(373 days)
Not Found
No
The description focuses on software control for managing pre-set modes and adjustable parameters (pressure, heat, time) based on user input, not on learning or adaptive algorithms.
Yes
The device is intended to treat postsurgical medical and/or surgical conditions for which localized thermal therapy is indicated, which defines it as a therapeutic device.
No
Explanation: The device is described as providing "heat and compression therapy" and is "intended to treat postsurgical medical and/or surgical conditions." It delivers physical therapy rather than making a diagnosis.
No
The device description clearly states it is an "AC powered, software-controlled multimodality device" and includes physical components like a suit with air pressure and heat cables connected to a computerized power unit. It also mentions hardware testing like Electromagnetic Compatibility / Electrical Safety and Material Heat Testing.
Based on the provided text, the Flowpresso Device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Flowpresso's Function: The Flowpresso Device applies heat and compression therapy externally to the patient's body. It does not analyze any biological samples.
- Intended Use: The intended use clearly states it's for treating postsurgical medical and/or surgical conditions using localized thermal therapy. This is a physical therapy application, not a diagnostic one.
- Device Description: The description details a physical suit with air pressure and heat cables, designed for external application to the body. There is no mention of sample collection or analysis.
Therefore, the Flowpresso Device falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Flowpresso Device combines heat and compression therapy. Flowpresso is intended to treat post traumatic and post-surgical 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.
Product codes (comma separated list FDA assigned to the subject device)
IRP, IRT
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Back/Hip, arm, leg, feet
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Electromagnetic Compatibility / Electrical Safety: Testing performed in accordance with ANSI/AAMI ES60601-1:2005 + A1:2012, IEC 60601-1:2005 + A1:2012, and EN60601-1:2006 +A1:2013. Results indicated the device is safe.
Biocompatibility: Patient contact materials verified in accordance with ISO 10993-5 (in vitro cytotoxicity), ISO 10993-10 (irritation and skin sensitization).
Material Heat Testing: Garment material testing conducted in accordance with 16 CFR 1610 Standard for the Flammability of Clothing Textiles and test procedure per 16 CFR 1610.6. Sample met class 1 normal flammability requirements. Further testing with IEC 60601-2-35:2021 showed all pieces remain well within tolerance of 40°C.
Cleaning, Disinfection and Shelf-Life Testing: Durability test performed confirming safe use and disinfection of garment without deterioration due to cleaning.
Software Validation: Software validation testing completed to confirm Flowpresso software meets performance requirements and specifications, following FDA Guidance Documents and Industry Standards. Software is a Moderate Level of Concern.
Performance - Bench: Tested for proper system operation. Test and verification results indicate Flowpresso conforms to predetermined specifications and operates within safety limits. Tests performed include Pressure Accuracy Test, Seam Strength Test, Hose Integrity Test, Failure Mode Test, and Garment V&V Testing Report.
Key results: Flowpresso is substantially equivalent to the predicate device, Therm-X (K193550), in intended use and technological characteristics, and is safe and effective.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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.
1
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
2
OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
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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4
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 Ltd |
Unit 7, 144 Third Ave | |
Tauranga 3110, New Zealand | |
+64 27 5443424 | |
Primary Contact: | Samantha Nava |
President | |
Tilia Bridge LLC | |
Tel: (660) 234-2202 | |
Email: samnava@tiliabridge.com | |
Company Contact: | Desiree De Spong |
Chief Executive | |
Email: 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 Compression | |
Therapy | Heat and/or Cold | |
Compression Therapy | ||
510(k) Submitter/Holder: | Medella Health Ltd | Zenith Technical |
Innovations, LLC. (Zenith) | ||
510(k) Number: | K223729 | K193550 |
Classification: | Class II | Class II |
Regulation Number: | 890.5650 Powered Inflatable | |
Tube Massager | 890.5650 Powered Inflatable | |
Tube 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
5
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.
6
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.
7
| Characteristic | Predicate Device
Therm-X | Subject device
Flowpresso | Similar | Different | Comparison |
|-------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|-----------|-----------------------------------------------------------------------------------------------------------------------|
| Indications
for Use | Therm-X (Therm-X Home
and Therm-X AT) combines
cold,
heat, contrast, and
compression therapy.
Therm-X is intended to treat
post-surgical and acute
injuries to reduce edema,
swelling, and pain for which
cold and compression are
indicated. It is intended to
treat post traumatic and
postsurgical medical
and/or surgical conditions
for which localized thermal
therapy (hot or cold)
indicated.
Therm-X (Therm-X Home
and Therm-X AT) is
intended to be
used by, or on the order of,
licensed health care
professionals in
rehabilitation
facilities, outpatient clinics,
athletic training settings, and
home settings. | The Flowpresso Device
combines heat and
compression therapy.
Flowpresso is intended to treat
post traumatic and post-surgical
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. | | X | The major difference
between the subject and
predicate device is
Therm-X also combines
cold and contrast. |
| Characteristic | Predicate Devices
Therm-X | Subject device
Flowpresso | Similar | Different | Comparison |
| Intended
Users | Health Care Professionals
and lay users (under
prescription) | Health Care Professionals | | X | Flowpresso is not
intended for home use. |
| Number of
patients that
can be treated
at one time | One | One | X | | |
| Two
programmable
Cycles | Configuration of two
programmable cycles | Configuration of two
programmable cycles | X | | |
Detailed Comparison of the Subject and Predicate Device
8
Functions
| Treatment
Time | Custom: 3-40 minutes | 01-40 minutes | x | ||
---|---|---|---|---|---|
Heat | |||||
Therapy | Default: 105°F, 107°F, 110°F | ||||
Custom: 105°F - 110°F | |||||
Default, continuous: | |||||
105°F, 107°F | |||||
Custom, continuous: | |||||
105°F - 107°F | Default: 86°F – 104°F | x | Flowpresso operates at a | ||
lower temperature |
9
| Characteristi
C | Predicate Devices
Therm-X | Subject device
Flowpresso | Simila
r | Different | Comparison |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|-------------|-----------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Compression
Pressure
Levels | Available in following levels:
Lite (5 mm Hg)
Low (20 mm Hg)
Medium (45 mm Hg)
High (70 mm Hg)
Calf: 50 - 70 mmHg
Foot: 90 – 130mmHg | 5-130mm/Hg | | × | Flowpresso delivers up to
130mm/Hg.
Pressure range is
dependent on patient
comfort levels and are
adjusted in real-time. |
| Static or
Intermittent
Pressure | Both | Both | × | | |
| Power
Down | Available | Available | × | | |
| Password
Protection | Available | Not Available | | × | |
| Storage
Cycle Usage
Data | Available | Not Available | | × | |
10
Physical Unit
| Characteristic | Predicate Device
Therm-X | Subject device
Flowpresso | 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 of
coolant | 18 pounds | X | | |
| Heating
Mechanism | Thermoelectric | Thermotherapy | | X | Thermotherapy consists
of application of heat or
for the purpose of
changing the cutaneous,
intra-articular and core
temperature of soft tissue
with the intention of
improving the symptoms
of certain conditions. |
| User Interface | Touch Screen | Touch Screen | X | | |
Electrical
| Line
voltage | 100-240V | 110-220V | X | |
---|---|---|---|---|
Line | ||||
Frequency | 50/60 Hz | 50/60 Hz | X | |
Electrical | ||||
Safety | ||||
Standards | ANSI/AAMI | |||
ES60601-1:2005/(R)2012 | ||||
CAN/CSA C22.2 No. | ||||
60601-1:2014 Type B | ||||
IEC 60601-1-2 | ANSI/AAMI ES60601- | |||
1:2005 + A1:2012 | ||||
IEC 60601-1:2005 + | ||||
A1:2012 | ||||
EN60601-1:2006 +A1:2013 | X |
11
Environment
| Characteristic | Predicate Device
Therm-X | Subject device
Flowpresso | Similar | Different | Comparison |
|-------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|---------|-----------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Operating
Temperature | 60°F - 80°F (16°C – 27°C) | 60°F - 80°F (16°C - 27°C) | X | | |
| Storage
Temperature | 33°F - 122°F (1°C - 50°C) | 33°F - 122°F (1°C - 50°C) | X | | |
| Operating
Humidity | Below 60% Noncondensing | Below 60% Noncondensing | X | | |
| Storage
Humidity | Below 60% Noncondensing | Below 60% Noncondensing | X | | |
| Operating
Atmospheric
Pressure and
Altitude | 700 hPa – 1060 hPa
(corresponds to a max. elevation
of 9,842 ft. 6 in (3000 m)) | 700 hPa – 1060 hPa
(corresponds to a max. elevation
of 9,842 ft. 6 in (3000m)) | X | | |
| Characteristic | Predicate Device
Therm-X | Subject device
Flowpresso | Similar | Different | Comparison |
| | | | | | |
| Types of
Garments | Various anatomical thermal
garments for: Back, Elbow,
Shoulder, Knee, Ankle, Hip.
DVT Garments: Calf and Foot | Various anatomical
thermal/compression garments
for: Back/Hip, arm, leg, feet | X | | Both devices are
intended to be an
upper body, lower
body, or full body
experience, which is
based on the patients'
individual needs. |
| Patient
Contacting
Material | Thermal garment reusable
(multi-patient) - 30 denier
nylon coated in urethane.
DVT – 200 denier nylon
coated in urethane. | Needle cotton, non-conductive
and non-woven lining. All
encompassed with a PVC
material. | X | | Flowpresso device is
PVC material that
internally holds needle
cotton, non-conductive
heat, and non-woven
lining. |
| Multi-Patient
Use and Single-
Patient Use
Wraps | Multi-Patient Use and Single-
Patient Use Available | Multi-Patient Use | | X | Flowpresso wraps are
not available for single
use |
| Biocompatibility | Cytotoxicity testing per ISO
10993-5
Sensitization testing per ISO
10993-10
Irritation testing per
ISO 10993-10 | Cytotoxicity testing per ISO
10993-5
Sensitization testing per ISO
10993-10
Irritation testing per
ISO 10993-10 | X | | |
| Garment
Flammability
Testing | - | 16 CFR 1610 Standard for the
Flammability of Clothing Textiles | | X | Flowpresso material
was tested to meet
safety standards. |
| Sterile/Non-
Sterile | Non-sterile only | Non-sterile only | X | | |
| Characteristic | Predicate Device
Therm-X | Subject device
Flowpresso | Similar | Different | Comparison |
| Cleaning
Disinfection
Validation of
Labeling | Yes- for Multi-Patient use
reusable wraps | Yes- for Multi-Patient use
reusable wraps | X | | |
| Human Factors
testing to
confirm
intended users
have found
instructions for
cleaning and
disinfection
easy to use | Yes- for Multi-Patient use
reusable wraps | Yes- for Multi-Patient use
reusable wraps | X | | |
| Expected Life of
Garments | Based on frequency of use
and continued functional
performance | Based on frequency of use and
continued functional
performance | X | | |
| Validation of
repeated
cleaning and
disinfection for
reusable
garments | Yes- for Multi-Patient use
reusable wraps | Yes- for Multi-Patient use
reusable wraps | X | | |
12
Accessories/Garments
13
14
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
15
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.