The Biofusionary Bebe System is indicated to be used to generate deep heat within body tissues for treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies.

Device Description

The Biofusionary Bebe is used for diathermic heating of tissue. The Biofusionary Bebe hand piece tip is comprised of a coil shaped antenna which directs the flow of current parallel to the tissue surface, without contacting the tissue surface, thereby directing the magnetic component of the electromagnetic energy into tissue to result in the formation of eddy currents in tissue. These eddy currents encounter resistance, leading to localized heating.

AI/ML Overview

This 510(k) premarket notification describes the Biofusionary Bebe System, a shortwave diathermy device intended for generating deep heat within body tissues to treat conditions like pain, muscle spasms, and joint contractures. The submission primarily focuses on establishing substantial equivalence to a predicate device (Chattanooga Group-Intelect SWD 100, K083433) rather than a standalone clinical study for therapeutic effectiveness.

Here's an analysis of the acceptance criteria and supporting studies, to the extent provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance

The submission doesn't present a formalized table of acceptance criteria with specific quantitative targets for clinical outcomes. Instead, it relies on demonstrating that the device meets product specifications and performs comparably to the predicate device in terms of heating capabilities and safety.

Acceptance Criteria (Implied from testing)	Reported Device Performance
Conformance to product specifications	"The results showed the system met specification."
Heating capabilities: Therapeutic temperature (40 °C) achievement	Achieved 40 °C at surface in approx. 5 min.
	Achieved 40 °C at 1cm in 5-10 min.
	Achieved 40 °C at 2cm in 8-13 min.
Heating capabilities: Surface temperature not exceeding 45 °C	Surface of phantom did not exceed 45 °C for the duration of the study.
Usability: Adequacy of User Manual and protocols	Instructions were adequate; users understood and could apply the device.
Safety: Safe levels of exposure to electromagnetic energy (IEEE 95.1-2005)	Passed occupational testing in accordance with IEEE 95.1-2005.
Similarity to predicate device in heating capabilities and safety precautions	"The results of heating studies also support the substantial equivalence of the Biofusionary Bebe with the predicate device."

2. Sample Size Used for the Test Set and Data Provenance

Heating Characterization Studies (Benchtop): Phantoms and ex vivo porcine skin tissue were used. No specific sample sizes for these tests are provided.
In Vivo Studies: "in vivo studies on rats" were conducted. No specific sample size is provided.
Clinical Studies: "two clinical studies completed to further determine feasibility and safety and effectiveness." No specific sample size is provided for these. The document states they were "feasibility and safety and effectiveness" studies, implying they might not be large-scale effectiveness trials.
Usability Study: "naive users were first instructed to review the User Manual and protocols for use of the device, followed by actual use of the device in a mock setting." No specific sample size for users is provided.

Data Provenance: The document does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective. Given the nature of a 510(k) submission and the description of "clinical studies," they were likely prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable for this type of device and submission. The "ground truth" for heating capabilities was derived from instrument measurements (temperature probes in phantoms/tissue). For usability, direct observation and questioning of users served as the assessment method. For safety, compliance with engineering standards (IEEE 95.1-2005) was the basis.

4. Adjudication Method for the Test Set

Not applicable. The testing described involves objective measurements (temperature, electromagnetic field levels) or direct observation/feedback in the usability study, rather than expert adjudication of interpretations.

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

Not applicable. This device is a shortwave diathermy system, a therapeutic medical device, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies are not relevant in this context.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Not applicable. This device is not an AI algorithm. It's a hardware-based therapeutic device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Heating Capabilities: Measured temperature readings within phantoms and ex vivo porcine tissue. This is an objective, instrument-based "ground truth."
Usability: User feedback and direct observation of user interaction with the device and manual.
Safety: Compliance with established engineering and safety standards (e.g., IEEE 95.1-2005).
Clinical Studies (Feasibility, Safety, Effectiveness): The document does not explicitly detail the ground truth or endpoints for the "two clinical studies." However, for diathermy devices, effectiveness would typically be gauged by physiological measurements (e.g., actual tissue temperature increases in vivo) and potentially patient-reported outcomes for pain relief or improved function, monitored for safety endpoints like adverse events. The document only states they were "to further determine feasibility and safety and effectiveness."

8. The Sample Size for the Training Set

Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

9. How the Ground Truth for the Training Set Was Established

Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

Summary

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MAR 1 0 2014

Section 5: 510(k) Summary

K121123 510(k)#

General Information

Classification	Class II
Trade Name	Biofusionary Bebe™ System
Product Code:	IMJ
Regulation Number:	21 CFR 890.5290
Common Name:	Shortwave Diathermy
Submitter	Rocky Mountain Biosystems, Inc3930 Youngfield StreetWheat Ridge, CO 80033Tel: (303)277-1140Fax: (303)277-1150
Contact	Kevin Marchitto, Ph.D.
Date:	March 5, 2014

Intended Use

Predicate Device(s)

Chattanooga Group-Intelect SWD 100, K083433

Device Description

Materials

The Biofusionary Bebe is comprised of the following main components: Main console containing the major electrical components including:

Radiofrequency (RF) generator .
Control module .

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Footswitch .
Recirculating chiller .
Isolation transformer .
Connection ports for hand piece, footswitch and power cord .

Hand piece incorporating:

Treatment tip .
Umbilical connection to main console. .

All materials used in the manufacture of the Biofusionary Bebe are suitable for this use and have been used in numerous, previously cleared products.

Testing

Product testing was conducted to evaluate conformance to product specification. The results showed the system met specification.

Additionally, the product passed numerous bench studies where heating capabilities were evaluated; these include bench top studies on tissue phantoms and samples of ex vivo porcine skin tissue, in vivo studies on rats and two clinical studies completed to further determine feasibility and safety and effectiveness.

In heating characterization studies, phantoms were used to mimic treatment sites. A heating treatment protocol described in the User Manual resulted in reaching a therapeutic level of 40 °C in approximately 5 minutes at the surface. · A temperature of 40 °C was reached within 5 to 10 minutes at 1cm and within 8 to 13 minutes at 2 cm. The surface of the phantom did not exceed 45 ℃ for the duration of the study.

A usability study was conducted in which naive users were first instructed to review the User Manual and protocols for use of the device, followed by actual use of the device in a mock setting. The users were questioned and observed. The results of the study indicated that the instructions were adequate. The users understood the instructions and could apply the device according to the instructions.

Occupational testing for safe levels of exposure to electromagnetic energy was performed in accordance with the safety standard IEEE 95.1-2005.

#	Standards #	StandardsOrganization	Standards Title	Version	date
1	13485	ISO	Medical Devices - QualityManagement Systems -Requirements for regulatorypurposes	2003	1/16/2012
2	14971	ISO	Medical Devices - Risk Management- Part 1: Application of risk analysis	2007	1/16/2012
3	10993-1	ISO	Biological Evaluation of MedicalDevices - Part 1 - Evaluation andTesting	2009	1/16/2012
4	EN 60601-1 (1990)+A1 (1993)+A2 (1995)+A12 (1993)+A13 (1996)	IEC	Medical electrical equipment -General requirements for safety	60601-1(1990)+A1 (1993)+A2 (1995)+A12 (1993)	1/16/2012
	+Corrigenda (July1994)			+A13 (1996)+Corrigenda(July 1994)
5	EN 60601-2-3	IEC	*Medical electrical equipment - Part2: Particular requirements for thesafety of short-wave therapyequipment	1993	1/16/2012
6	EN 55011 (2009)+A1 (2010)	IEC	Industrial, scientific and medicalequipment, Radio-frequencydisturbance characteristics. Limitsand methods of measurement	EN 55011(2009)+A1 (2010)	1/16/2012
7	IEC 60601-1-2	IEC	Essential Performance, Risk Analysisand Immunity Testing	3rd ed. (2007-03)	1/16/2012
8	CISPR 16-1	CISPR	Specification for radio disturbanceand immunity measurementapparatus and methods - Part 1:Radio disturbance and immunitymeasuring apparatus	Ed. 2.1 (2002-10)	1/16/2012
9	CISPR 11	CISPR	Industrial, scientific and medical(ISM) radio-frequency equipment -Electromagnetic disturbancecharacteristics - Limits and methodsof measurement.	Ed. 5.0 (2009-05)	1/16/2012
10	CISPR 16-2	CISPR	Specification for radio disturbanceand immunity measurementapparatus and methods - Part 2:Methods of measurement ofdisturbances and immunity	Ed/ 2.0 (2003-07)	1/16/2012
11	CISPR 16-3	CISPR	Specification for radio disturbanceand immunity measurementapparatus and methods - Part 3:Reports and recommendations ofCISPR	Ed. 1.1 (2002-08)	1/16/2012
12	CISPR 16-4	CISPR	Part 4-1: Uncertainties, statistics andlimit modeling - Uncertainties instandardized EMC tests	Ed. 1.0 (2002-05)	1/16/2012
13	EN 61000-3-3	IEC	Limits - Limitation of voltagechanges. voltage fluctuations andflicker in public low-voltage supplysystems, for equipment with ratedcurrent ≤ 16 A per phase and notsubject to conditional connection.	2008	1/16/2012
14	EN 61000-3-2+A1 (2009)+ A2 (2009)	IEC	Electromagnetic compatibility(EMC) - Part 3-2 - Limits - Limitsfor harmonic current emissions(equipment input current ≤ 16 A perphase)	2006+A1 (2009)+ A2 (2009)	1/16/2012
15	EN 60601-1-4	IEC	Collateral Standard - Programmableelectronic systems	2000	1/16/2012
16	IEEE C95.1	IEEE	Safety Levels with Respect toHuman Exposure to RadiofrequencyElectromagnetic Fields, 3 kHz to 300GHz.	2005	1/16/2012

The Biofusionary Bebe complies with the following performance standards:

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The 60601-2-3 standard is not recognized by the FDA

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Summary of Substantial Equivalence

The Rocky Mountain Biosystems, Inc, Biofusionary Bebe™ is equivalent to the predicate product. The indications for use, basic overall function, methods of manufacturing, and materials used are substantially equivalent. The results of heating studies also support the substantial equivalence of the Biofusionary Bebe with the predicate device.

Technological Characteristics

The predicate product, the Chatanooga Intelect, is supplied with two different electrodes: the Monode (Drum) Electrode is an induction coil for treatment of mid-sized areas. The Diplode is a capacitive coupled set of electrodes for treatment of large areas and for treatment of suitable body parts that can be warmed from three sides at the same time. The device may be operated in pulsed or continuous mode.

The drum electrode, an induction coil, has a 14 cm diameter. It is fixed in size and attached to a boom that allows it to be positioned at a single location on the patient. The fixed nature of the electrode allows the operator to provide hands-free treatment of a 14 cm diameter area of the skin.

The operation of the Biofusionary Bebe device is most similar to the use of the Intelect Monode Electrode used in continuous mode

The Biofusionary Bebe device has a hand piece with 3 cm diameter tip. The device operates in continuous mode at 170W. The device allows the operator to treat a 12 cm diameter area by choosing timer settings and protocols. Hands-free operation is not possible.

Power delivery

Both devices operate at 27.1 MHz.

The Intelect allows for operation in a pulsed mode (200 W) with a variable duty cycle, or a continuous mode (100 W) with variable power settings. The Biofusionary Bebe operates in a fixed continuous mode at 170W.

The operation of the Biofusionary Bebe device is most similar to the use of the Intelect Monode used in continuous mode operation.

Applicator

The Intelect is supplied with a drum electrode, the induction coil, which has a 14 cm diameter. It is fixed in size and attached to a boom that allows it to be positioned at a single location on the patient. The fixed nature of the electrode allows the operator to provide hands-free treatment of a 14 cm diameter area of the skin.

The Biofusionary Bebe device has a hand piece with 3 cm diameter tip. The device allows the operator to treat a 12 cm diameter area by choosing timer settings and protocols. Hands-free operation is not possible.

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Heating Capabilities

Two different electrode configurations are available for the Intelect. The Monode (Drum) Electrode is an induction coil for treatment of mid-sized areas. The Diplode is a capacitive coupled set of electrodes for treatment of large areas and for treatment of suitable body parts that can be warmed from three sides at the same time.

The devices manage deep or shallow heating capabilities in similar manner:

Both devices heat to therapeutic temperatures for a minimum of 1 minute, and the maximum recommended treatment time is 30 minutes. Both devices provide therapeutic heating for the duration of the treatment cycle, once the therapeutic temperature is reached.

Both devices provide instructions and warnings for variable depth heating.

The Intelect User Manual directs: "The Electrode-Skin Distance (ESD) must be small for surface warming and large for depth warming. A larger Electrode-Skin Distance (ESD) is necessary for patients with a thick layer of subcutaneous fat in order to achieve the necessary warming of deep-lying tissue."

The Biofusionary Bebe provides protocols in the User Manual that aid the operator in applying heat to the tissues appropriately.

Safety Precautions:

Patient treatment criteria and warnings are provided in the User Manuals of both the Intelect and Biofusionary Bebe to assure safe and effective treatment:

The Intelect manual recommends four different dosage levels for operation using patient feedback to accommodate patients with different pain sensation levels, the lowest level being used for those who cannot sense pain.

The Biofusionary Bebe requires user feedback to determine the appropriate conditions of treatment. The User Manual provides warnings and protocols to address patients with little or no sensation of pain.

Both devices rely on patient feedback to avoid the risk of excessive warming, and both devices provide similar warnings, cautions and contraindications in their User Manuals.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - W(166-G609 Silver Spring, MD 20993-0002

March 10, 2014

Rocky Mountain Biosystems, Inc. c/o Kevin Marchitto President 3930 Youngfield Street Wheat Ridge. CO 80033

K121123 Re:

Trade Name: Biofusionary Bebe™M System · Regulation Number: 21 CFR 890.5290 Regulation Name: Shortwave Diathermy Regulatory Class: Class II Product Code: IMJ Dated: January 6, 2014 Received: January 8, 2014

Dear Mr. Marchitto:

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 cither 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 I'DA '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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 of 3 - Mr. Kevin Marchitto

forth in the quality systems (QS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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,

Joyce M. Whang -S

for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known) K121123

Device Name Biofusionary Bebe System

Indications for Use (Describe)

The Biofusionary Bebe System is indicated to be used to generate deep heat within body tissues for the treatment of nedical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies.

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

FORM FDA 3881 (1/14)

PSC Publishing Services (301) 443-6740 단

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Regulation Number and Section

§ 890.5290 Shortwave diathermy.

(a)
Shortwave diathermy for use in applying therapeutic deep heat for selected medical conditions —(1)Identification. A shortwave diathermy for use in applying therapeutic deep heat for selected medical conditions is a device that applies to specific areas of the body electromagnetic energy in the radiofrequency (RF) bands of 13.56 megahertz (MHz) or 27.12 MHz 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)
Nonthermal shortwave therapy —(1)Identification. A nonthermal shortwave therapy is a prescription device that applies to the body pulsed electromagnetic energy in the RF bands of 13.56 MHz or 27.12 MHz and that is intended for adjunctive use in the palliative treatment of postoperative pain and edema of soft tissue by means other than the generation of deep heat within body tissues as described in paragraph (a) of this section.(2)
Classification: Class II (special controls). The device is classified as class II. The special controls for this device are:(i) Components of the device that come into human contact must be demonstrated to be biocompatible.
(ii) Appropriate analysis/testing must demonstrate that the device is electrically safe and electromagnetically compatible in its intended use environment.
(iii) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Non-clinical performance testing must characterize the output waveform of the device and demonstrate that the device meets appropriate output performance specifications. The output characteristics and the methods used to determine these characteristics, including the following, must be determined:
(A) Peak output power;
(B) Pulse width;
(C) Pulse frequency;
(D) Duty cycle;
(E) Characteristics of other types of modulation that may be used;
(F) Average measured output powered into the RF antenna/applicator;
(G) Specific absorption rates in saline gel test load or other appropriate model;
(H) Characterization of the electrical and magnetic fields in saline gel test load or other appropriate model for each RF antenna and prescribed RF antenna orientation/position; and
(I) Characterization of the deposited energy density in saline gel test load or other appropriate model.
(iv) A detailed summary of the clinical testing pertinent to use of the device to demonstrate the effectiveness of the device in its intended use.
(v) Labeling must include the following:
(A) Output characteristics of the device;
(B) Recommended treatment regimes, including duration of use; and
(C) A detailed summary of the clinical testing pertinent to the use of the device and a summary of the adverse events and complications.
(vi) Nonthermal shortwave therapy devices marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with these special controls.