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.

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. 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. 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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Intersurgical Flo-Guard Breathing Filter:

1. Table of Acceptance Criteria and Reported Device Performance

Characteristic Compared	Acceptance Criteria (Predicate Device)	Reported Device Performance (1690030 Flo-Guard Breathing Filter)
Product Labeling	99.99% BFE & VFE	99.99% BFE & 99.95% VFE
Intended Use	Reduce bacterial/viral transmissions	Reduce bacterial/viral transmissions
Target Population	All	All (Adult target patient population)
Environment of Use	Clinical	Clinical (Healthcare and home environments)
Maximum Duration of Use	(Not explicitly stated for predicate)	24 hours
Physical Characteristics	Round/Cylindrical	Round/Cylindrical
Approximate Volume (ml)	74 ml	82 ml
Resistance (at 30 l/min)	0.7 cm H2O	0.4 cm H2O
Weight	29 g	28 g
Type of Filtration	Electrostatic	Electrostatic

Note: The document establishes substantial equivalence by comparing the proposed device to a predicate device (Respironics Breathing Filter K973797). Therefore, the predicate device's specifications serve as the de facto "acceptance criteria" for the new device to demonstrate similar performance. The "Reported Device Performance" column shows how the new device compares.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size for any specific "test set" in the traditional sense of a clinical or lab study involving a human population. Instead, the comparison is made on characteristics of the device filters themselves.

Sample Size: Not specified in terms of number of devices tested for each characteristic. It refers to "the Flo-Guard" as a general type.
Data Provenance: The testing for characteristics like resistance, filtration efficiency, and volume was conducted internally or at an external test house. The country of origin of the data is not specified, but the applicant company is based in Liverpool, NY, USA. The testing appears to be prospective in nature, performed specifically for regulatory submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not applicable to this type of device submission. The "ground truth" for a breathing filter is not established by expert consensus on clinical findings or images. Instead, it's based on objective, measurable physical and functional characteristics of the device (e.g., bacterial filtration efficiency, resistance to flow).
The document implies that established laboratory methods (e.g., "Henderson rig" for filtration efficiency) are used, which are standard, objective measurements rather than subjective expert interpretations.

4. Adjudication Method for the Test Set

Not applicable. Since the "ground truth" is determined by objective physical and functional measurements, there is no need for expert adjudication. The tests produce quantitative results that are then compared against established standards or predicate device performance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is typically performed for diagnostic devices where human readers interpret medical images or data, and AI assistance might improve their accuracy. This submission is for a medical device (breathing filter) with objective performance metrics, not an AI-based diagnostic tool. Therefore, human-in-the-loop performance with or without AI assistance is not relevant or reported.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a physical breathing filter, not an algorithm or AI system. Its performance is inherent to the device itself, not an independent algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on objective physical and functional measurements using standardized laboratory test methods. These include:

Bacterial Filtration Efficiency (BFE) and Viral Filtration Efficiency (VFE): Determined by specialized external testing (e.g., using a "Henderson rig").
Resistance to Flow: Measured by applying rated flow and recording pressure increase.
Approximate Volume: Calculated using internal pressure recordings and gas laws.
Weight: Measured using a calibrated balance.
Leakage: Tested by maintaining internal pressure and measuring air flow.
Maximum Duration of Use: Verified through conditioning tests (e.g., 24 hours on a ventilator, 24 hours on moisture return rig).

8. The Sample Size for the Training Set

Not applicable. This device is not an AI algorithm or a machine learning model, so there is no "training set" in the context of data-driven model development.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set for an AI model, the concept of establishing ground truth for it does not apply here.

Summary

{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:

{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]RespironicsK973797
510 K
Product Labeling	99.99% BFE & 99.95% VFE SeePerformance Testing Data.	99.99% BFE & VFE
Intended Use	It is designed to reducebacterial/viral transmissionsbetween the patient and equipment.	It is designed to reducebacterial/viral transmissionsbetween the patient andequipment.
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:

Prescription Use XXX (Per 21 CFR 801.109)

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

Regulation Number and Section

§ 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).