(337 days)
The HAMILTON-C3 ventilator is intended to provide positive pressure ventilatory support to adults and optionally infants and neonates.
Intended areas of use:
· In the intensive care ward, intermediate care ward, emergency ward, long term acute care hospital or in the recovery room
· During transfer of ventilated patients within the hospital
The HAMILTON-C3 ventilator is a medical device intended for use by qualified, trained personnel under the direction of a physician and within the limits of its stated technical specifications.
The HAMILTON-C3 is designed for adult, paediatric, infant, and neonatal patients requiring invasive or noninvasive ventilation support. It covers a full range of clinical requirements, including invasive ventilation, automated ventilation with Adaptive Support Ventilation (ASV), and noninvasive ventilation.
The 510(k) submission intends to add the following new features to the previously cleared ventilator HAMILTON-C3:
- The following two new ventilation modes for adult / pediatric patient group: ● (S)CMV and SIMV
- SpO2 monitoring option
This section describes the acceptance criteria and the study proving the device meets those criteria, based on the provided text.
1. Table of acceptance criteria and reported device performance:
| Acceptance Criteria (Guidelines/Standards Met) | Reported Device Performance (Compliance) |
|---|---|
| ANSI/AAMI ES60601-1 (2005/ (R) 2012): Medical electrical equipment General - Requirements for Safety | Compliant; all applicable requirements met. |
| IEC 60601-1-2 (2014): Medical electrical equipment – Part 1-2: General Requirements for Basic Safety and Essential Performance – Collateral Standard: Electromagnetic Compatibility - Requirements and Tests | Compliant; all applicable requirements met. |
| ISO 80601-2-12 (2011): Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators | Compliant; all applicable requirements met. |
| IEC 60601-1-8 (2006 + Am.1: 2012): Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems | Compliant; all applicable requirements met. |
| IEC 60601-1-6 (2010 + A1 :2013): Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability | Compliant; all applicable requirements met. |
| IEC 62366 (2008)+A1(2014): Medical devices Application of usability engineering to medical devices | Compliant; all applicable requirements met. |
| IEC 62304 (2006): Medical device software Software life-cycle processes | Compliant; additional software verification and validation testing conducted as recommended by FDA guidance. Software considered a "major" level of concern. |
| ISO 80601-2-55 (2011): Medical electrical equipment -- Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors | Compliant; all applicable requirements met. |
| ISO 80601-2-61 (2011): Medical electrical equipment -- Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment | Compliant; all applicable requirements met. |
| Performance of new ventilation modes ((S)CMV and SIMV) | Waveform performance testing conducted, and data shown to be substantially equivalent to legally marketed devices (specifically, the HAMILTON-G5 which uses the same algorithms for these modes). |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
The provided text focuses on device performance testing against regulatory standards and software validation. It mentions "waveform performance testing" for the new ventilation modes. However, it does not specify the sample size for any test sets used in performance testing, nor does it detail the data provenance (e.g., country of origin, retrospective/prospective nature of data).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
This information is not provided in the document. The testing described is primarily technical compliance and performance against established engineering standards and validated software functionality, rather than a clinical study requiring expert ground truth for interpretation of outcomes.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not provided. The text describes bench testing and software validation, not a study design involving adjudication of human interpretations.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
A multi-reader multi-case (MRMC) comparative effectiveness study was not mentioned in the provided text. The device is a ventilator, and the testing described is related to its technical performance and safety, not a diagnostic or interpretive AI system that human readers would use.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The document describes "Software Design and Validation" processes, "bench testing of the device," and "waveform performance testing" for the new ventilation modes. These types of tests are inherently "standalone" in that they evaluate the device's algorithmic and mechanical performance directly against engineering specifications and expected outputs, without direct human intervention as part of the core performance measurement, other than operating the test equipment. So, yes, standalone algorithm performance was assessed though not explicitly called out as such.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the device's technical performance and safety is derived from the international and national standards and guidelines listed (e.g., ANSI/AAMI ES60601-1, IEC 60601-1-2, ISO 80601-2-12). For the new ventilation modes, "waveform performance testing" was conducted, implying that the ground truth for correct operation were the expected waveform characteristics and parameters as defined by the ventilator's design specifications and the algorithms derived from the predicate HAMILTON-G5.
8. The sample size for the training set:
A "training set" is typically associated with machine learning or artificial intelligence models. As this document describes a medical device (ventilator) and its compliance with technical standards and software validation, there is no mention of a training set in the context of machine learning. The "training" for such a device would refer to its design, development, and engineering phases.
9. How the ground truth for the training set was established:
Since there is no mention of a training set in the context of machine learning, this question is not applicable. The "ground truth" for the device's design and functionality is established through engineering principles, medical device regulatory requirements, and the functionalities of predicate devices.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three overlapping profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 27, 2017
Hamilton Medical AG Annemarie Höft Quality Engineer Via Crusch 8 Bonaduz, 7402 SWITZERLAND
Re: K161450
Trade/Device Name: Hamilton-C3 Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: Class II Product Code: CBK, DQA Dated: March 20, 2017 Received: March 23, 2017
Dear Ms. Höft:
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.
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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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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" (21 CFR 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,
Image /page/1/Picture/8 description: The image contains a signature and a name. The signature is a complex series of loops and lines. The name next to the signature reads "Tina Kiang-S".
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K161450
Device Name HAMILTON-C3
Indications for Use (Describe)
The HAMILTON-C3 ventilator is intended to provide positive pressure ventilatory support to adults and optionally infants and neonates.
Intended areas of use:
· In the intensive care ward, intermediate care ward, emergency ward, long term acute care hospital or in the recovery room
· During transfer of ventilated patients within the hospital
The HAMILTON-C3 ventilator is a medical device intended for use by qualified, trained personnel under the direction of a physician and within the limits of its stated technical specifications.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for Hamilton Medical. The logo is blue and consists of the word "HAMILTON" in large, bold letters, with a stylized "H" symbol to the right. Below "HAMILTON" is the word "MEDICAL" in a similar font but slightly smaller. Underneath the two words is the phrase "Intelligent Ventilation since 1983" in a smaller, lighter font.
Image /page/3/Picture/1 description: The image shows the logo for HAMILTON-C3. The logo is written in a sans-serif font and is blue. The letters are rounded and have a soft appearance. The word "HAMILTON" is followed by a dot and then "C3".
510(k) SUMMARY
l. SUBMITTER
Hamilton Medical AG Via Crusch 8 Bonaduz, 7402 Switzerland
Phone: +41 58 610 1225 +41 58 610 0020 Fax:
Contact Person: Annemarie Höft, Quality Engineer Frederike Brühschwein, Senior Manager Regulatory Affairs Date Prepared: 2017-04-24
-
II. DEVICE
Name of Devices: HAMILTON-C3 Common or Usual Name: Continuous ventilator Regulation Number and Name: Ventilator, Continuous (21 CFR 868.5895) Device Classification: 2 Product Code: CBK (subsequent: DQA) -
III. PREDICATE DEVICES HAMILTON-C3 (K123637) HAMILTON-G5 (K131774)
IV. DEVICE DESCRIPTION
The HAMILTON-C3 is designed for adult, paediatric, infant, and neonatal patients requiring invasive or noninvasive ventilation support. It covers a full range of clinical requirements, including invasive ventilation, automated ventilation with Adaptive Support Ventilation (ASV), and noninvasive ventilation.
The 510(k) submission intends to add the following new features to the previously cleared ventilator HAMILTON-C3:
- The following two new ventilation modes for adult / pediatric patient group: ● (S)CMV and SIMV
- SpO2 monitoring option
V. INDICATIONS FOR USE
The HAMILTON-C3 ventilator is intended to provide positive pressure ventilatory support to adults and pediatrics and optionally infants and neonates. Intended areas of use:
- In the intensive care ward, intermediate care ward, emergency ward, long term acute care hospital or in the recovery room
- During transfer of ventilated patients within the hospital
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Image /page/4/Picture/0 description: The image contains the logo for Hamilton Medical. The logo is in blue and consists of the words "HAMILTON MEDICAL" stacked on top of each other. Below the logo is the text "Intelligent Ventilation since 1983".
Image /page/4/Picture/1 description: The image shows the word "HAMILTON-C3" in a stylized, sans-serif font. The letters are all in blue. The letters are rounded and have a playful appearance.
The HAMILTON-C3 ventilator is a medical device intended for use by qualified, trained personnel under the direction of a physician and within the limits of its stated technical specifications.
COMPARISON OF TECHNOLOGY CHARACTERISTICS WITH THE PREDICATE DEVICES VI.
A comparative summary of the technological characteristics of the HAMILTON-C3 with the primary predicate and reference devices is presented below.
| Parameters | Application device:HAMILTON-C3 | Predicate device:CurrentlymarketedHAMILTON-C3 | Predicate device:CurrentlymarketedHAMILTON-G5 | Comparison |
|---|---|---|---|---|
| Intended use | The HAMILTON-C3ventilator isintended toprovide positivepressureventilatory supportto adults andpediatrics andoptionally infantsand neonates.Intended areas ofuse:In theintensive careward,intermediatecare ward,emergencyward, longterm acutecare hospitalor in therecoveryroomDuringtransfer ofventilatedpatientswithin thehospitalThe HAMILTON-C3ventilator is amedical deviceintended for use byqualified, trainedpersonnel underthe direction of aphysician andwithin the limits ofits stated technical | The HAMILTON-C3ventilator isintended toprovide positivepressureventilatory supportto adults,paediatrics,infants, andneonates.Intended areas ofuse:In theintensive careward or in therecoveryroom.Duringtransfer ofventilatedpatientswithin thehospital.The HAMILTON-C3ventilator is amedical deviceintended for use byqualified, trainedpersonnel underthe direction of aphysician andwithin the limits ofits stated technicalspecifications. | The HAMILTON-G5ventilator isdesigned forintensive careventilation of adultand paediatricpatients, andoptionally infantand neonatalpatients. Thedevice is intendedfor use in thehospital andinstitutionalenvironmentwhere healthcareprofessionalsprovide patientcare. TheHAMILTON-G5ventilator isintended for use byproperly trainedpersonnel underthe directsupervision of alicensed physician.The HAMILTON-G5ventilator may beused for transportwithin a hospital orhospital-typefacility -- providedcompressed gas issupplied.The device is not tobe used in thepresence offlammableanesthetic agents | Substantiallyequivalent |
| specifications. | or other ignitionsources. Theventilator is not tobe used in anenvironment withmagneticresonance imaging(MRI) equipment.The device is notintended fortransportationoutside thehospital or for usein the homeenvironment. | |||
| Productclassificationcode | CBK (subsequent:DQA) | CBK | CBK (subsequent:DQA) | SubstantiallyEquivalent |
| CFR citation | 21 CFR 868.5895 | 21 CFR 868.5895 | 21 CFR 868.5895 | SubstantiallyEquivalent |
| Principaloperator | Qualified, trainedpersonnel underthe direction of aphysician | Qualified, trainedpersonnel underthe direction of aphysician | Qualified, trainedpersonnel underthe direction of aphysician | SubstantiallyEquivalentSame principaloperator as onHAMILTON-C3 andHAMILTON-G5 |
| Environmentof use | Intended areas ofuse:●In theintensive careward,intermediatecare ward,emergencyward, longterm acutecare hospitalor in therecoveryroom●Duringtransfer ofventilatedpatientswithin thehospital | Intended areas ofuse:●In theintensive careward or in therecoveryroom.●Duringtransfer ofventilatedpatientswithin thehospital. | Intended areas ofuse:●In theintensive careward,intermediatecare ward,emergencyward, longterm acutecare hospitalor in therecoveryroom●Duringtransfer ofventilatedpatientswithin thehospital | SubstantiallyEquivalentSame environmentof us as onHAMILTON-C3 andHAMILTON-G5 |
| Intendedpatientpopulation | Adults, pediatrics,infants andneonates | Adults, pediatrics,infants andneonates | Adults, pediatrics,infants andneonates | SubstantiallyEquivalentSame Intendedpatient populationas on HAMILTON-C3 and HAMILTON-G5 |
| Patientinterface | Deliveredinvasively (via ETtube) ornoninvasively (viamask) | Deliveredinvasively (via ETtube) ornoninvasively (viamask) | Deliveredinvasively (via ETtube) ornoninvasively (viamask) | SubstantiallyEquivalentSame patientinterface as onHAMILTON-C3 andHAMILTON-G5 |
| Power source | AC, DC, Battery | AC, DC, Battery | AC, Battery | SubstantiallyEquivalentPower source isunchanged. |
| Operationalmodes | PCV+ SPONT APVcmv /(S)CMV+ APVsimv /SIMV+ ASV (only foradult/pediatric patients) PSIMV+ DuoPAP APRV NIV NIV-ST nCPAP-PS(only forneonatalpatients) (S)CMV (onlyforadult/pediatricpatients) SIMV (onlyforadult/pediatricpatients) | PCV+ SPONT (S)CMV+SIMV+ ASV (only foradult/pediatricpatients) PSIMV+ DuoPAP APRV NIV NIV-ST nCPAP-PS(only forneonatalpatients) | (S)CMV (onlyfor adult andpediatricpatients) P-CMV SIMV (only foradult andpediatricpatients) P-SIMV SPONT APVcmvAPVsimv ASV (only foradult andpediatricpatients) DuoPAP APRV NIV (only foradult andpediatricpatients) NIV-ST (onlyfor adult andpediatricpatients) nCPAP-PS(only forneonatalpatients) VS | SubstantiallyEquivalent |
| Electricalsafety | IEC 60601-1: 2005(3rd Edition): allapplicablerequirements met. | IEC 60601-1:1988(A1:1991 +A2:1995): allapplicablerequirements met. | IEC 60601-1: 2005(3rd Edition): allapplicablerequirements met. | SubstantiallyEquivalent |
| Emergency airintake | In case of a powersupply, technical,or pneumaticsfailure the ambientvalve allowsspontaneous | In case of a powersupply, technical,or pneumaticsfailure the ambientvalve allowsspontaneous | In case of a powersupply, technical,or pneumaticsfailure the ambientvalve allowsspontaneous | SubstantiallyEquivalentSame emergencyair intake as onHAMILTON-C3 andHAMILTON-G5 |
| Activeexhalationvalve? | Yes, pneumatic | Yes, pneumatic | Yes, pneumatic | SubstantiallyEquivalentActive exhalation isunchanged. |
| Alarms andmonitoring | Yes | Yes | Yes | SubstantiallyEquivalent |
| Supply gas | Oxygen, ambientair | Oxygen, ambientair | Oxygen, Air, Heliox | SubstantiallyEquivalent |
| Method ofsupply gaspressurization | Internal turbine forair, compressedsource for 02 | Internal turbine forair, compressedsource for 02 | Compressedsource for Air, 02,Heliox | SubstantiallyEquivalent |
| CO2monitoringoption | Yes | Yes | Yes | SubstantiallyEquivalentCO2 monitoring isunchanged. |
| SpO2monitoringoption | Yes | No | Yes | SubstantiallyEquivalent |
| Differences intechnologicalcharacteristics | Embedded-system type:EM10AInternal flowsensor withthe ability todetect reflowFlashing-alarm lamp | Embedded-system type:EM10AInternal flowsensorwithout theability todetect reflowAlarm lampnot flashing,onlyilluminated | Embedded-system type:EM01AInternal flowvalve withoutthe ability todetect reflowFlashing-alarm lamp | SubstantiallyEquivalent |
Table 1: Comparison of HAMILTON-C3 with predicate device
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Image /page/5/Picture/0 description: The image contains the logo for Hamilton Medical. The logo is in blue and consists of the words "HAMILTON" and "MEDICAL" stacked on top of each other. Below the logo is the text "Intelligent Ventilation since 1983".
Image /page/5/Picture/1 description: The image shows the logo for HAMILTON-C3. The logo is written in a sans-serif font and is a bright blue color. The letters are bold and easy to read.
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Image /page/6/Picture/0 description: The image contains the logo for Hamilton Medical. The logo has the word "HAMILTON" on the top line with a symbol to the right of the word. The word "MEDICAL" is on the second line, and the phrase "Intelligent Ventilation since 1983" is on the third line. All of the text and the symbol are in blue.
Image /page/6/Picture/1 description: The image shows the word "HAMILTON.C3" in blue font. The letters are bold and rounded. The word is written in all capital letters.
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Image /page/7/Picture/0 description: The image contains the logo for Hamilton Medical. The logo is in blue and consists of the word "HAMILTON" stacked on top of the word "MEDICAL". To the right of the word "HAMILTON" is a blue circle with a white "H" inside. Below the logo is the text "Intelligent Ventilation since 1983".
Image /page/7/Picture/1 description: The image shows the text "HAMILTON-C3" in a bold, sans-serif font. The text is a solid blue color. The letters are rounded and have a slightly cartoonish appearance. The word "HAMILTON" is followed by a dot and then the letter "C" and the number "3".
As can be seen in the table above, the application device HAMILTON-C3 has the same technological characteristics as the predicate HAMILTON-C3, with the exception of its internal flow sensor. The applicant device HAMILTON-C3 add new (S)CMV and SIMV ventilation mode which have same algorithms for delivering breaths as the predicate device HAMILTON-G5.
Altogether, the technological characteristics of the application device HAMILTON-C3 are substantially equivalent to the predicate devices. Thus, the comparison of the HAMILTON-C3 to its predicate devices does not raise new safety and effectiveness concerns.
VII. PERFORMANCE DATA
The following performance and nonclinical data are provided in support of the substantial equivalence determination.
The Software Design and Validation process, together with the bench testing of the device, demonstrated that the HAMILTON-C3 operates as intended.
In particular, testing demonstrated that the HAMILTON-C3 is compliant with the following guidelines and standards:
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Image /page/8/Picture/0 description: The image contains the logo for Hamilton Medical. The logo is in blue and consists of the words "HAMILTON" and "MEDICAL" stacked on top of each other. To the right of the word "HAMILTON" is a circular symbol. Below the logo is the text "Intelligent Ventilation since 1983".
Image /page/8/Picture/1 description: The image shows the logo for HAMILTON-C3. The logo is written in a sans-serif font and is blue. The letters are rounded and have a playful appearance. The word "HAMILTON" is followed by a dot and then the number "C3".
- ANSI/AAMI ES60601-1 (2005/ (R) 2012): Medical electrical equipment General -Requirements for Safety
- -IEC 60601-1-2 (2014): Medical electrical equipment – Part 1-2: General Requirements for Basic Safety and Essential Performance – Collateral Standard: Electromagnetic Compatibility - Requirements and Tests
- -ISO 80601-2-12 (2011): Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
- -IEC 60601-1-8 (2006 + Am.1: 2012): Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
- -IEC 60601-1-6 (2010 + A1 :2013): Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- IEC 62366 (2008)+A1(2014): Medical devices Application of usability engineering to medical devices
- IEC 62304 (2006): Medical device software Software life-cycle processes -
- -ISO 80601-2-55 (2011): Medical electrical equipment -- Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors
- -ISO 80601-2-61 (2011): Medical electrical equipment -- Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
Additional software verification and validation testing were conducted and documentation was provided as recommended by the FDA's "Guidance for Industry and FDA Staff: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "major" level of concern, since a failure or latent flaw in the software could directly result in serious injury or death to the patient or operator.
Testing of the modified HAMILTON-C3, with the new features, was conducted. The new ventilation modes were subjected to waveform performance testing. The data provided from these tests was shown to be substantially equivalent to the legally marketed devices.
Since only materials already used in earlier 510(k)s are introduced with this 510(k), Hamilton Medical did not conduct any additional biocompatibility testing.
VIII. CONCLUSION
The results of verification, validation, and testing activities demonstrate that the modified HAMILTON-C3 ventilator is as safe and as effective as the legally marketed devices identified herein.
§ 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).