Airway Gas Sampling Set, disposable, Adult/Pediatric, TPE, 3m/10ft, Airway Gas Sampling Set, disposable, Adult/Pediatric, TPE, 2m/7ft, Airway Gas Sampling Set, disposable, Infant, TPE, 2m/7ft, Airway Adapter with Luer Connector, Adult/Pediatric

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. Bluepoint Medical GmbH & Co. KG % Stephen Gorski President Imagenix, Inc. S65 W35739 Piper Road Eagle, Wisconsin 53119 Re: K190824 Trade/Device Name: Bluepoint Medical Airway Gas Sampling Products Regulation Number: 21 CFR 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: Class II Product Code: CCK, CCL Dated: November 13, 2019 Received: November 15, 2019 Dear Stephen Gorski: 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. 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 {1}------------------------------------------------ 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 medical devices and radiation-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, Todd Courtney Assistant Director DHT1C: Division of ENT, 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) ## Device Name Bluepoint Medical Airway Gas Sampling Products ## Indications for Use (Describe) The Airway Gas Sampling Products are intended for continuous monitoring of expired and inspired respiratory gases. The Airway Gas Sampling Products are single patient use devices with a cumulative duration of use of up to 72 hours. The Airway Gas Sampling Products include Airway Gas Sampling Sets with integrated gas sampling lines, and an Airway Adapter without sample line, both for use with compatible GE Healthcare sidestream respiratory gas modules and patient monitors utilizing these modules. The Airway Gas Sampling Sets are provided in two sizes: large for use with adult/pediatric patients, and small for use with infant patients, for connection to the patient's breathing crecuit. They are provided in two lengths: 3 meter/10 feet, and 2 meter/7 feet. The Airway Gas Sampling Sets are intended for continuous monitoring of Carbon Dioxide (CO2), Oxygen (O2), and respiratory rate in professional/hospital care environments where agents are NOT used, such as intensive care units (ICU), emergency department (ED), coronary care unit (CCU), post anesthesia care unit (PACU) and in-hospital patient transport. The Airway Adapter is provided in a large size for use with adult/pediatric patients, for connection to the patient's breathing circuit, and may be used with separately supplied gas sample lines. The Airway Adapter is intended for professional use environments and applications specified for the connected respiratory gas modules and patient monitors. The Airway Gas Sampling Products are intended for use by qualified medical personnel only. Prescription use only. | Type of Use ( <i>Select one or both, as applicable</i> ) | | |---------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------| | <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | **CONTINUE ON A SEPARATE PAGE IF NEEDED.** This section applies only to requirements of the Paperwork Reduction Act of 1995. ***DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*** The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) Summary in accordance with 21 CFR 807.92 # K190824 | (a) | (1) | Submitted by: | Bluepoint Medical GmbH & Co. KG<br>An der Trave 15<br>Selmsdorf 23923<br>Germany<br>Tel.: +49 (38823) 548 8000<br>Fax: +49 (38823) 548 8029<br>b.lindner(at)bluepoint-medical.com | | | |-----|-----|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|--| | | | Contact Person: | Mr. Bernd Lindner | | | | | | Position/Title: | Managing Director | | | | | | Date of Preparation: | | November 13, 2019 | | | | (2) | Trade Name: | | Airway Gas Sampling Products | | | | | Common/Classification Name: | | Carbon dioxide gas analyzer; Oxygen gas analyzer; | | | | | Product Code(s): | | 21 CFR §868.1400; CCK<br>21 CFR §868.1720; CCL | | | | | Class: | | Class II | | | | (3) | Predicate Device: | | Substantial Equivalence to: | | | | | K Number | Model | Manufacturer | | | | | K051092 | Gas Sampling Line, disposable, PVC/PE, included accessories in:<br>Datex-Ohmeda S/5 Compact<br>Airway Module (Model Family E-CAIOVX) E-CAIOVX, E-CAIOV,<br>E-CAIO, E-COVX, E-COV, E-CO<br>& Accessories | GE Healthcare | | | | | Reference Device<br>K946044 | Disposable Gas Sampling Lines<br>(includes adult airway adapter) | Catheter Research, Inc.<br>(subsequently CareFusion) | | | | | Reason for Submission: | | New Device(s) | | {4}------------------------------------------------ #### (4) Description of Device: The Bluepoint Medical disposable Airway Gas Sampling Products offered in this submission are specified for use with compatible GE Healthcare side stream respiratory gas modules and patient monitors utilizing these modules. The Airway Gas Sampling Products include two product series: - . Disposable Airway Gas Sampling Sets with airway adapter and integrated side stream TPE gas sampling lines - . Disposable Airway Adapter with female Luer Connector and without sample line The Airway Gas Sampling Sets are offered in both Adult/Pediatric and Infant airway sizes. Two lengths of the Adult/Pediatric size are offered: 3m/10ft, and 2m/7ft. The Infant size is offered in 2m/7ft. The Airway Gas Sampling Sets are constructed with the following features: - . Rigid clear medical grade plastic airway adapter designed for connection to patient breathing circuit - . TPE (thermoplastic elastomer) gas sampling lines with moisture management properties that support their specified use duration of up to 72 hours - . Molded male Luer connector for attachment to GE Healthcare respiratory gas modules The Airway Adapter without sample line is offered in an Adult/Pediatric size, and includes a molded female Luer connector for attachment of a clinician-selected gas sample line. All devices are disposable and labeled for single patient use. #### Intended use: (5) Bluepoint Medical Airway Gas Sampling Products are designed for continuous monitoring of CO2, O2, and respiratory rate. Measurement of patient respiratory gases has been a standard of care in critical care monitoring for over 25 years. Monitoring these gases provides information on a patient's CO2 production. O2 utilization, respiratory rates and patterns, and pulmonary/aveolar status. ## Indications for Use: The Airway Gas Sampling Products are intended for continuous monitoring of expired and inspired respiratory gases. The Airway Gas Sampling Products are single patient use devices with a cumulative duration of use of up to 72 hours. The Airway Gas Sampling Products include Airway Gas Sampling Sets with integrated gas sampling lines, and an Airway Adapter without sample line, both for use with compatible GE Healthcare sidestream respiratory gas modules and patient monitors utilizing these modules. The Airway Gas Sampling Sets are provided in two sizes: large for use with adult/pediatric patients, and small for use with infant patients, for connection to the {5}------------------------------------------------ patient's breathing circuit. They are provided in two lengths: 3 meter/10 feet, and 2 meter/7 feet. The Airway Gas Sampling Sets are intended for continuous monitoring of Carbon Dioxide (CO2), Oxygen (O2), and respiratory rate in professional/hospital care environments where anesthetic agents are NOT used, such as intensive care units (ICU), emergency department (ED), coronary care unit (CCU), post anesthesia care unit (PACU) and in-hospital patient transport. The Airway Adapter is provided in a large size for use with adult/pediatric patients, for connection to the patient's breathing circuit, and may be used with separately supplied gas sample lines. The Airway Adapter is intended for professional use environments and applications specified for the connected respiratory gas modules and patient monitors. The Airway Gas Sampling Products are intended for use by qualified medical personnel only. Prescription use only. # Discussion of Differences in Indications to the Predicate Devices: The submitted device and referenced predicate devices have the following differences in their indication statements regarding respiratory gas monitoring: - For the submitted device, the monitoring is defined as: continuous monitoring . of expired and inspired respiratory gases; in two sizes: large for use with adult/pediatric patients, and small for use with infant patients; for use with compatible GE Healthcare sidestream respiratory gas modules and patient monitors utilizing these modules: the Airway Gas Sampling Sets are intended for continuous monitoring of Carbon Dioxide (CO2), Oxygen (O2) for up to 72 hours use duration. - . For the Datex-Ohmeda (now GE CARESCAPE) Respiratory Modules, the monitoring is defined as: for monitoring respiratory parameters (CO2. 02. N20. anesthetic agents, anesthetic aqent identification and respiratory rate) and ventilatory parameters (airway pressure, flow and volume) of adult, pediatric and neonatal patients and gas exchange parameters (VC02 . V02) of adult and pediatric patients. - For the Carefusion airway adapter, the monitoring is defined as: for delivering . patient breathing gases to GE Healthcare gas modules for monitoring CO2, 02, N2O and anesthetic agents. The differences in the wording of the subject and predicate device indications for use are not critical to the intended use of the subject devices for the specified respiratory gas monitoring and do not affect the safety and effectiveness of the device when used as labeled for the following reasons: - . Slight differences in terminology are equivalent, i.e. all claims are readily understandable as referring to respiratory gas monitoring. The Airway Gas Sampling Products do not claim measurement of airway pressure and flow parameters. - All devices claim continuous monitoring of respiratory gas with compatibility to ● GE Healthcare respiratory gas modules. - The subject device provides clarification regarding the limitation for ● measurement of Carbon Dioxide (CO2), Oxygen (O2) and respiratory rate for {6}------------------------------------------------ the Airway Gas Sampling Sets. The 72 hours use duration has been validated for testing. Therefore, in consideration of the above, the differences identified are not critical to the intended use of the devices for respiratory gas monitoring and do not affect the safety and effectiveness of the device when used as labeled. ### (6) Technological Characteristics: The Bluepoint Medical Airway Gas Sampling Products utilize components with the same measurement principles for aspirated sidestream respiratory gas sampling, including the same general housing construction. | Product/Feature | | | | | |---------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|---------------------------------------------| | Product/Feature | Bluepoint Medical<br>Airway Gas Sampling<br>Products | Primary Predicate<br>Device: Gas Sampling<br>Line, disposable,<br>PVC/PE, included<br>accessories in: Datex-<br>Ohmeda S/5 Compact<br>Airway Module (Model<br>Family E-CAIOVX) E-<br>CAIOVX, E-CAIOV, E-<br>CAIO, E-COVX, E-COV,<br>E-CO & Accessories | Reference Device:<br>Carefusion airway<br>adapter | | | Manufacturer | Bluepoint Medical<br>GmbH & Co. KG | GE Healthcare | Catheter Research, Inc.<br>(now Carefusion/<br>Vyaire) | | | Model Number(s) | 8090121531<br>8090121521<br>8090121522<br>3090121002 | 2097307-001<br>2097307-002<br>2097307-003 | 400149-002 | | | 510(k) Number | (pending - this<br>submission) | K051092 | Cleared in K946044 | | | Patient Population | Adult/Pediatric;<br>Infant | Adult through Neonatal | Not specified; | | | Use/Application | Side stream airway gas<br>sampling | Side stream airway gas<br>sampling | Side stream airway gas<br>sampling | | | Application Site | Breathing gases, patient<br>airway | Breathing gases, patient<br>airway | Breathing gases, patient<br>airway | | | Disposable Single<br>Patient Use | ✔ YES | ✔ YES | ✔ YES | | | Provided Sterile | No - nonsterile in sealed<br>plastic bag | No - nonsterile in sealed<br>plastic bag | No - nonsterile in sealed<br>plastic bag | | | Product/Feature | Bluepoint Medical<br>Airway Gas Sampling<br>Products | Primary Predicate<br>Device: Gas Sampling<br>Line, disposable,<br>PVC/PE, included<br>accessories in: Datex-<br>Ohmeda S/5 Compact<br>Airway Module (Model<br>Family E-CAIOVX) E-<br>CAIOVX, E-CAIOV, E-<br>CAIO, E-COVX, E-COV,<br>E-CO & Accessories | Reference Device:<br>Carefusion airway<br>adapter | | | Monitoring System<br>Compatibility | GE Healthcare<br>sidestream respiratory<br>gas modules and patient<br>monitors utilizing these<br>modules | Datex-Ohmeda S5 (now<br>GE CARESCAPE)<br>Respiratory modules<br>and Compact Airway<br>modules for monitoring<br>CO2, O2, N2O and<br>anesthetic agents and<br>with E-miniC for<br>monitoring CO2 | Listed accessory for GE<br>Healthcare gas modules | | | Duration of Use | 72 hours | 24 hours | Not specified | | | Total System Response<br>Time (per ISO 80601-2-<br>55) for sample lines | < 3.0 s (CO2, O2) with<br>Carescape module | < 3.3 s (CO2, O2) with<br>Carescape module | Not specified for airway<br>adapter | | | Airway Adapter Housing<br>- interface to breathing<br>circuit | Conical connectors:<br>22/15 mm; ISO 5356-1<br>taper | (none: see sample line<br>connections below) | Conical connectors:<br>22/15 mm; ISO 5356-1<br>taper | | | Sample Line<br>Connections | ISO 594-1 6% Luer<br>taper:<br>Male Luer: Airway Gas<br>Sampling Sets<br>ISO 594-2 6% Luer lock<br>fitting:<br>Female Luer: Airway<br>adapter | ISO 594-1 6% Luer<br>taper:<br>Male Luer: Gas<br>Sampling Lines | ISO 594-2 6% Luer lock<br>fitting:<br>Female Luer: Airway<br>adapter | | | Airway Adapter Housing<br>- Dead Space | Adult/<br>Pediatric:<br>≤ 6.6 cm3 | Infant:<br>≤ 0.5 cm3 | (none: sample line is<br>separate from airway<br>adapter) | Adult/ Pediatric size<br>only:<br>≤ 6.0 cm3 | | Sample Line Length(s)<br>(Applicable to Airway<br>Gas Sampling Sets and<br>Sample Lines, not to<br>single airway adapter) | 8090121531:<br>3 meter/10 feet<br>8090121521:<br>8090121522:<br>2 meter/7 feet | 2097307-xxx:<br>-001: 2 meter/7 feet<br>-002: 3 meter/10 feet<br>-003: 6 meter/20 feet | (none, no sample line on<br>single airway adapter) | | | Sample Line Diameter<br>(Applicable to Airway<br>Gas Sampling Sets and<br>Sample Lines, not to<br>single airway adapter) | 1.2 mm I.D.<br>2.6 mm O.D.<br>(Sets with integrated<br>sample lines) | 1.2 mm I.D.<br>2.8 mm O.D.<br>(all sample lines) | (none, no sample line on<br>single airway adapter) | | | Product/Feature | Bluepoint Medical<br>Airway Gas Sampling<br>Products | Primary Predicate<br>Device: Gas Sampling<br>Line, disposable,<br>PVC/PE, included<br>accessories in: Datex-<br>Ohmeda S/5 Compact<br>Airway Module (Model<br>Family E-CAIOVX) E-<br>CAIOVX, E-CAIOV, E-<br>CAIO, E-COVX, E-COV,<br>E-CO & Accessories | Reference Device:<br>Carefusion airway<br>adapter | | | Environment of Use | Professional use<br>environments and<br>applications specified for<br>the connected<br>respiratory gas modules<br>and patient monitors. | Not specified for gas<br>sampling line;<br>referenced to the<br>connected gas modules<br>with professional users; | Not specified for gas<br>sampling line;<br>referenced to the<br>connected gas modules<br>with professional users; | | # Comparison of Technological Features to Predicate Devices: {7}------------------------------------------------ {8}------------------------------------------------ # Page 6 of 7 As summarized above, the Bluepoint Medical Airway Gas Sampling Products utilize equivalent technological characteristics and specifications as the listed predicate devices. #### Non-Clinical Tests Submitted: (b) (1) Bluepoint Medical disposable Airway Gas Sampling Products have been verified and validated to meet requirements for compatibility with GE Healthcare side stream respiratory gas modules, and to meet current applicable standards and guidelines for safety and performance per the following standards and test documents. These include: # Biocompatibility - ISO 10993-1: Biological evaluation of medical devices Part 1: Evaluation and . testing within a risk management process - ISO 10993-5: Biological evaluation of medical devices Part 5: Tests for in . vitro cytotoxicity - ISO 10993-10: Biological evaluation of medical devices Part 10: Tests for ● irritation and skin sensitization - ISO 18562-1: Biocompatibility evaluation of breathing gas pathways in ● healthcare applications – Part 1: Evaluation and testing within a risk management process - ISO 18562-2: Biocompatibility evaluation of breathing gas pathways in . healthcare applications - Part 2: Tests for emissions of particulate matter - ISO 18562-3: Biocompatibility evaluation of breathing gas pathways in ● healthcare applications - Part 3: Tests for emissions of volatile organic compounds (VOCs). - Biocompatibility of extractable and leachables was performed by extraction in . polar and non-polar solvents, followed by chemical characterization. A comprehensive inhalation risk assessment on the was performed in accordance with ISO 10993-17 for the allowable limits of leachable substances, and threshold of toxicological concern per the CDER ICH M7 quidance. The devices met the acceptance criteria for biocompatibility and acceptable risk. {9}------------------------------------------------ # Performance Testing Performance testing has been performed with representative GE Healthcare respiratory gas modules. Performance testing was executed on new device samples and on samples that that have undergone accelerated aging to the duration of the proposed shelf life of three years> - ISO 80601-2-55: Medical electrical equipment Part 2-55: Particular . requirements for the basic safety and essential performance of respiratory gas monitors (NOTE: Applicable sub-parts only: accuracy, sampling delay, rise time) - . Extended time (72 hour) moisture testing has been performed to verify the moisture management properties of the devices meet the specified duration. The devices met the acceptance criteria for integration and performance. # Compliance Standards Compliance of the devices was evaluated for the following standards: - ISO 5356-1. Anaesthetic and respiratory equipment Conical connectors -. Part 1: Cones and sockets - ISO 594-1, Conical fittings with a 6% (Luer) taper for syringes, needles and ● certain other medical equipment - Part 1: General requirements - ISO 594-2, Conical fittings with a 6% (Luer) taper for syringes, needles and ● certain other medical equipment - Part 1: Lock Fittings The devices met the acceptance criteria for the applicable parts. # Risk Management Risk management, risk and hazard analysis of the Airway Gas Sampling Products was performed to the following standard: - . Application of risk management to medical devices per ISO 14971 The devices met the acceptance criteria for residual risks. In summary, the Airway Gas Sampling Products met acceptance criteria for biocompatibility, performance, and conformance to the applicable standards. Residual risks met criteria for acceptability for the intended use. #### (2) Clinical Tests Submitted: (none) #### (3) Conclusions from Tests: As described in (b)(1) and (b)(2) above, the disposable Airway Gas Sampling Products are substantially equivalent to the predicate device as supported by performance testing, applicable standards compliance evaluation, and biocompatibility testing. The results of all tests demonstrate that the disposable Airway Gas Sampling Products meet specified requirements for device compatibility and is substantially equivalent to the predicate device without raising different questions of safety and effectiveness.