THERMOFLO HCH, THERMOFLO FILTER

K090738 · Arc Medical, Inc. · CAH · Jul 27, 2009 · Anesthesiology

Device Facts

• Record ID: K090738
• Device Name: THERMOFLO HCH, THERMOFLO FILTER
• Applicant: Arc Medical, Inc.
• Product Code: CAH · Anesthesiology
• Decision Date: Jul 27, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5260
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

FilterFlo™ and ThermoFlo™ are disposable breathing circuit filters/HMEs. FilterFlo™ reduces airborne/liquid-borne cross-contamination of micro-organisms and particulates in anesthetic or ventilator circuits. ThermoFlo™ combines filtration with heat and moisture exchange (HME) to condition breathing gases for patients with bypassed upper airways. Used in hospitals, sub-acute institutions, and pre-hospital settings. Operated by clinicians during mechanical ventilation or emergency/transport ventilation. Devices are single-patient use, replaced every 24 hours. Benefit: prevents contamination and provides necessary gas conditioning when heated humidifiers are impractical.

Clinical Evidence

Bench testing only. Comparative performance testing conducted between subject and predicate devices, including BFE/VFE filtration, resistance to flow, internal volume, and HME performance. Results demonstrated substantial equivalence.

Technological Characteristics

Disposable breathing circuit filters and HMEs. Materials are identical to predicate devices. Functions as a mechanical barrier for filtration and a passive heat/moisture exchanger for gas conditioning. No electronic components, software, or energy sources.

Indications for Use

Indicated for patients requiring mechanical ventilation or anesthesia with tidal volumes between 250-1500 ml (for ThermoFlo™) to reduce cross-contamination and provide gas conditioning (heat and moisture exchange) when upper airways are bypassed.

Regulatory Classification

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.

Predicate Devices

• Pharma Systems - Bact Trap filters (K903056)
• Pharma Systems - Bact HME (K903058)
• Drager - Care Star 30 and Twin Star 55 (K072002)

Submission Summary (Full Text)

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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™ filter<br>ThermoFlo™ Filter/HME |
| Common/Usual Name: | Bacterial filter and Heat and Moisture Exchanger |
| Classification Name/Code: | CAH - breathing circuit / bacterial filter |
| Device: | FilterFlo™ filter<br>ThermoFlo™ filter/HME |
| Predicate Devices: | Pharma Systems - K903056 - Bact Trap filters<br>Pharma Systems - K903058 - Bact HME<br>Drager - 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 -

- Identical technology to ARC Medical (Pharma Systems) K903056 and K903058 and . Drager (K072002)
#### 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 -

- Identical to predicate ARC Medical (Pharma Systems) K903056 and K903058 .
#### 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 [phone] or [phone] 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:

K090738

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