(237 days)
The Galileo Gold ventilator is intended to provide positive pressure ventilatory support to Adults, Pediatrics and Infants. The device is intended for use in the hospital and institutional environment where healthcare professionals provide patient care, including use as a patient bedside or for intra-facility transport, provided compressed gas is supplied. The device is not intended for transport, outside the hospital or for use in the home environment.
The Galileo ventilator is a legally marketed intensive care ventilator (K982910, K001686). The four modifications included in this application are purely software-related and do not change the hardware of the Galleo Gold ventilator. This application is for the following options to the Galileo Gold ventilator: DuoPAP and APRV modes, NIV mode, MMV+ mode, and TRC feature.
Here's a summary of the acceptance criteria and the study information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes modifications to an existing ventilator (GALILEO Gold) rather than a novel device requiring specific clinical performance metrics like sensitivity, specificity, or accuracy for a diagnostic task. Therefore, the "acceptance criteria" here relate to demonstrating substantial equivalence to predicate devices and ensuring the new software features do not introduce safety or effectiveness concerns. The performance is reported in terms of successful testing and comparison to predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| DuoPAP & APRV Modes: | DuoPAP & APRV Modes: |
| - Automatic and regular switchover between two pre-set pressure levels functioning correctly | Yes (No difference to predicate devices: PB 840, Raphael) |
| - Ventilated patient can breathe freely at either pressure level | Yes (No difference to predicate devices) |
| - Spontaneous breaths may be pressure-supported if desired | Yes (No difference to predicate devices) |
| - "Control breaths" synchronized to spontaneous breaths | Yes (No difference to predicate devices) |
| NIV Mode: | NIV Mode: |
| - Underlying mode is Pressure Support | Yes (No differences to predicate device: Evita 4 NIV option) |
| - Inspiration is patient-triggered | Yes (No differences to predicate device) |
| - Inspiration is pressure-limited | Yes (No differences to predicate device) |
| - Inspiration is flow-cycled (first) and time-cycled (second) | Yes (No differences to predicate device) |
| - Indicated for spontaneously breathing patients only | Yes (No differences to predicate device) |
| - Apnea ventilation possible | Yes (No differences to predicate device) |
| TRC Feature: | TRC Feature: |
| - Minimizes additional Work of Breathing (WoB) caused by ET-tube or tracheostomy tube | Yes (No difference to predicate device: Evita 4 ATC option) |
| - Compensates resistance from ET-tube or tracheostomy tube | Yes (No difference to predicate device) |
| - Applies instantaneous opposite counter-force to offset the resistance | Yes (No difference to predicate device) |
| - Compensation works in inspiration and expiration phases | Yes (No difference to predicate device) |
| - Users must set up tube type, size, and compensation intensity | Yes (No difference to predicate device) |
| - Displays on-line a calculated intra-tracheal pressure curve | Yes (No difference to predicate device) |
| MMV+ Mode: | MMV+ Mode: |
| - User sets target minute ventilation | Yes (Matches Evita 4 MMV, Servo1, Servo 300A Automode) |
| - User sets target tidal volume | Yes (Matches Evita 4 MMV, Servo1, Servo 300A Automode) |
| - User sets target rate | Yes (Matches Evita 4 MMV - minimum mandatory rate only, Servo1, Servo 300A Automode) |
| - Regulated inspiratory pressure | Yes (Matches Servo1, Servo 300A Automode (PRVC & VS); Evita 4 MMV does not) |
| - Regulated respiratory rate | Yes (Matches Evita 4 MMV; Servo1, Servo 300A Automode does not) |
| - Assured minimum target minute ventilation | Yes (Matches Evita 4 MMV, Servo1, Servo 300A Automode) |
| - Switch between mandatory and spontaneous breaths | Yes (Matches Servo1, Servo 300A Automode; Evita 4 MMV does not) |
| Overall Software Safety & Performance: | Overall Software Safety & Performance: |
| - No performance deviations during modular, integration, and system testing | "As presented within the accompanying documentation, there were no performance deviations observed or documented during modular, integration and system testing." |
| - Compliance with ASTM Standard F1100-93 (Ventilator Performance) | "The ventilator performance has been further evaluated in accordance to the ASTM Standard F1100-93. The graphical analyses of the waveforms shows that there is no new question raised regarding safety and effectiveness of the complete instrument and its new features." |
| - No impact on microcomputer system (execution times, reaction times, overall load) | "The impact of the new software on the microcomputer system (execution times of the different communication processes, reaction times and the overal load) were tested and documented. As presented within the accompanying documentation, there were no performance deviations observed or documented during the testing." |
| - Substantial equivalence to predicate devices for each new mode/feature for intended use cases | "There are no significant differences between the new Galileo Gold features and its predicates." (This is the overarching conclusion drawn from the detailed feature comparison tables for each mode.) Found substantially equivalent by FDA (K040574). |
2. Sample Size Used for the Test Set and Data Provenance:
The document describes software modifications to an existing device, and the testing focuses on functional verification and validation, rather than clinical trials with patient data.
- Test Set Sample Size: Not applicable in the traditional sense of a clinical trial test set. The "test set" consisted of various test cases, scenarios, and configurations for modular, integration, and system testing of the software features. Specific numbers of test cases or their characteristics are not provided in this summary.
- Data Provenance: The testing was conducted internally by Hamilton Medical AG (Switzerland) as part of the device modification and regulatory submission process. It is a prospective test in the sense that custom tests were designed and executed to verify the functionality of the new software. There is no indication of retrospective patient data being used.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable in the context of this type of device submission. Ground truth, in this context, would refer to the expected functional behavior and performance defined by engineering specifications, relevant standards (like ASTM F1100-93), and comparisons to legally marketed predicate devices. This is established through engineering design, regulatory standards, and comparison to existing, approved devices, not via expert consensus on clinical findings.
4. Adjudication Method for the Test Set:
Not applicable. The testing described is a verification and validation process against predefined specifications and predicate devices, not subjective clinical assessment requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study assesses how human readers perform with and without an AI assistant, which is relevant for diagnostic or interpretive AI devices. The GALILEO Gold ventilator modification is a software update for a therapeutic device, not a diagnostic AI system.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Yes, in a sense. The core of the testing involved evaluating the new software features in a standalone capacity (i.e., the algorithm/software's execution and its impact on the ventilator's function) without explicitly human-in-the-loop performance studies as would be conducted for AI diagnostic tools. The "System tests were executed with a complete instrument, i.e. the new software together with the existing Galileo Gold hardware," which assesses the algorithm's performance within the device itself.
7. Type of Ground Truth Used:
The "ground truth" for this submission is based on:
- Engineering Specifications and Design Requirements: The new software features were developed to specific engineering criteria.
- Performance Standards: Compliance with relevant standards, such as ASTM Standard F1100-93 for ventilator performance.
- Functional Equivalence to Predicate Devices: The detailed comparison tables demonstrate that the new features function equivalently and do not introduce significant differences compared to the predicate devices.
- Absence of Deviations: The successful completion of modular, integration, and system testing without observed or documented performance deviations.
8. Sample Size for the Training Set:
Not applicable. This device is a medical ventilator with software modifications, not a machine learning or AI algorithm that requires a training set of data for learning patterns. The software is programmed with specific logic and control algorithms.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of device. The software's "logic" is established through conventional software engineering and ventilator control algorithms, based on physiological principles and intended clinical functionality.
{0}------------------------------------------------
| Project-Name : GALILEO Gold 510(k) Submission HAMILTON MEDICAL AG | Doc.-No.: E35103_Part: | ||
|---|---|---|---|
| Doc.-Title : | GALILEO Gold Ventilator Modification Part 10 - 510(k) Summary | Doc.-Version : 1.1 | |
| 10 | SUMMARY | OCT 27 2004 | |
| APPLICANTS NAME ANDADDRESS | Hamilton Medical AGVia NovaCH-7403 RhaezuensSwitzerland | ||
| APPLICANTS CONTACT PERSON | Dr. Andreas ScheibePhone: +41 81 660 60 10Fax: +41 81 660 60 20e-mail: ascheibe@hamilton-medical.ch | ||
| APPLICANTS CONTACT PERSONIN THE USA | Hamilton Medical Inc.Mr. David ThompsonPost Office Box 30008Reno, NV 89520Phone: 775-858-3200, Extension 349Fax: 775-856-5621e-mail: thompson@hammed1.comEstablishment Registration 2937708 | ||
| DATE THE SUMMARY WASPREPARED | |||
| COMMON NAME | Continuous Ventilator | ||
| PROPRIETARY NAME | GALILEO Gold | ||
| PURPOSE OF SUBMISSION | New features for existing, legally marketed instrumentin the US (K982910, K001686) | ||
| CLASSIFICATION | Name: Ventilator, Continuous (per 21 CFR 868.5895)Panel: AnesthesiologyCode: CBK | ||
| REGULATORY STATUS | 1. Current Device Class: Class 22. Performance Standards & Special Controls: None |
{1}------------------------------------------------
| Кчиф574 | |||
|---|---|---|---|
| Project-Name : | GALILEO Gold 510(k) Submission HAMILTON MEDICAL AG | Doc.-No.: E35103 Part 2 | |
| Doc.-Title : | GALILEO Gold Ventilator Modification Part 10 - 510(k) Summary | Doc.-Version : 1.1 |
PREDICATE DEVICE IDENTIFICATION
| Legally marketed devices to which equivalence is being claimed | ||||
|---|---|---|---|---|
| Predicate DeviceDuoPAP and APRV modes | Manufacturer | 510(k) number(s) | Classification | |
| RAPHAEL | HAMILTON MedicalAG | K02267 | Ventilator, Continuous,Facility Use per 21CFR 868.5895 | |
| Puritan Bennett 840 | Nellcor Puritan-Bennett | K984535, K001646 | Ventilator, Continuous,Facility Use per 21CFR 868.5895 | |
| NIV modeEvita 4 | DraegerMedizintechnik AG | K010093 | Ventilator, Continuous,Facility Use per 21CFR 868.5895 | |
| MMV+ modeSiemens Servo' | Siemens-Elema AB | K010925, K022132 | Ventilator, Continuous,Facility Use per 21CFR 868.5895 | |
| Siemens Servo 300A | Siemens-Elema AB | K970839 | Ventilator, Continuous,Facility Use per 21CFR 868.5895 | |
| Evita 4 | DraegerMedizintechnik AG | K980642 | Ventilator, Continuous,Facility Use per 21CFR 868.5895 | |
| TRC featureEvita 4 | DraegerMedizintechnik AG | K992608 | Ventilator, Continuous,Facility Use per 21CFR 868.5895 |
| announce and states of the contrôleant of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the contribution of | Separate of the country of consisted on the consideration of | Property and Personal Property of |
|---|---|---|
| A . S.1001 | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------..Now and was a second and a not a mayCall State Charles Children Children Comment Com-Canada Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Ca.. | I I see to real a management come an:4. 17 - 51.5 ----------------------------------------------------------------------------. |
| .Section of the station of the collection of | of contract from to the partmentof the count of the children and the collection of the comments of |
{2}------------------------------------------------
| Project-Name : | GALILEO Gold 510(k) Submission HAMILTON MEDICAL AG | Doc .- No. : | E35103 Part 2 |
|---|---|---|---|
| Doc .- Title : | GALILEO Gold Ventilator Modification Part 10 - 510(k) Summary | Doc .-Version : | 1.1 |
DEVICE DESCRIPTION
The Galileo ventilator is a legally marketed intensive care ventilator (K982910, K001686). The four modifications included in this application are purely software-related and do not change the hardware of the Galleo Gold ventilator.
This application is for the following options to the Galileo Gold ventilator:
- . The DuoPAP (Duo Positive Airway Pressure ventilation) and APRV (Airway Pressure Release Ventilation) ventilation modes technically almost identical. In both modes, the ventilator alternates the airway pressure between two positive levels according to the preset controls. The ventilated patient can breathe at either pressure level. The spontaneous breaths are synchronized with the automatic switchover between the two pressure levels.
- . The NIV (Non-Invasive Ventilation) mode is designed to facilitate ventilation assistance in a noninvasive way (e.g. a facial, a nasal mask or a mouth piece) between the ventilator and the patient's airway.
- The MMV* (Mandatory Minute Ventilation with Advanced Performance) mode is a pressure-controlled, . minute volume-constant ventilation with controlled P & and ventilation rate. The patient pressure is controlled to PEEP + Psp during the insufflation and to PEEP during the expiration. The patient target pressure is identical for the mandatory and for the spontaneous breaths. The mandatory ventilation rate and the inspiration time are set by the clinician. Depending on the patient's spontaneous breath rate, some mechanical breaths are added to achieve the mandatory rate.
- TRC (Tube Resistance Compensation) is a feature to minimize the patient's work of breathing to . overcome the additional airway resistance due to the presence of an ET-tube or a tracheotomy tube.
INTENDED USE
The GALILEO Gold is intended to provide positive pressure ventilatory support in intensive care units.
INTENDED OPERATOR
The GALILEO Gold is intended for use by properly trained personnel under the direct supervision of a licensed physician. In the US, federal laws restricts this device to sale by or on the order of a physician.
INTENDED PATIENT POPULATIONS
The GALILEO Gold is intended for intensive care ventilation of adults, pediatric and infant patients.
INTENDED USE ENVIRONMENT
The GALILEO Gold is intended for use at the bedside and for transport within a hospital or hospital-type facility, provided compressed gas is supplied.
The GALILEO Gold is not to be used in the presence of flammable anesthetic agents or other ignition sources. The GALILEO Gold is not to be used in an environment with magnetic resonance imaging (MRI) equipment.
SUBSTANTIAL EQUIVALENCE
The DuoPAP and the APRV mode of the GALILEO Gold is substantially equivalent to the DuoPAP and APRV modes of the RAPHAEL ventilator and to the BiLevel mode of the Puritan-Bennett 840 ventilator system. The NIV mode of the GALILEO Gold is substantially equivalent to NIV option of the Evita 4 ventilator. The TRC feature of the GALILEO Gold is substantially equivalent to the ATC option of the Evita 4 ventilator. The MMV+ mode of the GALILEO Gold is substantially equivalent to the Evita 4 ventilator and to the Automode of the Servo 300A and Servo' ventilators.
| C. Danuser | 1 18 800Page 4 of | 902004-01-29 |
|---|---|---|
| Copyright by・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・0) 0. | ----------------------------------------------------------------------.Comments of the program and the comments of the country22 11 11 11 11 11 11 11 11 11.Carlos Controller Comments of- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -consistential consideration of the comments of the com-Carlos Concession ComersMarch Market Children Street we well was and the was and200 "printand the contribution of the countthe was an a superior of the control ofand the state of the county ofand the contract and the problem of the promotive of the country------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | .1 - 3 - 5 - 1 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 -Comments of the Research and Children11 11 2 111 2 2 2 1 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2CONFIDENTIAL . |
{3}------------------------------------------------
| K444571 | |||
|---|---|---|---|
| Project-Name : | GALILEO Gold 510(k) Submission | HAMILTON MEDICAL AG | Doc.-No. : E35103 Part 2 |
| Doc.-Title : | GALILEO Gold Ventilator Modification Part 10 - 510(k) Summary | Doc.-Version : 1.1 |
SUMMARY OF PERFORMANCE TESTS
The performance/qualification testing of the new added Galileo Gold features (DuoPAP/APRV, NIV, TRC and MMV') has been done on modular, integration and system level. The modular and integration testing of the new software based features have been successfully performed for each individual new mode. System tests were executed with a complete instrument, i.e. the new software together with the existing Galileo Gold hardware. As presented within the accompanying documentation, there were no performance deviations observed or documented during modular, integration and system testing.
The ventilator performance has been further evaluated in accordance to the ASTM Standard F1100-93. The graphical analyses of the waveforms shows that there is no new question raised regarding safety and effectiveness of the complete instrument and its new features.
As the implementation of the new software features in the Galileo Gold instrument did not include any new hardware, certain tests could be omitted (e.g. the ASTM F-1100 endurance testing, the EMC testing and the EN-60601-1 and EN 60601-1-2). However, the impact of the new software on the microcomputer system (execution times of the different communication processes, reaction times and the overal load) were tested and documented. As presented within the accompanying documentation, there were no performance deviations observed or documented during the testing.
COMPARISON OF GALILEO GOLD NEW FEATURES TO PREDICATE DEVICES
The four following tables compare the major technological performance characteristics of the new Galleo Gold features to its predicate devices. There are no significant differences between the new Galileo Gold features and its predicates.
MAJOR FEATURE COMPARISON
DUOPAP & APRV (DUAL PRESSURE VENTJLATION MODE)
| Function | DuoPAP & APRV | BiLevel | DuoPAP & APRV | Discussion of the differences |
|---|---|---|---|---|
| Product name | Galileo Gold | PB 840 | Raphael | --- |
| Manufacturer | Hamilton Medical | Nellcor Puritan-Bennett | Hamilton Medical | --- |
| The 510(K) number | To be assigned | K970460, K984535,K993071, K001646,K021573 | K022679 | --- |
| Automatic and regularswitchover between twopre-set pressure levels | Yes | Yes | Yes | Nodifference |
| The ventilated patient canbreathe freely at eitherpressure level | Yes | Yes | Yes | Nodifference |
| The spontaneous breathsmay be pressure-supportedif desired | Yes | Yes | Yes | Nodifference |
| The "control breaths" aresynchronized to thespontaneous breaths by theventilated patients | Yes | Yes | Yes | Nodifference |
| C. Danuser | Page 5 of 7 | 2004-01-29 |
|---|---|---|
| © Copyright by HAMILTON MEDICAL AG | CONFIDENTIAL |
{4}------------------------------------------------
| Project-Name : | GALILEO Gold 510(k) Submission | HAMILTON MEDICAL AG | Doc.-No. : | E35103_Part 2 |
|---|---|---|---|---|
| Doc.-Title : | GALILEO Gold Ventilator Modification Part 10 - 510(k) Summary | Doc.-Version : | 1.1 |
NIV MODE (NON INVASIVE VENTILATION MODE)
| Function | NIV | NIV option | Discussion of thedifferences |
|---|---|---|---|
| Product name | Galileo Gold | Evita | --- |
| Manufacturer | Hamilton Medical | Draeger | --- |
| The 510(k) | To be assigned | K961687, K980642,K992608, K010093 | --- |
| Underlying mode | Pressure support | Pressure support | No differences |
| How the inspiration istriggered | Patient-triggered | Patient-triggered | No differences |
| How the inspiration islimited | Pressure-limited | Pressure-limited | No differences |
| How the inspiration isterminated | Flow-cycled (first)Time-cycled (second) | Flow cycled (first)Time-cycled (second) | No differences |
| Indicated patient population | For spontaneouslybreathing patients only | For spontaneouslybreathing patients only | No differences |
| Apnea ventilation possible? | Yes | Yes | No differences |
TRC (TUBUS RESISTANCE COMPENSATION):
| TRC | ATC option | Discussion ofdifferences | |
|---|---|---|---|
| Function | |||
| Product name | Galileo Gold | Evita 4 | --- |
| Manufacturer | Hamilton Medical | Draeger | --- |
| 510(k) number | To be assigned | K961687,K980642,K992608,K010093 | --- |
| To minimize additional WoBpt caused by ET-tube or tracheostomy tube | Yes | Yes | No difference |
| Compensate the resistance from an ET-tubeor a tracheostomy tube | Yes | Yes | No difference |
| Apply instantaneous opposite counter-forceto offset the resistance | Yes | Yes | No difference |
| Compensation works in both inspiration andexpiration phases | Yes | Yes | No difference |
| Users must set up the tube type, size andcompensation intensity | Yes | Yes | No difference |
| Display on-line a calculated intra-trachealpressure curve | Yes | Yes | No difference |
| C. Danuser | Page 6 of 7 | 2004-01-29 |
|---|---|---|
| © Copyright by HAMILTON MEDICAL AG | CONFIDENTIAL |
{5}------------------------------------------------
| Project-Name: | GALILEO Gold 510(k) Submission HAMILTON MEDICAL AG | Doc.-No.: | E35103 Part 2 |
|---|---|---|---|
| Doc.-Title: | GALILEO Gold Ventilator Modification Part 10 - 510(k) Summary | Doc.-Version: | 1.1 |
MMV* (MANDATORY MINUTE VENTILATION WITH ADVANCED PERFORMANCE)
| Major feature of ventilation | MMV+ | MMV | Automode | |
|---|---|---|---|---|
| Product name | Galileo Gold | Evita 4 | Servo1 and Servo 300 A | |
| Manufacturer | HamiltonMedical | Draeger | Siemens | |
| PRVC | VS | |||
| User sets target minute ventilation | Yes | Yes | Yes | No |
| User sets target tidal volume | Yes | Yes | Yes | No |
| User sets target rate | Yes | Yes(only theminimummandatoryrate) | Yes | No |
| Regulated inspiratory pressure | Yes | No | Yes | Yes |
| Regulated respiratory rate | Yes | Yes | No | No |
| Assured minimum target minuteventilation | Yes | Yes | Yes | No |
| Switch between mandatory andspontaneous breaths | Yes | No | Yes |
| t the first of the first of the first of the first of the first of the first for the first for the first for the first for the first for the first for the first for the firstJanuser | aloe | |
|---|---|---|
| CALLA10. 14. 11As a version of " " " ":.Property and an an and the province© GT- CODVI-- ANDRECHOAL - | August 4 - 1 - 1 - 1 - 1 - 1 - 1 - 1 -... .. SALE FERAnd Include and | 2004-01-Company Comments of ChildrenCall And Childer Species Children March 19 to ChildrenC = = = = = = = = = = = = = = = = = = = = = = =. |
| AND AUGUALL LA-LA-LA-LA-. MILE E E MILLE B LE BELL B LE LEBERT . BE COLLECT . CONTRACT . CONTRACT . CONTRACT . CONTRACT . CONTACT . CONTACT . CONTACT . CONTACT . CONTACT . CONTACT . CONTACT . CONTAC | MARKA ARRENA ARABARA AND AND AND AND ANDStation Andrews Children Arts Children Company Company Company Company Company Company Company Company Company Company Company Company Company Company Company Company CompanyState and the designed and second consideration of the commender of the commended to the commend | ARTHERComments of the consisted to the |
{6}------------------------------------------------
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.
Public Health Service
OCT 2 7 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. J. David Thompson General Manager Hamilton Medical, Incorporated P.O. Box 30008 Reno. Nevada 89520
Re: K040574
Trade/Device Name: Galileo Gold Ventilator Regulation Number: 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: September 30, 2004 Received: October 1, 2004
Dear Mr. Thompson:
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.
{7}------------------------------------------------
Page 2 -- Mr. Thompson
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 (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{8}------------------------------------------------
INDICATIONS FOR USE
510(k) Number: K 040574
Device Name: Galileo Gold ventilator
- The Galileo Gold ventilator is intended to provide positive pressure ventilatory Indication for Use: support to Adults, Pediatrics and Infants. The device is intended for use in the hospital and institutional environment where healthcare professionals provide patient care, including use as a patient bedside or for intra-facility transport, provided compressed gas is supplied. The device is not intended for transport, outside the hospital or for use in the home environment.
Prescription Use X (Per 21 CFR 801 Subpart D)
OR
Over-The-Counter Use __ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Century O, on for AAC
(Division Sign-Off) (Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: kφ4φS74
Page 1 of _1
§ 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).