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. 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.

AI/ML Overview

This document is a 510(k) premarket notification for the Oxylog 3000 plus ventilator. It primarily focuses on demonstrating substantial equivalence to predicate devices and adherence to relevant safety standards. It does not contain information about explicit acceptance criteria for device performance in a clinical study, nor does it describe a study specifically designed to prove the device meets such criteria in terms of clinical outcomes or diagnostic accuracy. Instead, it details performance testing against technical and safety standards.

Therefore, many of the requested sections (2, 3, 4, 5, 6, 7, 8, 9) regarding a study proving acceptance criteria cannot be answered from the provided text.

Here's a breakdown of what can be extracted and inferred:

1. A table of acceptance criteria and the reported device performance

The document doesn't explicitly state "acceptance criteria" in a table format with corresponding "reported device performance" in terms of clinical efficacy or diagnostic accuracy. Instead, it refers to compliance with various safety and performance standards as the basis for demonstrating that the device is "as safe, as effective, and performs as well as or better than the predicate devices."

The acceptance criteria are implicitly defined by the requirements of the standards listed, and the reported device performance is stated as having "met" these requirements.

Acceptance Criterion (implicitly by standard compliance)	Reported Device Performance (as stated)
IEC 60601-1:2006 (Basic safety & essential performance)	Met (implied by "all system and design requirements...have been met")
IEC 60601-1-2:2007 (EMC requirements)	Met (implied by "all system and design requirements...have been met")
ISO 10651-3:1997 (Emergency & transport ventilators)	Met (implied by "all system and design requirements...have been met")
IEC 60601-1-6:2004 (Usability)	Met (implied by "all system and design requirements...have been met")
IEC 60601-1-8:2006 (Alarm systems)	Met (implied by "all system and design requirements...have been met")
ISO 14971:2007 (Risk management)	Met (implied by "all system and design requirements...have been met")

The "study" that proves the device meets these criteria is referred to as "verification and validation testing." The document states: "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."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The testing described is against technical standards, not typically a clinical trial with a "test set" of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. Ground truth as typically understood in clinical studies (e.g., for diagnostic accuracy) is not applicable here as the submission describes engineering and performance testing against standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document. Adjudication methods are relevant for clinical studies, not typically for compliance testing against engineering standards.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not provided and is not applicable. The Oxylog 3000 plus is a ventilator, not an AI-assisted diagnostic or interpretation device that would involve human "readers" or "AI assistance."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not provided and is not applicable. The device is a ventilator, not an algorithm being evaluated for standalone performance. Its functions (like AutoFlow) are integral to the device's operation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the verification and validation testing, the "ground truth" would be the defined parameters and requirements within each of the listed IEC and ISO standards. For example, electrical safety requirements (IEC 60601-1-2), ventilation performance specifications (ISO 10651-3), or usability criteria (IEC 60601-1-6). The device's performance is measured against these established technical benchmarks.

8. The sample size for the training set

This information is not provided and is not applicable. Training sets are generally associated with machine learning or AI model development, which is not described for this ventilator.

9. How the ground truth for the training set was established

This information is not provided and is not applicable for the same reasons as #8.

Summary

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Oxylog 3000 plus

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K103625

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

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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

August 2011

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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

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・・・

Drägger

List of performance testing:

Performance was tested in compliance with following standards:

IEC 60601-1 :2006	Medical electrical equipment - Part 1: Generalrequirements for basic safety and essentialperformance
IEC 60601-1-2 : 2007	Medical electrical equipment - Part 1-2: Generalrequirements for basic safety and essentialperformance - Collateral standard: Electromagneticcompatibility - Requirements and tests
ISO 10651-3: 1997	Lung ventilators for medical use - Part 3: ParticularRequirements for emergency and transport ventilators
IEC 60601-1-6 : 2004	Medical electrical equipment - Part 1-6: Generalrequirements for basic safety and essentialperformance - Collateral standard - Usability
IEC 60601-1-8: 2006	Medical electrical equipment - Part 1-8: Generalrequirements for basic safety and essentialperformance - Collateral standard: Generalrequirements, tests and guidance for alarm systems inmedical electrical equipment and medical electricalsystems
ISO 14971: 2007	Medical devices - Application of risk management tomedical devices

August 2011

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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.

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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

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Indications for Use

510(k) Number (if known): K103625

Device Name: Oxylog 3000 plus

Indications for Use:

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

Regulation Number and Section

§ 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).