RENASYS FOAM NPWT WOUND DRESSING KITS WITH SUCTION PAD; RENASYS GAUZE NPWT WOUND DRESSING KITS WITH SUCTION PAD; RENASYS

Q: Who is the manufacturer of RENASYS FOAM NPWT WOUND DRESSING KITS WITH SUCTION PAD; RENASYS GAUZE NPWT WOUND DRESSING KITS WITH SUCTION PAD; RENASYS?

Smith & Nephew, Inc. filed the 510(k) submission for RENASYS FOAM NPWT WOUND DRESSING KITS WITH SUCTION PAD; RENASYS GAUZE NPWT WOUND DRESSING KITS WITH SUCTION PAD; RENASYS (K110647).

Q: What is the FDA product code for RENASYS FOAM NPWT WOUND DRESSING KITS WITH SUCTION PAD; RENASYS GAUZE NPWT WOUND DRESSING KITS WITH SUCTION PAD; RENASYS?

OMP. It is classified under 21 CFR 878.4780 as a Class 2 device in the General, Plastic Surgery panel.

Q: What is the regulatory pathway for RENASYS FOAM NPWT WOUND DRESSING KITS WITH SUCTION PAD; RENASYS GAUZE NPWT WOUND DRESSING KITS WITH SUCTION PAD; RENASYS?

510(k) clearance (submission type: Traditional).

Q: What are the predicate devices for RENASYS FOAM NPWT WOUND DRESSING KITS WITH SUCTION PAD; RENASYS GAUZE NPWT WOUND DRESSING KITS WITH SUCTION PAD; RENASYS?

RENASYS-F NPWT Foam Dressing kits (K082211); Versatile 1 Wound Vacuum System (K042134).

Q: Who can help prepare an FDA 510(k) submission like RENASYS FOAM NPWT WOUND DRESSING KITS WITH SUCTION PAD; RENASYS GAUZE NPWT WOUND DRESSING KITS WITH SUCTION PAD; RENASYS?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K110647 · Smith & Nephew, Inc. · OMP · Jun 22, 2011 · General, Plastic Surgery

Device Facts

Record ID	K110647
Device Name	RENASYS FOAM NPWT WOUND DRESSING KITS WITH SUCTION PAD; RENASYS GAUZE NPWT WOUND DRESSING KITS WITH SUCTION PAD; RENASYS
Applicant	Smith & Nephew, Inc.
Product Code	OMP · General, Plastic Surgery
Decision Date	Jun 22, 2011
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4780
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The RENASYS™ Foam and Gauze Wound Dressing Kits with Softport are intended to be used in conjunction with Smith & Nephew NPWT systems. Smith & Nephew NPWT systems are indicated for patients who would benefit from a suction device (negative pressure wound therapy) as it may promote wound healing via the removal of fluids, including irrigation and body fluids, wound exudates and infectious materials. Examples of appropriate wound types include: chronic, acute, traumatic, sub-acute and dehisced wounds, ulcers (such as pressure or diabetic), partial-thickness burns, flaps and grafts.

Device Story

RENASYS Foam and Gauze NPWT Wound Dressing Kits with Softport are single-use dressing kits designed for use with Smith & Nephew NPWT systems (e.g., RENASYS EZ, EZ Plus, GO). The Softport assembly acts as a conduit between the wound dressing and the NPWT device canister, transmitting negative pressure and collecting wound exudate. The kits include wound fillers (polyurethane foam or antimicrobial gauze), a Softport assembly, and a transparent film drape. The Softport is designed to maintain function for up to 72 hours and includes a controlled leak path to prevent false blockage or leak alarms. The device is used in clinical settings by healthcare providers to manage wound exudate and promote healing. The system benefits patients by facilitating the removal of infectious materials and fluids from various wound types.

Clinical Evidence

Bench testing only. Verification and validation testing confirmed the Softport assembly functions as a conduit for negative pressure and exudate collection, maintains performance for 72 hours, and includes a controlled leak path. Biocompatibility testing (cytotoxicity, skin irritation, skin sensitization) was successfully completed per ISO 10993.

Technological Characteristics

Materials: Polyurethane foam, antimicrobial gauze, polyurethane film, 3-D knit polyester fabric, non-woven polyester, polyurethane drape with adhesive. Connectivity: Passive conduit for NPWT systems. Sterilization: Ethylene Oxide or Gamma Irradiation. Softport assembly includes a controlled leak path.

Indications for Use

Indicated for patients requiring negative pressure wound therapy (NPWT) to promote healing via fluid removal. Applicable for chronic, acute, traumatic, sub-acute, dehisced wounds, pressure/diabetic ulcers, partial-thickness burns, flaps, and grafts.

Regulatory Classification

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.

Predicate Devices

RENASYS-F NPWT Foam Dressing kits (K082211)
Versatile 1 Wound Vacuum System (K042134)

Related Devices

K162129 — RENASYS-G Gauze Dressing Kits with Soft Port · Smith & Nephew, Inc. · Aug 31, 2016
K243576 — RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port; RENASYS Gauze Wound Dressing Kit with AIRLOCK Technology and Soft Port · Smith & Nephew Medical, Ltd. · Feb 18, 2025
K202783 — Renasys-F XL Foam Dressing Kit With Soft Port, Renasys XL Transparent Film Dressing · Smith & Nephew Medical Limited · Jan 14, 2022
K082211 — RENASYS-F NEGATIVE PRESSURE WOUND THERAPY FOAM DRESSING KITS · Smith & Nephew, Inc. · Nov 14, 2008
K133333 — UNI NPWT FOAM DRESSING KIT, UNI NPWT FOAM DRESSING KIT, UNI NPWT FOAM DRESSING KIT · Blue Ocean Medical Product, LLC · Dec 31, 2014

Submission Summary (Full Text)

{0}------------------------------------------------ #### 510(k) Summary RENASYS™ Foam and Gauze NPWT Wound Dressing Kits with Softport™ JUN 2 2 2011 1. Submitter: Smith & Nephew, Inc. 970 Lake Carillon Drive, Suite 110 St. Petersburg, FL 33716 2. Contact: Laura D. Reynolds, RAC Director Requlatory Affairs 727-329-7702 - ന്ന് Date Prepared: May 16, 2011 - Device Name: RENASYS™ Foam and Gauze NPWT Wound Dressing Kits with Softport 4. Classification Name/Code: Powered Suction Pump / 21 CFR 878.4780 Product Classification: Class II Product Code: OMP #### Predicate Device Information: 5. - RENASYS-F NPWT Foam Dressing kits ர் - Smith & Nephew, Inc. b. - 510(k) # K082211 C. - Versatile 1 Wound Vacuum System ರ. - BlueSky Medical (Smith & Nephew, Inc.) e. - 510(k) #K042134 f. #### 6. Device Description: With the exception of the Softport™ assembly, there are no changes to the components in the currently marketed foam and gauze wound dressing kits. The RENASYS™ Foam and Gauze Wound Dressing Kits with Softport consist of the following components: Foam Kits: Polyurethane foam wound filler, a Softport assembly and transparent film drape. The foam kits are supplied sterile, single use and are offered in three sizes; small, medium and large. Gauze Kits: Antimicrobial qauze wound filler, a Softport assembly, non-adherent wound contact layer, transparent film drape, saline bullet, No Sting Skin Prep and wound ruler. The Gauze kits are offered in four sizes: small, medium, large and extra-large. The individual components of the kit are packed sterile and kitted in a non-sterile kit package. The kit is single use. The Softport assembly attaches to an exudate canister to carry exudate from the wound. The kits are designed specifically for use with the RENASYS EZ / EZ Plus and RENASYS GO negative pressure wound therapy devices and canisters which have been cleared under 510(k) numbers K091470, K102001 and K083375. {1}------------------------------------------------ K110647 Page 2/4 #### 7. Intended Use: The RENASYS™ Foam and Gauze Wound Dressing Kits with Softport are intended to be used in conjunction with Smith & Nephew NPWT systems. Smith & Nephew NPWT systems are indicated for patients who would benefit from a suction device (neqative pressure wound therapy) as it may promote wound healing via the removal of fluids, including irrigation and body fluids, wound exudates and infectious materials. Examples of appropriate wound types include: chronic, acute, traumatic, sub-acute and dehisced wounds, ulcers (such as pressure or diabetic), partial-thickness burns, flaps and grafts. ## 8. Summary of Non-Clinical Testing: The RENASYS Foam and Gauze Wound Dressing Kits with Softport were evaluated under a number of verification and validation tests to ensure performance requirements were met. - . The Softport shall serve as a conduit between RENASYS EZ and RENASYS GO NPWT therapy devices and NPWT wound dressings by transmitting negative pressure and collecting exudate flows. - The Softport shall function throughout the recommended maximum elapsed time of 72 . hours between dressing changes. - . The Softport will continue to serve as a conduit between RENASYS EZ and RENASYS GO NPWT therapy devices and NPWT wound dressings by transmitting negative pressure and collecting exudate flows when compressed at its terminal end (atop the wound dressing). - The Softport shall incorporate a controlled leak path that does not contribute to . RENASYS EZ and RENASYS GO NPWT therapy devices false blockage or leak alarms. With the exception of the Softport™ assembly, none of the components in the currently marketed foam and gauze dressing kits have changed. Biocompatibility on all components has been successfully completed in accordance with applicable parts of ISO 10993. The following biocompatibility testing for the Softport assembly has been successfully completed per applicable parts of ISO 10993: - . Cytotoxicity - Skin Irritation - Skin Sensitization . #### 9. Conclusion: The RENASYS™ Foam and Gauze NPWT Wound Dressing Kits with Softport are substantially equivalent in design, materials, technology, function and intended use to the predicate devices named above. Verification and validation testing has been conducted to demonstrate the device is safe and effective for the intended use. {2}------------------------------------------------ K110647 page 34 # Renasys Foam and Gauze NPWT Wound Dressing Kits with Softport Device Comparison Table | Device: | Smith & Nephew New Device: | Predicate Device: | Predicate Device: | |-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------| | Name: | RENASYS™ - Foam and Gauze Wound Dressing Kits with Softport | RENASYS-F NPWT Foam Dressing kit | Versatile 1 Wound Vacuum System (including gauze wound dressing kits) | | 510(k): | K110647 | K082211 | K042134 | | Manufacturer: | Smith & Nephew, Inc. | Smith & Nephew, Inc. | Blue Sky Medical (Smith & Nephew, Inc.) | | Intended Use: | The RENASYS™ Foam and Gauze NPWT Wound Dressing Kits with Softport are Intended to be used in conjunction with Smith & Nephew NPWT systems. Smith & Nephew NPWT systems are indicated for patients who would benefit from a suction device (negative pressure wound therapy) as it may promote wound healing via the removal of fluids, including irrigation and body fluids, wound exudates and infectious materials. Examples of appropriate wound types include: chronic, acute, traumatic, sub-acute and dehisced wounds, uicers (such as pressure or diabetic), partial- thickness burns, flaps and grafts. | Foam dressing kits are intended to be used in conjunction with Smith & Nephew Negative Pressure Wound Therapy systems to deliver negative pressure to the wound. Smith & Nephew NPWT systems are indicated for patients who would benefit from a suction device particularly as the device may promote wound healing. NPWT is appropriate for use on the following wounds: · Pressure ulcers · Diabetic / neuropathic ulcers · Venous insufficiency ulcers · Traumatic wounds · Post-operative and dehisced surgical wounds · Explored fistulas · Skin flaps and grafts | Indicated for patients who wound benefit from a suction device particularly as the device may promote wound healing. | | Materials: | Wound Filler: | | | | | Hydrophobic, Polyurethane foam or Antimicrobial Gauze Softport assembly: Polyurethane film, 3-D knit polyester fabric, Polyurethane foam, Non-woven polyester, Polyurethane drape with adhesive coating, Polyurethane drape | Hydrophobic, Polyurethane foam Silicone drain PVC Tube Polyurethane drape | Antimicrobial Gauze Silicone drain PVC Tube Polyurethane drape | | Single-use or Reusable: | Single-use | Single-use | Single-use | | Method of Sterilization: | Ethylene Oxide Or Individual kit components individually sterilized by Ethylene Oxide or Gamma Irradiation. | Ethylene Oxide | Individual kit components individually sterilized by Ethylene Oxide or Gamma Irradiation. | | Biocompatibility: | All components comply with ISO 10993 | All components comply with ISO 10993 | All components comply with ISO 10993 | | Packaging: | Components packaged loose in a pouch then sterilized Or Pre-packaged and sterilized and placed in package as a | Components packaged loose in a pouch then sterilized | Pre-packaged and sterilized and placed in package as a convenience kit | {3}------------------------------------------------ K 110647 page 4/4 {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Smith & Nephew, Inc. % Ms. Laura Reynolds Director, Regulatory Affairs 970 Lake Carillon Drive St. Petersburg, Florida 33716 JUN 2 2 2011 Re: K110647 Trade/Device Name: RENASYS™ Foam and Gauze NPWT Wound Dressing Kits with Softport" Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: II Product Code: OMP, BTA Dated: June 13, 2011 Received: June 14, 2011 Dear Ms. Reynolds: 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 {5}------------------------------------------------ Page 2 - Ms. Laura Reynolds 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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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 vours. E. Keith Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ ### Indications for Use 510(k) Number (if known): K110647 Device Name: RENASYS™ Foam and Gauze NPWT Wound Dressing Kits with Softport™ Indications for Use: The RENASYS™ Foam and Gauze NPWT Wound Dressing Kits with Softport are intended to be used in conjunction with Smith & Nephew NPWT systems. Smith & Nephew NPWT systems are indicated for patients who would benefit from a suction device (negative pressure wound therapy) as it may promote wound healing via the removal of fluids, including irrigation and body fluids, wound exudates and infectious materials. Examples of appropriate wound types include: chronic, acute, traumatic, sub-acute and dehisced wounds, ulcers (such as pressure or diabetic), partial-thickness burns, flaps and grafts. Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) | | Daniel Krone for MXM Concurrence of CDRH, Office of Device Evaluation (ODE) | |--|------------------------------------------------------------------------------------| | | (Division Sign-Off) | | | Division of Surgical, Orthopedic, | | | and Restorative Devices | Smith & Nephew - Proprietary Information 510(k) Number K110647