(392 days)
No
The summary does not mention AI, ML, or related terms, and the device description focuses on traditional ventilator functionalities and control systems.
Yes
The device is a ventilator system designed for respiratory support and mechanical ventilation, which are therapeutic interventions for patients.
No
This device is a ventilator system used for respiratory support and mechanical ventilation, not for diagnosing medical conditions.
No
The device description explicitly states it is a "dual-microprocessor-based, touch-screen controlled; critical care ventilator" and mentions testing of an "Internal Air Compressor," indicating it is a hardware device with integrated software, not a software-only medical 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, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Puritan Bennett 980 Series Ventilator System is a mechanical ventilator. Its function is to provide respiratory support and deliver air and oxygen directly to the patient's lungs. It does not analyze biological samples.
- Intended Use: The intended use clearly states it's for providing "respiratory support or mechanical ventilation" to patients.
- Device Description: The description focuses on its role in delivering ventilation and managing breathing parameters.
The information provided consistently describes a life-support device that interacts directly with the patient's respiratory system, not a device that analyzes samples outside the body.
N/A
Intended Use / Indications for Use
The Puritan Bennett 980 Series Ventilator System is designed for use on patient population sizes from Neonatal (NICU) through Adult who require respiratory support or mechanical ventilation and weigh a minimum of 0.3kg (0.66lb). It is suitable for service in hospital (institutions) and intra-hospital transport to provide continuous positive pressure ventilatory support using medical oxygen and compressed medical air from either an internal air compressor or external air sources to deliver oxygen concentrations of 21% to 100%. Ventilatory support can be delivered invasively or non-invasively to patients who require the following types of ventilator support
- Positive Pressure Ventilation, delivered invasively (via endotracheal tube or tracheotomy tube) or noninvasively (via mask or nasal prongs)
- Assist/Control, SIMV, or Spontaneous modes of ventilation
Product codes
CBK
Device Description
The Puritan Bennett 980 Series Ventilator System is a dual-microprocessor-based, touch-screen controlled; critical care ventilator intended to provide continuous ventilation for neonate to adult patients who require either invasive ventilation or non-invasive ventilation. It can be used in hospitals and institutions and for intra –hospital transport applications with access to the appropriate services.
The ventilator system offers features for patient comfort while delivering sensitive, precise breaths to critically ill patients. The product ventilates Neonatal, Pediatric, and Adult patients with predicted body weights from 0.3 kg, and with tidal volumes for mandatory volume controlled breaths from 2 mL to 2500 mL.
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
Neonatal (NICU) through Adult
Intended User / Care Setting
hospital (institutions) and 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)
Substantial equivalence was shown through the following verification & validation:
- Human Factors/Usability & Design Validation
- Software Verification
- System Integration
- Controls
- Electrical Safety/EMC
- Internal Air Compressor testing, including endurance and VOCs
- Standards Compliance testing
- o AIM 7351731, rev 2.0
- o IEC 60601-1-2, 300 edition
- IEC ISO 60601-1, 30 edition o
- o EN ISO 80601-2-55:2011
- o EN ISO 80601-2-12: 2011
- IEC 62366: 2007 O
- O IEC 60601-1-8: 2006
- IEC 62304: 2006 O
The results of these non-clinical verifications & validations demonstrate that the subject Puritan Bennett™ 980 Series Ventilator System can be considered substantially equivalent to the predicates.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Puritan Bennett™ 980 Series Ventilator System (K131252)
Reference Device(s)
Puritan Bennett™ 840 Series Ventilator System (K151252), Maquet Servo-U (K151814)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 contains two logos. The logo on the left is the Department of Health and Human Services logo. The logo on the right is the Food and Drug Administration logo. The FDA logo is in blue and contains the words "FDA U.S. FOOD & DRUG ADMINISTRATION".
October 27, 2017
Covidien Kelsey Lee Regulatory Affairs Manager 6135 Gunbarrel Ave Boulder, Colorado 80301
Re: K162738
Trade/Device Name: Puritan Bennett 980 Ventilator System Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous ventilator Regulatory Class: Class II Product Code: CBK Dated: October 19, 2017 Received: October 20, 2017
Dear Kelsey Lee:
This letter corrects our substantially equivalent letter of October 27, 2017.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
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 (DICE) 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 (DICE) 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.
Michael J. Ryan -S
for 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
2
Indications for Use
510(k) Number (if known) K162738
Device Name Puritan Bennett 980 Series Ventilator System
Indications for Use (Describe)
The Puritan Bennett 980 Series Ventilator System is designed for use on patient population sizes from Neonatal (NICU) through Adult who require respiratory support or mechanical ventilation and weigh a minimum of 0.3kg (0.66lb). It is suitable for service in hospital (institutions) and intra-hospital transport to provide continuous positive pressure ventilatory support using medical oxygen and compressed medical air from either an internal air sources to deliver oxygen concentrations of 21% to 100%. Ventilatory support can be delivered invasively to patients who require the following types of ventilator support
-
Positive Pressure Ventilation, delivered invasively (via endotracheal tube or tracheotomy tube) or non-invasively (via mask or nasal prongs)
-
Assist/Control, SIMV, or Spontaneous modes of ventilation
| 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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3
510(k) Summary
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807.92, this information serves as a 510k Summary for the Puritan Bennett™ 980 Series Ventilator System.
| Submitted By: | Covidien
6135 Gunbarrel Avenue
Boulder, CO 80301 |
|-----------------------------------|----------------------------------------------------------------------------------------|
| Date: | October 27, 2017 |
| Contact Person: | Kelsey Lee
Regulatory Affairs Manager
(303) 305-2760 |
| Proprietary Name: | Puritan Bennett™ 980 Series Ventilator System |
| Common Name: | Ventilator, Continuous, Facility Use |
| Device Classification Regulation: | 21 CFR 868.5895 – Class II |
| Device Product Code & Panel: | CBK |
| Predicate Devices: | Puritan Bennett™ 980 Series Ventilator System
(K131252) |
| Reference Device: | Puritan Bennett™ 840 Series Ventilator System
(K151252)
Maquet Servo-U (K151814) |
4
Device Description
The Puritan Bennett 980 Series Ventilator System is a dual-microprocessor-based, touch-screen controlled; critical care ventilator intended to provide continuous ventilation for neonate to adult patients who require either invasive ventilation or non-invasive ventilation. It can be used in hospitals and institutions and for intra –hospital transport applications with access to the appropriate services.
The ventilator system offers features for patient comfort while delivering sensitive, precise breaths to critically ill patients. The product ventilates Neonatal, Pediatric, and Adult patients with predicted body weights from 0.3 kg, and with tidal volumes for mandatory volume controlled breaths from 2 mL to 2500 mL.
Indications for Use/Intended Use
The subject Puritan Bennett 980 Series Ventilator System has similar indications for use as the predicate Puritan Bennett 980 Series Ventilator System:
The Puritan Bennett 980 Series Ventilator System is designed for use on patient population sizes from Neonatal (NICU) through Adult who require respiratory support or mechanical ventilation and weigh a minimum of 0.3kg (0.66lb). It is suitable for service in hospital (institutions) and intra-hospital transport to provide continuous positive pressure ventilatory support using medical oxygen and compressed medical air from either an internal air compressor or external air sources to deliver oxygen concentrations of 21% to 100%. Ventilatory support can be delivered invasively or non-invasively to patients who require the following types of ventilator support
-
Positive Pressure Ventilation, delivered invasively (via endotracheal tube or tracheotomy tube) or noninvasively (via mask or nasal prongs)
-
Assist/Control, SIMV, or Spontaneous modes of ventilation
The subject indications have been clarified to include the use of the optional internal air compressor or external air sources of gas to deliver between 21% and 100% oxygen.
5
Technological Characteristics Comparison
The subject Puritan Bennett 980 Ventilator System has the same intended population, principles of operation and fundamental technology as the predicate Puritan Bennett 980 Ventilator System. Additionally, the subject device is considered a derivative of the predicate device in terms of the software and hardware modifications. The subject device has the following similar technological characteristics as the predicate Maquet SERVO-U:
- -Capnography Monitoring
- -Exhalation Flow Sensor labelling
- -Trending Option
- -Pendant Mount Configuration
- -Optional Internal Air Compressor
Substantial Equivalence – Non-Clinical Evidence
Substantial equivalence was shown through the following verification &validation:
- Human Factors/Usability & Design Validation ●
- Software Verification
- System Integration
- Controls
- Electrical Safety/EMC
- Internal Air Compressor testing, including endurance and VOCs
- Standards Compliance testing
- o AIM 7351731, rev 2.0
- o IEC 60601-1-2, 300 edition
- IEC ISO 60601-1, 30 edition o
- o EN ISO 80601-2-55:2011
- o EN ISO 80601-2-12: 2011
- IEC 62366: 2007 O
- O IEC 60601-1-8: 2006
- IEC 62304: 2006 O
The results of these non-clinical verifications & validations demonstrate that the subject Puritan Bennett™ 980 Series Ventilator System can be considered substantially equivalent to the predicates.
Substantial Equivalence – Clinical Evidence
N/A - Clinical evidence was not necessary to show substantial equivalence
Substantial Equivalence - Conclusions
Substantial equivalence is shown similar technological characteristics, intended use, principles of operation and verification and validation. The subject Puritan Bennett™ 980 Series Ventilator System has software and hardware enhancements to maintain the intended performance of the device.
No new questions of safety and effectiveness have been raised because of these changes and addition of features. From the evidence presented in the Premarket Notification, the subject device can be considered substantially equivalent to the predicate devices.