Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus
Device Facts
| Record ID | K221836 |
|---|---|
| Device Name | Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus |
| Applicant | Drägerwerk AG & Co. KGaA |
| Product Code | CAH · Anesthesiology |
| Decision Date | Dec 7, 2022 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.5260 |
| Device Class | Class 2 |
| Attributes | Pediatric |
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.
Device Story
Breathing circuit filters; designed for use with ventilators and anesthesia machines; filter inhaled/exhaled gases against microbiological/particulate matter. Filter CareStar Plus uses electrostatic filtration; Filter SafeStar Plus uses mechanical filtration; Filter/HME TwinStar Plus combines filtration with foam for passive humidification (HME). Devices feature standard conical connectors and luer ports for gas sampling. Used in clinical settings by trained medical personnel. Output is filtered, humidified (TwinStar) gas delivered to patient. Benefits include reduced cross-contamination risk and maintenance of airway moisture.
Clinical Evidence
No clinical data. Bench testing only. Performance validated against ISO 23328-1/2, ISO 9360-1, and ASTM F2101 standards. Testing confirmed filtration efficiency (BFE/VFE), pneumatic compliance, leakage, pressure drop, and moisture return/loss metrics meet specified acceptance criteria.
Technological Characteristics
Housing: Polypropylene (SafeStar Plus includes paper/glass fibers). Filtration: Electrostatic or mechanical (HEPA class H13 for mechanical). HME: Polyurethane foam impregnated with calcium chloride. Connectivity: Standard conical connectors with luer lock. Standards: ISO 23328-1/2, ISO 9360-1, ISO 5356-1, ISO 80369-7, ASTM F2101, ISO 10993, ISO 18562-1. Non-sterile.
Indications for Use
Indicated for bacterial and viral filtration in anesthetic and respiratory breathing circuits. Filter CareStar Plus: pediatric (100-500ml tidal volume) and adult patients. Filter SafeStar Plus: adult patients. Filter/HME TwinStar Plus: adult, pediatric, and neonatal patients. All devices are for single-patient use up to 24 hours by trained medical personnel.
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
- Bact-Trap (K202459)
- HepaShield Breathing System Filter (K191909)
- VR Medical Heat and Moisture Exchanger Filter (K132709)
Reference Devices
- EMS Electra Filter and Filter/HME (K013122)
Submission Summary (Full Text)
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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.
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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)
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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<br>Moislinger Allee 53-55<br>23542 Lübeck, Germany<br>Establishment's registration number: 9611500 | |
| Contact Person: | Dr. Bettina Moebius<br>Head of Regulatory Affairs Central<br>E-Mail: Bettina.moebius@draeger.com<br>Telephone: +49 451 882 4100 | |
| Applicant's US Contact Person: | Tom Hirte<br>Head of Regulatory Affairs<br>E-Mail: tom.hirte@draeger.com<br>Telephone: (978) 3796461 | |
| Date prepared: | December 6, 2022 | |
| Device Name: | Trade Name: | Filter CareStar Plus,<br>Filter SafeStar Plus,<br>Filter/HME TwinStar Plus |
| | Classification Name:<br>Regulation Number:<br>Product Code:<br>Class: | Filter, Bacterial,<br>Breathing Circuit<br>21 CFR § 868.5260<br>CAH<br>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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## 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/<br>Indications for Use | Bidirectionally breathing system filter<br>against bacterial and viral contamination<br>for anesthetic and respiratory use.<br><br>All devices are intended for single use up<br>to 24 hours and must be used by trained<br>medical personnel only. The devices are<br>designed for use with ventilators and<br>anesthesia machines.<br><br>They are intended for use in pediatric (with<br>a tidal volume between 100 and 500 ml)<br>and adult patients, depending on the<br>respective device. | Bact Trap filter is a breathing system<br>filter which is designed to reduce<br>possible airborne or liquid-borne cross<br>contamination with microrganisms and<br>particulate matter via anaesthetic or<br>ventilator breathing systems.<br><br>The Bact Trap filter may either be used<br>on the patient side or on the device side<br>of the ventilator anaesthetic device. | Similar |
| Patient Population | Adult and pediatric patients with a tidal<br>volume from 100 to 1500 ml | Adult patients with a tidal volume from 50<br>to 1500 ml | Similar |
| Device configuration | Straight with luer port | - | - |
| Materials | Housing: Polypropylene<br>Filter media: Polypropylene with synthetic<br>fibers | Housing: SBC, Polypropylene, Polyethylene<br>Filter media: Acrylic and Polypropylene fibers | Similar |
| Traditional 510(k) | 510(k) Summary | | |
| Sterility | Non-sterile | Non sterile | Same |
| Application | Disposable<br>up to 24 hours | Disposable<br>up to 24 hours | 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 and ASTM F2101 compliant | Same |
| Compliance, leakage<br>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 | Electrostatic filtration method | Electrostatic filtration method | Same |
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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<br>Filter CareStar Plus | Predicate Device<br>Bact-Trap | Comments |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|
| Connectors | Standard conical connectors<br>Luer lock port for gas sampling | Standard conical connectors<br>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%<br>VFE: ≥ 99,9 % | BFE: > 99,999 %<br>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 /<br>Indications for Use | Bidirectionally breathing system filter<br>against bacterial and viral contamination<br>for anesthetic and respiratory use.<br>All devices are intended for single use up<br>to 24 hours and must be used by trained<br>medical personnel only. The devices are<br>designed for use with ventilators and<br>anesthesia machines.<br>They are intended for use in adult<br>patients. | Flexicare's HepaShield Bacterial Viral<br>Breathing System Filters are intended to<br>reduce the transmission of bacteria and<br>viruses to/from a patient during<br>anesthesia. For use with ventilators,<br>anesthesia machines and open flow<br>systems where filtration of inspired<br>and/or expired gases is desired.<br>Flexicare's HepaShield Bacterial Viral<br>Breathing System Filters are single use<br>devices for use on a single patient for up<br>to 24hrs and are available in adult size.<br>Flexicare's HepaShield Bacterial Viral<br>Breathing System Filters are designed to<br>be used in hospital environments by<br>trained personnel. | Similar |
| Patient Population | Adult patients with a tidal volume from 100<br>to 1500 ml | Adult patients with a tidal volume of 141<br>to 800 ml | Similar |
| Device configuration | Straight and angular versions with luer<br>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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| Traditional 510(k) | 510(k) Summary | | |
|------------------------------------------|-------------------------------------------------------------------------------------------------|---------------------------------------------------|---------|
| Materials | Housing: Polypropylene<br>Filter media: Paper with glass fibers<br>Casting compound: Polyolefin | Unknown | - |
| Sterility | Non-sterile | Sterile and no-sterile variants | similar |
| Application | Disposable<br>Up to 24h | Disposable<br>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<br>compliant | ISO 23328-1 compliant and ASTM F2101<br>compliant | Same |
| Compliance, Leakage<br>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<br>Luer lock port for gas sampling | Standard conical connectors<br>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 %<br>VFE: ≥ 99,999 % | BFE: 99,99999 %<br>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 | < 2ml / min | Different | |
| Compliance | ≤ 1 ml / kPa | 0.057 ml / cmH2O | Similar | |
| Specification | Proposed Device | Predicate Device | Reference Device | Comments |
| | Filter/HME TwinStar Plus | VR Medical Heat and Moisture<br>Exchanger Filter | EMS Electra Filter and Filter/HME | |
| Manufacturer | Drägerwerk AG & Co. KGaA | VR Medical Technology Co. | Engineered Medical Systems,<br>Inc. | |
| 510(k) Number | K221836 | K132709 | K013122 | |
| Regulation Number | 868.5260 Breathing circuit<br>bacterial filter | 868.5260 Breathing circuit<br>bacterial filter | 868.5260 Breathing circuit<br>bacterial filter | Same |
| Product Code | CAH | CAH | CAH | Same |
| Classification | Class II | Class II | Class II | Same |
| Intended Use /<br>Indications for Use | Bidirectionally breathing system<br>filter against bacterial and viral<br>contamination for anesthetic and<br>for respiratory use, as well as heat<br>and moisture exchanger for<br>humidifying respired gases for the<br>patient.<br>All devices are intended for single<br>use up to 24 hours and must be<br>used by trained medical personnel<br>only. The devices are designed for<br>use with ventilators and<br>anesthesia machines.<br>They are intended for use in adult,<br>pediatric and neonatal patients,<br>depending on the respective<br>device. | The Heat and Moisture<br>Exchanger and Filter is a<br>disposable single-use device<br>indicated for patient…
