(373 days)
The Flowpresso Device combines heat and compression therapy. Flowpresso is intended to treat postsurgical medical and/or surgical conditions for which localized thermal therapy are indicated.
Flowpresso is intended to be used by, or on the order of, licensed health care professionals based in rehabilitation facilities, outpatient clinics and athletic training settings.
The Flowpresso Compression Device is an AC powered, software-controlled multimodality device, designed to be used in a clinical setting, and under the direction, prescription, or supervision of a licensed healthcare professional.
Flowpresso is a non-invasive physical suit that delivers compression, and heat therapy. The suit has air pressure and heat cables that are connected to a computerized power unit that controls ranges and duration of treatment.
The Flowpresso consists of various inflatable wraps that cover the back/hip and extremities of a fully clothed patient with Velcro fasteners. These multi patient use garments are designed to accommodate different anatomical shapes and sizes of patients that can be cleaned and disinfected in between uses to be reused for different patients. The suit has 22 individual internal chambers that inflate sequentially before its predecessor completely deflates, to provide a progressive pressure without any flow back.
Flowpresso is controlled by an intuitive touch screen computer interface, allowing the user to manage the therapy modalities as well as easily adjust the monitor treatment times, temperature, and compression settings. Flowpresso has two separate modes: sports or relaxation, with different cycles to deliver a specific and individual experience that is supervised by a health care provider. The therapy lasts forty (40) minutes where the health provider will be available to make any adjustments throughout the duration of therapy.
The session begins with air pressure to give the patient a comfortable increased pressure, followed by heat. The health care provider is responsible for adjusting settings of pressure/heat to ensure the patient is comfortable for the entirety of the forty (40) minute session.
The provided document describes the Medella Health Limited FLOWpresso device and its 510(k) summary, comparing it to a predicate device, the Therm-X (K193550). The document focuses on demonstrating substantial equivalence rather than presenting an independent clinical study to establish performance against acceptance criteria in the typical sense of a diagnostic or treatment efficacy study.
Here's an analysis of the acceptance criteria and study information provided, extracting what's available and noting what's not, based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of quantitative acceptance criteria for clinical performance (e.g., sensitivity, specificity, or treatment success rates) and then report the device's performance against those criteria in a clinical setting. Instead, it focuses on demonstrating substantial equivalence to a predicate device through technical and safety testing.
The "acceptance criteria" can be inferred from the various tests performed to ensure the device is safe and performs according to its specifications and regulatory standards. The "reported device performance" are the qualitative findings of passing these tests.
| Acceptance Criteria (Inferred from testing) | Reported Device Performance (Qualitative Findings) |
|---|---|
| Compliance with Electrical Safety Standards (e.g., ANSI/AAMI ES60601-1, IEC 60601-1, EN60601-1) | Verification results indicate the device is safe. |
| Compliance with Biocompatibility Standards (e.g., ISO 10993-5, ISO 10993-10) | Patient contact materials were verified. |
| Compliance with Flammability Standards (e.g., 16 CFR 1610, IEC 60601-2-35) | Sample met Class 1 - normal flammability requirements. All pieces remained well within tolerance of 40°C. |
| Validation of Cleaning, Disinfection, and Durability for Multi-Patient Use | Durability test confirmed safe use and disinfection for the garment's life without deterioration. |
| Software Validation (against performance requirements and specifications) | Confirmed that Flowpresso software meets its performance requirements and specifications. |
| Proper operation of the system (e.g., Pressure Accuracy, Seam Strength, Hose Integrity, Failure Mode) | Test and verification results indicate Flowpresso conforms to its predetermined specifications and operates within safety limits. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The testing described appears to be bench testing and materials testing, not a clinical trial involving a "test set" of patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable and not provided. Since the document describes technical and safety testing rather than a clinical study evaluating diagnostic accuracy or treatment outcome against a "ground truth" established by experts, this detail is absent.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. Adjudication methods (like 2+1, 3+1 consensus) are used in studies where human expert review or consensus is needed to establish ground truth for clinical cases, which is not the type of study described here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
This information is not applicable and not provided. MRMC studies are typically for evaluating AI in diagnostic imaging or other areas where human readers interpret cases, and the document describes a physical therapy device. The FLOWpresso device does not appear to involve AI/human reader interaction in its described function.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable and not provided. The FLOWpresso is a physical hardware device with software controls, not a standalone algorithm. While software validation was performed, it's for controlling the device, not for independent diagnostic or predictive tasks.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the safety and performance tests described, the "ground truth" consists of established engineering standards, material specifications, and regulatory requirements. For example:
- Electrical safety: Adherence to ANSI/AAMI ES60601-1, IEC 60601-1.
- Biocompatibility: Adherence to ISO 10993-5, ISO 10993-10.
- Flammability: Adherence to 16 CFR 1610.
- Software performance: Conformance to established performance requirements and specifications.
- Bench testing: Conformance to predetermined specifications (e.g., pressure accuracy, seam strength).
There is no mention of clinical ground truth (e.g., pathology, outcomes data, or expert consensus on clinical cases) in this 510(k) summary, as it's not a clinical efficacy study.
8. The Sample Size for the Training Set
This information is not applicable and not provided. The device is a physical therapy device; there is no mention of an algorithm that would require a "training set" of data in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided for the same reasons as in point 8.
Summary of the Study Presented:
The document describes bench testing, material testing, and software validation to demonstrate the safety and technical performance of the FLOWpresso device and its substantial equivalence to a predicate device (Therm-X). The "study" is a collection of engineering and materials tests conducted against recognized industry standards and internal specifications. It is a design verification and validation effort rather than a clinical effectiveness study. The purpose is to show that the device meets safety and performance requirements for a Class II medical device, enabling its market clearance based on substantial equivalence. It does not contain information about clinical outcomes, patient data, or AI performance metrics.
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Image /page/0/Picture/0 description: The image contains 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, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 21, 2023
Medella Health Limited % Samantha Nava Managing Director Tilia Bridge 1506 Summer City Dr Houston, Texas 77047
Re: K223729
Trade/Device Name: FLOWpresso Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP, IRT Dated: December 7, 2023 Received: December 12, 2023
Dear Samantha Nava:
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 (the 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 available 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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.
Heather L. Dean -S
Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Rehabilitation Devices
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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) K223729
Device Name FLOWpresso
Indications for Use (Describe)
The Flowpresso Device combines heat and compression therapy. Flowpresso is intended to treat postsurgical medical and/or surgical conditions for which localized thermal therapy are indicated.
Flowpresso is intended to be used by, or on the order of, licensed health care professionals based in rehabilitation facilities, outpatient clinics and athletic training settings.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| 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
Medella Health Ltd K223729
This summary of the 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1900 and CFR 807.92.
| Date: | 7th December 2023 |
|---|---|
| Submitter: | Medella Health LtdUnit 7, 144 Third AveTauranga 3110, New Zealand+64 27 5443424 |
| Primary Contact: | Samantha NavaPresidentTilia Bridge LLCTel: (660) 234-2202Email: samnava@tiliabridge.com |
| Company Contact: | Desiree De SpongChief ExecutiveEmail: desiree@flowpresso.co.nz |
Device Name and Classification:
| Trade Name: | Flowpresso |
|---|---|
| Common Names: | Heat and Compression Therapy |
| Classification: | Class II |
| Regulation Number: | 21CFR 890.5650, Powered Inflatable Tube Massager |
| Classification Panel: | Physical Medicine |
| Product Code: | IRP, IRT |
Predicate Device:
| Subject | Predicate | |
|---|---|---|
| Trade Name: | Flowpresso | Therm-X |
| Common Name: | Heat and CompressionTherapy | Heat and/or ColdCompression Therapy |
| 510(k) Submitter/Holder: | Medella Health Ltd | Zenith TechnicalInnovations, LLC. (Zenith) |
| 510(k) Number: | K223729 | K193550 |
| Classification: | Class II | Class II |
| Regulation Number: | 890.5650 Powered InflatableTube Massager | 890.5650 Powered InflatableTube Massager |
| Classification Panel: | Physical Medicine | Physical Medicine |
| Product Code: | IRP, IRT | IRP, ILO, JOW |
1 Device Description
The Flowpresso Compression Device is an AC powered, software-controlled multimodality device, designed to be used in a clinical setting, and under the direction, prescription, or
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supervision of a licensed healthcare professional.
Flowpresso is a non-invasive physical suit that delivers compression, and heat therapy. The suit has air pressure and heat cables that are connected to a computerized power unit that controls ranges and duration of treatment.
The Flowpresso consists of various inflatable wraps that cover the back/hip and extremities of a fully clothed patient with Velcro fasteners. These multi patient use garments are designed to accommodate different anatomical shapes and sizes of patients that can be cleaned and disinfected in between uses to be reused for different patients. The suit has 22 individual internal chambers that inflate sequentially before its predecessor completely deflates, to provide a progressive pressure without any flow back.
Flowpresso is controlled by an intuitive touch screen computer interface, allowing the user to manage the therapy modalities as well as easily adjust the monitor treatment times, temperature, and compression settings. Flowpresso has two separate modes: sports or relaxation, with different cycles to deliver a specific and individual experience that is supervised by a health care provider. The therapy lasts forty (40) minutes where the health provider will be available to make any adjustments throughout the duration of therapy.
The session begins with air pressure to give the patient a comfortable increased pressure, followed by heat. The health care provider is responsible for adjusting settings of pressure/heat to ensure the patient is comfortable for the entirety of the forty (40) minute session.
2 Indications for Use
The Flowpresso Device combines heat and compression therapy. Flowpresso is intended to treat post traumatic and post-surgical medical and/or surqical conditions for which localized thermal therapy are indicated.
Flowpresso is intended to be used by, or on the order of, licensed health care professionals based in rehabilitation facilities, outpatient clinics and athletic training settings.
3 Risk Analysis Method
Flowpresso was assessed to determine the risks to health, associated with the device and evaluate risks related to safety, effectiveness, and usability. A risk analysis was conducted in according with ISO 14971:2007 and ISO14971:2012, Medical devices - Application of risk management to medical devices. All risks have been found acceptable.
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4 Substantial Equivalence Information
Flowpresso is equivalent to Therm-X (K193550) by Zenith Technical Innovations, LLC. (Zenith), currently on the market. Flowpresso has the same intended use and indications for use, as the predicate device and uses equivalent overall design and operating principals as the predicate device.
The table below provides a detailed comparison of Flowpresso to the predicate device.
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| Characteristic | Predicate DeviceTherm-X | Subject deviceFlowpresso | Similar | Different | Comparison |
|---|---|---|---|---|---|
| Indicationsfor Use | Therm-X (Therm-X Homeand Therm-X AT) combinescold,heat, contrast, andcompression therapy.Therm-X is intended to treatpost-surgical and acuteinjuries to reduce edema,swelling, and pain for whichcold and compression areindicated. It is intended totreat post traumatic andpostsurgical medicaland/or surgical conditionsfor which localized thermaltherapy (hot or cold)indicated.Therm-X (Therm-X Homeand Therm-X AT) isintended to beused by, or on the order of,licensed health careprofessionals inrehabilitationfacilities, outpatient clinics,athletic training settings, andhome settings. | The Flowpresso Devicecombines heat andcompression therapy.Flowpresso is intended to treatpost traumatic and post-surgicalmedical and/or surgicalconditions for which localizedthermal therapy are indicated.Flowpresso is intended to beused by, or on the order of,licensed health careprofessionals based inrehabilitation facilities,outpatient clinics and athletictraining settings. | X | The major differencebetween the subject andpredicate device isTherm-X also combinescold and contrast. | |
| Characteristic | Predicate DevicesTherm-X | Subject deviceFlowpresso | Similar | Different | Comparison |
| IntendedUsers | Health Care Professionalsand lay users (underprescription) | Health Care Professionals | X | Flowpresso is notintended for home use. | |
| Number ofpatients thatcan be treatedat one time | One | One | X | ||
| TwoprogrammableCycles | Configuration of twoprogrammable cycles | Configuration of twoprogrammable cycles | X |
Detailed Comparison of the Subject and Predicate Device
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Functions
| TreatmentTime | Custom: 3-40 minutes | 01-40 minutes | x | ||
|---|---|---|---|---|---|
| HeatTherapy | Default: 105°F, 107°F, 110°FCustom: 105°F - 110°FDefault, continuous:105°F, 107°FCustom, continuous:105°F - 107°F | Default: 86°F – 104°F | x | Flowpresso operates at alower temperature |
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| CharacteristiC | Predicate DevicesTherm-X | Subject deviceFlowpresso | Similar | Different | Comparison |
|---|---|---|---|---|---|
| CompressionPressureLevels | Available in following levels:Lite (5 mm Hg)Low (20 mm Hg)Medium (45 mm Hg)High (70 mm Hg)Calf: 50 - 70 mmHgFoot: 90 – 130mmHg | 5-130mm/Hg | × | Flowpresso delivers up to130mm/Hg.Pressure range isdependent on patientcomfort levels and areadjusted in real-time. | |
| Static orIntermittentPressure | Both | Both | × | ||
| PowerDown | Available | Available | × | ||
| PasswordProtection | Available | Not Available | × | ||
| StorageCycle UsageData | Available | Not Available | × |
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Physical Unit
| Characteristic | Predicate DeviceTherm-X | Subject deviceFlowpresso | Similar | Different | Comparison |
|---|---|---|---|---|---|
| Dimensions(W x H x D) | 10.5" x 9" x 15" | 12" x 6" x 15.5" | X | ||
| Weight | 15 pounds when full ofcoolant | 18 pounds | X | ||
| HeatingMechanism | Thermoelectric | Thermotherapy | X | Thermotherapy consistsof application of heat orfor the purpose ofchanging the cutaneous,intra-articular and coretemperature of soft tissuewith the intention ofimproving the symptomsof certain conditions. | |
| User Interface | Touch Screen | Touch Screen | X |
Electrical
| Linevoltage | 100-240V | 110-220V | X | |
|---|---|---|---|---|
| LineFrequency | 50/60 Hz | 50/60 Hz | X | |
| ElectricalSafetyStandards | ANSI/AAMIES60601-1:2005/(R)2012CAN/CSA C22.2 No.60601-1:2014 Type BIEC 60601-1-2 | ANSI/AAMI ES60601-1:2005 + A1:2012IEC 60601-1:2005 +A1:2012EN60601-1:2006 +A1:2013 | X |
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Environment
| Characteristic | Predicate DeviceTherm-X | Subject deviceFlowpresso | Similar | Different | Comparison |
|---|---|---|---|---|---|
| OperatingTemperature | 60°F - 80°F (16°C – 27°C) | 60°F - 80°F (16°C - 27°C) | X | ||
| StorageTemperature | 33°F - 122°F (1°C - 50°C) | 33°F - 122°F (1°C - 50°C) | X | ||
| OperatingHumidity | Below 60% Noncondensing | Below 60% Noncondensing | X | ||
| StorageHumidity | Below 60% Noncondensing | Below 60% Noncondensing | X | ||
| OperatingAtmosphericPressure andAltitude | 700 hPa – 1060 hPa(corresponds to a max. elevationof 9,842 ft. 6 in (3000 m)) | 700 hPa – 1060 hPa(corresponds to a max. elevationof 9,842 ft. 6 in (3000m)) | X | ||
| Characteristic | Predicate DeviceTherm-X | Subject deviceFlowpresso | Similar | Different | Comparison |
| Types ofGarments | Various anatomical thermalgarments for: Back, Elbow,Shoulder, Knee, Ankle, Hip.DVT Garments: Calf and Foot | Various anatomicalthermal/compression garmentsfor: Back/Hip, arm, leg, feet | X | Both devices areintended to be anupper body, lowerbody, or full bodyexperience, which isbased on the patients'individual needs. | |
| PatientContactingMaterial | Thermal garment reusable(multi-patient) - 30 deniernylon coated in urethane.DVT – 200 denier nyloncoated in urethane. | Needle cotton, non-conductiveand non-woven lining. Allencompassed with a PVCmaterial. | X | Flowpresso device isPVC material thatinternally holds needlecotton, non-conductiveheat, and non-wovenlining. | |
| Multi-PatientUse and Single-Patient UseWraps | Multi-Patient Use and Single-Patient Use Available | Multi-Patient Use | X | Flowpresso wraps arenot available for singleuse | |
| Biocompatibility | Cytotoxicity testing per ISO10993-5Sensitization testing per ISO10993-10Irritation testing perISO 10993-10 | Cytotoxicity testing per ISO10993-5Sensitization testing per ISO10993-10Irritation testing perISO 10993-10 | X | ||
| GarmentFlammabilityTesting | - | 16 CFR 1610 Standard for theFlammability of Clothing Textiles | X | Flowpresso materialwas tested to meetsafety standards. | |
| Sterile/Non-Sterile | Non-sterile only | Non-sterile only | X | ||
| Characteristic | Predicate DeviceTherm-X | Subject deviceFlowpresso | Similar | Different | Comparison |
| CleaningDisinfectionValidation ofLabeling | Yes- for Multi-Patient usereusable wraps | Yes- for Multi-Patient usereusable wraps | X | ||
| Human Factorstesting toconfirmintended usershave foundinstructions forcleaning anddisinfectioneasy to use | Yes- for Multi-Patient usereusable wraps | Yes- for Multi-Patient usereusable wraps | X | ||
| Expected Life ofGarments | Based on frequency of useand continued functionalperformance | Based on frequency of use andcontinued functionalperformance | X | ||
| Validation ofrepeatedcleaning anddisinfection forreusablegarments | Yes- for Multi-Patient usereusable wraps | Yes- for Multi-Patient usereusable wraps | X |
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Accessories/Garments
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5 Testing:
Flowpresso was verified and validated in accordance with documented Verification & Validation plans and protocols to ensure conformance with established performance criteria. See below for the type of tests performed.
Electromagnetic Compatibility / Electrical Safety:
Electromagnetic Compatibility/Electrical Safety testing was performed in accordance with the following standards:
- ANSI/AAMI ES60601-1:2005 + A1:2012. Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Essential Performance.
- IEC 60601-1:2005 + A1:2012. Medical electrical equipment Part 1: General requirements for basic safety and essential performance.
- EN60601-1:2006 +A1:2013. Medical electrical equipment Part 1: General requirements for basic safety and essential performance
Verification results indicated that the device is safe.
Biocompatibility:
The Flowpresso patient contact materials were verified in accordance with the following standards:
- . ISO 10993-5, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity.
- ISO 10993-10, Biological evaluation of medical devices Part 10: Tests for irritation and . skin sensitization.
- ISO 10993-10, Biological evaluation of medical devices Part 10: Tests for irritation and ● skin sensitization.
Material Heat Testing:
The Flowpresso garment material testing was conducted in accordance with 16 CFR 1610 Standard for the Flammability of Clothing Textiles and the Test Procedure as per 16 CFR 1610.6. According to the test result, the submitted sample met the class 1 - normal flammability requirements defined in 16.CFR 1610. Further testing was conducted in accordance with IEC 60601-2-35:2021 Medical Electrical equipment Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads, and mattresses and intended for heating in medical use showing that all pieces remain well within tolerance of 40°C.
6 Cleaning, Disinfection and Shelf-Life Testing:
Flowpresso garments are intended for use over clothed skin only. They are provided nonsterile and not intended to be user sterilized. Cleaning instructions are provided for multipatient use garments.
The Flowpresso components and garments do not have a definitive shelf live based on
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packaging or time. Expected life is based on frequency of use and continued functional performance. Durability test has been performed and has confirmed the safe use and disinfection of a Flowpresso garment for the duration of the garment's life without evidence of deterioration of the garment due to cleaning.
7 Software Validation:
Medella Health has conducted software validation testing on the Flowpresso software and confirmed that Flowpresso software meets its performance requirements and specifications. Software Validation has been completed according to an established Validation procedure and FDA Guidance Documents and Industry Standards:
- General Principles of Software Validation; Final Guidance for Industry and FDA Staff, ● January 11, 2002
- . Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 11, 2005
The Software is a Moderate Level of Concern as per FDA guidance. All required items related to software as required by FDA guidance have been included in this submission.
8 Performance - Bench:
Flowpresso has been tested for performance to verify the proper operation of the system. Test and verification results indicate that Flowpresso conforms to its predetermined specifications and operates within safety limits.
The following Tests have been performed:
- Pressure Accuracy Test .
- Seam Strength Test
- Hose Integrity Test ●
- Failure Mode Test ●
- Garment V&V Testing Report
9 Substantial Equivalence Conclusions
In conclusion, the intended use for Flowpresso is substantially equivalent to that of the predicate device. The technological characteristics comparison demonstrates that Flowpresso is equivalent to the predicate device, and the testing shows that Flowpresso is substantially equivalent to the predicate device and assures that Flowpresso is as safe and effective as the predicate devices.
§ 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).