(30 days)
Not Found
No
The document describes a standard occlusive wound dressing system and does not mention any AI or ML components or functionalities.
Yes
The device is intended to facilitate the normal wound healing process by providing a moist environment and allowing the introduction of topical wound treatments, which are therapeutic actions.
No
The device is described as an occlusive wound dressing intended to facilitate wound healing and permit the introduction of topical treatments, not to diagnose medical conditions.
No
The device description explicitly states it consists of an occlusive wound dressing, a tubeset connection, and a small fluid-delivery component, all of which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide a moist wound healing environment and permit the introduction of topical wound treatments. This is a direct therapeutic application to the body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device is described as an occlusive wound dressing with components for fluid delivery. This aligns with a medical device used for wound care, not an in vitro diagnostic device.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The Aplion Topical Care System does not fit this description.
N/A
Intended Use / Indications for Use
The Aplion Topical Care System is an occlusive wound dressing which is intended to provide a moist wound healing environment to facilitate the normal wound healing process. It also permits the introduction of topical wound treatment solutions and suspensions.
Product codes
NAD
Device Description
An occlusive wound dressing is a nonresorbable, sterile or non-sterile device intended to cover a wound, to provide or support a moist wound environment, and to allow the exchange of gasses such as oxygen and water vapor through the device. It consists of a piece of synthetic polymeric material, such as polyurethane, with or without an adhesive backing (21 CFR 878.4020).
The Aplion Topical Care System ("Aplion System") consists of an occlusive wound dressing, a tubeset connection, and a small fluid-delivery component.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4020 Occlusive wound dressing.
(a)
Identification. An occlusive wound dressing is a nonresorbable, sterile or non-sterile device intended to cover a wound, to provide or support a moist wound environment, and to allow the exchange of gases such as oxygen and water vapor through the device. It consists of a piece of synthetic polymeric material, such as polyurethane, with or without an adhesive backing. This classification does not include an occlusive wound dressing that contains added drugs such as antimicrobial agents, added biologics such as growth factors, or is composed of materials derived from animal sources.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter subject to the limitations in § 878.9.
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K091133
page 1 of 2
MAY 20 2009
510(k) SUMMARY Occlusive Wound Dressing Date of Summary: 04/17/09
A. General Provisions Submitter's Name: Aplion Medical, LLC. Submitter's Address: 2425 South 900 West Salt Lake City, UT 84119 Contact Person: Curtis Jensen Quality Manager, Ceramatec, Inc. Classification Name: Occlusive Wound Dressing 21 CFR 878.4020 Aplion Topical Care System Proprietary Name: Common Name: Occlusive Wound Dressing
B. Name of Predicate Device(s)
- Occlusive Wound Dressing (Product Code NAD): K020781 . Kinetic Concepts, Inc., Wound Cell Transparent Dressing
- . Occlusive Wound Dressing (Product Code - NAD): K060046 Enzysurge, Ltd., Dermastream
C. Device Description
An occlusive wound dressing is a nonresorbable, sterile or non-sterile device intended to cover a wound, to provide or support a moist wound environment, and to allow the exchange of gasses such as oxygen and water vapor through the device. It consists of a piece of synthetic polymeric material, such as polyurethane, with or without an adhesive backing (21 CFR 878.4020).
The Aplion Topical Care System ("Aplion System") consists of an occlusive wound dressing, a tubeset connection, and a small fluid-delivery component.
D. Indications for Use
The Aplion Topical Care System is an occlusive wound dressing which is intended to provide a moist wound healing environment to facilitate the normal wound healing process. It also permits the introduction of topical wound treatment solutions and suspensions.
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K09//33
Page 2 of 2
E. Safety and Biocompatibility
Safety and Biocompatibility Summary
As a Class I, 510(k) exempt device, FDA review of the Aplion System is not necessary; nonetheless the materials used in the Aplion System were chosen for their biocompatibility, function, and suitability for the intended use of the device. Biocompatibility testing of the entire system was completed according to ISO 10993-1 and 510(k) Memorandum G95-1. Details on the individual materials and the biocompatibility test results are included in this submission.
The Aplion System has been tested to and complies with all applicable Safety and Biocompatibility Standards.
F. Conclusion
The Aplion System, subject of this 510(k), is substantially equivalent to the Wound Cell Transparent Dressing (Kinetic Concepts; K020781) and the Dermastream (Enzysurge; K060046) products previously cleared by FDA.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA", which is arranged in a circular fashion around the left side of the logo. The logo is simple and monochromatic.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 20 2009
Aplion Medical, LLC % Ceramatec, Inc. Mr. Curtis Jensen Quality Manager 2425 South 900 West Salt Lake City, Utah 84119
Re: K091133
Trade/Device Name: Aplion Topical Care System Regulation Number: 21 CFR 878.4020 Regulation Name: Occlusive wound dressing Regulatory Class: I Product Code: NAD Dated: April 17, 2009 Received: April 20, 2009
Dear Mr. Jensen:
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 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 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at
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Page 2 - Mr. Curtis Jensen
(240) 276-0115. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at (240) 276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
page 1 of 1
510(k) Number (if known): K091133
Device Name: Aplion Topical Care System
Indications for Use: The Aplion Topical Care System is an occlusive wound dressing which is intended to provide a moist wound healing environment to facilitate the normal wound healing process. It also permits the introduction of topical wound treatment solutions and suspensions.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
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Over-The-Counter Use (21 CFR 801 Subpart C)
(Please do not write below this line – Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David Kramer
for MXM
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
| 510(k) Number | K091133 |
|---|---|
| --------------- | --------- |
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