(300 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 sets for training/testing.
Yes
The device is described as an emergency and transport ventilator, which is used to provide mandatory or assisted ventilation to patients, thereby directly treating or alleviating a condition.
No
The Oxylog 3000 plus is described as a ventilator for patients requiring mandatory or assisted ventilation, which is a therapeutic device, not a diagnostic one. Its intended use focuses on providing respiratory support rather than identifying or characterizing a medical condition.
No
The device description clearly states it is a physical ventilator ("emergency and transport ventilator") and mentions hardware components like a carrying system, O2 cylinder, and ventilation hose. The performance studies also refer to testing against hardware standards (IEC 60601-1, etc.) and include mechanical and electrical testing.
Based on the provided information, the Oxylog 3000 plus is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's a "time-cycled, volume controlled and pressure controlled emergency and transport ventilator for patients requiring mandatory or assisted ventilation." This describes a device that directly interacts with a patient's respiratory system to provide life support.
- Device Description: The description reinforces its function as a ventilator used for emergency and transport situations.
- 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 at the point of care for analyzing biological samples.
Therefore, the Oxylog 3000 plus is a therapeutic medical device, specifically a ventilator, and not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Oxylog 3000 plus is a time-cycled, volume controlled and pressure controlled emergency and transport ventilator for patients requiring mandatory or assisted ventilation with a tidal volume from 50 mL upwards.
Product codes (comma separated list FDA assigned to the subject device)
CBK, BTL
Device Description
The Oxylog 3000 plus, a new device of the Oxylog family of emergency and transport ventilators, is intended as successor of the current Oxylog 3000. It is based on the existing Oxylog 3000 and Oxylog 2000 plus with slight adaptations like different software and a different front panel to enable the new functionality AutoFlow and CO2 measurement in the device. The Oxylog 3000 plus can be used as a stand alone unit or in a carrying system. This system protects the device and provides space for an O2 cylinder. The bags of the carrying system can be used to store accessories like a ventilation hose or mask. The carrying system can be used in ambulances and hospitals. It can be mounted by means of an universal wall holder.
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 and under the supervision of trained healthcare professionals, e.g. doctors, nurses, emergency medical technicians, respiratory therapists, and paramedics.
Intended environment of use:
- Mobile use for emergency patients, in both outdoor and indoor environments.
- During transport in ambulances or aircraft, including helicopters.
- In accident and emergency departments.
- When moving ventilated patients around the hospital.
- In the recovery room.
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 plus have been met. Qualification included hazard analysis, system level qualification and verification / validation testing.
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.
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
Oxylog 3000 plus
ﭘ
ﻪ ﻨ
510(k) Summary according to 21 CFR 807.92
Applicant's Name and Address:
Draeger Medical GmbH Moislinger Allee 53-55 23542 Luebeck Germany
Establishment Registration Number: 9611500
Contact Person:
Ulrich Schröder Director Regulatory & Clinical Affairs
Tel. No .: + 49 (451) 882-3648 Fax No .: + 49 (451) 882-3018
Applicant's US Contact Person:
Joyce Kilroy VP Processes, Quality & Regulatory Affairs
Tel. No.: (215) 660-2626 Fax No .: (267) 721-5424
Date submission was prepared:
August 24, 2011
Device Name:
Trade Name: Oxylog 3000 plus Common Name: Ventilator
Classification:
Class II
Regulation No. Device Product Code Preferred Code Oxylog 3000 plus: 868.5895 Ventilator, continuous, СВК Code for predicates (Oxylog 3000, Oxylog 2000 plus and Oxalog 2000:: 868.5895 Ventilator, continuous, свк
August 2011
FDA CDRH DMC
AUG 30 2011
Received
OCT - 6 2011
1
ン
Reason for the 510(k): Substantial Equivalence:
The new Oxylog 3000 plus has been compared to the following 3 predicative devices: the Oxylog 2000 plus (K082600), the Oxylog 3000 (K062267) and the Oxylog 2000 (K984577).
All 4 devices are intended to be used for patients for emergency and transport. All devices contain the equivalent set of ventilation modes and follow the same use philosophy.
The variations between the labeling are minimal due to the evolving development changes from the early 1990s until today.
The Oxylog 3000 plus and Oxylog 3000 (K062267) are intended for patients with a tidal volume from 50 mL upwards. Oxylog 2000 (K984577) plus and Oxylog 2000 plus (K082600) are intended for patients with a tidal volume from 100 mL upwards.
Drawn from all information presented in this submission it is summarized that Oxylog 3000 plus is as safe, as effective, and performs as well as or better than the predicate devices.
Legally Marketed Device to which Substantial Equivalence is claimed:
| 510(k) number | Trade name | Company |
|---|---|---|
| K984577 | Oxylog 2000 | Draeger Medical GmbH |
| K062267 | Oxylog 3000 | |
| K082600 | Oxylog 2000 plus |
Executive Summary
This documentation covers the Oxylog 3000 plus, a new device of the Oxylog family of emergency and transport ventilators.
The Oxylog 3000 plus is intended as successor of the current Oxylog 3000. The ventilator is based on the existing Oxylog 3000 and Oxylog 2000 plus with slight adaptations like different software and a different front panel to enable the new functionality AutoFlow and CO2 measurement in the device.
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 plus have been met. Qualification included hazard analysis, system level qualification and verification / validation testing.
Device Description:
Indications for Use
The Oxylog 3000 plus is a time-cycled, volume controlled and pressure controlled emergency and transport ventilator for patients requiring mandatory or assisted ventilation with a tidal volume from 50 mL upwards.
August 2011
2
Intended operator
The device is intended for use by and under the supervision of trained healthcare professionals, e.g. doctors, nurses, emergency medical technicians, respiratory therapists, and paramedics.
Enviroment of use
Intended environment of use:
-
Mobile use for emergency patients, in both outdoor and indoor environments.
-
During transport in ambulances or aircraft, including helicopters.
-
In accident and emergency departments.
-
When moving ventilated patients around the hospital.
-
In the recovery room.
The following ventilation modes are offered:
·VC-CMV / VC-AC:
oVolume Controlled --- Controlled Mandatory Ventilation with or without PEEP oVolume Controlled - Assist Control with or without PEEP
·VC-SIMV: Volume Controlled -- Synchronized Intermittent Mandatory Ventilation
·PC- BIPAP: Pressure Controlled- Biphasic Positive Airway Pressure
·PC - SIMV+: Pressure Controlled- Synchronized Intermittent Mandatory Ventilation •Spn-CPAP: Spontaneous breathing- Continuous Positive Airway Pressure
Additional settings for ventilation:
·Pressure support can be supplied in the ventilation modes VC-SIMV, PC-BIPAP, Son-CPAP.
· Apnoea ventilation for spontaneously breathing patients: in the ventilation mode Spn-CPAP.
·AutoFlow (optional); in the ventilation modes VC-CMV, VC-AC and VC-SIMV. ·NIV: in the ventilation modes: Spn-CPAP (/PS), PC-BIPAP (/PS), VC-CMV / AF, VC-AC / AF and VC-SIMV / AF. Using the NIV mode, non-intubated patients can be ventilated with a mask.
The Oxylog 3000 plus can be used as a stand alone unit or in a carrying system. This system protects the device and provides space for an O2 cylinder. The bags of the carrying system can be used to store accessories like a ventilation hose or mask. The carrying system can be used in ambulances and hospitals. It can be mounted by means of an universal wall holder.
August 2011
3
・・・
Drägger
List of performance testing:
Performance was tested in compliance with following standards:
| IEC 60601-1 :2006 | Medical electrical equipment - Part 1: General
requirements for basic safety and essential
performance |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 60601-1-2 : 2007 | Medical electrical equipment - Part 1-2: General
requirements for basic safety and essential
performance - Collateral standard: Electromagnetic
compatibility - Requirements and tests |
| ISO 10651-3: 1997 | Lung ventilators for medical use - Part 3: Particular
Requirements for emergency and transport ventilators |
| IEC 60601-1-6 : 2004 | Medical electrical equipment - Part 1-6: General
requirements for basic safety and essential
performance - Collateral standard - Usability |
| IEC 60601-1-8: 2006 | Medical electrical equipment - Part 1-8: General
requirements for basic safety and essential
performance - Collateral standard: General
requirements, tests and guidance for alarm systems in
medical electrical equipment and medical electrical
systems |
| ISO 14971: 2007 | Medical devices - Application of risk management to
medical devices |
August 2011
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The logo is surrounded by a circular border containing the text "U.S. Department of Health & Human Services USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Joyce Kilroy Vice President Processes. Quality & Regulatory Affairs Draeger Medical Systems, Incorporated 3135 Quarry Road Telford, Pennsylvania 18969
OCT - 6 2011
Re: K103625
Trade/Device Name: Oxylog 3000 plus Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK, BTL Dated: September 30, 2011 Received: October 3, 2011
Dear Ms. Kilroy:
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. Tn addition, FDA may publish further announcements concerning your device in the Federal Register.
5
Page 2 - Ms. Kilrov
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 (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); 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/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRHis) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Parl 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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Nh for
Anthony D. Watson. B.S., M.S.. M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known): K103625
Device Name: Oxylog 3000 plus
Indications for Use:
The Oxylog 3000 plus is a time-cycled, volume controlled and pressure controlled emergency and transport ventilator for patients requiring mandatory or assisted ventilation 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)
L. Schult
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Page 1 of 1
510(k) Number: _ K 1036 25