, & joint contractures that may be associated (2) with:
- Adhesive capsulitis .
- . Bursitis with slight calcification
- . Myositis
- Soft tissue injuries
- . Shortened tendons due to past injuries & scare tissues.

Identical to Sonopulse Compact 1 MHz (K131309):

- Localized increase in blood flow. (1)
- Increased range of motion of contracted joints. (2)

### VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE DEVICES

The table on the following pages demonstrates substantial equivalence of the JAS Pulse device to its predicate devices in terms of indications for use and technological characteristics:

The JAS Pulse device has two operating modes: High and Low. The High mode produces a continuous waveform at an acoustic intensity of 1.4 W/cm2 (Output Power of 1.59 W). The predicate devices are also able to operate a continuous waveform at the same intensity. The Low mode produces a pulsed waveform with a duty cycle of 50% and pulse repetition of 10 ms (100Hz). The acoustic intensity produced during Low mode is 0.7W/cm2 (Output Power of 0.79 W). The predicate devices can also operate with the same duty cycle, pulse repetition and acoustic intensity.

Regarding technological characteristics, the maximum effective intensity of the JAS Pulse is 1.4W/cm2 (Continuous) and 0.7 W/cm2 (Pulsed), while the Sonopulse is 3 W/cm2, the US-101L is 2 W/cm2 (Continuous) and 3 W/cm2 (Pulsed), and the Soleo Sono is 1W/cm². The maximum output power of the JAS Pulse is 1.59 W (Continuous) and 0.79 W (Pulsed), while the Sonopulse 21 W, the US-101L is 11 W (Continuous) and 16.5 W (Pulsed), and the Soleo Sono is 1 W. The ERA of the JAS Pulse is 1.133 cm compared to 1 cm2 (Sonopulse), 5.5 cm2 (US-101L). or 7 cm2 (Soleo Sono). Differences between the JAS Pulse and the predicate devices were evaluated in performance and effectiveness testing and the JAS Pulse was found to be substantially equivalent to the predicate devices.

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| Device Feature/<br>Manufacturer | JAS Pulse<br>Subject Device | Ito<br>US-101L<br>Primary Predicate | IBRAMED<br>Sonopulse Compact 1MHz<br>Predicate Device | Zimmer<br>Soleo Sono<br>Predicate Device | Comparison to<br>Predicates |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | Current (K161628) | K112520 | K131309 | K121059 | Current to Predicates |
| Indications for<br>Use | Application of therapeutic<br>ultrasound for:<br>• Pain.<br>• Pain relief, muscle spasms,<br>and joint contractures.<br>• Relief of pain, muscle<br>spasms, and joint<br>contractures that may be<br>associated with:<br>○ Adhesive capsulitis,<br>○ Bursitis with slight<br>calcification,<br>○ Myositis,<br>○ Soft tissue injuries,<br>and<br>○ Shortened tendons<br>due to past injuries<br>and scar tissues.<br>• Relief of pain, muscle<br>spasms, and joint<br>contractures resulting<br>from:<br>○ Capsular tightness,<br>and<br>○ Capsular scarring.<br>• Localized increase in<br>blood flow.<br>• Increased range of motion<br>of contracted joints using<br>heat and stretch<br>techniques. | The US-101L, US-103S<br>are indicated for use in<br>applying therapeutic<br>deep heat in body tissue<br>for the treatment of<br>selected medical<br>conditions including for<br>relief of pain, muscle<br>spasms, & joint<br>contractures. | Therapeutic ultrasound<br>• Pain relief<br>• Reduction of muscle spasms<br>• Localized increase in blood flow<br>• Increase range of motion of<br>contracted joints using heat &<br>stretch techniques. | Ultrasound Therapy<br>Relief of pain, muscle<br>spasms, & joint<br>contractures<br>Relief of pain, muscle<br>spasms, & joint<br>contractures that may be<br>associated with:<br>• Adhesive capsulitis<br>• Bursitis with slight<br>calcification<br>• Myositis<br>• Soft tissue injuries<br>• Shortened tendons due<br>to past injuries & scare<br>tissues.<br>Relief of pain, muscle<br>spasms, & joint<br>contractures resulting<br>from:<br>• Capsular tightness<br>• Capsular scarring | Identical to Soleo<br>Sono:<br>(1) Relief of pain,<br>muscle spasms,<br>& joint<br>contractures.<br>(2) Relief of pain,<br>muscle spasms,<br>& joint<br>contractures that<br>may be<br>associated with:<br>• Adhesive<br>capsulitis<br>• Bursitis with<br>slight<br>calcification<br>• Myositis<br>• Soft tissue<br>injuries<br>• Shortened<br>tendons due to<br>past injuries &<br>scare tissues.<br>Identical to<br>Sonopulse:<br>(1) Localized<br>increase in<br>blood flow.<br>(2) Increased range<br>of motion of<br>contracted<br>joints. |
| Device Feature/<br>Manufacturer | JAS Pulse<br>Subject Device | Ito<br>US-101L<br>Primary Predicate | IBRAMED<br>Sonopulse Compact 1MHz<br>Predicate Device | Zimmer<br>Soleo Sono<br>Predicate Device | Comparison to<br>Predicates |
| 510(k) | Current (K161628) | K112520 | K131309 | K121059 | Current to Predicates |
| System<br>Components | ABS plastic material with<br>screw assembly construction<br>The transducer is constructed<br>of Ultem plastic with a molded<br>silicone grip | Plastic enclosure with<br>handheld transducer<br>applicator. | Plastic enclosure with handheld<br>transducer applicator. | PC-ABS plastic material<br>with screw assembly<br>construction | Identical in plastic<br>construction to each<br>predicate. |
| Console/generator<br>Dimensions (L x<br>W x H) | 10.5cm x 6.7cm x 2.5cm | 5.5cm x 5.9cm x 13.4cm | 16.6cm x 27cm x 12.5cm | 32.2cm x 23.4cm x 13cm | Different, but does<br>not adversely affect<br>safety and<br>effectiveness of the<br>subject device |
| Console/generator<br>Weight (kg) | 0.151 kg<br>(with transducer) | 0.200 kg<br>(with transducer) | 1.400 kg<br>(with transducer) | 2.100 kg | Different, but does<br>not adversely affect<br>safety and<br>effectiveness of the<br>subject device |
| Treatment head<br>dimensions (L x<br>W x H cm) | 6.35cm x 2.54cm x 2.54cm | 13.4 cm x 5.9 cm x 5.5<br>cm | 20cm x 6.35cm x 6.35cm | 23cm x 5cm x 5cm | Different, but does<br>not adversely impact<br>safety and<br>effectiveness of the<br>subject device |
| Treatment head<br>weight (kg) | 0.026kg | 0.200 kg<br>(with generator) | 1.400 kg<br>(with generator) | 0.850kg | Different, but does<br>not adversely impact<br>safety and<br>effectiveness of the<br>subject device |
| Power Source | AC Line 100-240V<br>50/60 Hz | AC 100-240 V<br>50/60 Hz | AC Line 100-240V<br>50/60 Hz | AC 100-240 V<br>50/60 Hz | Identical power<br>source specifications. |
| Device Feature/<br>Manufacturer | JAS Pulse<br>Subject Device | Ito<br>US-101L<br>Primary Predicate | IBRAMED<br>Sonopulse Compact 1MHz<br>Predicate Device | Zimmer<br>Soleo Sono<br>Predicate Device | Comparison to<br>Predicates |
| 510(k) | Current (K161628) | K112520 | K131309 | K121059 | Current to Predicates |
| Patient Leakage<br>Current: Normal<br>Condition | 3uA<br>Meets IEC 60601-1, section 8.7<br>LEAKAGE CURRENTS<br>and<br>PATIENT AUXILIARY<br>CURRENTS | Information not provided<br>in the publically<br>available 510(k) | Information not provided in the<br>publically available 510(k) | < 1mA | Similar |
| Patient Leakage<br>Current: Single<br>Fault Condition | 5uA<br>Meets IEC 60601-1, section 8.7<br>LEAKAGE CURRENTS<br>and<br>PATIENT AUXILIARY<br>CURRENTS | Information not provided<br>in the publically<br>available 510(k) | Information not provided in the<br>publically available 510(k) | <0.5mA | Similar. |
| Crystal material | PZT | PZT | PZT | PZT | Identical to each<br>predicate. |
| Technology of<br>ultrasound<br>generation | Piezoelectric | Piezoelectric | Piezoelectric | Piezoelectric | Identical to each<br>predicate in<br>piezoelectric<br>technology to<br>generate ultrasound<br>energy is industry<br>standard. |
| Acoustic working<br>frequency and<br>accuracy | 1.0 MHz ± 10% | 1.0 MHz ± 10% | 1.1 MHz ± 10% | 0.8 MHz ± 10%<br>2.4 MHz ± 10% | Within range of<br>ultrasound diathermy<br>devices per CFR<br>890.5300 (a) |
| Treatment<br>Waveform Modes | Pulsed & Continuous | Pulsed & Continuous | Pulsed & Continuous | Pulsed & Continuous | Identical to each<br>predicate. |
| Device Feature/<br>Manufacturer | JAS Pulse<br>Subject Device | Ito<br>US-101L<br>Primary Predicate | IBRAMED<br>Sonopulse Compact 1MHz<br>Predicate Device | Zimmer<br>Soleo Sono<br>Predicate Device | Comparison to<br>Predicates |
| 510(k) | Current (K161628) | K112520 | K131309 | K121059 | Current to Predicates |
| Timer settings<br>and accuracy | 0 - 15 minutes ± 0.2 minutes | 0 - 30 minutes ± 1<br>minute | 0 - 30 minutes<br>(accuracy not listed) | 0 - 30 minutes<br>(accuracy not listed) | Equivalent to each<br>predicate.<br>Treatment time is<br>determined by size of<br>treatment site. JAS<br>Pulse allows for<br>multiple sessions to<br>treat larger areas as<br>noted in JAS Pulse<br>Instruction Manual. |
| Beam Type | Collimated | Collimated | Collimated | Collimated | Identical to each<br>predicate. |
| Applicator Size | Diameter: 2.56 cm<br>Area: 5.15 cm² | Diameter:2.1cm<br>Area: 3.5 cm² | Diameter: 3cm<br>Area: 7cm² | Diameter: 1.3 cm<br>Area: 1 cm² | Different but does<br>not adversely impact<br>safety and<br>effectiveness of the<br>subject device. |
| Maximum value<br>of the effective<br>intensity and<br>accuracy (not to<br>exceed 3W/cm²) | Continuous (High): 1.4 W/ cm²<br>Pulsed (Low): 0.7 W/ cm²<br>(all values ± 20%) | Continuous: 2 W/cm²<br>Pulsed: 3 W/cm²<br>(all values ± 20%) | Continuous: 3.0 W/ cm²<br>Pulsed: 3.0 W/cm²<br>(all values ± 20%) | Continuous:<br>1W/cm² (800kHz)<br>1.1W/cm² (2.4MHz)<br>Pulsed:<br>1W/cm² (800kHz)<br>1.1W/cm² (2.4MHz)<br>(all values ± 20%) | Different but does<br>not adversely impact<br>safety and<br>effectiveness of the<br>subject device and<br>complies with<br>IEC60601-2-5 |
| Device Feature/<br>Manufacturer | JAS Pulse<br>Subject Device | Ito<br>US-101L<br>Primary Predicate | IBRAMED<br>Sonopulse Compact 1MHz<br>Predicate Device | Zimmer<br>Soleo Sono<br>Predicate Device | Comparison to<br>Predicates |
| 510(k) | Current (K161628) | K112520 | K131309 | K121059 | Current to Predicates |
| Output Power | Continuous (High): 1.59W<br>Pulsed (Low): 0.79W<br>(all values ± 20%) | Continuous: 0 - 11 W<br>Pulsed: 0 - 16.5 W<br>(all values ± 20%) | Continuous: 7 cm² : 0.7 - 21 W<br>Pulsed: 7 cm² : 0.7 - 21 W<br>(all values ± 20%) | Continuous:<br>1cm²: 0 - 1W (800kHz)<br>0 - 0.6W (2.4MHz)<br>Pulsed:<br>1cm²: 0 - 1W (800kHz)<br>0 - 0.6W (2.4MHz)<br>(all values…