(150 days)
Not Found
No
The device description and performance studies focus on standard ultrasonic diathermy technology and electrical safety, with no mention of AI or ML.
Yes.
The device is described as a "physical medicine ultrasonic diathermy device" that applies "therapeutic ultrasound" to "treat injured or painful areas of the body in order to alleviate symptoms and to stimulate blood flow," directly indicating its therapeutic purpose.
No
The device description and intended use clearly state that the JAS Pulse is a therapeutic ultrasound device used to alleviate symptoms and stimulate blood flow for various conditions, not to diagnose them.
No
The device description explicitly states it consists of a handheld transducer and an electrical control unit, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a therapeutic application of ultrasound for treating pain, muscle spasms, joint contractures, and increasing blood flow and range of motion. This is a direct treatment applied to the patient's body.
- Device Description: The device description details a physical medicine ultrasonic diathermy device that generates sound waves to penetrate tissue for therapeutic purposes. It is applied externally to the patient.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (like blood, urine, or tissue) or to provide diagnostic information about a patient's condition. IVDs are used to diagnose diseases or other conditions, including a state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae.
- Performance Studies: The performance studies mentioned focus on electrical safety and electromagnetic compatibility, which are relevant for therapeutic devices, not typically for IVDs.
In summary, the JAS Pulse is a therapeutic device that applies energy to the body for treatment, not a device used to perform tests on samples to provide diagnostic information.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
IMI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Ito US-101L (K112520), IBRAMED Sonopulse Compact 1 MHz (K131309), Zimmer Soleo Sono (K121059)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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
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)
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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.
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| 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) |