(106 days)
No
The summary describes a negative pressure wound therapy kit with standard components and functionality. There is no mention of AI, ML, or any computational analysis of data for decision-making or automated adjustments.
Yes.
The intended use of the NewEra REVA Kit is to promote wound healing by preparing the wound bed, reducing edema, promoting granulation tissue formation, and removing exudate and infectious material, which are all therapeutic actions.
No
Explanation: The device is intended to treat wounds by promoting healing, reducing edema, removing exudate, and promoting granulation tissue formation. It is a therapy device, not for diagnosing conditions.
No
The device description clearly outlines physical components like a drain, skirt, cleanser, film, and ruler, and describes their physical interaction with a wound and a NPWT pump. There is no mention of software as the primary or sole component.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use and device description clearly state that the NewEra REVA Kit is used on wounds to promote healing by removing exudate and applying negative pressure. It does not involve testing or analyzing samples taken from the body.
- The device description focuses on physical components and their function in wound care. It describes a kit with a drain, skirt, cleanser, adhesive, and dressing materials that interact with a pump to create a negative pressure environment on the wound surface.
- The performance studies described are related to the device's ability to deliver negative pressure and remove exudate from the wound. These are functional tests of a wound care device, not diagnostic tests.
Therefore, the NewEra REVA Kit falls under the category of a wound care device, not an In Vitro Diagnostic.
N/A
Intended Use / 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 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
Product codes
OMP
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Acute, extended, and home care
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
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
K131542, K113820, K081009, K071056, K063059
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/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
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
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.
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 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: 615-468-2491 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
4
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 . (615) 468-2491 . (615) 472-8455 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.
5
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 . (615) 468-2491 . (615) 472-8455 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
Comparison | New Era REVA Kit | Predicate KCI
NPWT Gauze Dressing
(K123507) | Predicate Renasys
Gauze NPWT Dressing
Kit (K110647) |
|------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | Integrated Healing
Technologies, LLC. | KCI | Smith & Nephew |
| Product Type: | Negative Pressure Wound
Therapy System | Negative Pressure
Wound Therapy System
(Gauze Component) | Power Suction Pump &
Accessories |
| 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
Skin flaps and grafts
● | The KCI NPWT Gauze
Dressing is intended to
be used with the following
KCI Therapy Units
(ActiV.A.C., InfoV.A.C.,
V.A.C. Simplicity, V.A.C.
Freedom, V.A.C. ATS
and V.A.C. Ulta Therapy
Systems). 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 formation and
perfusion, and by
removing exudate and
infection material.
Wound types include
chronic, acute, traumatic,
subacute and dehisced
wounds, partial-thickness
burns, ulcers (such as
diabetic, pressure or
venous insufficiency),
flaps and grafts. The KCI | The RENASYS h 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. |
| Element of
Comparison | New Era REVA Kit | Predicate KCI
NPWT Gauze Dressing
(K123507) | Predicate Renasys
Gauze NPWT Dressing
Kit (K110647) |
| | | NPWT Gauze Dressing is
not intended for use with
instillation therapy,
intermittent therapy or
over closed incisions. | |
| User Population: | Acute, extended, and home care | Acute, extended, and home care | Acute, extended, and home care |
| Dressing:
• Material
• Configura
tion | Dialkyl Carbamoyl Chloride
on an acetate mesh
7 x 9 in. sheets, multiple
size sheets available for
small, medium and large
wounds | Antimicrobial gauze
(Polyhexamethylene
Biguanide 0.2%)
Identical to the large size
of Renasys Gauze NPWT
Dressing kit | Antimicrobial gauze
(Polyhexamethylene
Biguanide 0.2%)
Multiple sizes available
in roll and pad for small,
medium and large
wounds |
| Drape | Same as predicates | Polyurethane film with
adhesive | Polyurethane film with
adhesive |
| Interface pad and
tubing | REVA | V.A.C. SensaT.R.A.C.
Pad | Softport assembly |
| Wound
measuring ruler | Same as predicates | Provided | Provided |
| Accessories:
Wound cleanser,
skin prep | Provided | Not provided | Provided |
| NPWT Therapy
Units
Compatibility | Compatible with pumps that
are 510(k) approved and
can operate at -50 mmHg to
-150 mmHg in a continuous
or intermittent therapy mode | Compatible with the
following KCI V.A.C.
Negative Pressure
Wound Therapy Units:
ActiV.A.C.
InfoV.A.C.
V.A.C. ATS
V.A.C. Freedom
V.A.C. Simplicity
V.A.C. Ulta | Compatible with S&N
therapy units:
RENASYS EZ
RENASYS GO |
| Single-use or
Reusable: | Single-use | Single-use | Single-use |
| Method of
Sterilization: | Individual kit components
individually sterilized by
Gamma Irradiation | Unknown | Individual kit
components individually
sterilized by Ethylene
Oxide or Gamma
Irradiation |
| Element of
Comparison | New Era REVA Kit | Predicate KCI
NPWT Gauze Dressing
(K123507) | Predicate Renasys
Gauze NPWT Dressing
Kit (K110647) |
| Packaging: | Pre-packaged, sterilized
and placed in package as a
convenience kit | Unknown | Pre-packaged, sterilized
and placed in package
as a convenience kit |
| Biocompatibility: | Meets ISO 10993 | Unknown | Meets ISO 10993 |
Substantial Equivalence Chart
6
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-· (615) 472-8455 FAX
7
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 · (615) 468-2491 · (615) 472-8455 FAX