(182 days)
The Cardinal Health NPWT PRO/PRO to GO/PRO at Home systems are an integrated wound management system. indicated for the application of continual or intermittent negative pressure wound therapy to the wound as the device may promote wound healing by the removal of fluids, including wound exudates, irrigation fluids, body fluids and infectious materials. The systems are intended for patients with chronic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), The systems are intended for use in acute, extended and home care settings.
The Cardinal Health NPWT PRO family of systems are AC-powered, portable suction devices with battery backup that provide localized negative pressure wound therapy when used with the Cardinal NPWT Dressings to remove fluid, irrigation solutions and infectious materials from the wound. The systems consist of a powered suction pump device with a built-in placement holder for the fluid collection canister, various sizes and shapes of polyurethane foam dressings, canister tubing with clamps and connectors, and polyurethane drapes with adhesive. The systems are intended for use on patients with chronic, acute, traumatic, sub-acute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts. The Cardinal Health NPWT PRO family of systems provides care in the acute, extended and home care settings.
The provided document is a 510(k) summary for the Cardinal Health NPWT PRO/PRO to GO/PRO at Home Systems. It outlines the device description, indications for use, comparison with a predicate device, and performance data submitted to support substantial equivalence.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state formal "acceptance criteria" for the device's main therapeutic function (wound healing or fluid removal) in a quantitative manner. Instead, the performance data focuses on demonstrating safety, basic functionality, and usability comparable to a predicate device.
| Acceptance Criterion (Implicit/Derived) | Reported Device Performance |
|---|---|
| Electrical Safety (Compliance with relevant standards) | The system complies with the IEC 60601-1 and IEC 60601-1-11 standards for safety. |
| Electromagnetic Compatibility (EMC) (Compliance with relevant standards) | The system complies with the IEC 60601-1-2 standard for EMC. |
| Software Functionality and Safety (Verification & Validation) | Software verification and validation testing were conducted. The software was considered a "Moderate" level of concern. Documentation was provided as recommended by FDA guidance. |
| Clinical Usability (Safe and effective use by intended users) | A single-center, unblinded, observational, simulated use usability evaluation was conducted. Results were used to update the risk analysis plan and user manual, suggesting that identified usability issues were addressed to ensure safe and effective use. The study concluded that the device should perform as well as the predicate. |
2. Sample Size Used for the Test Set and Data Provenance:
- Clinical Usability Testing:
- Sample Size: 34 adult Healthcare Professionals (HCPs) and lay-user Subjects as patient/caregiver surrogates.
- Data Provenance: The study was a "single-center" evaluation, implying a single location (country not specified, but likely US given FDA submission). It was a "simulated use" study, making it prospective observational data for usability, not clinical efficacy in actual patient settings.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
- Electrical Safety, EMC, Software V&V: These tests are typically performed by engineers and technicians following established protocols. The document does not specify the number or qualifications of experts involved in these specific tests.
- Clinical Usability Testing: The "Healthcare Professionals (HCPs)" served as subjects testing the device's usability. Their qualifications are not explicitly detailed beyond being "Healthcare Professionals." The "ground truth" for this test would be the objective observation of their interactions with the device and their subjective feedback on its usability and any errors/challenges encountered. No external experts were explicitly mentioned for establishing a ground truth of the usability itself, as the users were the evaluators.
4. Adjudication Method for the Test Set:
- Clinical Usability Testing: The document states that a "final interview to capture root cause for any use errors or close calls, and any remaining Subject feedback or questions was conducted." This suggests a form of 1:1 interview and data collection from each participant, rather than a multi-expert adjudication panel for the test results. There's no mention of a formal 2+1 or 3+1 adjudication method. For the other performance tests (Electrical Safety, EMC, Software V&V), these are typically pass/fail criteria based on objective measurements against standards, so adjudication is not usually applicable in the same way.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted for this device. This type of study is typically used for diagnostic devices (e.g., imaging AI) and involves comparing human reader performance with and without AI assistance across multiple cases. The Cardinal Health NPWT system is a therapeutic device, not a diagnostic one, so an MRMC study is not relevant here.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Not applicable. This device is a physical, powered suction pump system, not an AI algorithm. Its function inherently involves a human user (HCP or patient/caregiver). Performance is not assessed as an "algorithm only" in the way an AI diagnostic tool would be. The "software verification and validation testing" evaluates the internal logic and safety of the device's software, which is a component of the overall system, but not in a "standalone algorithm" context for clinical efficacy.
7. Type of Ground Truth Used:
- Electrical Safety & EMC: Compliance with international safety standards (IEC 60601 series). The "ground truth" is adherence to these objective, measurable standards.
- Software Verification & Validation: Adherence to defined software requirements and FDA guidance. The "ground truth" is the confirmation that the software performs as specified and safely.
- Clinical Usability Testing: Observations of user interaction, identification of use errors or close calls, and subjective feedback from the users (HCPs and lay-user surrogates). The "ground truth" here is the objective and subjective data collected on the device's practical usability.
8. Sample Size for the Training Set:
- Not applicable / Not explicitly stated. This device is a hardware system with embedded software. It is not an AI/machine learning device that typically involves a distinct "training set" of data in the way a diagnostic algorithm (e.g., for image analysis) requires. The software developed for the device would have undergone development and testing, but not typically referred to as a "training set" in this context.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As implied above, this is not an AI/ML device requiring a data training set with established ground truth labels in the typical sense. The software development process would involve establishing "ground truth" for its own functionality through design specifications, coding standards, and rigorous testing against those specifications.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 20, 2015
Cardinal Health % Ms. Allison Scott Navigant Consulting Incorporated 9001 Wesleyan Road, Suite 200 Indianapolis. Indiana 46268
Re: K143016
Trade/Device Name: Cardinal Health NPWT PRO/PRO to GO/PRO at Home Systems Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: OMP Dated: March 16, 2015 Received: March 17, 2015
Dear Ms. Scott:
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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
for
Sincerely yours,
David Krause -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
Cardinal Health NPWT PRO/PRO to GO/PRO at Home Systems
Indications for Use (Describe)
The Cardinal Health NPWT PRO/PRO to GO/PRO at Home systems are an integrated wound management system. indicated for the application of continual or intermittent negative pressure wound therapy to the wound as the device may promote wound healing by the removal of fluids, including wound exudates, irrigation fluids, body fluids and infectious materials. The systems are intended for patients with chronic, subacute and dehisced wounds, partialthickness burns, ulcers (such as diabetic or pressure), The systems are intended for use in acute, extended and home care settings.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| > Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
I. Submitter Information
Cardinal Health 1500 S Waukegan Road Waukegan, IL 60085
Allison Scott, RAC Contact Person: 317.228.8700 Allison.Scott@Navigant.com
April 14, 2015 Date Prepared:
II. Device Information
| Name of Device: | Cardinal Health NPWT ProCardinal Health NPWT Pro to GoCardinal Health NPWT Pro at Home |
|---|---|
| Common Name: | Negative Pressure Wound Therapy Powered Suction Pump |
| Classification Name(s): | Powered Suction Pump (21 CFR 878.4780) |
| Regulatory Class: | II |
| Product Code: | OMP |
III. Predicate Device
| 510(k) Number | Device Name | Submitter Name |
|---|---|---|
| K111333 | Antlia III WTS | InnovativeTherapies, Inc. |
This predicate has not been subject to a design-related recall.
The SVED® Wound Treatment System (K093564) submitted by Innovative Therapies, Inc. is used as a reference device in this submission.
IV. Device Description
The Cardinal Health NPWT PRO family of systems are AC-powered, portable suction devices with battery backup that provide localized negative pressure wound therapy when used with the Cardinal NPWT Dressings to remove fluid, irrigation solutions and infectious materials from the wound. The systems consist of a powered suction pump device with a built-in placement holder for the fluid collection canister, various sizes and shapes of polyurethane foam dressings, canister tubing with clamps and connectors, and polyurethane drapes with adhesive. The systems are intended for use on patients with chronic, acute, traumatic, sub-acute and dehisced wounds, partial-thickness burns,
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ulcers (such as diabetic or pressure), flaps and grafts. The Cardinal Health NPWT PRO family of systems provides care in the acute, extended and home care settings.
The Cardinal Health NPWT PRO family of systems consists of the same powered suction pump components and foam dressing components, and functions the same as the Antlia III Wound Treatment System. The Cardinal Health NPWT PRO family of systems includes a built-in placement holder for the 300cc or 500cc collection canisters. They have a pushbutton ON/OFF operation with five user-selectable pressure settings. The system produces optional negative pressure settings of 50mmHg, 75mmHg, 100mmHg, 125mmHg, and 150mmHg. It has alarms for Low Pressure/Leak, Full Canister, Low Battery and Service Timer. These alarms include both audible and visual indications.
The purpose of this 510(k) submission is to update the Antlia III Wound Treatment System (WTS) into three separate, but similar devices: Cardinal Health NPWT PRO, Cardinal Health NPWT PRO to Go, and Cardinal Health NPWT PRO at Home. The following updates have been made:
- The Cardinal Health NPWT PRO family of systems has an updated indications . for use to include partial-thickness burns. This better aligns the indications for use with the "OMP" regulation definition.
- . The Cardinal Health NPWT PRO family of systems provides care in the acute and extended clinical and home care settings
- There is an enhancement to the pressure control for full canister alarm ●
- There are enhancements to the therapy timer .
- There are updates to the pump graphics and associated software controls
V. Intended Use(s)
The Cardinal Health NPWT PRO/PRO to GO/PRO at Home systems are an integrated wound management system, indicated for the application of continual or intermittent negative pressure wound therapy to the wound as the device may promote wound healing by the removal of fluids, including wound exudates, irrigation fluids, body fluids and infectious materials. The systems are intended for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts. The systems are intended for use in acute, extended and home care settings.
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VI. Comparison of Technological Characteristics
This submission is to provide an update to the existing cleared Antlia III WTS into three different configurations. The subject and predicate devices are based on the following same technical elements:
- Continuous and Intermittent negative pressure wound therapy treatment modes
- 50mmHg, 75mmHg, 100mmHg, 125mmHg & 150mmHg Negative Pressure ● Ranges
- Pressure sensing technology within the pump
- Available for use with 300cc and 500cc canisters
- Use AC and Rechargeable battery
The following differences exist between the subject and predicate devices:
- The Cardinal Health NPWT PRO family of systems has updated Indications for ● Use to include partial-thickness burns. This better aligns the Indications for Use with the "OMP" regulation definition.
- The Cardinal Health NPWT PRO family of systems provides care in the acute and ● extended clinical and home care settings
- The Cardinal Health NPWT PRO systems have had other changes including: ●
- o Enhanced pressure control for full canister alarm
- o Enhanced therapy timer
- o Updates to the pump graphics and associated software controls
VII. Performance Data
The following performance data were provided in support of the substantial equivalence determination.
Electrical Safety and Electromagnetic Compatibility (EMC)
Electrical safety and EMC testing were conducted on the Antlia III WTS. The system complies with the IEC 60601-1 and IEC 60601-1-11 standards for safety and the IEC 60601-1-2 standard for EMC.
Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff. "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "Moderate" level of concern, since a failure or latent flaw in the software could directly result in minor injury to the patient or operator.
Clinical Usability Testing
A single-center, unblinded, observational, simulated use usability evaluation of the Cardinal Health NPWT PRO at Home System with 34 adult Healthcare Professionals (HCPs) and lay-user Subjects as patient/caregiver surrogates. Following enrollment and training, approximately half of each Subject cohort was guided through either [1] a Directed Use Case trial in which they were asked to read and follow the written instructions to complete study tasks (documentation validation), or through [2] an Unassisted Use Case trial in which the written instructions were made available but the
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Subjects were free to decide to use them (interface usability validation). A final interview to capture root cause for any use errors or close calls, and any remaining Subject feedback or questions was conducted before releasing the Subject from the study. Results from the study were used to update the risk analysis plan and user manual, as needed.
VIII. Conclusions
The clinical usability testing and software verification and validation demonstrate that the Cardinal Health NPWT PRO family of systems should perform as well as the predicate device in the specified use conditions.
§ 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.