· 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 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.

AI/ML Overview

This document is a 510(k) premarket notification for the "JAS Pulse™ Ultrasonic Therapy" device. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study. Therefore, much of the requested information (like sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone performance) is not applicable or present in this type of regulatory submission.

However, based on the provided text, we can extract the acceptance criteria in terms of technical performance and safety standards, and confirm that the device meets these criteria through various non-clinical performance data.

Here's a breakdown of the information that can be extracted, and an explanation of why other requested information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are defined by the technical specifications of the predicate devices and compliance with recognized standards. The "Comparison to Predicates" column effectively serves as the reported device performance relative to these criteria.

Device Feature/Criterion	Acceptance Criteria (from Predicates / Standards)	Reported Device Performance (JAS Pulse)	Conclusion
Indications for Use	Consistent with predicate devices for therapeutic ultrasound applications (e.g., pain relief, muscle spasms, joint contractures, localized increase in blood flow, increased ROM).	Identical to various aspects of predicate devices.	Equivalent
System Components	Plastic enclosure, handheld transducer applicator.	ABS plastic with screw assembly, Ultem plastic transducer with molded silicone grip.	Identical in plastic construction to each predicate.
Power Source	AC Line 100-240V, 50/60 Hz.	AC Line 100-240V, 50/60 Hz.	Identical.
Crystal Material	PZT (Piezoelectric ceramic).	PZT.	Identical.
Technology of Ultrasound Generation	Piezoelectric.	Piezoelectric.	Identical (industry standard).
Acoustic Working Frequency	Within range of 1.0 MHz ± 10% (some predicates list 0.8 MHz to 2.4 MHz).	1.0 MHz ± 10%.	Within range of ultrasound diathermy devices per CFR 890.5300 (a).
Treatment Waveform Modes	Pulsed & Continuous.	Pulsed & Continuous.	Identical.
Timer Settings & Accuracy	0-30 minutes, with varying accuracies listed for predicates.	0 - 15 minutes ± 0.2 minutes.	Equivalent (treatment time dependent on area, multiple sessions allowed for larger areas).
Beam Type	Collimated.	Collimated.	Identical.
Maximum Effective Intensity	Not to exceed 3 W/cm² (with ±20% accuracy specified for predicates).	Continuous (High): 1.4 W/cm² ± 20%; Pulsed (Low): 0.7 W/cm² ± 20%.	Different from some predicates but within standard and complies with IEC60601-2-5.
Maximum Output Power	Various values (e.g., 0-21W for predicates, with ±20% accuracy).	Continuous (High): 1.59W ± 20%; Pulsed (Low): 0.79W ± 20%.	Similar to Soleo Sono; different from others but complies with IEC60601-2-5.
Maximum Temporal-Maximum Output Power	Various values (e.g., 1-21W for predicates, with ±20% accuracy).	Continuous (High): 1.59W ± 20%; Pulsed (Low): 0.79W ± 20%.	Different from some predicates but complies with IEC60601-2-5.
Maximum Temporal-Maximum Intensity	Various values (e.g., 1-3 W/cm² for predicates, with ±20% accuracy).	Continuous (High): 1.4 W/cm² ± 20%; Pulsed (Low): 0.7 W/cm² ± 20%.	Different from some predicates but complies with IEC60601-2-5.
Pulse Duration	Various settings for continuous and pulsed modes across predicates.	Continuous (High): 10ms; Pulsed (Low): 5ms.	Identical to settings of 100Hz at 50% duty cycle, and 100%.
Pulse Repetition	Various settings for continuous and pulsed modes across predicates.	Continuous (High): 10ms (100Hz); Pulsed (Low): 10ms (100Hz).	No direct comparison provided in table for this specific parameter, but implied by duty cycle match.
Duty Factor	Continuous: 100%; Pulsed: various (e.g., 5-50%).	Continuous (High): 100%; Pulsed (Low): 50%.	Identical to SoleoSono, Sonopulse, US-101L 100% and 50% duty cycle settings.
Ratio of Temporal Maximum Output Power to Output Power	Continuous: 1:1; Pulsed: various (e.g., 2:1 to 20:1).	Continuous (High): 1:1; Pulsed (Low): 2:1.	Equivalent to predicate at equivalent settings.
Maximum Patient Contact Surface Temperature	Meets IEC 60601-2-5, section 201.11 protection against excessive temperature.	Transducer surface does not exceed 43 ℃ when measured under test conditions 201.11.1.3.101.1 as stated in IEC 60601-2-5.	Same.
Beam Nonuniformity Ratio (BNR)	Various values (e.g., 3.5 ± 30% to 4.3:1 or less for predicates).	2.5 ± 30%.	Different from some predicates but complies with IEC60601-2-5.
Effective Radiating Area (ERA)	Various values (e.g., 1 cm² to 7 cm² with ±20% accuracy for predicates).	1.133 cm² ± 20%.	Similar to Soleo Sono 1cm² treatment applicator; different from others but complies with IEC60601-2-5.
Electrical Safety Standards Compliance	IEC 60601-1, IEC 60601-2-5, IEC 60601-1-2.	IEC 60601-1, IEC 60601-2-5, IEC 60601-1-2.	Identical.
Electromagnetic Compatibility (EMC)	IEC 60601-1-2 Edition 3: 2007-03.	JAS Pulse demonstrated compliance.	Met.
Electrical Safety (Specific Standards)	AAMI/ANSI ES 60601-1:2005/(R)2012 and A1:2012.	JAS Pulse demonstrated compliance.	Met.
Usability (Specific Standards)	IEC 60601-1-6 Edition 3.0: 2010-01, AAMI 62366.	JAS Pulse demonstrated compliance.	Met.
Specific Ultrasonic Safety (Specific Standards)	IEC 60601-2-5: Edition 3.0 2009-07.	JAS Pulse demonstrated compliance.	Met.

2. Sample size used for the test set and the data provenance:

Sample Size (Test Set): Not applicable. This submission relies on performance testing against standards and comparison to predicate device specifications, not a clinical test set of patients.
Data Provenance: Not applicable for clinical data. The performance data is based on laboratory testing of the device against recognized standards and technical comparisons to predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of Experts: Not applicable. Ground truth from experts (e.g., radiologists) is typically for diagnostic imaging devices, not therapeutic devices like this one that are evaluated based on physical performance and safety metrics.
Qualifications of Experts: Not applicable.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Adjudication Method: Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

MRMC Study: No, an MRMC study was not done. This type of study is relevant for diagnostic devices where human interpretation of medical images is involved, often in the context of AI assistance. This device is a therapeutic ultrasound device.
Effect Size: Not applicable.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

Standalone Performance: Not directly applicable in the terms usually associated with AI/diagnostic algorithms. The "standalone" performance for this device refers to its physical output characteristics (acoustic intensity, power, frequency, temperature, etc.) when operated according to its design. This performance was evaluated through laboratory testing against the relevant IEC standards (e.g., IEC 60601-2-5 for ultrasonic physiotherapy equipment).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Type of Ground Truth: The "ground truth" for this device, in a regulatory context focused on substantial equivalence, is defined by the established safety and performance requirements set by international standards (e.g., IEC 60601-1, IEC 60601-2-5, IEC 60601-1-2) and the known technical specifications of legally marketed predicate devices. Laboratory measurements demonstrating compliance with these standards and equivalence to predicate specifications serve as the evidence.

8. The sample size for the training set:

Sample Size (Training Set): Not applicable. This device is not an AI/machine learning product that requires training data in the traditional sense.

9. How the ground truth for the training set was established:

Ground Truth Establishment (Training Set): Not applicable.

Summary

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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

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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 (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

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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: (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)

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IV. DEVICE DESCRIPTION

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/Manufacturer	JAS PulseSubject Device	ItoUS-101LPrimary Predicate	IBRAMEDSonopulse Compact 1MHzPredicate Device	ZimmerSoleo SonoPredicate Device	Comparison toPredicates
510(k)	Current (K161628)	K112520	K131309	K121059	Current to Predicates
Indications forUse	Application of therapeuticultrasound for:• Pain.• Pain relief, muscle spasms,and joint contractures.• Relief of pain, musclespasms, and jointcontractures that may beassociated with:○ Adhesive capsulitis,○ Bursitis with slightcalcification,○ Myositis,○ Soft tissue injuries,and○ Shortened tendonsdue to past injuriesand scar tissues.• Relief of pain, musclespasms, and jointcontractures resultingfrom:○ Capsular tightness,and○ Capsular scarring.• Localized increase inblood flow.• Increased range of motionof contracted joints usingheat and stretchtechniques.	The US-101L, US-103Sare indicated for use inapplying therapeuticdeep heat in body tissuefor the treatment ofselected medicalconditions including forrelief of pain, musclespasms, & jointcontractures.	Therapeutic ultrasound• Pain relief• Reduction of muscle spasms• Localized increase in blood flow• Increase range of motion ofcontracted joints using heat &stretch techniques.	Ultrasound TherapyRelief of pain, musclespasms, & jointcontracturesRelief of pain, musclespasms, & jointcontractures that may beassociated with:• Adhesive capsulitis• Bursitis with slightcalcification• Myositis• Soft tissue injuries• Shortened tendons dueto past injuries & scaretissues.Relief of pain, musclespasms, & jointcontractures resultingfrom:• Capsular tightness• Capsular scarring	Identical to SoleoSono:(1) Relief of pain,muscle spasms,& jointcontractures.(2) Relief of pain,muscle spasms,& jointcontractures thatmay beassociated with:• Adhesivecapsulitis• Bursitis withslightcalcification• Myositis• Soft tissueinjuries• Shortenedtendons due topast injuries &scare tissues.Identical toSonopulse:(1) Localizedincrease inblood flow.(2) Increased rangeof motion ofcontractedjoints.
Device Feature/Manufacturer	JAS PulseSubject Device	ItoUS-101LPrimary Predicate	IBRAMEDSonopulse Compact 1MHzPredicate Device	ZimmerSoleo SonoPredicate Device	Comparison toPredicates
510(k)	Current (K161628)	K112520	K131309	K121059	Current to Predicates
SystemComponents	ABS plastic material withscrew assembly constructionThe transducer is constructedof Ultem plastic with a moldedsilicone grip	Plastic enclosure withhandheld transducerapplicator.	Plastic enclosure with handheldtransducer applicator.	PC-ABS plastic materialwith screw assemblyconstruction	Identical in plasticconstruction to eachpredicate.
Console/generatorDimensions (L xW 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 doesnot adversely affectsafety andeffectiveness of thesubject device
Console/generatorWeight (kg)	0.151 kg(with transducer)	0.200 kg(with transducer)	1.400 kg(with transducer)	2.100 kg	Different, but doesnot adversely affectsafety andeffectiveness of thesubject device
Treatment headdimensions (L xW x H cm)	6.35cm x 2.54cm x 2.54cm	13.4 cm x 5.9 cm x 5.5cm	20cm x 6.35cm x 6.35cm	23cm x 5cm x 5cm	Different, but doesnot adversely impactsafety andeffectiveness of thesubject device
Treatment headweight (kg)	0.026kg	0.200 kg(with generator)	1.400 kg(with generator)	0.850kg	Different, but doesnot adversely impactsafety andeffectiveness of thesubject device
Power Source	AC Line 100-240V50/60 Hz	AC 100-240 V50/60 Hz	AC Line 100-240V50/60 Hz	AC 100-240 V50/60 Hz	Identical powersource specifications.
Device Feature/Manufacturer	JAS PulseSubject Device	ItoUS-101LPrimary Predicate	IBRAMEDSonopulse Compact 1MHzPredicate Device	ZimmerSoleo SonoPredicate Device	Comparison toPredicates
510(k)	Current (K161628)	K112520	K131309	K121059	Current to Predicates
Patient LeakageCurrent: NormalCondition	3uAMeets IEC 60601-1, section 8.7LEAKAGE CURRENTSandPATIENT AUXILIARYCURRENTS	Information not providedin the publicallyavailable 510(k)	Information not provided in thepublically available 510(k)	< 1mA	Similar
Patient LeakageCurrent: SingleFault Condition	5uAMeets IEC 60601-1, section 8.7LEAKAGE CURRENTSandPATIENT AUXILIARYCURRENTS	Information not providedin the publicallyavailable 510(k)	Information not provided in thepublically available 510(k)	<0.5mA	Similar.
Crystal material	PZT	PZT	PZT	PZT	Identical to eachpredicate.
Technology ofultrasoundgeneration	Piezoelectric	Piezoelectric	Piezoelectric	Piezoelectric	Identical to eachpredicate inpiezoelectrictechnology togenerate ultrasoundenergy is industrystandard.
Acoustic workingfrequency andaccuracy	1.0 MHz ± 10%	1.0 MHz ± 10%	1.1 MHz ± 10%	0.8 MHz ± 10%2.4 MHz ± 10%	Within range ofultrasound diathermydevices per CFR890.5300 (a)
TreatmentWaveform Modes	Pulsed & Continuous	Pulsed & Continuous	Pulsed & Continuous	Pulsed & Continuous	Identical to eachpredicate.
Device Feature/Manufacturer	JAS PulseSubject Device	ItoUS-101LPrimary Predicate	IBRAMEDSonopulse Compact 1MHzPredicate Device	ZimmerSoleo SonoPredicate Device	Comparison toPredicates
510(k)	Current (K161628)	K112520	K131309	K121059	Current to Predicates
Timer settingsand accuracy	0 - 15 minutes ± 0.2 minutes	0 - 30 minutes ± 1minute	0 - 30 minutes(accuracy not listed)	0 - 30 minutes(accuracy not listed)	Equivalent to eachpredicate.Treatment time isdetermined by size oftreatment site. JASPulse allows formultiple sessions totreat larger areas asnoted in JAS PulseInstruction Manual.
Beam Type	Collimated	Collimated	Collimated	Collimated	Identical to eachpredicate.
Applicator Size	Diameter: 2.56 cmArea: 5.15 cm²	Diameter:2.1cmArea: 3.5 cm²	Diameter: 3cmArea: 7cm²	Diameter: 1.3 cmArea: 1 cm²	Different but doesnot adversely impactsafety andeffectiveness of thesubject device.
Maximum valueof the effectiveintensity andaccuracy (not toexceed 3W/cm²)	Continuous (High): 1.4 W/ cm²Pulsed (Low): 0.7 W/ cm²(all values ± 20%)	Continuous: 2 W/cm²Pulsed: 3 W/cm²(all values ± 20%)	Continuous: 3.0 W/ cm²Pulsed: 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 doesnot adversely impactsafety andeffectiveness of thesubject device andcomplies withIEC60601-2-5
Device Feature/Manufacturer	JAS PulseSubject Device	ItoUS-101LPrimary Predicate	IBRAMEDSonopulse Compact 1MHzPredicate Device	ZimmerSoleo SonoPredicate Device	Comparison toPredicates
510(k)	Current (K161628)	K112520	K131309	K121059	Current to Predicates
Output Power	Continuous (High): 1.59WPulsed (Low): 0.79W(all values ± 20%)	Continuous: 0 - 11 WPulsed: 0 - 16.5 W(all values ± 20%)	Continuous: 7 cm² : 0.7 - 21 WPulsed: 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 ± 20%)	Similar to SoleoSono.Different fromSonopulse and US-101L but does notadversely impact thesafety andeffectiveness of thesubject device andcomplies with IEC60601-2-5
Maximum valueof the temporal-maximum outputpower andaccuracy (W)	Continuous (High): 1.59WPulsed (Low): 0.79W(all values ± 20%)	Continuous: 11WPulsed: 16.5W(all values ± 20%)	Continuous: 7 cm² : 21 WPulsed: 7 cm² : 21 W(all values ± 20%)	Continuous: 1cm2: 1WPulsed: 1cm2: 1W(all values ± 20%)	Different but doesnot adversely impactsafety andeffectiveness of thesubject device andcomplies withIEC60601-2-5
Maximum valueof temporal-maximumintensity andaccuracy	Continuous (High): 1.4 W/ cm²Pulsed (Low): 0.7 W/ cm²(all values ± 20%)	Continuous: 2 W/ cm²Pulsed: 3 W/ cm²(all values ± 20%)	Continuous: 3.0 W/ cm²Pulsed: 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 doesnot adversely impactsafety andeffectiveness of thesubject device andcomplies withIEC60601-2-5
Device Feature/Manufacturer	JAS PulseSubject Device	ItoUS-101LPrimary Predicate	IBRAMEDSonopulse Compact 1MHzPredicate Device	ZimmerSoleo SonoPredicate Device	Comparison toPredicates
510(k)	Current (K161628)	K112520	K131309	K121059	Current to Predicates
Pulse duration	Continuous (High):10msPulsed (Low): 5ms	Continuous:10msPulsed: .5ms, 1ms, 2ms,3ms, 4ms, 5ms, 10msdepending on selectedprogram	Continuous:10ms (10ms pulse repetition selected),6.3ms (6.3ms pulse repetitionselected), 2.1ms (2.1ms pulsedrepetition selected)Pulsed: 0.42 ms, 1.05 ms, 1.24 ms, 2ms, 3.15 ms, 5ms depending onselected program	Continuous:50ms (50ms pulserepetition selected),20ms (20ms pulserepetition selected),10ms (10ms pulserepetition selected)Pulsed: 1ms, 2ms, 3.3ms,4ms, 5ms, 6.7ms, 10ms,16.7ms, 20ms, 25ms,50ms depending onselected program	Identical to settings100Hz at 50% dutycycle, and 100%
Pulse repetition	Continuous (High):10ms(100Hz)Pulsed (Low):10ms (100Hz)	Continuous:10ms (100 Hz)Pulsed: 10ms (100 Hz)	Continuous: 10ms,6.3ms, 2.1ms(100Hz,10Hz,48 Hz)Pulsed: 10ms,6.3ms, 2.1ms(100Hz,10Hz,48 Hz)Depending on selected program.	Continuous:50ms, 20ms, 10ms(20Hz,50Hz,100Hz)Pulsed: 50ms, 20ms,10ms (20Hz,50Hz,100Hz)Depending on selectedprogram.
Duty factor andaccuracy	Continuous (High):100%Pulsed (Low): 50%	Continuous: 100%Pulsed: 5%, 10%, 20%,30%, 40%, 50%	Continuous: 100%Pulsed: 20%, 50%	Continuous: 100%Pulsed: 50%, 30%, 20%,10%	Identical toSoleoSono,Sonopulse, US-101L100% and 50% dutycycle settings
Ratio of temporalmaximum outputpower to theoutput power	Continuous (High): 1:1,Pulsed (Low): 2:1	Continuous: 1:1Pulsed: 20:1, 10:1, 5:1,3.3:1, 3:1, 2:1	Continuous: 1:1Pulsed: 5:1, 2:1	Continuous: 1:1Pulsed: 2:1, 3:1. 5:1, 10:1	Equivalent topredicate atequivalent settings.
Device Feature/Manufacturer	JAS PulseSubject Device	ItoUS-101LPrimary Predicate	IBRAMEDSonopulse Compact 1MHzPredicate Device	ZimmerSoleo SonoPredicate Device	Comparison toPredicates
510(k)	Current (K161628)	K112520	K131309	K121059	Current to Predicates
Maximum patientcontact surfacetemperature of thetreatment headunder simulatedor actual useconditions for alloperatingconditions(continuallyoperated formaximumtreatment time)(°C)	Transducer surface does notexceed 43 ℃ when measuredunder test conditions201.11.1.3.101.1 as stated inIEC 60601-2-5.	Meets IEC 60601-2-5,section 201.11Protection againstexcessive temperatureand other HAZARDS.	Meets IEC 60601-2-5, section 201.11Protection against excessivetemperature and other HAZARDS.	Meets IEC 60601-2-5,section 201.11 Protectionagainst excessivetemperature and otherHAZARDS.	Same
BeamNonuniformityRatio (BNR) andaccuracy	2.5 ± 30%	3.5 ± 30%	7 cm²: 3	4.3:1 or less	Different but doesnot adversely impactsafety andeffectiveness of thesubject device andcomplies withIEC60601-2-5

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Device Feature/Manufacturer	JAS PulseSubject Device	ItoUS-101LPrimary Predicate	IBRAMEDSonopulse Compact 1MHzPredicate Device	ZimmerSoleo SonoPredicate Device	Comparison toPredicates
510(k)	Current (K161628)	K112520	K131309	K121059	Current to Predicates
Effectiveradiating area(ERA) andaccuracy (cm2)	1.133 cm2 ± 20%	5.5 cm2 ± 20%	7 cm2(accuracy not listed)	1 cm2: 1,08 cm2 (0,8 MHz)0,54 cm2 (2,4 MHz)(all values ± 20%)	Similar to SoleoSono 1cm2 treatmentapplicator.Different fromSonopulse andUS_101L but doesnot adversely impactsafety andeffectiveness of thesubject device andcomplies withIEC60601-2-5
Electrical SafetyStandardsCompliance	IEC 60601-1IEC 60601-2-5IEC 60601-1-2	IEC 60601-1IEC 60601-2-5IEC 60601-1-2	IEC 60601-1IEC 60601-2-5IEC 60601-1-2	IEC 60601-1IEC 60601-2-5IEC 60601-1-2	Identical to eachpredicate forcompliance.

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VII. PERFORMANCE DATA

The following performance data were provided in support of substantial equivalence of JAS Pulse to its predicate devices:

Electrical Safety and Electromagnetic Compatibility (EMC)

JAS Pulse electrical safety & EMC testing to the following FDA recognized standards was conducted with the JAS Pulse demonstrating compliance:

IEC 60601-1-2 Edition 3: 2007-03 ●
AAMI/ANSI ES 60601-1:2005/(R)2012 and A1:2012 ●
IEC 60601-1-6 Edition 3.0: 2010-01 ●
AAMI 62366 ●
IEC 60601-2-5: Edition 3.0 2009-07 ●

CONCLUSIONS VIII.

The JAS Pulse™ (JAS Pulse) Ultrasonic Therapy device has the same indications for use as the predicate ultrasound diathermy devices in application of therapeutic ultrasound for pain relief. JAS Pulse devices were tested to current FDA recognized and international electrical safety, EMC, and ultrasonic physiotherapy equipment standards demonstrating compliance. Software verification and validation with risk analysis of the JAS Pulse device was further conducted to identify and mitigate associated risks.

In summary, the JAS Pulse device is substantially equivalent (SE) to existing predicate ultrasound devices determined SE by FDA and as listed in Section III of this Summary.

Regulation Number and Section

§ 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.