Who is the manufacturer of Reprieve by RegenesisTM?

Regenesis Biomedical, Inc. filed the 510(k) submission for Reprieve by RegenesisTM (K223620).

What is the FDA product code for Reprieve by RegenesisTM?

IMJ. It is classified under 21 CFR 890.5290 as a Class 2 device in the Physical Medicine panel.

What is the regulatory pathway for Reprieve by RegenesisTM?

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

Who can help prepare an FDA 510(k) submission like Reprieve by RegenesisTM?

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

Reprieve by RegenesisTM

K223620 · Regenesis Biomedical, Inc. · IMJ · May 24, 2023 · Physical Medicine

Device Facts

Record ID	K223620
Device Name	Reprieve by RegenesisTM
Applicant	Regenesis Biomedical, Inc.
Product Code	IMJ · Physical Medicine
Decision Date	May 24, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 890.5290
Device Class	Class 2
Attributes	Therapeutic

Indications for Use

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.

Device Story

Reprieve is a prescription shortwave diathermy (SWD) device for home use. It consists of a base unit and treatment applicators. The device generates a 27.12 MHz radiofrequency (RF) signal delivered via applicators to body tissues. It operates in continuous wave (100% duty cycle) or pulsed wave modes (200-1000Hz pulse rate; 20-100µsec pulse width). The base unit includes an LCD screen, buttons, and an LED light bar. Circuitry monitors applicator contact with the patient to regulate power output (up to 10W). Treatment time is preset to 30 minutes to prevent overtreatment. The device is operated by a nontechnical adult, with or without immediate clinician supervision. The deep heating effect is intended to provide therapeutic warmth for pain relief and muscle spasm reduction. The device is powered by an external A/C to D/C power supply.

Clinical Evidence

Bench testing only. In vitro muscle phantom testing demonstrated therapeutic deep heating (40-45°C) at 1-2cm depth for 15-20 minutes, with surface and 3cm depth temperatures not exceeding 45°C. Usability/human factors validation study with representative naïve users confirmed safe and effective operation for critical tasks in a home-use environment.

Technological Characteristics

Shortwave diathermy device; 27.12 MHz RF energy; 10W max power. Materials: Polycarbonate/ABS (generator), Polycarbonate Makrolon™ 2458 (applicator), PVC (cable), Autoflex EB polyester film (interface). Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-11, IEC 60601-2-3, IEC 62366-1, ISO 10993-1:2018. Non-sterile. Connectivity: External A/C to D/C power supply.

Indications for Use

Indicated for adults (not children) for deep tissue heating to treat pain and muscle spasms in soft tissue injuries or overtraining.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

ViaTherm BOOST Diathermy System (K173300)

Reference Devices

ThermoPro (K161862)
Intelect SWD100 (K083433)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in large, bold, blue letters, and the word "ADMINISTRATION" in smaller, blue letters below. 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. {1}------------------------------------------------ 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 {2}------------------------------------------------ ## 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## 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 Chavez 5301 North Pima Road Scottsdale, AZ 85250 USA Email: Randy.Chavez@regenesisbio.com Mobile: 480-297-5800 Fax: 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 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. | | Indications for Use | 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. | {4}------------------------------------------------ ### 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 | ViaTherm BOOST Diathermy System | Regenesis Biomedical Inc. Reprieve by Regenesis™ | Comment | |-------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use/Indication For Use | To generate deep heating within body tissues for the treatment of conditions such as relief of pain and muscle spasms. | To generate deep heating within body tissues for the treatment of conditions such as relief of pain and muscle spasms. | Same as predicate | | Trade/Device Name | BOOST Diathermy System | Reprieve by Regenesis™ | --- | | 510(k) Number | K173300 | K223620 | --- | | Class | II | II | Same as predicate | | Product Code | IMJ | IMJ | Same as predicate | | Regulation Number | 21 CFR 890.5290 | 21 CFR 890.5290 | Same as predicate | | Regulation Name | Shortwave Diathermy Device | Shortwave Diathermy Device | Same as predicate | | Target Population | Adults (not to be used on children) whose medical conditions would be treated, in whole or in part, with therapeutic warmth. Some examples of these types of medical conditions are as follows: pain and swelling in soft tissue injuries; muscle spasms or pain due to injury or overtraining. | Adults (not to be used on children) whose medical conditions would be treated, in whole or in part, with therapeutic warmth. Some examples of these types of medical conditions are as follows: pain and swelling in soft tissue injuries; muscle spasms or pain due to injury or overtraining. | Same as predicate | | Attribute | ViaTherm BOOST Diathermy System | Regenesis Biomedical Inc. Reprieve by Regenesis™ | Comment | | Intended Environment for Use | OTC device intended for use by patients in non-clinical environments, including the home. | Prescription device designed for home use by a nontechnical operator with or without the immediate supervision of a healthcare practitioner. | Prescription use versus OTC does not raise issues of safety or effectiveness | | Design | User-friendly device designed with safety mechanisms that enable it to be effectively and safely operated by a nontechnical adult in non- clinical environments, including the home setting. | User-friendly device designed with safety mechanisms that enable it to be effectively and safely operated by a nontechnical adult in a non- clinical setting. | Same as predicate | | Mechanism of Action | Deep heating of tissue by therapeutic application of radio frequency electrical currents. | Deep heating of tissue by therapeutic application of radio frequency electrical currents. | Same as predicate | | Anatomical Site Locations | Multi-use therapy garments for target location areas of 5 to 18 square inches: Arm (e.g., bicep, wrist, forearm), back, shoulder, leg (e.g., thigh, knee, calf), foot | Multi-purpose treatment applicator pad(s) usable on all typical target locations, up to 28 square inches: Arm (e.g., bicep, wrist, forearm), back, shoulder, leg (e.g., thigh, knee, calf), foot | Treatment applicators are designed for use on similar body locations, differences do not raise issues of safety or effectiveness | | Treatment time | 40-45 minutes | 35-45 minutes | Similar treatment times, differences do not raise issues of safety or effectiveness | | Available warming control | Single setting as directed by patient. | Single setting as directed by clinician. | Both devices have single setting for use, does not raise issues of safety or effectiveness | | Thermal performance | Achieves 4°C temperature rise at 25 minutes. | Achieves 4°C temperature rise at 25 minutes. | Same as predicate | | Attribute | ViaTherm BOOST 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 | ViaTherm BOOST Diathermy System | Regenesis Biomedical Inc. Reprieve by RegenesisTM | Comment | | Operating Frequency | Radiofrequency as defined per 21 CFR 890.5290: 13.56 MHz | Radiofrequency as defined per 21 CFR 890.5290: 27.12 MHz | Both devices use the radiofrequency spectrum as defined by regulatory statute and safety standards, the difference does not raise issues of safety or effectiveness | | RF Power | 5W | <10W | Both devices use less than 10W of power and can be classified as low power devices per IEC 60601-2-3. As both devices use less than 10W of power, the difference does not raise issues of safety or effectiveness | | RF Connector | BNC (patient accessible) | SMA (not patient accessible) | Both connectors provide RF connection, but have different threading; the difference does not raise issues of safety or effectiveness | | 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 an external A/C to D/C power supply (40W, medical grade Class II wall plug) | Both devices use DC power to deliver RF energy, the difference does not raise issues of safety or effectiveness | | Attribute | ViaTherm BOOST Diathermy System | Regenesis Biomedical Inc. Reprieve by Regenesis™ | Comment | | Duty Cycle | Continuous Wave (100%) | Continuous Wave (100%) Pulsed Wave (Varies due to pulse parameters. These parameters are selected by the clinician and can range from 20-100μ pulse width and 200-1000Hz pulse rate, resulting in a range of duty cycles from 0.4 to 10.0%) | Both devices have a continuous wave mode. The pulsed wave mode can be selected by the ordering clinician. The addition of pulsed wave modes for a prescription shortwave diathermy device that range in power from 0.3 to 7.0 W of power, similar to the 5.0 W of power of the predicate device, and settings similar to the reference predicate devices does not raise issues of safety or effectiveness | | Load Standing Wave Ratio (LSWR) | 3.0:1 max | 1.5:1 max | Improved LSWR allows for more efficient RF delivery over a wide variety of body loads, therefore the difference does not raise issues of safety or effectiveness | | Weight (base unit) | 1.6 lbs. | 5.0 lbs. | Both devices are lightweight, the difference does not raise issues of safety or effectiveness | | Attribute | ViaTherm BOOST 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 allows for LCD screen and applicator storage, the difference does not raise issues of safety or effectiveness | | Sterility | Non-sterile | Non-sterile | Same as predicate | | Operating Temperatures | 59 to 104 °F (15 to 40 °C) at relative humidity of 30%-90% (noncondensing) and pressure of 700-1060 hPa. | 41 to 104 °F (5 to 40 °C) at relative humidity of 15%-90% (noncondensing) and pressure of 700-1060 hPa. | Similar operating temperatures, the difference does not raise issues for safety or effectiveness | | Storage Temperatures | 50 to 140 °F (10 to 60 °C) at relative humidity of 15%-90% (noncondensing) and pressure of 700-1060 hPa. | -13 to 158 °F (-25 to 70 °C) at relative humidity of 15%-90% (noncondensing) and pressure of 700-1060 hPa. | Wider storage temperature range, the difference does not raise issues of safety or effectiveness | | Coil design | Two flat spiral coils embedded in a fabric garment applicator | Single flat spiral coil embedded in a polycarbonate applicator | Both devices use spiral coils to generate RF field, the difference does not raise issues of safety or effectiveness | | Radiation Safety | Established | Established | Same as predicate | | RF Shielding | Yes | Yes | Same as predicate | | Designed to meet Electrical Safety Standards | IEC 60601-1 IEC 60601-1-2 IEC 60606-1-6 IEC 60601-1-11 | IEC 60601-1 IEC 60601-1-2 IEC 60606-1-6 IEC 60601-1-11 IEC 60601-2-3 | Additional safety standard that is specific to shortwave medical devices does not raise issues of safety or effectiveness | {5}------------------------------------------------ {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ {9}------------------------------------------------ {10}------------------------------------------------ | Performance Data | The following performance data were provided in support of the substantial equivalence determination. | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Electrical Safety and electromagnetic compatibility (EMC)…

Reprieve by RegenesisTM

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

Reference Devices

Submission Summary (Full Text)

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Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

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Special Controls

Predicate Devices

Reference Devices

Submission Summary (Full Text)

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