Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical filtration and humidification properties of the breathing circuit filters, with no mention of AI or ML capabilities.

Therapeutic

No.
These devices are described as breathing circuit filters and heat and moisture exchangers that filter air against contaminants and humidify respired gases. They do not directly treat a disease or condition.

Diagnostic

No
The device description states that the product is a "breathing circuit filter" used to "filter the inhaled and/or the exhaled air of the patient against microbiological and particulate matter." This indicates a therapeutic or supportive function rather than a diagnostic one.

SaMD (Software as a Medical Device)

No

The device description clearly states the devices are physical breathing circuit filters enclosing filter material in a housing, and some include foam for HME function. This indicates a hardware device, not software only.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health, such as diagnosing a disease or monitoring a condition.
Device Function: The description clearly states that these devices are "breathing circuit filters used to filter the inhaled and/or the exhaled air of the patient against microbiological and particulate matter from the gases in the breathing circuit." They are designed to protect the patient and the equipment from contamination within the breathing system.
Intended Use: The intended use is for "Bidirectionally breathing system filter against bacterial and viral contamination for anesthetic and respiratory use." This is a function related to the delivery of gases to and from the patient, not the analysis of bodily specimens.
No Specimen Analysis: There is no mention of the device analyzing any biological samples from the patient.

Therefore, these breathing system filters fall under the category of medical devices used in respiratory and anesthetic care, but they are not IVDs.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Filter CareStar Plus Intended use Bidirectionally breathing system filter against bacterial and viral contamination for anesthetic and respiratory use.

Indications

All devices are intended for single use up to 24 hours and must be used by trained medical personnel only. The devices are designed for use with ventilators and anesthesia machines.

They are intended for use in pediatric (with a tidal volume between 100 and adult patients, depending on the respective device.

Filter SafeStar Plus Intended use Bidirectionally breathing system filter against bacterial and viral contamination for anesthetic and respiratory use.

Indications

All devices are intended for single use up to 24 hours and must be used by trained medical personnel only. The devices are designed for use with ventilators and anesthesia machines. They are intended for use in adult patients.

Filter/HME TwinStar Plus

Intended use

Bidirectionally breathing system filter against bacterial and viral contamination for anesthetic and for respiratory use, as well as heat and moisture exchanger for humidifying respired gases for the patient.

Indications

All devices are intended for single use up to 24 hours and must be used by trained medical personnel only. The devices are designed for use with ventilators and anesthesia machines.

They are intended for use in adult, pediatric and neonatal patients, depending on the respective device.

Product codes (comma separated list FDA assigned to the subject device)

CAH

Device Description

The devices are breathing circuit filters used to filter the inhaled and/or the exhaled air of the patient against microbiological and particulate matter from the gases in the breathing circuit. They enclose a filter material in a housing that fits to standard breathing system connectors.

Additionally, there are breathing system filters combined with a foam to function as HME (Heat and Moisture Exchangers) for passively humidifying the inspired air.

The portfolio contains the following types of breathing circuit filters:

Filter CareStar Plus are electrostatic filters for use against contamination with microorganisms
. Filter SafeStar Plus are mechanical filters for use against contamination with microorganisms
Filter/HME TwinStar Plus are filters for use against contamination with microorganisms and for passive humidification of breathing gases

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Filter CareStar Plus: pediatric (with a tidal volume between 100 and 500 ml) and adult patients
Filter SafeStar Plus: adult patients
Filter/HME TwinStar Plus: adult, pediatric and neonatal patients

Intended User / Care Setting

trained medical personnel only. The devices are designed for use with ventilators and anesthesia machines.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-clinical testing was performed for biocompatibility; technical system requirements, including technical data and essential safety and performance; connectors; and human factors engineering. Key results include:

ISO 9360-1:2000 (Determination and Evaluation of Pneumatic Compliance, Pneumatic Leakage, Pressure Drop (Pneumatic Resistance)) - PASSED
ISO 5356-1:2015 (Evaluation of Conical Connectors) - PASSED
ISO 80369-7:2021 (Luer Lock Connector) - PASSED
IEC 60601-1:2005 (Product's Ability to Withstand Damage from Dropping) - PASSED
ISTA 3A (Product Durability During Transport, Mechanical Aspects) - PASSED
ISO 23328-1:2003 (Filtration Efficiency (Particulate Matter) incl. Usage Time) - PASSED
ASTM F2101:2019 (Filtration Efficiency (Viral and Bacterial)) - PASSED
ISO 10993:2018 and ISO 18562-1:2017 (Evaluation of Product's Biological Compatibility) - PASSED
ISO 9360-1:2000 (Evaluation of HME Water Loss, Resistance) - PASSED

Clinical Testing: N/A.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Filtration efficiency (Filter CareStar Plus): BFE: >= 99,99%, VFE: >= 99,9 %
Filtration efficiency (Filter SafeStar Plus): BFE: >= 99,999 %, VFE: >= 99,999 %
Filtration efficiency (Filter/HME TwinStar Plus): BFE: >= 99,98 %, VFE: >= 99,9 %

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K202459, K191909, K132709

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K013122

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 7, 2022

Drägerwerk AG & Co. KGaA Luise Lang Regulatory Affairs Manager Moislinger Allee 53-55 Lüebeck, Schleswig-Holstein 23542 Germany

Re: K221836

Trade/Device Name: Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus Regulation Number: 21 CFR 868.5260 Regulation Name: Breathing Circuit Bacterial Filter Regulatory Class: Class II Product Code: CAH Dated: November 4, 2022 Received: November 4, 2022

Dear Luise Lang:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

1

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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-

combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Bifeng Qian -S

Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K221836

Device Name

Filter CareStar Plus / Filter SafeStar Plus / Filter/HME TwinStar Plus

Indications for Use (Describe) Filter CareStar Plus Intended use Bidirectionally breathing system filter against bacterial and viral contamination for anesthetic and respiratory use.

Indications

All devices are intended for single use up to 24 hours and must be used by trained medical personnel only. The devices are designed for use with ventilators and anesthesia machines.

They are intended for use in pediatric (with a tidal volume between 100 and adult patients, depending on the respective device.

Filter SafeStar Plus Intended use Bidirectionally breathing system filter against bacterial and viral contamination for anesthetic and respiratory use.

Indications

All devices are intended for single use up to 24 hours and must be used by trained medical personnel only. The devices are designed for use with ventilators and anesthesia machines. They are intended for use in adult patients.

Filter/HME TwinStar Plus

Intended use

Bidirectionally breathing system filter against bacterial and viral contamination for anesthetic and for respiratory use, as well as heat and moisture exchanger for humidifying respired gases for the patient.

Indications

All devices are intended for single use up to 24 hours and must be used by trained medical personnel only. The devices are designed for use with ventilators and anesthesia machines.

They are intended for use in adult, pediatric and neonatal patients, depending on the respective device.

Type of Use (Select one or both, as applicable)

X | Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Image /page/4/Picture/1 description: The image shows the word "Dräger" in a bold, blue font. The "ä" in Dräger has two dots above it. The word is the logo for the Dräger company, which specializes in medical and safety technology.

Traditional 510(k) - K221836 510(k) Summary

510(k) Premarket Notification Summary
Submitter:	Drägerwerk AG & Co. KGaA
Moislinger Allee 53-55
23542 Lübeck, Germany
Establishment's registration number: 9611500
Contact Person:	Dr. Bettina Moebius
Head of Regulatory Affairs Central
E-Mail: Bettina.moebius@draeger.com
Telephone: +49 451 882 4100
Applicant's US Contact Person:	Tom Hirte
Head of Regulatory Affairs
E-Mail: tom.hirte@draeger.com
Telephone: (978) 3796461
Date prepared:	December 6, 2022
Device Name:	Trade Name:	Filter CareStar Plus,
Filter SafeStar Plus,
Filter/HME TwinStar Plus
	Classification Name:
Regulation Number:
Product Code:
Class:	Filter, Bacterial,
Breathing Circuit
21 CFR § 868.5260
CAH
II

Predicate Device:

The Filter CareStar Plus is substantially equivalent to the Bact-Trap from Pharma Systems AB (K202459).

The Filter SafeStar Plus is substantially equivalent to the HepaShield Breathing System Filter from Flexicare Medical Limited (K191909)

The Filter/HME TwinStar Plus is substantially equivalent to VR Medical Heat and Moisture Exchanger Filter from VR Medical Technology Co. (K132709).

Reference Device (for Filter/HME TwinStar Plus):

EMS Electra Filter and Filter/HME (K013122)

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Image /page/5/Picture/1 description: The image shows the word "Dräger" in blue font. The font is bold and sans-serif. The two dots above the "a" are also blue. The word is likely a logo for the Dräger company, which is a German company that makes medical and safety technology.

Traditional 510(k)

510(k) Summary

Device Description

The devices are breathing circuit filters used to filter the inhaled and/or the exhaled air of the patient against microbiological and particulate matter from the gases in the breathing circuit. They enclose a filter material in a housing that fits to standard breathing system connectors.

Additionally, there are breathing system filters combined with a foam to function as HME (Heat and Moisture Exchangers) for passively humidifying the inspired air.

The portfolio contains the following types of breathing circuit filters:

Filter CareStar Plus are electrostatic filters for use against contamination with microorganisms
. Filter SafeStar Plus are mechanical filters for use against contamination with microorganisms
Filter/HME TwinStar Plus are filters for use against contamination with microorganisms and for passive humidification of breathing gases

Indications for Use

Filter CareStar Plus

Intended use

Bidirectionally breathing system filter against bacterial and viral contamination for anesthetic and respiratory use.

Indications

All devices are intended for single use up to 24 hours and must be used by trained medical personnel only. The devices are designed for use with ventilators and anesthesia machines.

They are intended for use in pediatric (with a tidal volume between 100 and 500 ml) and adult patients, depending on the respective device.

Filter SafeStar Plus:

Intended use

Bidirectionally breathing system filter against bacterial and viral contamination for anesthetic and respiratory use.

Indications

All devices are intended for single use up to 24 hours and must be used by trained medical personnel only. The devices are designed for use with ventilators and anesthesia machines. They are intended for use in adult patients.

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Image /page/6/Picture/1 description: The image shows the word "Dräger" in a bold, sans-serif font. The word is blue. The two dots above the "a" are also blue. The word is easily readable and the image is clear.

Traditional 510(k)

510(k) Summary

Filter/HME TwinStar Plus:

Intended use

Bidirectionally breathing system filter against bacterial and viral contamination for anesthetic and for respiratory use, as well as heat and moisture exchanger for humidifying respired gases for the patient.

Indications

All devices are intended for single use up to 24 hours and must be used by trained medical personnel only. The devices are designed for use with ventilators and anesthesia machines. They are intended for use in adult, pediatric and neonatal patients, depending on the respective device.

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Traditional 510(k) 510(k) Summary

Comparison to Predicate

Filter CareStar Plus

Specification	Proposed Device	Predicate Device	Comments
	Filter CareStar Plus	Bact-Trap
Manufacturer	Drägerwerk AG & Co. KGaA	Pharma Systems AB	-
510(k) Number	K221836	K202459	-
Regulation Number	868.5260 Breathing circuit bacterial filter	868.5260 Breathing circuit bacterial filter	Same
Product Code	CAH	CAH	Same
Classification	Class II	Class II	Same
Intended Use/
Indications for Use	Bidirectionally breathing system filter
against bacterial and viral contamination
for anesthetic and respiratory use.

All devices are intended for single use up
to 24 hours and must be used by trained
medical personnel only. The devices are
designed for use with ventilators and
anesthesia machines.

They are intended for use in pediatric (with
a tidal volume between 100 and 500 ml)
and adult patients, depending on the
respective device. | Bact Trap filter is a breathing system
filter which is designed to reduce
possible airborne or liquid-borne cross
contamination with microrganisms and
particulate matter via anaesthetic or
ventilator breathing systems.

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Image /page/8/Picture/0 description: The image shows the word "Dräger" in a bold, sans-serif font. The word is blue. The two dots above the "a" are also blue.

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Image /page/9/Picture/0 description: The image shows the word "Dräger" in blue font. The font is bold and sans-serif. The two dots above the "a" are also blue and are slightly larger than the rest of the letters. The word is centered and takes up most of the image.

Traditional 510(k)

510(k) Summary

| Specification | Proposed Device
Filter CareStar Plus | Predicate Device
Bact-Trap | Comments |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|
| Connectors | Standard conical connectors
Luer lock port for gas sampling | Standard conical connectors
Luer lock port for gas sampling | Same |
| General Performance | | | |
| Resistance | @30 l/min: ≤ 1.3 mbar | @30 l/min: = 1.1 mbar | Similar |
| Filtration efficiency | BFE: ≥ 99,99%
VFE: ≥ 99,9 % | BFE: > 99,999 %
VFE: > 99,99 % | Similar |
| Shelf-Life | 3 years | 3 years | Same |
| Dead Space | 20 to 35 ml | 23 to 76 ml | Similar |
| Leakage at 70 mbar | ≤ 15 ml / min | Not stated | - |
| Compliance | ≤ 1 ml / kPa | Not stated | - |
| Specification | Proposed Device | Predicate Device | Comments |
| | Filter SafeStar Plus | HepaShield Breathing System Filter | |
| Manufacturer | Drägerwerk AG & Co. KGaA | Flexicare Medical Limited | |
| 510(k) Number | K221836 | K191909 | |
| Regulation Number | 868.5260 Breathing circuit bacterial filter | 868.5260 Breathing circuit bacterial filter | Same |
| Product Code | CAH | CAH | Same |
| Classification | Class II | Class II | Same |
| Intended Use /
Indications for Use | Bidirectionally breathing system filter
against bacterial and viral contamination
for anesthetic and respiratory use.
All devices are intended for single use up
to 24 hours and must be used by trained
medical personnel only. The devices are
designed for use with ventilators and
anesthesia machines.
They are intended for use in adult
patients. | Flexicare's HepaShield Bacterial Viral
Breathing System Filters are intended to
reduce the transmission of bacteria and
viruses to/from a patient during
anesthesia. For use with ventilators,
anesthesia machines and open flow
systems where filtration of inspired
and/or expired gases is desired.
Flexicare's HepaShield Bacterial Viral
Breathing System Filters are single use
devices for use on a single patient for up
to 24hrs and are available in adult size.
Flexicare's HepaShield Bacterial Viral
Breathing System Filters are designed to
be used in hospital environments by
trained personnel. | Similar |
| Patient Population | Adult patients with a tidal volume from 100
to 1500 ml | Adult patients with a tidal volume of 141
to 800 ml | Similar |
| Device configuration | Straight and angular versions with luer
port | Straight with luer port | Similar |

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Image /page/10/Picture/1 description: The image shows the word "Dräger" in a bold, sans-serif font. The word is a dark blue color. The two dots above the "a" are also dark blue. The background is white.

Traditional 510(k)

510(k) Summary

Filter SafeStar Plus

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Image /page/11/Picture/0 description: The image shows the word "Dräger" in a bold, sans-serif font. The word is blue. The two dots above the "a" are also blue.

Traditional 510(k)	510(k) Summary
Materials	Housing: Polypropylene
Filter media: Paper with glass fibers
Casting compound: Polyolefin	Unknown	-
Sterility	Non-sterile	Sterile and no-sterile variants	similar
Application	Disposable
Up to 24h	Disposable
Up to 24h	Same
Biocompatibility testing	ISO 10993 and ISO 18562-1 compliant	ISO 10993 and ISO 18562-1 compliant	Same
Filtration performance	ISO 23328-1 compliant and ASTM F2101
compliant	ISO 23328-1 compliant and ASTM F2101
compliant	Same
Compliance, Leakage
and pressure drop	ISO 23328-2 and ISO 9360-1 compliant	ISO 23328-2 and ISO 9360-1 compliant	Same
Technological Characteristics
Principle of Operation	Mechanical filtration method	Mechanical filtration method	Same

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Image /page/12/Picture/0 description: The image shows the word "Dräger" in a bold, sans-serif font. The word is a dark blue color. The two dots above the "a" are also dark blue. The logo is simple and modern.

Traditional 510(k)

510(k) Summary

Specification	Proposed Device	Predicate Device	Comments
	Filter SafeStar Plus	HepaShield Breathing System Filter
Connectors	Standard conical connectors
Luer lock port for gas sampling	Standard conical connectors
Luer lock port for gas sampling	Same
General Performance
Resistance	@30 l/min: ≤ 2 mbar	@30 l/min: = 1.7 mbar	Similar
Filtration efficiency	BFE: ≥ 99,999 %
VFE: ≥ 99,999 %	BFE: 99,99999 %
VFE: 99,9999 %	Similar
Shelf-Life	5 years	5 years	Same
Dead Space	55 to 90 ml	47 ml	Different
Leakage at 70 mbar	≤ 15 ml / min	150 cc.	Similar
Device configuration	Straight and angular versions with
luer port	-	-	-
Materials	Housing: Polypropylene
Filter media: Polypropylene with
synthetic fibers (except Filter/HME
TwinStar HEPA Plus, which uses paper
with glass fibers)
HME-Media: Polyurethane
impregnated with calcium chloride	Housing: K-Resine
Filter media: Polyolefin synthetic
fibers (except VR005 which uses
paper with glass fibers)
HME-Media: Polyurethane
impregnated with calcium chloride	Housing: Polystyrene
Filter media: Electrostatic
polypropylene	Different
Sterility	Non-sterile	Non-sterile	Unknown	Same
Traditional 510(k)	510(k) Summary
Application	Disposable
up to 24 hours	Disposable
up to 24 hours	Disposable
up to 24 hours	Same
Biocompatibility
testing	ISO 10993 and ISO 18562-1
compliant	ISO 10993 compliant	Unknown	Similar
Filtration
performance	ISO 23328-1 compliant and ASTM
F2101 compliant	ISO 23328-1 compliant	Unknown	Similar
Compliance,
Leakage and
pressure drop	ISO 23328-2 and ISO 9360-1
compliant	Unknown	Unknown	-
Technological Characteristics
Principle of
Operation	Electrostatic or mechanical
filtration method combined with a
foam for passive humidification	Electrostatic or mechanical
filtration method combined with a
foam for passive humidification	Electrostatic filtration method
combined with a foam for passive
humidification	Same
Traditional 510(k)	510(k) Summary
Connectors	Standard conical connectors
Luer lock port for gas sampling	Standard conical connectors
Luer lock port for gas sampling	Standard conical connectors
Luer lock port for gas sampling	Same
General Performance
Resistance
Adult	@30 l/min: ≤ 1.6 mbar	@30 l/min: ≤ 1.5 mbar	@30 l/min: not stated	Similar
Neonatal /
Pediatric	@15 l/min: ≤ 1.5 mbar	-	@20 l/min: 1.0 cmH2O
Filtration efficiency
BFE
VFE	≥ 99,98 %
≥ 99,9 %	99.999 %
99.99%	≥ 99.999 %
≥ 99.99 %	Similar
Moisture loss / Moisture return¹
Adult	Moisture loss @ Vt= 500 ml
≤ 10.9 mg/l
(which results in a moisture return
of ≥ 33,1 mg/l)	Moisture loss @ Vt = 500 ml:
≤ 10.5 mg/l	Moisture return @ Vt = 1000 cc:
= 32 mg/l	Similar
Pediatric	Moisture loss @ Vt = 250 ml:
≤ 11.8 mg/l
(which results in a moisture return
of ≥ 32,2 mg/l)	-	Moisture return@ Vt = 250 cc:
= 32 mg/l	Similar
Neonatal	Moisture loss @ Vt=50ml:
≤ 10.3 mg/l
(which results in a moisture return
of ≥ 33.7 mg/l)	-	Moisture return @ Vt= 50 ml:
= 30 mg/l	Similar
Shelf-Life	3 or 5 years, depending on the
respective device	Not stated	Not stated	-
Dead space	9 to 90 ml	60 to 85 ml	10 to 65 ml	Similar
Leakage at 70 mbar	≤ 15ml / min	-	-	-
Compliance	≤ 1ml / kPa	-	-	-

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Traditional 510(k) 510(k) Summary

Filter/HME TwinStar Plus

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Image /page/14/Picture/0 description: The image shows the word "Dräger" in blue font. The font is bold and sans-serif. The two dots above the "a" are also blue. The word is likely a logo for the Dräger company, which is a German company that makes medical and safety technology.

Traditional 510(k)

510(k) Summary

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Image /page/16/Picture/0 description: The image shows the word "Dräger" in blue font. The word is written in a bold, sans-serif font. The two dots above the "a" are also blue. The background is white.

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Traditional 510(k) 510(k) Summary

Image /page/17/Picture/5 description: The image shows the word "Dräger" in blue font. The "ä" in Dräger has two dots above it. The font is bold and sans-serif. The background is white.

1 Moisture return = 44 mg/l – moisture loss

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Image /page/18/Picture/1 description: The image shows the word "Dräger" in a bold, sans-serif font. The word is blue. The two dots above the "a" are also blue.

Traditional 510(k) 510(k) Summary

Discussion of Non-clinical Testing

The devices Filter CareStar Plus, Filter SafeStar Plus and Filter/HME TwinStar Plus are new products and have undergone extensive testing to qualify it with e.g. national and international consensus standards, technical system requirements and other requirements. The following identified verification and validation activities necessary to establish substantial equivalence to the predicate device were carried out and wellestablished method, the evidence is included in this 510(k) submission.

Biocompatibility ●
Technical system requirements, including
- o Technical data
- o Essential safety and performance
Connectors .
Human factors engineering .

Summary of non-clinical testing

Test method	Purpose	Acceptance criteria	Result
ISO 9360-1:2000	Determination and
Evaluation of Pneumatic
Compliance	compliance is less than or
equal to 1mL/kPa at 15,
30, 60, and 70 hPa	PASSED
ISO 9360-1:2000	Determination and
Evaluation of Pneumatic
Leakage	pneumatic leakage is less
than or equal to 50mL/min
at 70hPa.	PASSED
ISO 9360-1:2000	Determination and
Evaluation of Pressure
Drop (Pneumatic
Resistance)	pneumatic
resistance/pressure drop is
acc. to IfU value	PASSED
ISO 5356-1:2015	Evaluation of Conical
Connectors (ISO 5356-1)	cone dimensions comply
with ISO 5356-1.	PASSED
ISO 80369-7:2021	Luer Lock Connector
(ISO 80369-7)	Luer-Lock connector fulfills
the requirements laid out
in ISO 80369-7.	PASSED
IEC 60601-1:2005	Product's Ability to
Withstand Damage from
Dropping	When dropped, the
product should not suffer
any damage which
influences its function.	PASSED

ISTA 3A	Product Durability During
Transport, Mechanical
Aspects	- the packaging shows no
or minor damage

the DUT shows no signs
of damage and retains
functionality after
simulated transport. | PASSED |
| ISO 23328-1:2003 | Filtration Efficiency
(Particulate Matter) incl.
Usage Time | - adult and pediatric
electrostatic filters achieve
a filtration efficiency of

90% before and after the
specified usage time

neonatal filters achieve a
filtration efficiency
of >75% before and after
the specified usaqe time
mechanical filters
achieve a filtration
efficiency of >99% before
and after the specified
usage time
mechanical filters
achieve a HEPA
classification ≥ class H13 | PASSED |
| ASTM F2101:2019 | Filtration Efficiency (Viral
and Bacterial) | - electrostatic filters
achieve 99.99% (bacterial)
and 99.9% (viral) filtration
efficiency
electrostatic filters for neo
applications achieve
99.98% (bacterial) and
99.9% (viral) filtration
efficiency. | PASSED |
| ISO 10993:2018
and ISO 18562-
1:2017 | Evaluation of Product's
Biological Compatibility
(ISO 10993:2018 and
ISO 18562-1:2017) | evaluation according
to ISO 10993:2018 and/or
ISO 18562-1:2017 | PASSED |
| ISO 9360-1:2000 | Evaluation of HME Water
Loss, Resistance | ·pediatric/neonatal: The
moisture loss shall be