FILTER CARESTAR 30; FILTER SAFESTAR 55; FILTER/HME TWINSTAR 55

K072002 · Draeger Medical AG & Co. KG · CAH · Jan 31, 2008 · Anesthesiology

Device Facts

• Record ID: K072002
• Device Name: FILTER CARESTAR 30; FILTER SAFESTAR 55; FILTER/HME TWINSTAR 55
• Applicant: Draeger Medical AG & Co. KG
• Product Code: CAH · Anesthesiology
• Decision Date: Jan 31, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5260
• Device Class: Class 2

Intended Use

Breathing system filters for anesthetic and respiratory use and heat and moisture exchangers (HMEs) for humidifying respired gases in humans. Breathing system filters for anesthetic and respiratory use. Breathing system filters for anesthetic and respiratory use.

Device Story

Disposable breathing circuit filters and heat/moisture exchangers (HMEs) designed for anesthetic and ventilator systems; bi-directional protection against cross-contamination via filtration of microorganisms and particulates. CareStar 30 uses electrostatic filter pad; SafeStar 55 uses mechanical pleated filter pad; TwinStar 55 combines electrostatic filter with HME functionality. Devices feature plastic housing with standard 22mm/15mm connectors and luer lock gas sampling ports. Used in clinical settings (OR, ICU, transport) by healthcare professionals. Filters placed on patient or device side of circuit. Benefits include reduced equipment contamination, patient protection, and gas humidification for ventilated patients. Single-use, replaced every 24 hours.

Clinical Evidence

Bench testing only. Performance data provided for bacterial filtration efficiency (BFE) and viral filtration efficiency (VFE) (up to 99.9999%), resistance to flow (0.7-1.4 cmH2O at 30 L/min), internal volume (30-55 mL), and moisture loss (7.1 mg/L for TwinStar 55). Testing conducted by Nelson Labs.

Technological Characteristics

Housing: Polypropylene (PP). Filter media: PP with synthetic fibers (electrostatic) or paper with glass fiber (mechanical). Connectors: 22mm/15mm per EN ISO 5326. Gas sampling port: Luer lock. Filtration mechanism: Electrostatic or mechanical. Disposable, single-use.

Indications for Use

Indicated for humans requiring mechanical ventilation or anesthesia. Used to reduce airborne or liquid-borne cross-contamination with microorganisms and particulate matter in breathing circuits. TwinStar 55 indicated for patients with bypassed upper airways requiring gas conditioning (humidification). Suitable for emergency ventilation and transport.

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

• Datex-Ohmeda HMEF 750 (K031653)
• Air Safety HEPA and non-HEPA Filters (K033008)
• Datex-Ohmeda Mini-Filter/S (K030990)
• Datex-Ohmeda Uni-Filter Junior (K030990)
• Bacstop, Bacstop mini, Bacstop Humini (K014282)
• EMS HEPA Filter (K013089)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for Dräger medical. The word "Dräger" is in bold, and the word "medical" is in a thinner font. Below the logo, it says "A Dräger and Siemens Company" in a smaller font.

# 510(k) Summary

K072002

## Summary of Safety and Effectiveness

JAN 31 2008

#### Applicants Name and Address:

Dräger Medical AG & Co. KG Moislinger Allee 53-55 23542 Lübeck Germany

#### Contact Person:

Dr. Karin Luebbers Senior Manager Regulatory Affairs

Tel. No.: + 49 [phone] Fax No.: + 49 (451) 882-7-5367

### Applicants US Contact Person

Ms. Kathy Anderson Sr. Director Regulatory Affairs

Tel. No .: [phone] Fax No .: [phone]

#### Date submission was prepared:

2007-07-13

#### Device Name:

| Trade Name: | Filter CareStar 30 |
|--------------|------------------------------------|
| Common Name: | Breathing circuit bacterial filter |
| Trade Name: | Filter SafeStar 55 |
| Common Name: | Breathing circuit bacterial filter |
| Trade Name: | Filter/HME TwinStar 55 |
| Common Name: | Breathing circuit bacterial filter |

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## Breathing System Filters

**Dräger**medical

A Dräger and Siemens Company

#### Classification:

| Regulation No. | Device | Product Code |
|----------------|-----------------------------------------------|--------------|
| 868.5260 | Breathing circuit bacterial filter | (73CAH) |
| 868.5375 | Heat and moisture condenser (artificial nose) | (73BYD) |

#### Legally Marketed Device to which Substantial Equivalence is claimed:

| 510(k) number | Trade name | Company |
|---------------|--------------------------------------------------------------|--------------|
| K031653 | Datex-Ohmeda HMEF 750 | Datex-Ohmeda |
| K033008 | Air Safety HEPA and non-HEPA Filters | AirSafety |
| K030990 | Datex-Ohmeda Mini-Filter/S<br>Datex-Ohmeda Uni-Filter Junior | Datex-Ohmeda |
| K014282 | Bacstop, Bacstop mini, Bacstop Humini | Munktell |
| K013089 | EMS HEPA Filter | EMS |

#### Device Description:

The filters CareStar 30 and SafeStar 55 are designed to reduce possible air or liquid borne cross contamination with microorganisms via anesthetic or ventilator breathing systems. The strategic use of an effective breathing filter protects, bi-directionally, both the patient and equipment.

The filter CareStar 30 contains an electrostatic filter pad while the filter SafeStar 55 incorporates a mechanical pleated filter pad. Both filters consist of a plastic body which incorporates 22 female / 15 male connectors in accordance with EN ISO 5326 and a luer lock connector which may only be used for gas monitoring.

The Filter/HME TwinStar 55 is designed to combine the feature of reducing possible cross contamination with micro-organisms and an ideal heat and moisture return.

The Filter/HME TwinStar 55 consist of a plastic body which incorporates an electrostatic filter pad, 22 female / 15 male connectors in accordance with EN ISO 5326 and a gas luer lock connector which may only be used for gas monitoring.

| | Filter<br>CareStar 30<br>MP01770 | Filter<br>SafeStar 55<br>MP01790 | Filter/HME<br>TwinStar 55<br>MP01805 |
|-------------------------------------------|----------------------------------|------------------------------------|--------------------------------------|
| Filtration efficiency<br>(by Nelson Lab.) | 99.999% (BFE*)<br>99.99% (VFE*) | 99.9999% (BFE*)<br>99.9999% (VFE*) | 99.999% (BFE*)<br>99.99% (VFE*) |
| Filtration mechanism | electrostatic | mechanical | electrostatic |
| Resistance to flow | (0.7 cmH2O<br>at 30 L/min) | (1.4 cmH2O<br>at 30 L/min) | (0.7 cmH2O<br>at 30 L/min) |
| Internal volume | 30 mL | 55 mL | 55 mL |

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## Breathing System Filters

A Dräger and Siemens Company

| Filter<br>CareStar 50<br>MP01770-10 | Filter<br>SafeStar 55<br>MP01790 | Filter / HME<br>SafeStar 55<br>MP01790 | |
|-------------------------------------|----------------------------------|----------------------------------------|----------------------------|
| Recommended tidal<br>volume | 100 to 1500 mL | 200 to 1500 mL | 200 to 1500 mL |
| Conical connectors<br>ISO 5356 | 22m/15f - 22f/15m | 22m/15f - 22f/15m | 22m/15f - 22f/15m |
| moisture loss<br>ISO 9360 | No | No | 7,1 mg/L<br>at VT = 500 mL |
| Gas sampling port | Yes | Yes | Yes |
| Materials: | | | |
| Housing: | PP | PP | PP |
| Filter medium | PP with synth. fibres | Paper with glass<br>fibre | Paper with glass<br>fibre |

BFE: Bacterial filtration efficiency

VFE: Virus filtration efficiency

#### Intended Use:

| Product | Intended use: |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| Filter/HME TwinStar | Breathing system filters for anesthetic and respiratory use and heat<br>and moisture exchangers (HMEs) for humidifying respired gases in<br>humans |
| Filter CareStar | Breathing system filters for anesthetic and respiratory use |
| Filter SafeStar | Breathing system filters for anesthetic and respiratory use |

### Substantial Equivalence:

The intended use of the breathing circuit filters is comparable to the referenced predicate devices.

The comparison of the data shows similar values for the key performance data. Proposed devices show similar values in filtration efficiency, dead space, resistance to flow and recommended tidal volumes when compared to the legally marketed devices.

It must be pointed out that there is an interdependency regarding filtration efficiency, moisture loss, dead space and resistance to flow. A higher amount of media will result in a higher efficiency in filtration or humidification but with the consequence of having more dead space and higher resistance to flow.

In summary Dräger Medical AG & Co. KG has demonstrated that the proposed devices are safe and effective. They are considered to be substantially equivalent to currently marketed predicate devices which have been previously cleared by the FDA.

017

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Image /page/3/Picture/2 description: The image is a circular logo for the Department of Health and Human Services, USA. The logo features the department's emblem, which is a stylized representation of an eagle with three lines forming its body and head. The emblem is positioned to the right of the circle's center. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged around the upper half of the circle's perimeter.

JAN 31 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Draeger Medical AG & Company KG C/O Ms. Kathy Anderson Senior Director Regulatory Affairs Draeger Medical System, Incorporated 3135 Quarry Road Telford, Pennsylvania 18969

Re: K072002

Trade/Device Name: Breathing System Filter CareStar 30, Breathing System Filter SafeStar 55, Breathing System Filter /Heat and Moisture Exchanger TwinStar 55 Regulation Number: 868.5260 Regulation Name: Breathing Circuit Bacterial Filter Regulatory Class: II Product Code: CAH Dated: January 25, 2008 Received: January 28, 2008

Dear Ms. Anderson:

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.

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Page 2 – Ms. Anderson

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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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.

Chiu Lin, Ph.D.

Chiu Lin. Ph.D. 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

510(k) Number (if known): K072002

Device Name:

Breathing System Filter CareStar 30. Breathing System Filter SafeStar 55, Breathing System Filter / Heat and Moisture Exchanger TwinStar 55

Indications for Use:

CareStar 30 and SafeStar 55 are Breathing System Filters which are designed to reduce possible airborne or liquid-borne cross contamination with micro-organisms and particulate matter via anaesthetic or ventilator breathing systems.

The products may either be used on the patient side or on the device side of the ventilator/ anaesthetic device and are used as a hygienic measure alternatively to decontamination of breathing system and/or breathing gas conveying parts of the ventilator.

TwinStar 55 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 Exchanger 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 products are the only conditioning opportunity of breathing gases in cases of emergency ventilation or during transport since Heated Humidifiers are almost impossible to use.

The products mentioned above are designed for disposable use and should be changed at least every 24 hours.

Prescription Use Prescription Use _____________________________________________________________________________________________________________________________________________________________

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mair Tholm

Division Sign-Off) )ivision of Anesthesiology, General Hospital ofection Control, Dental Devices

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