The Cardinal Health NPWT SVED system is 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 system is intended for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts. The system is intended for use in acute, extended and home care settings.

Device Description

The SVED® Wound Treatment System is an AC-powered, portable suction device with battery backup that provides localized negative pressure wound therapy when used with the Cardinal NPWT Dressings to remove fluid, irrigation solutions and infectious materials from the wound. The system consists of a powered suction pump device with a built-in placement holder for the fluid collection canister, various sizes and shapes of polyurethane foam dressing, canister tubing with clamps and connectors, polyurethane drape with adhesive, and irrigation tubing with clamps and connectors. The system is 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 SVED ® Wound Treatment System provides care in the acute, extended and home care settings.

AI/ML Overview

The provided text describes a 510(k) summary for the Sved® Wound Treatment System, which is a negative pressure wound therapy device. However, it does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of diagnostic accuracy, which is typically what such questions refer to when asking about "device performance" in medical AI/diagnostic devices.

Instead, the document details:

Regulatory information: Device name, classification, predicate device, and intended use.
Technological characteristics: Comparison to the predicate device, highlighting similar and differing features.
Performance data (non-clinical): Electrical safety, EMC, software verification and validation, and a clinical usability study.

Therefore, many of the requested elements for a diagnostic performance study cannot be extracted from this document.

Here's a breakdown of what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Electrical Safety	The system complies with the IEC 60601-1 standards for safety (implicitly accepted as meeting the standard).
EMC Compliance	The system complies with the IEC 60601-1-2 standard for EMC (implicitly accepted as meeting the standard).
Software V&V	Software verification and validation testing were conducted, and documentation was provided as recommended by FDA guidance. The software was considered a "Moderate" level of concern. (Acceptance is that V&V was completed according to guidance, ensuring safety and functionality as intended for a moderate-concern device).
Clinical Usability	A single-center, unblinded, observational, simulated use usability evaluation was conducted. Results were used to update the risk analysis plan and user manual, as needed. (Acceptance is that usability issues were identified and addressed, contributing to safe and effective use. Specific pass/fail criteria for usability are not stated, but the outcome implies an acceptable level of usability was achieved after any necessary revisions).
Pneumatic Performance (Implied)	The device operates at 70mmHg, 120mmHg & 150mmHg Pressure Ranges, and has continuous and intermittent treatment modes. (Implied acceptance is that these pressure ranges are maintained accurately and consistently, though specific performance metrics like pressure accuracy or flow rates are not detailed as acceptance criteria).

2. Sample size used for the test set and the data provenance:

Clinical Usability Test: 34 adult Healthcare Professionals (HCPs) and lay-user Subjects (patient/caregiver surrogates).
Data Provenance: Single-center, simulated use. No specific country of origin is mentioned, but the FDA submission context usually implies US-based or internationally accepted standards. The study was prospective in its design (enrollment, training, guided tasks, interview).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This question is not applicable to the usability study described. The study evaluated user interaction and potential use errors rather than diagnostic accuracy against a ground truth. For the software V&V, specific experts are not mentioned, but the V&V process itself aims to ensure compliance with design specifications.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable for the usability study. The usability study involved observation and interviews to capture user feedback and identify use errors rather than adjudicating a diagnostic outcome.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a negative pressure wound therapy system, not an AI-powered diagnostic tool for human readers. No MRMC study was described.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable as this is not an AI diagnostic algorithm. The device has software, but its "standalone" performance would be related to its mechanical and electronic functions (e.g., maintaining pressure, alarm functionality) rather than an AI-driven diagnostic interpretation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable for a usability study. For electrical safety and EMC, the "ground truth" is adherence to the specified IEC standards. For software, the "ground truth" is adherence to software requirements and specifications.

8. The sample size for the training set:

Not applicable. This document describes performance validation, not an AI model requiring a training set. The usability study involved a "training" phase for the participants, but this is distinct from an AI model's training set.

9. How the ground truth for the training set was established:

Not applicable as there is no AI training set involved.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 4, 2015

Cardinal Health % Allison Scott Navigant Consulting Incorporated 9001 Wesleyan Road, Suite 200 Indianapolis. Indiana 46268

Re: K142916

Trade/Device Name: Sved® Wound Treatment System Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: OMP Dated: January 23, 2015 Received: January 26, 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.

Sincerely yours,

David Krause -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. for 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) K142916

RT12516

Device Name Sved® Wound Treatment System

Indications for Use (Describe)

The Cardinal Health NPWT SVED system is an integrated wound management system, indicated for the application of continual or intermittent negative pressure wound as the device may promote wound healing by the removal of fluids, including wound exudates, irrigation fluids and infectious materials. The system is intended for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts. The system is intended for use in acute, extended and home care settings.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) Summary Sved Wound Treatment System Cardinal Health

510(k) Summary

I. Submitter Information

Cardinal Health 1500 S Waukegan Road Waukegan, IL 60085

Allison Scott, RAC Contact Person: 317-228-8719 Allison.Scott@Navigant.com

Date Prepared: January 23, 2015

II. Device Information

Name of Device: Common Name: Classification Name(s): Regulatory Class: II Product Code: OMP

Sved® Wound Treatment System Negative Pressure Wound Therapy Powered Suction Pump Powered Suction Pump (21 CFR 878.4780)

III. Predicate Device

510(k) Number	Device Name	Submitter Name
K093564	SVED Wound Treatment	Innovative
	System	Therapies, Inc.

This predicate has not been subject to a design-related recall. No reference devices were used in this submission.

IV. Device Description

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V. Intended Use(s)

VI. Comparison of Technological Characteristics

This submission is to provide an update to the existing cleared Sved® Wound Treatment System. The subject and predicate devices are based on the following same technical elements:

. Continuous and Intermittent treatment modes
70mmHg, 120mmHg & 150mmHg Pressure Ranges ●
Pressure sensing technology within the pump
Available for use with 300cc and 500cc canisters ●
. Use AC and Rechargeable battery

The following technological differences exist between the subject and predicate devices:

. The updated Sved® Wound Treatment System has an updated indications for use to include partial-thickness burns. This better aligns the indications for use with the "OMP" regulation definition.
. The updated Sved® Wound Treatment System has had other enhancements including:
- o Enhanced solenoid activation on AC to DC transition
- Enhancements to the Leak Alarm O
- Changed the alarm volume level scale to provide a way for the caregiver O to adjust the volume.
- New motor with the same specifications as the previous motor o
- O Addition of LED Therapy Timer/Display

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 Sved® Wound Treatment System. The system complies with the IEC 60601-1 standards for safety and the IEC 60601-1-2 standard for EMC.

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510(k) Summary Sved Wound Treatment System Cardinal Health

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 Sved 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 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 electrical safety and EMC testing and software verification and validation demonstrate that the Sved® Wound Treatment System should perform as well as the predicate device in the specified use conditions.

Regulation Number and Section

§ 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.