(302 days)
Not Found
No
The device description and performance studies focus on basic pump functionality, pressure control, and alert systems, with no mention of AI or ML terms or capabilities.
Yes
The device is intended to manage the environment of surgical incisions and remove exudate via negative pressure wound therapy, which are therapeutic actions.
No
The Kendall™ Negative Pressure Wound Therapy Incision Management Device is intended for the management of surgical incisions by applying negative pressure to remove exudate. It is a therapeutic device, not one that identifies or diagnoses a condition.
No
The device description explicitly states it is a "portable, single use, battery operated (lithium AA) suction pump with a canister," indicating it is a hardware device with integrated software for control and alerts.
Based on the provided information, the Kendall™ Negative Pressure Wound Therapy (NPWT) Incision Management Device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to manage the environment of surgical incisions by applying negative pressure to remove exudate. This is a therapeutic function, not a diagnostic one.
- Device Description: The device is a suction pump with a canister designed to apply negative pressure to a wound. It does not analyze biological samples (like blood, urine, or tissue) to provide diagnostic information.
- Lack of IVD Characteristics: The description does not mention any components or processes related to in vitro analysis of samples. There is no mention of reagents, assays, or any form of laboratory testing.
In summary, the device is a therapeutic medical device used for wound management, not an IVD used for diagnosing diseases or conditions by examining samples outside the body.
N/A
Intended Use / Indications for Use
The Kendall™ Negative Pressure Wound Therapy (NPWT) Incision Management Device, when used with a Kendall™ NPWT Incision Management Dressing Kit, is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closed environment and removing exudate via the application of negative pressure wound therapy. The system is intended for use in acute, extended and home care settings.
Product codes (comma separated list FDA assigned to the subject device)
OMP
Device Description
The Kendall™ Negative Pressure Wound Therapy (NPWT) Incision Management (IM) Device is a portable, single use, battery operated (lithium AA) suction pump with a canister. The device, when connected to a Kendall™ NPWT Incision Management Dressing Kit, applies negative pressure to an incision site that is closed with sutures or staples. The device can be set at negative pressures of -50mmHg to -125mmHg in 5mmHg increments. The device will stop working after 7 days and cannot be restarted. Visual and audible alerts from the device alerts the user to possible leaks, blockages, a full canister, low batteries, and therapy time out.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
surgical incisions
Indicated Patient Age Range
Adult single patient
Intended User / Care Setting
acute, extended and home care 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)
Bench Testing:
- Pressure Test verifies the ability to maintain expected pressure at the wound site, based on an acceptable pressure between -50 and -125mmHg in 5mmHg increments and that the device is capable of measuring the pressure at the wound site comparable to the predicate device.
- Occlusion Detection Test verifies the device would alert in the presence of a blockage condition (i.e. blocked tubing). This alerts the user of suboptimal therapy.
- Leak Alert Testing verifies the device would alert in the presence of a leak condition (i.e. improperly sealed dressing). This alerts the user of suboptimal therapy.
- Full Canister Alert Testing verifies the device would alert in the presence of a full canister. This alerts the user of suboptimal therapy.
- Device Multi-orientation Test verifies the canister did not leak and the subject device is functional in a series of orientations that could be expected.
- Battery Alert Test verifies the device would alert in the presence of a low battery condition. This alerts the user to change batteries to avoid suboptimal therapy.
- Design Validation Testing validates the performance when in a simulated use scenario, running the device for 7 days with pseudo-exudate.
There were no Human Clinical or Animal Performance Studies required for substantial equivalence determination.
Usability Testing:
Usability Testing was performed per ISO 62366-1 and ANSI/AAMI HE 75. Testing was performed using lay users who represent patients and lay caregivers to support the use of the device in the home environment and with clinicians to support the use of the device in the hospital.
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.
PREVENA PLUS DUO Incision Management System (K180855)
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
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
June 4, 2021
Cardinal Health % Jillian Connery Principal Specialist Regulatory Affairs Patient Recovery, Cardinal Health 777 West Street Mansfield, Massachusetts 02048
Re: K202217
Trade/Device Name: Kendall™ NPWT Incision Management Device Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: OMP Dated: May 5, 2021 Received: May 7, 2021
Dear Jillian Connery:
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
1
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,
for Lixin Liu, Ph.D.
Acting Assistant Director DHT4B: Division 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) K202217
Device Name
Kendall™ Negative Pressure Wound Therapy Incision Management Device
Indications for Use (Describe)
The Kendall™ Negative Pressure Wound Therapy (NPWT) Incision Management Device, when used with a Kendall™ NPWT Incision Management Dressing Kit, is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closed environment and removing exudate via the application of negative pressure wound therapy. The system is 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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3
Section 5 510(k) Summary
1. 510(k) Owner:
Cardinal Health 3651 Birchwood Drive Waukegan, IL 60085
Contact: Christine Kuntz Nassif/ Jillian Connery Title: RA Manager/ Principal RA Specialist 777 West Street Mansfield, MA 02048 Telephone: (508) 618-3756/ (614) 270-8991
Date Prepared: June 3, 2021
2. Device:
Kendall™ NPWT Incision Management Device Trade Name: Common Name: Negative Pressure Wound Therapy Powered Suction Pump Classification Panel: General & Plastic Surgery Regulation Number: 21 CFR 878.4780 Product Code: OMP Classification: Class II
3. Predicate Devices:
PREVENA PLUS DUO Incision Management System (K180855)
4. Device Description:
The Kendall™ Negative Pressure Wound Therapy (NPWT) Incision Management (IM) Device is a portable, single use, battery operated (lithium AA) suction pump with a canister. The device, when connected to a Kendall™ NPWT Incision Management Dressing Kit, applies negative pressure to an incision site that is closed with sutures or staples. The device can be set at negative pressures of -50mmHg to -125mmHg in 5mmHg increments. The device will stop working after 7 days and cannot be restarted. Visual and audible alerts from the device alerts the user to possible leaks, blockages, a full canister, low batteries, and therapy time out.
5. Indications for Use:
The Kendall™ Negative Pressure Wound Therapy (NPWT) Incision Management Device, when used with a Kendall™ NPWT Incision Management Dressing Kit, is intended to manage the environment of surgical incisions that continue to drain following
4
sutured or stapled closure by maintaining a closed environment and removing exudate via the application of negative pressure wound therapy. The system is intended for use in acute, extended and home care settings.
| Feature | Kendall™ NPWT Incision
Management Device | PREVENA PLUS DUO
Incision Management
System (K180855) |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | The Kendall™ Negative Pressure
Wound Therapy (NPWT) Incision
Management Device, when used with
a Kendall™ NPWT Incision
Management Dressing Kit, is 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. The system is
intended for use in acute, extended
and home care settings. | The PREVENA PLUS
DUO Incision
Management System is
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. |
| Product Code | OMP | OMP |
| Patient
Population | Adult single patient | Adult single patient |
| Environment of
Use | Hospitals, Clinics, Long Term Care
and Home Care settings | Not specified |
| Dressing Kit | Kendall™ NPWT IM Dressing Kit | Prevena Plus Peel & Place
Dressing, Prevena Plus
Customizable Dressing |
| Weight | 0.43 lbs. | 0.64 lbs. |
| Pressure Range | - 50mmHg to -125mmHg using
5mmHg increments | -125mmHg |
| Pressure
Sensing | Same as predicate | Wound bed |
| Canister
Volume | 50 mL | 150 mL |
| Operator
Interface | On/Off Button, Up/Down Buttons | On/Off Button, Alert
Mute Button |
| Power Source | 2 AA non-rechargeable lithium
Batteries | Rechargeable battery |
| Useful Life | Up to 7 days | Up to 14 days* |
| Alerts/Alarms | Visual and audible alerts to indicate
air leak, blockage, canister full, low
battery | Visual and audible alarms
to indicate air leak,
blockage, canister
full/missing, low battery |
| | | system fault |
| Therapy Time
Indicator | Yes | Yes |
| Sterilization | Non-sterile | Non-sterile |
6. Technological Characteristics Comparison:
5
*-Note, Prevena Plus dressing is indicated to be changed after 7 days.
At a high level, the Kendall™ NPWT Incision Management Device and the predicate device are based on the following same technological elements:
- Indications for Use ●
- Patient Population
- Dressing Kit (both indicated for up to 7 days)
- Use of a multi-lumen tubing for identification of blockages .
- Negative pressure measurement at wound site ●
- . Canister to hold removed exudate
- Visual and audible alerts to indicate air leak, blockage, canister full, low battery
- Therapy life indicator
The following technological differences exist between the subject and predicate device:
- . Prevena Plus is used with the Prevena Plus Peel & Place or the Prevena Plus Customizable Dressing, the Kendall™ NPWT IM Dressing is used with the Kendall NPWT Incision Management Device. The predicate device has been tested to different dressings; whereas the subject device has been tested to the Kendall™ NPWT IM Dressing Kit and is indicated for use with only the Kendall™ NPWT IM Dressing Kit.
- Prevena Plus disposable negative pressure pump is cleared for up to 14-day use, . however the dressing is indicated to be replaced after 7 days. The Kendall™ NPWT IM Dressing Kit can be used for up to 7 days. The Instructions for Use specify a maximum use of 7 days at which time, the pump will be permanently disabled. The subject device has been tested to the 7 day use.
- Prevena Plus is set at -125mmHg. Kendall™ NPWT IM Device can be set at negative . pressures of -50mmHg to -125mmHg in 5mmHg increments. The pressure tests were done at both extremes of the pressure range to verify effectiveness.
- Prevena Plus has a larger canister volume (150 mL) as compared to Kendall™ NPWT ● IM Device with 50 mL. The Prevena Plus has a larger canister as it is indicated for a longer use time. The canister for the subject device may be replaced and the user is instructed on how to do so.
- Prevena Plus weighs slightly more than the Kendall™ NPWT IM Device. The minor ● weight difference should not affect the user operating the device.
- Prevena Plus has a rechargeable battery. Kendall™ NPWT IM Device uses 2 AA . lithium batteries. The batteries supplied with the device are lithium, but can be replaced with other AA batteries, if required. The lithium batteries supplied are in conformance with IEC 62133: 2012; however, the user is instructed how to change
6
batteries if needed. The user is recommended to use lithium batteries for best performance.
These differences are not critical to the intended use of the device. When the Kendall™ NPWT Incision Management Device is used as indicated with the Kendall™ NPWT Incision Management Dressing Kit, these differences do not raise different questions of safety and effectiveness and are not critical to the intended use.
7. Performance Data:
Sterilization and Shelf Life
The Kendall™ NPWT IM Device, Canister and carry case are provided non-sterile. The Kendall™ NPWT IM Device is packaged with the Kendall™ NPWT IM Dressing Kit, which includes a 3 year expiration date. For this reason, the package labels include a threeyear shelf life.
Biocompatibility Testing
The Kendall™ NPWT Incision Management Device is categorized as surface contacting device on intact skin for a contact duration defined as prolonged (between 24 hours and 30 days). Sensitization, Irritation and Cytotoxicity complies with ISO 10993-1 and FDA Guidance "Use of International Standard ISO 10993 - Part 1: Evaluation and testing within a risk management process".
Software
The software documentation in this submission has been assembled according to the recommendations in the FDA document, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. The software Level of Concern has been evaluated and determined to be Moderate, and appropriate documentation included in the submission.
Electromagnetic Compatibility and Electrical Safety
The Kendall™ NPWT Incision Management Device complies with the following standards:
- ANSI/AAMI ES 60601-1: 2005/(R)2012 and A1: 2012, C1: 2009/(R)2012 and A2: ● 2010/(R)2012
- IEC 60601-1-2: 2014 ●
- IEC 60601-1-6: 2010 + A1: 2013
- IEC 60601-1-11: 2015 ●
- ISO 10993-5: 2009 .
- ISO 10993-10: 2010 ●
- . ANSI/AAMI HE 75: 2009/(R)2018
7
- IEC 62366-1: 2015 + CORRIGENDIUM 1 (2016) ●
Non-Clinical Testing
The following performance data were provided in support the conclusion that the proposed device is substantially equivalent to the predicate device.
Bench Testing
The following testing has been conducted to support the conclusion that the proposed device is substantially equivalent to the predicate device:
- Pressure Test verifies the ability to maintain expected pressure at the wound site, ● based on an acceptable pressure between -50 and -125mmHg in 5mmHg increments and that the device is capable of measuring the pressure at the wound site comparable to the predicate device.
- Occlusion Detection Test verifies the device would alert in the presence of a . blockage condition (i.e. blocked tubing). This alerts the user of suboptimal therapy.
- Leak Alert Testing verifies the device would alert in the presence of a leak condition (i.e. improperly sealed dressing). This alerts the user of suboptimal therapy.
- . Full Canister Alert Testing verifies the device would alert in the presence of a full canister. This alerts the user of suboptimal therapy.
- . Device Multi-orientation Test verifies the canister did not leak and the subject device is functional in a series of orientations that could be expected.
- . Battery Alert Test verifies the device would alert in the presence of a low battery condition. This alerts the user to change batteries to avoid suboptimal therapy.
- . Design Validation Testing validates the performance when in a simulated use scenario, running the device for 7 days with pseudo-exudate.
There were no Human Clinical or Animal Performance Studies required for substantial equivalence determination.
Usability Testing
Usability Testing was performed per ISO 62366-1 and ANSI/AAMI HE 75. Testing was performed using lay users who represent patients and lay caregivers to support the use of the device in the home environment and with clinicians to support the use of the device in the hospital.
8. Conclusion:
The performance data demonstrate that the proposed Kendall™ NPWT Incision Management Device functions as intended and is considered substantially equivalent to the predicate device.