(170 days)
No
The description focuses on the hardware components and the generation of radiofrequency energy for therapeutic heating. There is no mention of AI, ML, or any data processing that would suggest such capabilities.
Yes
The device is indicated for generating deep heating within body tissues for the treatment of conditions such as relief of pain and muscle spasms, which classifies it as a therapeutic device.
No
The Reprieve device is indicated for generating deep heating within body tissues for treatment of conditions like pain and muscle spasms. It is a shortwave diathermy device, which is a therapeutic rather than a diagnostic tool. Its function is to deliver energy to tissue, not to obtain information about the body.
No
The device description clearly outlines hardware components including a base unit, treatment applicators, power supply, LCD screen, buttons, LED light bar, and coaxial cables, which are integral to its function of generating and delivering radiofrequency energy.
Based on the provided information, the Reprieve by Regenesis™ device is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "generate deep heating within body tissues for the treatment of conditions such as relief of pain and muscle spasms." This describes a therapeutic device that acts directly on the body.
- Device Description: The description details a shortwave diathermy (SWD) device that delivers radiofrequency energy to the body through applicators. This is consistent with a physical therapy or therapeutic device, not a device that analyzes samples from the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on these samples, or providing diagnostic information based on such analysis.
- Performance Studies: The performance studies focus on electrical safety, usability, biocompatibility, software validation, and bench testing using an in vitro muscle phantom to demonstrate heating capabilities. These are typical tests for a therapeutic device, not an IVD.
In summary, the Reprieve by Regenesis™ device is a therapeutic device designed to treat conditions by applying energy to the body, not a device that performs diagnostic tests on biological samples.
N/A
Intended Use / 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.
Product codes
IMJ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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
Indicated Patient Age Range
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.
Intended User / Care Setting
Prescription device designed for home use by a nontechnical operator with or without the immediate supervision of a healthcare practitioner.
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
The following performance data were provided in support of the substantial equivalence determination.
Electrical Safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing was conducted on the Reprieve device and complies with the following standards:
• IEC 60601-1: General requirements for basic safety and essential performance
• IEC 60601-2-3: Particular requirements for the basic safety and essential performance 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 electrical equipment and medical electrical systems used in the home healthcare environment
• IEC 62366-1: Medical devices – Part 1: Application of usability engineering to medical devices
Usability/Human Factors
A validation study was completed to evaluate the usability/human factors of the Reprieve device and the associated labeling. The representative naïve users completed simulated-use tasks and answered knowledge comprehension questions to 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 that mitigations addressing use-related risks made during Reprieve device design and development were effective. Usability and Human Factors testing was conducted on the Reprieve device and complies with the FDA guidance document Applying Human Factors and Usability Engineering to Medical Devices issued February 3, 2016.
Biocompatibility
Reprieve meets the requirements of ISO 10993-1:2018, ISO 14971:2019, and FDA General Guidance on the Use of International Standard ISO 10993-1, dated September 4, 2020; for a surface device that has long-term (>30 days) contact with intact 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 guidance documents:
Guidance for Industry and FDA Staff – Guidance for the Content of Premarket 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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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.
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
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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 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. |
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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 | 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 | 30 days) contact with
intact 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 guidance
documents: |
| Guidance for Industry and FDA Staff – Guidance for the Content of
Premarket 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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