(266 days)
The EPIFLO-28 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-28 is an oxygen delivery device 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 twenty eight days 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 is a 510(k) Summary for the EPIFLO-28 device. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria with quantified performance metrics against a defined ground truth.
Therefore, many of the requested elements for describing specific acceptance criteria and a study proving their attainment are not explicitly present in the provided text. The document describes performance testing to validate specifications and clinical studies for biocompatibility and usability but does not detail a study designed to prove acceptance criteria in the manner usually seen for AI/ML device clearances (e.g., sensitivity, specificity, AUC against a gold standard).
However, I can extract the information that is available and indicate where the requested information is not provided.
Acceptance Criteria and Device Performance (as inferred or generally stated):
| Acceptance Criteria (Inferred from 510(k) Summary) | Reported Device Performance (from 510(k) Summary) |
|---|---|
| Oxygen Delivery Duration: Continuous oxygen delivery for a specified period. | EPIFLO-28 delivers continuous oxygen for 28 days. (Predicate delivered for 15 days). |
| Oxygen Concentration: Delivery of near 100% pure oxygen. | EPIFLO-28 delivers 98 to 100 percent oxygen. |
| Oxygen Flow Rate: Consistent oxygen delivery rate. | EPIFLO-28 delivers oxygen at a rate of ~3.0 ml/hour. |
| Biocompatibility: No adverse biological reactions with patient contact. | Biocompatibility testing for enclosure (cytotoxicity, sensitization, irritation) and cannula (cytotoxicity, sensitization, irritation, material mediated pyrogenicity) were performed. A toxicological risk assessment found no chemical compound above the conservative threshold of toxicological concern. Clinical study evaluated local tissue response to the delivery cannula, showing a reduction in pro-inflammatory cytokines, proteases, and macrophages at Week 4. |
| Usability: User-friendly for lay users and healthcare professionals. | Usability study conducted with lay users (n=17) and healthcare professionals (n=18). (A separate clinical study with the predicate device also assessed usability with n=61 patients.) |
| Safety and Effectiveness: Comparable to the predicate device. | Concluded to be "as safe and as effective as the predicate device" based on performance tests and clinical validation. |
| EMC Compatibility: Meets electromagnetic compatibility requirements. | EMC compatibility testing was performed. |
| LED Operation: Indicator lights function correctly. | LED operation verification was performed, with EPIFLO-28 having two indicator LEDs (green and red) for normal operation and error state/end of life. |
Detailed Study Information:
-
Sample size used for the test set and the data provenance:
- Biocompatibility (local tissue response): Wounds from an unspecified number of subjects were evaluated. Data provenance is not specified (e.g., country of origin, retrospective/prospective).
- Usability (EPIFLO-28): 17 lay users and 18 healthcare professionals. Data provenance is not specified.
- Usability (Predicate device): 61 patients over up to 12 weeks. Data provenance is not specified.
- For performance testing related to oxygen delivery specifications, LED operation, and EMC compatibility, specific sample sizes and data provenance are not provided.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not explicitly stated. For a medical device like the EPIFLO-28 (a topical oxygen delivery system), the "ground truth" for performance is typically objective measurements (e.g., oxygen concentration, flow rate, duration). For biocompatibility, it involves laboratory tests and clinical evaluation of tissue response by qualified personnel (e.g., pathologists, clinicians), but the number and specific qualifications are not detailed. For usability, the "ground truth" is user feedback and observations, not an expert-established clinical diagnosis.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable / Not explicitly stated. This type of adjudication method is usually relevant for diagnostic devices where subjective interpretation of images/data by multiple experts is involved to establish a consensus ground truth. For this device, performance is evaluated by objective measurements and biocompatibility by laboratory findings and clinical observations.
-
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, an MRMC study was not done. This type of study is specific to diagnostic AI/ML systems where human readers interpret medical images/data. The EPIFLO-28 is a therapeutic device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. The EPIFLO-28 is a physical medical device, not an AI/ML algorithm. Its "performance" inherently involves its physical operation, not an algorithm's output.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Biocompatibility: Laboratory test results (cytotoxicity, sensitization, irritation, pyrogenicity, extractables/leachables analysis) and clinical evaluations of wound fluid, tissue punch biopsies for pro-inflammatory cytokines, proteases, and macrophages.
- Usability: User feedback, observations, and responses to questions in case report forms.
- Performance (Oxygen Delivery, etc.): Objective measurements against engineering specifications.
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The sample size for the training set:
- Training set concept is not applicable. As this is a physical medical device and not an AI/ML system, there is no "training set" in the context of machine learning.
-
How the ground truth for the training set was established:
- Not applicable. See point 7.
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December 13, 2019
Neogenix, LLC dba Ogenix Srinivasan Sarangapani President 3401 Enterprise Pkwy, Suite 340 Beachwood, Ohio 44122
Re: K190742
Trade/Device Name: EPIFLO-28 Regulation Number: 21 CFR 878.5650 Regulation Name: Topical Oxygen Chamber For Extremities Regulatory Class: Class II Product Code: KPJ Dated: November 12, 2019 Received: November 12, 2019
Dear Srinivasan 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. 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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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 (OS) 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 mediation-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,
Kimberly M. Ferlin, Ph.D. Assistant Director (acting) 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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Indications for Use
510(k) Number (if known) K190742
Device Name EPIFLO-28
Indications for Use (Describe)
The EPIFLO-28 is intended to provide topical oxygen to treat 1) skin ulcerations due to diabetes, venous stasis, post-surgical infections and gangrenous lesions, 2) amputations/infected stumps, 4) Skin grafts, 5) burns, and 6) frostbite
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CER 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) SUMMARY FOR EPIFLO-28
1. SPONSOR
Neogenix, LLC DBA Ogenix 3401 Enterprise Pkwy, Suite 340 Beachwood, OH 44122
Contact Person: Srinivasan (Sarang) Sarangapani, President 781-702-6732 Telephone:
Date Prepared: December 13, 2019
2. Device Name
| Proprietary Name: | EPIFLO-28 |
|---|---|
| Common/Usual Name: | Transdermal continuous Oxygen Therapy System |
| Classification Name: | Topical oxygen chamber for extremities |
| 21 CFR 878.5650 – Class II (Special Controls) |
Product Code: KPJ
3. PREDICATE DEVICES
EPIFLO System - K120764
4. Device Description
EPIFLO-28 is an oxygen delivery device 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 twenty eight days 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-28 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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6. Technological Characteristics and Substantial Equivalence
The predicate device EPIFLO System (7 & 15 day models) as well as the current model EPIFLO-28 delivers oxygen to the wound at ambient pressure (typically 1 atmosphere). The predicate devices as well as the EPIFLO-28 deliver near 100 percent pure oxygen to the wound site at a rate of ~ 3 mL/hr). Both the Predicate EPIFLO 7 & 15 day models and the EPIFLO-28 are single patient, single use disposable devices. The Membrane Electrode Assembly in the EPIFLO-28 is the same as used in the predicate device EPIFLO System (7&15 day models).
The predicate device provides continuous oxygen for 15 days, whereas EPIFLO-28 provides continuous oxygen for 28 days. The predicate device uses different blinking rates of the red indicator light to indicate normal operation and end of life. EPIFLO-28 has two indicator LEDs (green and red) to indicate normal operation and error state and/or end of life. There is no error state indication in the predicate device. EPIFLO-28 has the same footprint as the predicate device, but is taller by quarter of an inch. The delivery cannula was changed from the predicate.
7. Performance Testing
Testing was conducted to validate that the EPIFLO-28 performed according to its specifications. These tests included performance testing for oxygen delivery per the specification for labeled durations, LED operation verification and EMC compatibility. Test methods were the same or more as used in the predicate device.
Biocompatibility testing for EPIFLO-28 enclosure (permanent contact with intact skin) included: cytotoxicity, sensitization, and irritation; for the oxygen delivery cannula (permanent contact with breached/compromised skin) the tests included: cytotoxicity, sensitization, irritation, and material mediated pyrogenicity. In addition, the cannula was subjected to an extractable/leachable analysis. A toxicological risk assessment was performed on the chemical compounds identified in the extractables/leachables testing; no chemical compound was detected above the conservative threshold of toxicological concern. To address the local tissue response to the delivery cannula, a clinical study evaluated wounds exposed to the delivery cannula throuqh wound measurements, wound fluid, and tissue punch biopsies collected weekly for 4 weeks. The wound fluid and punch biopsies were evaluated for pro-inflammatory cytokines, proteases, and macrophaqes and the results demonstrated a reduction in pro-inflammatory cytokines, proteases, and macrophages at the Week 4 follow up.
To address usability in the home environment, patients (n = 61) in a clinical study used the predicate device for up to 12 weeks. At each visit, patients answered questions in the case report forms about any issues with using the device. A usability study was also conducted with the subject device to evaluate lay user (n = 17) and healthcare professional (n = 18) user experience with the EPIFLO-28.
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CONCLUSIONS 8.
EPIFLO-28 delivers the same oxygen therapy as the predicate device, but does so for a longer period before replacement is required. It also has the same risk/benefit profile as the predicate. Based on these facts, and based on the results of the performance tests and clinical validation performed by Ogenix, it is concluded that EPIFLO-28 is as safe and as effective as the predicate device.
§ 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.