(181 days)
Not Found
No
The device description and key metrics focus on the physical filtration properties of the device, and there are no mentions of AI, ML, or related concepts.
No
The device is a filter for inspired and expired gases in ventilation and anesthesia systems, which prevents the passage of bacteria and viruses. It does not directly treat a medical condition or disease.
No
The device description states it is a "machine-side filter" for filtration of gases, and its indicated use is for ventilators, anesthesia machines, and open flow systems. Its performance metrics are bacterial and viral filtration efficiencies. These characteristics indicate its function is therapeutic/protective (filtration), not diagnostic.
No
The device description clearly states it is a "machine-side filter" and incorporates "standard 15 / 22 mm connectors" and a "pleated paper fiber for filtration," indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for filtering inspired and expired gases in respiratory circuits connected to ventilators, anesthesia machines, and open flow systems. This is a mechanical function related to gas delivery and patient respiration, not the analysis of biological samples to diagnose or monitor a medical condition.
- Device Description: The device is described as a machine-side filter using a pleated paper fiber. This aligns with a mechanical filtration device, not a device designed to perform in vitro tests.
- Lack of IVD Characteristics: The description does not mention any components or functions related to:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or treatment decisions based on in vitro analysis.
The device's function is purely related to filtering gases within a respiratory circuit, which falls under the category of a respiratory support or accessory device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
For use with ventilators, anesthesia machines, and open flow systems where filtration of inspired and / or expired gases is desired. To be placed at the machine -side of the circuit only. Single patient use. Duration of use up to 24 hours.
Product codes (comma separated list FDA assigned to the subject device)
73 CAH
Device Description
The Munktell Gard Filter is a machine-side filter and incorporate standard 15 / 22 mm connectors. The depth filter uses a pleated paper fiber for filtration.
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
Any patient (adult)
Intended User / Care Setting
Home, Hospital, Sub-acute Institutions
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 data within the submission demonstrates that the proposed devices when compared to the predicate devices are safe and effective and are substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Bacterial filtration - BFE - Nelson Lab. 99.9999%
Viral filtration - VFE - Nelson Lab. 99.9999%
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
1014281
Munktell Filter AB Box 300 S 790 20, Grycksbo, Sweden
Non-Confidential Summary of Safety and Effectiveness
Page 1 of 2 April 15, 2002
| Munktell Filter AB
Box 300
S 790 20 Grycksbo, Sweden | Tel - 011 (46) 23-683-80
Fax - 011 (46) 23-401-15 |
|------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| Official Contact: | Gustav Kyrk - Managing Director |
| Proprietary or Trade Name: | Gard Filter |
| Common/Usual Name: | Bacterial / Viral Filter |
| Classification Name: | Filter, Bacterial, Breathing Circuit |
| Predicate Devices: | Mallinckrodt Sterivent (HEPA) – K941676
ARC Filter – K011212
Porous Media – DBF 23 – K964979 |
Device Description: July 2017 11:43 11:00 11:00 10:00 10:00
The Munktell Gard Filter is a machine-side filter and incorporate standard 15 / 22 mm connectors. The depth filter uses a pleated paper fiber for filtration.
| Intended Use: | ||
|---|---|---|
| Indicated Use -- | For use with ventilators, anesthesia machines, and open flow | |
| systems where filtration of inspired and / or expired gases is | ||
| desired. Tobe placed at the machine-side of the circuit only. | ||
| Intended for single patient use up to 24 hours. | ||
| Environment of Use -- | Home. Hospital. Sub-acute Institutions |
1
Non-Confidential Summary of Safety and Effectiveness Page 2 of 2 April 15, 2002
General Technical Characteristics
1
| Attribute | Munktell - Proposed devices |
|---|---|
| Indications for use - To filter inspired and / or | |
| expired gases | Same |
| Intended for single patient use, up to 24 hours | Yes |
| Prescription | Yes |
| Intended population | Any patient (adult) |
| Intended Environment of Use | Home, Hospital, Sub-acute institutions |
| Placement at machine side of circuit only | Yes |
| Design | |
| Gas sampling port | Yes |
| Standard 15/22 mm connectors | Yes |
| Dead Space (ml) | 124 ml |
| Resistance to flow | $≤$ 1.6 cm H2O @ 60 lpm |
| Bacterial filtration - BFE - Nelson Lab. | 99.9999% |
| Viral filtration - VFE - Nelson Lab. | 99.9999% |
| Weight (gm) | 60 gm |
| Materials | |
| Housing polystyrene | Yes |
| Filter media | Paper microfiber |
| Performance Standards | |
| None under Section 514 | Yes |
| ISO 5356-1 Conical 15/22 | Yes |
Differences between Other Legally Marketed Predicate Devices
The data within the submission demonstrates that the proposed devices when compared to the predicate devices are safe and effective and are substantially equivalent to the predicate devices.
2
Image /page/2/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around it. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 6 2002
Munktell Filter AB c/o Mr. Paul Dryden ProMedic, Inc. 6329 W. Waterview Court McCordsville, IN 46055
Re: K014281 Gard Filter, Model # 321 111 Regulation Number: 868.5260 Regulation Name: Breathing Circuit Filter Regulatory Class: II (two) Product Code: 73 CAH Dated: April 2, 2002 Received: April 3, 2002
Dear Mr. Dryden:
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,
3
Page 2 - Mr. Paul Dryden
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
| Indications for Use . Me . Mar . 1988 . 1998 | |
|---|---|
| 510(k) Number: | K014281 |
| Device Name: | Gard Filter |
| Intended Use: | For use with ventilators, anesthesia machines, and open flow |
| systems where filtration of inspired and / or expired gases is | |
| desired. To be placed at the machine -side of the circuit only. | |
| Single patient use. Duration of use up to 24 hours. |
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Cardiqyascular & Resoir- to ... "Bevices 510(k) Number LO
Prescription Use (Per CFR 801.109)
or
Over-the-counter use __