(170 days)
The Reprieve by Regenesis™ device is indicated to generate deep heating within body tissues for the treatment of conditions such as relief of pain and muscle spasms.
The Reprieve by Regenesis™ device (Reprieve) is a prescription shortwave diathermy (SWD) device consisting of a single base unit connected to one or two treatment applicators. The device connects to A/C power through an external, off-the-shelf, power supply generating radiofrequency energy which delivers SWD through the treatment applicator(s).
The base unit houses an LCD screen with four raised buttons, two on each side of the LCD screen, and an LED light bar. The back of the base unit has a molded slot to accommodate the treatment applicator(s), a pouch to store the power supply, and a cable wrapping loop to organize the treatment applicator cables. The bottom of the base unit has an opening to connect the A/C power supply. The treatment factory-affixed coaxial cables. The top is the treatment side of the applicator is a darker color to distinguish it from the lighter-colored bottom, the non-treatment side. The top also has circular imagery denoting the center of the applicator. The Reprieve device generates a 27.12 MHz RF signal that has a 100% duty cycle when programmed to continuous wave (CW) mode. When prescribed for pulsed wave (PW) mode, the pulse rate (e.g., pulses per second) can be varied from 200Hz to 1000Hz in 200Hz increments, and the pulse width (e.g., the elapsed time the pulse is on) from 20µsec to 100µsec in 20µsec increments.
The provided text describes the acceptance criteria and the studies performed for the Reprieve by Regenesis™ device, a shortwave diathermy system.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria and reported device performance in the format of specific numerical values for each criterion. Instead, it states that the device "complies with" or "meets the requirements" of various standards and that usability results were "positive" and demonstrated effectiveness. The thermal performance is given as achieving a "4°C temperature rise at 25 minutes," which matches the predicate.
Below is a table summarizing the mentioned performance aspects and the statements regarding their compliance/results:
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Electrical Safety and Electromagnetic Compatibility (EMC) | Complies with IEC 60601-1, IEC 60601-2-3, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-11 |
| Usability/Human Factors | Validation study results were positive, demonstrating effective mitigation of use-related risks. Complies with FDA guidance on Applying Human Factors and Usability Engineering to Medical Devices and IEC 62366-1. |
| Biocompatibility | Meets requirements of ISO 10993-1:2018, ISO 14971:2019, and FDA General Guidance on the Use of International Standard ISO 10993-1. Considered safe for long-term (>30 days) contact with intact skin. |
| Software Verification and Validation | Documentation provided as recommended by FDA guidance documents; demonstrates compliance with IEC 62304. Software considered "moderate" level of concern. |
| Bench Testing (Therapeutic Deep Heating) | Achieved therapeutic deep heating between 40-45°C at 1-2cm depth for 15-20 minutes in an in vitro muscle phantom. Intramuscular tissue temperature from surface to 3cm did not exceed 45°C. Demonstrated a similar 4°C temperature rise at 1cm depth as the predicate device. |
| Overall Safety and Effectiveness (Substantial Equivalence) | Device is as safe and effective as the predicate shortwave diathermy (SWD) device. No additional claims associated with new technological features (pulsed SWD). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set:
- Usability/Human Factors: "representative naïve users" were used. A specific number is not provided.
- Bench Testing: An "in vitro muscle phantom" was used. This is not a human sample size.
- Other tests (Electrical Safety, Biocompatibility, Software V&V) are compliance or engineering tests and do not involve human test sets in the same way.
- Data Provenance:
- The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. Given the nature of these tests (bench, usability validation), they would typically be prospective studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- For the technical tests (electrical safety, EMC, biocompatibility, software V&V, bench testing), the ground truth is established by adherence to recognized international standards and guidances (e.g., IEC, ISO, FDA guidances). These are not typically evaluated by human experts establishing ground truth in a clinical sense, but by qualified personnel performing the testing and analyses according to standard protocols.
- For the Usability/Human Factors study, "representative naïve users" were observed performing tasks. The "ground truth" here is compliance with usability principles and demonstration that mitigations were effective. There is no mention of external experts defining ground truth for the users' performance; rather, the study itself assesses user performance against predefined objectives.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- The document does not describe any adjudication method for the test sets. The studies conducted are primarily performance, safety, and compliance tests against engineering standards and usability goals, rather than studies requiring expert consensus on clinical diagnoses or outcomes.
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
- No, an MRMC comparative effectiveness study was not done.
- The device described is a medical device for therapeutic deep heating, not an AI-assisted diagnostic tool for human readers. Therefore, there is no discussion of human readers, AI assistance, or effect sizes related to such a study.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- The concept of "standalone" algorithm performance without human-in-the-loop is relevant to AI/imaging devices. This device is a shortwave diathermy system. Its performance evaluation involves bench testing (e.g., thermal performance in a phantom) and usability studies with human users, but not an "algorithm-only" performance in the context of diagnostic AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Electrical Safety and EMC: Ground truth is defined by the requirements of the specified IEC standards.
- Usability/Human Factors: Ground truth is established by predefined success criteria for tasks performed by users and adherence to FDA guidance and IEC standards for usability.
- Biocompatibility: Ground truth is defined by meeting the requirements of ISO 10993-1:2018 and FDA guidances.
- Software Verification and Validation: Ground truth is defined by compliance with FDA guidance documents and IEC 62304.
- Bench Testing: Ground truth for thermal performance is established by objective temperature measurements within an in vitro muscle phantom against predefined therapeutic temperature ranges and safety limits.
8. The sample size for the training set
- This device is a physical medical device (shortwave diathermy system), not an AI/machine learning algorithm that requires a training set in that context. Therefore, the concept of a "training set" for an algorithm is not applicable here. The design and development of the device would involve engineering, prototyping, and iterative testing, but not an AI training set.
9. How the ground truth for the training set was established
- As explained in point 8, the device does not employ an AI/machine learning algorithm in the sense that would require a "training set" with ground truth data for model learning. Thus, this question is not applicable.
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May 24, 2023
Regenesis Biomedical Inc. Randy Chavez VP Regulatory Affairs & Quality Assurance 5301 N Pima Road, Ste 150 Scottsdale, Arizona 85250
Re: K223620
Trade/Device Name: Reprieve by RegenesisTM Regulation Number: 21 CFR 890.5290 Regulation Name: Shortwave Diathermy Regulatory Class: Class II Product Code: IMJ Dated: May 23, 2023 Received: May 23, 2023
Dear Randy Chavez:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Lauren E. Woodard -S
for Amber Ballard, PhD Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K223620
Device Name Reprieve by Regenesis™
Indications for Use (Describe)
The Reprieve by Regenesis™ device is indicated to generate deep heating within body tissues for the treatment of conditions such as relief of pain and muscle spasms.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
| 510(k) Summary | This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.92. |
|---|---|
| Submitter | Regenesis Biomedical, Inc. |
| Contact Person | Randy Chavez5301 North Pima RoadScottsdale, AZ 85250 USAEmail: Randy.Chavez@regenesisbio.comMobile: 480-297-5800Fax: 866-857-8792 |
| Date Prepared | May 23, 2023 |
| Product Name | Reprieve by Regenesis™ |
| Common Name | Shortwave Diathermy |
| Device Classification | Class II |
| Product Code | IMJ |
| Predicate Devices | Predicate device:• ViaTherm BOOST Diathermy System (K173300).Reference devices:• ThermoPro (K161862)• Intelect SWD100 (K083433)No secondary predicate devices were used in this submission. |
| Device Description | The Reprieve by Regenesis™ device (Reprieve) is a prescription shortwave diathermy (SWD) device consisting of a single base unit connected to one or two treatment applicators. The device connects to A/C power through an external, off-the-shelf, power supply generating radiofrequency energy which delivers SWD through the treatment applicator(s).The base unit houses an LCD screen with four raised buttons, two on each side of the LCD screen, and an LED light bar. The back of the base unit has a molded slot to accommodate the treatment applicator(s), a pouch to store the power supply, and a cable wrapping loop to organize the treatment applicator cables. The bottom of the base unit has an opening to connect the A/C power supply. The treatment |
| factory-affixed coaxial cables. The top is the treatment side of the applicator is adarker color to distinguish it from the lighter-colored bottom, the non-treatmentside. The top also has circular imagery denoting the center of the applicator.The Reprieve device generates a 27.12 MHz RF signal that has a 100% duty cycle whenprogrammed to continuous wave (CW) mode. When prescribed for pulsed wave (PW)mode, the pulse rate (e.g., pulses per second) can be varied from 200Hz to 1000Hz in200Hz increments, and the pulse width (e.g., the elapsed time the pulse is on) from20µsec to 100µsec in 20µsec increments. | |
| Indications forUse | The Reprieve by Regenesis™ device is indicated to generate deep heating within bodytissues for the treatment of conditions such as relief of pain and muscle spasms. |
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Comparison of Technological Characteristics with Predicate Device
The table below lists and compares the technological characteristics of the Reprieve by Regenesis™ device and the predicate device, the ViaTherm BOOST Diathermy System.
| Attribute | ViaThermBOOST Diathermy System | Regenesis Biomedical Inc.Reprieve by Regenesis™ | Comment |
|---|---|---|---|
| IntendedUse/IndicationFor Use | To generate deep heatingwithin body tissues for thetreatment of conditions suchas relief of pain and musclespasms. | To generate deep heatingwithin body tissues for thetreatment of conditions suchas relief of pain and musclespasms. | Same as predicate |
| Trade/DeviceName | BOOST Diathermy System | Reprieve by Regenesis™ | --- |
| 510(k) Number | K173300 | K223620 | --- |
| Class | II | II | Same as predicate |
| Product Code | IMJ | IMJ | Same as predicate |
| RegulationNumber | 21 CFR 890.5290 | 21 CFR 890.5290 | Same as predicate |
| RegulationName | Shortwave Diathermy Device | Shortwave Diathermy Device | Same as predicate |
| TargetPopulation | Adults (not to be used onchildren) whose medicalconditions would be treated,in whole or in part, withtherapeutic warmth. Someexamples of these types ofmedical conditions are asfollows: pain and swelling insoft tissue injuries; musclespasms or pain due to injuryor overtraining. | Adults (not to be used onchildren) whose medicalconditions would be treated,in whole or in part, withtherapeutic warmth. Someexamples of these types ofmedical conditions are asfollows: pain and swelling insoft tissue injuries; musclespasms or pain due to injuryor overtraining. | Same as predicate |
| Attribute | ViaThermBOOST Diathermy System | Regenesis Biomedical Inc.Reprieve by Regenesis™ | Comment |
| IntendedEnvironmentfor Use | OTC device intended for useby patients in non-clinicalenvironments, including thehome. | Prescription device designedfor home use by anontechnical operator with orwithout the immediatesupervision of a healthcarepractitioner. | Prescription useversus OTC doesnot raise issues ofsafety oreffectiveness |
| Design | User-friendly device designedwith safety mechanisms thatenable it to be effectively andsafely operated by anontechnical adult in non-clinical environments,including the home setting. | User-friendly device designedwith safety mechanisms thatenable it to be effectively andsafely operated by anontechnical adult in a non-clinical setting. | Same as predicate |
| Mechanism ofAction | Deep heating of tissue bytherapeutic application ofradio frequency electricalcurrents. | Deep heating of tissue bytherapeutic application ofradio frequency electricalcurrents. | Same as predicate |
| Anatomical SiteLocations | Multi-use therapy garmentsfor target location areas of 5to 18 square inches: Arm(e.g., bicep, wrist, forearm),back, shoulder, leg (e.g.,thigh, knee, calf), foot | Multi-purpose treatmentapplicator pad(s) usable on alltypical target locations, up to28 square inches: Arm (e.g.,bicep, wrist, forearm), back,shoulder, leg (e.g., thigh,knee, calf), foot | Treatmentapplicators aredesigned for use onsimilar bodylocations,differences do notraise issues ofsafety oreffectiveness |
| Treatment time | 40-45 minutes | 35-45 minutes | Similar treatmenttimes, differencesdo not raise issuesof safety oreffectiveness |
| Availablewarmingcontrol | Single setting as directed bypatient. | Single setting as directed byclinician. | Both devices havesingle setting foruse, does not raiseissues of safety oreffectiveness |
| Thermalperformance | Achieves 4°C temperaturerise at 25 minutes. | Achieves 4°C temperaturerise at 25 minutes. | Same as predicate |
| Attribute | ViaThermBOOST Diathermy System | Regenesis Biomedical Inc.Reprieve by Regenesis™ | Comment |
| Materials | Generator | Generator –Polycarbonate/ABS | Both devices utilize materials that are biocompatible for the intended use based on the nature and duration of contact which does not raise issues of safety or effectiveness |
| Therapy Garment Material | Treatment Applicator Pad Material | ||
| • Futuro™ 3M, composed of polyurethane foam, nylon, polyester, polyethylene, and spandex• Velcro Extender Strap | • Polycarbonate Makrolon™ 2458 | ||
| Charger Cord | Treatment Applicator Cable – polyvinyl chloride (PVC) | ||
| Patient Interface – 100% cotton | Patient Interface – Autoflex EB (polyester film) | ||
| Safety factors | The device treatment is intended to be self-administered in the home. The device is battery operated. It contains circuit boards that determine if the garment is making sufficient contact with the user, and if so, will output the designated power. The treatment time is based on the life of the battery, preventing the user from over treating. | The device treatment is intended to be self-administered in the home. The device is connected to an external power supply. It contains circuit boards that determine if the device is delivering sufficient power based on contact with the user, and if required, will increase or decrease the needed output power within a 10W limitation. The treatment time is preset to 30 minutes, preventing the user from over treating. | Both devices are intended to be self-administered at home with power control based on applicator contact with patient and time limited. The differences to not raise issues of safety or effectiveness |
| Biocompatibility | Established | Established to ISO 10993-1:2018 | Same as predicate |
| Attribute | ViaThermBOOST Diathermy System | Regenesis Biomedical Inc.Reprieve by RegenesisTM | Comment |
| OperatingFrequency | Radiofrequency as definedper 21 CFR 890.5290: 13.56 MHz | Radiofrequency as definedper 21 CFR 890.5290: 27.12 MHz | Both devices usethe radiofrequencyspectrum asdefined byregulatory statuteand safetystandards, thedifference does notraise issues ofsafety oreffectiveness |
| RF Power | 5W | <10W | Both devices useless than 10W ofpower and can beclassified as lowpower devices perIEC 60601-2-3. Asboth devices useless than 10W ofpower, thedifference does notraise issues ofsafety oreffectiveness |
| RF Connector | BNC (patient accessible) | SMA (not patient accessible) | Both connectorsprovide RFconnection, buthave differentthreading; thedifference does notraise issues ofsafety oreffectiveness |
| Impedance | 50 Ohms nominal | 50 Ohms nominal | Same as predicate |
| Power Supply | Ni-MH AA – 1.2V x4 (4.8V),2000 mAh | DC power provided by anexternal A/C to D/C powersupply (40W, medical gradeClass II wall plug) | Both devices useDC power todeliver RF energy,the difference doesnot raise issues ofsafety oreffectiveness |
| Attribute | ViaThermBOOST Diathermy System | Regenesis Biomedical Inc.Reprieve by Regenesis™ | Comment |
| Duty Cycle | Continuous Wave (100%) | Continuous Wave (100%)Pulsed Wave (Varies due topulse parameters. Theseparameters are selected bythe clinician and can rangefrom 20-100μ pulse widthand 200-1000Hz pulse rate,resulting in a range of dutycycles from 0.4 to 10.0%) | Both devices havea continuous wavemode. The pulsedwave mode can beselected by theordering clinician.The addition ofpulsed wavemodes for aprescriptionshortwavediathermy devicethat range inpower from 0.3 to7.0 W of power,similar to the 5.0 Wof power of thepredicate device,and settings similarto the referencepredicate devicesdoes not raiseissues of safety oreffectiveness |
| Load StandingWave Ratio(LSWR) | 3.0:1 max | 1.5:1 max | Improved LSWRallows for moreefficient RFdelivery over awide variety ofbody loads,therefore thedifference does notraise issues ofsafety oreffectiveness |
| Weight (baseunit) | 1.6 lbs. | 5.0 lbs. | Both devices arelightweight, thedifference does notraise issues ofsafety oreffectiveness |
| Attribute | ViaThermBOOST Diathermy System | Regenesis Biomedical Inc.Reprieve by Regenesis™ | Comment |
| Size (base unit) | 2.25" x 4.875" x 6.5" | 6.1" x 11.3" x 11.4" | Larger size allowsfor LCD screen andapplicator storage,the difference doesnot raise issues ofsafety oreffectiveness |
| Sterility | Non-sterile | Non-sterile | Same as predicate |
| OperatingTemperatures | 59 to 104 °F (15 to 40 °C) atrelative humidity of 30%-90%(noncondensing) andpressure of 700-1060 hPa. | 41 to 104 °F (5 to 40 °C) atrelative humidity of 15%-90%(noncondensing) andpressure of 700-1060 hPa. | Similar operatingtemperatures, thedifference does notraise issues forsafety oreffectiveness |
| StorageTemperatures | 50 to 140 °F (10 to 60 °C) atrelative humidity of 15%-90%(noncondensing) andpressure of 700-1060 hPa. | -13 to 158 °F (-25 to 70 °C) atrelative humidity of 15%-90%(noncondensing) andpressure of 700-1060 hPa. | Wider storagetemperature range,the difference doesnot raise issues ofsafety oreffectiveness |
| Coil design | Two flat spiral coilsembedded in a fabricgarment applicator | Single flat spiral coilembedded in a polycarbonateapplicator | Both devices usespiral coils togenerate RF field,the difference doesnot raise issues ofsafety oreffectiveness |
| Radiation Safety | Established | Established | Same as predicate |
| RF Shielding | Yes | Yes | Same as predicate |
| Designed tomeet ElectricalSafetyStandards | IEC 60601-1IEC 60601-1-2IEC 60606-1-6IEC 60601-1-11 | IEC 60601-1IEC 60601-1-2IEC 60606-1-6IEC 60601-1-11IEC 60601-2-3 | Additional safetystandard that isspecific toshortwave medicaldevices does notraise issues ofsafety oreffectiveness |
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| PerformanceData | The following performance data were provided in support of the substantialequivalence determination. |
|---|---|
| Electrical Safety and electromagnetic compatibility (EMC) | |
| Electrical safety and EMC testing was conducted on the Reprieve device and complieswith the following standards: | |
| • IEC 60601-1: General requirements for basic safety and essentialperformance• IEC 60601-2-3: Particular requirements for the basic safety and essentialperformance of short-wave therapy equipment• IEC 60601-1-2: Collateral Standard: Electromagnetic disturbances -Requirements and tests• IEC 60601-1-6: Collateral standard: Usability• IEC 60601-1-11: Collateral Standard: Requirements for medical electricalequipment and medical electrical systems used in the home healthcareenvironment• IEC 62366-1: Medical devices – Part 1: Application of usability engineering tomedical devices | |
| Usability/Human Factors | |
| A validation study was completed to evaluate the usability/human factors of theReprieve device and the associated labeling. The representative naïve userscompleted simulated-use tasks and answered knowledge comprehension questionsto evaluate the usability of the Reprieve device for critical tasks applicable in a home-use environment. | |
| The results of the usability validation study were positive and demonstrated thatmitigations addressing use-related risks made during Reprieve device design anddevelopment were effective. Usability and Human Factors testing was conducted onthe Reprieve device and complies with the FDA guidance document Applying HumanFactors and Usability Engineering to Medical Devices issued February 3, 2016. | |
| Biocompatibility | |
| Reprieve meets the requirements of ISO 10993-1:2018, ISO 14971:2019, and FDAGeneral Guidance on the Use of International Standard ISO 10993-1, datedSeptember 4, 2020; for a surface device that has long-term (>30 days) contact withintact skin and can be considered safe for use as intended. | |
| Software Verification and Validation Testing | |
| Software verification and validation testing was conducted on the Reprieve device.Documentation was provided as recommended by the following FDA guidancedocuments: | |
| Guidance for Industry and FDA Staff – Guidance for the Content ofPremarket Submissions for Software Contained in Medical Devices. May 11, 2005 Content of Premarket Submissions for Management of Cybersecurity in Medical Devices – Guidance for Industry and Food and Drug Administration Staff. October 2, 2014 | |
| The documents submitted demonstrate compliance with IEC 62304: Medical device software - Software life cycle processes. | |
| The software for this device was considered a “moderate” level of concern as, prior to mitigation of hazards, a failure of the software could result in minor injury to a user of the device. | |
| Bench Testing | |
| The Reprieve by Regenesis™ device demonstrated through temperature testing in an in vitro muscle phantom therapeutic deep heating between 40-45°C at a 1-2cm depth from the surface of the treatment applicator for 15-20 minutes. This testing was also evaluated at the surface and at a 3cm depth to assure that intramuscular tissue temperature from the surface to 3cm did not exceed 45°C. | |
| Conclusions | The Reprieve by Regenesis™ (Reprieve) device is as safe and effective as the predicate shortwave diathermy (SWD) device. |
| The Reprieve device has the same intended uses and indications, similar technological characteristics, and principles of operation as the predicate device. The results of bench testing demonstrate a similar increase of 4°C at 1cm depth for both the Reprieve device and the predicate device. Both use radiofrequency energy as defined per 21 CFR 890.5290, either 13.56 MHz or 27.12 MHz. The Reprieve device is indicated for prescription use and has additional SWD technological features with pulsed SWD options similar to the reference SWD devices. There are no additional claims associated with the additional SWD technological features. Usability validation testing demonstrated the Reprieve device can be used safely and effectively in the intended home-use patient population. The Reprieve device is compliant to the same safety standards as the predicate device, demonstrating the safe design of the Reprieve device. The technological differences raise no issues of safety or effectiveness. Therefore, the Reprieve by Regenesis™ device is substantially equivalent to the predicate device. |
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§ 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.