(13 days)
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.
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.
This 510(k) summary describes Replacement Oxygen Concentrator Filters manufactured by Porous Media. The submission focuses on demonstrating substantial equivalence to existing predicate devices.
Here's an analysis of the acceptance criteria and study information provided, framed around a typical AI/medical device study structure, even though this submission is for physical filters and not an AI device. I will address each point from your request using the provided text.
1. A table of acceptance criteria and the reported device performance
For these oxygen concentrator filters, "acceptance criteria" are primarily based on demonstrating identical technical specifications and intended use to legally marketed predicate devices. The "reported device performance" is the direct assertion of these identical specifications. The submission is a comparison study, not a performance study against predefined thresholds for a novel device.
| Acceptance Criteria (Predicate Specification) | Porous Media Device Performance |
|---|---|
| Intended Use | Identical |
| Filtration Efficiency (e.g., 99.999% BFE, 99.99% @ 0.3 µm, 99.97% @ 0.3 µm) | Identical |
| Filter Material (e.g., Glass microfiber, Polyester) | Identical |
| Housing Material (e.g., Polystyrene, Nylon 6/6, Polypropylene) | Identical |
| Air Flow Resistance (e.g., 4.0 inH2O @ 100 scfh, 35.0 inH2O @ 4.50 scfm, 3.0 cmH2O @ 100 slpm) | Identical |
| Maximum Flow Rate (e.g., 100 LPM) | Identical |
| Connections (e.g., Male 22mm ISO, 3/8" FNPT, 1/4"-18 FNPT, 3/8" Hose Barbs, 1/8" Hose Barbs, 22mm ISO Male/Female) | Identical |
| Part Number (corresponds to specific predicate) | Specific Porous Media Part Number (e.g., DBF24) |
| Compatibility with Oxygen Concentrator Models | Identical (e.g. DeVilbiss 303 Series, Respironics Millennium Series, Invacare Platinum Series) |
The study essentially proves the device meets the "acceptance criteria" by showing a feature-by-feature match with the predicate devices, thereby establishing substantial equivalence, which is the primary regulatory pathway for 510(k) devices. There is no independent performance study detailed here, as the performance is assumed to be equivalent to the predicate.
The following points are typically relevant for AI/algorithm-based medical devices. Since this submission is for physical filters, these specific questions regarding AI algorithms and ground truth methods are not directly applicable to the provided text. I will address them by stating their non-applicability or reinterpreting them in the context of a physical device.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not Applicable: This submission is for physical filters. There is no "test set" in the context of an AI algorithm evaluation. The "data" here refers to the specifications of the predicate devices and the filters themselves. The comparison is against published and known specifications of existing, approved devices. No specific "sample size" of devices was tested for this submission beyond the comparison to the existing designs. The data provenance is essentially from the design and manufacturing specifications of both the predicate devices and the Porous Media filters. No geographical or retrospective/prospective distinction is relevant here.
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)
- Not Applicable: There is no "ground truth" in the AI sense for these physical filters. The "ground truth" for the comparison is the published, legally established specifications of the predicate oxygen concentrator filters, which are accepted by the FDA. The experts involved would likely be engineers, quality control specialists, and regulatory affairs personnel from Porous Media and potentially consultants verifying the comparison, but not "experts establishing ground truth" in a diagnostic sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable: No adjudication method is described or required for comparing physical device specifications. The comparison is a direct, objective matching of technical parameters.
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
- Not Applicable: This is a submission for physical filters, not an AI-assisted diagnostic device. Therefore, no MRMC study, human readers, or AI assistance is involved.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This is for physical filters, not an independent algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable (in the AI sense): For this submission, the "ground truth" is the established technical specifications and performance characteristics of the legally marketed predicate devices, as approved by the FDA in their original 510(k) clearances. This is a regulatory "ground truth" rather than a clinical one.
8. The sample size for the training set
- Not Applicable: There is no "training set" as this is not an AI device.
9. How the ground truth for the training set was established
- Not Applicable: As there is no AI training set, there is no ground truth establishment for it.
{0}------------------------------------------------
2. 510(k) Summary
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 OxygenConcentrators | Identical |
| FiltrationEfficiency | 99.999% BFE | Identical |
| Filter Material | Glass microfiber | Identical |
| Housing Material | Polystyrene or approved equivalent | Identical |
| Air FlowResistance | 4.0 inH2O @ 100 scfh | Identical |
| Maximum FlowRate | 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 OxygenConcentrators | 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 FlowRate | 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 |
| FiltrationEfficiency | 99.999% BFE | Identical |
| Filter Material | Glass microfiber | Identical |
| Housing Material | Polystyrene or approved equivalent | Identical |
| Air FlowResistance(@ 4.50 scfm) | 35.0 inH2O (Platinum 5)18.0 inH2O (Platinum 10)7.0 inH2O (non-Platinum) | Identical |
| Maximum FlowRate | 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 OxygenConcentrators | Identical |
| FiltrationEfficiency | 99.999% BFE | Identical |
| Filter Material | Glass microfiber | Identical |
| Housing Material | Polystyrene or approved equivalent | Identical |
| Air FlowResistance | 3.0 cmH2O @ 100 slpm | Identical |
| Maximum FlowRate | 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 SeriesOxygen Concentrators | Identical |
| FiltrationEfficiency | 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 OxygenConcentrators | Identical |
| FiltrationEfficiency | 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 OxygenConcentrators | Identical |
| FiltrationEfficiency | 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 |
| FiltrationEfficiency | 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 OxygenConcentrators | Identical |
| FiltrationEfficiency | 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
§ 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).