(436 days)
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No
The provided text describes a standard critical care ventilator and does not mention any AI or ML capabilities.
Yes
The device is intended to provide continuous ventilation to patients with respiratory failure or insufficiency, directly treating their condition.
No
The device is described as a ventilator, which provides respiratory support, not a diagnostic function.
No
The device description explicitly states it is an "electronically controlled, powered machine," indicating it is a hardware device with software components, not a software-only 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, or tissue) to provide information about a person's health.
- V8800 Function: The V8800 Critical Care Ventilator is a machine that provides mechanical respiratory support directly to a patient. It does not analyze biological specimens.
- Intended Use: The intended use clearly states it's for providing continuous ventilation to patients with respiratory issues, not for diagnostic testing of samples.
Therefore, the V8800 Critical Care Ventilator falls under the category of a therapeutic medical device, not an IVD.
N/A
Intended Use / Indications for Use
The V8800 Critical Care Ventilator is an electronically controlled, powered machine intended to provide continuous ventilation to patients with respiratory failure or respiratory insufficiency, requiring respiratory support.
The V8800 Critical Care Ventilator may be used by trained professional health care providers under the supervision of a physician.
The V8800 Critical Care Ventilator is intended for patients ranging from pediatric to adult, and for use in a wide variety of clinical conditions. Specifically, the V8800 Critical Care Ventilator is applicable for adult and pediatric patients weighing at least 3.5 kg (7.7 Ibs.), who require the following types of ventilator support: Positive Pressure Ventilation, delivered invasively (by ET or Tracheotomy tube) or non-invasively (by mask) via Assist/Control, SIMV, CPAP and other modes of ventilation.
The V8800 Critical Care Ventilator is not intended for use with neonatal pediatric patients weighing less than 3.5 kg (7.7 lbs.) whose approximate age range is from birth to 1 month of age.
The V8800 Crtical Care Ventilator is intended for use in hospital-type facilities. It may be used during intra-hospital transport provided that electrical power and compressed gas are supplied.
Product codes
CBK, CCK, BTI, BTT
Device Description
The V8800 Critical Care Ventilator is an electronically controlled, powered machine intended to provide continuous ventilation to patients with respiratory failure or respiratory insufficiency, requiring respiratory support.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
pediatric to adult, specifically for adult and pediatric patients weighing at least 3.5 kg (7.7 lbs.). Not intended for use with neonatal pediatric patients weighing less than 3.5 kg (7.7 lbs.) whose approximate age range is from birth to 1 month of age.
Intended User / Care Setting
trained professional health care providers under the supervision of a physician. Intended for use in hospital-type facilities and during intra-hospital transport provided that electrical power and compressed gas are supplied.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring a symbol that resembles a stylized caduceus or a representation of human figures.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 6, 2013
Oricare, Incorporated Mr. David Jamison Executive Vice President 1900 AM Drive Quakertown, PA 18951
Re: K120931
Trade/Device Name: Oricare V8800 Critical Care Ventilator Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK, CCK, BTI, BTT Dated: May 16, 2013 Received: May 17, 2013
Dear Mr. Jamison:
We have reviewed vour 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.
1
Page 2 - Mr. Jamison
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 devicerelated adverse events) {21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers. International and Consumer Assistance 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.
Susan Runner DOS,MA Mary S. Runner -S
Kwame Ulmer, M.S. 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 Statement
510 (k) Number K120931 Device Name: Oricare V8800 Critical Care Ventilator
Indications for Use:
The V8800 Critical Care Ventilator is an electronically controlled, powered machine intended to provide continuous ventilation to patients with respiratory failure or respiratory insufficiency, requiring respiratory support.
The V8800 Critical Care Ventilator may be used by trained professional health care providers under the supervision of a physician.
The V8800 Critical Care Ventilator is intended for patients ranging from pediatric to adult, and for use in a wide variety of clinical conditions. Specifically, the V8800 Critical Care Ventilator is applicable for adult and pediatric patients weighing at least 3.5 kg (7.7 Ibs.), who require the following types of ventilator support: Positive Pressure Ventilation, delivered invasively (by ET or Tracheotomy tube) or non-invasively (by mask) via Assist/Control, SIMV, CPAP and other modes of ventilation.
The V8800 Critical Care Ventilator is not intended for use with neonatal pediatric patients weighing less than 3.5 kg (7.7 lbs.) whose approximate age range is from birth to 1 month of age.
The V8800 Crtical Care Ventilator is intended for use in hospital-type facilities. It may be used during intra-hospital transport provided that electrical power and compressed gas are supplied.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/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)
Anya C. Harry
FD
| Digitally signed by Anya C. Harry |
|---|
| DN: C=US, O=U.S. Government, ou=HHS, |
| ou=FDA, ou=People, cn=Anya C. Harry, |
| 0.9.2342.19200300.100.1.1=0011315590 |
| Date: 2013.06.05 17:36:12 -04'00' |
(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital
Division of Anesthesiology, General Devices Division of Anesthouldness Infection Control.
412093
510(k) Number: