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

• K Number: K142956
• Device Name: NewEra Small Dome Kit, NewEra Medium Dome Kit, NewEra Large Dome Kit
• Manufacturer: Integrated Healing Technologies
• Date Cleared: 2015-02-24 ( 133 days)
• Product Code: OMP
• Regulation Number: 878.4780

Intended Use

The NewEra Dome Kit is intended to be used with the NewEra I and II pumps. The system is intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formations and 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.

Predicate Devices

K123507, K110647

Reference Devices

K131542, K113820, K071056, K063059

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the physical components and function of a negative pressure wound therapy kit, with no mention of AI or ML.

Therapeutic

Yes
The device is intended to promote wound healing, reduce edema, promote granulation tissue formation, and remove exudate and infectious material, all of which are therapeutic actions.

Diagnostic

No

Explanation: The device is described as a "Negative Pressure Wound Therapy (NPWT) system" intended to "create an environment that promotes wound healing" by preparing the wound bed, reducing edema, promoting granulation tissue formation, and removing exudate. Its function is therapeutic, not diagnostic.

SaMD (Software as a Medical Device)

No

The device description clearly outlines a kit containing physical components such as a dome, cleanser, compresses, film, and a ruler, all of which are hardware. The performance studies also focus on the physical performance of these components.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use clearly describes a system for wound healing by applying negative pressure to the wound bed, removing exudate, and promoting tissue formation. This is a therapeutic intervention applied directly to the body, not a diagnostic test performed on samples taken from the body.
• Device Description: The components of the kit (dome, cleanser, compress, film, etc.) are all related to wound care and the application of negative pressure. None of the components are designed to analyze biological samples for diagnostic purposes.
• Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.), diagnostic markers, or any process that would lead to a diagnosis.

Therefore, the NewEra Dome Kit falls under the category of a therapeutic medical device for wound care, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The NewEra Dome Kit is intended to be used with the NewEra I and II pumps. The system is intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formations and 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

Product codes

OMP

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.

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 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.

Key Metrics

Not Found

Predicate Device(s)

K123507, K110647

Reference Device(s)

K131542, K113820, K071056, K063059

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

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 [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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Indications for Use

510(k) Number (if known) K142956

Device Name NewEra Dome Kit

Indications for Use (Describe)

The NewEra Dome Kit is intended to be used with the NewEra I and II pumps. The system is intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formations and by removing exudate and infectious material.

NPWT is appropriate for use on the following wounds:

• · Pressure Ulcers
• · Diabetic/neuropathic ulcers
• · Venous insufficiency ulcers
• · Chronic, Acute, Traumatic, and Subacute wounds
• · Post-operative and dehisced surgical wounds

· Explored fistulas

• · Skin flaps and grafts
  Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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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 . [phone] . [phone] 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: [phone] Facsimile: 615-472-8455

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

Date Prepared: 10/10/2014

Name of Device

NewEra Dome Kit

Common or Usual Name

Negative Pressure Wound Therapy (NPWT) Kit

Classification Name

OMP - Negative pressure wound therapy powered suction pump (21 CFR 878.4780)

Predicate Devices

KCI NPWT Gauze Dressing Featuring SensaT.R.A.C. Technology (K123507);

RENASYS - G Gauze with RENASYS Soft Port (K110647)

Indications for Use

The NewEra Dome Kit is intended to be used with the NewEra I and II pumps. The system is intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formations and perfusion, and by removing exudate and infectious material.

NPWT is appropriate for use on the following wounds:

• . Pressure Ulcers
• Diabetic/neuropathic ulcers .
• . Venous insufficiency ulcers
• . Chronic, Acute, Traumatic, and Subacute wounds
• . Post-operative and dehisced surgical wounds

4

Image /page/4/Picture/0 description: The image shows a logo with the letters "iht" in yellow, set against a gray oval background. A small white circle is positioned in the upper-left corner of the oval, serving as a visual accent. The letters are bold and appear to be a stylized font. The logo has a clean and modern design.

• 103 Forrest Crossing Boulevard . Suite 103 . Franklin, TN 37064 . [phone] . [phone] FAX
• Explored fistulas
• Skin flaps and grafts .

Device Description

The NewEra Dome Kit is a convenience kit offered in three sizes: small, medium, and large. The kit contains individually sterilized and packaged products, except PhaseOne which is not sterile. All products in the kit are 510(k) approved or exempt, except for the IHT NPWT dome (IHT dome). The kit includes an IHT dome to connect to a waste canister, PhaseOne Skin and Wound Cleanser, SkinTac, a ruler, one or more Cutimed Sorbact Compresses, and one or more transparent film IHT drapes (IHT drape), depending on the size. PhaseOne (K131542, K113820, K071056) and Cutimed Sorbact (K063059) are 510(k) approved devices. The IHT drape, SkinTac and ruler are Class I 510(k) exempt.

The PhaseOne is used to cleanse the wound. Cutimed Sorbact is then fluffed and filled into the wound. SkinTac is used on the border of the wound. The IHT Drape is applied to seal the wound. A hole is cut in the drape and the IHT NPWT dome is placed over the hole to allow suction. The NewEra Dome Kit attaches to an exudate canister to carry exudate from the wound and encourage wound closure.

The IHT dome and tubing are made of a medical grade thermoplastic elastomer, and the drapes and dome skirt are clear polyurethane films which are all common materials currently found in similar wound care products with established biocompatibility.

Technological Characteristics

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

Performance Data

Bench top performance and pressure testing was performed on the device to confirm the IHT Dome's ability to serve as a conduit between a NPWT Pump and NPWT dressing system for 72 hours. This testing confirmed that the IHT Dome and NewEra Dome kit delivered negative pressure for 72 hours, removed exudate for 72 hours, and contributed to no alarms. Further testing confirmed that the pressure delivered at the wound bed was the same as listed on the pump, that the pressure was delivered in the timely manner, and that the leak alarm occurred when a leak was manually created in the dressing.

A usability study was performed to validate the usability requirements for the NewEra Dome Kit with individuals who represented actual potential users. The users were trained and then asked to apply the NewEra Dome Kit to a wound model. All participants successfully applied the NewEra Dome Kit to the wound model.

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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 . [phone] . [phone] FAX

Substantial Equivalence

The NewEra Dome Kit is substantially equivalent in design, materials, technology, function and intended use to the predicate devices named above. Verification and validation testing has been conducted to demonstrate that the device is safe and effective for the intended use. A reference table is provided below comparing the NewEra Dome Kit to the predicates.

Integrated Healing Technologies' NewEra Dome Kit

| Element of
Comparison | New Era Dome 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 |
| Product Code: | OMP | OMP, FRO | OMP |
| Indications for
Use: | The NewEra Dome Kit is
intended to be used with the
NewEra pumps
(K082311). 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 | 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 | 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- |
| Element of
Comparison | New Era Dome Kit | Predicate KCI
NPWT Gauze Dressing
(K123507) | Predicate Renasys
Gauze NPWT Dressing
Kit (K110647) |
| | Chronic, Acute, Traumatic, and Subacute wounds Post-operative and dehisced surgical wounds Explored fistulas Skin flaps and grafts | burns, ulcers (such as
diabetic, pressure or
venous insufficiency),
flaps and grafts. The KCI
NPWT Gauze Dressing is
not intended for use with
instillation therapy,
intermittent therapy or
over closed incisions. | thickness burns, flaps
and grafts. |
| User Population: | Acute, extended, and home
care | Acute, extended, and
home care | Acute, extended, and
home care |
| Dressing:
• Material
• Configura | Dialkyl Carbamoyl Chloride
on an acetate mesh | Antimicrobial gauze
(Polyhexamethylene
Biguanide 0.2%) | Antimicrobial gauze
(Polyhexamethylene
Biguanide 0.2%) |
| tion | 7 x 9 in. sheets, multiple
size sheets available for
small, medium and large
wounds | Identical to the large size
of Renasys Gauze NPWT
Dressing kit | 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 | IHT Dome | 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 the
NewEra I & II pumps
(K082311) | 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, except | Unknown | Individual kit
components individually
sterilized 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 · [phone] · [phone] 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 · [phone] · [phone] FAX
-------------------------------------------------------------------------------------------------------	--	--	--	--

| Element of
Comparison | New Era Dome Kit | Predicate KCI
NPWT Gauze Dressing
(K123507) | Predicate Renasys
Gauze NPWT Dressing
Kit (K110647) |
|------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------|---------------------------------------------------------------------------|
| | the PhaseOne which is not
sterile | | |
| 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 |
| Summary of non-
clinical tests
conducted for
determination of
substantial
equivalence | The NewEra Dome Kit was evaluated under a number of design verification and
validation tests to assure performance requirements for delivery of negative
pressure wound therapy were met.
The NewEra Dome Kit, when used with the NewEra I or II pump, delivers
negative pressure, as specified, to the wound for a period of 72 hours. The NewEra Dome Kit, when used with the NewEra I or II pump, removes
exudate from the wound for a period of 72 hours. The NewEra Dome Kit, when used with the NewEra I or II pump, does not
contribute to alarms. Was applied successfully by users in a usability study. | | |
| Summary of
clinical tests
conducted for
determination of
substantial
equivalence | None required for determining substantial equivalence. | | |
| Conclusions
Drawn | Testing demonstrates that the NewEra Dome Kit, KCI NPWT Gauze dressing, and
Renasys Gauze NPWT Dressing Kit with Softport are substantially equivalent in
terms of both indications for use and delivery of negative pressure wound therapy. | | |