OXYGEN CONCENTRATOR FILTERS, MODELS DBF32, DBF24, DBF27, DBF25, DFC06 AND DDF47

{0}------------------------------------------------ #### 2. 510(k) Summary K061426 ## Applicant Porous Media 1350 Hammond Road St. Paul, MN 55110 Telephone: 651-653-2000 Fax: 651-653-2230 Contact: David Rasch ## Date April 19, 2006 ## Device Name Oxygen Concentrator Filters Please reference the following table for the Proprietary and Common names of the devices included in this submission. | Proprietary Name | Common Name | |------------------|-------------------------| | DBF32 | Bacterial Intake filter | | DBF24 | Bacterial Intake filter | | DBF27 | Bacterial Intake filter | | DBF25 | Bacterial Intake filter | | DFC06 | Compressor filter, HEPA | | DDF47 | Final bacteria filter | ## Classification Breathing Circuit Bacteria Filter, 21 CFR 868.5260 ## Substantial Equivalence Porous Media's devices identified in this submission are substantially equivalent to the filters installed and used in the following oxygen concentrators: - . Respironics Millennium (subject to pre-market notification K972614) and Millennium M10 Oxygen Concentrators (subject to pre-market notification K043006). - DeVilbiss 303 Series Oxygen Concentrators (subject to pre-market notification K953815), . DeVilbiss 505 Series Oxygen Concentrators (K991722), and DeVilbiss 515 Series Oxygen Concentrators (K991722). - . Invacare Platinum Series Oxygen Concentrators (K020386), The original component filters are approved for sale subject to the pre-market notifications outlined above. In each case the original filter is part of the 510(k) submitted for the oxygen. concentrator, such that, the original devices (oxygen concentrators) are indicated for use as oxygen generators and not filter devices. Because the original filters are not classified as separate devices, the Breathing Filter is included in this submission for the sole purpose of establishing the indications for use as a filter device. JUN - 5 2006 {1}------------------------------------------------ Porous Media's devices identified in this submission are substantially equivalent to AG Industries Breathing Filter Bacterial/Viral (K052087), such that both are used as replacement filters in medical devices. ## Device Description Room air is drawn into the compressor through the bacterial intake filter. From the compressor, the air passes through the compressor filter, if one is installed on the machine, and proceeds to the sieve beds. The sieve beds 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 filter before being supplied to the patient. ### Intended Use The devices identified in this submission are intended to help remove air-borne contaminants, including air borne bacteria and other particulate debris, from the air stream of an oxygen concentrator. ## Technical Comparison ### Technical Comparison, DBF24 Bacterial Intake Filter | Item | DeVilbiss | Porous Media | |--------------------------|----------------------------------------------|--------------| | Part Number | 493-0012-002 | DBF24 | | Intended Use | DeVilbiss 303 Series Oxygen<br>Concentrators | Identical | | Filtration<br>Efficiency | 99.999% BFE | Identical | | Filter Material | Glass microfiber | Identical | | Housing Material | Polystyrene or approved equivalent | Identical | | Air Flow<br>Resistance | 4.0 inH2O @ 100 scfh | Identical | | Maximum Flow<br>Rate | 100 LPM | Identical | | Connection | Male 22mm ISO | Identical | #### Technical Comparison, DBF27 Bacterial Intake Filter | Item | DeVilbiss | Porous Media | |-----------------------|-----------------------------------------------------|--------------| | Part Number | 493-0012-006 | DBF27 | | Intended Use | DeVilbiss 505 or 515 Series Oxygen<br>Concentrators | Identical | | Filtration Efficiency | 99.999% BFE | Identical | | Filter Material | Glass microfiber | Identical | | Housing Material | Polystyrene or approved equivalent | Identical | | Air Flow Resistance | 4.0 inH2O @ 100 scfh | Identical | | Maximum Flow<br>Rate | 100 LPM | Identical | | Connection | Male 22mm ISO | Identical | {2}------------------------------------------------ # Technical Comparison, DBF25 Bacterial Intake Filter | Item | Invacare | Porous Media | |-----------------------------------------|---------------------------------------------------------------------------------|--------------| | Part Number | 1131249 | DBF25 | | Intended Use | Invacare Oxygen Concentrators | Identical | | Filtration<br>Efficiency | 99.999% BFE | Identical | | Filter Material | Glass microfiber | Identical | | Housing Material | Polystyrene or approved equivalent | Identical | | Air Flow<br>Resistance<br>(@ 4.50 scfm) | 35.0 inH2O (Platinum 5)<br>18.0 inH2O (Platinum 10)<br>7.0 inH2O (non-Platinum) | Identical | | Maximum Flow<br>Rate | 100 LPM | Identical | | Connection | 3/8" FNPT | Identical | # Technical Comparison, DBF32 Bacterial Intake Filter | Item | Respironics | Porous Media | |--------------------------|-------------------------------------------------------|--------------| | Part Number | 100-6629-20 | DBF32 | | Intended Use | Respironics Millennium Series Oxygen<br>Concentrators | Identical | | Filtration<br>Efficiency | 99.999% BFE | Identical | | Filter Material | Glass microfiber | Identical | | Housing Material | Polystyrene or approved equivalent | Identical | | Air Flow<br>Resistance | 3.0 cmH2O @ 100 slpm | Identical | | Maximum Flow<br>Rate | 100 LPM | Identical | | Connections | 22mm ISO Male/Female | Identical | ## Technical Comparison, DFC06 Compressor Filters (DeVilbiss) | Item | DeVilbiss | Porous Media | |--------------------------|-----------------------------------------------------------|--------------| | Part Number | 493-0019-003 | DFC0644M03P | | Intended Use | DeVilbiss 303, 505, or 515 Series<br>Oxygen Concentrators | Identical | | Filtration<br>Efficiency | 99.99% @ 0.3 µm | Identical | | Filter Material | Glass microfiber | Identical | | Housing Material | Polyester | Identical | | Filtration Area | 57 in² | Identical | | Connections | ¼"-18 FNPT | Identical | {3}------------------------------------------------ ## Technical Comparison, DFC06 Compressor Filters (Respironics) | Item | Respironics | Porous Media | |--------------------------|-------------------------------------------------------|--------------| | Part Number | 100-0610-00 | DFC0676M03N | | Intended Use | Respironics Millennium Series Oxygen<br>Concentrators | Identical | | Filtration<br>Efficiency | 99.99% @ 0.3 $\mu$ m | Identical | | Filter Material | Glass microfiber | Identical | | Housing Material | Nylon 6/6 | Identical | | Filtration Area | 57 in² | Identical | | Connections | 3/8" Hose Barbs | Identical | ## Technical Comparison, DDF47 Final Bacteria Filter (DeVilbiss) | Item | DeVilbiss | Porous Media | |--------------------------|-----------------------------------------------------------|--------------| | Part Number | 493-0014-003 | DDF4711M02Y | | Intended Use | DeVilbiss 303, 505, or 515 Series Oxygen<br>Concentrators | Identical | | Filtration<br>Efficiency | 99.97% @ 0.3 µm | Identical | | Filter Material | Glass microfiber | Identical | | Housing Material | Polypropylene or approved equivalent | Identical | | Connection | 1/8" Hose Barbs | Identical | ## Technical Comparison, DDF47 Final Bacteria Filter (Invacare) | Item | Invacare | Porous Media | |--------------------------|--------------------------------------|--------------| | Part Number | P0750X030 | DDF4700M03Y | | Intended Use | Invacare Oxygen Concentrators | Identical | | Filtration<br>Efficiency | 99.97% @ 0.3 $\mu$ m | Identical | | Filter Material | Glass microfiber | Identical | | Housing Material | Polypropylene or approved equivalent | Identical | | Connection | 1/4" Hose Barbs | Identical | ## Technical Comparison, DDF47 Final Bacteria Filter (Respironics) | Item | Respironics | Porous Media | |--------------------------|-------------------------------------------------------|--------------| | Part Number | 369-0343-00 | DDF4711M03Y | | Intended Use | Respironics Millennium Series Oxygen<br>Concentrators | Identical | | Filtration<br>Efficiency | 99.97% @ 0.3 μm | Identical | | Filter Material | Glass microfiber | Identical | | Housing Material | Polypropylene or approved equivalent | Identical | | Connections | 1/8" Hose Barbs | Identical | {4}------------------------------------------------ Image /page/4/Picture/11 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of a bird. #### Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUN - 5 2006 Porous Media Corporation C/O Mr. Daniel W. Lehtonen Responsible Third Party Official Intertek Testing Services NA, Incorporated 2307 East Aurora Road, Unit B7 Twinsburg, Ohio 44087 Re: K061426 Trade/Device Name: Oxygen Concentrator Filters Regulation Number: 21 CFR 868.5260 Regulation Name: Breathing Circuit Bacterial Filter Regulatory Class: II Product Code: CAH Dated: May 22, 2006 Received: May 23, 2006 Dear Mr. Lehtonen: 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. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. {5}------------------------------------------------ ## Page 2 - Mr. Lehtonen 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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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, Senjita Y. Michael Davis Chiú Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ #### 1. Statement of Indications for Use ## Indications for Use 510(k) Number (if known): Device Name: Oxygen Concentrator Filters Indications for Use: Porous Media oxygen concentrator filters are 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, patient care facility, etc. Prescription Use Over-The-Counter Use XX AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) 1 Marthal Thold for Ann Graham Page of of Anesthesiology, General Hospital con Control, Dental De Number: K06 142 6