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.

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.

AI/ML Overview

The provided text describes the NewEra Dome Kit, a Negative Pressure Wound Therapy (NPWT) system. Here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Ability to serve as a conduit between NPWT Pump and NPWT dressing system for 72 hours.	Confirmed that the IHT Dome and NewEra Dome kit delivered negative pressure for 72 hours.
Ability to remove exudate for 72 hours.	Confirmed that the IHT Dome and NewEra Dome kit removed exudate for 72 hours.
No alarms contribution.	Confirmed that the IHT Dome and NewEra Dome kit contributed to no alarms.
Pressure delivered at the wound bed is the same as listed on the pump.	Confirmed that the pressure delivered at the wound bed was the same as listed on the pump.
Pressure delivered in a timely manner.	Confirmed that the pressure was delivered in a timely manner.
Leak alarm occurs when a leak is manually created in the dressing.	Confirmed that the leak alarm occurred when a leak was manually created in the dressing.
Usability requirements validated by actual potential users.	All participants successfully applied the NewEra Dome Kit to the wound model in a usability study.

2. Sample Size Used for the Test Set and Data Provenance

Bench top performance and pressure testing: No specific sample size is mentioned for this testing. It's implied to be conducted in a laboratory setting (benchtop). Data provenance is not specified beyond being "bench top."
Usability study: No specific sample size is mentioned for the usability study, only "individuals who represented actual potential users." The data is prospective, generated from the usability study.
No specific details on countries of origin are provided.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

There is no mention of experts being used to establish ground truth for the benchtop tests or the usability study in the provided text. The tests appear to be objective measurements (pressure, exudate removal, alarm function) and user performance.

4. Adjudication Method for the Test Set

No adjudication method is described for either the benchtop or usability testing. The benchtop tests likely involved direct measurement and observation. The usability study involved users applying the kit, and the "successful application" suggests a pass/fail outcome based on predefined criteria, not expert adjudication.

5. 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

The document does not describe an MRMC comparative effectiveness study or any involvement of AI. The device is a physical NPWT kit, not an AI-powered diagnostic or assistive tool.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

This question is not applicable as the NewEra Dome Kit is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

For the benchtop tests, the ground truth was based on objective physical measurements (e.g., pressure readings, observation of exudate removal, alarm activation) against predefined performance specifications.
For the usability study, the ground truth was based on the successful completion of predefined tasks by representative users.

8. The Sample Size for the Training Set

The document does not describe a "training set" as the device is a physical product and not an AI/machine learning model that requires training data.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable for the reasons stated in point 8.

Summary

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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

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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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Indications for Use

510(k) Number (if known) K142956

Device Name NewEra Dome 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

· 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)

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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 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

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, 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 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.

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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 ofComparison	New Era Dome 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
Product Code:	OMP	OMP, FRO	OMP
Indications forUse:	The NewEra Dome Kit isintended to be used with theNewEra pumps(K082311). The system isintended to create anenvironment that promoteswound 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●ulcers	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-thickness	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-
Element ofComparison	New Era Dome Kit	Predicate KCINPWT Gauze Dressing(K123507)	Predicate RenasysGauze NPWT DressingKit (K110647)
	Chronic, Acute, Traumatic, and Subacute wounds Post-operative and dehisced surgical wounds Explored fistulas Skin flaps and grafts	burns, ulcers (such asdiabetic, pressure orvenous insufficiency),flaps and grafts. The KCINPWT Gauze Dressing isnot intended for use withinstillation therapy,intermittent therapy orover closed incisions.	thickness burns, flapsand grafts.
User Population:	Acute, extended, and homecare	Acute, extended, andhome care	Acute, extended, andhome care
Dressing:• Material• Configura	Dialkyl Carbamoyl Chlorideon an acetate mesh	Antimicrobial gauze(PolyhexamethyleneBiguanide 0.2%)	Antimicrobial gauze(PolyhexamethyleneBiguanide 0.2%)
tion	7 x 9 in. sheets, multiplesize sheets available forsmall, medium and largewounds	Identical to the large sizeof Renasys Gauze NPWTDressing kit	Multiple sizes availablein roll and pad for small,medium and largewounds
Drape	Same as predicates	Polyurethane film withadhesive	Polyurethane film withadhesive
Interface pad andtubing	IHT Dome	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 theNewEra I & II pumps(K082311)	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, except	Unknown	Individual kitcomponents individuallysterilized by Ethylene

Substantial Equivalence Chart

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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

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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
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Element ofComparison	New Era Dome Kit	Predicate KCINPWT Gauze Dressing(K123507)	Predicate RenasysGauze NPWT DressingKit (K110647)
	the PhaseOne which is notsterile
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
Summary of non-clinical testsconducted fordetermination ofsubstantialequivalence	The NewEra Dome Kit was evaluated under a number of design verification andvalidation tests to assure performance requirements for delivery of negativepressure wound therapy were met.The NewEra Dome Kit, when used with the NewEra I or II pump, deliversnegative 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, removesexudate from the wound for a period of 72 hours. The NewEra Dome Kit, when used with the NewEra I or II pump, does notcontribute to alarms. Was applied successfully by users in a usability study.
Summary ofclinical testsconducted fordetermination ofsubstantialequivalence	None required for determining substantial equivalence.
ConclusionsDrawn	Testing demonstrates that the NewEra Dome Kit, KCI NPWT Gauze dressing, andRenasys Gauze NPWT Dressing Kit with Softport are substantially equivalent interms of both indications for use and delivery of negative pressure wound therapy.

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.