(493 days)
Not Found
No
The document describes a microprocessor-controlled device with various sensors and safety features, but there is no mention of AI or ML algorithms for data analysis, decision-making, or learning. The control logic appears to be based on predefined parameters and sensor inputs.
Yes
The device is a jet ventilator designed to provide ventilation during medical procedures, which directly supports and maintains physiological functions.
No
Explanation: The device is a jet ventilator designed for therapeutic purposes, specifically for ventilation during bronchoscopy and laryngoscopy, including airway surgery, LASER light application, foreign body removal, and supplemental oxygenation. While it includes sensors for monitoring ventilation parameters, these are for controlling the ventilation process and ensuring patient safety, not for diagnosing medical conditions.
No
The device description clearly outlines numerous hardware components, including sensors, a screen, a blender, a heating and humidification system, a roller pump, and a microprocessor. This indicates it is a physical medical device with integrated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The Monsoon Universal Jet Ventilator is a medical device used to provide ventilation (breathing support) to patients during specific medical procedures (bronchoscopy and laryngoscopy). It directly interacts with the patient's airway.
- Intended Use: The intended use clearly describes its application in surgical and clinical settings for airway management and ventilation, not for analyzing biological samples.
- Device Description: The description details components related to gas delivery, pressure monitoring, humidification, and control systems, all of which are consistent with a respiratory support device, not an IVD.
Therefore, the Monsoon Universal Jet Ventilator falls under the category of a therapeutic or life support medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Monsoon Universal Jet Ventilator is designed to use for bronchoscopy and laryngoscopy.
Jet ventilation applied with the Monsoon Universal Jet Ventilator is useful in airway surgery, as it is performed in thoracic surgery units and ENT surgery. Jet ventilation is the optimal ventilation technique during the application of LASER light, where the presence of an ETT bears the risk for ignition, airway fire and burn injuries. Jet ventilation is useful for the removal of foreign bodies from the airway (e.g. after accidental aspiration of foreign bodies) via rigid bronchoscopes, for supplemental oxygenation during lung surgery (when the operated lung must be recruited for additional oxygenation, but may not be ventilated conventionally for surgical reasons), for surgery of the lower trachea close to the carina (when during the reconstruction phase, no tight airway sealing can be achieved), for radiation therapy of lung metastasis (when the tidal movements of the chest during spontaneous respiration or conventional ventilation would preclude the focusing of the radiation beam onto the target.
The Monsoon Universal Jet Ventilator is intended for use during bronchoscopy or laryngoscopy in a hospital or other clinical setting.
Product codes (comma separated list FDA assigned to the subject device)
CBK, BTT
Device Description
All in one concept: In the past time, a jet ventilator system consisted of a jet ventilator and a humidifier, both made as individual units in separate enclosures. Now, those components in electronics became smaller and smaller, both units have been put together in one enclosure.
Airway pressure measurement: One of the key features of the MONSOON is the safety concept to avoid having excessive pressures occurring in the patient's airways. To reach this goal, a high pressure resistant sensor with excellent resolution in the working range of 1 to 200 cmH2O is used.
Bias flow: Another new feature in airway pressure measurement is the use of a small bias flow going through the airway pressure line, to eliminate the dead-space of the airway pressure line. In addition, the bias flow avoids, bacteria and humidity going back into the machine, creating contamination. If the airway pressure line is occluded, the bias flow makes the pressure rising and the ventilation is stopped immediately.
Display: A large screen displays the main parameters of ventilation and allows quick information of the anaesthetist about the status of the ventilation. A graphic indication of the airway pressure makes quantitative reading possible and allows quick access for parameter changes. Special functions are activated in menus and displayed on the screen.
Air / Oxygen blender: The MONSOON has a built in blender, which allows concentrations between 21 and 100 % oxygen. The access for changes is via a knob on the front panel. This parameter is accessible without going into menus, to allow a rapid change in case of emergency. The MONSOON uses an oxygen sensor, which is calibrated each time the unit, is switched on. If the ventilator can't reach the selected FiQ2, an alarm message appears on the screen, informing about a problem in the qas supply.
Bypass flow: The MONSOON has an additional outlet for gas, which can be adjusted from 0 to 70 LPM and a concentration between 21 % and 100 %. This feature allows mask ventilation of the patient for induction in anaesthesia or for emergency ventilation with a manual breathing bag.
Humidification and heating system: The MONSOON is equipped with a heating and humidification system, controlled by the microprocessor, which automatically adjusts the water injection and temperature of the jet gas. The water supply is based on the minute volume and therefore quarantees an efficient climatisation of the gas. In the MONSOON, the gas is preheated prior the injection of the water and therefore a saturation of the gas is achieved much easier. On the ventilator, all changes affecting the minute volume are controlled by the microprocessor, resulting in a reduction or increase of water injection. The temperature is controlled by a PT-100 temperature sensor and for safety; a thermostatic switch shuts down the heating system in case of a system failure. If the water supply is occluded or the bottle is empty, an alarm message on the screen informs the operator. The MONSOON has a small roller pump mounted on the right side of the unit, allowing easy access. A standard IV set is used to connect the bottle with the pump inlet.
Microprocessor and Memory: H8 532 (manufactured by Hitachi) Clock frequency 10MHz Memory devices: 27C512 (several types available) 64kB EPROM DS1386 (manufactured by Dallas) 32kB RAM timekeeper external watchdog
Sensors: 200 cmH2O pp-pressure sensor (Honeywell) monitoring pressure condition in Jet tube sampling on jet frequency max 2.5 samples per second; 200 cmH2O pip-pressure sensor (Honeywell) monitoring pressure condition 10 ms; 72.5 PSI driving-pressure sensor (Honeywell) monitoring driving pressure sampling rate maximum 200 ms; 142 cmH2O differential pressure sensor (Honeywell) monitoring jet flow in Jet tube sampling rate depending on jet frequency max 2.5 samples per second; 142 cmH2O differential pressure sensor (Honeywell) monitoring bypass flow in Jet tube sampling rate 10 ms; PT 100 temperature sensor (Jumo) regulates temperature of heating system sampling rate 500ms; EPL 10 Bubble detector (Argus) water detector sampling rate 100 ms
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
airway
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospital or other clinical setting.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).
0
510(k) Summary MONSOON
ACUTRONIC
MEDICAL SYSTEMS
Rev 3
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
1. Submitter's name, address, telephone number, contact person, and date summary prepared:
-
ACUTRONIC Medical Systems AG a. Fabrik im Schiffli CH - 8816 Hirzel, Switzerland Tel. 0041 1 729 70 80 Fax. 0041 1 729 70 81 e-mail: p.cavelti(@acutronic-medical.ch
DEC 2 0 2002 -
b. Contact Person: Pius Cavelti
Director Sales / Marketing -
Date Summary Prepared: September 25, 2002 C.
2. Name of device, including trade name and classification name:
- Trade/Proprietary Name: Monsoon a.
- Classification Name: Ventilator Continuous b.
3. Identification of the predicate device or legally marketed device or devices to which substantial equivalence is being claimed:
| Company: | ACUTRONIC Medical Systems AG |
|---|---|
| Device: | AMS-1000 Universal Jet Ventilator |
| 510(k) : | K863155 |
| Date Cleared: | 8/15/86 |
| Company: | ACUTRONIC Medical Systems AG |
| Device: | AMS-1020 Heated Jet Humidifier |
| 510(k) : | K863154 |
| Date Cleared: | 8/15/86 |
Image /page/0/Picture/19 description: The image shows two numbers separated by a vertical line. On the left side of the line, there are two zeros stacked on top of each other. On the right side of the line, there is the number 05. The numbers are bold and black.
1
-
- A description of the device that is the subject of the 510(k), including explanation of how the device functions, basic scientific concepts, significant physical and performance characteristics (design, material, physical properties):
All in one concept:
In the past time, a jet ventilator system consisted of a jet ventilator and a humidifier, both made as individual units in separate enclosures. Now, those components in electronics became smaller and smaller, both units have been put together in one enclosure.
Airway pressure measurement:
One of the key features of the MONSOON is the safety concept to avoid having excessive pressures occurring in the patient's airways. To reach this goal, a high pressure resistant sensor with excellent resolution in the working range of 1 to 200 cmH2O is used.
Bias flow:
Another new feature in airway pressure measurement is the use of a small bias flow going through the airway pressure line, to eliminate the dead-space of the airway pressure line. In addition, the bias flow avoids, bacteria and humidity going back into the machine, creating contamination. If the airway pressure line is occluded, the bias flow makes the pressure rising and the ventilation is stopped immediately.
Display:
A large screen displays the main parameters of ventilation and allows quick information of the anaesthetist about the status of the ventilation. A graphic indication of the airway pressure makes quantitative reading possible and allows quick access for parameter changes. Special functions are activated in menus and displayed on the screen.
Air / Oxygen blender:
The MONSOON has a built in blender, which allows concentrations between 21 and 100 % oxygen. The access for changes is via a knob on the front panel. This parameter is accessible without going into menus, to allow a rapid change in case of emergency. The MONSOON uses an oxygen sensor, which is calibrated each time the unit, is switched on. If the ventilator can't reach the selected FiQ2, an alarm message appears on the screen, informing about a problem in the qas supply.
Bypass flow:
The MONSOON has an additional outlet for gas, which can be adjusted from 0 to 70 LPM and a concentration between 21 % and 100 %. This feature allows mask ventilation of the patient for induction in anaesthesia or for emergency ventilation with a manual breathing bag,
Image /page/1/Picture/19 description: The image contains the number 006. The numbers are vertically stacked on top of each other. The numbers are in a bold, sans-serif font.
2
Rev 3
Humidification and heating system:
The MONSOON is equipped with a heating and humidification system, controlled by the microprocessor, which automatically adjusts the water injection and temperature of the jet gas. The water supply is based on the minute volume and therefore quarantees an efficient climatisation of the gas. In the MONSOON, the gas is preheated prior the injection of the water and therefore a saturation of the gas is achieved much easier. On the ventilator, all changes affecting the minute volume are controlled by the microprocessor, resulting in a reduction or increase of water injection. The temperature is controlled by a PT-100 temperature sensor and for safety; a thermostatic switch shuts down the heating system in case of a system failure. If the water supply is occluded or the bottle is empty, an alarm message on the screen informs the operator. The MONSOON has a small roller pump mounted on the right side of the unit, allowing easy access. A standard IV set is used to connect the bottle with the pump inlet.
Microprocessor and Memory:
H8 532 (manufactured by Hitachi) Clock frequency 10MHz Memory devices: 27C512 (several types available) 64kB EPROM DS1386 (manufactured by Dallas) 32kB RAM timekeeper external watchdog
Sensors:
200 cmH2O pp-pressure sensor (Honeywell) monitoring pressure condition in Jet tube sampling on jet frequency max 2.5 samples per second
200 cmH2O pip-pressure sensor (Honeywell) monitoring pressure condition 10 ms
72.5 PSI driving-pressure sensor (Honeywell) monitoring driving pressure sampling rate maximum 200 ms
142 cmH2O differential pressure sensor (Honeywell) monitoring jet flow in Jet tube sampling rate depending on jet frequency max 2.5 samples per second
142 cmH2O differential pressure sensor (Honeywell) monitoring bypass flow in Jet tube sampling rate 10 ms
PT 100 temperature sensor (Jumo) regulates temperature of heating system sampling rate 500ms
EPL 10 Bubble detector (Argus) water detector sampling rate 100 ms
0007
3
Fault-Detection:
PP sensor is periodically checked for disconnection, shortcut and defective membrane (period: depending on frequency setting) failure results in error message
PIP sensor is periodically checked for disconnection, shortcut and defective membrane (period: depending on frequency setting) failure results in error message
Driving pressure sensor is checked for disconnection & shortcut (period: depending on frequency setting) failure results in error message
Differential pressure sensors are periodically checked for disconnection & shortcut (period: depending on frequency setting) failure results in error message
Oxygen sensor is periodically checked for disconnection, shortcut and capacity (period: depending on actual regulated difference capacity only in auto calibration mode (startup routine)) failure results in error message
Full time gas input detection failure results in alarm message
Fully regulated temperature in heating system (timeout and high temperature alarm plus thermostatic HW security) failure results in alarm message
Fully regulated oxygen concentration with timeout function failure results in alarm message
Water supply is periodically checked failure results in alarm message
Alarm functions
General information
In case of an alarm, the MONSOON will display the alarm message on the screen and an acoustic alarm sounds. The acoustic alarm is ceased as soon as the alarm condition is cleared. However, the screen message remains until it is confirmed by pressing the alarm reset button. If you press alarm reset button while the alarm conditions is not cleared, there is an alarm mute for 1 minute activated, which depresses the acoustic alarm for this period. The screen inverses to make the user aware that the alarm mute is active.
The Monsoon has an alarm concept to allow a safe use of the equipment for patient and operator. The following section shows the different alarm types and their sources:
PIP too high:
This alarm is activated if the airway pressure exceeds the set limit. It is only measured if the Proximal Pressure line is connected with the unit and therefore requires double lumen catheters.
008
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5 of 8
PIP disconnect:
This alarm is activated if there was no pressure detected in the Proximal Pressure Line
PP too high:
This alarm is activated if the pressure in the Jet line remains above the set limit for the PP pressure. This alarm is a safety feature for the use of Jet Ventilation with single lumen catheters. It allows a security shut-off of the Jet Vertilator in case of an airway obstruction.
add water.
This alarm is activated when the water-detector in the unit doesn't detect any water.
System alarms
General information
These alarms signal the user a state of improper function of the device. There is no immediate danger to the patient but the device should be replaced and serviced by authorized personal (exception: low level of pressure input).
Specification and characteristics of the ventilation alarm
Application:
The ventilation device makes sure that max. oxygen level in the Jet ventilator is below a level of concern. The ventilation is periodically checked for ether disconnect (alarm level 1) or overload (alarm level 2) of the fan. This is an alarm, which cannot be disabled.
Specification and characteristics of the FIO2 not adjustable alarm
Application:
The FIO2 not adjustable alarm is evoked as soon as the O2 level can not be adjusted because of any other reason than missing ether O2 or airway pressure. There could be a mechanical problem or a system malfunction of the O2 regulation. If the O2 sensor could not be calibrated this alarm is also set active.
Specification and characteristics of the temperature alarm
Application:
. , , . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
The temperature is continuously watched by the controller. This is an alarm, which cannot be disabled. There is another security implied which cuts the heating power off if the temperature still rises above limitation given through software.
| | | | 0000
ﺍﻟﻤﺴﺎﻋﺪ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘ |
|------------------------------------|------------------|-----------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| File: 510(k) Summary MONSOON Rev 3 | Date: 07.08.2002 | Index: 03 | UV |
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Specification and characteristics of the low O2 pressure alarm
Application:
The O2 pressure is continuously watched by the controller and goes on if there is not enough pressure on the O2 inlet. This is an alarm, which cannot be disabled. The alarm resets itself if pressure is sufficient.
Specification and characteristics of the low air pressure alarm
Application:
The air pressure is continuously watched by the controller and goes on if there is not enough pressure on the air inlet. This is an alarm, which cannot be disabled. The alarm resets itself if pressure is sufficient.
Specification and characteristics of low bat alarm
Application:
Battery level is measured and in case of a worn out battery the message "low bat" is displayed next to the time and date. There is no alarm going off because the battery is not used unless the power failure fault. This battery has not a data backup function. In case of "low bat" a replacement of the battery is sufficient.
Specification and characteristics of Power failure alarm
Application:
Main-line is less than 95 VAC the beeper on the back panel sounds with interval supplied by battery power. This is an alarm which can not be disabled.
Specification and characteristics of MAINTENANCE REQUIRED alarm
Application:
Mistral has an integrated timer function for servicing intervals. After one year, on the display the message "MAINTENANCE REQUIRED" appears. The unit may still be used, however, a service engineer must be called for servicing of the equipment to assure a proper function.
6
Error functions
Overview
The error message signals a system malfunction. The error messages can be reset by the alarm button but if the malfunction is still detected the message immediately returns to the screen. In any of these cases the Monsoon needs a service.
| Type of
| error | Characteristic |
|---|---|
| PIP | |
| sensor | The PIP sensor is out of range |
| (probably disconnected or defect) | |
| PP sensor | The PP sensor is out of range |
| (probably disconnected or defect) | |
| DP | |
| sensor | The DP sensor is out of range |
| (probably disconnected or defect) | |
| O2 sensor | |
| is weak | O2 signal is getting to weak replace |
| the sensor |
5. Statement of intended use:
The Monsoon Universal Jet Ventilator is designed to use for bronchoscopy and laryngoscopy.
Indication for Use
Jet ventilation applied with the Monsoon Universal Jet Ventilator is useful in airway surgery, as it is performed in thoracic surgery units and ENT surgery. Jet ventilation is the optimal ventilation technique during the application of LASER light, where the presence of an ETT bears the risk for ignition, airway fire and burn injuries. Jet ventilation is useful for the removal of foreign bodies from the airway (e.g. after accidental aspiration of foreign bodies) via rigid bronchoscopes, for supplemental oxygenation during lung surgery (when the operated lung must be recruited for additional oxygenation, but may not be ventilated conventionally for surgical reasons), for surgery of the lower trachea close to the carina (when during the reconstruction phase, no tight airway sealing can be achieved), for radiation therapy of lung metastasis (when the tidal movements of the chest during spontaneous respiration or conventional ventilation would preclude the focusing of the radiation beam onto the target.
| File: 510(k) Summary MONSOON Rev 3 |
|---|
| ------------------------------------ |
0011
7
510(k) Summary MONSOON
8 of 8
Statement of how the technological characteristics of the device compare to those 6. of the predicate or legally marketed device.
| Technical feature | AMS-1000/1020 | MONSOON | Comment |
|---|---|---|---|
| EEP Limit | |||
| End Expiratory Pressure | |||
| Limit | Yes, measured in between | ||
| the pulses of Jet | |||
| insufflations. Valve opens | |||
| during pause to direct | |||
| pressure on pressure sensor | Yes, measured with a | ||
| high pressure resistant | |||
| pressure sensor. | |||
| Resolution 1 mbar | Due to availability of high | ||
| pressure resistant sensor, | |||
| quicker response of the | |||
| pressure limit = increased | |||
| patient safety | |||
| PIP Limit | |||
| Peak Inspiratory Pressure | |||
| Limit | Yes, measured through | ||
| proximal pressure line. | |||
| Purged every 30 minutes to | |||
| avoid bacterial contamination | Yes, measured through | ||
| proximal pressure line. | |||
| Purged continuously to | |||
| avoid bacterial | |||
| contamination and to | |||
| detect occlusion of line. | Quicker response of | ||
| pressure shut off in case of | |||
| airway occlusion due to | |||
| small bias flow in pressure | |||
| line. | |||
| Tidal volume | Yes, averaged over 5 breath | Yes, measures each | |
| pulse | Better resolution of volume | ||
| indication | |||
| Minute Volume | Yes, calculated, based on | ||
| frequency and TV | Yes, calculated, based | ||
| on frequency and TV | Better resolution and better | ||
| control of humidity due to | |||
| improved accuracy of MV | |||
| Humidity control | Yes, manually adjusted upon | ||
| visual control of trachea | Yes, automatically | ||
| controlled by | |||
| microprocessor based | |||
| on minute ventilation | Improved humidity due to | ||
| automatic adjustment of | |||
| water amount | |||
| Heating control | Yes, manually by operator, | ||
| based on temperature | |||
| display | Yes, automatically | ||
| controlled by | |||
| microprocessor, based | |||
| on minute ventilation and | |||
| flow | Increased patient safety | ||
| due to servo loop | |||
| regulation and automatic | |||
| control of parameters | |||
| Bypass flow | No | Yes, adjustable from 5 to | |
| 70 LPM | No need for conventional | ||
| anaesthesia machine for | |||
| induction | |||
| Pressure waveform | No, only numeric display | Yes, backlight display for | |
| indication of airway | |||
| pressure and | |||
| parameters | Better visualisation of | ||
| airway pressure as with | |||
| numerics only | |||
| Built-in air-oxygen | |||
| blender | No. Use of Bird blender | Yes, electronic blender | Compact size without need |
| for external tubings | |||
| Oxygen measurement | No. Need of separate oxygen | ||
| monitor | Yes, with automatic | ||
| calibration of sensor | |||
| during start-up | |||
| procedure | Ease of use. | ||
| Peep limit | No | Yes, with visual control | |
| on display | Useful for ARDS treatment | ||
| and if volume controlled | |||
| ventilation is performed | |||
| Inlet pressure controlled | |||
| by servo valve | No | Yes, if pressure limit is | |
| exceeded for more then | |||
| 3 s, the inlet pressure | |||
| valves close for patient | |||
| safety | In case of a jet valve | ||
| failure, the inlet pressure is | |||
| shut off automatically to | |||
| avoid overpressure in the | |||
| patients lung |
8
Image /page/8/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" around the perimeter. Inside the circle is an abstract image of an eagle or other bird-like figure.
DEC 20 2002
ood and Drug Administra 9200 Corporate Boulevaro Rockville MD 20850
ACUTRONIC Medical Systems AG C/O Mr. Terry Torzala Terry Torzala P.O. Box 85820 Tucson, Arizona 85754-5820
Re: K012691
Trade/Device Name: Monsoon Universal Jet Ventilator Regulation Number: 868.5895, 868.5450 Regulation Name: Ventilator Continuous, Respiratory Gas Humidifier Regulatory Class: II Product Code: CBK and BTT Dated: September 25, 2002 Received: September 26, 2002
Dear Mr. Torzala:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
9
Page 2 - Mr. Torzala
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Timothy A. Ulatowski
Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
10
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K012691
Device Name: Monsoon Universal Jet Ventilator
.
,
Indications For Use:
The Monsoon Universal Jet Ventilator is intended for use during bronchoscopy or laryngoscopy in a hospital or other clinical setting.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number. K D120661
Prescription Use J (Per 21 CFR 801.109)
OR
Over-The-Counter Use
Page