(272 days)
Not Found
No
The device description and performance studies focus on the physical filtration properties of the filters, with no mention of AI or ML technologies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is a replacement filter for oxygen concentrators, designed to remove contaminants from the air stream, not to directly treat or diagnose a medical condition.
No
The device description indicates that it is a replacement filter for oxygen concentrator machines, which are used to provide concentrated oxygen to patients. Its function is to remove contaminants from an air stream before it is supplied to the patient for therapeutic purposes, not to diagnose a condition. The performance studies also focus on filtration efficiency and biocompatibility, not diagnostic accuracy.
No
The device is described as physical filters intended for use in oxygen concentrator machines, with performance studies focused on filtration efficiency and biocompatibility, indicating a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the filters are for use in oxygen concentrator machines to remove contaminants from an air stream. This is a mechanical filtration process applied to air, not a diagnostic test performed on biological samples (like blood, urine, or tissue) to diagnose a disease or condition.
- Device Description: The description details the air flow through the oxygen concentrator and the role of the filters in purifying the air. This aligns with a respiratory support device component, not an IVD.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting or measuring substances in biological samples.
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition.
- Using reagents or assays.
The tests performed (Bacterial Filtration Efficiency, DOP Aerosol Test, Biocompatibility tests) are relevant to the performance and safety of a filter used in a medical device that interacts with air breathed by a patient, not to the diagnostic capabilities of an IVD.
N/A
Intended Use / Indications for Use
AG Industries 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, hospital, patient care facility, etc.
Product codes
CAH
Device Description
Room air is drawn into the compressor of a respiratory device through the bacterial intake filter. From the compress, 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 higher concentration of oxygen. The air then passes through the final filter before being supplied to the patient.
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, etc.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The following tests were performed to support substantial equivalence:
- Bacterial Filtration Efficiency
- Dioctyl Phthalate (DOP) Aerosol Test
- ISO Guinea Pig Maximization Test
- ISO Acute Systemic Injection Test
- MEM Elution Test
- Material Mediated Rabbit Pyrogen Test
The above tests confirmed that the performance of the subject filters is substantially equivalent to the predicate device(s). The Biocompatibility tests confirmed that the following filters BF500, BF200C, BF100 and BF600, which contain materials not in previously cleared devices, present no biocompatibility issues.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
KC091363
510(K) SUMMARY
FEB - 4 2010
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMVDA 1990 and 21 CFR §807.92.
510(k) number:
1. Submitter's Identification:
AG Industries 3637 Scarlet Oak Blvd. St Louis, MO 63122 USA Submitter Phone: (866) 222-8988 Submitter Fax: (970) 494-2052 Submitter Contact: Michael Amann Title: Vice-President Date Summary Prepared: 1-5-2009
2. Name of the Device:
Please reference the following table for Proprietary and Common names of the devices included in this submission.
| Proprietary Name | Common Name |
|---|---|
| AG1038831 | Compressor Filter |
| LL201 | Compressor Filter |
| LL202 | Compressor Filter |
| LL205 | Compressor Filter |
| HCF100 | Compressor Filter |
| BF910 (Platinum) | Compressor Filter |
| BF900 (Non-Platinum) | Compressor Filter |
| BF950 (Platinum and Non-Platinum) | Compressor Filter |
| BF200C | Bacterial Filter |
| BF100 | Bacterial Filter |
| BF500 | Bacterial Filter |
| BF600 | Bacterial Filter |
3. Predicate Device Information:
Comparison to Predicate Devices:
The above devices are compared to similar devices marketed by Porous Media which were cleared under K061426. The features of each are exhibited in the following tables.
1
| Feature | AG Industries | Porous Media
K061426 |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|
| Model | AG1038831 | DBF 32 |
| Intended Use | The filters are intended to help
remove air-borne contaminants,
including air borne bacteria and
other particulate debris, from the
air stream of a respiratory device. | Same |
| Filtration Efficiency | 99.9+% BFE | 99.999%BFE |
| Filter Material | Glass Microfiber | Same |
| Housing Material | Styrene Butadiene or approved
equivalent | Polystyrene or approved equivalent |
| Air Flow Resistance | 1.3 cm H20 @ 10 Lpm | 3.0 cm H2O @ 100 scfh |
| Maximum Flow Rate | 100 LPM | Same |
| Connection | 12.72 mm to fit machine | 22 mm ISO male/female |
| Feature | AG Industries | Porous Media
K061426 |
|-----------------------|------------------------------------------|------------------------------------|
| Model | LL205 | DBF 27 |
| Intended Use | Same as AG1038831 Above | Same |
| Filtration Efficiency | 99.99+% BFE | 99.999% BFE |
| Filter Material | Glass Microfiber | Same |
| Housing Material | Styrene Butadiene or approved equivalent | Polystyrene or approved equivalent |
| Air Flow Resistance | .78 cm H20 @ 10 Lpm | 4.0 cm H2O @ 100 scfh |
| Maximum Flow Rate | 100 LPM | 100 LPM |
| Connection | Male 22 mm ISO | Same |
.
2
| Feature | AG Industries | Porous Media
K061426 |
|-----------------------|---------------------------------------------|------------------------------------|
| Model | LL201 | DBF 24 |
| Intended Use | Same as AG1038831 Above | Same |
| Filtration Efficiency | 99.999+% BFE | 99.999% |
| Filter Material | Glass Microfiber | Same |
| Housing Material | Styrene Butadiene or approved
equivalent | Polystyrene or approved equivalent |
| Air Flow Resistance | 12.02 cm H20 @ 85 Lpm | 4.0 cm H2O @ 100 scfh |
| Maximum Flow Rate | 100 LPM | Same |
| Connection | Male 22 mm ISO | Same |
:
. . .
·
.
| Feature | AG Industries | Porous Media
K061426 |
|-----------------------|---------------------------------------------|------------------------------------|
| Model | LL202 | DBF 24 |
| Intended Use | Same as AG1038831 Above | Same |
| Filtration Efficiency | 99.9+% BFE | 99.999% |
| Filter Material | Glass Microfiber | Same |
| Housing Material | Styrene Butadiene or approved
equivalent | Polystyrene or approved equivalent |
| Air Flow Resistance | .39 cm H20 @ 10 Lpm | 4.0 cm H2O @ 100 scfh |
| Maximum Flow Rate | 100 LPM | Same |
| Connection | Male 22 mm ISO | Same |
:
:
:
3
| Feature | AG Industries | Porous Media
K061426 |
|-----------------------|---------------------------------------------|------------------------------------|
| Model | HCF100 | DBF 32 |
| Intended Use | Same as AG1038831 Above | Same |
| Filtration Efficiency | 99.999+% BFE | 99.999% |
| Filter Material | Glass Microfiber | Same |
| Housing Material | Styrene Butadiene or approved
equivalent | Polystyrene or approved equivalent |
| Air Flow Resistance | .33 cm H20 @ 10.5 Lpm | 3.0 cm H2O @ 100 scfh |
| Maximum Flow Rate | 100 LPM | Same |
| Connection | 22mm ISO Male/Female | Same |
.
| Feature | AG Industries | Porous Media
K061426 |
|-----------------------|---------------------------------------------|----------------------------------------------------|
| Model | BF910 (Platinum) | DBF 25 |
| Intended Use | Same as AG1038831 Above | Same |
| Filtration Efficiency | 99.99+% BFE | 99.999% |
| Filter Material | Glass Microfiber | Same |
| Housing Material | Styrene Butadiene or approved
equivalent | Polystyrene or approved equivalent |
| Air Flow Resistance | .4 cm H20 @ 5 Lpm | 18 in H2O (Platinum 10)
7 in H2O (non-Platinum) |
| Maximum Flow Rate | 100 LPM | Same |
| Connection | 3/8 " FNPT and 22mm OD | 3/8 " FNPT |
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
.
1
:
4
| Feature | AG Industries | Porous Media
K061426 |
|-----------------------|---------------------------------------------|----------------------------------------------------|
| Model | BF900 (Non-Platinum) | DBF 25 |
| Intended Use | Same as AG1038831 Above | Same |
| Filtration Efficiency | 99.999+% BFE | 99.999% |
| Filter Material | Glass Microfiber | Same |
| Housing Material | Styrene Butadiene or approved
equivalent | Polystyrene or approved equivalent |
| Air Flow Resistance | 1.6 cm H20 @ 84.9 LPM (Non-Platinum) | 18 in H2O (Platinum 10)
7 in H2O (non-Platinum) |
| Maximum Flow Rate | 100 LPM | Same |
| Connection | 3/8" FNPT and 22mm OD | 3/8" FNPT |
.
.
| Feature | AG Industries | Porous Media
K061426 |
|-----------------------|---------------------------------------------|----------------------------------------------------|
| Model | BF950 ( Platinum & Non
Platinum) | DBF 25 |
| Intended Use | Same as AG1038831 Above | Same |
| Filtration Efficiency | 99.999+% BFE | 99.999% |
| Filter Material | Glass Microfiber | Same |
| Housing Material | Styrene Butadiene or approved
equivalent | Polystyrene or approved equivalent |
| Air Flow Resistance | .45 cm H2O @ 10.3 LPM | 18 in H2O (Platinum 10)
7 in H2O (non-Platinum) |
| Maximum Flow Rate | 100 LPM | Same |
| Connection | 3/8" FNPT and 22mm OD | 3/8" FNPT |
.
5
| Feature | AG Industries | Porous Media
K061426 |
|-----------------------|-----------------------------------------|------------------------------------|
| Model | BF200C | DDF4711M03Y |
| Intended Use | Same as AG1038831 Above | Same |
| Filtration Efficiency | 99.999+% BFE | 99.999% |
| Filter Material | Glass Microfiber | Same |
| Housing Material | Polypropylene or approved
equivalent | Polystyrene or approved equivalent |
| Connection | 3/8" Hose Barb | 3/8" Hose Barb |
·
.
| Feature | AG Industries | Porous Media
K061426 |
|-----------------------|-----------------------------------------|------------------------------------|
| Model | BF100 | DDF4711M03Y |
| Intended Use | Same as AG1038831 Above | Same |
| Filtration Efficiency | 99.999+% | 99.999% |
| Filter Material | Glass Microfiber | Same |
| Housing Material | Polypropylene or approved
equivalent | Polystyrene or approved equivalent |
| Connection | 3/16"- ¼" Stepped Bar | 1/8" Hose Barb |
| Feature | AG Industries | Porous Media
K061426 |
|-----------------------|-----------------------------------------|------------------------------------|
| Model | BF500 | DDF4700M03Y |
| Intended Use | Same as AG1038831 Above | Same |
| Filtration Efficiency | 99.999+% | 99.97% |
| Filter Material | Glass Microfiber | Same |
| Housing Material | Polypropylene or approved
equivalent | Polystyrene or approved equivalent |
| Connection | 1/4" Straight Barb | Same |
ﺮ
,
6
| Feature | AG Industries | Porous Media
K061426 |
|-----------------------|-----------------------------------------|------------------------------------|
| Model | BF600 | DDF4711M03Y |
| Intended Use | Same as AG1038831 Above | Same |
| Filtration Efficiency | 99.999+% | 99.999% |
| Filter Material | Glass Microfiber | Same |
| Housing Material | Polypropylene or approved
equivalent | Polystyrene or approved equivalent |
| Connection | 1/8" Hose Barb | Same |
The following tests were performed to support substantial equivalence:
- . Bacterial Filtration Efficiency
- Dioctyl Phthalate (DOP) Aerosol Test
- . ISO Guinea Pig Maximization Test
- . ISO Acute Systemic Injection Test
- . MEM Elution Test
- . Material Mediated Rabbit Pyrogen Test
The above tests confirmed that the performance of the subject filters is substantially equivalent to the predicate device(s). The Biocompatibility tests confirmed that the following filters BF500, BF200C, BF100 and BF600, which contain materials not in previously cleared devices, present no biocompatibility issues.
4. Device Description:
COMPRESSOR & BACTERIA FILTERS ( AG1038831, LL205, LL201, LL202, HCF100, BF910, BF900, BF950, BF200C, BF100, BF500, BF600):
Room air is drawn into the compressor of a respiratory device through the bacterial intake filter. From the compress, 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 higher concentration of oxygen. The air then passes through the final filter before being supplied to the patient.
5. Intended Use:
AG Industries filters are replacement filters intended for use in oxygen concentrator machines to help remove contaminants, including air borne bacteria and other particulate
7
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, etc.
6. Discussion of Clinical Tests Performed:
Not applicable
7. Conclusions:
The subject devices have the same intended use and similar characteristics as the predicate devices. No new questions of safety or effectiveness are raised by differences in technology or materials. Thus, the AG Industies COMPRESSOR & BACTERIA FILTERS ( AG1038831, LL205, LL201, LL202, HCF100, BF910, BF900, BF950, BF200C, BF100, BF500, BF600) are substantially equivalent to the predicate devices.
8
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three arms or lines extending upwards, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged in a circular pattern around the figure. The text is in all caps and is separated by dots.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
FEB - 4 2010
ndd AG Industries C/O Mr. Ian Gordon Senior Vice-President Emergo Group, Incorporated 1705 South Capital of Texas Highway, Suite 500 Austin, Texas 78746
Re: K091363
Trade/Device Name: Compressor & Bacteria Filters (AG1038831, LL205, LL201, LL202, HCF100, BF910, BF900, BF950, BF200C, BF100, BF500, BF600
Regulation Number: 21 CFR 868.5260 Regulation Name: Breathing Circuit Bacterial Filter Regulatory Class: II Product Code: CAH Dated: January 21, 2010 Received: January 22, 2010
Dear Mr. Gordon:
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 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.
9
Page 2 - Mr. Gordon
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); 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 go to http://www.fda.gov/cdrh/comp/ for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Wh for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
10
INDICATIONS FOR USE
510(k) Number :
Device Name: COMPRESSOR & BACTERIA FILTERS ( AG1038831, LL205, LL201, LL202, HCF100, BF910, BF900, BF950, BF200C, BF100, BF500, BF600):
Indications for Use:
AG Industries 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, hospital, patient care facility, etc.
Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
L. Schultheiss
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
KO91363 510(k) Number: