(167 days)
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.
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
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The provided document describes three devices: Filter CareStar Plus, Filter SafeStar Plus, and Filter/HME TwinStar Plus. The table below compiles the acceptance criteria and reported performance for these devices based on the "Summary of non-clinical testing" section (pages 18-19).
| Test Method & Purpose | Acceptance Criteria | Reported Performance |
|---|---|---|
| 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 (Device Under Test) 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 usage 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 | 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 <=11mg/L at VT=50ml· pediatric: The moisture loss shall be <=12mg/L at VT=250ml· adult: The moisture loss shall be <=11mg/L at VT=500ml | PASSED |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample sizes used for each non-clinical test. It mentions that "The devices... have undergone extensive testing" but does not detail the number of units tested for each criterion. The data provenance is also not specified; however, given that the submitter is "Drägerwerk AG & Co. KGaA" based in "Lübeck, Germany" and they tested against international standards (ISO, ASTM, IEC), it is likely that the testing was conducted in a controlled laboratory environment, potentially in Germany or by a certified testing facility adhering to these standards. The testing appears to be prospective, specifically designed to verify the devices' adherence to the mentioned standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not mention the use of experts to establish ground truth for the non-clinical test set. The validation relies on adherence to established international and national standards (e.g., ISO, ASTM, IEC) rather than expert consensus on a test set. This implies that the "ground truth" is defined by the objective metrics and methodologies outlined in these standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
There is no mention of an adjudication method in the text for the non-clinical test set. Given the nature of the tests (physical and performance characteristics against standards), it's a pass/fail determination based on quantitative measurements against predefined criteria, not a subjective assessment requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
The document explicitly states "Summary of Clinical Testing N/A" (page 20). This indicates that no clinical studies, including MRMC comparative effectiveness studies involving human readers or AI assistance, were performed or submitted. The entire submission focuses on non-clinical performance and substantial equivalence based on technical characteristics and adherence to standards.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Since the devices are breathing circuit filters and not software or AI-powered devices, the concept of a "standalone (algorithm only)" performance study is not applicable. The device's performance is intrinsically mechanical and material-based, not algorithmic.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for this submission is based on established international and national consensus standards (e.g., ISO 9360-1, ISO 5356-1, ISO 80369-7, IEC 60601-1, ISTA 3A, ISO 23328-1, ASTM F2101, ISO 10993, ISO 18562-1). The device's performance is measured against the quantitative requirements and methodologies specified within these standards.
8. The sample size for the training set
This question is not applicable. The document describes physical medical devices (filters), not machine learning or AI models that require a "training set."
9. How the ground truth for the training set was established
This question is not applicable, as there is no training set for these devices.
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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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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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. KGaAMoislinger Allee 53-5523542 Lübeck, GermanyEstablishment's registration number: 9611500 | |
| Contact Person: | Dr. Bettina MoebiusHead of Regulatory Affairs CentralE-Mail: Bettina.moebius@draeger.comTelephone: +49 451 882 4100 | |
| Applicant's US Contact Person: | Tom HirteHead of Regulatory AffairsE-Mail: tom.hirte@draeger.comTelephone: (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 Circuit21 CFR § 868.5260CAHII |
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 filteragainst bacterial and viral contaminationfor anesthetic and respiratory use.All devices are intended for single use upto 24 hours and must be used by trainedmedical personnel only. The devices aredesigned for use with ventilators andanesthesia machines.They are intended for use in pediatric (witha tidal volume between 100 and 500 ml)and adult patients, depending on therespective device. | Bact Trap filter is a breathing systemfilter which is designed to reducepossible airborne or liquid-borne crosscontamination with microrganisms andparticulate matter via anaesthetic orventilator breathing systems.The Bact Trap filter may either be usedon the patient side or on the device sideof the ventilator anaesthetic device. | Similar |
| Patient Population | Adult and pediatric patients with a tidalvolume from 100 to 1500 ml | Adult patients with a tidal volume from 50to 1500 ml | Similar |
| Device configuration | Straight with luer port | - | - |
| Materials | Housing: PolypropyleneFilter media: Polypropylene with syntheticfibers | Housing: SBC, Polypropylene, PolyethyleneFilter media: Acrylic and Polypropylene fibers | Similar |
| Traditional 510(k) | 510(k) Summary | ||
| Sterility | Non-sterile | Non sterile | Same |
| Application | Disposableup to 24 hours | Disposableup 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, leakageand 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 DeviceFilter CareStar Plus | Predicate DeviceBact-Trap | Comments |
|---|---|---|---|
| Connectors | Standard conical connectorsLuer lock port for gas sampling | Standard conical connectorsLuer 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 filteragainst bacterial and viral contaminationfor anesthetic and respiratory use.All devices are intended for single use upto 24 hours and must be used by trainedmedical personnel only. The devices aredesigned for use with ventilators andanesthesia machines.They are intended for use in adultpatients. | Flexicare's HepaShield Bacterial ViralBreathing System Filters are intended toreduce the transmission of bacteria andviruses to/from a patient duringanesthesia. For use with ventilators,anesthesia machines and open flowsystems where filtration of inspiredand/or expired gases is desired.Flexicare's HepaShield Bacterial ViralBreathing System Filters are single usedevices for use on a single patient for upto 24hrs and are available in adult size.Flexicare's HepaShield Bacterial ViralBreathing System Filters are designed tobe used in hospital environments bytrained personnel. | Similar |
| Patient Population | Adult patients with a tidal volume from 100to 1500 ml | Adult patients with a tidal volume of 141to 800 ml | Similar |
| Device configuration | Straight and angular versions with luerport | 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: PolypropyleneFilter media: Paper with glass fibersCasting compound: Polyolefin | Unknown | - |
| Sterility | Non-sterile | Sterile and no-sterile variants | similar |
| Application | DisposableUp to 24h | DisposableUp 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 F2101compliant | ISO 23328-1 compliant and ASTM F2101compliant | Same |
| Compliance, Leakageand 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 connectorsLuer lock port for gas sampling | Standard conical connectorsLuer 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 | < 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 MoistureExchanger Filter | EMS Electra Filter and Filter/HME | ||
| Manufacturer | Drägerwerk AG & Co. KGaA | VR Medical Technology Co. | Engineered Medical Systems,Inc. | |
| 510(k) Number | K221836 | K132709 | K013122 | |
| Regulation Number | 868.5260 Breathing circuitbacterial filter | 868.5260 Breathing circuitbacterial filter | 868.5260 Breathing circuitbacterial filter | Same |
| Product Code | CAH | CAH | CAH | Same |
| Classification | Class II | Class II | Class II | Same |
| Intended Use /Indications for Use | Bidirectionally breathing systemfilter against bacterial and viralcontamination for anesthetic andfor respiratory use, as well as heatand moisture exchanger forhumidifying respired gases for thepatient.All devices are intended for singleuse up to 24 hours and must beused by trained medical personnelonly. The devices are designed foruse with ventilators andanesthesia machines.They are intended for use in adult,pediatric and neonatal patients,depending on the respectivedevice. | The Heat and MoistureExchanger and Filter is adisposable single-use deviceindicated for patients whorequire humidification during thedelivery of ventilator gases andprovide filtration for reducingpossible cross contaminationbetween patient and equipment.The products mentioned aboveare designed for disposable useand should be changed at leastevery 24 hours | For use with ventilators,anesthesia machines and openflow systems where filtration ofinspired and/or expired gases isdesired and to add maintain andretain moisture for the exhaledbreathe of the patient | Similar |
| Specification | Proposed Device | Predicate Device | Reference Device | Comments |
| Filter/HME TwinStar Plus | VR Medical Heat and MoistureExchanger Filter | EMS Electra Filter and Filter/HME | ||
| Patient Population | Neonatal, pediatric, and adultpatients with a tidal volume from30 to 1500 ml. | Adult patients with a tidal volumefrom 250 to 1500 ml | Neonatal, pediatric and adultpatients with a tidal volume from20 cc to > 150 cc. | Similar |
| Device configuration | Straight and angular versions withluer port | - | - | - |
| Materials | Housing: PolypropyleneFilter media: Polypropylene withsynthetic fibers (except Filter/HMETwinStar HEPA Plus, which uses paperwith glass fibers)HME-Media: Polyurethaneimpregnated with calcium chloride | Housing: K-ResineFilter media: Polyolefin syntheticfibers (except VR005 which usespaper with glass fibers)HME-Media: Polyurethaneimpregnated with calcium chloride | Housing: PolystyreneFilter media: Electrostaticpolypropylene | Different |
| Sterility | Non-sterile | Non-sterile | Unknown | Same |
| Traditional 510(k) | 510(k) Summary | |||
| Application | Disposableup to 24 hours | Disposableup to 24 hours | Disposableup to 24 hours | Same |
| Biocompatibilitytesting | ISO 10993 and ISO 18562-1compliant | ISO 10993 compliant | Unknown | Similar |
| Filtrationperformance | ISO 23328-1 compliant and ASTMF2101 compliant | ISO 23328-1 compliant | Unknown | Similar |
| Compliance,Leakage andpressure drop | ISO 23328-2 and ISO 9360-1compliant | Unknown | Unknown | - |
| Technological Characteristics | ||||
| Principle ofOperation | Electrostatic or mechanicalfiltration method combined with afoam for passive humidification | Electrostatic or mechanicalfiltration method combined with afoam for passive humidification | Electrostatic filtration methodcombined with a foam for passivehumidification | Same |
| Traditional 510(k) | 510(k) Summary | |||
| Connectors | Standard conical connectorsLuer lock port for gas sampling | Standard conical connectorsLuer lock port for gas sampling | Standard conical connectorsLuer 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 | ||||
| BFEVFE | ≥ 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 returnof ≥ 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 returnof ≥ 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 returnof ≥ 33.7 mg/l) | - | Moisture return @ Vt= 50 ml:= 30 mg/l | Similar |
| Shelf-Life | 3 or 5 years, depending on therespective 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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Traditional 510(k)
510(k) Summary
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Image /page/15/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/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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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 andEvaluation of PneumaticCompliance | compliance is less than orequal to 1mL/kPa at 15,30, 60, and 70 hPa | PASSED |
| ISO 9360-1:2000 | Determination andEvaluation of PneumaticLeakage | pneumatic leakage is lessthan or equal to 50mL/minat 70hPa. | PASSED |
| ISO 9360-1:2000 | Determination andEvaluation of PressureDrop (PneumaticResistance) | pneumaticresistance/pressure drop isacc. to IfU value | PASSED |
| ISO 5356-1:2015 | Evaluation of ConicalConnectors (ISO 5356-1) | cone dimensions complywith ISO 5356-1. | PASSED |
| ISO 80369-7:2021 | Luer Lock Connector(ISO 80369-7) | Luer-Lock connector fulfillsthe requirements laid outin ISO 80369-7. | PASSED |
| IEC 60601-1:2005 | Product's Ability toWithstand Damage fromDropping | When dropped, theproduct should not sufferany damage whichinfluences its function. | PASSED |
| ISTA 3A | Product Durability DuringTransport, MechanicalAspects | - the packaging shows noor minor damage- the DUT shows no signsof damage and retainsfunctionality aftersimulated transport. | PASSED |
| ISO 23328-1:2003 | Filtration Efficiency(Particulate Matter) incl.Usage Time | - adult and pediatricelectrostatic filters achievea filtration efficiency of>90% before and after thespecified usage time- neonatal filters achieve afiltration efficiencyof >75% before and afterthe specified usaqe time- mechanical filtersachieve a filtrationefficiency of >99% beforeand after the specifiedusage time- mechanical filtersachieve a HEPAclassification ≥ class H13 | PASSED |
| ASTM F2101:2019 | Filtration Efficiency (Viraland Bacterial) | - electrostatic filtersachieve 99.99% (bacterial)and 99.9% (viral) filtrationefficiency- electrostatic filters for neoapplications achieve99.98% (bacterial) and99.9% (viral) filtrationefficiency. | PASSED |
| ISO 10993:2018and ISO 18562-1:2017 | Evaluation of Product'sBiological Compatibility(ISO 10993:2018 andISO 18562-1:2017) | evaluation accordingto ISO 10993:2018 and/orISO 18562-1:2017 | PASSED |
| ISO 9360-1:2000 | Evaluation of HME WaterLoss, Resistance | ·pediatric/neonatal: Themoisture loss shall be<=11mg/L at VT=50ml·pediatric: The moistureloss shall be <=12mg/L atVT=250ml· adult: The moisture lossshall be <=11mg/L atVT=500ml | PASSED |
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| Standard Number and Version | Title |
|---|---|
| AAMI ANSI ISO 5356-1:2004 | Anaesthetic And Respiratory Equipment – Conical Connectors: Part 1: Cones And Sockets |
| ISO 18652-1:2017 | Biocompatibility Evaluation Of Breathing Gas Pathways In Healthcare Applications |
| AAMI / ANSI / IEC 62366-1:2015 | Medical devices - Part 1: Application of usability engineering to medical devices |
| ANSI AAMI ISO 10993-1:2018 | Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process |
| ASTM F2101-19:2019 | Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials |
| EN ISO 9360-1:2009 | Anaesthetic and respiratory equipment - Heat and moisture exchangers (HMEs) for humidifying respired gases in humans - Part 1: HMEs for use with minimum tidal volumes of 250 ml |
| EN ISO 23328-1:2008 | Breathing system filters for anaesthetic and respiratory use - Part 1: Salt test method to assess filtration performance |
| EN ISO 23328-2:2009 | Breathing system filters for anaesthetic and respiratory use - Part 2: Non-filtration aspects |
Summary of Clinical Testing
N/A..
Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the Filter CareStar Plus, Filter SafeStar Plus and Filter/HME TwinStar Plus are as safe, as effective and perform as well as or better than the legally marketed devices identified in this section.
- END -
§ 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).