(45 days)
The EPIFLO System is intended to provide topical oxygen to treat 1) skin ulcerations due to diabetes, venous stasis, post-surgical infections and gangrenous lesions, 2) pressure ulcers, 3) amputations/infected stumps, 4) skin grafts, 5) burns, and 6) frostbite.
EPIFLO is an oxygen delivery system that incorporates a disposable oxygen concentrator. It consists of (1) the oxygen concentrator, and (2) the sterile cannula. The oxygen concentrator is a single patient, single use, disposable, battery-operated device that is capable of delivering 98 to 100 percent oxygen continuously for seven or fifteen days (depending on the model) at a rate of ~3.0 ml/hour. The cannula conveys the oxygen from the oxygen concentrator to the area beneath the bandage overlying the wound.
The provided text describes the EPIFLO System, a transdermal continuous oxygen therapy device. However, it does not include a detailed study or specific acceptance criteria for device performance in the way typically expected for a medical device with measurable outcomes like accuracy or sensitivity/specificity.
Instead, the performance testing section (Section 7) states: "Testing was conducted to validate that the EPIFLO performed according to its specifications. These tests included performance testing for oxygen delivery per the specification for labeled durations, EMC compatibility and sterilization validation."
This indicates that the acceptance criteria were related to the device's functional specifications (e.g., oxygen delivery rate, duration, safety features) rather than clinical efficacy or diagnostic accuracy, as this is an oxygen delivery system, not a diagnostic or screening tool.
Given the information, I can only describe the reported device performance as it relates to its functional specifications, as specific metrics for clinical efficacy are not provided in this document.
Here's the breakdown of what can be extracted and what is not available in the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Oxygen Delivery Rate per specification | ~3.0 ml/hour |
| Oxygen Purity | 98 to 100 percent oxygen (near 100 percent pure oxygen) |
| Labeled Durations (continuous oxygen delivery) | Seven or fifteen days (depending on the model) |
| EMC compatibility | "EMC compatibility" testing was conducted and passed. |
| Sterilization validation | "Sterilization validation" testing was conducted and passed. |
| Ambient Pressure Operation | Operates at ambient pressure (typically 1 atmosphere) |
| Disposable, Single Patient, Single Use | Device adheres to this specification. |
Note: The document only states that testing was conducted to validate performance "according to its specifications." Specific numerical acceptance thresholds (e.g., "oxygen delivery must be 3.0 +/- 0.1 ml/hour") are not explicitly stated, but the reported performance values are presented as meeting these underlying, implied specifications.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The text mentions "Performance Testing" but does not detail the methodology, sample sizes, or nature of the test set (e.g., in-vitro, in-vivo, clinical subjects).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided. As this is a device for oxygen delivery, not a diagnostic system requiring expert interpretation of images or data, the concept of "ground truth" established by clinical experts in the traditional sense (e.g., radiologists for imaging) is not directly applicable to the functional performance testing described. Ground truth for functional tests would typically be established by calibrated measurement instruments.
4. Adjudication Method for the Test Set
This information is not provided.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not done or at least not described in this document. Such studies are typically for diagnostic or screening devices where human readers interpret data, often with and without AI assistance, to measure changes in diagnostic performance. The EPIFLO System is an oxygen delivery device, not a diagnostic tool requiring human interpretation.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The described performance testing focuses on the device's functional operation (oxygen delivery rate, purity, duration, EMC, sterilization). This is inherently a "standalone" evaluation of the device's physical and operational characteristics without human intervention influencing its core function. However, it's not "algorithm-only" performance as the device's primary function is mechanical/chemical oxygen generation and delivery, not data processing.
7. Type of Ground Truth Used
For the functional performance testing described (oxygen delivery, EMC, sterilization), the ground truth would likely be established by:
- Instrumental Measurement: Calibrated sensors and measurement tools for oxygen flow rate, purity, and duration.
- Standardized Test Methods: Protocols for EMC (Electromagnetic Compatibility) and sterilization validation, which typically have defined pass/fail criteria.
The document does not explicitly state the type of ground truth used, but these are the standard approaches for such device validations.
8. Sample Size for the Training Set
This information is not provided. As the EPIFLO System is a physical medical device (oxygen concentrator and cannula) and not an AI/ML algorithm requiring a training set, this question is not applicable in the context of this device.
9. How the Ground Truth for the Training Set Was Established
This information is not provided and is not applicable, as the device is not an AI/ML algorithm that requires a training set and corresponding ground truth.
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K120764 pugo 1/2
8.0 510k Statement or Summary
510(k) SUMMARY FOR EPIFLO
APR 2 7 2012
1. SPONSOR
Neogenix, LLC DBA Ogenix 3401 Enterprise Pkwy, Suite 340 Beachwood, OH 44122
Contact Person: Srinivasan (Sarang) Sarangapani, President Telephone: 781-702-6732
Date Prepared: April 26, 2012
2. Device Name
| Proprietary Name: | EPIFLO System |
|---|---|
| Common/Usual Name: | Transdermal continuous Oxygen Therapy System |
| Classification Name: | Topical oxygen chamber for extremities878.5650 – Class II (Special Controls) |
21 CFR
3. PREDICATE DEVICES
Oxybox System - K023456
Device Description 4.
EPIFLO is an oxygen delivery system that incorporates a disposable oxygen concentrator. It consists of (1) the oxygen concentrator, and (2) the sterile cannula. The oxygen concentrator is a single patient, single use, disposable, battery-operated device that is capable of delivering 98 to 100 percent oxygen continuously for seven or fifteen days (depending on the model) at a rate of ~3.0 ml/hour. The cannula conveys the oxygen from the oxygen concentrator to the area beneath the bandage overlying the wound.
5. INDICATIONS FOR USE
The EPIFLO System is intended to provide topical oxygen to treat 1) skin ulcerations due to diabetes, venous stasis, post-surgical infections and gangrenous lesions, 2) pressure ulcers, 3) amputations/infected stumps, 4) skin grafts, 5) burns, and 6) frostbite.
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K120764 page 2/2
Technological Characteristics and Substantial Equivalence હ.
The predicate device OxyBox as well as the current device EPIFLO delivers oxygen to the wound at ambient pressure (typically 1 atmosphere). The predicate devices as well as the EPIFLO deliver near 100 percent pure oxygen to the wound site at a rate of ~ 3 mL/hr). Both the Predicate OxyBox and the EPIFLO are single patient, single use disposable devices.
7. Performance Testing
Testing was conducted to validate that the EPIFLO performed according to its specifications. These tests included performance testing for oxygen delivery per the specification for labeled durations, EMC compatibility and sterilization validation.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name encircling a stylized eagle. The eagle is depicted with its wings spread, symbolizing protection and service. The seal is a symbol of the department's mission to enhance the health and well-being of all Americans.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Neogenix, LLC % Srinivasan Sarangapani, Ph.D. President 3401 Enterprise Parkway, Suite 340 Beachwood, Ohio 44122
APR 2 7 2012
Re: K120764
Trade/Device Name: EPIFLO System Regulation Number: 21 CFR 878.5650 Regulation Name: Topical oxygen chamber for extremities Regulatory Class: II Product Code: KPJ Dated: April 4, 2012 Received: April 6, 2012
Dear Dr. Sarangapani:
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
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Page 2 - Srinivasan Sarangapani, Ph.D.
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
ely yours,
J. Malkerson
Mark N. Melkerson Director 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
510(k) Number (if known): K120764 Device Name: EPIFLO System Indications For Use:
The EPIFLO System is intended to provide topical oxygen to treat 1) skin ulcerations due to diabetes, venous stasis, post-surgical infections and gangrenous lesions, 2) Pressure ulcers, 3) amputations/infected stumps, 4) Skin grafts, 5) burns, and 6) frostbite
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
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)
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Daniel Kreider Mkim
(Division Sign-Off) Division of Surgical, Orthopedio and Restorative Devices
510(k) Number K120764
§ 878.5650 Topical oxygen chamber for extremities.
(a)
Identification. A topical oxygen chamber for extremities is a device that is intended to surround a patient's limb and apply humidified oxygen topically at a pressure slightly greater than atmospheric pressure to aid healing of chronic skin ulcers such as bedsores.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance: Topical Oxygen Chamber for Extremities.” See § 878.1(e) for the availability of this guidance document.