(566 days)
No
The summary does not mention AI or ML, and the device description focuses on standard ventilator functionalities and controls.
Yes
The device is a ventilator intended to provide continuous or intermittent ventilatory support for individuals requiring mechanical ventilation, which directly treats or alleviates a medical condition.
No
The device is a ventilator, which provides respiratory support, not a diagnostic assessment.
No
The device description clearly indicates it is a ventilator, which is a hardware device with software control, not a software-only medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The LTV2 Series Ventilator is described as a device that provides mechanical ventilation to support breathing. It interacts directly with the patient's respiratory system, not with samples taken from the patient.
- Intended Use: The intended use clearly states it provides "continuous or intermittent ventilator support for the care of the individuals who require mechanical ventilation." This is a life support function, not a diagnostic test.
- Device Description: The description focuses on ventilation modes, controls, and patient support, not on analyzing biological samples.
Therefore, the LTV2 Series Ventilator falls under the category of a life support or respiratory medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
LTV2 model 2200 and 2150 ventilators are intended to provide continuous or intermittent ventilator support for the care of the individuals who require mechanical ventilation. The use environment is for institutional use. Institutional use includes ICU or other hospital environments including intra-hospital transport. The model 2200 can operate with high pressure O2. The model 2150 operates with low pressure oxygen.
The LTV2 Series Ventilators are intended to provide continuous or intermittent ventilatory support for the care of the individuals who require mechanical ventilation. The ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician. Specifically, the ventilator is applicable for adult and pediatric patients weighing at least 10 kg (22 lbs.), who require the following types of ventilatory support:
- . Positive Pressure Ventilation, delivered invasively or non-invasively (via mask).
- . Assist/Control, SIMV, CPAP, and NPPV modes of ventilation.
The ventilator is suitable for use in professional healthcare facilities, including during intrahospital transport.
Product codes (comma separated list FDA assigned to the subject device)
CBK
Device Description
The LTV2 Series ventilator supports adult and pediatric patients weighing at least 10 kg (22 lb) in professional healthcare facilities response with invasive or noninvasive ventilation presets. These settings can be easily refined using the touch-turn-touch interface on the LED display. The ventilator also provides a wide range of ventilation therapies to meet demanding patient needs, including volume control, pressure control, pressure support and spontaneous breath types. Combined with the spontaneous breathing trial function, the ultra-sensitive flow trigger facilitates weaning patients weighing at least 10 kg (22lb).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adult and pediatric patients weighing at least 10kg (22 lbs.).
Intended User / Care Setting
Qualified, trained personnel under the direction of a physician.
Professional healthcare facilities, institutional use including ICU or other hospital environments including intra-hospital transport.
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)
Design Verification included:
- Waveform
- Alarms
- Ventilation Controls
- Ventilation Displays
- Endurance
- Patient Circuit Testing
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.
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath. The logo is simple and professional, and it is easily recognizable.
Vyaire Medical Inc Colleen Watson Director, Regulatory Affairs 26125 N. Riverwoods Blvd. Mettawa. Illinois 60045
Re: K201082
Trade/Device Name: LTV2 Series Ventilators Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous ventilator Regulatory Class: Class II Product Code: CBK Dated: November 5, 2021 Received: November 8, 2021
Dear Colleen Watson:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Brandon Blakely, Ph.D. Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory, and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K201082
Device Name
LTV2 Series Ventilator (LTV2 model 2200 and 2150)
Indications for Use (Describe)
LTV2 model 2200 and 2150 ventilators are intended to provide continuous or intermittent ventilator support for the care of the individuals who require mechanical ventilation. The use environment is for institutional use. Institutional use includes ICU or other hospital environments including intra-hospital transport. The model 2200 can operate with high pressure O2. The model 2150 operates with low pressure oxygen.
Type of Use (Select one or both, as applicable)
| ☑ 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 "Vyaire Medical" logo. The logo features a stylized graphic on the left, consisting of overlapping red and blue shapes. To the right of the graphic is the company name, "Vyaire," in a bold, dark blue font, with the trademark symbol (™) next to it. Below "Vyaire" is the word "MEDICAL" in a smaller, lighter font.
Summary of Safety and Effectiveness
510k summary complying with 21 CFR 807.92.
1. SUBMITTER [21 CFR § 807.92(a)]
VYAIRE MEDICAL INC. 26125 North Riverwoods Blvd. Mettawa, IL 60045. USA
Colleen Watson. MSc. RAC. Contact Person: Alternate Contact Person: Jayme Yamaguchi-Owens
Date Prepared: November 10, 2021
2. Device [21 CFR § 807.92(a)(2)]
| Product Name: | LTV2 Series Ventilator (LTV2 model 2200 and 2150) |
|---|---|
| Device Name: | Ventilator, Continuous |
| Common Name: | Continuous or intermittent Ventilator |
| Classification Name: | Ventilator, continuous, facility use (21CFR 868.5895) |
| Regulatory Class: | II |
| Product Code: | CBK |
3. Predicate Device [21 CFR § 807.92(a)(3)]
This submission demonstrates substantial equivalence to the LTV 1200 Ventilator K060647 cleared on May 25th, 2006 and LTV 1100 cleared under K101643 on January 26th, 2011.
| Predicate Device Information | |||
|---|---|---|---|
| Predicate Device | Manufacturer | 510(k) Number | Cleared Device |
| LTV 1200 Ventilator | Pulmonetic Systems, Inc. | ||
| (Vyaire Medical, Inc.) | K060647 | 25 May 2006 | |
| LTV 1100 Ventilator | Carefusion (Vyaire | ||
| Medical, Inc.) | K101643 | 26 January 2011 |
Table 1: Predicate Device Information
Table 2: Reference Device Information
Reference Device Information
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| Predicate Device | Manufacturer | 510(k) Number | Cleared Device |
|---|---|---|---|
| TBird Vela Ventilator | Bird Product Corporation | ||
| (Vyaire Medical, Inc.) | K032451 | 17 March 2004 | |
| PALMTop PTV Models | |||
| 8/10 | Pulmonetic Systems, Inc. | ||
| (Vyaire Medical, Inc.) | K070594 | 01 August 2007 | |
| bellavista 1000/1000e | Imtmedical AG | ||
| Gewerbestrasse 8 | |||
| Buchs Sg, CH 9470 | K183364 | 13 September 2019 |
Device Description [21 CFR § 807.92(a)(4)] 4.
The LTV2 Series ventilator supports adult and pediatric patients weighing at least 10 kg (22 lb) in professional healthcare facilities response with invasive or noninvasive ventilation presets. These settings can be easily refined using the touch-turn-touch interface on the LED display. The ventilator also provides a wide range of ventilation therapies to meet demanding patient needs, including volume control, pressure control, pressure support and spontaneous breath types. Combined with the spontaneous breathing trial function, the ultra-sensitive flow trigger facilitates weaning patients weighing at least 10 kg (22lb).
Intended Use [21 CFR § 807.92(a)(5)] 5.
LTV2 model 2200 and 2150 ventilators are intended to provide continuous or intermittent ventilator support for the care of the individuals who require mechanical ventilation. The use of environment is for institutional use includes ICU or other hospital environments including intra-hospital transport. The model 2200 can operate with high pressure O2. The model 2150 operates with low pressure oxygen.
Indication for use
TheLTV2 Series Ventilators are intended to provide continuous or intermittent ventilatory support for the care of the individuals who require mechanical ventilation. The ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician. Specifically, the ventilator is applicable for adult and pediatric patients weighing at least 10 kg (22 lbs.), who require the following types of ventilatory support:
- . Positive Pressure Ventilation, delivered invasively or non-invasively (via mask).
- . Assist/Control, SIMV, CPAP, and NPPV modes of ventilation.
The ventilator is suitable for use in professional healthcare facilities, including during intrahospital transport.
6. Summary of Substantial Equivalence [21 CFR § 807.92(a)(6)]
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The fundamental scientific technology is the same for both proposed and predicate devices. It is based on mechanical control of breathing gas with a predetermined percentage of oxygen to provide control ventilation or to assist patient breathing. The LTV2 Series Ventilators are substantially equivalent to the predicate LTV1200 Ventilator and LTV 1100 regarding safety, design materials and intended use.
The proposed ventilator is designed to operate the same as the predicate devices. Successful test results (electrical safety testing, mechanical testing, software V&V, and waveform verification tests) ensured the proposed ventilator does not raise any different questions of safety and effectiveness. The table below outlines the similarities and differences between the device and predicate device.
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| Element of
Comparison | Proposed Device
LTV2 Series
Ventilators
(LTV2 2150 & LTV2
2200) | Primary
Predicate Device
LTV 1200 - (K060647) | Secondary
Predicate Device
LTV 1100 - (K101643) | Discussion of
Differences |
|-------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| Intended Use | Intended to provide
continuous or
intermittent ventilator
support for the care of
individuals who require
mechanical ventilation. | Intended to provide
continuous or intermittent
ventilator support for the care
of individuals who require
mechanical ventilation. | Intended to provide
continuous or intermittent
ventilator support for the
care of individuals who
require mechanical
ventilation. | Same |
| Indications for
Use | The LTV2 Series
Ventilators are intended
to provide continuous
or intermittent
ventilatory support for
the care of the
individuals who require
mechanical ventilation.
The ventilator is a
restricted medical
device intended for use
by qualified, trained
personnel under the
direction of a physician.
Specifically, the
ventilator is applicable
for adult and pediatric
patients weighing at
least 10kg (22 lbs.), who
require the following
types of ventilatory
support:
Positive Pressure
Ventilation,
delivered invasively
or non-invasively. Assist/Control,
SIMV, CPAP, and
NPPV modes of
ventilation. The ventilator is
suitable for use in
healthcare institutional
settings. | The LTV 1200 ventilator is
intended to provide
continuous or intermittent
ventilatory support for the
care of the individuals who
require mechanical
ventilation. The ventilator is a
restricted medical device
intended for use by qualified,
trained personnel under the
direction of a physician.
Specifically, the ventilator is
applicable for adult and
pediatric patients weighing at
least 5kg (11 lbs.), who
require the following types of
ventilatory support:
Positive Pressure
Ventilation, delivered
invasively (via ET tube) or
non-invasively (via mask). Assist/Control, SIMV,
CPAP, and NPPV modes
of ventilation. The ventilator is suitable for
use in institutional, home, or
transport settings. | The LTV 1100 ventilator is
intended to provide
continuous or intermittent
ventilatory support for the
care of the individuals who
require mechanical
ventilation. The ventilator
is a restricted medical
device intended for use by
qualified, trained
personnel under the
direction of a physician.
Specifically, the ventilator
is applicable for adult and
pediatric patients weighing
at least 5kg (11 lbs.), who
require the following types
of ventilatory support:
Positive Pressure
Ventilation, delivered
invasively (via ET
tube) or non-
invasively (via mask). Assist/Control, SIMV,
CPAP, and NPPV
modes of ventilation. The ventilator is suitable
for use in institutional,
home, or transport
settings. | Same |
| Element of
Comparison | Proposed Device
LTV2 Series
Ventilators
(LTV2 2150 & LTV2
2200) | Primary
Predicate Device
LTV 1200 - (K060647) | Secondary
Predicate Device
LTV 1100 - (K101643) | Discussion of
Differences |
| Principles of
Operation | Positive pressure
mechanical ventilator | Positive pressure mechanical
ventilator | Positive pressure
mechanical ventilator | Same |
| Patient
population | Targeted for adult and
pediatric patients
weighing at least 10kg
(22 lbs.). | Targeted for adult and
pediatric patients weighing at
least 5kg (11 Ibs.). | Targeted for adult and
pediatric patients weighing
at least 5kg (11 Ibs.). | Substantial
equivalent, increase
in lower weight
limit |
| Environment | The ventilator is
suitable for use in
healthcare institutional
settings. | The ventilator is suitable for
use in institutional, home, or
transport settings. | The ventilator is suitable
for use in institutional,
home, or transport
settings. | Substantial
equivalent for
healthcare
institutional
settings |
| Compatibility
with the
environment
and other
devices; | Storage:
Temperature: -20
degrees C without
relative humidity
control to + 60 degrees
C at 93% relative
humidity, non-
condensing. | Storage:
Temperature: -20 to
+60 degrees C.
Humidity: 10% to
95% Relative, non-
condensing | Storage:
Temperature: -20 to +60
degrees C. Humidity: 10%
to 95% Relative, non-
condensing | Substantial
equivalent,
designed and tested
to latest EMC
standards |
| | Operating:
Temperature:
+5 to +40
degrees C
Humidity: 15%
to 95% non- | Operating:
Temperature: +5 to
+40 degrees C
Humidity: 15% to
95% non-condensing | Operating:
Temperature: +5 to +40
degrees C
Humidity: 15% to 95%
non-condensing | |
| | condensing
EMC:
IEC 60601-1-2
Issue
2007/03/30
Edition 3 class
B for Emissions,
Immunity for
Life Supporting
Equipment | EMC:
60601-1-2
IEC:2001(E)
Sound level: | EMC:
60601-1-2 IEC:2001(E)
Sound level: | |
| | Sound level:
Not exceed 55
dBA (RMS) at
one meter | Not exceed 50 dBA
(RMS) at one meter | Not exceed 50 dBA (RMS)
at one meter | |
| Electrical
safety | Class II
Type BF | Class II
Type BF | Class II
Type BF | Same |
| Battery | Internal battery
Removable battery
optional | Internal battery: lower panel
door access for trained service
technician. | Internal battery: lower
panel door access for
trained service technician. | Substantial
equivalent |
| Element of
Comparison | Proposed Device
LTV2 Series
Ventilators
(LTV2 2150 & LTV2
2200) | Primary
Predicate Device
LTV 1200 - (K060647) | Secondary
Predicate Device
LTV 1100 - (K101643) | Discussion of
Differences |
| Internal
PEEP/PEEP
Compensation | Range: 0-20 cmH2O ± 1
cmH2O or 10%,
whichever is greater,
within 3 breaths.
(Mechanical/pneumatic
control) | Range: 0-20 cmH2O ± 1
cmH2O or 10%, whichever is
greater, within 3 breaths.
(Mechanical/pneumatic
control) | Range: 0-20 cmH2O ± 1
cmH2O or 10%, whichever
is greater, within 3
breaths.
(Mechanical/pneumatic
control) | Same |
| Bias Flow | Off or 5 to 15 LPM in
increments of 1 LPM. | Off or 10 LPM 10% or 1 LPM,
whichever is greater | Off or 10 LPM 10% or 1
LPM, whichever is greater | Substantially
Equivalent
(Reference device
K032451, K070594) |
| Ventilation
Mode | Control Mode
Assist/Control Mode
SIMV Mode
CPAP
NPPV
Apnea Backup | Control Mode
Assist/Control Mode
SIMV Mode
CPAP
NPPV
Apnea Backup | Control Mode
Assist/Control Mode
SIMV Mode
CPAP
NPPV
Apnea Backup | Same |
| Breath types | Pressure Control
Volume Control
Pressure Support
Spontaneous | Pressure Control
Volume Control
Pressure Support
Spontaneous | Volume Control
Pressure Support
Spontaneous | Same as predicate |
| Breath rate | 0-80 BPM | 0-80 BPM | 0-80 BPM | Same |
| Tidal volume | 50-2,000 mL | 50-2,000 mL | 50-2,000 mL | Same |
| Inspiratory
time | 0.3 - 9.9 seconds | 0.3-9.9 sec | 0.3-9.9 sec | Same |
| Pressure
control | 4 – 98 cmH20
(assist/Control &
SIMV/CPAP)
Off - 60 cmH2O (NPPV) | 1-99 cmH2O | Pressure control not
present | Substantially
equivalent |
| Pressure
support | 1-60 cmH2O | 1-60 cmH2O | 1-60 cmH2O | Same |
| Sensitivity | Off, 1-9 LPM | Off, 1-9 LPM | Off, 1-9 LPM | Same |
| 02% | 21–100% (LTV2200);
oxygen bleed flow (LTV
2150 and LTV 2200) | 21-100%; oxygen bleed flow | oxygen bleed flow% | Same as predicate |
| O2 flush | 1-3 min (LTV 2200 only) | 1-3 min | N/A | Same as predicate |
| PEEP/CPAP | 0 – 20 cmH2O | 0-20 cmH2O | 0–20 cmH2O | Same |
| Element of
Comparison | Proposed Device
LTV2 Series
Ventilators
(LTV2 2150 & LTV2
2200) | Primary
Predicate Device
LTV 1200 - (K060647) | Secondary
Predicate Device
LTV 1100 - (K101643) | Discussion of
Differences |
| Blender | LTV2 2200: High and
low oxygen inlet
pressure
LTV2 2150: Low oxygen
inlet pressure | High and low oxygen inlet
pressure | Low oxygen inlet pressure | Same |
| VOXP
(VENTILATOR
OPEN XML
PROTOCOL) | Present | Not present | Not present | Substantially
equivalent |
Table 3: Substantial Equivalence Comparison
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7. Performance Data [21 CFR § 807.92(b)(1)]
The LTV2 Series Ventilators was designed and tested in accordance with the following and FDA guidance documents and international standards
Standards / FDA guidance
| Standard # | Title |
|---|---|
| ANSI AAMI ES60601- | |
| 1:2005 + A1:2012 + | |
| C1:2009 + A2:2010 | Medical electrical equipment — part 1: General requirements |
| for basic safety and essential performance | |
| IEC 60601-1:2005 + | |
| A1:2012 | Medical electrical equipment — part 1: General requirements |
| for basic safety and essential performance | |
| IEC 60601-1-2 Edition | |
| 3.0 2007-03 | |
| 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. (General II (ES/EMC)) | |
| IEC 60601-1-2 Edition | |
| 4.0 2014-02 | Medical electrical equipment — part 1-2: general requirements |
| for basic safety and essential performance — collateral | |
| standard: electromagnetic compatibility — requirements and | |
| tests. (General II (ES/EMC)) | |
| IEC 60601-1-6 Edition | |
| 3.0 2010-01 | Medical electrical equipment — part 1-6: general requirements |
| for basic safety and essential performance — collateral | |
| standard: usability. (General I (QS/RM) |
Table 4: List of Standards
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| IEC 60601-1-8 Edition
2.1 2012-11 | 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. (General I (QS/RM)) |
|---------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 62304 First edition
2006-05
IEC Edition 1.1 2015-08 | Medical device software - software life cycle processes.
(Software/Informatics) |
| IEC 62366:2007
ANSI AAMI IEC 62366-
1:2015 | Medical devices – Application of usability engineering to
medical devices |
| ISO 80601-2-12 First
Edition: 2011 | Medical electrical equipment – part 2-12: particular
requirements for the safety of lung ventilators - critical care
ventilators [including: technical corrigendum 1 (2011) |
| ISO 5356-1 Third edition
2004-05-15 | Anaesthetic and respiratory equipment – Conical connectors:
Part 1: Cones and sockets |
| ISO 5367:2014 | Anaesthetic and respiratory equipment -- Breathing sets and
connectors |
| ISO 10993-1:2009 | Biological evaluation of medical devices - Part 1: Evaluation
and testing |
| ISO 14971:2007 | Medical devices - Applications of risk management to medical
devices |
Design Verification included:
- Waveform
- Alarms
- Ventilation Controls
- Ventilation Displays ●
- Endurance
- Patient Circuit Testing
Clinical Data [21 CFR § 807.92(b)(2)]
Based on the similarities in the safety and effectiveness profiles of the subject, predicate and reference devices, no clinical studies were deemed to needed to support this submission.
8. Conclusion [21 CFR § 807.92(b)(2)]
The non-clinical data support the safety and effectiveness of the proposed device. Also, test results demonstrate that the device is as safe and effective as the predicate and therefore substantially equivalent to the predicate device.