(267 days)
Exceleron Medical bacterial filters are single use replacement filters intended for use in oxygen concentrator machines to help remove contaminants, including air borne bacteria and other particulate debris from an air stream. When used with oxygen concentrator machines, the replacement filters may be used in the home, nursing home, hospital, patient care facility.
A breathing circuit bacterial filter is a device that is intended to remove microbiological and particulate matter from the gases in the breathing circuit of a respiratory device. The filter is a replaceable accessory device used in oxygen concentrators, either as intake filters or final patient filters. The function of the oxygen concentrator machine is to draw room air into the machine's compressor and concentrate the oxygen content before delivering filtered, oxygen rich air to the patient. From the compressor, the filtered air proceeds to the sieve beds. The sieve beds in the oxygen concentrator machine condition the air, by removing nitrogen from the air stream, which results in a higher concentration of oxygen. The air then passes through the final patient filter before being supplied to the patient. The Exceleron Medical bacterial intake filter and the final patient filter are intended to remove air borne bacteria and other particulate debris from the air stream.
The provided document describes the acceptance criteria and the study results for the Exceleron Bacterial Filter. Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Bacterial Filtration Efficiency (BFE) at an increased challenge | 99.9% to 99.999% |
| Air Flow Resistance | Comparable to or less than predicate devices |
| Biocompatibility (Cytotoxicity, Sensitization, Intracutaneous Reactivity) | Met biocompatibility requirements |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample size for the "test set" (i.e., the number of filters tested). It mentions "Design verification testing was performed for the Exceleron Bacterial Filter," implying a set of filters were manufactured and tested.
The data provenance is not specified regarding country of origin or whether it was retrospective or prospective. It is implied these were laboratory performance bench tests conducted by the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This product is a bacterial filter, not a diagnostic device requiring expert interpretation of results. Therefore, there were no experts used to establish ground truth in the context of human interpretation of medical images or data. Ground truth for performance was established through standardized physical and biological testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving human interpretation of data. This is a performance bench test for a physical device, so no such adjudication method was used. The performance was measured directly through scientific methods.
5. 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 is a physical filter device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical filter, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the performance tests was established through:
- Quantitative measurement for Bacterial Filtration Efficiency (BFE) based on particle counts and filtration capabilities.
- Quantitative measurement for Air Flow Resistance.
- Standardized biological tests (cytotoxicity, sensitization, intracutaneous reactivity) according to ISO 10993-1 for biocompatibility.
8. The sample size for the training set
Not applicable. This is a physical device, not a machine learning model, so there is no training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set for a physical device.
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FEB 2 6 2014
510(k) Summary Exceleron Bacterial Filter
Date Prepared: May 30, 2013 (Revised Feb 26, 2014)
- Submitter: Exceleron Medical 5000 Township Parkway St Paul, MN 55110 Telephone: 651- 855-1466 Fax: 651-855-1465
- Contact: Mr. Bernard Horwath Regulatory Affairs Consultant 4486 Timberline Ct Vadnais Heights, MN 55127 Telephone: 651-231-1761 Fax: 651-855-1465
Proprietary Name: Exceleron Bacterial Filter (See table below for specific models)
| PROPRIETARY NAME | COMMON NAME |
|---|---|
| DBX32 | Bacterial Intake Filter |
| DBX24 | Bacterial Intake Filter |
| DBX25xx | Bacterial Intake Filter |
| DBXEFLO | Bacterial Intake Filter |
| BDF47xx | Bacterial Patient Filter |
Common/Usual Name: Breathing Circuit Bacterial Filter
Classification Name: Breathing Circuit Bacterial Filter, Class II, Product Code CAH 21 CFR 868.5260
Establishment Registration Number: 3007709321
Description:
A breathing circuit bacterial filter is a device that is intended to remove microbiological and particulate matter from the gases in the breathing circuit of a respiratory device. The filter is a replaceable accessory device used in oxygen concentrators, either as intake filters or final patient filters. The function of the oxygen concentrator machine is to draw room air into the machine's compressor and concentrate the oxygen content before delivering filtered, oxygen rich air to the patient. From the compressor, the filtered air proceeds to the sieve beds. The sieve beds in the oxygen concentrator machine condition the air, by removing nitrogen from the air stream, which results in a higher concentration of oxygen. The air then passes through the final patient filter before being supplied to the patient. The Exceleron Medical bacterial intake filter and the final patient filter are intended to remove air borne bacteria and other particulate debris from the air stream.
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Indications for Use:
Exceleron Medical bacterial filters are single use replacement filters intended for use in oxygen concentrator machines to help remove contaminants, including air borne bacteria and other particulate debris from an air stream. When used with oxygen concentrator machines, the replacement filters may be used in the home, nursing home, hospital, patient care facility.
Substantial Equivalence:
The Exceleron Bacterial Filter is substantially equivalent to the following predicate devices:
Technological Characteristics:
Technically from a design and mechanism of action standpoint, the Exceleron Bacterial Filters are substantially equivalent to the predicate devices. All utilize a dimensionally equivalent molded housing containing glass microfiber filtration material with appropriate connector fittings for attachment to the applicable breathing circuit. Exceleron Bacterial Filters and the predicate devices have the same principle of operation and mechanism of action, namely air flows through the glass microfiber bed to remove contaminants, including air borne bacteria and other particulate debris.
All the filters are designed as replacement filters for use on oxygen concentrator machines, such as DeVilbiss, Respironics, and Invacare.
Biocompatibility:
The bacterial filter is a tissue contact device that filters the air delivered to the patient. As a result, a systematic risk analysis and biological evaluation were conducted in accordance with ISO 10993-1. Biological Evaluation of Medical Devices. The device was categorized as a tissue contact device with limited duration contact due to the dry gas pathway. As such the following tests were conducted per ISO 10993-1: cytotoxicity, sensitization and intracutaneous reactivity. This testing showed that the Exceleron Bacterial Filter devices meet the biocompatibility requirements for their intended use.
Performance Bench Testing:
Design verification testing was performed for the Exceleron Bacterial Filter to demonstrate physical and functional requirements were met. Testing included bacterial filtration efficiency (BFE) at an increased challenge and air flow resistance. All tests were successful. The Exceleron filters demonstrated BFE capabilities from 99.9% to 99.999%, which are in the same range as the predicate BFE numbers, and air flow resistance was comparable or less than the comparable products, demonstrating substantial equivalence.
Conclusion:
Through the data and information presented, Exceleron Medical, considers the Bacterial Filters substantially equivalent to the predicate devices already on the market (cleared by the 510(k) process) in terms of indications for use, scientific technology, design, materials, principle of operation and functional performance and present no new concerns about safety and effectiveness.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center = WO66-G609 Silver Spring, MD 20993-0002
February 26, 2014
Exceleron Medical C/O Mr. Bernard Horwath HRG 4486 Timberline Ct Vadnais Heights MN 55127
Re: K131626
Trade/Device Name: Exceleron Bacterial Filter Regulation Number: 21 CFR 868.5260 Regulation Name: Breathing Circuit Bacterial Filter Regulatory Class: II Product Code: CAH Dated: January 24, 2014 Received: January 28, 2014
Dear Mr. Horwath:
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
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Page 2 - Mr. Horwath
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 Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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,
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for
Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K131626
Device Name Exceleron Bacterial Filter
Indications for Use (Describe)
Exceleron Medical bacterial filters are single use replacement filters intended for use in oxygen concentrator machines to help remove contaminants, including air borne bacteria and other particulate debris from an air stream. When used with oxygen concentrator machines, the replacement filters may be used in the home, norsing home, hospital, patient care facility.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
J Over-The-Counter Use (21 CFR 801 Subpart C)
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Anva C. Harry -S 2014.02.26 16:25:56 -05'00'
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§ 868.5260 Breathing circuit bacterial filter.
(a)
Identification. A breathing circuit bacterial filter is a device that is intended to remove microbiological and particulate matter from the gases in the breathing circuit.(b)
Classification. Class II (performance standards).