NewEra Small REVA Kit, NewEra Medium REVA Kit, NewEra Large REVA Kit

K143301 · Integrated Healing Technologies · OMP · Mar 3, 2015 · General, Plastic Surgery

Device Facts

• Record ID: K143301
• Device Name: NewEra Small REVA Kit, NewEra Medium REVA Kit, NewEra Large REVA Kit
• Applicant: Integrated Healing Technologies
• Product Code: OMP · General, Plastic Surgery
• Decision Date: Mar 3, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4780
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The NewEra REVA Kit is intended to be used with the NewEra 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 Skin flaps and grafts

Device Story

NewEra REVA Kit is a single-use convenience kit for negative pressure wound therapy (NPWT); functions as a conduit between a compatible NPWT pump and the wound bed. Kit includes REVA drain, PhaseOne wound cleanser, SkinTac, ruler, Cutimed Sorbact compresses, and transparent film drapes. Clinician cleanses wound with PhaseOne; applies SkinTac to peri-wound; packs wound with fluffed Cutimed Sorbact; places REVA drain; seals with IHT drape. System connects to an exudate canister and external NPWT pump. Pump applies negative pressure (-50 to -150 mmHg) to remove exudate/infectious material, reduce edema, and promote granulation/perfusion. Used in acute, extended, and home care settings. Output is the physical removal of wound fluids and maintenance of negative pressure environment; assists clinicians in wound bed preparation for closure. Benefits include promoted healing by secondary or tertiary intention.

Clinical Evidence

No clinical data. Bench testing confirmed 72-hour performance for pressure delivery, exudate removal, and alarm activation. Usability study with potential users validated application of the kit to a wound model.

Technological Characteristics

Convenience kit containing silicone REVA drain/anchor and polyurethane film drapes. Compatible with 510(k) cleared NPWT pumps operating at -50 to -150 mmHg. Materials meet ISO 10993 biocompatibility standards. Components sterilized via Gamma Irradiation. System is single-use.

Indications for Use

Indicated for patients requiring negative pressure wound therapy (NPWT) for pressure, diabetic/neuropathic, venous insufficiency, chronic, acute, traumatic, subacute, post-operative, dehisced wounds, skin 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

• KCI NPWT Gauze Dressing Featuring SensaT.R.A.C. Technology (K123507)
• RENASYS - G Gauze with RENASYS Soft Port (K110647)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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

March 3, 2015

Integrated Healing Technologies Mr. Ian Baird Manager of Regulatory & Technology Affairs 103 Forrest Crossing Boulevard, Suite 103 Franklin, Tennessee 37064

Re: K143301

Trade/Device Name: NewEra REVA Kit Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: OMP Dated: January 22, 2015 Received: January 27, 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

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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 [phone] or [phone] 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 [phone] or [phone] 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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

510(k) Number (if known) K143301

#### Device Name NewEra REVA Kit

#### Indications for Use (Describe)

The NewEra REVA Kit is intended to be used with the NewEra 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
- · Skin flaps and grafts

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

[X] 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)

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

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103 Forrest Crossing Boulevard . Suite 103 . Franklin, TN 37064 . [phone] . [phone] FAX

#### 510(k) SUMMARY

#### Integrated Healing Technologies' NewEra REVA 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: [phone] Facsimile: 615-472-8455

Contact Person: Ian Baird, Manager of Regulatory & Technology Affairs

Date Prepared: 01/22/2015

#### Name of Device

NewEra REVA Kit

#### Common or Usual Name

Negative Pressure Wound Therapy (NPWT) Kit

#### Classification Name

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 REVA Kit is intended to be used with the NewEra 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

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Image /page/4/Picture/0 description: The image shows a logo with the letters 'iht' in yellow, stylized in a rounded, sans-serif font. The letters are positioned against a gray, oval-shaped background that resembles a stylized fish or egg shape. A small white circle is located to the upper left of the 'i' in 'iht', adding a visual element to the design.

103 Forrest Crossing Boulevard . Suite 103 . Franklin, TN 37064 . [phone] . [phone] FAX

- Skin flaps and grafts
### Device Description

The NewEra REVA Kit is a convenience kit offered in three sizes: small, medium, and large. The kit contains individually sterilized and packaged products. All products in the kit are 510(k) approved or exempt, except for the IHT NPWT REVA (REVA). The kit includes a REVA 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, K081009, K071056) and Cutimed Sorbact (K063059) are 510(k) approved devices. The IHT drape (NAD), SkinTac (KOX) and ruler (FTY) are Class I 510(k) exempt.

The PhaseOne is used to cleanse the wound. SkinTac is used on the 2" surrounding surface area of the wound (peri-wound). The wound is measured, and the REVA drain is cut to a length apropriate for the wound. The REVA drain is wrapped in Cutimed Sorbact, and Cutimed Sorbact is fluffed and filled appropriately into the wound. The REVA skirt is used to cover over and seal the wound. An IHT Drape is provided for additional material if necessary. The NewEra REVA Kit attaches to an exudate canister to carry exudate from the wound. The NewEra REVA Kit interacts with a NPWT pump that applies a negative pressure to the wound via the components of the kit.

The REVA drain and anchor are made of silicone, and the skirt is a clear polyurethane film, which are all common materials currently found in similar wound care products with established biocompatibility.

#### Technological Characteristics

The NewEra REVA Kit attaches to an exudate canister to carry exudate from the wound. The NewEra REVA Kit interacts with a NPWT pump that applies a negative pressure to the wound via the components of the kit. The REVA has a unique, but similar design and is made of materials similar to its predicate devices.

#### Performance Data

Bench top testing was performed on the device to confirm REVA's ability to serve as a conduit between a NPWT Pump and NPWT dressing system for 72 hours. This testing confirmed that the IHT REVA and NewEra REVA 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 a timely manner, and that the leak alarm occurred as expected when a leak was manually created in the dressing. A usability study was performed to validate the usability requirements for the NewEra REVA Kit with individuals who represented actual potential users. The users were trained and then asked to apply the NewEra REVA Kit to a wound model. All participants successfully applied the NewEra REVA Kit to the wound model.

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Image /page/5/Picture/0 description: The image shows a logo for an organization, possibly named IHT. The logo features a gray, oval-shaped background with a white dot in the upper-left corner. The letters "iht" are displayed in yellow, with the "i" and "h" connected at the top. The bottom of the "t" extends below the oval shape.

103 Forrest Crossing Boulevard . Suite 103 . Franklin, TN 37064 . [phone] . [phone] FAX

#### Substantial Equivalence

The NewEra REVA 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 REVA Kit to the predicates.

#### Integrated Healing Technologies' NewEra REVA Kit

| Element of<br>Comparison | New Era REVA 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 |
| Indications for<br>Use: | The NewEra REVA Kit is<br>intended to be used with the<br>NewEra pumps. The<br>system is intended to create<br>an environment that<br>promotes 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<br>Chronic, Acute,<br>●<br>Traumatic, and<br>Subacute wounds<br>Post-operative and<br>●<br>dehisced surgical<br>wounds<br>Skin flaps and grafts<br>● | 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<br>burns, ulcers (such as<br>diabetic, pressure or<br>venous insufficiency),<br>flaps and grafts. The KCI | 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-<br>thickness burns, flaps<br>and grafts. |
| Element of<br>Comparison | New Era REVA Kit | Predicate KCI<br>NPWT Gauze Dressing<br>(K123507) | Predicate Renasys<br>Gauze NPWT Dressing<br>Kit (K110647) |
| | | NPWT Gauze Dressing is<br>not intended for use with<br>instillation therapy,<br>intermittent therapy or<br>over closed incisions. | |
| User Population: | Acute, extended, and home care | Acute, extended, and home care | Acute, extended, and home care |
| Dressing:<br>• Material<br>• Configura<br>tion | Dialkyl Carbamoyl Chloride<br>on an acetate mesh<br><br>7 x 9 in. sheets, multiple<br>size sheets available for<br>small, medium and large<br>wounds | Antimicrobial gauze<br>(Polyhexamethylene<br>Biguanide 0.2%)<br><br>Identical to the large size<br>of Renasys Gauze NPWT<br>Dressing kit | Antimicrobial gauze<br>(Polyhexamethylene<br>Biguanide 0.2%)<br><br>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 | REVA | 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 pumps that<br>are 510(k) approved and<br>can operate at -50 mmHg to<br>-150 mmHg in a continuous<br>or intermittent therapy mode | 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 | Unknown | Individual kit<br>components individually<br>sterilized by Ethylene<br>Oxide or Gamma<br>Irradiation |
| Element of<br>Comparison | New Era REVA Kit | Predicate KCI<br>NPWT Gauze Dressing<br>(K123507) | Predicate Renasys<br>Gauze NPWT Dressing<br>Kit (K110647) |
| 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 |

#### Substantial Equivalence Chart

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Image /page/6/Picture/0 description: The image shows a logo for IHT. The logo consists of a gray oval shape with a white dot in the upper left corner. Inside the oval are the letters "iht" in yellow. The letters are stylized and appear to be connected.

## Integrated Healing Technologies

103 Forrest Crossing Boulevard · Suite 103 · Franklin, TN 37064 · (615) 468-· [phone] FAX

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Image /page/7/Picture/0 description: The image shows a logo for an organization, possibly a company or institution. The logo features the letters "iht" in a bold, sans-serif font. The letters are colored in a bright yellow or gold hue. The "i" is positioned inside a gray oval shape, with a white dot above it, resembling an eye. A horizontal line runs beneath the letters, also in the same yellow/gold color, adding a sense of grounding to the design.

## Integrated Healing Technologies

103 Forrest Crossing Boulevard · Suite 103 · Franklin, TN 37064 · [phone] · [phone] FAX