(389 days)
AnapnoGuard 100 Respiratory Guard System is intended for airway management by oral/nasal intubation while providing continuous endotracheal cuff pressure control using non-invasive measurement and monitoring of carbon dioxide concentration in the subglottic space and evacuation of secretions from above the endotracheal tube's cuff.
AnapnoGuard 100 Respiratory Guard System is comprised of the following three main components: The AnapnoGuard endotracheal tube (ETT) with inflatable cuff (FDA cleared under K093126). The AnapnoGuard 100 Respiratory Guard System interconnection harness of tubes, connecting the ETT to the AnapnoGuard 100 control unit The AnapnoGuard 100 Respiratory Guard System control unit which consists of the following main modules: Host computer (PC) Microcontroller (MCU) Suction module (regulator and flow potency meter): including . a set of valves and pipes controlling the secretions suction/evacuation from above the ETT cuff. Rinsing module: Pumps saline to rinse the Suction and Vent/ ● CO2 lumens. CO2 analyzer module: including CO2 analyzer assembly, ● pump, valve and flow filter which sucks air from the subglottic space above the ETT cuff into the CO2 analyzer. . Cuff pressure module: includes two pressure gauges which monitor cuff pressure, a miniature air pump and two valves. Pneumatic module: valves, pipes and filters . Connectors panel for connecting the interconnection harness . (ETT), vacuum, trap bottle, rinsing fluid and filters. Operation buttons panel and navigation wheel . I/O communication panel . Display monitor . AnapnoGuard 100 Respiratory Guard System, including its three components monitors leak between the endotracheal tube's cuff and the trachea by measuring the Carbon Dioxide levels in the subglottic area above the cuff through a dedicated lumen in the endotracheal tube. Detection of a high level of Carbon Dioxide is an objective indicator for a leak (improper sealing of the trachea by the endotracheal tube cuff). The system continuously monitors and adjusts the cuff pressure to prevent a leak at minimum possible pressure (all within pressure limits preset by the user). Preventing a leak reduces the likelihood of aspiration of secretions from the upper airways into the lungs and increases the likelihood for no loss of ventilation and delivery of anesthetic and nebulized drugs into the lungs. Keeping the cuff pressure as low as possible reduces the mechanical pressure of the cuff on the tracheal tissue throughout the intubation period. The system also performs evacuation of secretions from above the endotracheal tube's cuff through a dedicated lumen at the dorsal side of the endotracheal tube.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance
The document describes several performance criteria derived from a comparison with predicate devices and specific performance bench tests. The clinical study primarily focuses on the effectiveness of the AnapnoGuard 100 Respiratory Guard System in optimizing cuff pressure and reducing CO2 leakage.
Table 1: Acceptance Criteria and Reported Device Performance
| Feature/Metric | Acceptance Criteria (from predicate/bench tests) | Reported Device Performance (from clinical study/bench tests) |
|---|---|---|
| Cuff Pressure Control | ||
| Minimum measured pressure | 15 mmHg (PYTON predicate) | 0 mmHg (AnapnoGuard 100) |
| Maximal cuff pressure | 22 mmHg (PYTON predicate) | 33 mmHg (AnapnoGuard 100) |
| Control Accuracy | ± 0.73 mmHg (PYTON predicate) | ± 0.1 mmHg (AnapnoGuard 100) |
| Recording Accuracy | ± 0.73 mmHg (PYTON predicate) | ± 0.1 mmHg (AnapnoGuard 100) |
| Pressure drop Alarm time | N/A (PYTON predicate) | 0.2 Sec (AnapnoGuard 100) |
| Cuff Pressure Safety Test | Maintain pressures precision and safety boundaries | Validated: Design maintains cuff pressures precision and safety boundaries. |
| Pressure Maintenance Comparison | To maintain constant pressure (Tracoe) | Compared favorably: Ability to maintain constant pressure compared to Tracoe Pressure Regulator demonstrated. |
| CO2 Leakage / Measurement | ||
| CO2 Sensor Precision Test | N/A | Test performed. (Specific precision not quantified in this summary, but device claims ±0.1 mmHg control/recording accuracy.) |
| Overall duration and level of around ETT cuff leakage (CO2 Area under the Curve - AUC) | Non-inferiority to standard of care/reduction in leakage | Study Group: 0.09±0.04 Control Group: 0.22±0.32 (Statistically significant reduction in study group, p<0.001) |
| Number of cuff pressure measurements within safety accepted range (24-40 cmH2O) | Higher proportion within range vs. standard of care | Normalized number of cuff pressure measurements within safety range in Study group > twice the control group (mean ratio Study/Control = 2.03, P<0.001) |
| Number of significant CO2 leakages (≥2mmHg in subglottic space) | Reduction vs. standard of care | Significantly lower in Study group (0.056) vs. Control group (0.642) (Mean Ratio Study/Control = 0.09, p<0.001) |
| Suction Module | ||
| Suction Pressure Range | -15 to -225 mmHg (SIMEX predicate) | -20 up to -120 mmHg (AnapnoGuard 100) (Within predicate range) |
| Flow Rate | 8 L/Min (SIMEX predicate) | 0 to 15 L/min (AnapnoGuard 100) |
| Suction Safety Test | Evaluate safe suction | Evaluated: Suction identified as safe. |
| Determination of AnapnoGuard suction capacity | To perform suction according to viscosity and rate of secretion production | Validated: Ability to perform suction of secretions according to viscosity and rate of secretion production of average patient. |
| Integrated System & Usability | ||
| Integrated Performance Test | Perform when operating in full spectrum | Performed: Performance demonstrated when operating in full spectrum using a patient simulator. |
| Physiological closed loop | Compliance with 60601-1-10 | Evaluated: Between CO2 measurements and suction control via bench testing and theoretical study in conformance to applicable clauses of 60601-1-10. |
| Usability/Human Factors | Safe and effective use by intended users | Cleary indicated User Manual and GUI are clear. Demonstrated safety and effectiveness when operated by intended hospital professional team. |
| Adverse Events | No serious or device-related adverse events | No serious or device related adverse events were recorded throughout the study. |
Note: Some acceptance criteria are implicitly met by "similarity" or "within parameters" based on predicate device comparison, while others are direct test outcomes.
Study Details
Here's a breakdown of the specific information requested regarding the studies:
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: The clinical study enrolled intensive care and post-operative patients expected to be mechanically ventilated for at least 12 hours. The exact number of patients is not explicitly stated in the provided text.
- Data Provenance: The study was a prospective, two-arms controlled and multi-center study. The country of origin is not specified, but the applicant (Hospitech Respiration Ltd) is based in Israel, suggesting the study might have been conducted there or internationally.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the text. The ground truth for the clinical study was based on objective measurements by the AnapnoGuard 100 control unit itself (CO2 levels, cuff pressure measurements) rather than human expert interpretation of an image or signal for diagnostic purposes.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- None (N/A): The clinical study did not involve human interpretation requiring adjudication. The primary endpoints (CO2 AUC, cuff pressure measurements, significant leakages) were direct, quantifiable output from the device.
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: An MRMC comparative effectiveness study was not conducted. This device is not an AI diagnostic tool that assists human readers in interpreting data; rather, it's an automated system for managing airway parameters. The study compared the device's automated full clinical mode against a "standard of care" manual monitoring approach, not human readers with or without AI.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, effectively: The "Study group" in the clinical trial represents the AnapnoGuard 100 Respiratory Guard System operating in its "full clinical mode, where the subglottic secretions suction and cuff pressure control was enabled (ON mode)." This is a standalone performance of the device's automated functions without continuous human intervention to adjust cuff pressure based on leak detection. The "Control group" was monitored manually, but the device's CO2 detection was still used to measure outcome. The results directly reflect the performance of the device's integrated algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for the clinical study's primary and secondary endpoints was based on objective, quantitative measurements obtained directly from the AnapnoGuard 100 control unit. This includes:
- CO2 levels in the subglottic space (to determine cuff leakage).
- Cuff pressure measurements.
8. The sample size for the training set:
- The document does not mention a training set in the context of machine learning or AI models. Given the device's nature (closed-loop control system rather than a diagnostic AI), it likely uses pre-programmed logic and algorithms based on physiological principles rather than a trainable model from a large dataset. Therefore, a "training set" as commonly understood in AI/ML is not applicable or not disclosed.
9. How the ground truth for the training set was established:
- As a training set (in the AI/ML sense) is not mentioned or implied, the method for establishing its ground truth is not applicable or not provided. The device's operation is based on established engineering and physiological principles.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized caduceus, which is a staff entwined by two snakes, often used as a symbol of medicine and healthcare.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 16, 2016
Hospitech Respiration Ltd c/o Yoram Levy Qsite General Manager Osite 31 Haavoda St. Binyamina 30500 Israel
Re: K150157
Trade/Device Name: AnapnoGuard 100 Respiratory Guard System Regulation Number: 21 CFR 868.5750 Regulation Name: Inflatable Tracheal Tube Cuff Regulatory Class: Class II Product Code: BSK, BTR Dated: December 19, 2015 Received: December 28, 2015
Dear Mr. Levy,
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. 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 801; medical device reporting (reporting of medical
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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K150157
Device Name
AnapnoGuard 100 Respiratory Guard System
Indications for Use (Describe)
AnapnoGuard 100 Respiratory Guard System is intended for airway management by oral/nasal intubation while providing continuous endotracheal cuff pressure control using non-invasive measurement and monitoring of carbon dioxide concentration in the subglottic space and evacuation of secretions from above the endotracheal tube's cuff.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Image /page/3/Picture/0 description: The image shows the logo for Hospitech Respiration. The logo features a blue letter H with serifs, positioned in front of a globe-like grid. The text "Hospitech Respiration" is written in blue below the symbol.
510(K) SUMMARY
AnapnoGuard 100 Respiratory Guard System 510(k) Number K150157
| Applicant's Name: | Hospitech Respiration Ltd20 Hamagshimim StreetKiryat Matalon,Petach-Tikva, 4934829IsraelTEL: (972)3-919-1648,FAX: (972)3-919-1647 |
|---|---|
| Contact Person: | Yoram Levy, Qsite31 Haavoda StreetBinyamina, Israel 30500Tel (972)4-638-8837; Fax (972)4-638-0510Yoram@qsitemed.com |
| Trade Name: | AnapnoGuard 100 Respiratory Guard System |
| SummaryPreparation Date:Classification: | January 15, 2015Classification name: Cuff, tracheal tube, inflatableProduct Code: BSKRegulation No: 21 CFR 868.5750Class: IIPanel: Anesthesiology |
| Device Description: | AnapnoGuard 100 Respiratory Guard System is comprised of thefollowing three main components:The AnapnoGuard endotracheal tube (ETT) with inflatable cuff (FDA cleared under K093126). The AnapnoGuard 100 Respiratory Guard System interconnection harness of tubes, connecting the ETT to the AnapnoGuard 100 control unit The AnapnoGuard 100 Respiratory Guard System control unit which consists of the following main modules: Host computer (PC) Microcontroller (MCU) |
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Image /page/4/Picture/0 description: The image shows a logo for Hospitech Respiration. The logo features a blue letter "H" in a serif font, positioned in front of a globe-like structure made of thin lines. Below the "H" and the globe, the words "Hospitech Respiration" are written in a simple, sans-serif font. The overall design is clean and corporate, suggesting a company involved in global healthcare or respiratory technology.
- Suction module (regulator and flow potency meter): including . a set of valves and pipes controlling the secretions suction/evacuation from above the ETT cuff.
- Rinsing module: Pumps saline to rinse the Suction and Vent/ ● CO2 lumens.
- CO2 analyzer module: including CO2 analyzer assembly, ● pump, valve and flow filter which sucks air from the subglottic space above the ETT cuff into the CO2 analyzer.
- . Cuff pressure module: includes two pressure gauges which monitor cuff pressure, a miniature air pump and two valves.
- Pneumatic module: valves, pipes and filters .
- Connectors panel for connecting the interconnection harness . (ETT), vacuum, trap bottle, rinsing fluid and filters.
- Operation buttons panel and navigation wheel .
- I/O communication panel .
- Display monitor .
AnapnoGuard 100 Respiratory Guard System, including its three components monitors leak between the endotracheal tube's cuff and the trachea by measuring the Carbon Dioxide levels in the subglottic area above the cuff through a dedicated lumen in the endotracheal tube. Detection of a high level of Carbon Dioxide is an objective indicator for a leak (improper sealing of the trachea by the endotracheal tube cuff). The system continuously monitors and adjusts the cuff pressure to prevent a leak at minimum possible pressure (all within pressure limits preset by the user).
Preventing a leak reduces the likelihood of aspiration of secretions from the upper airways into the lungs and increases the likelihood for no loss of ventilation and delivery of anesthetic and nebulized drugs into the lungs. Keeping the cuff pressure as low as possible reduces the mechanical pressure of the cuff on the tracheal tissue throughout the intubation period.
The system also performs evacuation of secretions from above the endotracheal tube's cuff through a dedicated lumen at the dorsal side of the endotracheal tube.
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Image /page/5/Picture/0 description: The image shows the logo for Hospitech Respiration. The logo features a blue letter "H" with serifs, positioned in front of a globe-like grid. The text "Hospitech Respiration" is written in a simple, sans-serif font below the emblem.
Indication for Use:
AnapnoGuard 100 Respiratory Guard System is intended for airway management by oral/nasal intubation while providing continuous endotracheal cuff pressure control using noninvasive measurement and monitoring of carbon dioxide concentration in the subglottic space and evacuation of secretions from above the endotracheal tube's cuff.
Predicate Devices: Substantial equivalence to the following predicate devices is claimed:
| Device Name | 510k No | Clearance Date |
|---|---|---|
| PYTON Cuff PressureRegulator | K092733 | Feb 26, 2010 |
| SIMEX subglotticAspiration System (suction) | K141255 | September 22, 2014 |
| Hospitech RespirationAnapnoGuard EndotrachealTube (ETT) | K093126 | March 2, 2010 |
Reference devices:
| Device Name | 510k No | Clearance Date |
|---|---|---|
| Covidien SealGuard™ Evac | K082520 | October 2, 2008 |
| TELEFLEX ISISTM | K091761 | October 29, 2009 |
| Mallinckrodt Ty-CareClosed Suction System | K031997 | November 25, 2003 |
| SUNMED CuffAlert™ | K081805 | Nov 14, 2008 |
| Ohio Push-To-SetIntermittent and ContinuousVacuum Regulators | class IIProduct Code KDPRegulation No. 21CFR 880.6740 | |
| NS Series Vacuum/PressureGauges | K081778 | Sep 12, 2008 |
| MicroCap Plus/NPB-75 | K024300 | Apr 03, 2003 |
| Hamilton Cuff PressureRegulator (IntelliCuff) | K103803 | Nov 3 , 2011 |
| Boehringer LaboratoriesCASS Regulator Model3720 | class IIProduct Code KDPRegulation No. 21CFR 880.6740 |
Hospitech AnapnoGuard™ 100 Respiration Guard System – 510k Notification
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Image /page/6/Picture/0 description: The image shows the Hospitech Respiration logo. The logo features a blue letter H with serifs, positioned in front of a wireframe globe. The text "Hospitech Respiration" is written in blue below the letter H.
| Characteristic | AnapnoGuard 100 Respiratory Guard System (Submitted) | PYTON Cuff Pressure Regulator (K092733) |
|---|---|---|
| Intended use | AnapnoGuard 100 Respiratory Guard System is intended for airway management by oral/nasal intubation while providing continuous endotracheal cuff pressure control using non-invasive measurement and monitoring of carbon dioxide concentration in the subglottic space and evacuation of secretions from above the endotracheal tube's cuff. | To measure and regulate intra-cuff pressures of endotracheal supraglottic airways or tracheostomy tubes. The PYTON is intended for use on patients who are intubated. |
| Regulatory Class | II | II |
| Product Code, Regulation Number | BSK21 CFR 868.5750 | BSK21 CFR 868.5750 |
| Minimum measured pressure | 0 mmHg | 15 mmHg20 Cm H2O |
| Maximal cuff pressure | 33 mmHg (47 cmH2O) | 22 mmHg30 Cm H2O |
| Control Accuracy | $\pm$ 0.1 mmHg (0.13 cmH2O) | $\pm$ 0.73 mmHg ( $\pm$ 1 cmH2O) |
| Recording Accuracy | $\pm$ 0.1 mmHg (0.13 cmH2O) | $\pm$ 0.73 mmHg ( $\pm$ 1 cmH2O) |
| Pressure drop Alarm timePressure rise alarm time | 0.2 Sec | NA |
| Power Supply | 110 – 220 V with backup battery | 110 – 220 V with backup battery |
Comparison with PYTON Pressure Regulator predicate device
Comparison for the SIMEX subglottic suction predicate device
| AnapnoGuard 100 Respiratory GuardSystem (Submitted) | K141255SIMEX subglotticAspiration System | |
|---|---|---|
| Manufacturer | Hospitech Respiration Ltd. | SIMEX Medizintechnik, GmbH |
| Intended use | AnapnoGuard 100 Respiratory GuardSystem is intended for airwaymanagement by oral/nasal intubationwhile providing continuous | The SIMEX subglotticAspiration System modelscuff M and cuff S areindicated for vacuumsuction, extraction. |
| AnapnoGuard 100 Respiratory GuardSystem (Submitted) | K141255SIMEX subglotticAspiration System | |
| endotracheal cuff pressure control usingnon-invasive measurement andmonitoring of carbon dioxideconcentration in the subglottic spaceand evacuation of secretions from abovethe endotracheal tube's cuff. | aspiration and removal ofsurgical fluids, tissue(including bone), bodilyfluids or infectiousmaterials from wounds orfrom patient's airway orrespiratory system, eitherduring surgery or atpatient's bed side. | |
| Product Code,RegulationNumber | BSK21 CFR 868.5750 | BTA21 CFR 878.4780 |
| Regulatory Class | II | II |
| Suction PressureRange | -20 up to -120 mmHg | -15 to -225 mmHg(-20 to -300 mbar) |
| Mode ofoperation | ManualIntermittent | ManualIntermittent: |
| Closed System | Yes | Yes |
| Indications forsingle patientuse | No | No |
| Allows ETTreplacementwithoutdisconnectingpatient fromventilator | Yes | Yes |
| Manual controlof vacuum | Yes | Yes |
| PatientPopulation | Adults | Adults and pediatric |
| Evacuation ofsecretions fromabove theendotrachealtube's cuff | yes | Yes |
| Biocompatibility | All materials that come in contact withthe patient body or liquids are | Same |
| AnapnoGuard 100 Respiratory GuardSystem (Submitted) | K141255SIMEX subglotticAspiration System | |
| biocompatible and compliant with ISO10993-1 | ||
| Flow Rate | 0 to 15 L/min | 8 L/Min |
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Image /page/7/Picture/0 description: The image shows the logo for Hospitech Respiration. The logo features a blue letter H inside of a blue dome shape. Above the dome is a wireframe globe. Below the logo is the text "Hospitech Respiration".
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Image /page/8/Picture/0 description: The image shows the logo for Hospitech Respiration. The logo features a blue letter H in a serif font, set against a backdrop of a wireframe globe. Below the symbol, the words "Hospitech Respiration" are written in a blue, sans-serif font.
Comparison for the AnapnoGuard ETT
| Characteristics | ProposedAnapnoGuard 100 RespiratoryGuard System | Hospitech RespirationAnapnoGuard EndotrachealTube (ETT)(K093126) |
|---|---|---|
| Intended use | AnapnoGuard 100 RespiratoryGuard System is intended forairway management byoral/nasal intubation whileproviding continuousendotracheal cuff pressurecontrol using non-invasivemeasurement and monitoring ofcarbon dioxide concentration inthe subglottic space andevacuation of secretions fromabove the endotracheal tube'scuff. | The AnapnoGuard EndotrachealTube is indicated for airwaymanagement by oral or nasalintubation of the trachea and forevacuation or drainage of thesubglottic space. |
| Product Code | BSK | BTR |
| Regulation No. | 21 CFR 868.5750 | 21 CFR 868.5730 |
| Classification | Class II | Class II |
| Supplied/use | Disposable (ETT portion) | Disposable |
| Prescriptionuse/OTC use | Prescription use | Prescription use |
| Environment ofuse | Hospitals, Intensive Care Units,Mobile Intensive Care units andClinics. | Same |
| Intended users | Health care professionals | Same |
| Intendedpopulation | All ages, up to the appropriateETT size | Same |
| Biocompatibility | All materials are biocompatibleand compliant with ISO 10993-1 | Same |
| Sterilizationmethod | ETO | ETO |
| PerformanceStandards | ISO 5361 | Same |
| Characteristics | ProposedAnapnoGuard 100 RespiratoryGuard System | Hospitech RespirationAnapnoGuard EndotrachealTube (ETT)(K093126) |
| Sizes (InputDiameter) [mm] | 6.5, 7.0, 7.5, 8.0, 8.5, 9.0 mm | Same |
| Murphy's Eye | With or without | Same |
| Number oflumens (exceptmain lumen) | 4 of which 2 are combined intoone suction lumen:1: suction x 22: Vent, rinsing, air sampling3: Cuff inflation/deflation | Same |
| Suction lumens | Two suction lumens combinedinto one at the proximal end,outside the tube wall | Same |
| Tracheal tubemaximumperiod | 29 days | 29 days |
| Reusable ordisposable | Disposable | Disposable |
| StorageEnvironment | Ambient Temperature: -20° C to40°C (-4°F to 104°F)Pressure: 430 mmHg to 795mmHg | Same |
| Operatingenvironment | Ambient temperature: 0÷50°C(32°F - 122°F)Humidity: 10÷80% non-condensing Altitude: -1,250 feetto 15,000 feet | Same |
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Image /page/9/Picture/0 description: The image shows the logo for Hospitech Respiration. The logo features a blue letter H inside of a white globe. Below the globe, the words "Hospitech Respiration" are written in blue.
The AnapnoGuard 100 Respiratory Guard System primary predicate device is the PYTON Cuff Pressure Regulator (K092733) for its cuff pressure control. It has similar intended use and technology as the cuff pressure control of the AnapnoGuard 100 Respiratory Guard System section. The AnapnoGuard 100's limits of presetting the target cuff pressure range are within the PYTON Cuff Pressure Regulator predicate device limits. The AnapnoGuard 100 ETT is the same ETT that was cleared as Hospitech's AnapnoGuard Endotracheal Tube (ETT) K093126.
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Image /page/10/Picture/0 description: The image shows the logo for Hospitech Respiration. The logo features a blue letter "H" in a serif font, positioned in front of a globe-like structure made of intersecting lines. Below the "H" and the globe, the words "Hospitech Respiration" are written in a blue, sans-serif font. The logo appears to be designed to convey a sense of global reach and expertise in the field of respiration technology.
The Hospitech AnapnoGuard 100 Respiratory Guard System Cuff Pressure Monitor is as safe and as effective as the PYTON Cuff Pressure Regulator (K092733) and referenced to the Hamilton Cuff Pressure Regulator (IntelliCuff) (K103803. The AnapnoGuard 100 Respiratory Guard System cuff pressure unit has similar intended use and technological characteristics and is within the cuff pressure of these devices.
The AnapnoGuard 100 Respiratory Guard System suction unit is as safe and as effective as the K141255 SIMEX subglottic Aspiration System. The K141255 SIMEX subglottic Aspiration System predicate devices, has similar intended use and technology and is as safe and as effective as the AnapnoGuard 100 Respiratory Guard System regarding the suction power and the cyclical and automatic suctioning and it can define the length and the interval of the suction as it is done by the AnapnoGuard 100 Respiratory Guard System.
The vacuum pressure of the AnapnoGuard 100 Respiratory Guard System is within the vacuum pressure parameters of its predicate device.
Performance Standards:
AnapnoGuard 100 Respiratory Guard System complies with the following voluntary standards:
- IEC 60601-1:2005/EN 60601-1:2006 Medical Electrical . Equipment – Part 1, General requirements for basic safety and essential performance 3rd Edition
- IEC 60601-1-2:2007 (Electromagnetic compatibility (EMC) ●
- ISO 5361:2012 (Anesthetic and Respiratory Equipment -. Tracheal Tubes and Connectors)
- . EN ISO 10993-1:2003 Biological Evaluation of Medical Devices
- ISO 14971:2007 Risk management for medical devices ●
- 60601-1-10:2014 General Requirements for Basic Safety and ● Essential Performance - Collateral Standard: Requirements for
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Image /page/11/Picture/0 description: The image shows the logo for Hospitech Respiration. The logo features a blue letter H with serifs, placed in front of a globe made of thin blue lines. The text "Hospitech Respiration" is written in blue below the logo.
the Development of Physiologic Closed-Loop Controllers. (General II (ES/EMC))
Performance Bench Tests
The following bench performance testing was performed:
| Name of test | Purpose |
|---|---|
| ETT:Determination of Cuff RestingDiameter | Measure the cuff resting diameter. |
| ETT:Resistance to Tube Collapse | Validate that the tube doesn't cave infrom inward cuff pressure |
| ETT:Resistance to Cuff Herniation | Validate that the cuff does not herniatethe tube's airway. |
| ETT:Cuff Symmetry | Validate the symmetry of the cuff. |
| Suction Module:Suction Safety Test | Evaluate that the suction is safe. |
| Suction Module:Determination ofAnapnoGuard suction capacity | Validate the ability of theAnapnoGuard 100 system to performsuction of the secretions according tothe viscosity and rate of secretionproduction of the average patient. |
| Cuff pressure:Cuff Pressure Safety Test | Validate the AnapnoGuard 100 designin maintaining cuff pressures precisionand safety boundaries |
| CO2 Analyzer:CO2 Sensor Precision Test | Test the CO2 Sensor Precision. |
| Cuff Pressure:Pressure MaintenanceComparison (Tracoe) | Compare the ability of the AG 100 tomaintain constant pressure incomparison to the existing TracoePressure Regulator |
| System:Integrated Performance Test | Test the performance of the systemwhen operating in full spectrum usinga patient simulator. |
| Physiological closed loop | Evaluate the physiological closed loopbetween the CO2 measurements andthe suction control. This was done bybench testing and theoretical study inconformance to applicable clauses of60601-1-10 |
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Image /page/12/Picture/0 description: The image shows the Hospitech Respiration logo. The logo features a blue letter "H" with serifs, positioned in front of a globe-like grid. The words "Hospitech Respiration" are written in blue below the logo. The font appears to be sans-serif.
Bench testing demonstrated that the AnapnoGuard 100 Respiratory Guard System is as safe and as efficient for performing its intended use.
Preclinical Performance Data
The safety and feasibility of the AnapnoGuard 100 Respiratory Guard System were not evaluated by pre-clinical study.
Human factors/usability studies
A total of 45 professional team participants, the target population for operating the AnapnoGuard 100 Respiratory Guard System, were enrolled in the study.
The results of this usability study clearly indicate that User Manual and the Graphic Use Interface (GUI) of the AnapnoGuard 100 Respiratory Guard System are clear. The usability study demonstrated the safety and effectiveness use of the device, when operated by intended user's hospital professional team.
Summary of Clinical Performance Data:
Background
The clinical performance of the AnapnoGuard 100 Respiratory Guard System as airway management tool in mechanically ventilated patients was evaluated in prospective, two arms controlled and multi-center study.
Methods
The study included intensive care and post-operative patients expected to be mechanically ventilated for at least 12 hours. Following screening and enrollment, patients were randomized to study or control group.
Study group patients were intubated with the AnapnoGuard ETT and connected to the control unit of the AnapnoGuard 100 Respiratory Guard System operating in its full clinical mode, where the subglottic secretions suction and cuff pressure control was enabled (ON mode).
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Control group patients were treated according to the current standard of care- patients were intubated with the AnapnoGuard ETT and connected to the control unit of the AnapnoGuard 100 Respiratory Guard System where the subglottic secretions suction was enabled but cuff pressure control was disabled (OFF mode). The cuff pressure in the control group was monitored manually according to standard of care in the ICU. In both groups, the presence of CO2 levels above the cuff was measured by the AnapnoGuard 100 control unit.
The primary end point of the study was the overall duration and level of around ETT cuff leakage (determined by CO2 Area under the Curve (AUC)). Secondary end points included number of cuff pressure measurements within the safety accepted range (24 to 40cmH2O) and number of significant CO2 leakage (readings at ≥2mmHg in the subglottic space). The non-inferiority hypothesis, compared to the standard of care use today was tested (by the primary endpoint). In addition, the performance safety of the AnapnoGuard 100 Respiratory Guard System system was evaluated by monitoring and recording device related adverse events.
Results
The average AUC of CO2 leakage, calculated for the study group was significantly lower compare to control group (0.09±0.04 vs. 0.22±0.32 respectively, This result was found to be statistically significant (p<0.001). The significant reduction in CO2 leakage in study group indicates the efficacy of the AnapnoGuard 100 Respiratory Guard System (while operating in full clinical mode) in optimizing cuff pressure, and the efficacy of AnapnoGuard 100 Respiratory Guard System as airway management tool.
Additional aspects of cuff pressure control during mechanical ventilation were:
- Number of cuff pressure measurements within the safety accepted range. Study result indicated that the normalized number of cuff pressure measurements within the safety range in the Study group more than twice the result of the control group (mean ratio Study / Control= 2.03, P<0.001).
- Measurements of significant leakages (CO2) were significantly lower in Study group compare to control group
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Image /page/14/Picture/0 description: The image shows the logo for Hospitech Respiration. The logo features a blue letter "H" with serifs, positioned in front of a globe-like structure made of thin, curved lines. The globe is white with blue lines. Below the "H" and the globe, the words "Hospitech Respiration" are written in a simple, sans-serif font, with "Hospitech" appearing above "Respiration".
(0.056 vs. 0.642 respectively, Mean Ratio Study / Control=0.09, p<0.001).
Furthermore, no serious or device related adverse events were recorded throughout the study.
These findings further support the performance efficacy of the AnapnoGuard 100 Respiratory Guard System in optimizing cuff pressure and indicating its efficacy as airway management tool.
Conclusions
The AnapnoGuard 100 Respiratory Guard System was proven to meet the safety and effectiveness endpoints
Substantial equivalence conclusion
The performance tests and the clinical study that were conducted shows that the AnapnoGuard 100 Respiratory Guard System is as safe and effective as the listed predicate devices without raising any new questions of safety and efficacy.
§ 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).