Who is the manufacturer of JAS Pulse(TM) Ultrasonic Therapy?

Bonutti Research, Inc. filed the 510(k) submission for JAS Pulse(TM) Ultrasonic Therapy (K161628).

What is the FDA product code for JAS Pulse(TM) Ultrasonic Therapy?

IMI. It is classified under 21 CFR 890.5300 as a Class 2 device in the Physical Medicine panel.

What is the regulatory pathway for JAS Pulse(TM) Ultrasonic Therapy?

510(k) clearance (submission type: Abbreviated).

Who can help prepare an FDA 510(k) submission like JAS Pulse(TM) Ultrasonic Therapy?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

JAS Pulse(TM) Ultrasonic Therapy

Q: What are the predicate devices for JAS Pulse(TM) Ultrasonic Therapy?

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

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)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image is a logo for the Department of Health & Human Services - USA. The logo is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is an emblem that features a stylized representation of three human profiles facing to the right, with flowing lines beneath them that could represent water or fabric. 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 {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 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 {2}------------------------------------------------ # 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) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 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: (217) 342-3412, ext. 5106 Fax: (217) 342-1043 ### 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) {4}------------------------------------------------ ### 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. {5}------------------------------------------------ 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. {6}------------------------------------------------ | Device Feature/ Manufacturer | JAS Pulse Subject Device | Ito US-101L Primary Predicate | IBRAMED Sonopulse Compact 1MHz Predicate Device | Zimmer Soleo Sono Predicate Device | Comparison to Predicates | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) | Current (K161628) | K112520 | K131309 | K121059 | Current to Predicates | | 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, ○ Bursitis with slight calcification, ○ Myositis, ○ Soft tissue injuries, and ○ Shortened tendons due to past injuries and scar tissues. • Relief of pain, muscle spasms, and joint contractures resulting from: ○ Capsular tightness, and ○ Capsular scarring. • Localized increase in blood flow. • Increased range of motion of contracted joints using heat and stretch techniques. | The US-101L, US-103S are indicated for use in applying therapeutic deep heat in body tissue for the treatment of selected medical conditions including for relief of pain, muscle spasms, & joint contractures. | Therapeutic ultrasound • Pain relief • Reduction of muscle spasms • Localized increase in blood flow • Increase range of motion of contracted joints using heat & stretch techniques. | Ultrasound Therapy Relief of pain, muscle spasms, & joint contractures Relief of pain, muscle spasms, & joint contractures that may be associated with: • Adhesive capsulitis • Bursitis with slight calcification • Myositis • Soft tissue injuries • Shortened tendons due to past injuries & scare tissues. Relief of pain, muscle spasms, & joint contractures resulting from: • Capsular tightness • Capsular scarring | Identical to Soleo Sono: (1) Relief of pain, muscle spasms, & joint contractures. (2) Relief of pain, muscle spasms, & joint contractures that may be associated with: • Adhesive capsulitis • Bursitis with slight calcification • Myositis • Soft tissue injuries • Shortened tendons due to past injuries & scare tissues. Identical to Sonopulse: (1) Localized increase in blood flow. (2) Increased range of motion of contracted joints. | | Device Feature/ Manufacturer | JAS Pulse Subject Device | Ito US-101L Primary Predicate | IBRAMED Sonopulse Compact 1MHz Predicate Device | Zimmer Soleo Sono Predicate Device | Comparison to Predicates | | 510(k) | Current (K161628) | K112520 | K131309 | K121059 | Current to Predicates | | System Components | ABS plastic material with screw assembly construction The transducer is constructed of Ultem plastic with a molded silicone grip | Plastic enclosure with handheld transducer applicator. | Plastic enclosure with handheld transducer applicator. | PC-ABS plastic material with screw assembly construction | Identical in plastic construction to each predicate. | | Console/generator Dimensions (L x 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 not adversely affect safety and effectiveness of the subject device | | Console/generator Weight (kg) | 0.151 kg (with transducer) | 0.200 kg (with transducer) | 1.400 kg (with transducer) | 2.100 kg | Different, but does not adversely affect safety and effectiveness of the subject device | | Treatment head dimensions (L x W x H cm) | 6.35cm x 2.54cm x 2.54cm | 13.4 cm x 5.9 cm x 5.5 cm | 20cm x 6.35cm x 6.35cm | 23cm x 5cm x 5cm | Different, but does not adversely impact safety and effectiveness of the subject device | | Treatment head weight (kg) | 0.026kg | 0.200 kg (with generator) | 1.400 kg (with generator) | 0.850kg | Different, but does not adversely impact safety and effectiveness of the subject device | | Power Source | AC Line 100-240V 50/60 Hz | AC 100-240 V 50/60 Hz | AC Line 100-240V 50/60 Hz | AC 100-240 V 50/60 Hz | Identical power source specifications. | | Device Feature/ Manufacturer | JAS Pulse Subject Device | Ito US-101L Primary Predicate | IBRAMED Sonopulse Compact 1MHz Predicate Device | Zimmer Soleo Sono Predicate Device | Comparison to Predicates | | 510(k) | Current (K161628) | K112520 | K131309 | K121059 | Current to Predicates | | Patient Leakage Current: Normal Condition | 3uA Meets IEC 60601-1, section 8.7 LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS | Information not provided in the publically available 510(k) | Information not provided in the publically available 510(k) | < 1mA | Similar | | Patient Leakage Current: Single Fault Condition | 5uA Meets IEC 60601-1, section 8.7 LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS | Information not provided in the publically available 510(k) | Information not provided in the publically available 510(k) | <0.5mA | Similar. | | Crystal material | PZT | PZT | PZT | PZT | Identical to each predicate. | | Technology of ultrasound generation | Piezoelectric | Piezoelectric | Piezoelectric | Piezoelectric | Identical to each predicate in piezoelectric technology to generate ultrasound energy is industry standard. | | Acoustic working frequency and accuracy | 1.0 MHz ± 10% | 1.0 MHz ± 10% | 1.1 MHz ± 10% | 0.8 MHz ± 10% 2.4 MHz ± 10% | Within range of ultrasound diathermy devices per CFR 890.5300 (a) | | Treatment Waveform Modes | Pulsed & Continuous | Pulsed & Continuous | Pulsed & Continuous | Pulsed & Continuous | Identical to each predicate. | | Device Feature/ Manufacturer | JAS Pulse Subject Device | Ito US-101L Primary Predicate | IBRAMED Sonopulse Compact 1MHz Predicate Device | Zimmer Soleo Sono Predicate Device | Comparison to Predicates | | 510(k) | Current (K161628) | K112520 | K131309 | K121059 | Current to Predicates | | Timer settings and accuracy | 0 - 15 minutes ± 0.2 minutes | 0 - 30 minutes ± 1 minute | 0 - 30 minutes (accuracy not listed) | 0 - 30 minutes (accuracy not listed) | Equivalent to each predicate. Treatment time is determined by size of treatment site. JAS Pulse allows for multiple sessions to treat larger areas as noted in JAS Pulse Instruction Manual. | | Beam Type | Collimated | Collimated | Collimated | Collimated | Identical to each predicate. | | Applicator Size | Diameter: 2.56 cm Area: 5.15 cm² | Diameter:2.1cm Area: 3.5 cm² | Diameter: 3cm Area: 7cm² | Diameter: 1.3 cm Area: 1 cm² | Different but does not adversely impact safety and effectiveness of the subject device. | | Maximum value of the effective intensity and accuracy (not to exceed 3W/cm²) | Continuous (High): 1.4 W/ cm² Pulsed (Low): 0.7 W/ cm² (all values ± 20%) | Continuous: 2 W/cm² Pulsed: 3 W/cm² (all values ± 20%) | Continuous: 3.0 W/ cm² Pulsed: 3.0 W/cm² (all values ± 20%) | Continuous: 1W/cm² (800kHz) 1.1W/cm² (2.4MHz) Pulsed: 1W/cm² (800kHz) 1.1W/cm² (2.4MHz) (all values ± 20%) | Different but does not adversely impact safety and effectiveness of the subject device and complies with IEC60601-2-5 | | Device Feature/ Manufacturer | JAS Pulse Subject Device | Ito US-101L Primary Predicate | IBRAMED Sonopulse Compact 1MHz Predicate Device | Zimmer Soleo Sono Predicate Device | Comparison to Predicates | | 510(k) | Current (K161628) | K112520 | K131309 | K121059 | Current to Predicates | | Output Power | Continuous (High): 1.59W Pulsed (Low): 0.79W (all values ± 20%) | Continuous: 0 - 11 W Pulsed: 0 - 16.5 W (all values ± 20%) | Continuous: 7 cm² : 0.7 - 21 W Pulsed: 7 cm² : 0.7 - 21 W (all values ± 20%) | Continuous: 1cm²: 0 - 1W (800kHz) 0 - 0.6W (2.4MHz) Pulsed: 1cm²: 0 - 1W (800kHz) 0 - 0.6W (2.4MHz) (all values…

JAS Pulse(TM) Ultrasonic Therapy

Device Facts

Indications for Use

Device Story

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JAS Pulse(TM) Ultrasonic Therapy

Device Facts

Indications for Use

Device Story

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Indications for Use

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Submission Summary (Full Text)

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