(389 days)
No
The description details a system with a host computer, microcontroller, and various modules for sensing, control, and suction. While it performs continuous monitoring and adjustment, the mechanism described appears to be based on direct measurement and control loops (e.g., adjusting cuff pressure based on CO2 levels) rather than AI/ML algorithms learning from data. There is no mention of AI, ML, or related terms, nor are there descriptions of training or test data sets which would be typical for an AI/ML device submission.
Yes.
The device provides continuous endotracheal cuff pressure control and evacuates secretions, which are therapeutic actions aimed at managing the airway and preventing complications.
No.
The device is primarily intended for airway management, continuous endotracheal cuff pressure control, and secretion evacuation. While it measures and monitors carbon dioxide (CO2) in the subglottic space to detect leaks and optimize cuff pressure, this monitoring is performed as a component of its primary therapeutic/management functions, not a standalone diagnostic purpose. The CO2 measurement serves as an "objective indicator for a leak" within the context of managing the airway and preventing aspiration, rather than diagnosing a disease or condition. The device's "Intended Use" explicitly states "airway management" and "providing continuous endotracheal cuff pressure control" and "evacuation of secretions."
No
The device description explicitly lists multiple hardware components including a host computer (PC), microcontroller (MCU), suction module, rinsing module, CO2 analyzer module, cuff pressure module, pneumatic module, connectors panel, operation buttons panel, navigation wheel, and display monitor. It also includes an endotracheal tube and an interconnection harness. This is clearly a system with significant hardware components, not a software-only device.
Based on the provided information, the AnapnoGuard 100 Respiratory Guard System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is focused on airway management through oral/nasal intubation, continuous endotracheal cuff pressure control, monitoring of subglottic CO2 concentration (as an indicator of leak), and evacuation of secretions. These are all related to managing the patient's airway and preventing complications during intubation.
- Device Description: The device components and their functions (cuff pressure control, suction, rinsing, CO2 analysis for leak detection) are all directly involved in managing the patient's physiological state and the function of the endotracheal tube.
- Lack of In Vitro Testing: The description does not mention any testing of samples (blood, urine, tissue, etc.) outside of the body for diagnostic purposes. The CO2 measurement is performed in situ in the subglottic space to assess the seal of the cuff, not to diagnose a disease or condition based on a sample.
- Predicate and Reference Devices: The predicate and reference devices listed are all related to airway management, cuff pressure control, suction, and CO2 monitoring in vivo, not in vitro diagnostic testing.
In summary, the AnapnoGuard 100 Respiratory Guard System is a device used for managing a patient's airway during intubation and monitoring the effectiveness of that management. It does not perform diagnostic testing on samples outside of the body.
N/A
Intended Use / Indications for 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.
Product codes
BSK, BTR
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
airway
Indicated Patient Age Range
All ages, up to the appropriate ETT size
Intended User / Care Setting
Intended users: Health care professionals
Environment of use: Hospitals, Intensive Care Units, Mobile Intensive Care units and Clinics.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Bench Performance Tests:
- ETT: Determination of Cuff Resting Diameter (Purpose: Measure the cuff resting diameter.)
- ETT: Resistance to Tube Collapse (Purpose: Validate that the tube doesn't cave in from inward cuff pressure)
- ETT: Resistance to Cuff Herniation (Purpose: Validate that the cuff does not herniate the tube's airway.)
- ETT: Cuff Symmetry (Purpose: Validate the symmetry of the cuff.)
- Suction Module: Suction Safety Test (Purpose: Evaluate that the suction is safe.)
- Suction Module: Determination of AnapnoGuard suction capacity (Purpose: Validate the ability of the AnapnoGuard 100 system to perform suction of the secretions according to the viscosity and rate of secretion production of the average patient.)
- Cuff pressure: Cuff Pressure Safety Test (Purpose: Validate the AnapnoGuard 100 design in maintaining cuff pressures precision and safety boundaries)
- CO2 Analyzer: CO2 Sensor Precision Test (Purpose: Test the CO2 Sensor Precision.)
- Cuff Pressure: Pressure Maintenance Comparison (Tracoe) (Purpose: Compare the ability of the AG 100 to maintain constant pressure in comparison to the existing Tracoe Pressure Regulator)
- System: Integrated Performance Test (Purpose: Test the performance of the system when operating in full spectrum using a patient simulator.)
- Physiological closed loop (Purpose: Evaluate the physiological closed loop between the CO2 measurements and the suction control. This was done by bench testing and theoretical study in conformance to applicable clauses of 60601-1-10)
Bench testing demonstrated that the AnapnoGuard 100 Respiratory Guard System is as safe and as efficient for performing its intended use.
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.
Clinical Performance Data:
Study type: Prospective, two arms controlled and multi-center study.
Sample size: Not explicitly stated, but includes intensive care and post-operative patients.
Method: Patients were randomized to study or control group.
Study group: Intubated with AnapnoGuard ETT and connected to the control unit of the AnapnoGuard 100 Respiratory Guard System operating in full clinical mode (subglottic secretions suction and cuff pressure control enabled).
Control group: Intubated with AnapnoGuard ETT and connected to the control unit of the AnapnoGuard 100 Respiratory Guard System with subglottic secretions suction enabled but cuff pressure control disabled. Cuff pressure was monitored manually.
In both groups, CO2 levels above the cuff were measured by the AnapnoGuard 100 control unit.
Primary endpoint: Overall duration and level of around ETT cuff leakage (determined by CO2 Area under the Curve (AUC)). Non-inferiority hypothesis was tested.
Secondary endpoints: 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).
Adverse events were monitored.
Key Results:
- The average AUC of CO2 leakage in the study group was significantly lower compared to the control group (0.09±0.04 vs. 0.22±0.32 respectively). This result was statistically significant (p
§ 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).
0
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
1
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
2
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)
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 Druq 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
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 Ltd
20 Hamagshimim Street
Kiryat Matalon,
Petach-Tikva, 4934829
Israel
TEL: (972)3-919-1648,
FAX: (972)3-919-1647 |
|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Yoram Levy, Qsite
31 Haavoda Street
Binyamina, Israel 30500
Tel (972)4-638-8837; Fax (972)4-638-0510
Yoram@qsitemed.com |
| Trade Name: | AnapnoGuard 100 Respiratory Guard System |
| Summary
Preparation Date:
Classification: | January 15, 2015
Classification name: Cuff, tracheal tube, inflatable
Product Code: BSK
Regulation No: 21 CFR 868.5750
Class: II
Panel: Anesthesiology |
| Device Description: | 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) |
4
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.
5
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 Pressure | ||
| Regulator | K092733 | Feb 26, 2010 |
| SIMEX subglottic | ||
| Aspiration System (suction) | K141255 | September 22, 2014 |
| Hospitech Respiration | ||
| AnapnoGuard Endotracheal | ||
| Tube (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-Care | ||
| Closed Suction System | K031997 | November 25, 2003 |
| SUNMED CuffAlert™ | K081805 | Nov 14, 2008 |
| Ohio Push-To-Set | ||
| Intermittent and Continuous | ||
| Vacuum Regulators | class II | |
| Product Code KDP | ||
| Regulation No. 21CFR 880.6740 | ||
| NS Series Vacuum/Pressure | ||
| Gauges | K081778 | Sep 12, 2008 |
| MicroCap Plus/NPB-75 | K024300 | Apr 03, 2003 |
| Hamilton Cuff Pressure | ||
| Regulator (IntelliCuff) | K103803 | Nov 3 , 2011 |
| Boehringer Laboratories | ||
| CASS Regulator Model | ||
| 3720 | class II | |
| Product Code KDP | ||
| Regulation No. 21CFR 880.6740 |
Hospitech AnapnoGuard™ 100 Respiration Guard System – 510k Notification
6
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 | BSK | |
| 21 CFR 868.5750 | BSK | |
| 21 CFR 868.5750 | ||
| Minimum measured pressure | 0 mmHg | 15 mmHg |
| 20 Cm H2O | ||
| Maximal cuff pressure | 33 mmHg (47 cmH2O) | 22 mmHg |
| 30 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 time | ||
| Pressure 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 Guard
System (Submitted) | K141255
SIMEX subglottic
Aspiration System |
|-------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Hospitech Respiration Ltd. | SIMEX Medizintechnik, GmbH |
| Intended use | AnapnoGuard 100 Respiratory Guard
System is intended for airway
management by oral/nasal intubation
while providing continuous | The SIMEX subglottic
Aspiration System models
cuff M and cuff S are
indicated for vacuum
suction, extraction. |
| | AnapnoGuard 100 Respiratory Guard
System (Submitted) | K141255
SIMEX subglottic
Aspiration System |
| | 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. | aspiration and removal of
surgical fluids, tissue
(including bone), bodily
fluids or infectious
materials from wounds or
from patient's airway or
respiratory system, either
during surgery or at
patient's bed side. |
| Product Code,
Regulation
Number | BSK
21 CFR 868.5750 | BTA
21 CFR 878.4780 |
| Regulatory Class | II | II |
| Suction Pressure
Range | -20 up to -120 mmHg | -15 to -225 mmHg
(-20 to -300 mbar) |
| Mode of
operation | Manual
Intermittent | Manual
Intermittent: |
| Closed System | Yes | Yes |
| Indications for
single patient
use | No | No |
| Allows ETT
replacement
without
disconnecting
patient from
ventilator | Yes | Yes |
| Manual control
of vacuum | Yes | Yes |
| Patient
Population | Adults | Adults and pediatric |
| Evacuation of
secretions from
above the
endotracheal
tube's cuff | yes | Yes |
| Biocompatibility | All materials that come in contact with
the patient body or liquids are | Same |
| | AnapnoGuard 100 Respiratory Guard
System (Submitted) | K141255
SIMEX subglottic
Aspiration System |
| | biocompatible and compliant with ISO
10993-1 | |
| Flow Rate | 0 to 15 L/min | 8 L/Min |
7
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".
8
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 | Proposed
AnapnoGuard 100 Respiratory
Guard System | Hospitech Respiration
AnapnoGuard Endotracheal
Tube (ETT)
(K093126) |
|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. | The AnapnoGuard Endotracheal
Tube is indicated for airway
management by oral or nasal
intubation of the trachea and for
evacuation or drainage of the
subglottic 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 |
| Prescription
use/OTC use | Prescription use | Prescription use |
| Environment of
use | Hospitals, Intensive Care Units,
Mobile Intensive Care units and
Clinics. | Same |
| Intended users | Health care professionals | Same |
| Intended
population | All ages, up to the appropriate
ETT size | Same |
| Biocompatibility | All materials are biocompatible
and compliant with ISO 10993-1 | Same |
| Sterilization
method | ETO | ETO |
| Performance
Standards | ISO 5361 | Same |
| Characteristics | Proposed
AnapnoGuard 100 Respiratory
Guard System | Hospitech Respiration
AnapnoGuard Endotracheal
Tube (ETT)
(K093126) |
| Sizes (Input
Diameter) [mm] | 6.5, 7.0, 7.5, 8.0, 8.5, 9.0 mm | Same |
| Murphy's Eye | With or without | Same |
| Number of
lumens (except
main lumen) | 4 of which 2 are combined into
one suction lumen:
1: suction x 2
2: Vent, rinsing, air sampling
3: Cuff inflation/deflation | Same |
| Suction lumens | Two suction lumens combined
into one at the proximal end,
outside the tube wall | Same |
| Tracheal tube
maximum
period | 29 days | 29 days |
| Reusable or
disposable | Disposable | Disposable |
| Storage
Environment | Ambient Temperature: -20° C to
40°C (-4°F to 104°F)
Pressure: 430 mmHg to 795
mmHg | Same |
| Operating
environment | Ambient temperature: 0÷50°C
(32°F - 122°F)
Humidity: 10÷80% non-
condensing Altitude: -1,250 feet
to 15,000 feet | Same |
9
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.
7
10
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
11
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 Resting | |
| Diameter | Measure the cuff resting diameter. |
| ETT: | |
| Resistance to Tube Collapse | Validate that the tube doesn't cave in |
| from inward cuff pressure | |
| ETT: | |
| Resistance to Cuff Herniation | Validate that the cuff does not herniate |
| the 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 of | |
| AnapnoGuard suction capacity | Validate the ability of the |
| AnapnoGuard 100 system to perform | |
| suction of the secretions according to | |
| the viscosity and rate of secretion | |
| production of the average patient. | |
| Cuff pressure: | |
| Cuff Pressure Safety Test | Validate the AnapnoGuard 100 design |
| in maintaining cuff pressures precision | |
| and safety boundaries | |
| CO2 Analyzer: | |
| CO2 Sensor Precision Test | Test the CO2 Sensor Precision. |
| Cuff Pressure: | |
| Pressure Maintenance | |
| Comparison (Tracoe) | Compare the ability of the AG 100 to |
| maintain constant pressure in | |
| comparison to the existing Tracoe | |
| Pressure Regulator | |
| System: | |
| Integrated Performance Test | Test the performance of the system |
| when operating in full spectrum using | |
| a patient simulator. | |
| Physiological closed loop | Evaluate the physiological closed loop |
| between the CO2 measurements and | |
| the suction control. This was done by | |
| bench testing and theoretical study in | |
| conformance to applicable clauses of | |
| 60601-1-10 |
12
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).
13
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