(83 days)
No
The 510(k) summary describes a passive wound dressing kit and its intended use with a negative pressure pump. There is no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is intended to promote wound healing by removing excess exudates, infectious material, and tissue debris, which is a therapeutic function.
No
The device is a wound dressing kit used for negative pressure wound therapy, specifically designed to promote wound healing by removing exudates, infectious material, and tissue debris. It does not perform any diagnostic functions.
No
The device description explicitly lists physical components like foam dressing, occlusive drape, silicon suction dome, and tubing, indicating it is a hardware-based medical device kit.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Theia NPWT Foam Wound Dressing Kit is a medical device used for applying negative pressure to wounds to promote healing. It is a physical therapy applied externally to the body.
- Intended Use: The intended use clearly describes a therapeutic application to wounds, not a diagnostic test performed on a sample.
- Device Description: The description details physical components like foam, drape, and tubing, consistent with a wound dressing system, not a diagnostic kit.
Therefore, the Theia NPWT Foam Wound Dressing Kit falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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
Product codes (comma separated list FDA assigned to the subject device)
OMP
Device Description
The Theia NPWT Foam Wound Dressing Kit without the pump includes a foam dressing composed of a reticulated flexible polyether based polyurethane hydrophobic foam material, an occlusive drape and silicon suction dome with negative pressure tubing. Theia NPWT Foam Wound Dressing Kits are available in three sizes; 1) small, 2) medium and 3) large.
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
Prescription Use (Part 21 CFR 801 Subpart D)
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Testing:
The non - clinical testing for the Theia NPWT Foam Wound Dressing Kit is identical to the testing conducted in K133333 for the predicate device.
Clinical Performance Data:
No clinical study was conducted.
Substantial Equivalence:
The Theia NPWT Foam Wound Dressing Kit is substantially equivalent to the currently marketed UNI NPWT Foam Wound Dressing Kit, (K133333, Blue Ocean Medical Products, LLC). Both of these NPWT foam wound dressing kits are 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. Both the Theia NPWT Foam Wound Dressing and the UNI NPWT Foam Wound Dressing Kits are 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.
Both the Theia NWPT Foam Wound Dressing Kits and the predicate dressing kits contain the same components, namely a foam wound dressing, a dome assembly consisting of a dome port, skirt and tubing, and an occlusive drape. Each of the kit components in the Theia NPWT dressing kits have the same design and are manufactured of the same materials as the UNI NPWT dressing kit components. The Theia NPWT Foam Wound Dressing kits are provided in Small, Medium and Large, determined by the dimensions of the foam wound dressing contained in the kit, the same sizes provided in the predicate, UNI NPWT Foam Wound Dressing kits.
Conclusion:
The Theia Foam Wound Dressing Kits are substantially equivalent to the currently marketed UNI NPWT Foam Wound Dressing Kit (K133333) having the same indications for use, technological characteristics, design and materials, and do not raise new issues of safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 29, 2016
LC Medical Concepts, Inc. Ms. Dana M. Ledgerwood Chief Executive Officer P.O. Box 502 Penfield, New York 14526
Re: K161570
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: May 1, 2016 Received: June 7, 2016
Dear Ms. Ledgerwood:
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 devicerelated 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.
1
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/ResourcesforYou/Industry/default.htm. 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
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
2
Indications for Use
510(k) Number (if known) K161570
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 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
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) |
|---|---|
| ------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------ |
[X] Prescription Use (Part 21 CFR 801 Subbart DI ounter Use (21 CFR 801 Subbart C)
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3
510(k) Summary
| Date Prepared: | August 24, 2016 |
|---|---|
| Sponsor: | LC Medical Concepts, Inc. |
| PO Box 502 | |
| Penfield, NY 14526 | |
| 510(k) Contact: | Ms. Dana Ledgerwood |
| PO Box 502 | |
| Penfield, NY 14526 | |
| Telephone: 585-203-7652 | |
| e-mail: dm@lcmedicalconcepts.com | |
| Trade Name: | Theia NPWT Foam Wound Dressing Kit |
| Common Name: | Foam Dressing Kit |
| Classification: | Powered Suction Pump |
| 21 CFR 878.4780 | |
| Class II | |
| Product Code: | OMP - Pump, Portable, Aspiration (manual or powered) |
| Panel: | General & Plastic Surgery |
| Predicate Device: | UNI NPWT Foam Dressing Kit (K133333) |
Indications For Use:
The Theia NPWT Foam 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 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
- . Traumatic Wounds
- Post-Operative and Dehisced Surgical Wounds .
- . Skin Flap and Grafts
Device Description:
The Theia NPWT Foam Wound Dressing Kit without the pump includes a foam dressing composed of a reticulated flexible polyether based polyurethane hydrophobic foam material, an
4
occlusive drape and silicon suction dome with negative pressure tubing. Theia NPWT Foam Wound Dressing Kits are available in three sizes; 1) small, 2) medium and 3) large.
Technical Characteristics:
| Technical Characteristics:
| Feature Comparison Chart | ||
|---|---|---|
| Feature | Theia NPWT Foam Wound Dressing Kit | UNI NPWT Foam Wound Dressing Kit |
| K133333 | ||
| Indications For Use | 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 UNI NPWT Foam Dressing Kit is intended to
be used in conjunction with the Simex Negative
Pressure Wound Therapy Pumps (K113291) for the
application of pressure wound therapy to the
wound. When used in conjunction with the Simex
Negative Pressure Wound Therapy Pumps, the
UNI 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 UNI NPWT Foam 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 |
| Product Code | OMP | OMP |
| Technology | The foam wound dressing functions as the
dressing material used to pack the wound.
The dome aids in removal of fluids/exudate from
the wound to the collection canister of the NPWT
suction pump.
The tubing as part of the dome assembly aids in
the removal of fluids/exudates from the wound to
the collection canister while maintaining a sealed
application.
The occlusive drape is a semipermeable,
transparent sheet applied over the foam dressing
to cover the peri wound area and ensure a proper
seal. | The foam wound dressing functions as the
dressing material used to pack the wound.
The dome aids in removal of fluids/exudate
from the wound to the collection canister of
the NPWT suction pump.
The tubing as part of the dome assembly aids
in the removal of fluids/exudates from the
wound to the collection canister while
maintaining a sealed application.
The occlusive drape is a semipermeable,
transparent sheet applied over the foam
dressing to cover the peri wound area and
ensure a proper seal. |
| Foam Dressing
Material | Flexible Polyether Polyurethane Foam | Flexible Polyether Polyurethane Foam |
| Hydrophobic | Yes | Yes |
| Dome Assembly: | Consists of Dome, Skirt and Tubing | Consists of Dome, Skirt and Tubing |
| | Dome Material: Thermoplastic Elastomer | Dome Material: Thermoplastic Elastomer |
| | Skirt Material: Polyurethane Medical Tape with
Adhesive Backing | Skirt Material: Polyurethane Medical Tape with
Adhesive Backing |
| | Tubing Material: PVC | Tubing Material: PVC |
| Occlusive Drape | Semipermeable, polyurethane (polymeric) transparent
film | Semipermeable, polyurethane (polymeric)
transparent film |
| Foam Dressing
Dimensions: | Small 10 x 8 x 3 cm | Small 10 x 8 x 3 cm |
| | Medium 20 x 13 x 3 cm | Medium 20 x 13 x 3 cm |
| | Large 25 x 16 x 3 cm | Large 25 x 16 x 3 cm |
| Used in conjunction
with NPWT pumps | For use with Simex NPWT Pumps (K113291) | For use with Simex NPWT Pumps (K113291) |
| NPWT pump
provided with | No | No |
| Dressing Kit | | |
| Provided Sterile | Yes | Yes |
| Single Use Only | Yes | Yes |
| Biocompatible | Yes | Yes |
5
Non-clinical Testing:
The non - clinical testing for the Theia NPWT Foam Wound Dressing Kit is identical to the testing conducted in K133333 for the predicate device.
Clinical Performance Data:
No clinical study was conducted.
Substantial Equivalence:
The Theia NPWT Foam Wound Dressing Kit is substantially equivalent to the currently marketed UNI NPWT Foam Wound Dressing Kit, (K133333, Blue Ocean Medical Products, LLC). Both of these NPWT foam wound dressing kits are 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. Both the Theia NPWT Foam Wound Dressing and the UNI NPWT Foam Wound Dressing Kits are 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.
Both the Theia NWPT Foam Wound Dressing Kits and the predicate dressing kits contain the same components, namely a foam wound dressing, a dome assembly consisting of a dome port, skirt and tubing, and an occlusive drape. Each of the kit components in the Theia NPWT dressing kits have the same design and are manufactured of the same materials as the UNI NPWT dressing kit components. The Theia NPWT Foam Wound Dressing kits are provided in Small, Medium and Large, determined by the dimensions of the foam wound dressing contained in the kit, the same sizes provided in the predicate, UNI NPWT Foam Wound Dressing kits.
Conclusion:
The Theia Foam Wound Dressing Kits are substantially equivalent to the currently marketed UNI NPWT Foam Wound Dressing Kit (K133333) having the same indications for use, technological characteristics, design and materials, and do not raise new issues of safety and effectiveness.