The Oxylog 2000 plus is a time-cycled, volume controlled emergency and transport ventilator with pressure support for patients requiring mandatory or assisted ventilation with a tidal volume from 100 mL upwards.

Device Description

The Oxylog 2000 p/us is a time-cycled, volume controlled emergency and transport ventilator with pressure support for patients requiring mandatory or assisted ventilation with a tidal volume from 100 ml. upwards. The device is intended for use by and under the supervision of trained healthcare professionals. The device is intended for use in the following environments:

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.

AI/ML Overview

This document concerns the 510(k) Notification for the Dräger Oxylog 2000 plus ventilator. The submission primarily focuses on establishing substantial equivalence to previously marketed devices rather than presenting a detailed study proving the device meets specific performance acceptance criteria through clinical trials or extensive standalone performance testing.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not contain a table of specific, quantitative acceptance criteria (e.g., accuracy, precision for ventilation parameters) for the Oxylog 2000 plus. Instead, it states:

Criterion Type	Acceptance Criteria (Implicit)	Reported Device Performance
Safety	Compliance with applicable standards (IEC60601-1, IEC60601-1-2)	"Safety testing was conducted per IEC60601-1, IEC60601-1-2 and other applicable standards with respect to mechanical, electrical and biocompatibility."
System & Design Requirements	Fulfillment of all system and design requirements	"The results of all verification and validation testing demonstrate that all system and design requirements for the Oxylog 2000 plus device have been met."

2. Sample size used for the test set and the data provenance

The document does not describe a test set in the context of clinical or performance data for the Oxylog 2000 plus as one might expect for an AI/diagnostic device. The "testing" mentioned is related to engineering verification and validation of the device's design against safety and system requirements, not patient data or clinical outcomes. Therefore, information on sample size and data provenance (country of origin, retrospective/prospective) for a clinical test set is not applicable here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable as the submission does not describe a test set requiring expert-established ground truth related to clinical performance or diagnostic accuracy.

4. Adjudication method for the test set

This information is not applicable as there is no described test set requiring adjudication.

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

An MRMC comparative effectiveness study is not applicable here. The Oxylog 2000 plus is a ventilator, not a diagnostic device that assists human readers.

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

A "standalone" performance study in the context of an algorithm's performance is not applicable to this device. The document describes engineering verification and validation of the device itself (hardware and software combined), not an isolated algorithm. The device's performance is inherently "standalone" in its function as a ventilator, but this is not the typical meaning in the context of AI/diagnostic device submissions.

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

The "ground truth" used in the context of the described testing is related to engineering specifications, regulatory standards (like IEC60601 series), and internal design requirements. For example, the "ground truth" for electrical safety would be defined by the limits set in IEC60601-1-2. There is no mention of clinical ground truth (e.g., patient outcomes, expert consensus on a diagnosis) because this is not a diagnostic device.

8. The sample size for the training set

This information is not applicable. The device is a ventilator, and there is no mention of an AI model being "trained" in the sense of machine learning using a distinct training set of data. Its performance is based on its engineered design and programming, not a learning algorithm developed from a training dataset.

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

This information is not applicable, as there is no described training set.

Summary of the Study:

The study described is not a clinical trial or a performance study comparing the device against human performance or a diagnostic gold standard. Instead, it is an engineering verification and validation process executed to demonstrate that the Oxylog 2000 plus ventilator meets its design requirements and complies with relevant safety standards (IEC60601-1, IEC60601-1-2). This type of testing is typical for medical devices that are primarily hardware-based and perform a functional role (like a ventilator) rather than an interpretative or diagnostic role. The FDA's 510(k) clearance for this device, based on "substantial equivalence" to predicate devices (Oxylog 2000 and Oxylog 3000), relies on this engineering evidence and the comparison of specifications and intended use.

Summary

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510(k) Notification Oxylog 2000 plus QM08 146

K082600 page 1 of 2

Drägermedical

A Dräger and Siemens Company

NOV 26 2008

510(k) Summary (Section 5)

acc. to 807.92

Applicant's Name and Address:	Dräger Medical b.v.Kanaaldijk 295683CR BestThe Netherlands
Contact Person:	Mr. Hans VeningsVice President Processes, Quality and Regulatory Affairs
	Phone: +31 499 331331Fax: +31 499 331222
Applicants US Contact Person:	Ms. Joyce KilroyVice President Processes, Quality and Regulatory
	Phone: (215) 721-5400Fax: (215) 721-5424
Date submission was prepared:	2008-09-02
Device Name:
Common Name:	Ventilator
Classification Name:	Ventilator, Continuous
Regulation Number:	21 CRF 868.5895
Class:	II

Legally Marketed Device Identification: Oxylog 2000 plus

Device Description:

Mobile use for emergency patients, in both outdoor and indoor environments;
During transport in ambulances or aircraft, including helicopters;
트 In accident and emergency departments;
해 When moving ventilated patients around the hospital;
트 In the recovery room.

Legally marketed devices to which substantial equivalence is claimed:

510(k) Number	Device Name
K984577	Oxylog 2000
K062267	Oxylog 3000

type	release status	effective date	number	organization	page/of
TEMPLATE	RELEASED	30.09.2004	DMS PQ2160 A4	Dräger Medical	1/2

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Image /page/1/Picture/0 description: The image shows the logo for Dräger medical, a Dräger and Siemens Company. The word "Dräger" is in bold, with two dots above the "a", while "medical" is in a thinner, non-bold font. Above the logo, there is some faded text that appears to say "page 2 of 2".

510(k) Notification Oxylog 2000 plus QM08_146

Substantial Equivalence:

The Oxylog 2000 plus is found substantially equivalent to the Oxylog 3000 (K062267). For those asepcts where the devices differ, the Oxylog 2000 plus is found substantially equivalent to the Oxylog 2000 (K984577).

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 2000 plus device have been met.

Qualification included hazard analysis, system level qualification and verification / validation tests.

type	release status	effective date	number	organization	page/of
TEMPLATE	RELEASED	30.09.2004	DMS PQ2160 A4	Dräger Medical	2/2

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 6 2008

Dräger Medical, B.V. C/O Ms. Joyce Kilroy Vice President Processes, Quality and Regulatory Dräger Medical Systems, Incorporated 3135 Quarry Road Telford, Pennsylvania 18969

Re: K082600

Trade/Device Name: Oxylog 2000 Plus Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: September 2, 2008 Received: September 10, 2008

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 gencral 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.

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Page 2 - Ms. Kilroy

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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-frec number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Suatte Y. Michie Omd.

Chiu Lin, Ph.D. Director Division of Ancsthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known):

Device Name: Oxylog 2000 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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Koszta-Cola

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K082600

Page 1 of 1

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).