NewEra Small Dome Kit, NewEra Medium Dome Kit, NewEra Large Dome Kit

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other to create a sense of depth and unity. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 February 24, 2015 Integrated Healing Technologies Mr. Ian Baird Manager of Regulatory & Technology Affairs 103 Forrest Crossing Boulevard, Suite 103 Franklin, Tennessee 37064 Re: K142956 Trade/Device Name: NewEra Dome Kit Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: OMP Dated: January 9, 2015 Received: January 13, 2015 Dear Mr. Baird: 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ #### Indications for Use 510(k) Number (if known) K142956 Device Name NewEra Dome Kit Indications for Use (Describe) The NewEra Dome Kit is intended to be used with the NewEra I and II pumps. The system is intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formations and by removing exudate and infectious material. NPWT is appropriate for use on the following wounds: - · Pressure Ulcers - · Diabetic/neuropathic ulcers - · Venous insufficiency ulcers - · Chronic, Acute, Traumatic, and Subacute wounds - · Post-operative and dehisced surgical wounds · Explored fistulas - · Skin flaps and grafts 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW." The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. 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}------------------------------------------------ Image /page/3/Picture/0 description: The image shows a logo with the letters 'iht' in yellow. The 'i' has a white dot above it, and the letters are partially covered by a gray oval shape. A yellow line extends from the bottom of the 't' towards the lower left corner of the image, creating a sense of movement or direction. 103 Forrest Crossing Boulevard . Suite 103 . Franklin, TN 37064 . (615) 468-2491 . (615) 472-8455 FAX #### 510(k) SUMMARY #### Integrated Healing Technologies' NewEra Dome Kit #### Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared: Integrated Healing Technologies 103 Forrest Crossing Blvd. Suite 103 Franklin, TN 37064 Phone: 615-468-2491 Facsimile: 615-472-8455 Contact Person: Ian Baird, Manager of Regulatory & Technology Affairs Date Prepared: 10/10/2014 #### Name of Device NewEra Dome Kit #### Common or Usual Name Negative Pressure Wound Therapy (NPWT) Kit #### Classification Name OMP - Negative pressure wound therapy powered suction pump (21 CFR 878.4780) #### Predicate Devices KCI NPWT Gauze Dressing Featuring SensaT.R.A.C. Technology (K123507); RENASYS - G Gauze with RENASYS Soft Port (K110647) #### Indications for Use The NewEra Dome Kit is intended to be used with the NewEra I and II pumps. The system is intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formations and perfusion, and by removing exudate and infectious material. NPWT is appropriate for use on the following wounds: - . Pressure Ulcers - Diabetic/neuropathic ulcers . - . Venous insufficiency ulcers - . Chronic, Acute, Traumatic, and Subacute wounds - . Post-operative and dehisced surgical wounds {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows a logo with the letters "iht" in yellow, set against a gray oval background. A small white circle is positioned in the upper-left corner of the oval, serving as a visual accent. The letters are bold and appear to be a stylized font. The logo has a clean and modern design. - 103 Forrest Crossing Boulevard . Suite 103 . Franklin, TN 37064 . (615) 468-2491 . (615) 472-8455 FAX - Explored fistulas - Skin flaps and grafts . #### Device Description The NewEra Dome Kit is a convenience kit offered in three sizes: small, medium, and large. The kit contains individually sterilized and packaged products, except PhaseOne which is not sterile. All products in the kit are 510(k) approved or exempt, except for the IHT NPWT dome (IHT dome). The kit includes an IHT dome to connect to a waste canister, PhaseOne Skin and Wound Cleanser, SkinTac, a ruler, one or more Cutimed Sorbact Compresses, and one or more transparent film IHT drapes (IHT drape), depending on the size. PhaseOne (K131542, K113820, K071056) and Cutimed Sorbact (K063059) are 510(k) approved devices. The IHT drape, SkinTac and ruler are Class I 510(k) exempt. The PhaseOne is used to cleanse the wound. Cutimed Sorbact is then fluffed and filled into the wound. SkinTac is used on the border of the wound. The IHT Drape is applied to seal the wound. A hole is cut in the drape and the IHT NPWT dome is placed over the hole to allow suction. The NewEra Dome Kit attaches to an exudate canister to carry exudate from the wound and encourage wound closure. The IHT dome and tubing are made of a medical grade thermoplastic elastomer, and the drapes and dome skirt are clear polyurethane films which are all common materials currently found in similar wound care products with established biocompatibility. #### Technological Characteristics The NewEra Dome Kit attaches to an exudate canister to carry exudate from the wound. The NewEra Dome Kit interacts with a NPWT pump that applies a negative pressure to the wound via the components of the kit. The dome has a unique, but similar design and is made of materials similar to its predicate devices. #### Performance Data Bench top performance and pressure testing was performed on the device to confirm the IHT Dome's ability to serve as a conduit between a NPWT Pump and NPWT dressing system for 72 hours. This testing confirmed that the IHT Dome and NewEra Dome kit delivered negative pressure for 72 hours, removed exudate for 72 hours, and contributed to no alarms. Further testing confirmed that the pressure delivered at the wound bed was the same as listed on the pump, that the pressure was delivered in the timely manner, and that the leak alarm occurred when a leak was manually created in the dressing. A usability study was performed to validate the usability requirements for the NewEra Dome Kit with individuals who represented actual potential users. The users were trained and then asked to apply the NewEra Dome Kit to a wound model. All participants successfully applied the NewEra Dome Kit to the wound model. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows a logo for IHT. The logo features a gray oval shape with a white dot in the upper left corner. The letters "iht" are written in yellow and are positioned inside the oval. A horizontal line is located below the oval and the letters. 103 Forrest Crossing Boulevard . Suite 103 . Franklin, TN 37064 . (615) 468-2491 . (615) 472-8455 FAX #### Substantial Equivalence The NewEra Dome Kit is 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 that the device is safe and effective for the intended use. A reference table is provided below comparing the NewEra Dome Kit to the predicates. #### Integrated Healing Technologies' NewEra Dome Kit | Element of<br>Comparison | New Era Dome Kit | Predicate KCI<br>NPWT Gauze Dressing<br>(K123507) | Predicate Renasys<br>Gauze NPWT Dressing<br>Kit (K110647) | |----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer: | Integrated Healing<br>Technologies, LLC. | KCI | Smith & Nephew | | Product Type: | Negative Pressure Wound<br>Therapy System | Negative Pressure<br>Wound Therapy System<br>(Gauze Component) | Power Suction Pump &<br>Accessories | | Product Code: | OMP | OMP, FRO | OMP | | Indications for<br>Use: | The NewEra Dome Kit is<br>intended to be used with the<br>NewEra pumps<br>(k082311). The system is<br>intended to create an<br>environment that promotes<br>wound healing by<br>secondary or tertiary<br>(delayed primary) intention<br>by preparing the wound bed<br>for closure, reducing<br>edema, promoting<br>granulation tissue<br>formations and perfusion,<br>and by removing exudate<br>and infectious material.<br>NPWT is appropriate for<br>use on the following<br>wounds:<br>Pressure Ulcers<br>●<br>Diabetic/neuropathic<br>●<br>ulcers<br>Venous insufficiency<br>●<br>ulcers | The KCI NPWT Gauze<br>Dressing is intended to<br>be used with the following<br>KCI Therapy Units<br>(ActiV.A.C., InfoV.A.C.,<br>V.A.C. Simplicity, V.A.C.<br>Freedom, V.A.C. ATS<br>and V.A.C. Ulta Therapy<br>Systems). The system is<br>intended to create an<br>environment that<br>promotes wound healing<br>by secondary or tertiary<br>(delayed primary)<br>intention by preparing the<br>wound bed for closure,<br>reducing edema,<br>promoting granulation<br>tissue formation and<br>perfusion, and by<br>removing exudate and<br>infection material.<br>Wound types include<br>chronic, acute, traumatic,<br>subacute and dehisced<br>wounds, partial-thickness | The RENASYS h Foam<br>and Gauze Wound<br>Dressing Kits with<br>Softport are intended to<br>be used in conjunction<br>with Smith & Nephew<br>NPWT systems. Smith &<br>Nephew NPWT systems<br>are indicated for patients<br>who would benefit from<br>a suction device<br>(negative pressure<br>wound therapy) as it<br>may promote wound<br>healing via the removal<br>of fluids, including<br>irrigation and body<br>fluids, wound exudates<br>and infectious materials.<br>Examples of appropriate<br>wound types include:<br>chronic, acute,<br>traumatic, sub-acute<br>and dehisced wounds,<br>ulcers (such as pressure<br>or diabetic), partial- | | Element of<br>Comparison | New Era Dome Kit | Predicate KCI<br>NPWT Gauze Dressing<br>(K123507) | Predicate Renasys<br>Gauze NPWT Dressing<br>Kit (K110647) | | | Chronic, Acute, Traumatic, and Subacute wounds Post-operative and dehisced surgical wounds Explored fistulas Skin flaps and grafts | burns, ulcers (such as<br>diabetic, pressure or<br>venous insufficiency),<br>flaps and grafts. The KCI<br>NPWT Gauze Dressing is<br>not intended for use with<br>instillation therapy,<br>intermittent therapy or<br>over closed incisions. | thickness burns, flaps<br>and grafts. | | User Population: | Acute, extended, and home<br>care | Acute, extended, and<br>home care | Acute, extended, and<br>home care | | Dressing:<br>• Material<br>• Configura | Dialkyl Carbamoyl Chloride<br>on an acetate mesh | Antimicrobial gauze<br>(Polyhexamethylene<br>Biguanide 0.2%) | Antimicrobial gauze<br>(Polyhexamethylene<br>Biguanide 0.2%) | | tion | 7 x 9 in. sheets, multiple<br>size sheets available for<br>small, medium and large<br>wounds | Identical to the large size<br>of Renasys Gauze NPWT<br>Dressing kit | Multiple sizes available<br>in roll and pad for small,<br>medium and large<br>wounds | | Drape | Same as predicates | Polyurethane film with<br>adhesive | Polyurethane film with<br>adhesive | | Interface pad and<br>tubing | IHT Dome | V.A.C. SensaT.R.A.C.<br>Pad | Softport assembly | | Wound<br>measuring ruler | Same as predicates | Provided | Provided | | Accessories:<br>Wound cleanser,<br>skin prep | Provided | Not provided | Provided | | NPWT Therapy<br>Units<br>Compatibility | Compatible with the<br>NewEra I & II pumps<br>(k082311) | Compatible with the<br>following KCI V.A.C.<br>Negative Pressure<br>Wound Therapy Units:<br>ActiV.A.C.<br>InfoV.A.C.<br>V.A.C. ATS<br>V.A.C. Freedom<br>V.A.C. Simplicity<br>V.A.C. Ulta | Compatible with S&N<br>therapy units:<br>RENASYS EZ<br>RENASYS GO | | Single-use or<br>Reusable: | Single-use | Single-use | Single-use | | Method of<br>Sterilization: | Individual kit components<br>individually sterilized by<br>Gamma Irradiation, except | Unknown | Individual kit<br>components individually<br>sterilized by Ethylene | #### Substantial Equivalence Chart {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows a logo for IHT. The logo is a gray oval with the letters "iht" in yellow. There is a white dot above the "i" in "iht". The bottom of the "iht" letters are dripping yellow. ### Integrated Healing Technologies 103 Forrest Crossing Boulevard · Suite 103 · Franklin, TN 37064 · (615) 468-2491 · (615) 472-8455 FAX {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows a logo for IHT. The logo features the letters "iht" in yellow, with the "i" having a white dot above it. The letters are positioned in front of a gray oval shape. The bottom of the oval is cut off by a horizontal yellow line. ## Integrated Healing Technologies | 103 Forrest Crossing Boulevard · Suite 103 · Franklin, TN 37064 · (615) 468-2491 · (615) 472-8455 FAX | | | | | |-------------------------------------------------------------------------------------------------------|--|--|--|--| |-------------------------------------------------------------------------------------------------------|--|--|--|--| | Element of<br>Comparison | New Era Dome Kit | Predicate KCI<br>NPWT Gauze Dressing<br>(K123507) | Predicate Renasys<br>Gauze NPWT Dressing<br>Kit (K110647) | |------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------|---------------------------------------------------------------------------| | | the PhaseOne which is not<br>sterile | | | | Packaging: | Pre-packaged, sterilized<br>and placed in package as a<br>convenience kit | Unknown | Pre-packaged, sterilized<br>and placed in package<br>as a convenience kit | | Biocompatibility: | Meets ISO 10993 | Unknown | Meets ISO 10993 | | Summary of non-<br>clinical tests<br>conducted for<br>determination of<br>substantial<br>equivalence | The NewEra Dome Kit was evaluated under a number of design verification and<br>validation tests to assure performance requirements for delivery of negative<br>pressure wound therapy were met.<br>The NewEra Dome Kit, when used with the NewEra I or II pump, delivers<br>negative pressure, as specified, to the wound for a period of 72 hours. The NewEra Dome Kit, when used with the NewEra I or II pump, removes<br>exudate from the wound for a period of 72 hours. The NewEra Dome Kit, when used with the NewEra I or II pump, does not<br>contribute to alarms. Was applied successfully by users in a usability study. | | | | Summary of<br>clinical tests<br>conducted for<br>determination of<br>substantial<br>equivalence | None required for determining substantial equivalence. | | | | Conclusions<br>Drawn | Testing demonstrates that the NewEra Dome Kit, KCI NPWT Gauze dressing, and<br>Renasys Gauze NPWT Dressing Kit with Softport are substantially equivalent in<br>terms of both indications for use and delivery of negative pressure wound therapy. | | |