(129 days)
FilterFlo™ filter is a breathing system filter which is designed to reduce possible airborne or liquid-borne cross contamination with micro-organisms and particulate matter via anesthetic or ventilator breathing systems.
The FilterFlo™ filter may either be used on the patient side or on the device side of the ventilator / anesthetic device and is used as a hygienic measure alternatively to decontamination of breathing system and / or breathing gas conveying parts of the ventilator.
The ThermoFlo™ filter/HME is a breathing system filter and a Heat and Moisture Exchanger. The combination of a filter and a Heat and Moisture Exchanger offer the benefit of both product features. Heat and Moisture Exchangers are used as a conditioning system for mechanically ventilated patients whose upper airways are bypassed. In almost all cases of mechanical ventilation they are a fully valid alternative to heated humidifiers. The product is the only conditioning opportunity of breathing gases in cases of emergency ventilation or during transport since heated humidified are almost impossible to use. The ThermoFlo™ filter/HME should be used with patients who have a Tidal Volume between 250 - 1500 ml.
The products mentioned above are designed as disposable single patient use and should be changed at least every 24 hours.
The ARC Medical filter and filter / HME are standard breathing circuit filters or filter / HMEs.
Here's a breakdown of the acceptance criteria and study information for the ARC Medical FilterFlo™ filter and ThermoFlo™ filter/HME, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary does not explicitly list numerical "acceptance criteria" for the filters in the way one might see for an AI algorithm. Instead, the submission relies on demonstrating substantial equivalence to predicate devices. The performance criteria are implicitly those met by the predicate devices. The study performed was comparative, showing that the proposed devices performed equivalently to these established predicate devices.
| Performance Characteristic | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (Comparative Testing) |
|---|---|---|
| BFE/VFE Filtration | Equivalent to predicate devices | Substantially equivalent to predicate devices |
| Resistance to Flow | Equivalent to predicate devices | Substantially equivalent to predicate devices |
| Internal Volume | Equivalent to predicate devices | Substantially equivalent to predicate devices |
| HME Performance | Equivalent to predicate devices | Substantially equivalent to predicate devices |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a separate "test set" in the context of typical AI algorithm evaluation with patient data. Instead, it refers to "comparative performance testing" of the physical devices.
- Sample Size: Not explicitly stated in terms of the number of devices tested for each characteristic. It would typically involve a statistically relevant number of units for each test (e.g., n=3, n=5, or more, depending on the test standard).
- Data Provenance: This is not applicable in the sense of patient data origin. The testing would have been conducted in a laboratory or manufacturing environment. Based on the manufacturer's location (Tucker, GA, USA), the testing was likely done in the USA. This was a prospective test conducted specifically for this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This is not applicable as the device is a physical medical device (breathing circuit filter/HME), not an AI algorithm requiring human expert ground truth for image interpretation or diagnosis. The "ground truth" here is objective physical performance measurements according to established test methods.
4. Adjudication Method for the Test Set
This is not applicable as the evaluation involves objective physical performance measurements against established standards or predicate device performance, not subjective expert assessment requiring adjudication.
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
This is not applicable. This device is a physical breathing circuit filter/HME, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study and effect size in the context of AI assistance are not relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
This is not applicable. This device is a physical filter/HME, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the tested device performance characteristics (BFE/VFE filtration, resistance to flow, internal volume, HME performance) is based on objective physical measurements obtained through standard engineering and laboratory test methods, calibrated against established industry standards or by direct comparison to the performance of the legally marketed predicate devices.
8. The Sample Size for the Training Set
This is not applicable. There is no "training set" in the context of an AI algorithm for this physical device.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set for an AI algorithm.
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f090738
510(k) Summary Page 1 of 2 18-June-09
JUL 2 7 2009
| ARC Medical, Inc. | |
|---|---|
| 4296 Cowan Road | Tel - 800-950-2720 |
| Tucker, GA 30084 | Fax - 404-373-8385 |
| Official Contact: | Harold B. Norris - President |
| Proprietary or Trade Name: | FilterFlo™ filterThermoFlo™ Filter/HME |
| Common/Usual Name: | Bacterial filter and Heat and Moisture Exchanger |
| Classification Name/Code: | CAH - breathing circuit / bacterial filter |
| Device: | FilterFlo™ filterThermoFlo™ filter/HME |
| Predicate Devices: | Pharma Systems - K903056 - Bact Trap filtersPharma Systems - K903058 - Bact HMEDrager - K072002 - Care Star 30 and Twin Star 55 |
Device Description:
The ARC Medical filter and filter / HME are standard breathing circuit filters or filter / HMEs.
Indications for Use:
FilterFlo™ filter is a breathing system filter which is designed to reduce possible airborne or liquid-borne cross contamination with micro-organisms and particulate matter via anesthetic or ventilator breathing systems.
The FilterFlo™ filter may either be used on the patient side or on the device side of the ventilator / anesthetic device and is used as a hygienic measure alternatively to decontamination of breathing system and / or breathing gas conveying parts of the ventilator.
The ThermoFlo™ filter/HME is a breathing system filter and a Heat and Moisture Exchanger. The combination of a filter and a Heat and Moisture Exchanger offer the benefit of both product features. Heat and Moisture Exchangers are used as a conditioning system for mechanically ventilated patients whose upper airways are bypassed. In almost all cases of mechanical ventilation they are a fully valid alternative to heated humidifiers. The product is the only conditioning opportunity of breathing gases in cases of emergency ventilation or during transport since heated humidified are almost impossible to use. The ThermoFlo™ filter/HME should be used with patients who have a Tidal Volume between 250 - 1500 ml.
The products mentioned above are designed as disposable single patient use and should be changed at least every 24 hours.
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510(k) Summary Page 2 of 2 18-June-09
Patient Population: Specified by tidal volumes for the filter/HME
Environment of Use: Hospital, sub-acute institutions, and pre-hospital
The ThermoFlo™ filter/HME and FilterFlo™ filter are viewed as substantially equivalent to the predicate devices because:
Indications -
- Identical to predicate -- Drager Care Star 30 and Twin Star 55 (K072002) .
Technology -
Materials -
- The materials in patient contact have not been changed and are identical to predicate . devices - ARC Medical (Pharma Systems) K903056 and K903058.
Environment of Use -
Comparative Performance Testing -
- We have performed comparative performance testing between the proposed and predicate ● devices. The tests included -- BFE / VFE Filtration testing, resistance to flow, internal volume, HME performance.
- We found that the performances were substantially equivalent. .
Differences -
There are no differences between the predicates and the proposed device. We are only changing the indications for use.
Page S2.45
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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized caduceus, a symbol often associated with medicine and healthcare.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
ARC Medical, Incorporated C/O Mr. Paul Dryden President ProMedic, Incorporated 24301 Woodsage Drive Bonita Springs, Florida 34134-2958
JUL 2 7 2009
Re: K090738
Trade/Device Name: ThermoFlo™ Filter/HME, FilterFloTM Filter Regulation Number: 21 CFR 868.5260 Regulation Name: Breathing Circuit Bacterial Filter Regulatory Class: II Product Code: CAH Dated: June 18, 2009 Received: June 30, 2009
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 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.
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Page 2- Mr. 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); 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/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,
J
Susan Runner, D.D.S., M.A. Acting Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
Page 1 of 1
510(k) Number:
Device Name:
ThermoFlo™ filter/HME FilterFlo™ filter
Indications for Use:
FilterFlo™ filter is a breathing system filter which is designed to reduce possible airborne or liguid-borne cross contamination with micro-organisms and particulate matter via anesthetic or ventilator breathing systems.
The FilterFloTM filter may either be used on the patient side or on the device side of the ventilator / anesthetic device and is used as a hygienic measure alternatively to decontamination of breathing system and / or breathing gas conveying parts of the ventilator.
The ThermoFlo™ filter/HME is a breathing system filter and a Heat and Moisture Exchanger. The combination of a filter and a Heat and Moisture Exchanger offer the benefit of both product features. Heat and Moisture Exchangers are used as a conditioning system for mechanically ventilated patients whose upper airways are bypassed. In almost all cases of mechanical ventilation they are a fully valid alternative to heated humidifiers. The product is the only conditioning opportunity of breathing gases in cases of emergency ventilation or during transport since heated humidified are almost impossible to use. The ThermoFlo™ filter/HME should be used with patients who have a Tidal Volume between 250 - 1500 ml.
The products mentioned above are designed as disposable single patient use and should be changed at least every 24 hours.
Prescription Use XX (Part 21 CFR 801 Subpart D)
or
Over-the-counter use (21 CFR 807 Subpart C) .
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sian-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K8900738
Page S2.43
§ 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).