Kendall NPWT Incision Management Dressing Kit

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July 31, 2020 Cardinal Health Christine Kuntz-Nassif Regulatory Affairs Manager 777 West Street Mansfield, MA 02048 Re: K191101 Trade/Device Name: Kendall NPWT Incision Management Dressing Kit Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: OMP Dated: June 29, 2020 Received: July 1, 2020 Dear Christine Kuntz-Nassif: 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. 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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, Anjana Jain, 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K191101 Device Name Kendall NPWT Incision Management Dressing Kit Indications for Use (Describe) The Kendall NPWT Incision Management Dressing Kit, when used with a Cardinal Health NPWT CATALYST, ALLY or ALLY TO GO Devices, 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 Cardinal Health NPWT CATALYST, ALLY TO GO System is intended for use in acute, extended and home care settings. | Type of Use (Select one or both, as applicable) | | |------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------| | <div style="display:flex; align-items:center;"><div> Prescription Use (Part 21 CFR 801 Subpart D)</div></div> | <div style="display:flex; align-items:center;"><div> Over-The-Counter Use (21 CFR 801 Subpart C)</div></div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## 510(k) Summary ## 1. 510(k) Owner: Cardinal Health 3651 Birchwood Drive Waukegan, IL 60085 Telephone: (954) 585-5145 Contact: Christine Kuntz-Nassif Title: Regulatory Affairs Manager Date Prepared: July 31, 2020 ## 2. Device: Trade Name: Kendall NPWT Incision Management Dressing Kit Common Name: Negative Pressure Wound Therapy Dressing Kit Classification Panel: General & Plastic Surgery Regulation Number: 21 CFR 878.4780 Product Code: OMP Classification: Class II ## 3. Predicate Devices: Prevena Plus Incision Management System (K180855) ## 4. Device Description: The Kendall Negative Pressure Wound Therapy Incision Management Dressing Kit is a wound dressing kit to be used with cleared Cardinal Health Negative Pressure Wound Therapy (NPWT) CATALYST, ALLY, and ALLY to GO systems (K171499). The disposable single-use sterile Kendall NPWT Incision Management Dressing Kit consists of five dressing configurations, tubing, and drape strips. The dressing covers the closed surgical site and forms a seal over the sutured or stapled surgical site. The proximal end of the tubing is attached to the dressing while the distal end of the tubing attaches to an exudate canister. The powered suction pump delivers negative pressure to the dressing to aid in the removal of exudate from the wound into the exudate canister. The drape strips are used to patch any air leaks if necessary. #### 5. Indications for Use: The Kendall NPWT Incision Management Dressing Kit, when used with Cardinal Health NPWT CATALYST, ALLY, and ALLY TO GO Devices, 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 Cardinal Health NPWT CATALYST, ALLY, or ALLY TO GO System is intended for use in acute, extended and home care settings. {4}------------------------------------------------ ## 6. Technological Characteristics Comparison | Elements of | Proposed Device | Predicate Device | |------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Comparison | Kendall NPWT Incision Management Dressing Kit | Prevena Plus Incision Management<br>System | | Indications for Use | The Kendall NPWT Incision Management<br>Dressing Kit, when used with a Cardinal Health<br>CATALYST, ALLY or ALLY TO GO NPWT<br>Devices, is intended to manage the environment of<br>surgical incisions that continue to drain following<br>sutured or stapled closure by maintaining a closed<br>environment and removing exudate via the<br>application of negative pressure wound therapy.<br>The Cardinal Health NPWT CATALYST, ALLY,<br>or ALLY TO GO System is intended for use in<br>acute, extended and home care settings. | The Prevena Plus Incision Management<br>System is intended to manage the<br>environment of surgical incisions that<br>continue to drain following sutured or<br>stapled closure by maintaining a closed<br>environment and removing exudate via the<br>application of negative pressure wound<br>therapy. | | Product Code | OMP | OMP | | Patient Population | Adult | Adult | | Environment of Use | Hospitals, Clinics, Long Term Care and Home<br>Care settings | Hospitals, Clinics, Long Term Care and<br>Home Care settings | | Reusable | Single use only | Single use only | | Sterilization | EtO | EtO | | Dressing Kit<br>Components | • Layered dressing containing a film drape, foam<br>and contact underlayer that wicks fluid away from<br>the surface of the incision<br>• Dual lumen polyvinyl urethane tubing with<br>SpeedConnect to connect to dressing and Twist<br>'N Connect ABS exudate canister connector<br>• Drape strips | • Layered dressing containing a film<br>drape, foam and contact underlayer<br>containing Iconic Silver that wicks fluid<br>away from the surface of the incision<br>• Tubing with SENSAT.R.A.C to connect<br>to dressing and exudate canister<br>connector<br>• Patch/Sealing strips, drapes | | Dressing Sizes | • 10 x 20 cm<br>• 10 x 41 cm<br>• 15 x 20 cm<br>• 10 x 30.5 cm<br>• 15 x 30.5 cm | • 35 cm Peel and Place<br>• 20 cm Peel and Place<br>• 13 cm Peel and Place<br>• Customizable | | Compatible NPWT<br>Devices | • CATALYST<br>• ALLY<br>• ALLY TO GO | • Prevena Plus | | Negative Pressure at<br>Wound Site | • ALLY/ALLY TO GO: -50, -75, -100, -125,<br>-150mmHg<br>• CATALYST: -70, -120, -150mmHg | • -125mmHg | | Use Life of Dressing | 7 days maximum | 14 days maximum | ## Table of Comparison to Predicate Device At a high level, the Kendall NPWT Incision Management Dressing Kit and the predicate device are based on the following same technological elements: - Indications for Use - Environment of Use - · Patient Population - · Use of drape/sealing strips to patch potential leaks in the dressing - · Use of a multi-lumen tubing for identification of blockages - · Connections at proximal end to dressing and distal end to exudate canister - · Layered dressing containing foam and non-stick contact layer - Single use only {5}------------------------------------------------ The following technological differences exist between the subject and predicate device: - . Prevena skin interface layer contains silver to reduce microbial colonization in the fabric, Kendall NPWT Incision Management Dressing does not contain silver - . Prevena dressing kit is used at -125mmHg. Kendall NPWT Incision Management Dressing Kit can be used at the following negative pressures: -50mmHg, -75mmHg. -100mmHg, -125mmHg and -150mmHg with the ALLY/ALLY TO GO and-70mmHg, -120mmHg and -150mmHg with the CATALYST. These differences are not critical to the intended use of the device. When the Kendall NPWT Incision Management Dressing Kit is used as indicated, these differences do not affect the safety and effectiveness and are not critical to the intended use. ## 7. Performance Data ## Biocompatibility Testing: The biocompatibility of the Kendall NPWT Incision Management Dressing Kit has been demonstrated through testing per ISO 10993-1 to support limited contact exposure (>24 hours to <30 days) on a breached or compromised surface. The biocompatibility testing included the following: - Cytotoxicity - Sensitization ● - Irritation ● - Acute Systemic Toxicity ● - Pyrogenicity ● - Subacute/Subchronic Toxicity ● - 4 Week Full Thickness Wound Healing in Rats ● ## Non-Clinical Testing #### Bench Testing The following testing has been conducted to support the conclusion that the proposed device is substantially equivalent to the predicate device: - Absorbency to demonstrate that the proposed incision management dressing can; in the absence of negative pressure absorb wound exudate. - Alert Testing to demonstrate that the Kendall NPWT Incision Management Dressing Kit does not inhibit the NPWT CATALYST/ALLY Systems from detecting and producing an alert of leaks, or occlusion detection/canister full. - . Useful Life Testing to confirm the proposed Kendall NPWT Incision Management Dressing Kit can maintain target pressure and transport a simulated exudate away from the wound site into a fluid collection canister over the useful life of the dressing comparable to the predicate device. There were no Human Clinical or Animal Performance Studies required for substantial equivalence determination. {6}------------------------------------------------ ## 8. Conclusion: The performance data demonstrate that the proposed Kendall NPWT Incision Management Dressing Kits function as intended and are considered substantially equivalent to the predicate device and does not raise different questions of safety and effectiveness.