(212 days)
Not Found
No
The device description and performance studies focus on physical filtration properties and resistance to flow, with no mention of AI or ML algorithms.
No.
The device is a breathing filter designed to protect against bacterial/viral transmissions. It doesn't directly treat or mitigate a disease or condition in a patient; instead, it prevents cross-contamination within a breathing system.
No
The device is a breathing filter designed to reduce bacterial/viral transmissions, protecting the patient and respiratory equipment. It does not perform any diagnostic functions.
No
The device is a physical breathing filter designed to reduce bacterial/viral transmissions in breathing systems. The description focuses on its physical characteristics, performance metrics related to airflow and filtration, and testing methods for these physical properties. There is no mention of software components or functions.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to reduce bacterial/viral transmissions in breathing systems to protect the patient and respiratory equipment. This is a function related to the physical filtering of air within a breathing circuit, not the diagnosis of a disease or condition using in vitro methods (testing samples like blood, urine, or tissue).
- Device Description: The device is classified as "Breathing Circuit Bacterial Filters" (21 CFR 868.5260) and has a product code of CAH. These classifications are for respiratory devices, not IVDs. The description focuses on the physical design and function of the filter within a breathing system.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information. The device's function is purely mechanical filtration.
Therefore, the Intersurgical Flo-Guard Breathing Filter is a respiratory device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Intersurgical Flo - Guard Breathing Filter is for use at machine end connections in home and hospital breathing system applications. It is designed to reduce bacterial/viral transmissions in order to protect the patient and respiratory equipment.
The filter is single patient use for an adult target patient population, is intended for use within breathing systems in healthcare and home environments where ventilation is required and a maximum duration of 24 hours.
Product codes
CAH
Device Description
The breathing filer is classified as "Breathing Circuit Bacterial Filters" according to 21 CFR 868.5260. They are all in Regulatory Class II and have a product code of CAH.
Principle of operation:
The Flo-Guard breathing filter is designed to be placed at the machine end of a breathing system to protect the patient and machine against cross contamination while maintaining a low resistance across a wide range of flow rates. The gas flow path is simple, the pathway is through the 22F to the 22M connection on the inspiratory breath and should the filter be used on the expiratory side, from the 22M to the 22F on the expired breath.
The Flo-Guard is a single use product. The low resistance makes it an ideal filter for use in both the hospital and the home where high flow rates may potentially be used; this includes CPAP, BIPAP and cough assist applications. The filter has been designed to protect between the machine and breathing circuit interfaces.
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
adult
Intended User / Care Setting
Home and hospital breathing system applications
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
Leakage is tested by applying and maintaining an internal gas pressure by introducing air into the filter and recording the flow of air required maintaining that pressure.
Resistance to flow is tested by measuring the pressure increase at the rated flow through the filter Filtration efficiency is tested at an external test house by use of the Henderson rig.
Compressible volume is by recording internal pressure over time and using a derivative of the gas law P V = P2V2Weight was measure by use of a calibrated balance. The filter is intended for use for a maximum duration of 24 hours. This has been verified through conditioning testing. Filters were tested after 24 hours on a ventilator and after 24 hours on the moisture return rig.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The 1690030 is a Bacterial/viral filter capable of delivering low resistance values at high flows. It is designed to accompany BiPAP circuits and cough assist circuits for systems and is an expiratory silencer kit for neonatal ventilators also to be available as a stand alone low resistance product. The Respironics device is also a low resistance breathing system bacterial filter.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
Appendix D. 510(k) Summary of Safety and Effectiveness
Name: INTERSURGICAL INCORPORATED Address: 417 Electronics Parkway Liverpool, NY 13088 Date: October 11. 2012 Contact Person: Michael Zalewski - VP RA/QA/CS Phone Number: 315-451-2900 Fax Number: 315-451-3696
NOV 2 2012
Description of Device:
The breathing filer is classified as "Breathing Circuit Bacterial Filters" according to 21 CFR 868.5260. They are all in Regulatory Class II and have a product code of CAH.
Principle of operation:
The Flo-Guard breathing filter is designed to be placed at the machine end of a breathing system to protect the patient and machine against cross contamination while maintaining a low resistance across a wide range of flow rates. The gas flow path is simple, the pathway is through the 22F to the 22M connection on the inspiratory breath and should the filter be used on the expiratory side, from the 22M to the 22F on the expired breath.
The Flo-Guard is a single use product. The low resistance makes it an ideal filter for use in both the hospital and the home where high flow rates may potentially be used; this includes CPAP, BIPAP and cough assist applications. The filter has been designed to protect between the machine and breathing circuit interfaces.
Predicate Devices:
The 1690030 - Intersurgical Flo - Guard Breathing Filter is substantially equivalent to the Respironics Breathing Filter. The Respironics Filter is made by King Systems. The Respironics Bacteria Filter 342077 was chosen as a suitable predicate as the intended use and specification is similar to that of the Flo-Guard 1690030 filter. The 1690030 and the 342007 are both intended to be used as an accessory for CPAP and bi-level devices. Both devices are single use and both intended to be used as a bacterial filter.
The devices have comparable sizes, volumes and weights. The two devices have similar flow vs. pressure curves and the bacterial filtration efficiencies are similar. Both the 1690030 and 342077 have 22mm conical taper connections. See the technological characteristic summary for performance details.
Indications for Use:
The Intersurgical Flo - Guard Breathing Filter is for use at machine end connections in home and hospital breathing system applications. It is designed to reduce bacterial/viral transmissions in order to protect the patient and respiratory equipment.
1
Appendix D. 510(k) Summary of Safety and Effectiveness
Indications for Use (continued):
The filter is single patient use for an adult target patient population, is intended for use within breathing systems in healthcare and home environments where ventilation is required and a maximum duration of 24 hours.
Technological Characteristics Summary:
The intended use of the Intersurgical Flo - Guard Breathing Filter is comparable to the referenced predicate device. The comparison of the data shows similar values for the key performance characteristics. Proposed devices show similar values for filtration efficiency, dead space and resistance to flow when compared to the legally marketed devices.
| Characteristic Compared | [510(k) DEVICE]
1690030 | [PREDICATE DEVICE]
Respironics
K973797 |
|--------------------------|-------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| 510 K | | |
| Product Labeling | 99.99% BFE & 99.95% VFE See
Performance Testing Data. | 99.99% BFE & VFE |
| Intended Use | It is designed to reduce
bacterial/viral transmissions
between the patient and equipment. | It is designed to reduce
bacterial/viral transmissions
between the patient and
equipment. |
| Target Population | All | All |
| Environment of Use | Clinical | Clinical |
| Maximum Duration of Use | 24 hours | |
| Physical Characteristics | Round/Cylindrical | Round/Cylindrical |
| Approximate Volume(ml) | 82 ml | 74 ml |
| Resistance | 0.4 cm H20 at 30 l/min | 0.7 cm H20 at 30 l/min |
| Weight | 28 g | 29 g |
| Type of Filtration | Electrostatic | Electrostatic |
Characteristics and performance criteria
The 1690030 is a Bacterial/viral filter capable of delivering low resistance values at high flows. It is designed to accompany BiPAP circuits and cough assist circuits for systems and is an expiratory silencer kit for neonatal ventilators also to be available as a stand alone low resistance product. The Respironics device is also a low resistance breathing system bacterial filter.
Test methods:
Leakage is tested by applying and maintaining an internal gas pressure by introducing air into the filter and recording the flow of air required maintaining that pressure.
Resistance to flow is tested by measuring the pressure increase at the rated flow through the filter Filtration efficiency is tested at an external test house by use of the Henderson rig.
Compressible volume is by recording internal pressure over time and using a derivative of the gas law P V = P2V2Weight was measure by use of a calibrated balance. The filter is intended for use for a maximum duration of 24 hours. This has been verified through conditioning testing. Filters were tested after 24 hours on a ventilator and after 24 hours on the moisture return rig.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized depiction of an eagle or bird-like figure with outstretched wings, rendered in a simple, bold design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
2017
NOV
Intersurgical, Incorporated
Mr. Michael Zalewski
Vice President – RA/QA/CS
417 Electronics Parkway
Liverpool, New York 13088
Re: K121026
Trade/Device Name: 1690030 Flo - Guard Breathing Filter Regulation Number: 21 CFR 868.5260 Regulation Name: Breathing Circuit Bacterial Filter Regulatory Class: II Product Code: CAH Dated: October 11, 2012 Received: October 16, 2012
Dear Mr. Zalewski:
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.
3
Page 2- Mr. Zalewski
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/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm 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/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,
hh 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
4
10. INDICATIONS FOR USE
510(k) Number (if known):
Device Name:
1690030 Flo - Guard Breathing Filter
Indications For Use:
The Intersurgical Flo - Guard Breathing Filter is for use at machine end connections in home and hospital breathing system applications. It is designed to reduce bacterial/viral transmissions in order to protect the patient and respiratory equipment.
The filter is single patient use for an adult target patient population, is intended for use within breathing systems in healthcare and home environments where ventilation is required and a maximum duration of 24 hours.
Prescription Use XXX (Per 21 CFR 801.109)
or
Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH
L. Schultheis
(Division Sign-Off) Division of Anestheslology, General Hospital Infection Control, Dental Devices
510(k) Number: K121026
б