(233 days)
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
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 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 provided text describes a 510(k) premarket notification for a medical device called "Theia NPWT Foam Wound Dressing Kit." This notification aims to demonstrate the device's substantial equivalence to a legally marketed predicate device.
Here's an analysis of the acceptance criteria and study information:
Acceptance Criteria and Reported Device Performance
The core of the submission is to demonstrate substantial equivalence to a predicate device. This means showing that the new device is as safe and effective as a legally marketed device that does not require premarket approval. The acceptance criteria are implicitly met by comparing the subject device's features and performance to those of the predicate device and demonstrating that any differences do not raise new questions of safety or effectiveness.
The document directly compares the subject device (K211277) to its predicate (K161570) in Table 1: Subject vs. Predicate Theia NPWT Foam Wound Dressing Kit Comparison (pages 5-6).
Here's a summary of the key comparison points relevant to "acceptance criteria" for substantial equivalence:
| Feature | Acceptance Criteria (Predicate Device K161570 performance/characteristics) | Reported Device Performance (Subject Device K211277 performance/characteristics) | Met? |
|---|---|---|---|
| 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. | Yes |
| Indications For Use | 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. Appropriate for use on: Pressure Ulcers, Diabetic/Neuropathic Ulcers, Venous Insufficiency Ulcers, Traumatic Wounds, Post-Operative and Dehisced Surgical Wounds, Skin Flap and Grafts. | 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. Appropriate for use on: Pressure Ulcers, Diabetic/Neuropathic Ulcers, Venous Insufficiency Ulcers, Traumatic Wounds, Post-Operative and Dehisced Surgical Wounds, Skin Flap and Grafts. | Yes |
| Type of Use | Prescription Only | Prescription Only | Yes |
| User | Healthcare professional | Healthcare professional | Yes |
| Intended Use Environment | Hospital or long-term care clinic setting | Hospital or long-term care clinic setting | Yes |
| Foam Dressing Thickness | 3.0 cm | 1.5 cm | No |
| Associated NPWT Pump | SIMEX Negative Pressure Wound Therapy Pumps (K113291) | CCT Mini or CCT1 Negative Pressure Wound Drainage Pumps (K082311) | No |
| Other Features | (e.g., Single Use, Kit Components, Foam Material, Sterilization Method, Packaging) - Identical | (e.g., Single Use, Kit Components, Foam Material, Sterilization Method, Packaging) - Identical | Yes |
Note: The primary differences are the foam thickness and the specified compatible NPWT pumps. The manufacturer's rationale for substantial equivalence (page 7) states: "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)." This implies that despite the differences in foam thickness and compatible pump, the performance in terms of suction and fluid removal is deemed equivalent.
Study Information
The document describes the performance data provided to support the substantial equivalence claim.
-
Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a number of specific "samples" or "cases" for what one might typically refer to as a clinical "test set" in an AI context. The testing described is bench testing, which likely involves multiple repetitions or configurations, but a specific "sample size" is not provided in numerical terms.
- Data Provenance: The studies are bench performance testing. This means the data was generated in a lab setting, not from human or animal subjects. Therefore, there is no country of origin for clinical data. The studies are not retrospective or prospective in the clinical sense, as they are non-clinical bench tests.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The "ground truth" here is based on engineering specifications and physical measurements in a bench test environment (e.g., demonstrating uniform pressure delivery, effective fluid removal). There is no mention of human experts establishing a "ground truth" in the way one would for diagnostic imaging.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This concept typically applies to clinical studies where experts review cases for ground truth establishment. For bench testing, results are typically determined by measurement against predefined engineering or performance criteria.
-
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. This device is a passive foam wound dressing kit used in conjunction with a negative pressure pump, and is not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance is not relevant or reported.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in the context of bench testing. The "Bench Performance Testing" evaluates the device's physical performance (e.g., fluid removal, pressure maintenance) in a controlled, simulated environment, without direct human intervention as part of the performance measurement. The "algorithm" here is the physical design and function of the device.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Engineering specifications and physical measurements. For example, the "ground truth" for "effectively removing wound fluids" would be a measurable volume of fluid removed over time, and for "pressure is delivered uniformly," it would involve pressure mapping and measurement against specified pressure ranges.
-
The sample size for the training set:
- Not applicable. This device does not involve an AI algorithm that requires a "training set" in the computational learning sense. The design and manufacturing processes are likely informed by engineering principles and possibly prior iterations, but not a data training set for an AI model.
-
How the ground truth for the training set was established:
- Not applicable. As there is no AI algorithm training set, there is no ground truth establishment for it.
In summary:
The submission focuses on demonstrating substantial equivalence through a comparison of technological characteristics and bench performance testing. No clinical studies, animal studies, or AI-related performance studies (such as MRMC or standalone AI performance) were conducted or are relevant for this type of medical device as presented in this document. The "acceptance criteria" are implicitly met by showing the subject device's equivalence to the predicate in terms of intended use, indications for use, and physical performance under simulated conditions, despite minor differences in foam thickness and compatible pumps.
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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
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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
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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)
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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, ModelsUN1083S, 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
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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.
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K211277
| Feature | Theia NPWTDressing Kit(Subject Device) | Theia NPWTDressing 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 isintended to be used in conjunctionwith a negative pressure pump for theapplication of negative pressurewound therapy to the wound. | The Theia NPWT Dressing Kit isintended to be used in conjunctionwith a negative pressure pump for theapplication of negative pressurewound therapy to the wound. |
| Indications ForUse | The Theia NPWT Foam WoundDressing Kit is intended to be used inconjunction with the CCT Mini orCCT1 Negative Pressure WoundDrainage Pumps for the application ofnegative pressure wound therapy tothe wound. When used inconjunction with the CCT Mini orCCT1 Negative Pressure WoundDrainage Pumps, the Theia NPWTFoam Wound Dressing Kit isindicated for patients who wouldbenefit from a suction device,particularly as the device maypromote wound healing by removalof excess exudates, infectiousmaterial and tissue debris. | The Theia NPWT Foam WoundDressing Kit is intended to be used inconjunction with the SIMEXNegative Pressure Wound TherapyPumps (K113291) for the applicationof negative pressure wound therapy tothe wound. When used in conjunctionwith the SIMEX Negative PressureWound Therapy Pumps, the TheiaNPWT Foam Wound Dressing Kit isindicated for patients who wouldbenefit from a suction device,particularly as the device maypromote wound healing by removal ofexcess exudates, infectious materialand tissue debris. |
| The Theia NPWT Foam WoundDressing Kit is appropriate for use onthe following wounds:• Pressure Ulcers• Diabetic/Neuropathic Ulcers• Venous Insufficiency Ulcers• Traumatic Wounds• Post-Operative and DehiscedSurgical Wounds• Skin Flap and Grafts | The Theia NPWT Foam WoundDressing Kit is inappropriate for use onthe following wounds:• Pressure Ulcers• Diabetic/Neuropathic Ulcers• Venous Insufficiency Ulcers• Traumatic Wounds• Post-Operative and DehiscedSurgical Wounds• Skin Flap and Grafts | |
| Type of Use | Prescription Only | Prescription Only |
| User | Healthcare professional | Healthcare professional |
| Intended UseEnvironment | Hospital or long-term care clinicsetting | Hospital or long-term care clinicsetting |
| Feature | Theia NPWTDressing Kit(Subject Device) | Theia NPWTDressing Kit(Predicate Device) |
| Single Use orReusable | Single Use | Single Use |
| FoamDressingDimensionsand ModelNumbers | 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 Widthx Thickness in cm. Three sizes(small, medium, and large) in onethickness:• Model UN1083S (Small): 10x8x3• Model UN20133M (Medium):20x13x3• Model UN25163L (Large):25x16x3 |
| KitComponents | One foam dressing, occlusive drape(s)(1 in the small kit and 2 in the mediumand large kits), and one domeassembly (dome, skirt, and drainagetubing with luer lock and clamp) | One foam dressing, occlusive drape(s)(1 in the small kit and 2 in the mediumand large kits), and one domeassembly (dome, skirt, and drainagetubing with luer lock and clamp) |
| Kit ComponentFunction | • Foam wound dressing is used topack the wound.• Occlusive drape creates andmaintains a seal over the peri-wound area and foam dressing.• Dome Assembly provides apathway for wound exudate to flowfrom the wound/dressing to thepump exudate canister. | • Foam wound dressing is used topack the wound.• Occlusive drape creates andmaintains a seal over the peri-wound area and foam dressing.• Dome Assembly provides apathway for wound exudate toflow from the wound/dressing tothe pump exudate canister. |
| Foam DressingMaterial | Black Polyether Polyurethane Foam | Polyether Polyurethane Foam |
| Dome Material | Thermoplastic Elastomer | Thermoplastic Elastomer |
| OcclusiveDrapeMaterial | Semipermeable, polyurethane(polymeric) transparent film | Semipermeable, polyurethane(polymeric) transparent film |
| Skirt Material | Polyurethane Medical Tape withAdhesive Backing | Polyurethane Medical Tape withAdhesive Backing |
| TubingMaterial | PVC | PVC |
| DressingMaterialsBiocompatible | Yes | Yes |
| NPWT pumpprovided with | No | No |
| Feature | Theia NPWTDressing Kit(Subject Device) | Theia NPWTDressing Kit(Predicate Device) |
| dressing kit | ||
| Dressing KitProvidedSterile | Yes | Yes |
| SterilizationMethod | Gamma Radiation | Gamma Radiation |
| Packaging | Tyvek pouch | Tyvek pouch |
Table 1: Subject vs. Predicate Theia NPWT Foam Wound Dressing Kit Comparison
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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).
§ 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.