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

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.

AI/ML Overview

Here's an analysis of the provided text regarding the NewEra REVA Kit, focusing on answering your questions about acceptance criteria and the study proving it.

First, it's very important to note that this document is a 510(k) Premarket Notification from 2015, which is a submission to the FDA to demonstrate substantial equivalence to a previously legally marketed device (predicate device). It is not a clinical trial report or a detailed stand-alone performance study. Therefore, a lot of the information you've requested regarding AI algorithm performance (like MRMC studies, training set size/ground truth, number of experts for ground truth, etc.) is not applicable to this type of medical device (a physical wound therapy kit) and thus is not present in the document.

The "studies" described here are benchtop performance tests and a usability study, not clinical efficacy trials or AI algorithm performance evaluations.

Acceptance Criteria and Reported Device Performance

For the NewEra REVA Kit, the "acceptance criteria" are implicitly derived from the performance claims of the predicate devices and the physical properties required for a negative pressure wound therapy (NPWT) system. The "performance" is demonstrated through benchtop testing.

Acceptance Criteria (Implicit from NPWT Functionality)	Reported Device Performance (NewEra REVA Kit)
Ability to deliver negative pressure to the wound bed for sustained periods (e.g., 72 hours).	Confirmed that the IHT REVA and NewEra REVA kit delivered negative pressure for 72 hours.
Ability to remove exudate from the wound for sustained periods (e.g., 72 hours).	Confirmed that the IHT REVA and NewEra REVA kit removed exudate for 72 hours.
Proper functioning and absence of unintended alarms.	Confirmed that the IHT REVA and NewEra REVA kit contributed to no alarms.
Accurate delivery of the set pressure to the wound bed.	Confirmed that the pressure delivered at the wound bed was the same as listed on the pump.
Timely delivery of pressure.	Confirmed that the pressure was delivered in a timely manner.
Functionality of leak detection/alarm system.	Confirmed that the leak alarm occurred as expected when a leak was manually created in the dressing.
Usability and ease of application by intended users.	A usability study was performed. All participants successfully applied the NewEra REVA Kit to the wound model.
Biocompatibility of materials.	Materials (silicone, polyurethane film) are common in similar wound care products. Device meets ISO 10993 (stated in comparison table).
Compatibility with NPWT pumps (range of negative pressure, continuous/intermittent modes).	Compatible with pumps that are 510(k) approved and can operate at -50 mmHg to -150 mmHg in a continuous or intermittent therapy mode. (Implicitly met by connecting to such pumps).
Sterilization effectiveness and packaging integrity.	Individual kit components individually sterilized by Gamma Irradiation. Pre-packaged, sterilized, and placed in package as a convenience kit. (Implicitly met by standard sterilization and packaging).

Study Details (Based on available information for this type of device)

Sample size used for the test set and the data provenance:
- Benchtop Testing: The document does not specify a numerical sample size (e.g., how many REVA kits were tested). It simply states "Bench top testing was performed on the device to confirm REVA's ability..."
- Usability Study: The document states that "individuals who represented actual potential users" were used, but does not specify the number of participants in the usability study.
- Data Provenance: The testing appears to be prospective (performed for this submission) and conducted by the manufacturer, Integrated Healing Technologies. No country of origin for the data is explicitly stated beyond the company's location in Franklin, Tennessee, USA.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable to this type of device and study. Benchtop tests typically rely on measurement instruments and standardized procedures. The usability study would involve user observation and feedback, not "expert ground truth" in the diagnostic sense.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This method is typically used in diagnostic imaging studies where multiple readers interpret images, and their disagreement is resolved through adjudication. This device is a physical wound therapy kit, and the studies performed (benchtop and usability) do not involve such interpretation.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. This type of study relates to AI-powered diagnostic systems, which is not what the NewEra REVA Kit is. The device is a physical negative pressure wound therapy kit.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device does not involve an AI algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable/Implicit:
  - For benchtop tests, the "ground truth" is the physical laws and engineering specifications that dictate how the device should perform (e.g., if it's set to -125 mmHg, it should deliver -125 mmHg). This is measured by calibrated equipment.
  - For the usability study, the "ground truth" is whether participants could successfully complete the tasks (applying the kit to a wound model) and potentially their subjective feedback on ease of use.
The sample size for the training set:
- Not applicable. This device does not use a "training set" as it is not an AI/machine learning model.
How the ground truth for the training set was established:
- Not applicable. (See point 7).

In summary: The document details a 510(k) submission for a physical medical device (NPWT kit). The "studies" involve benchtop engineering tests and a usability observation, designed to demonstrate that the device functions as intended and is substantially equivalent to existing predicate devices. Concepts like AI algorithms, training sets, expert ground truth for image interpretation, and MRMC studies are not relevant to this type of submission or device.

Summary

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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 (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

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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)

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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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

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 . (615) 468-2491 . (615) 472-8455 FAX

Skin flaps and grafts

Device Description

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 . (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 ofComparison	New Era REVA Kit	Predicate KCINPWT Gauze Dressing(K123507)	Predicate RenasysGauze NPWT DressingKit (K110647)
Manufacturer:	Integrated HealingTechnologies, LLC.	KCI	Smith & Nephew
Product Type:	Negative Pressure WoundTherapy System	Negative PressureWound Therapy System(Gauze Component)	Power Suction Pump &Accessories
Indications forUse:	The NewEra REVA Kit isintended to be used with theNewEra pumps. Thesystem is intended to createan environment thatpromotes wound healing bysecondary or tertiary(delayed primary) intentionby preparing the wound bedfor closure, reducingedema, promotinggranulation tissueformations and perfusion,and by removing exudateand infectious material.NPWT is appropriate foruse on the followingwounds:Pressure Ulcers●Diabetic/neuropathic●ulcersVenous insufficiency●ulcersChronic, Acute,●Traumatic, andSubacute woundsPost-operative and●dehisced surgicalwoundsSkin flaps and grafts●	The KCI NPWT GauzeDressing is intended tobe used with the followingKCI Therapy Units(ActiV.A.C., InfoV.A.C.,V.A.C. Simplicity, V.A.C.Freedom, V.A.C. ATSand V.A.C. Ulta TherapySystems). The system isintended to create anenvironment thatpromotes wound healingby secondary or tertiary(delayed primary)intention by preparing thewound bed for closure,reducing edema,promoting granulationtissue formation andperfusion, and byremoving exudate andinfection material.Wound types includechronic, acute, traumatic,subacute and dehiscedwounds, partial-thicknessburns, ulcers (such asdiabetic, pressure orvenous insufficiency),flaps and grafts. The KCI	The RENASYS h Foamand Gauze WoundDressing Kits withSoftport are intended tobe used in conjunctionwith Smith & NephewNPWT systems. Smith &Nephew NPWT systemsare indicated for patientswho would benefit froma suction device(negative pressurewound therapy) as itmay promote woundhealing via the removalof fluids, includingirrigation and bodyfluids, wound exudatesand infectious materials.Examples of appropriatewound types include:chronic, acute,traumatic, sub-acuteand dehisced wounds,ulcers (such as pressureor diabetic), partial-thickness burns, flapsand grafts.
Element ofComparison	New Era REVA Kit	Predicate KCINPWT Gauze Dressing(K123507)	Predicate RenasysGauze NPWT DressingKit (K110647)
		NPWT Gauze Dressing isnot intended for use withinstillation therapy,intermittent therapy orover closed incisions.
User Population:	Acute, extended, and home care	Acute, extended, and home care	Acute, extended, and home care
Dressing:• Material• Configuration	Dialkyl Carbamoyl Chlorideon an acetate mesh7 x 9 in. sheets, multiplesize sheets available forsmall, medium and largewounds	Antimicrobial gauze(PolyhexamethyleneBiguanide 0.2%)Identical to the large sizeof Renasys Gauze NPWTDressing kit	Antimicrobial gauze(PolyhexamethyleneBiguanide 0.2%)Multiple sizes availablein roll and pad for small,medium and largewounds
Drape	Same as predicates	Polyurethane film withadhesive	Polyurethane film withadhesive
Interface pad andtubing	REVA	V.A.C. SensaT.R.A.C.Pad	Softport assembly
Woundmeasuring ruler	Same as predicates	Provided	Provided
Accessories:Wound cleanser,skin prep	Provided	Not provided	Provided
NPWT TherapyUnitsCompatibility	Compatible with pumps thatare 510(k) approved andcan operate at -50 mmHg to-150 mmHg in a continuousor intermittent therapy mode	Compatible with thefollowing KCI V.A.C.Negative PressureWound Therapy Units:ActiV.A.C.InfoV.A.C.V.A.C. ATSV.A.C. FreedomV.A.C. SimplicityV.A.C. Ulta	Compatible with S&Ntherapy units:RENASYS EZRENASYS GO
Single-use orReusable:	Single-use	Single-use	Single-use
Method ofSterilization:	Individual kit componentsindividually sterilized byGamma Irradiation	Unknown	Individual kitcomponents individuallysterilized by EthyleneOxide or GammaIrradiation
Element ofComparison	New Era REVA Kit	Predicate KCINPWT Gauze Dressing(K123507)	Predicate RenasysGauze NPWT DressingKit (K110647)
Packaging:	Pre-packaged, sterilizedand placed in package as aconvenience kit	Unknown	Pre-packaged, sterilizedand placed in packageas 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-· (615) 472-8455 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 · (615) 468-2491 · (615) 472-8455 FAX

Regulation Number and Section

§ 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.