(88 days)
Not Found
No
The summary describes a standard emergency and transport ventilator with no mention of AI or ML capabilities, image processing, or data training/testing.
Yes
The device is described as an "emergency and transport ventilator" for patients, which directly provides respiratory support, hence performing a therapeutic function.
No
Explanation: The device description clearly states that the Oxylog 3000 is an "emergency and transport ventilator." Its function is to support breathing, not to diagnose a condition.
No
The device description clearly states it is a "time-cycled, volume-constant and pressure controlled emergency and transport ventilator," which is a hardware device. The summary also mentions safety testing per IEC60601-1, which is a standard for the safety of medical electrical equipment, further indicating it is a hardware device.
Based on the provided information, the Oxylog 3000 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the Oxylog 3000 is an emergency and transport ventilator. This is a life-support device used to assist or control a patient's breathing.
- Device Description: The description reinforces its function as a ventilator.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment. IVD devices are typically used in laboratories or point-of-care settings for testing biological samples.
Therefore, the Oxylog 3000 falls under the category of a medical device used for direct patient care, specifically respiratory support, rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Oxylog 3000 is a time-cycled, volume-constant and pressure controlled emergency and transport ventilator for patients with a tidal volume from 50 mL upwards.
Product codes (comma separated list FDA assigned to the subject device)
CBK
Device Description
The Oxylog 3000 is a time-cycled, volume-constant and pressure controlled emergency and transport ventilator for patients with a tidal volume from 50 mL upwards. The device is intended for use by trained healthcare professionals, i.e. doctors, nurses, technicians, respiratory therapists, paramedics.
The device is intended for mobile use for emergency medical care or primary care of emergency patients:
- During transport in emergency rescue vehicles or aircrafts including helicopters .
. In accident and emergency departments, in the recovery room.
Mobile use for secondary transfers:
- During transfer by road or air '
- l When moving ventilated patients around in the hospital.
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
Not Found
Intended User / Care Setting
The device is intended for use by trained healthcare professionals, i.e. doctors, nurses, technicians, respiratory therapists, paramedics.
The device is intended for mobile use for emergency medical care or primary care of emergency patients:
- During transport in emergency rescue vehicles or aircrafts including helicopters .
. In accident and emergency departments, in the recovery room.
Mobile use for secondary transfers:
- During transfer by road or air '
- l When moving ventilated patients around in the hospital.
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)
Safety testing was conducted per IEC60601-1, IEC60601-1-2 and other applicable standards with respect to mechanical, electrical and biocompatibility.
The results of all verification and validation testing demonstrate that all system and design requirements for the Oxylog 3000 device have been met.
Qualification included hazard analysis, system level qualification and verification / validation tests.
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.
K984577, K040790, K003068, K942938, K042468, K042607
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
Image /page/0/Picture/1 description: The image shows the logo for Dräger medical, along with the number K062267 written above it. The Dräger medical logo is in bold, with the word "Dräger" in a larger font than the word "medical". Below the logo, it says "A Dräger and Siemens Company" in a smaller font. The number K062267 is written in a handwritten style.
510(k) Summary
acc. to 807.92
OCT 3 1 2006
| Submitter's Name and Address: | Dräger Medical b.v.
Kanaaldijk 29
5683CR Best
The Netherlands |
|-------------------------------|------------------------------------------------------------------------------|
| Contact Person: | Mr. Hans Venings
Vice President Processes, Quality and Regulatory Affairs |
| | |
| Phone: | +31 499 331331 |
| Fax: | +31 499 331222 |
| Applicants US Contact Person: | Mr. Bryan Overton
Regulatory Affairs |
| | |
| Phone: | (215) 721-5400 |
| Fax: | (215) 721-5424 |
| Date submission was prepared: | 2006-07-31 |
| Device Name: | Ventilator |
| Common Name: | Ventilator, Continuous |
| Classification Name: | 21 CRF 868.5895 |
| Regulation Number: | II |
| Class: | |
Legally Marketed Device Identification: Oxylog 3000#### Device Description:
The Oxylog 3000 is a time-cycled, volume-constant and pressure controlled emergency and transport ventilator for patients with a tidal volume from 50 mL upwards. The device is intended for use by trained healthcare professionals, i.e. doctors, nurses, technicians, respiratory therapists, paramedics.
The device is intended for mobile use for emergency medical care or primary care of emergency patients:
- During transport in emergency rescue vehicles or aircrafts including helicopters .
. In accident and emergency departments, in the recovery room.
Mobile use for secondary transfers:
- During transfer by road or air '
- l When moving ventilated patients around in the hospital.
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Image /page/1/Picture/1 description: The image shows the logo for Dräger Medical. The logo is in black and features the word "Dräger" in a bold, stylized font with an umlaut over the "a". Below the logo is the text "A Dräger and Siemens Company" in a smaller font. The logo is simple and professional, and it is likely used on the company's products, website, and marketing materials.
Predicate Devices:
| 510(k) Number | Device Name |
|---|---|
| K984577 | Oxylog 2000 |
| K040790 | LTV 1000 |
| K003068 | Savina |
| K942938 | Crossvent-4 |
| K042468 | iVent 201 |
| K042607 | Primus US |
Substantial Equivalence:
The Oxylog 3000 is found similar to the Oxylog 2000 (K984577) and the transport features of the LTV 1000 (K040790).
The Oxylog 3000 incorporates a Pressure Controlled Ventilation plus mode and a Pressure Support mode identical to the Savina ventilator (K003068). Furthermore, the Oxylog 3000 uses the same operating principle as the Savina.
Specific features and setting ranges of the Oxylog 3000 are found similar to those features on the Crossvent-4 ventilator (K942938) and the iVent 201 ventilator (K042468).
The accessories of the Oxylog 3000 are similar to the accessories of the LTV 1000 (K040790) and the accessories of the Primus US (K042607).
Summary of Performance Testing:
Safety testing was conducted per IEC60601-1, IEC60601-1-2 and other applicable standards with respect to mechanical, electrical and biocompatibility.
The results of all verification and validation testing demonstrate that all system and design requirements for the Oxylog 3000 device have been met.
Qualification included hazard analysis, system level qualification and verification / validation tests.
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, in the center. Encircling the caduceus are the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The seal is presented in black and white.
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dräger Medical B.V. C/O Mr. Bryan Overton Regulatory Affairs Dräger Medical, Incorporated 3135 Quarry Road Telford, Pennsylvania 18969
OCT 3 1 2006
Re: K062267
Trade/Device Name: Oxylog 3000 Regulation Number: 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: July 31, 2006 Received: August 4, 2006
Dear Mr. Overton:
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.
3
Page 2 - Mr. Overton
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.
Syette Y. Michael Davis
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
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Image /page/4/Picture/0 description: The image shows the logo for Dräger Medical. The word "Dräger" is in bold, with two dots above the "a". The word "medical" is next to it in a thinner font. Below the logo, it says "A Dräger and Siemens Company".
INDICATIONS FOR USE STATEMENT
Indications for Use
510(k) Number (if known):
Device Name: Oxylog 3000
Indications for Use:
is document / contents is forbidden without express authority. All rights reserved. Refer to protection notice ISO 16016. Drager Med
Oxylog 3000 is a time-cycled, volume-constant and pressure controlled emergency and transport ventilator for patients with a tidal volume from 50 mL upwards.
| 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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Sign-Off) | |
|---|---|
| ion of Anesthesiology, General Hospital, | |
| ...ion Control, Dental Devices | |
| ) Number: | K062267 |
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