(163 days)
Not Found
No
The description mentions a "computerbased representation of a protocol" for managing pressure support, which suggests a rule-based or algorithmic approach rather than AI/ML. There are no mentions of AI, DNN, or ML in the provided text.
Yes
The device is a ventilator, which is used to support or replace breathing, directly treating a physiological function.
No
The device is described as a "long-term ventilator" and "intensive care ventilator" intended to "stabilize the patient's spontaneous breathing" and "reduce inspiratory support." Its function is therapeutic, providing breathing assistance, rather than diagnostic, which would involve identifying a disease or condition.
No
The device description explicitly states it is a "time-cycled microprocessor-controlled intensive care ventilator," which is a hardware device. The SmartCare™/PS is an option for this hardware device, described as a "computerbased representation of a protocol," implying software functionality within the hardware.
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 EvitaXL is a ventilator, a device that assists or controls breathing. It directly interacts with the patient's respiratory system.
- Intended Use: The intended use describes providing respiratory support and assisting with the weaning process. This is a therapeutic and monitoring function, not a diagnostic test performed on a sample.
- Device Description: The description focuses on the mechanical and software aspects of a ventilator.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory tests.
Therefore, the EvitaXL falls under the category of a medical device used for respiratory support, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The EvitaXL is a long-term ventilator for intensive care for adults, children, and infants with a body weight of at least 3 kg (6.6 lbs).
With SmartCare™/PS the EvitaXL is intended to stabilize the patient's spontaneous breathing in a "comfortable zone" and to reduce inspiratory support for adults and children with a body weight of at least 15 kg (33 lbs). The patients should be haemodynamically stable with adequate oxygenation and spontaneous breathing. SmartCare can be used for intubated or tracheotomized patients. Patients with body weight between 15 and 35 kq (33.1 and 77.8 lbs) must be endotracheally intubated and ventilated with active humidification.
SmartCare™/PS is contraindicated in case of severe COPD and severe neurologic disorder that affects the cerebral control mechanism of the spontaneous breathing pattern.
Product codes
CBK
Device Description
The EvitaXL is a time-cycled microprocessor-controlled intensive care ventilator. The option SmartCare™ for the EvitaXL has been developed for assisting physicians and respiratory therapists with the standardization of the weaning process used in intensive care units. The system uses a computerbased representation of a protocol and focusses on the management of pressure support.
Scope of this submission is an extension of claims made in the promotional material, while the itself remains unchanged except for minor modifications that led to non-filing decisions for use, the intended use and the instructions for use also remain unchanged.
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
The EvitaXL is a long-term ventilator for intensive care for adults, children, and infants with a body weight of at least 3 kg (6.6 lbs).
With SmartCare™/PS the EvitaXL is intended to stabilize the patient's spontaneous breathing in a "comfortable zone" and to reduce inspiratory support for adults and children with a body weight of at least 15 kg (33 lbs). Patients with body weight between 15 and 35 kq (33.1 and 77.8 lbs) must be endotracheally intubated and ventilated with active humidification.
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)
Reference Device(s)
Not Found
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
510(k) Summary SmartCare Option for EvitaXL
FEB - 6 2006
510(k) Summa
Urgermedica
A Dräger and Siemens Company
| Submitter's Name and Address: | | Dräger Medical AG & Co. KG
Moislinger Allee 53-55
23542 Lübeck
Germany
acc. to 21 CFR 807.92 | |
|--------------------------------|----------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|----------------------------------------------|
| Contact Person: | | Dr Karin Luebbers
Senior Manager Regulatory Affairs | |
| | | Phone:
Fax: | + 49 (451) 882-5367
- 49 (451) 882-7-5367 |
| Applicant's US Contact Person: | | Ms Kathy Anderson
Senior Director Regulatory Affairs | |
| | | Phone:
Fax: | (215) 660-2078
(215) 721-5424 |
| Date submission was prepared: | | July 31st, 2007 | |
| Device Name: | Common Name:
Classification Name:
Regulation Number:
Class: | Intensive Care Ventilator
Continuous Ventilator
21 CFR 868.5895
2 | |
Legally Marketed Device Identification: EvitaXL with SmartCare Option (K051263)
Device Description:
The EvitaXL is a time-cycled microprocessor-controlled intensive care ventilator. The option SmartCare™ for the EvitaXL has been developed for assisting physicians and respiratory therapists with the standardization of the weaning process used in intensive care units. The system uses a computerbased representation of a protocol and focusses on the management of pressure support.
Scope of this submission is an extension of claims made in the promotional material, while the itself remains unchanged except for minor modifications that led to non-filing decisions for use, the intended use and the instructions for use also remain unchanged.
Intended Use:
The SmartCare/PS system is designed to stabilize the patient's spontaneous breathing in a "comfortable zone" and to reduce inspiratory support. SmartCare can be used for intubated or tracheotomized patients. Patients with body weight between 15 and 35 kg (33.1 and 77.8 lbs) must be endotracheally intubated and ventilated with active humidification. The patients should be haemodynamically stable with adequate oxygenation and spontaneous breathing.
Predicate Device:
| 510(k) Number | |
|---|---|
| K051263 |
Device Name EvitaXL
Manufacturer Dräger Medical AG & Co. KG
Substantial Equivalence:
The device and its labelling are identical to the predicate device. Substancial equivalence is claimed on that basis.
| type | release status | effective date | number | organization | page/of |
|---|---|---|---|---|---|
| TEMPLATE | RELEASED | 30.09.2004 | DMS PQ2160 A4 | Dräger Medical | |
| AG & Co. KG | 1/1 |
1
Image /page/1/Picture/1 description: The image contains the text 'Public Health Service'. The text is in a simple, sans-serif font and is horizontally aligned. The words are stacked on a single line.
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of a human figure in profile, with three overlapping heads suggesting a sense of community or interconnectedness. The figure is positioned to the right of the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA", which is arranged in a circular fashion around the logo.
FEB - 6 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dräger Medical AG & Co. KG C/O Ms. Kathy Anderson Senior Director, Regulatory Affairs Draeger Medical Systems, Incorporated 3135 Quarry Road Telford, Pennsylvania 18969
Re: K072412
Trade/Device Name: EvitaXL with Option SmartCare Regulation Number: 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: January 18, 2008 Received: January 23, 2008
Dear Ms. Anderson:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
2
Page 2 - Ms. Anderson
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); 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.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known):
EvitaXL with Option SmartCare Device Name:
The EvitaXL is a long-term ventilator for intensive care for Indications For Use: adults, children, and infants with a body weight of at least 3 kg (6.6 lbs).
With SmartCare™/PS the EvitaXL is intended to stabilize the patient's spontaneous breathing in a "comfortable zone" and to reduce inspiratory support for adults and children with a body weight of at least 15 kg (33 lbs). The patients should be haemodynamically stable with adequate oxygenation and spontaneous breathing. SmartCare can be used for intubated or tracheotomized patients. Patients with body weight between 15 and 35 kq (33.1 and 77.8 lbs) must be endotracheally intubated and ventilated with active humidification.
SmartCare™/PS is contraindicated in case of severe COPD and severe neurologic disorder that affects the cerebral control mechanism of the spontaneous breathing pattern.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mui Thulul
Division Sign-Off) Jivision of Anesthesiology, General Hospital nfection Control, Dental Devices
KD77417 510(k) Number:
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