(49 days)
Not Found
No
The description focuses on traditional electro-pneumatic control systems and does not mention any AI or ML components or functionalities.
Yes
The device is described as an "Infant Ventilator" used to "provide ventilation to neonatal, infant, and pediatric patients." Ventilation is a therapeutic intervention aimed at supporting or replacing the function of the lungs in breathing.
No
The device description indicates its purpose is to provide ventilation to patients, and its functions are related to controlling airflow and pressure for breathing support. There is no mention of it being used to diagnose conditions or diseases.
No
The device description explicitly details electro-pneumatic and pneumatic subsystems, indicating the presence of hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide ventilation to neonatal, infant, and pediatric patients." This describes a device that directly supports a patient's respiratory function, which is a therapeutic or life-support function, not an in vitro diagnostic function.
- Device Description: The description details an "electro-pneumatic, continuous flow, time cycled, pressure limited infant ventilator." It describes the mechanical and electronic components involved in delivering air and oxygen to a patient. This aligns with a respiratory support device, not a device used to examine specimens outside the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring substances in specimens
- Providing information for diagnosis, monitoring, or screening based on specimen analysis
Therefore, the Sechrist Millennium Infant Ventilator is a medical device used for respiratory support, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of the device is to provide ventilation to neonatal, infant, and pediatric patients.
Product codes (comma separated list FDA assigned to the subject device)
73 CBK
Device Description
The Sechrist Millennium Infant Ventilator is an electro-pneumatic, continuous flow, time cycled, pressure limited infant ventilator. It is designed to ventilate neonatal to pediatric patients in Assist/Control, Synchronous Intermittent Mandatory Ventilation (SIMV), Continuous Positive Airway Pressure (CPAP), and Standby modes. In addition, pressure triggered ventilation and spontaneous breathing is also provided.
The ventilator has an electronically controlled pneumatic system. The pneumatic subsystem consist of an air/oxygen mixer, continuous flow control, pressure controls, and waveform control.
The electronically controlled subsystem uses the respiratory rate and inspiratory time control inputs to activate or deactivate the exhalation valve. The electronic subsystem also includes the pressure trigger sensing and manual breath functions.
Comprehensive alarm, display, and measurement subsystems are designed to provide patient safety and ease of user interface.
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, infant, and pediatric patients.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Model IV-100B K833982A, V.I.P. Bird Infant Ventilator K895541/K901885
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).
0
NOV 1 0 1999
510(K) SUMMARY 9-21-99
Device Name:
| Classification Name: | Continuous ventilator |
|---|---|
| Common Name: | Infant ventilator |
| Proprietary Name: | Millennium |
| Devices to which | |
| Equivalence is Claimed: | Model IV-100B K833982A |
| V.I.P. Bird Infant Ventilator K895541/K901885 | |
| Contact: | Greg Godfrey, Vice President |
| Quality Assurance & Regulatory Affairs | |
| 4225 E. La Palma Avenue | |
| Anaheim, CA 92807 | |
| Phone: (714) 579-8400 Fax: (714) 579-0814 |
Indication for Use
The intended use of the device is to provide ventilation to neonatal, infant, and pediatric patients.
Device Description
The Sechrist Millennium Infant Ventilator is an electro-pneumatic, continuous flow, time cycled, pressure limited infant ventilator. It is designed to ventilate neonatal to pediatric patients in Assist/Control, Synchronous Intermittent Mandatory Ventilation (SIMV), Continuous Positive Airway Pressure (CPAP), and Standby modes. In addition, pressure triggered ventilation and spontaneous breathing is also provided.
The ventilator has an electronically controlled pneumatic system. The pneumatic subsystem consist of an air/oxygen mixer, continuous flow control, pressure controls, and waveform control.
The electronically controlled subsystem uses the respiratory rate and inspiratory time control inputs to activate or deactivate the exhalation valve. The electronic subsystem also includes the pressure trigger sensing and manual breath functions.
Comprehensive alarm, display, and measurement subsystems are designed to provide patient safety and ease of user interface.
Performance Standards
No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for infant ventilators.
1
510(K) SUMMARY 9-21-99
Summary of Substantial Equivalence
There are no significant changes in the intended use, performance specifications, or principal of operation of the Millennium Infant Ventilator. Existing technology, consistent with that used in comparative ventilators, has been incorporated into the design of this device. Cosmetic enhancements were made to the displays and packaging of the device. The addition of a trigger mechanism provides the ability to synchronize ventilation and includes SIMV and trigger sensitivity. Additional enhancements, not available on the cleared device, include CPAP+ backup, standby, breath type display, high rate alarm, and an hour meter.
Conclusion
Modifications made to the device do not affect the intended use or alter the fundamental scientific technology of the device. Therefore, the modified device is substantially equivalent to the cleared devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the circumference. Inside the circle is a stylized image of a human figure in profile, with three parallel lines extending from the head, resembling a bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 0 1999
Mr. Greg Godfrey Sechrist Industries, Inc. 4225 E. La Palma Avenue Anaheim, CA 92807
Re: K993167 Millennium™ Infant/Pediatric Ventilator Requlatory Class: II (two) Product Code: 73 CBK Dated: October 12, 1999 Received: October 14, 1999
Dear Mr. Godfrey:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Mr. Greg Godfrey
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Jean H. Westerduin fro,
Celia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known): ±833982A-_K 99 3167
Device Name: Sechrist Millennium Infant Ventilator
Indications for Use:
The intended use of the device is to provide ventilation to neonatal, infant, and pediatric patients.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter______________________________________________________________________________________________________________________________________________________________
(Optional Format 1-1-96)
foAweitesher
Sechrist Industries, Inc. Special 510(k) Millennium Infant Ventilator