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.

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.

AI/ML Overview

Here's an analysis of the provided text regarding the Dräger Medical breathing system filters, focusing on the acceptance criteria and the study proving compliance.

It's important to note that this document is a 510(k) Summary, which typically provides a high-level overview of the device and its substantial equivalence to predicate devices, rather than a detailed study report. Therefore, specific details about study design, raw data, or comprehensive statistical analyses are often summarized or omitted.

1. Table of Acceptance Criteria and Reported Device Performance

The document provides performance specifications for the devices, comparing them to generally accepted standards for breathing system filters. The "acceptance criteria" are implied by the listed performance values and the claim of substantial equivalence to predicate devices.

Performance Characteristic	Acceptance Criteria (Implied by Predicate Devices / Standards)	Reported Device Performance (CareStar 30)	Reported Device Performance (SafeStar 55)	Reported Device Performance (TwinStar 55)
Filtration Efficiency	High (comparable to predicate devices)	99.999% (BFE)99.99% (VFE)	99.9999% (BFE)99.9999% (VFE)	99.999% (BFE)99.99% (VFE)
Resistance to Flow	Low (acceptable for breathing systems)	0.7 cmH2O at 30 L/min	1.4 cmH2O at 30 L/min	0.7 cmH2O at 30 L/min
Internal Volume	Specific range (related to dead space)	30 mL	55 mL	55 mL
Recommended Tidal Volume	Specified ranges (for appropriate patient application)	100 to 1500 mL	200 to 1500 mL	200 to 1500 mL
Conical Connectors	ISO 5356 compliance	22m/15f - 22f/15m	22m/15f - 22f/15m	22m/15f - 22f/15m
Moisture Loss	Acceptable for HME (ISO 9360)	No (N/A for filter only)	No (N/A for filter only)	7.1 mg/L at VT = 500 mL
Gas Sampling Port	Presence (if applicable)	Yes	Yes	Yes
Materials	Biocompatible (implied)	Housing: PPFilter: PP/synth. fibres	Housing: PPFilter: Paper/glass fibre	Housing: PPFilter: Paper/glass fibre

*BFE: Bacterial filtration efficiency; VFE: Virus filtration efficiency

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

The document states filtration efficiency tests were done "by Nelson Lab." Nelson Laboratories is a well-known contract research organization specializing in microbiology and material testing for medical devices.

Sample Size for Test Set: Not explicitly stated in the provided document. Standard laboratory testing, especially for filtration efficiency, would involve a statistically significant number of samples, but the exact count is not given here.
Data Provenance: The document implies the data comes from laboratory testing (Nelson Labs). This is not patient-specific clinical data. It is a prospective test of the physical properties and performance of the manufactured devices. The country of origin for Nelson Labs is the United States.

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

This type of device (breathing system filter) does not typically involve human expert adjudication for its primary performance metrics like filtration efficiency or resistance to flow. These are objective, quantifiable physical properties measured by laboratory equipment.
Therefore, the concept of "ground truth established by experts" in the way it applies to image-based diagnostics is not relevant here. The "ground truth" for the test results is established by the methods and standards used by Nelson Laboratories, which are highly specialized technicians and scientists in their field.

4. Adjudication Method for the Test Set

Not applicable (see point 3). Performance metrics are determined by laboratory measurements according to established test standards (e.g., for BFE/VFE, resistance to flow, moisture loss).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI vs. Without AI Assistance

No. This is a hardware medical device (breathing system filter), not an AI-powered diagnostic or therapeutic tool. Therefore, MRMC studies and AI assistance are not applicable.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

No. This is not an algorithm or AI device. The performance data presented is the "standalone" performance of the physical device itself in a laboratory setting.

7. The Type of Ground Truth Used

For physical performance metrics (filtration efficiency, resistance to flow, internal volume, moisture loss), the ground truth is derived from standardized laboratory testing methods and measurements. These methods are designed to objectively quantify the device's physical properties under controlled conditions. This is not pathology, expert consensus (in the clinical sense), or outcomes data.

8. The Sample Size for the Training Set

Not Applicable. This is a physical device, not a machine learning model. Therefore, there is no "training set" in the context of AI/ML. The device's design and manufacturing processes are refined based on engineering principles and material science, not data training.

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

Not Applicable. (See point 8).

Summary of the Study Proving Device Meets Acceptance Criteria:

The document states that the performance data for filtration efficiency was "[measured] by Nelson Lab." It also lists other performance characteristics such as resistance to flow, internal volume, and moisture loss. The study demonstrating that the device meets criteria is implicitly the laboratory testing conducted by Nelson Laboratories and Dräger Medical's internal R&D, which measured these specific physical and biological filtration properties of the filters.

The overall claim of the 510(k) submission is Substantial Equivalence. This means the applicant argues that the proposed devices (Filter CareStar 30, Filter SafeStar 55, Filter/HME TwinStar 55) are as safe and effective as existing, legally marketed predicate devices (listed in the document). The "study" isn't a comprehensive clinical trial but rather a comparison of key performance data to established values of predicate devices and relevant ISO/EN standards. The document states:

"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."

The acceptance criteria are therefore implicitly defined by the performance benchmarks set by these predicate devices and relevant industry standards (like EN ISO 5326 and ISO 9360), which the new devices' laboratory test results must meet or demonstrate equivalence to. The FDA's clearance (K072002) signifies their agreement that this substantial equivalence has been demonstrated.

Summary

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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 (451) 882-5367 Fax No.: + 49 (451) 882-7-5367

Applicants US Contact Person

Ms. Kathy Anderson Sr. Director Regulatory Affairs

Tel. No .: (215) 660-2078 Fax No .: (215) 721-5424

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

Drägermedical

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/SDatex-Ohmeda Uni-Filter Junior	Datex-Ohmeda
K014282	Bacstop, Bacstop mini, Bacstop Humini	Munktell
K013089	EMS HEPA Filter	EMS

Device Description:

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.

	FilterCareStar 30MP01770	FilterSafeStar 55MP01790	Filter/HMETwinStar 55MP01805
Filtration efficiency(by Nelson Lab.)	99.999% (BFE)99.99% (VFE)	99.9999% (BFE)99.9999% (VFE)	99.999% (BFE)99.99% (VFE)
Filtration mechanism	electrostatic	mechanical	electrostatic
Resistance to flow	(0.7 cmH2Oat 30 L/min)	(1.4 cmH2Oat 30 L/min)	(0.7 cmH2Oat 30 L/min)
Internal volume	30 mL	55 mL	55 mL

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Breathing System Filters

A Dräger and Siemens Company

FilterCareStar 50MP01770-10	FilterSafeStar 55MP01790	Filter / HMESafeStar 55MP01790
Recommended tidalvolume	100 to 1500 mL	200 to 1500 mL	200 to 1500 mL
Conical connectorsISO 5356	22m/15f - 22f/15m	22m/15f - 22f/15m	22m/15f - 22f/15m
moisture lossISO 9360	No	No	7,1 mg/Lat VT = 500 mL
Gas sampling port	Yes	Yes	Yes
Materials:
Housing:	PP	PP	PP
Filter medium	PP with synth. fibres	Paper with glassfibre	Paper with glassfibre

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 heatand moisture exchangers (HMEs) for humidifying respired gases inhumans
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 (240) 276-0120. 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 (800) 638-2041 or (301) 443-6597 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:

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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510(k) Number:

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).