(268 days)
Not Found
No
The document describes a heated breathing circuit and its accessories, focusing on mechanical, thermal, and electrical safety, and functional performance. There is no mention of AI or ML in the intended use, device description, or performance studies.
No.
The device is a breathing circuit used to deliver humidified gas from a humidifier to a patient, it does not directly treat a disease or condition, but rather aids in the delivery of breathing gas.
No
The device description clearly states its purpose is to conduct humidified breathing gas from a humidifier to a patient, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a "disposable breathing circuit with humidifier chamber" and mentions "mechanical, thermal safety, environmental conditions, electrical safety and electromagnetic compatibility" testing, indicating it is a physical hardware device.
Based on the provided text, these devices are not IVDs (In Vitro Diagnostics).
Here's why:
- Intended Use/Indications for Use: The intended use is to conduct humidified breathing gas from a humidifier to a patient. This is a therapeutic function related to respiratory support, not a diagnostic test performed on samples taken from the body.
- Device Description: The description confirms they are breathing circuits designed for delivering humidified gas to neonatal patients. This aligns with a respiratory support device, not an IVD.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The devices are clearly described as components of a respiratory support system used in a clinical setting.
N/A
Intended Use / Indications for Use
VentStar Helix dual heated N Exten. Kit (MP02280): Inspiratory heated disposable breathing circuit with humidifier chamber for connection to a humidifier MR850 by Fisher & Paykel, for neonatal patients with a tidal volume of up to 100 mL, for conducting humidified breathing gas from humidifier to patient.
VentStar Helix heated (N) Plus (MP02608): Inspiratory heated disposable breathing circuit with humidifier chamber for connection to a humidifier MR850 by Fisher & Paykel, for neonatal patients with a tidal volume of up to 100 mL, for conducting humidified breathing gas from humidifier to patient.
Product codes (comma separated list FDA assigned to the subject device)
BZE
Device Description
The subject devices (VentStar Helix Dual Heated N Exten. Kit and VentStar Helix Heated (N) Plus), two inspiratory (and expiratory) heated disposable breathing circuits with humidifier chamber are designed for neonatal patients with a tidal volume of up to 100 mL, for conduction of humidified breathing gas from the humidifier to the patient. VentStar Helix Dual Heated N Exten. Kit is a dual heated breathing circuit and VentStar Helix Heated (N) Plus is a single heated breathing circuit to be connected to a humidifier MR850 by Fisher and Paykel, both tested for system compatibility and released for use with Dräger Babylog VN-Series ventilators.
Additionally, this submission comprises a neonatal humidifier chamber and a double connector for connection to the ventilators as accessories to the above mentioned medical devices.
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
Neonatal patients
Intended User / Care Setting
The device is intended for stationary use in hospitals and medical rooms or for intrahospital patient transport.
Do not use the device in the following environments of use:
- -Magnetic resonance imaging
- -During electrocautery
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 of the breathing circuits has been performed covering mechanical, thermal safety, environmental conditions, electrical safety and electromagnetic compatibility, functional verification, and performance capacity and accuracy. Verification and validation testing was conducted in conformance to the FDA recognized standards as listed below. Performance data related to each proposed modification has been tested and evaluated. High level summary reports included in this 510(k) demonstrate that the subject devices are substantially equivalent to the predicate device.
Electrical Safety and Electromagnetic Compatibility (EMC)
Electrical safety and EMC testing were conducted for VentStar Helix Dual Heated N Exten. Kit and VentStar Helix heated (N) Plus. The devices comply with the IEC 60601-1 for basic safety and performance and the IEC 60601-1-2 standard for EMC.
Further Performance Testing
To demonstrate performance and functionality, VentStar Helix Dual Heated N Exten. Kit and VentStar Helix heated (N) Plus were tested and meet all applicable requirements of the following standards:
- . ISO 5367: Anaesthetic and respiratory equipment -- Breathing sets and connectors
- . ISO 80601-2-12: Medical electrical equipment. Particular requirements for basic safety and essential performance of critical care ventilators
- . ISO 5356-1: Anaesthetic and respiratory equipment -- Conical connectors -- Part 1: Cones and sockets
- . ISO 80601-2-74: Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment (Gap Analysis)
Biocompatibility Testing
All materials used in the fabrication of the heated breathing systems and also the completed products were evaluated through biological qualification safety tests as outlined in ISO 10993-1 "Biological Evaluation of Medical Devices" and the international standard series of ISO 18562 "Biocompatibility evaluation of breathing gas pathways in healthcare". These materials were also tested in accordance with industry recognized test methods and were found to be acceptable for the intended use. The following tests were performed:
- . Test for emissions of particulate matter (PM) according to ISO 18562-2
- Test for emission of VOC with additional humidity according to ISO 18562-3
- . Test for leachables in condensate according to ISO 18562-4
- . Extracting according to ISO 10993-18 (Exhaustive extraction in Water, Isopropanol; simulated use extraction with Isopropanol)
- . Material characterization according to ISO 10993-18 (2009-08) (organic and inorganic extractables/ leachables)
- . Cytotoxicity according to ISO 10993-5
- Sensitization according to ISO 10993-10 .
- . Irritation according to ISO 10993-10
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Not Found
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
§ 868.5270 Breathing system heater.
(a)
Identification. A breathing system heater is a device that is intended to warm breathing gases before they enter a patient's airway. The device may include a temperature controller.(b)
Classification. Class II (performance standards).
0
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.
June 14, 2023
Dräegerwerk AG & Co. KGaA Jan Upmeier Regulatory Affairs Manager Moislinger Allee 53-55 Luebeck, Schleswig-Holstein 23542 Germany
Re: K222822
Trade/Device Name: VentStar Helix dual heated N Exten. Kit (MP02280), VentStar Helix heated (N) Plus (MP02608) Regulation Number: 21 CFR 868.5270 Regulation Name: Breathing system heater Regulatory Class: Class II Product Code: BZE Dated: May 17, 2023 Received: May 17, 2023
Dear Jan Upmeier:
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-reportingcombination-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.
Ethan L. Nyberg -S
for James J. Lee. Ph.D. Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K22822
Device Name
VentStar Helix Dual heated N Exten. Kit / VentStar Helix heated (N) Plus
Indications for Use (Describe)
VentStar Helix dual heated N Exten. Kit (MP02280): Inspiratory heated disposable breathing circuit with humidifier chamber for connection to a humidifier MR850 by Fisher & Paykel, for neonatal patients with a tidal volume of up to 100 mL, for conducting humidified breathing gas from humidifier to patient.
VentStar Helix heated (N) Plus (MP02608): Inspiratory heated disposable breathing circuit with humidifier chamber for connection to a humidifier MR850 by Fisher & Paykel, for neonatal patients with a tidal volume of up to 100 mL, for conducting humidified breathing gas from humidifier to patient.
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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3
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: | Jan Upmeier
Regulatory Affairs Manager
E-Mail: jan.upmeier@draeger.com
Telephone: +49 451 882 8474 |
| Applicant's US Contact Person: | Darlene Thibodeau
Head of Quality Assurance and Compliance
E-Mail: darlene.thibodeau@draeger.com
Telephone: 978 773-1060 |
| Date prepared: | June 14th, 2023 |
| Device Name: | Trade Name: VentStar Helix Dual
Heated N Exten. Kit / VentStar Helix Heated (N) Plus
Classification Name: Breathing system heater
Regulation Number: 21 CFR 868.5270
Product Code: BZE
Class: II |
| Predicate Device: | Primary predicate for VentStar Helix Dual Heated N
Exten. Kit: RT265 Dual Heated Infant Breathing Circuit,
Fisher & Paykel HealthCare, cleared via K103767;
Secondary predicate for VentStar Helix Heated (N) Plus
MP00308 VentStar heated (N), Drägerwerk AG & Co.
KGaA, cleared via K103618 |
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510(k) Summary
Device Description
The subject devices (VentStar Helix Dual Heated N Exten. Kit and VentStar Helix Heated (N) Plus), two inspiratory (and expiratory) heated disposable breathing circuits with humidifier chamber are designed for neonatal patients with a tidal volume of up to 100 mL, for conduction of humidified breathing gas from the humidifier to the patient. VentStar Helix Dual Heated N Exten. Kit is a dual heated breathing circuit and VentStar Helix Heated (N) Plus is a single heated breathing circuit to be connected to a humidifier MR850 by Fisher and Paykel, both tested for system compatibility and released for use with Dräger Babylog VN-Series ventilators.
Additionally, this submission comprises a neonatal humidifier chamber and a double connector for connection to the ventilators as accessories to the above mentioned medical devices.
Indications for Use
VentStar Helix dual heated N Exten. Kit (MP02280): Inspiratory and expiratory heated disposable breathing circuit with humidifier chamber for connection to a humidifier MR850 by Fisher & Paykel, for neonatal patients with a tidal volume of up to 100 mL, for conducting humidified breathing gas from humidifier to patient.
VentStar Helix heated (N) Plus (MP02608): Inspiratory heated disposable breathing circuit with humidifier chamber for connection to a humidifier MR850 by Fisher & Paykel, for neonatal patients with a tidal volume of up to 100 mL, for conducting humidified breathing gas from humidifier to patient.
Environments of use
The device is intended for stationary use in hospitals and medical rooms or for intrahospital patient transport.
Do not use the device in the following environments of use:
- -Magnetic resonance imaging
- -During electrocautery
Comparison to Predicate
Drägerwerk AG & Co KGaA concludes that VentStar Helix Dual Heated N Exten. Kit (MP02280) in Table 1 is substantial equivalent to the Fisher & Paykel's product REF RT265 (K103767) and VentStar Helix heated (N) Plus (MP02608) in Table 2 is substantial equivalent to the Drägerwerk AG & Co KGaA's VentStar heated (N) REF MP00308 (K102618).
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510(k) Summary
| Table 1: Comparison Table VentStar Helix Dual Heated N Exten. Kit (MP02280) | |||
|---|---|---|---|
| Substantial Equivalence | |||
| Discussion | Subject of Submission | Primary Predicate Device | Comments |
| Product Name | MP02280 | REF RT265 | |
| 510(k) Number | K222822 | K103767 | |
| Indications for use | VentStar Helix dual heated N Exten. Kit | ||
| (MP02280): Inspiratory and expiratory heated | |||
| disposable breathing circuit with humidifier | |||
| chamber for connection to a humidifier MR850 by | |||
| Fisher & Paykel, for neonatal patients with a tidal | |||
| volume of up to 100 mL, for conducting humidified | |||
| breathing gas from humidifier to patient. | The dual-heated breathing circuits are | ||
| intended as conduits of breathing gas for | |||
| ventilation of infant patients, and to maintain | |||
| the temperature of humidified inspired gas. | |||
| The RT265 is used for flow rates greater than | |||
| 4 L/min, and the RT266 is for flow rates | |||
| between 0.3 and 4 L/min. | Similar | ||
| Description | Dual-heated breathing circuits with humidifier | ||
| chamber | Dual-heated breathing circuits with humidifier | ||
| chamber | Same | ||
| Heater | for connection to a Fisher & Paykel humidifier | ||
| MR850 | for connection to a Fisher & Paykel humidifier | ||
| MR850 | Same | ||
| Patient Population | Neonatal patients with a tidal volume of up to 100 | ||
| mL and a weight up to 8 kg. | Infants, tidal volume 33 mg/L | Invasive ventilation up to 60 L/min > 33 mg/L | Same |
| Non-invasive ventilation at 2 to 60 L/min > 12 | |||
| mg/L | Non-invasive ventilation up to 120 L/min > 10 | ||
| mg/L | Different | ||
| Breathing gas temperature | |||
| at Y-Piece | Adjusted and controlled by Fisher & Paykel | ||
| MR850 humidifier | Adjusted and controlled by Fisher & Paykel | ||
| MR850 humidifier | Same | ||
| Electrical Connection Data | 22 V, 2,73 A, 60 W | ||
| 14 Ω inspiratory | |||
| 12 Ω expiratory (MP02650) | 22 V, 2.73 A, 60 W, 50/60 Hz | Same | |
| Ventilation modes | VentStar Helix dual heated (N) Plus is suitable for | ||
| standard ventilation modes, such as | |||
| Synchronized Intermittend Mandatory Ventilation | |||
| (SIMV), Mandatory Minute Ventilation (MMV), and | |||
| Continuous Positive Airway Pressure (CPAP) as | |||
| well as for High Frequency Oscillation (HFO) | No information is provided in the IFU, suitable | ||
| for delivery of breathing gas. | Similar |
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510(k) Summary
Table 2: Comparison Table VentStar Helix heated (N) Plus (MP02608)
| Substantial Equivalence
| Discussion | Subject of Submission | Reference Predicate Device | Comments |
|---|---|---|---|
| Product Name | MP02608 | MP00308 | - |
| 510(k) Number | K222822 | K102618 | - |
| Indications for use | VentStar Helix heated (N) Plus (MP02608): | ||
| Inspiratory heated disposable breathing circuit | |||
| with humidifier chamber for connection to a | |||
| humidifier MR850 by Fisher & Paykel, for | |||
| neonatal patients with a tidal volume of up to 100 | |||
| mL, for conducting humidified breathing gas from | |||
| humidifier to patient. | VentStar heated (N) (MP00308): Disposable | ||
| inspiratory heated breathing circuit for | |||
| connection to a Fisher & Paykel MR850 | |||
| humidifier, for conveying moistened breathing | |||
| gas between the humidifier and neonatal | |||
| patients with a body weight of up to 5 kg (11 | |||
| lbs). | Similar | ||
| Substantial Equivalence | |||
| Discussion | Subject of Submission | Reference Predicate Device | Comments |
| Product Name | MP02608 | MP00308 | - |
| Description | Single-heated breathing circuits with humidifier | ||
| chamber | Single-heated breathing circuits with | ||
| humidifier chamber | Same | ||
| Heater | For connection to a Fisher & Paykel humidifier | ||
| MR850 | For connection to a Fisher & Paykel | ||
| humidifier MR850 | Same | ||
| Patient Population | Neonatal patients | Neonatal patients | Same |
| Application | Disposable | Disposable | Same |
| Hose diameter (Inner | |||
| Diameter) | 11 mm ID | Heated hose: 14 mm ID | |
| Non-heated hose: 10 mm ID | Different | ||
| Color | Inspiratory limb: blue spiral on colorless hose | ||
| Expiratory limb: white spiral on colorless hose | |||
| with water trap | Inspiratory limb: transparent with white | ||
| heating wire inside the limp | |||
| Expiratory limb: transparent | Different | ||
| Heating Wire | Inspiratory limb: in the wall of the circuit | ||
| Expiratory limb: none | Inspiratory limb: white heating wire inside the | ||
| limp | |||
| Expiratory limb: none | Different | ||
| Connectors | ISO 5356-1 Conical Connectors | ISO 5356-1 Conical Connectors | Same |
| Patient Connector | Y-piece with ISO cone 15 mm female according | ||
| to ISO 5356-1 | Y-piece with ISO cone 15 mm female | ||
| according to ISO 5356-1 | Same | ||
| Device Connector | 11.5 mm female (ID) connector according to ISO | ||
| 5356-1 | 15 mm male (OD)/11.5 mm female (ID) | ||
| connector according to ISO 5356-1 | Same | ||
| Length | Inspiratory Limb 1.70 m ±10% (66,9 inch ±10%), including 40 cm | ||
| (15.74 in) hose extension | 1.2 m ±10% (47 inch ±10%) including 30 cm | ||
| (11.81 inch ±10%) hose extension | Different | ||
| Expiratory Limb 1.40 m ± 90 mm (55 ±3.54 inch) | 1.1 m ± 60 mm (43,30 ±2.36 inch) | ||
| Humidifier Connection 0.50 m ± 40 mm (19.7 ±1.58 inch) | 0.3 m ± 10 mm (11.81 ±0.39 inch) | ||
| Substantial Equivalence | |||
| Discussion | Subject of Submission | Reference Predicate Device | Comments |
| Product Name | MP02608 | MP00308 | - |
| Resistance | Inspiratory: | ||
| at 2.5 L/min 33 mg/L | |||
| Non-invasive ventilation at 2 to 60 L/min > 12 | |||
| mg/L | Invasive ventilation at 4 to 30 L/min >33 mg/L | ||
| Non-invasive ventilation at 4 to 30 L/min > 12 | |||
| mg/L | Different | ||
| Breathing gas temperature | |||
| at Y-Piece | Adjusted and controlled by Fisher & Paykel | ||
| MR850 humidifier | Adjusted and controlled by Fisher & Paykel | ||
| MR850 humidifier | Same | ||
| Substantial Equivalence | |||
| Discussion | Subject of Submission | Reference Predicate Device | Comments |
| Product Name | MP02608 | MP00308 | - |
| Electrical Connection Data | 22 V, 2.73 A, 60 W | ||
| $14 \Omega$ inspiratory | 22 V, 2,73 A, 60 W, | ||
| $16 \Omega$ inspiratory | Same | ||
| Ventilation modes | VentStar Helix dual heated (N) Plus is suitable for standard ventilation modes, such as Synchronized Intermittend Mandatory Ventilation (SIMV), Mandatory Minute Ventilation (MMV), and Continuous Positive Airway Pressure (CPAP) as well as for High Frequency Oscillation (HFO). | Suitable for standard ventilation modes, such as Synchronized Intermittend Mandatory Ventilation (SIMV), Mandatory Minute Ventilation (MMV), and Continuous Positive Airway Pressure (CPAP) as well as for High Frequency Oscillation (HFO). | Same |
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510(k) Summary
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510(k) Summary
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510(k) Summary
The indications for use and fundamental scientific technology are the same for both proposed and predicate devices.
As demonstrated in the nonclinical testing the different technological characteristics do not raise any new questions of safety and effectiveness when compared to the predicate devices.
11
510(k) Summary
Performance Data
Non-clinical testing of the breathing circuits has been performed covering mechanical, thermal safety, environmental conditions, electrical safety and electromagnetic compatibility, functional verification, and performance capacity and accuracy. Verification and validation testing was conducted in conformance to the FDA recognized standards as listed below. Performance data related to each proposed modification has been tested and evaluated. High level summary reports included in this 510(k) demonstrate that the subject devices are substantially equivalent to the predicate device.
Electrical Safety and Electromagnetic Compatibility (EMC)
Electrical safety and EMC testing were conducted for VentStar Helix Dual Heated N Exten. Kit and VentStar Helix heated (N) Plus. The devices comply with the IEC 60601-1 for basic safety and performance and the IEC 60601-1-2 standard for EMC.
Further Performance Testing
To demonstrate performance and functionality, VentStar Helix Dual Heated N Exten. Kit and VentStar Helix heated (N) Plus were tested and meet all applicable requirements of the following standards:
- . ISO 5367: Anaesthetic and respiratory equipment -- Breathing sets and connectors
- . ISO 80601-2-12: Medical electrical equipment. Particular requirements for basic safety and essential performance of critical care ventilators
- . ISO 5356-1: Anaesthetic and respiratory equipment -- Conical connectors -- Part 1: Cones and sockets
- . ISO 80601-2-74: Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment (Gap Analysis)
12
Traditional 510(k) 510(k) Summary
K222822
Biocompatibility Testing
All materials used in the fabrication of the heated breathing systems and also the completed products were evaluated through biological qualification safety tests as outlined in ISO 10993-1 "Biological Evaluation of Medical Devices" and the international standard series of ISO 18562 "Biocompatibility evaluation of breathing gas pathways in healthcare". These materials were also tested in accordance with industry recognized test methods and were found to be acceptable for the intended use. The following tests were performed:
- . Test for emissions of particulate matter (PM) according to ISO 18562-2
- Test for emission of VOC with additional humidity according to ISO 18562-3
- . Test for leachables in condensate according to ISO 18562-4
- . Extracting according to ISO 10993-18 (Exhaustive extraction in Water, Isopropanol; simulated use extraction with Isopropanol)
- . Material characterization according to ISO 10993-18 (2009-08) (organic and inorganic extractables/ leachables)
- . Cytotoxicity according to ISO 10993-5
- Sensitization according to ISO 10993-10 .
- . Irritation according to ISO 10993-10
13
510(k) Summary
List of Consensus Standards
| Standards Number | Standards Title | FDA Recognition
No. + date |
|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|
| ISO
10993-1
Fifth Edition
2018 | Biological evaluation of medical devices - Part 1: Evaluation and
testing within a risk management process | 2-258 01/14/2019 |
| ISO
18562-1
First Edition
2017 | Biocompatibility evaluation of breathing gas pathways in healthcare
applications - Part 1: Evaluation and testing within a risk
management process | 1-134
06/07/2018 |
| IEC
60601-1-2
Edition 4.0
2014 | Medical electrical equipment - Part 1-2: General requirements for
basic safety and essential performance - Collateral Standard:
Electromagnetic disturbances - Requirements and tests | 19-8
09/17/2018 |
| ISO
18190
First Edition
2016 | Anaesthetic and respiratory equipment - General requirements for
airways and related equipment | 1-120
01/14/2019 |
| ANSI AAMI
ES60601-1
2005/(R)2012 | Medical electrical equipment - Part 1: General requirements for basic
safety and essential performance (IEC 60601-1:2005, MOD) and
A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) | 19-4
07/09/2014 |
| ISO
80601-2-12
First Edition
2011 | Medical electrical equipment - Part 2-12: Particular requirements for
the safety of lung ventilators - Critical care ventilators [Including:
Technical Corrigendum 1 (2011)] | 1-98
01/30/2014 |
| ISO
80601-2-74
First Edition
2017 | Medical electrical equipment - Part 2-74: Particular requirements for
basic safety and essential performance of respiratory humidifying
equipment | 1-138
01/14/2019 |
| IEC
60601-1-6
Edition 3.1
2013 | Medical electrical equipment - Part 1-6: General requirements for
basic safety and essential performance - Collateral standard:
Usability | 5-89
06/27/2016 |
| IEC
62366-1
Edition 1.0
2015 | Medical devices - Part 1: Application of usability engineering to
medical devices [Including CORRIGENDUM 1 (2016)] | 5-114
12/23/2016 |
| ISO
5356-1
Third Edition
2004 | Anaesthetic and respiratory equipment - Conical connectors: Part 1:
Cones and sockets | 1-62
03/16/2012 |
| ISO
5367
Fifth Edition
2014 | Anaesthetic and respiratory equipment -- Breathing sets and
connectors | 1-103
08/14/2015 |
| ISO
14971
Third Edition
2019 | Medical devices - Application of risk management to medical devices | 5-125
12/23/2019 |
14
Traditional 510(k) K222822 510(k) Summary
Conclusion
Based on the indications for use/intended use, technological characteristics, performance/nonclinical testing, and comparison to the predicate devices, the subject devices are substantially equivalent to the legally marketed predicate devices and raise no new safety and effectiveness questions compared to the predicate devices.
- END -