(103 days)
The CPM is intended to continuously measure and automatically maintain the cuff pressure of an endotracheal tube or tracheostomy tube that has been set by the user/clinician during mechanical ventilation. The CPM is intended for use with adult and pediatric patients during mechanical ventilation in the listed areas:
Intensive care unit (ICU)
Recovery room
Emergency medical care
Medical emergency vehicles when the patient is being transported
During transport within and outside of the hospital
The Puritan Bennett™ Cuff Pressure Manager (CPM) continuously measures and automatically maintains cuff pressure during ventilation of patients using a cuffed endotracheal tube or tracheostomy tube. It is an integrated and continuous cuff pressure control solution that secures airway management in intensive care units, recovery room and during interhospital and intrahospital transport.
It operates in range of 5-50 cm H2O of user-set cuff pressures for various cuffed endotracheal tubes to provide suitable solutions for various clinical patient situations. The Puritan Bennett™ Cuff Pressure Manager introduces some new small features and convenient user interface to maximize safe use and usability. Both manual adjusting and one-click inflation function are provided alternatively for user's preference to start inflation. Measure mode allows user to observe the cuff pressure without device intervening before taking actions. Auto Key-lock feature help to avoid mis-operation when there's no user intervene for a long time. For inflation, room air is used and no contact to the respiratory gas system of a patient occurs. It is not intended to connect with ventilator.
The cuff pressure manager is designed with closed loop mechanism which is Pl controlled, and the software level of concern is Class C/Major concern.
The Puritan Bennett™ Cuff Pressure Manager is provided non-sterile and no re-processing is required. A sterile extension tube is equipped with the Puritan Bennett™ Cuff Pressure Manager for inflating/deflating or measuring cuff pressure. The associated accessories include:
- Extension Tube with filter Rechargeable Li-ion Battery Mounting Rack AC/DC Adaptor
The provided document describes the Puritan Bennett™ Cuff Pressure Manager (CPM) and its substantial equivalence to a predicate device (IntelliCuff Cuff Pressure Controller, K150893). The information mainly focuses on technical specifications, safety, and performance evaluations, primarily through bench testing against recognized standards. There is no mention of a study involving human or animal subjects, ground truth, expert adjudication, or multi-reader multi-case studies in the provided text.
Based on the available information, the acceptance criteria and device performance relate to technical specifications and compliance with various international standards for medical devices.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily defined by the specified technical characteristics and compliance with the referenced industry standards. The reported device performance is indicated by its adherence to these specifications and successful completion of the described tests.
| Characteristic | Acceptance Criteria (from Proposed Device Specs) | Reported Device Performance |
|---|---|---|
| Operation Altitude | -411m to 4000m above sea level | Complies with specified range |
| Operation Temperature | 0°C to 40°C / 32°F to 104°F (operating) | Complies with specified range |
| Operation Relative Humidity | 10% to 95% noncondensing (operating) | Complies with specified range |
| Electrical Safety | Class-II Type BF in accordance with IEC 60601-1 and IEC 60601-1-12 | Complies with specified standards |
| Electromagnetic Compatibility | In accordance with IEC 60601-1-2 | Complies with specified standard |
| Alarm | In accordance with IEC 60601-1-8 | Complies with specified standard |
| AC Power Input | 85 to 264 VAC / 47 to 63 Hz; 7.5 VA typical, 15 VA maximum | Operates within specified range |
| Battery Requirement | 3.6 V / 2300mAh Li-ion rechargeable battery; supports 4 hours operation | Complies with specified battery type and operation duration |
| Default Inflation Pressure Settings | 25 cm H2O | 25 cm H2O |
| Pressure Hold Default Pressure Increase | 5 cm H2O | 5 cm H2O |
| Pressure Hold Maximum Allowable Pressure | 50 cm H2O | 50 cm H2O |
| Pressure Hold Time Setting Range | 5 minutes to 30 minutes | 5 minutes to 30 minutes |
| Pressure Hold Time Factory Default Setting | 5 minutes | 5 minutes |
| Pressure Setting Range | 5 to 50 cm H2O | 5 to 50 cm H2O |
| Pressure Unit Switching | cm H2O, hPa, mbar | Supports all specified units |
| Resolution (setting/display) | +/-1cm H2O | +/-1cm H2O |
| Pressure Accuracy (Display) | ±1.5 cm H2O | Achieved ±1.5 cm H2O |
| Pressure Accuracy (Adjustment) | ±1 cm H2O | Achieved ±1 cm H2O |
| Alarm Priority (High Priority) | Low Pressure (including cuff leakage), High Pressure, Battery is depleted, Technical Errors | Functions as specified |
| Alarm Volume | 50 dB(A) ±5 dB(A) within 1 m distance | Achieved within specified range |
| Applied Pressure Range in Deflation Mode | -45 cm H2O | Achieved -45 cm H2O |
| Pressure Monitoring Resolution | ±0.01 cm H2O (0.01 mbar) | Achieved ±0.01 cm H2O |
| Essential Performance | Applied cuff pressure must be maintained and monitored. If higher or lower than set limits (±1cm H2O), must be detected and alarm activated. | Demonstrated conformance to this requirement |
| Extension Tube with Filter | Yes | Yes |
| Connector Compatibility | Compatible with endotracheal tube (ETT) or tracheostomy tube (TT) | Compatible as specified |
| Software Class of Concern | Class C/Major concern (as indicated in device description) | Verified and validated for this level of concern |
| Sterilization (Extension tube) | Sterile by EtO validation per ISO 11135:2014 and 10993-7: 2008 AC:2009 | Validated |
| Shelf Life (Extension tube) | 5 years shelf life per ASTM F1980:16 | Validated |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of clinical data or human-derived data. The testing described is primarily bench testing of the device's hardware and software components. For these types of tests, samples would refer to the number of devices or components tested. This information is not provided in the document.
Data provenance is not applicable in the sense of country of origin of patient data, as no clinical or patient data was used. All described tests are non-clinical, likely performed by the manufacturer, Covidien llc, in China or its designated testing facilities. The tests are retrospective in the sense that they are conducted on manufactured devices before market release.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as there is no "test set" requiring expert ground truth in the context of clinical images or patient data. The ground truth for the technical performance tests is established by the engineering specifications and recognized international standards themselves.
4. Adjudication method for the test set
This is not applicable as there is no clinical test set requiring expert 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
No MRMC comparative effectiveness study was done as the device is a cuff pressure manager, not an AI-assisted diagnostic or interpretative tool for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This concept is not directly applicable to this device in the traditional sense of an "algorithm only" performance study for image analysis or diagnosis. The device itself is an automated system for managing cuff pressure, and its performance is inherently a "standalone" evaluation of its functional accuracy and safety. The performance tests ("Function and performance Test-Cuff Pressure Manager") demonstrate the algorithm (closed-loop PI control) and device's ability to maintain pressure automatically without human intervention.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the device's performance is established by:
- Technical Specifications: The design parameters and target performance values set by the manufacturer.
- International Standards: Compliance with recognized standards like IEC 60601 series for electrical safety, EMC, alarms, usability, and software, as well as ISO standards for sterilization, biological evaluation, and connectors.
- Benchmark Testing: Comparison against the predicate device's known performance characteristics (though the specific "ground truth" for this comparison is the predicate's established performance).
8. The sample size for the training set
This is not applicable as the device is not an AI/ML model that requires a training set of data in the typical sense. Its control mechanism is a PI controller, a traditional engineering control system, not a learned AI model.
9. How the ground truth for the training set was established
This is not applicable as there is no training set for an AI/ML model. The "ground truth" for the device's control logic is based on engineering and physiological principles for maintaining appropriate cuff pressure.
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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: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
Covidien Ilc Jenny Liu Regulatory Affairs Specialist 6F, Building 3, 2388 Chenhang Road, Minhang District Shanghai 201114 China
Re: K202874
Trade/Device Name: Puritan Bennett Cuff Pressure Manager Regulation Number: 21 CFR 868.5750 Regulation Name: Inflatable Tracheal Tube Cuff Regulatory Class: Class II Product Code: BSK Dated: December 8, 2020 Received: December 10, 2020
Dear Jenny Liu:
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 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
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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
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Indications for Use
510(k) Number (if known) K202874
Device Name
Puritan Bennett™ Cuff Pressure Manager
Indications for Use (Describe)
The CPM is intended to continuously measure and automatically maintain the cuff pressure of an endotracheal tube or
tracheostomy tube that has been set by the user/clinician during mechanical ventilation. The CPM is intended for use with
adult and pediatric patients during mechanical ventilation in the listed areas:
| Intensive care unit (ICU) |
|---|
| Recovery room |
| Emergency medical care |
| Medical emergency vehicles when the patient is being transported |
| During transport within and outside of the hospital |
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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510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
General Information
| Submitter Name: | Covidien IIc |
|---|---|
| Address: | 6F, Building 3, 2388 Chenhang Road, Minhang DistrictShanghai 201114, China |
| Contact Person: | Jenny LiuRegulatory Affairs SpecialistTelephone: +86 15618808588Fax: +86 21 3323-0131Email: jenny.liu@medtronic.com |
| Date Prepared: | January 9, 2021 |
| Device Name | |
| Proprietary Name | Puritan Bennett™ Cuff Pressure Manager |
| Common Name | Cuff Pressure Manager |
| Classification Name | Cuff, Tracheal Tube, Inflatable |
| Device Class | Class II |
| Product Code | BSK |
| CFR Section | 21 CFR 868.5750 |
| Catalog Numbers | 180-03, 180-05 |
Predicate Device
The Puritan Bennett™ Cuff Pressure Manager was compared to and found to be substantially equivalent to the following legally marketed products.
Proprietary Name: IntelliCuff
Common Name: Cuff Pressure Controller
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| 510(k) Number: | K150893 (cleared January 29, 2016) |
|---|---|
| Manufacturer | Hamilton Medical AG |
Device Description
The Puritan Bennett™ Cuff Pressure Manager (CPM) continuously measures and automatically maintains cuff pressure during ventilation of patients using a cuffed endotracheal tube or tracheostomy tube. It is an integrated and continuous cuff pressure control solution that secures airway management in intensive care units, recovery room and during interhospital and intrahospital transport.
It operates in range of 5-50 cm H2O of user-set cuff pressures for various cuffed endotracheal tubes to provide suitable solutions for various clinical patient situations. The Puritan Bennett™ Cuff Pressure Manager introduces some new small features and convenient user interface to maximize safe use and usability. Both manual adjusting and one-click inflation function are provided alternatively for user's preference to start inflation. Measure mode allows user to observe the cuff pressure without device intervening before taking actions. Auto Key-lock feature help to avoid mis-operation when there's no user intervene for a long time. For inflation, room air is used and no contact to the respiratory gas system of a patient occurs. It is not intended to connect with ventilator.
The cuff pressure manager is designed with closed loop mechanism which is Pl controlled, and the software level of concern is Class C/Major concern.
The Puritan Bennett™ Cuff Pressure Manager is provided non-sterile and no re-processing is required. A sterile extension tube is equipped with the Puritan Bennett™ Cuff Pressure Manager for inflating/deflating or measuring cuff pressure. The associated accessories include:
- Extension Tube with filter Rechargeable Li-ion Battery Mounting Rack AC/DC Adaptor
Intended Use / Indications for Use
The CPM is intended to continuously measure and automatically maintain the cuff pressure of an endotracheal tube or tracheostomy tube that has been set by the user/clinician during mechanical ventilation. The CPM is intended for use with adult and pediatric patients during mechanical ventilation in the listed areas:
Intensive care unit (ICU) Recovery room Emergency medical care Medical emergency vehicles when the patient is being transported During transport within and outside of the hospital
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Comparison of Technological Characteristics with Predicate Device
The intended use and indication for use for Puritan Bennett™ Cuff Pressure Manager is equivalent to those for the predicate devices, except for limitation of use in operation room, ship, jet and helicopter.
They are similar in fundamental scientific technology in that they are all multi-patient; controller is multiuse; extension tubes are sterile (EtO), single use; inflation/deflation of an endotracheal tube or tracheostomy tube; user set pressure; software controls pressure and automatic pressure maintenance; and AC and batter power supply.
The technical differences between the Puritan Bennett™ Cuff Pressure Manager and predicate device do not raise different issues of safety or effectiveness.
The following Table 10-1 represents a summary of the major technological characteristics of the proposed and predicate devices.
| Characteristic | Proposed Device Puritan Bennett™ CuffPressure Manager | Predicate Device IntelliCuff CuffPressure Controller (K150893) |
|---|---|---|
| Operation altitude | -411m to 4000m above sea level | -650 to 7,620 m above sea level |
| Operation temperature | 0° C to 40° C / 32° F to 104° F (operating),0° C to 50° C / 32° C to 122° F (storage) | -15° C to 50° C / 5° F to 122° F(operating),-15° C to 70° C / 5° C to 158° F(storage) |
| Operation relative humidity | 10% to 95% noncondensing (operating) / 10% to95% noncondensing (storage) | 5% to 95% noncondensing (operating) /5% to 95% noncondensing (storage) |
| Connection with ventilator | The device is not designed connected to anymechanical ventilator. | The device can be connected to anymechanical ventilator. |
| Sterilization | Cuff Pressure Manager is provided non-sterile.Extension tube is provided sterile by EtO. | Controller is provided non-sterile.Cuff Pressure tube is provided sterile byEtO. |
| Electrical safety | Class-II Type BF in accordance with IEC 60601-1and IEC 60601-1-12 | Class-II Type BF in accordance with IEC60601-1 and IEC 60601-1-12 |
| ElectromagneticCompatibility | In accordance with IEC 60601-1-2 | In accordance with IEC 60601-1-2 |
| Alarm | In accordance with IEC 60601-1-8 | In accordance with IEC 60601-1-8 |
| Sensor | Two Sensors | Two Sensors |
| AC power input | 85 to 264 VAC / 47 to 63 Hz ; 7.5 VA typical, 15 VAmaximum | 100 to 240 VAC / 50 to 60 Hz ± 10%;1.25 VA typical, 3.25 VA maximum |
| Characteristic | Proposed Device Puritan Bennett™ CuffPressure Manager | Predicate Device IntelliCuff CuffPressure Controller (K150893) |
| Battery Requirement | 3.6 V /2300mAh Li-ion rechargeable battery.A fully charged battery supports 4 hours operation. | AA (IEC-HR6) NiMH rechargeable 1.2 V,> 1900 mA (two pieces to support energysupply).A fully charged battery supports 5 hoursoperation. |
| Increase/Decrease TargetPressure | Yes | Yes |
| Measure Mode | Yes | No |
| Power on Self Test | Yes | Yes |
| Time-limited Pressure Hold | Yes | Yes |
| One-Click Deflation | Yes | Yes |
| One-Click Inflation | YesInflate to default target pressure when user press"One-Click Inflation" Button. | NoInflate to default target pressure themoment pressing "Power on" button. |
| Manual Key Lock | Yes | Yes |
| Auto Key Lock | Yes | No |
| Default inflation pressuresettings | 25 cm H2O | 25 cm H2O |
| Pressure hold defaultpressure increase | 5 cm H2O | 5 cm H2O |
| Pressure hold maximumallowable pressure | 50 cm H2O | 55 cm H2O |
| Pressure hold time settingrange | 5 minutes to 30 minutes | 5, 10 minutes |
| Pressure hold time factorydefault setting | 5 minutes | 5 minutes |
| Pressure setting range | 5 to 50 cm H2O | 5 to 50 cm H2O |
| Pressure unit switching | 1) cm H2O2) hPa3) mbar | 1) cm H2O2) hPa3) mbar |
| Resolution(setting/display) | +/-1cm H2O | +/-1cm H2O |
| Characteristic | Proposed Device Puritan Bennett™ CuffPressure Manager | Predicate Device IntelliCuff CuffPressure Controller (K150893) |
| Pressure Accuracy | Pressure Accuracy (Display): ±1.5 cm H2OPressure Accuracy (Adjustment): ±1 cm H2O | Pressure Accuracy (Display): ±2 cmH2OPressure Accuracy (Adjustment): ±1cm H2O |
| Alarm Priority | High Priority Alarm:Low Pressure (including cuff leakage), HighPressure, Battery is depleted, Technical Errors, | High Priority Alarm:Cuff system leakage, battery criticallylow, Technical fault |
| Medium Priority Alarm:Battery is very low | Medium Priority Alarm:Pressure above set limit, cuff deflated,battery 10%, Deactivation impossible | |
| Alarm Volume | 50 dB(A) ±5 dB(A)within 1 m distance | 56.5 dB(A) ± 6 dB(A) within 1 m distance |
| Applied pressure range indeflation mode | -45 cm H2O | -100 cm H2O (-100 mBar) |
| Pressure monitoringresolution | ±0.01 cm H2O (0.01 mbar) | ±0.1 mbar |
| Essential Performance | The applied cuff pressure must be maintained andmonitored. If it is higher or lower than the set limits(±1cm H2O), this must be detected and theoperator informed through an alarm. | The applied cuff pressure must bemaintained and monitored. If it is higheror lower than the set limits(±2mbar), thismust be detected and the operatorinformed through an alarm. |
| Extension Tube with Filter | Yes | Yes |
| Connector compatibility | Compatible with endotracheal tube (ETT) ortracheostomy tube (TT) | Compatible with endotracheal tube (ETT)or tracheostomy tube (TT) |
Table 10-1 Comparison between proposed device and predicate device
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Verification and validation activities were successfully completed. Evidence of safety and effectiveness in support of substantial equivalence were obtained from design verification and validation testing. The design differences were found to not affect safety or performance through applicable design verification activities that demonstrated conformance to applicable technical design specifications and performance requirements, applicable medical device performance standards and other non-clinical testing.
Performance Testing - Bench
1. Electrical Safety and Electromagnetic Compatibility Test
Electrical safety and EMC testing were conducted on the Puritan Bennett™ Cuff Pressure Manager. The device complies with the following standards:
- . ANSI AAMI ES60601-1:2005/(R)2012 And A1:2012, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
- . IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
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- . IEC 60601-1-8:2006+AMD1:2012 Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
- . IEC 60601-1-12:2014 Medical electrical equipment Part 1-12: General requirements for basic safety and essential performance — Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment
- . AIM 7351731 Rev. 2.00 2017-02-23 Medical Electrical Equipment and System Electromagnetic Immunity Test for Exposure to Radio Frequency Identification Readers
2. Function and performance Test-Cuff Pressure Manager
- . Cuff Pressure Manager function and performance evaluation per technical specification
- . Battery performance study on new and aged battery
- . Transportation movement simulation test (vibration test, bump test and broad-band random vibration test) per EN 1789:2007+A2:2014
- . Performance test on ETT of different size and material
- . Benchmark test to compare with predicate device
- . The performance of the closed loop design is verified per applicable clauses in IEC 60601-1-10.
3. Function and performance Test-Extension tube
- . Extension tube performance evaluation per technical specification
- . Luer connector connectivity test per ISO 594-1:1986 and ISO 80369-7:2016
- . Stability Test
- -Accelerated aging test for 5 years shelf life per ASTM F1980:16
- -Packaging stability test per ASTM F88/F88M:2015, ASTM F1929:2015
- . Sterilization validation per ISO 11135:2014 and 10993-7: 2008 AC:2009
4. Software Test
- . Software Unit Test
- . Software Integration Test
- . User Interface Test
- . Software Verification & Validation Test
Cybersecurity 5.
- . Cybersecurity assessment per FDA Guidance "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices".
- . Penetration test
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6. Usability Test
Usability /human factor testing is performed per IEC 60601-1-6:2010+AMD1:2013 and IEC 62366-1:2015:
- . Validate performance meets user need and intended use identified in customer requirement.
- Validate potential use error per risk and hazard analysis .
- . Validate Instructions for Use
Consensus standards utilized
| Standards for Declaration of Conformity | FDA-RecognizedStandard No. |
|---|---|
| ANSI AAMI ES60601-1:2005/(R)2012 And A1:2012, Medical electrical equipment - Part 1:General requirements for basic safety and essential performance | 19-4 |
| IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basicsafety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests | 19-8 |
| IEC 60601-1-8:2006+AMD1:2012 Medical electrical equipment - Part 1-8: Generalrequirements for basic safety and essential performance - Collateral Standard: Generalrequirements, tests and guidance for alarm systems in medical electrical equipment andmedical electrical systems | 5-76 |
| IEC 60601-1-12:2014 Medical electrical equipment Part 1-12: General requirements for basicsafety and essential performance - Collateral Standard: Requirements for medical electricalequipment and medical electrical systems intended for use in the emergency medical servicesenvironment | 19-15 |
| IEC 60601-1-6:2010+AMD1:2013 Medical electrical equipment - Part 1-6: Generalrequirements for basic safety and essential performance - Collateral standard: Usability | 5-89 |
| IEC 62366-1:2015 Medical devices - Application of usability engineering to medical devices | 5-114 |
| IEC 62304: 2015 Medical device software - Software life cycle processes | 13-79 |
| ISO 14971:2007 Medical devices: Application of risk management to medical devices | 5-40 |
| ANSI/AAMI ST67:2011(R2017) Sterilization of health care products-Requirements andGuidance for selecting a sterility assurance level (SAL) for products labeled "STERILE" | 14-314 |
| ISO 11135:2014 Sterilization of health care products - Ethylene oxide - Requirements fordevelopment, validation and routine control of a sterilization process for medical devices | 14-452 |
| ISO 10993-7: 2008 AC:2009 Biological evaluation of medical devices - Part 7: Ethylene oxidesterilization residuals | 14-408 |
| ASTM F88/F88M:2015 Standard Test Method for Seal Strength of Flexible Barrier Materials | 14-482 |
| ASTM F1929:2015 Standard Test Method for Detecting Seal Leaks in Porous MedicalPackaging by Dye Penetration | 14-484 |
| ASTM F1980:16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for MedicalDevices | 14-497 |
| ISO 15223-1:2016 Medical devices - Symbols to be used with medical device labels, labelingand information to be supplied - Part 1: General requirement | 5-117 |
| ISO 594-1:1986 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain othermedical equipment — Part 1: General requirements | 6-11 |
| ISO 80369-7:2016 Small-bore connectors for liquids and gases in healthcare applications —Part 7: Connectors for intravascular or hypodermic applications | 5-115 |
| AIM 7351731 Rev. 2.00 2017-02-23 Medical Electrical Equipment and SystemElectromagnetic Immunity Test for Exposure to Radio Frequency Identification Readers | 19-30 |
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Performance Testing – Animal
No animal data are included in this submission.
Performance Testing - Clinical
No clinical data are included in this submission.
Conclusion
The evaluation testing concludes that the Puritan Bennett™ Cuff Pressure Manager was found to be substantially equivalent to the predicate device.
§ 868.5750 Inflatable tracheal tube cuff.
(a)
Identification. An inflatable tracheal tube cuff is a device used to provide an airtight seal between a tracheal tube and a patient's trachea.(b)
Classification. Class II (performance standards).