(80 days)
The Rapid Reboot Compression Therapy System is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas in people who are in good health. The Rapid Reboot Compression Therapy System simulates kneading and stroking of tissues by using an inflatable garment.
Rapid Reboot Compression Therapy System ("Rapid Reboot") consists of an air pump, air pressure sensor, and sleeves working together as one unit. The air pump is connected to the dedicated sleeves via a series of hoses; each sleeve has four (4) compression chambers. The compression massage direction is from limb end to body center. By inflating the air chambers sequentially and then deflating as one cycle, the pressure can be adjusted to avoid any discomfort to the patient. The sleeve works under the action of sensor and microprocessor. Software controls the timing and pressure reflected by the sensor, cycling airflow into and out of the sleeves to compress body
The provided text describes the "Rapid Reboot Compression Therapy System" and its substantial equivalence determination. However, it does not include detailed acceptance criteria or a specific study proving the device meets those criteria in the way typically found for AI/ML-driven medical devices (e.g., performance metrics like sensitivity, specificity, or AUC, alongside sample sizes for test and training sets, expert qualifications for ground truth, etc.). This document solely focuses on demonstrating substantial equivalence to predicate devices based on indications for use, technological characteristics, and compliance with general medical device standards.
Therefore, most of the requested information regarding acceptance criteria and performance study details for an AI/ML device is not present in the provided text.
Here's an attempt to answer based only on the available information:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) or device performance against such metrics. Instead, it demonstrates compliance with general medical device standards and substantial equivalence to predicate devices.
| Acceptance Criteria (from text) | Reported Device Performance (from text) |
|---|---|
| Electrical Safety IEC 60601-1:2014 | Met the requirements of the standard |
| EMC IEC 60601-1-2:2014 | Met the requirements of the standard |
| Biocompatibility EN ISO 10993-5:2009 | Met the requirements of the standard |
| Biocompatibility EN ISO 10993-10:2010 | Met the requirements of the standard |
| Substantial Equivalence to Predicates for Indications for Use, and similar technological and performance characteristics | "Substantially equivalent to the legally marketed Relaxor Perfect Touch Air Massaging System (primary predicate) and Normatec Pulse and Pulse Pro (secondary predicate) for Indication for Use, and it is substantially equivalent in technological and performance characteristics to Pt 1002 Pressure Therapy System (reference device).""It is at least as safe and effective as the predicate devices and technologically comparable to the reference device, and doesn't raise any new safety and/or effectiveness concerns." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The document describes performance testing based on compliance with general safety, EMC, and biocompatibility standards for the device itself, not on analyzing patient data or clinical images. It's a physical device, not an AI/ML diagnostic or prognostic system.
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)
Not applicable. This is not a study requiring expert-established ground truth on patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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 study was not done. The device is a compression therapy system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical therapy system, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. Ground truth as typically understood for AI/ML performance on clinical data is not relevant here. The "ground truth" equivalent would be the established requirements of the referenced IEC and ISO standards that the device was tested against.
8. The sample size for the training set
Not applicable. The device is not an AI/ML model trained on data.
9. How the ground truth for the training set was established
Not applicable.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 14, 2018
Rapid Reboot Recovery Products, LLC % John Gillespy FDA Consulting, LLC 1100 Del Lago Cir #104 Palm Beach Gardens, Florida 33410
Re: K182668
Trade/Device Name: Rapid Reboot Compression Therapy System Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP Dated: September 17, 2018 Received: September 25, 2018
Dear John Gillespy:
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.
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
{1}------------------------------------------------
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Vivek J. Pinto -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
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K182668
Device Name
Rapid Reboot Compression Therapy System
Indications for Use (Describe)
The Rapid Reboot Compression Therapy System is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas in people who are in good health. The Rapid Reboot Compression Therapy System simulates kneading and stroking of tissues by using an inflatable garment.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
|X | 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
| 1. | 510(k) Submitter: | Rapid Reboot Recovery Products, LLC1396 W 200 S Bldg 2A, Lindon, UT 84042Phone: 801-899-7511Email: david@rapidreboot.com | |
|---|---|---|---|
| 2. | Company Contact: | David Johnson, CEO | |
| 3. | Date of Submission: | September 17, 2018 | |
| 4. | 510(k) Preparer: | John F. Gillespy, MBAFDA 510k Consulting, LLCPalm Beach Gardens, FL 33410Phone: 386-243-4332Email: john@fda510kconsultants.com | |
| 5. | Device Classification: | Trade name:Common name:Device:Regulation:Class:Product Code: | Rapid Reboot Compression Therapy SystemPowered Inflatable Tube MassagerMassager, Powered Inflatable Tube890.56502IRP |
| 6. | Predicate (Primary): | Applicant:Device:510(k) Number: | Salton, Inc (Washington, DC)Relaxor Perfect Touch Air Massaging SystemK030437 |
| Predicate (Secondary): | Applicant:Device:510(k) Number: | NormaTec Industries, LP (Newton, PA)NormaTec Pulse; Norma Tec Pulse ProK160608 | |
| Reference: | Applicant:Device:510(k) Number: | Xiamen Senyang Co, Ltd (Xinglin Xiamen,China)Pt 1002 Pressure Therapy SystemK161907 |
-
- Indications For Use... The Rapid Reboot Compression Therapy System is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas in people who are in good health. The Rapid Reboot Compression Therapy System simulates kneading and stroking of tissues by using an inflatable garment.
{4}------------------------------------------------
-
- Device Description... Rapid Reboot Compression Therapy System ("Rapid Reboot") consists of an air pump, air pressure sensor, and sleeves working together as one unit. The air pump is connected to the dedicated sleeves via a series of hoses; each sleeve has four (4) compression chambers. The compression massage direction is from limb end to body center. By inflating the air chambers sequentially and then deflating as one cycle, the pressure can be adjusted to avoid any discomfort to the patient. The sleeve works under the action of sensor and microprocessor. Software controls the timing and pressure reflected by the sensor, cycling airflow into and out of the sleeves to compress body
| Name | Rapid Reboot Compression Therapy System |
|---|---|
| Pressure (mmHg) | 0~200 mmHg |
| Mode | Mode A and Mode B, and the initial is A |
| Interval | 50S |
| Time(min) | Time 0-30, selection (10, 20, 30min) |
| Pressure Time | Pressure, 20-200mmHg, Mode A/B, 0-30Min |
9. Technical Characteristics
[Remainder of page left intentionally blank]
{5}------------------------------------------------
10. Comparison To Predicate
Table 5 – Comparison With Predicate
| Device | Subject Device | Primary Predicate | Secondary Predicate | Reference Device | Comparison |
|---|---|---|---|---|---|
| Manufacturer | Rapid Reboot RecoveryProducts, LLC | SALTON, INC | NORMATEC INDUSTRIES, LP | XIAMEN SENYANG CO,LTD | NA |
| 510(k)Number | K182668 | K030437 | K160608 | K161907 | NA |
| Model Name | Rapid Reboot CompressionTherapy System | Relaxor Perfect Touch AirMassaging System | NormaTec Pulse andNormaTec Pulse Pro | Pt 1002 | NA |
| Classification | Class II Device, IRP (21CFR890.5650) | Class II Device, IRP (21CFR890.5650) | Class II Device, IRP (21CFR890.5650) | Class II Device, IRP (21CFR890.5650) | Same |
| Indications forUse (IFU) | The Rapid RebootCompression TherapySystem is intended for thetemporary relief of minormuscle aches and pains andfor the temporary increasein circulation to the treatedareas in people who are ingood health. The RapidReboot CompressionTherapy System simulateskneading and stroking oftissues by using aninflatable garment. | The Perfect Touch AirMassaging System is indicatedfor the temporary relief ofminor muscle aches and painsand for the temporaryincrease in circulation to thetreated areas in people whoare in good health. The PerfectTouch simulates kneading andstroking of tissues by using aninflatable garment. | The NormaTec Pulse and PulsePro is an air pressure massagerintended to temporarily relieveminor muscle aches and/orpains, and to temporarilylincrease circulation to thetreated areas. | Indicated for treatmentof medical conditionssuch as primarylymphedema, edemafollowing trauma andsport injuries, postimmobilizationedema, venousinsufficiencies,lymphedema | Same as Relaxorand NormaTec(predicates). |
| OTC or Rx | ОТС | ОТС | ОТС | Rx | Same aspredicates |
| Environmentof Use: | Clinics, hospital, athletetraining, and homeenvironments | Home environment | Clinics, hospital, athletetraining, and homeenvironments | Clinics, hospital, athletetraining and homeenvironments | Essentially thesame |
{6}------------------------------------------------
| Standards | IEC 60601-1:2014; IEC60601-1-2:2014; EN ISO10993-5:2009 & EN ISO10993-10:2010 | Not available | ES 60601-1; IEC 60601-1-2;IEC 60601-1-11 | IEC 60601-1:2014; IEC60601-1-2:2014; EN ISO10993-5:2009 & EN ISO10993-10:2010 | Meets consensusstds for ES, EMC,Biocompatibility |
|---|---|---|---|---|---|
| Mode ofCompression | Sequential/Peristaltic | Sequential/Peristaltic | Sequential/Peristaltic andPulsing | Sequential/Peristaltic | Same except forNormaTecpulsing mode. |
| PowerSource | 110 V, 60Hz | 120V, 60Hz | 100- 240 VAC input | 110 V, 60Hz | Same |
| Therapy Time | User determines therapytime. Choose from 10, 20,or 30 minute session time,with option to addadditional 10 minutes toany therapy time. | Has 15 minute sessions. | User determines therapytime, with range of 10minutes to a continuoussession. | User determines therapytime. Choose from 10,20, or 30 minute sessiontime, with option to addadditional 10 minutes toany therapy time. | Same exceptNormatec allowsunrestricted timeuse. |
| Max PressureMin Pressure | 0-200 mmHg | 80 to 250 mmHg | 30-110 mmHg | 0-200 mmHg | Same as Xiamen,similar toRelaxor. |
| Number ofChambers | 4 Chambers | 12 chambers | 5 chambers | 4 Chambers | Same exceptRelaxor has morechambers |
| CompressionApplicatorGarmentsSleeveMaterial | Nylon with a Polyurethanelaminate | Nylon with a Polyurethanelaminate | Nylon with apolyurethanelaminate | Nylon with aPolyurethane laminate | Same |
| HousingMaterialsAndConstructions | Molded ABS enclosure | Molded ABS enclosure | Molded ABS enclosure | Molded ABS enclosure | Same |
| Patient contact | Non-conductiveattachments | Non-conductive attachments | Non-conductiveattachments | Non-conductiveattachments | Same |
| PowerConsumption | 30W | 26W | 14W | 30W | Same |
{7}------------------------------------------------
| Cycle time | 1 min 20 sec | Range of 15 sec to 1 min 5 sec | 7 min 10 sec | 1 min 20 sec | Same exceptRelaxor hasvariable cycletime andNormatec isslightly slower | "Leg" Attachment | Leg (consisting of foot, calf,knee, upper leg) | Leg (consisting of foot and calf). | Leg (consisting of foot, calf,knee, upper leg). | Leg (consisting or foot,calf, knee, upper leg) | Same |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Size and photo | 10" x 6.5" x 5"Image: Rapid Reboot device | 9" x 6" x 6"Image: Relaxor device | 4" x 5" x 9"Image: Normatec device | 10" x 6.5" x 5"Image: Leg compression device | All are tabletopor handheldportable | Leg AttachmentPhotos | Image: Leg Attachment Photos 1 | Image: Leg Attachment Photos 2 | Image: Leg Attachment Photos 3 | Image: Leg Attachment Photos 4 | Same |
| Weight | 5.8 pounds | 3.2 pounds | 3.6 pounds | 5.8 pounds | Difference isimmaterial | Leg AttachmentSizes | X-Short: 14" x 41"Short: 14" x 43"Medium: 14" x 45"Long: 14" x 48"X-Long: 14" x 52" | One size: 10" x 22" | Short: 14" x 43"Standard: 14" x 48"Tall: 14" x 60" | Small: 11" x 35"Large: 11" x 43" | Slight variation.Rapid Rebootoffers twoadditional sizesto NormaTec, tobetter suit theanatomy of eachuser. |
| Modes (Inflationsequences, allpreprogrammed) | 2 modes: "A" mode inflatesand deflates chambers frombottom up (distal toproximal chambers), one ata time. "B" mode alsoinflates chambers frombottom up, but maintainspressure in lower chambersas works its way to top.Then all chambers releasepressure at same time onceall chambers havesequentially inflated. | 1 mode: inflates and deflateschambers from bottom up(distal to proximal chambers),one at a time. | 2 different mode settings:"Sequential" mode is sameas "A" mode for RapidReboot, inflating chambersfrom bottom up (distal toproximal), one at a time."Normatec Pulse MassagePattern" pulses one zonewhile previous two hold,moving sequentially upextremity. | 2 modes: "A" modeinflates and deflateschambers from bottomup (distal to proximalchambers), one at atime. "B" mode alsoinflates chambers frombottom up, butmaintains pressure inlower chambers asworks its way to top.Then all chambersrelease pressure at sametime once all chambershave sequentiallyinflated. | reference device.All devices havesequential mode(distal toproximalchambers). | "Hip" Attachment | Hip (consisting of upperlegs, glutes, hips, lowerback) | Back (consisting of lower andmid back) | Hip (consisting of upperlegs, glutes, hips, lowerback) | Waist (consisting oflower and mid back) | Same asNormaTec |
| Modes (visualdescription) | Mode A: | Only has one mode. Followsthis sequence: | "Sequential:" | Mode A: | Same | Hip AttachmentPhotos | Image: Hip Attachment Photos 1 | Image: Hip Attachment Photos 2 | Image: Hip Attachment Photos 3 | Image: Hip Attachment Photos 4 | Same asNormaTec |
| Image: Mode A | Image: Mode A sequence | Image: Sequential | Image: Mode A | Image: Same | |||||||
| Image: Mode B | Mode B: | "Pulse Massage Pattern:"Image: Pulse Massage PatternZone 1 pulsesZone 2 pulses, Zone 1 holdsZone 3 pulses, Zone 1 & 2 holdZone 4 pulses, Zone 2 & 3 holdZone 5 pulses, Zone 3 & 4 hold | Image: Mode B | Same as Xiamen.Slight variationwith Normatecwhich holds upto 3 chambers ata time and RapidReboot holdingup to 4. |
{8}------------------------------------------------
{9}------------------------------------------------
{10}------------------------------------------------
| Hip AttachmentSizes | Regular:26" x 32"Large: 26"35" | One size: 14" x 40" | One size:28" x 32" | Small: 15" x 47"Large: 15" x 62" | Slight variation. |
|---|---|---|---|---|---|
| "Arm"Attachment | Arm (consisting of entirearm, shoulder, upper chestand back) | Arm (consisting of forearm,lower bicep) | Arm (consisting of entirearm, shoulder, upper chestand back) | Arm (consisting of entirearm, shoulder) | Same asNormaTec |
| Arm AttachmentPhotos | Image: Two Rapid Reboot arm attachments | Image: Person wearing Rapid Reboot arm attachment | Image: NormaTec arm attachment | Image: Blue arm attachment | Same |
| Arm AttachmentSizes | Regular: 18" x 38"Long: 18" x 44" | One size: 8" x "16 | One size: 16" x 38" | Small: 9" x 27"Large: 9" x 35" | Slight variation. |
| Safety Features | Button on display allowsuser to stop or pausetherapy session at any time. | Button on display allows userto stop or pause therapysession at any time. | Button on display allowsuser to stop or pausetherapy session at any time. | Button on display allowsuser to stop or pausetherapy session at anytime. | Same |
| SW/Firmware/MicroprocessorControl | Microprocessor | Microprocessor | Microprocessor | Microprocessor | Same |
{11}------------------------------------------------
| Technology | Compressor and valve system which sequentiallyinflates cells of appliance | Compressor and valve systemwhich sequentially inflates cellsof appliance | Compressor and valve system which sequentiallyinflates cells of appliance | Compressor and valve system whichsequentially inflates cellsof appliance | Same |
|---|---|---|---|---|---|
| ------------ | ------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------- | ------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------- | ------ |
[Rest of page left intentionally blank]
{12}------------------------------------------------
-
- Performance Testing... Rapid Reboot has been tested and met the requirements of the following standards:
-
- Electrical Safety IEC 60601-1:2014... Medical electrical equipment Part 1: General requirements for basic safety and essential performance
-
- EMC IEC 60601-1-2:2014... Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests;
-
- Biocompatibility EN ISO 10993-5:2009... Biological evaluations of medical devices -- Part 5: Tests for In Vitro cytotoxicity
-
- Biocompatibility EN ISO 10993-10:2010... Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
-
- Substantial Equivalence... Rapid Reboot Compression Therapy System is substantially equivalent to the legally marketed Relaxor Perfect Touch Air Massaging System (primary predicate) and Normatec Pulse and Pulse Pro (secondary predicate) for Indication for Use, and it is substantially equivalent in technological and performance characteristics to Pt 1002 Pressure Therapy System (reference device). Based on the Safety and Effectiveness test reports it is at least as safe and effective as the predicate devices and technologically comparable to the reference device, and doesn't raise any new safety and/or effectiveness concerns. Hence, it is clear that Rapid Reboot is substantially equivalent to that of the predicate devices and reference device.
§ 890.5650 Powered inflatable tube massager.
(a)
Identification. A powered inflatable tube massager is a powered device intended for medical purposes, such as to relieve minor muscle aches and pains and to increase circulation. It simulates kneading and stroking of tissues with the hands by use of an inflatable pressure cuff.(b)
Classification. Class II (performance standards).