(208 days)
The Invia Ease Negative Pressure Wound Therapy (NPWT) system is indicated for patients who would benefit from a suction device (Negative Pressure Wound Therapy) as when used on open wounds it creates an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and by removing exudates and infectious material. When used on closed surgical incisions, the Invia Ease NPWT System is also intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate via the application of Negative Pressure Wound Therapy (NPWT).
The Invia Ease NPWT system is intended for use in acute, extended and home care settings.
The Invia Ease NPWT system is appropriate for the following indications:
- Acute or subacute wounds
- Chronic wounds
- Dehisced wounds
- Pressure ulcers
- Diabetic/Neuropathic ulcers
- Venous insufficiency ulcers
- Traumatic wounds
- Partial thickness burns
- Flaps and grafts
- Closed surgical incisions
The Invia Ease Negative Pressure Wound Therapy (NPWT) System is a suction pump designed to help promote wound healing through Negative Pressure Wound Therapy (NPWT). The Invia Ease pump is reusable and portable pump intended to be used in acute, extended and home care settings.
The Invia Ease pump provides adjustable negative pressure with constant and intermittent therapy modes. Invia Ease NPWT System comprises the Invia Ease pump and the following accessories: Invia Ease canisters with integrated tubing, Invia Ease carrying case, Invia Ease handle, Invia Ease IV pole/ bed holder, and Invia Ease charger US.
The Invia Ease user interface includes two tactile buttons: an on/off button on the side of the pump and a mute button on the top of the pump. The pump is also equipped with a large touchscreen display on top of the pump, a status indicator bar on the front-side of the pump, which wraps around the side of the pump, as well as a charging port below the on/off button. Optical status of the pump is provided on the touchscreen and acoustic notifications are also used.
The pump is used with 300 ml, 500 ml and 1000 ml canisters that include a release button and canister tubing with Quick-Connector. The pump is compatible with Invia dressings (NPWT dressings from Medela AG) that interface via the Quick-Connector.
Invia Ease NPWT system is intended to be used in conjunction with the Invia dressings only.
The provided document is a 510(k) Premarket Notification from the U.S. FDA for the Medela AG Invia Ease Negative Pressure Wound Therapy (NPWT) System. It details the device, its intended use, comparison to a predicate device, and summaries of non-clinical tests.
However, this document does not contain information about the acceptance criteria or a study proving the device meets clinical acceptance criteria. The document explicitly states under "Summary of Clinical Tests" that "Clinical testing was not needed to support substantial equivalence."
Instead, the document focuses on non-clinical tests to demonstrate substantial equivalence to a predicate device. For devices like NPWT systems, "performance" is often assessed through engineering and bench testing rather than clinical trials for 510(k) clearance, unless there are significant technological differences or new indications for use that warrant clinical data.
Therefore, I can provide the following based on the document's content, focusing on non-clinical performance and "acceptance criteria" as defined by engineering standards and regulatory requirements for substantial equivalence:
Acceptance Criteria and Study for Medela AG Invia Ease Negative Pressure Wound Therapy (NPWT) System (K214112)
Based on the provided FDA 510(k) summary, the "acceptance criteria" are primarily defined by compliance with recognized engineering standards, biocompatibility, cybersecurity, usability, and functional performance benchmarks demonstrated through non-clinical testing, ensuring the device is substantially equivalent to its predicate. No clinical performance acceptance criteria or clinical studies are detailed, as they were not required for this 510(k) submission.
1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)
The document lists various non-clinical tests performed to demonstrate safety and effectiveness. The acceptance criteria are implicit in passing these tests and meeting the standards. "Reported device performance" implies the device successfully passed these tests.
| Acceptance Criteria Category/Test Type | Specific Acceptance Criterion (Implicit) | Reported Device Performance (as stated in document) |
|---|---|---|
| Risk Management | Compliance with ISO 14971: 2019 | Risk analysis performed in accordance with ISO 14971: 2019. |
| Electrical Safety | Compliance with ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Medical Electrical Equipment - Part 1: General requirements for Basic Safety and Essential Performance). | Meets IEC 60601-1 Standard. |
| Usability | Compliance with IEC 60601-1-6; 2013 (General requirements for basic safety and essential performance - Collateral standard: Usability) and FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices." | Usability testing conducted to validate use in acute, extended and home care settings in accordance with FDA guidance. |
| Alarm Systems | Compliance with IEC 60601-1-8: 2020 (General requirements, tests and guidance for alarm systems). | Subject device's approach to audio indicators uses more modern technology and meets IEC 60601-1-8 alarm standard for Low and Medium priority alarms. |
| Home Healthcare Environment | Compliance with IEC 60601-1-11:2015 (Requirements for medical electrical equipment and systems used in the home healthcare environment). | Test documentation provided (implied compliance). |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2:2014 (Edition 4.0) (Electromagnetic Disturbances - Requirements and Tests), AIM Standard 7351731 Rev. 2.00 2017-02-23 (RF Identification Readers), and ANSI IEEE C63.27-2017 (Wireless Coexistence). | Meets IEC 6060-1-2 Standard. |
| Battery Safety | Compliance with IEC 62133-2 Edition 1.0 2017-02 (Safety requirements for portable sealed secondary cells, for use in portable applications - Part 2: Lithium systems). | Test documentation provided (implied compliance). |
| Medical Suction Equipment | Compliance with ISO 10079-1 Third Edition 2015-11-01 (Medical suction equipment Part 1: Electrically powered suction equipment). | Test documentation provided (implied compliance). |
| Radio Frequency (RF) Compliance | Compliance with FCC, 47 C.F.R. Part 15 Subparts B and C. | Test documentation provided (implied compliance). |
| Sterilization & Shelf-Life | Compliance with FDA Guidance document "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile." | Information provided in accordance with FDA guidance. |
| Biocompatibility | Compliance with FDA Guidance document "Use of International Standard ISO 10993-1," and draft guidance "Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin." Specific tests: Cytotoxicity (ISO 10993-5), Intracutaneous reactivity (ISO 10993-10), Sensitization (ISO 10993-10). | Evaluation completed according to FDA Guidance. Canister and Tubing components were successfully evaluated for cytotoxicity, intracutaneous reactivity, and skin sensitization. |
| Software/Firmware | Compliance with FDA Guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" ("Moderate" level of concern). | Software/firmware verification and validation provided in accordance with FDA guidance. |
| Cybersecurity | Compliance with FDA Guidance document "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices." | Cybersecurity evaluation performed according to FDA guidance. |
| Bench Performance Testing | Device meets specifications under conditions of Intermittent and Constant therapy modes with power supplied from both internal battery and external AC/DC adapter, and with each compatible dressing kit. Tests include: Vacuum Performance (with leak), Noise, Pump Endurance, Pump Tightness, IP Protection - IP22, Filter, Battery Run time, Display Stability, Transport Validation. | Bench testing conducted to check that specifications were met. The listed tests were performed, and the device demonstrated compliance. For instance, Max. vacuum: -200 mmHg / -27 KPa; Min. vacuum: -40 mmHg / -5.3 KPa. IP rating meets IP22. Battery provides sufficient life. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not explicitly stated in terms of individual units tested, but the document refers to various bench tests. For biocompatibility, testing was performed on "Canister" and "Tubing" components. For performance, it mentions "all Medela AG cleared dressing kits." Without specific numbers, it is assumed standard engineering and quality control sample sizes were used to establish statistical confidence in meeting acceptance criteria during manufacturing and validation.
- Data Provenance: The tests are explicitly non-clinical bench tests performed by Medela AG, a company based in Switzerland. The data would originate from their internal testing and validation processes. Given the nature of 510(k) non-clinical submissions, this data is inherently prospective in the sense that it was generated specifically for the regulatory submission to prove design and manufacturing parameters.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- This question is not applicable as the document explicitly states, "Clinical testing was not needed to support substantial equivalence." Therefore, there was no test set requiring expert ground truth for clinical outcomes or diagnoses, as would be the case for AI/imaging devices. The "ground truth" for non-clinical tests is against engineering specifications and international standards which are established by consensus in their respective fields (e.g., electrical engineers for IEC 60601, toxicologists for ISO 10993).
4. Adjudication Method for the Test Set:
- None. As the study described is non-clinical bench testing to engineering specifications, there is no need for adjudication of human interpretation, which is typical for clinical studies involving multiple readers or subjective assessments.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
- No. An MRMC study is a clinical study format typically used for diagnostic devices (e.g., radiology AI). This device (Negative Pressure Wound Therapy System) is a treatment device, and no clinical studies were performed or required for its 510(k) clearance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done:
- Not applicable. This device is a physical medical device, not an AI algorithm. Its performance is inherent to its mechanical and software functions, which operate either independently or with human interaction (e.g., adjusting pressure). The performance is evaluated based on its functional output (e.g., vacuum pressure, alarm accuracy) rather than a diagnostic output.
7. The Type of Ground Truth Used:
- For the non-clinical tests, the "ground truth" is established by:
- Engineering Specifications: Designed performance parameters (e.g., vacuum levels, battery life, dimensions).
- International Standards: Published consensus standards for medical devices (e.g., IEC 60601 series for electrical safety, ISO 10993 for biocompatibility, ISO 14971 for risk management).
- Predicate Device Performance: Demonstrating substantial equivalence to the legally marketed predicate device (K172145) provides a comparative "truth" that the new device performs similarly in its core functions.
8. The Sample Size for the Training Set:
- Not applicable. This device is not an AI/ML algorithm that requires a training set in the conventional sense. The "training" in device development refers to design iterations, and the "set" would be the prototypes and components tested during the design process. No specific "training set" is relevant for this type of regulatory submission.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. (See point 8). The "ground truth" for the device's design and manufacturing is established through adherence to Good Manufacturing Practices (GMP), design controls, and iterative testing against engineering requirements and established safety/performance standards.
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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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 26, 2022
Medela AG Mike McAndrew Director of Ouality and Regulatory Americas Lattichstrasse 4b Baar, 6340 Switzerland
Re: K214112
Trade/Device Name: Invia Ease Negative Pressure Wound Therapy (NPWT) System Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: OMP Dated: June 15, 2022 Received: June 21, 2022
Dear Mike McAndrew:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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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 (OS) 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 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,
Julie Morabito, Ph.D. Assistant Director DHT4B: Division of of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control 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) K214112
Device Name Invia Ease NPWT system
Indications for Use (Describe)
The Invia Ease Negative Pressure Wound Therapy (NPWT) system is indicated for patients who would benefit from a suction device (Negative Pressure Wound Therapy) as when used on open wounds it creates an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and by removing exudates and infectious material. When used on closed surgical incisions, the Invia Ease NPWT System is also intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate via the application of Negative Pressure Wound Therapy (NPWT).
The Invia Ease NPWT system is intended for use in acute, extended and home care settings.
The Invia Ease NPWT system is appropriate for the following indications:
- Acute or subacute wounds
- Chronic wounds
- Dehisced wounds
- Pressure ulcers
- Diabetic/Neuropathic ulcers
- Venous insufficiency ulcers
- Traumatic wounds
- Partial thickness burns
- Flaps and grafts
- Closed surgical incisions
| 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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Medela AG Invia Ease NPWT system Traditional 510(k)
510(k) Summary Information (K214112)
In accordance with 21 C.F.R. §807.92(a) the following summary of information is provided:
| Date Summary Prepared: | July 12, 2022 |
|---|---|
| Submitter/Applicant: | Medela AGLättichstrasse 4bCH 6340 BaarSwitzerlandPhone: +41 41 562 51 51Fax: +41 41 562 51 00 |
| Primary Contact Person: | Mike McAndrewIn representation of Medela AGHead of Quality and Regulatory Americas at MedelaLLCPhone: +1 815 578 2376Email: Mike.McAndrew@medela.com |
| Device Information | Trade/Device Name: Invia Ease NPWT SystemRegulation Name: Powered Suction PumpRegulation Number: 21 CFR§878.4780Common Name: Negative Pressure Wound TherapyPump and AccessoriesDevice Classification Name: 878.4780 Powered SuctionPumpProduct Code: OMPRegulatory Class: IIReview Panel: General & Plastic Surgery |
| Predicate Device Information | K172145Manufacturer: Medela AGDevice Name: Invia Liberty NPWT systemThe predicate device has not been subject to a designrelated recall. |
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Device Description
The Invia Ease Negative Pressure Wound Therapy (NPWT) System is a suction pump designed to help promote wound healing through Negative Pressure Wound Therapy (NPWT). The Invia Ease pump is reusable and portable pump intended to be used in acute, extended and home care settings.
The Invia Ease pump provides adjustable negative pressure with constant and intermittent therapy modes. Invia Ease NPWT System comprises the Invia Ease pump and the following accessories: Invia Ease canisters with integrated tubing, Invia Ease carrying case, Invia Ease handle, Invia Ease IV pole/ bed holder, and Invia Ease charger US.
The Invia Ease user interface includes two tactile buttons: an on/off button on the side of the pump and a mute button on the top of the pump. The pump is also equipped with a large touchscreen display on top of the pump, a status indicator bar on the front-side of the pump, which wraps around the side of the pump, as well as a charging port below the on/off button. Optical status of the pump is provided on the touchscreen and acoustic notifications are also used.
The pump is used with 300 ml, 500 ml and 1000 ml canisters that include a release button and canister tubing with Quick-Connector. The pump is compatible with Invia dressings (NPWT dressings from Medela AG) that interface via the Quick-Connector.
Invia Ease NPWT system is intended to be used in conjunction with the Invia dressings only.
Indications for Use
The Invia Ease Negative Pressure Wound Therapy (NPWT) System is indicated for patients who would benefit from a suction device (Negative Pressure Wound Therapy) as when used on open wounds it creates an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudates and infectious material.
When used on closed surgical incisions, the Invia Ease NPWT System is also intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate via the application of Negative Pressure Wound Therapy (NPWT).
The Invia Ease NPWT System is intended for use in acute, extended and home care settings.
The Invia Ease NPWT System is appropriate for the following indications:
- Acute or subacute wounds -
- Chronic wounds -
- Dehisced wounds -
- Pressure ulcers -
- Diabetic/Neuropathic ulcers -
- Venous insufficiency ulcers -
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- Traumatic wounds -
- Partial thickness burns -
- Flaps and grafts -
- Closed surgical incisions -
Comparison of Technological Characteristics
The Invia Ease Negative Pressure Wound Therapy (NPWT) System is a modified version of the Invia Liberty NPWT System, which was most recently cleared in K172145.
The Invia Ease NPWT pump has the same intended use, similar indications for use, and has equivalent fundamental technology as the legally marketed predicate device to which substantial equivalency is claimed.
Both Invia Ease NPWT System and Invia Liberty use an equivalent suction aggregate to create the necessary vacuum in the same manner and provide same therapy modes: continuous and intermittent.
| Characteristic | Invia Liberty NPWT System(Predicate Device K172145) | Invia Ease NPWT System(Subject Device K214112) | Comment |
|---|---|---|---|
| Product code | OMP | OMP | Same |
| Indications forUse | The Invia Liberty NegativePressure Wound Therapy (NPWT)system is indicated for patients whowould benefit from a suction device(Negative Pressure WoundTherapy) as when used on openwounds it creates an environmentthat promotes wound healing bysecondary or tertiary (delayedprimary) intention by preparing thewound bed for closure, reducingedema, promoting granulationtissue formation and perfusion, andby removing exudate andinfectious material.When used on closed surgicalincisions, the Invia Liberty NPWTsystem is also intended to managethe environment of surgicalincisions that continue to drainfollowing sutured or stapled closureby maintaining a closedenvironment and removing exudatevia the application of NegativePressure Wound Therapy. | The Invia Ease Negative PressureWound Therapy (NPWT) system isindicated for patients who wouldbenefit from a suction device(Negative Pressure WoundTherapy) as when used on openwounds it creates an environmentthat promotes wound healing bysecondary or tertiary (delayedprimary) intention by preparing thewound bed for closure, reducingedema, promoting granulationtissue formation and perfusion, andby removing exudates andinfectious material.When used on closed surgicalincisions, the Invia Ease NPWTsystem is also intended to managethe environment of surgicalincisions that continue to drainfollowing sutured or stapled closureby maintaining a closedenvironment and removing exudatevia the application of NegativePressure Wound Therapy. | Equivalent. Theuse environmentis added, but it isalready includedin the Instructionsfor Use of thepredicate device |
| Characteristic | Invia Liberty NPWT System(Predicate Device K172145) | Invia Ease NPWT System(Subject Device K214112) | Comment |
| Contra-indications | The Invia Liberty NPWT system isappropriate for use for thefollowing indications:- Acute or subacute wounds- Chronic wounds- Dehisced wounds- Pressure ulcers- Diabetic/Neuropathic ulcers- Venous insufficiency ulcers- Traumatic wounds- Partial thickness burns- Flaps and grafts- Closed surgical incisionsContraindications:- Necrotic tissue with eschar present- Untreated osteomyelitis- Non-enteric and unexplored fistulas- Malignancy in the wound- Exposed vasculature- Exposed nerves- Exposed anastomotic site of blood vessels or bypasses- Exposed organs | The Invia Ease NPWT system isintended for use in acute, extendedand home care settings.The Invia Ease NPWT System isappropriate for the followingindications:- Acute or subacute wounds- Chronic wounds- Dehisced wounds- Pressure ulcers- Diabetic/Neuropathic ulcers- Venous insufficiency ulcers- Traumatic wounds- Partial thickness burns- Flaps and grafts- Closed surgical incisionsContraindications:- Necrotic tissue with eschar present- Untreated osteomyelitis- Non-enteric and unexplored fistulas- Malignancy in the wound (with exception of palliative care to enhance quality of life)- Exposed vasculature- Exposed nerves- Exposed anastomotic site of blood vessels or bypasses- Exposed organs | Similar |
| Intended Use | Negative Pressure Wound Therapy | Negative Pressure Wound Therapy | Same |
| Patientpopulation | Adult - multiple patient | Adult - multiple patient | Same |
| Environmentof Use | Acute, extended and home caresettings | Acute, extended and home caresettings | Same |
| Weight | 1.0 kg | 1.1 kg | Similar |
| Dimensions(l x w x h) | 170 x 90 x 150(without canister) | 175 x 90 x 125mm(without canister) | Similar |
| 290 x 95 x 235 mm(with 300 ml canister) | 203 x 90 x125(with 300 ml canister) | ||
| Characteristic | Invia Liberty NPWT System(Predicate Device K172145) | Invia Ease NPWT System(Subject Device K214112) | Comment |
| Standardsafety device | Bacteria and overflow protectionfilter | Bacteria and overflow protectionfilter | Same |
| Useful Life | 4000 hours | 2000 hours | Similar. Bothdevices providesufficient life forclinical use. |
| Software | Embedded | Embedded | Same |
| IP Protectionclass | IP33 | IP22 | Similar. Bothdevices provideadequateprotection fromingress of dust orwater. |
| Protectiontype | BF | BF | Same |
| Operatingambienttemperatures | +5 °C to +40°C | +5 °C to +40°C | Same |
| Operatingambienthumidity | 15...93% RH | 15 to 90% RH(non-condensing) | Similar. Bothdevices meet IEC60601 standards |
| Canistercapacity | 300 ml800 ml | 300 ml500 ml1000 ml | Similar. Bothdevices offermultiple canistersizes to meetmarket needs. |
| User Control | Five button keypad (power andarrow keys to navigate menus) | Mute button, On/Off Button andtouch screen | Similar. Bothdevices provideuser controls forsimilar functions. |
| Visualindicator | LCD display | LED Light indicator status | Similar |
| Characteristic | Invia Liberty NPWT System(Predicate Device K172145) | Invia Ease NPWT System(Subject Device K214112) | Comment |
| Audioindicator | Low batteryTube flushingLoss of negative pressure | "Low priority" alarms:– Battery low– Temperature high– No canister detected– Pump in wrong position"Medium priority" alarms:– Pause reminder– Battery empty– Internal temperature exceeded– High leakage– Blockage– Canister full– Defective charger– Pump error | Similar. Thesubject device'sapproach to audioindicators usesmore moderntechnology andmeets IEC 60601-1-8 alarmstandard for Lowand Mediumpriority alarms. |
| Max. vacuum | -200 mmHg / -27 KPa | -200 mmHg / -27 KPa | Same |
| Min. vacuum | -40 mmHg / -5.3 KPa | -40 mmHg / -5.3 KPa | Same |
| Vacuumregulationtype | Electric vacuum regulatorcontrolled by Software | Electric vacuum regulatorcontrolled by Software | Same |
| Vacuumgauge type | Electric vacuum sensor, digital dial | Electric vacuum sensor, digital dial | Same |
| Therapymodes | Continuous & intermittent | Continuous & intermittent | Same |
| Air Flushing | Adaptive air flush when a sensorythreshold is reached. | Adaptive air flush when a sensorythreshold is reached | Same |
| BlockageDetection | An acoustic signal will sound and ablockage symbol will appear on thedisplay when the Invia LibertyNPWT pump detects a blockage intubing. | An acoustic signal will sound and ablockage symbol will appear on thetouch screen. | Same |
| Power Source– Direct Plug-in | Switching Power Supply• Input: 100-240VAC, 50/60Hz,0.8A max.• Output: 12VDC, 2A (Max)• Off the Shelf plug connection topump | Switching Power Supply• Input: 100-240VAC, 50/60Hz,0.8A max.• Output: 12VDC, 2A (Max)• Custom magnetic connection topump | Similar |
| Characteristic | Invia Liberty NPWT System(Predicate Device K172145) | Invia Ease NPWT System(Subject Device K214112) | Comment |
| Power Source – InternalBattery | Rechargeable Li-Ion battery (2 cells)7.4VDC – 2500mAh | Rechargeable Li-Ion battery (4 cells)7.2VDC – 5000mAh | Similar |
| ElectricalSafety | Meets IEC 60601-1 Standard | Meets IEC 60601-1 Standard | Same |
| ElectromagneticCompatibility | Meets IEC 6060-1-2 Standard | Meets IEC 6060-1-2 Standard | Same |
| ElectricalInsulationClass | Class II (double insulated) | Class II (double insulated) | Same |
| CompatibleDressings | Invia Foam Dressing Kit with FitPads/m/l/xl (3 pcs) (087.6221/22/23/24)s/m/l (15 pcs) (087.6225/26/27)Invia Gauze Dressing Kit with FitPadmed/large (3 pcs) (087.7170/71)med (15 pcs) (087.7172)Invia FitPad (sterile) (087.0028)Invia Transparent Film (087.0030)Invia Abdominal Dressing Kit (087.6250)Invia Silverlon NPWTAntimicrobial Wound Contact Dressing,10 x 12 cm (US) (087.7001)12 x 20 cm (US) (087.7002)Invia White Foam NPWT, PVA foam dressingsmall (087.6303)large (087.6304) | Invia Foam Dressing Kit with FitPads/m/l/xl (3 pcs) (087.6221/22/23/24)s/m/l (15 pcs) (087.6225/26/27)Invia Gauze Dressing Kit with FitPadmed/large (3 pcs) (087.7170/71)med (15 pcs) (087.7172)Invia FitPad (sterile) (087.0028)Invia Transparent Film (087.0030)Invia Abdominal Dressing Kit (087.6250)Invia Silverlon NPWTAntimicrobial Wound Contact Dressing,10 x 12 cm (US) (087.7001)12 x 20 cm (US) (087.7002)Invia White Foam NPWT, PVA foam dressingsmall (087.6303)large (087.6304) | Same |
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Summary of Non-Clinical Tests
The Invia Ease NPWT System complies with voluntary standards for sterilization, biocompatibility, electrical safety, electromagnetic compatibility, use in acute, extended and home care settings and usability. The following performance data are provided in support of the substantial equivalence determination:
- Risk analysis in accordance with ISO 14971: 2019, Medical Devices - Application of Risk Management to Medical Devices.
- Testing in accordance with the following standards and regulations: ●
- ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and O A2:2010/(R)2012, Medical Electrical Equipment - Part 1: General requirements for Basic Safety and Essential Performance.
- IEC 60601-1-6; 2013 Medical electrical equipment Part 1-6: General o requirements for basic safety and essential performance - Collateral standard: Usability
- Medical electrical equipment Part 1-8: General IEC 60601-1-8: 2020 о requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
- IEC 60601-11:2015, Medical Electrical Equipment Part 1-11: General o requirements for Basic Safety and Essential Performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
- IEC 60601-1-2:2014 (Edition 4.0), Medical electrical equipment Part 1-2: General o requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements and Tests.
- AIM Standard 7351731 Rev. 2.00 2017-02-23, Medical Electrical Equipment and o System Electromagnetic Immunity Test for Exposure to Radio Frequency Identification Readers - An AIM Standard
- ANSI IEEE C63.27-2017, American National Standard for Evaluation of Wireless o Coexistence
- IEC 62133-2 Edition 1.0 2017-02. Secondary cells and batteries containing alkaline о or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems
- ISO 10079-1 Third Edition 2015-11-01, Medical suction equipment Part 1: o Electrically powered suction equipment [Including: Amendment 1 (2018)]
- FCC, 47 C.F.R. Part 15 Subparts B and C o
- Sterilization and shelf-life information in accordance with the FDA Guidance document Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile.
- A biocompatibility evaluation was completed according to the FDA Guidance document Use . of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" and draft guidance document Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin.
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| Component | Biocompatibility Test | ISO Standard |
|---|---|---|
| Canister | Cytotoxicity | ISO 10993-5 |
| Canister | Intracutaneous reactivity | ISO 10993-10 |
| Canister | Sensitization | ISO 10993-10 |
| Tubing | Cytotoxicity | ISO 10993-5 |
| Tubing | Intracutaneous reactivity | ISO 10993-10 |
| Tubing | Sensitization | ISO 10993-10 |
The subject device was evaluated for cytotoxicity, intracutaneous reactivity, skin sensitization:
- The software/firmware verification and validation were provided in accordance with the FDA Guidance document Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. The software for the subject devices was considered as a "Moderate" level of concern, since prior to mitigations of hazards, failure of the software could lead to minor injury, such as pain. Additionally, a cybersecurity evaluation was performed according to the FDA Guidance document Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.
- . The usability testing was conducted to validate the use in acute, extended and home care settings in accordance with the recommendations of the FDA guidance document Applying Human Factors and Usability Engineering to Medical Devices
- Bench testing was conducted to check that specifications were met under conditions of . Intermittent as well as Constant therapy modes with power supplied from both the internal battery and external AC/DC power adaptor and with each compatible dressing kit.
| List of bench testing performed |
|---|
| Performance Test of Invia Ease with all Medela AG cleared dressing kits |
| Vacuum Performance Test (with leak) |
| Noise Test |
| Pump Endurance Test |
| Pump Tightness Test |
| IP Protection - IP22 Test |
| Filter Test |
| Battery Run time Test |
| Display Stability Test |
| Transport Validation Invia Ease Pump & Accessories |
Summary of Clinical Tests
Clinical testing was not needed to support substantial equivalence.
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Conclusions
The tests demonstrate that the subject device is substantially equivalent to the legally marketed predicate device in terms of safety and effectiveness.
§ 878.4780 Powered suction pump.
(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.