(267 days)
Not Found
No
The device description and performance studies focus on the physical filtration properties of the device and do not mention any computational or learning-based components.
No.
The device is a bacterial filter for an oxygen concentrator, intended to remove contaminants from the air stream, not to directly treat a medical condition.
No
Explanation: The device is a bacterial filter for oxygen concentrators, designed to remove contaminants from an air stream. Its function is to filter air, not to diagnose medical conditions.
No
The device is a physical filter intended to remove contaminants from an air stream, not a software program.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to filter air for oxygen concentrators, removing bacteria and particulate debris from an air stream that is then delivered to a patient for breathing. This is a physical filtration process applied to a gas (air), not a test performed on a biological sample (like blood, urine, tissue, etc.) to diagnose a condition or provide information about a physiological state.
- Device Description: The description details a filter that removes physical contaminants from air. It doesn't mention any reagents, assays, or analysis of biological specimens.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Testing of biological samples.
- Diagnosis, monitoring, or screening of diseases or conditions.
- Measurement of analytes in biological fluids or tissues.
- Use of reagents or assays.
The device is a component of a respiratory support system, specifically an oxygen concentrator, and its function is to ensure the air delivered to the patient is clean. This falls under the category of a medical device, but not an IVD.
N/A
Intended Use / 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.
Product codes
CAH
Device 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.
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
Home, nursing home, hospital, patient care facility.
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
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.
Key Metrics
Bacterial Filtration Efficiency (BFE) capabilities from 99.9% to 99.999%.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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.
1
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.
2
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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
3
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
4
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
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Anva C. Harry -S 2014.02.26 16:25:56 -05'00'
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