Who is the manufacturer of Theia NPWT Foam Wound Dressing Kit?

Clear Choice Therapeutics, Inc. filed the 510(k) submission for Theia NPWT Foam Wound Dressing Kit (K211277).

What is the FDA product code for Theia NPWT Foam Wound Dressing Kit?

OMP. It is classified under 21 CFR 878.4780 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for Theia NPWT Foam Wound Dressing Kit?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Theia NPWT Foam Wound Dressing Kit?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Theia NPWT Foam Wound Dressing Kit

Q: What are the predicate devices for Theia NPWT Foam Wound Dressing Kit?

Theia NPWT Foam Wound Dressing Kit (K161570).

K211277 · Clear Choice Therapeutics, Inc. · OMP · Dec 16, 2021 · General, Plastic Surgery

Device Facts

Record ID	K211277
Device Name	Theia NPWT Foam Wound Dressing Kit
Applicant	Clear Choice Therapeutics, Inc.
Product Code	OMP · General, Plastic Surgery
Decision Date	Dec 16, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4780
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Theia NPWT Foam Wound Dressing Kit is intended to be used in conjunction with the CCT Mini or CCT1 Negative Pressure Wound Drainage Pumps for the application of negative pressure wound therapy to the wound. When used in conjunction with the CCT Mini or CCT1 Negative Pressure Wound Drainage Pumps, the Theia NPWT Foam Wound Dressing Kit is indicated for patients who would benefit from a suction device, particularly as the device may promote wound healing by removal of excess exudates, infectious material and tissue debris. The Theia NPWT Foam Wound Dressing Kit is appropriate for use on the following wounds: Pressure Ulcers Diabetic/Neuropathic Ulcers Venous Insufficiency Ulcers Traumatic Wounds Post-Operative and Dehisced Surgical Wounds Skin Flap and Grafts

Device Story

Sterile, single-use foam dressing kit for negative pressure wound therapy (NPWT). Components: reticular polyether-based polyurethane hydrophobic foam, occlusive drape, dome assembly with tubing/luer lock. Used with CCT Mini or CCT1 pumps (K082311) in institutional settings by healthcare professionals. Foam packs wound; drape creates seal; dome/tubing connects to pump canister. Pump delivers negative pressure to suction exudate. Facilitates wound healing by removing debris/exudates. Bench testing confirms uniform pressure delivery and fluid removal.

Clinical Evidence

Bench testing only. No clinical or animal studies conducted. Bench performance testing demonstrated effective removal of wound fluids and uniform pressure delivery across the dressing in simulated wound setups.

Technological Characteristics

Materials: black reticular polyether-based polyurethane foam, semipermeable polyurethane film drape, thermoplastic elastomer dome, PVC tubing. Dimensions: 1.5cm or 3.0cm thickness. Sterilization: Gamma radiation. Packaging: Tyvek pouch. Connectivity: mechanical connection to external NPWT pump.

Indications for Use

Indicated for patients requiring negative pressure wound therapy (NPWT) to promote healing via removal of excess exudates, infectious material, and tissue debris. Appropriate for pressure, diabetic/neuropathic, venous insufficiency, traumatic, post-operative/dehisced surgical wounds, and skin flaps/grafts.

Regulatory Classification

Identification

A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.

Predicate Devices

Theia NPWT Foam Wound Dressing Kit (K161570)

Reference Devices

CCT Mini or CCT1 Negative Pressure Wound Drainage Pumps (K082311)
SIMEX Negative Pressure Wound Therapy Pumps (K113291)

Related Devices

K161570 — Theia NPWT Foam Wound Dressing Kit-Small, Theia NPWT Foam Wound Dressing Kit-Medium, Theia NPWT Foam Wound Dressing Kit-Large · Lc Medical Concepts, Inc. · Aug 29, 2016
K082211 — RENASYS-F NEGATIVE PRESSURE WOUND THERAPY FOAM DRESSING KITS · Smith & Nephew, Inc. · Nov 14, 2008
K133333 — UNI NPWT FOAM DRESSING KIT, UNI NPWT FOAM DRESSING KIT, UNI NPWT FOAM DRESSING KIT · Blue Ocean Medical Product, LLC · Dec 31, 2014
K132004 — NPWT WOUND DRESSING KIT- MEDIUM, NPWT WOUND DRESSING KIT- LARGE · Creo Quality, LLC · May 2, 2014
K182458 — Longterm NPWT Foam Dressing Kit · Zhejiang Longterm Medical Technology Co., Ltd. · May 23, 2019

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration". December 16, 2021 Clear Choice Therapeutics, Inc. % Kathy Herzog Regulatory Consultant DuVal & Associates 1820 Medical Arts Building, 820 Nicollet Mall Minneapolis, Minnesota 55402 Re: K211277 Trade/Device Name: Theia NPWT Foam Wound Dressing Kit Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: OMP Dated: September 17, 2021 Received: September 20, 2021 Dear Kathy Herzog: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 {1}------------------------------------------------ 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Julie Morabito, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. 510(k) Number (if known) K211277 Device Name Theia NPWT Foam Wound Dressing Kit ### Indications for Use (Describe) The Theia NPWT Foam Wound Dressing Kit is intended to be used in conjunction with the CCT Mini or CCTI Negative Pressure Wound Drainage Pumps for the application of negative pressure wound therapy to the wound. When used in conjunction with the CCT Mini or CCT1 Negative Pressure Wound Drainage Pumps, the Theia NPWT Foam Wound Dressing Kit is indicated for patients who would benefit from a suction device, particularly as the device may promote wound healing by removal of excess exudates, infectious material and tissue debris. The Theia NPWT Foam Wound Dressing Kit is appropriate for use on the following wounds: - Pressure Ulcers - · Diabetic/Neuropathic Ulcers - · Venous Insufficiency Ulcers - · Traumatic Wounds - · Post-Operative and Dehisced Surgical Wounds - · Skin Flap 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) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # K211277 Page 1 of 5 ## 510(k) Summary This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92: #### I. SUBMITTER Clear Choice Therapeutics, Inc. 530 W. Cloverhurst Ave. Athens, GA 30606-4216 Phone: 217.377.4834 Contact Person: John Prince Date Prepared: November 18, 2021 #### II. DEVICE | Trade/Proprietary Names: | Theia NPWT Foam Wound Dressing Kit, Models UN1083S, UN20133M, and UN25163L, FWTS21, FWTM36, and FWTL44 | |--------------------------|--------------------------------------------------------------------------------------------------------------| | Common Name: | Foam Dressing Kit | | Regulation Number: | 21 CFR 878.4780 | | Regulation Name: | Powered Suction Pump | | Device Class: | II | | Product Code: | OMP | | Panel: | General & Plastic Surgery | #### PREDICATE DEVICE III. Theia NPWT Foam Wound Dressing Kit, K161570. This predicate has not been subject to a design-related recall. No reference devices were used in this submission. #### IV. DEVICE DESCRIPTION The Theia NPWT Foam Wound Dressing Kits are sterile, single use, disposable dressings for use with the CCT Mini or CCT1 Negative Pressure Wound Drainage pumps for the application of negative pressure wound therapy (NPWT) to the wound. The kits include a foam dressing made of black reticular polyether based polyurethane hydrophobic foam material, occlusive drape(s), and a dome assembly consisting of a single lumen dome, dome skirt, and drainage tubing with clamp and female luer lock connector. The foam {4}------------------------------------------------ # K211277 dressing covers the wound and the transparent occlusive drape covers the foam dressing and creates a seal around the wound. The drainage tubing connects to the exudate canister of the negative pressure pump. The powered negative pressure pump delivers negative pressure to the dressing to suction wound exudate into the exudate canister of the pump. The dressing kits are available in three sizes (small, medium, large) based on foam dressing size (length x width) and in two foam dressing thicknesses (1.5 and 3.0 cm), for a total of six dressing kits. The Theia NPWT Foam Wound Dressing Kits are for institutional use only with the CCT Mini and CCT1 pumps cleared through K082311. #### V. INDICATIONS FOR USE The Theia NPWT Foam Dressing Kit is intended to be used in conjunction with the CCT Mini or CCT1 Negative Pressure Wound Drainage Pumps for the application of negative pressure wound therapy to the wound. When used in conjunction with the CCT Mini or CCT1 Negative Pressure Wound Drainage Pumps, the Theia NPWT Foam Dressing Kit is indicated for patients who would benefit from a suction device, particularly as the device may promote wound healing by removal of excess exudates, infectious material and tissue debris. The Theia NPWT Foam Dressing Kit is appropriate for use on the following wounds: - Pressure Ulcers ● - Diabetic/Neuropathic Ulcers . - Venous Insufficiency Ulcers ● - o Traumatic Wounds - Post-Operative and Dehisced Surgical Wounds ● - Skin Flap and Grafts o ### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE Both the subject (1.5cm thick foam dressing) and predicate (3.0cm thick foam dressing) Theia NPWT Foam Wound Dressing Kits have the same Intended Use for the application of NPWT to the wound when used in conjunction with a negative pressure pump. The 1.5cm and 3.0cm thick foam dressing kits are identical except for the foam thickness, kit model numbers, and indicated negative pressure pumps as shown in Table 1. {5}------------------------------------------------ # K211277 | Feature | Theia NPWT Dressing Kit (Subject Device) | Theia NPWT Dressing Kit (Predicate Device) | |--------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | K Number | K211277 | K161570 | | Classification | 21 CFR 878.4780 | 21 CFR 878.4780 | | Product Code | OMP | OMP | | Class | II | II | | Intended Use | The Theia NPWT Dressing Kit is intended to be used in conjunction with a negative pressure pump for the application of negative pressure wound therapy to the wound. | The Theia NPWT Dressing Kit is intended to be used in conjunction with a negative pressure pump for the application of negative pressure wound therapy to the wound. | | Indications For Use | The Theia NPWT Foam Wound Dressing Kit is intended to be used in conjunction with the CCT Mini or CCT1 Negative Pressure Wound Drainage Pumps for the application of negative pressure wound therapy to the wound. When used in conjunction with the CCT Mini or CCT1 Negative Pressure Wound Drainage Pumps, the Theia NPWT Foam Wound Dressing Kit is indicated for patients who would benefit from a suction device, particularly as the device may promote wound healing by removal of excess exudates, infectious material and tissue debris. | The Theia NPWT Foam Wound Dressing Kit is intended to be used in conjunction with the SIMEX Negative Pressure Wound Therapy Pumps (K113291) for the application of negative pressure wound therapy to the wound. When used in conjunction with the SIMEX Negative Pressure Wound Therapy Pumps, the Theia NPWT Foam Wound Dressing Kit is indicated for patients who would benefit from a suction device, particularly as the device may promote wound healing by removal of excess exudates, infectious material and tissue debris. | | | The Theia NPWT Foam Wound Dressing Kit is appropriate for use on the following wounds: • Pressure Ulcers • Diabetic/Neuropathic Ulcers • Venous Insufficiency Ulcers • Traumatic Wounds • Post-Operative and Dehisced Surgical Wounds • Skin Flap and Grafts | The Theia NPWT Foam Wound Dressing Kit is inappropriate for use on the following wounds: • Pressure Ulcers • Diabetic/Neuropathic Ulcers • Venous Insufficiency Ulcers • Traumatic Wounds • Post-Operative and Dehisced Surgical Wounds • Skin Flap and Grafts | | Type of Use | Prescription Only | Prescription Only | | User | Healthcare professional | Healthcare professional | | Intended Use Environment | Hospital or long-term care clinic setting | Hospital or long-term care clinic setting | | Feature | Theia NPWT Dressing Kit (Subject Device) | Theia NPWT Dressing Kit (Predicate Device) | | Single Use or Reusable | Single Use | Single Use | | Foam Dressing Dimensions and Model Numbers | Model Number, Size, and dimensions (Length x Width x Thickness, in cm). • Model FWTS21 (Small): 10x8x1.5 • Model FWTM36 (Medium): 20x13x1.5 • Model FWTL44 (Large): 25x16x1.5 | Dimensions stated as Length x Width x Thickness in cm. Three sizes (small, medium, and large) in one thickness: • Model UN1083S (Small): 10x8x3 • Model UN20133M (Medium): 20x13x3 • Model UN25163L (Large): 25x16x3 | | Kit Components | One foam dressing, occlusive drape(s) (1 in the small kit and 2 in the medium and large kits), and one dome assembly (dome, skirt, and drainage tubing with luer lock and clamp) | One foam dressing, occlusive drape(s) (1 in the small kit and 2 in the medium and large kits), and one dome assembly (dome, skirt, and drainage tubing with luer lock and clamp) | | Kit Component Function | • Foam wound dressing is used to pack the wound. • Occlusive drape creates and maintains a seal over the peri- wound area and foam dressing. • Dome Assembly provides a pathway for wound exudate to flow from the wound/dressing to the pump exudate canister. | • Foam wound dressing is used to pack the wound. • Occlusive drape creates and maintains a seal over the peri- wound area and foam dressing. • Dome Assembly provides a pathway for wound exudate to flow from the wound/dressing to the pump exudate canister. | | Foam Dressing Material | Black Polyether Polyurethane Foam | Polyether Polyurethane Foam | | Dome Material | Thermoplastic Elastomer | Thermoplastic Elastomer | | Occlusive Drape Material | Semipermeable, polyurethane (polymeric) transparent film | Semipermeable, polyurethane (polymeric) transparent film | | Skirt Material | Polyurethane Medical Tape with Adhesive Backing | Polyurethane Medical Tape with Adhesive Backing | | Tubing Material | PVC | PVC | | Dressing Materials Biocompatible | Yes | Yes | | NPWT pump provided with | No | No | | Feature | Theia NPWT Dressing Kit (Subject Device) | Theia NPWT Dressing Kit (Predicate Device) | | dressing kit | | | | Dressing Kit Provided Sterile | Yes | Yes | | Sterilization Method | Gamma Radiation | Gamma Radiation | | Packaging | Tyvek pouch | Tyvek pouch | Table 1: Subject vs. Predicate Theia NPWT Foam Wound Dressing Kit Comparison {6}------------------------------------------------ {7}------------------------------------------------ #### PERFORMANCE DATA VII. The following performance data were provided in support of the substantial equivalence determination: ## Bench Performance Testing Bench testing has been performed to demonstrate that the 1.5cm or 3.0cm Theia NPWT Foam Wound Dressing Kits used with the CCT Mini or CCT1 pumps are capable of effectively removing wound fluids and that pressure is delivered uniformly across the dressing and in accordance with the pump pressure setting. The subject NPWT systems performed as intended in the simulated wound and pressure maintenance test setups, and all results were acceptable. ## Animal Performance Study No animal performance studies were conducted for the Theia NPWT Foam Wound Dressing Kit. ## Clinical Study No clinical studies were conducted for the Theia NPWT Foam Wound Dressing Kit. #### CONCLUSIONS VIII. The subject and predicate Theia NPWT Foam Wound Dressing Kits have the same Intended Use. The technological characteristics comparison and results of the verification testing provide evidence that the subject Theia NPWT Foam Wound Dressing Kits are substantially equivalent to the predicate Theia NPWT Foam Wound Dressing Kits (K161570), and the performance of these dressing kits when used in conjunction with CCT pumps (K082311) is substantially equivalent to the performance of the predicate dressing kits used in conjunction with SIMEX pumps (K113291).