Savina is a long term ventilator unit designed for patients with a tidal volume of 50 ml or more and is used in the intensive care areas, recovery rooms, inter and intra hospital transport and subacute care facilities. NIV means Non-Invasive Ventilation and supports the mask application mode. The NIV Option is available for Savina with SW 2.0. The NIV Option for Savina expands the range of available ventilation strategies to include Non-Invasive Ventilation. NIV is not a new ventilation mode but a different format to deliver ventilation to the patient. With the NIV Option activated, the user can switch the ventilator during preparation of the machine into one of two application modes: a) "Tube" application mode, b) "Mask" application mode. The "Tube" application mode corresponds to the reqular behavior of the device if the NIV option is not activated. If the "Mask" application mode is selected, the user gains the option to configure parts of the device integrated monitoring to adapt the specific need of the mask ventilated patient.

AI/ML Overview

The provided text describes the "NIV Option for Savina" device, which is an enhancement to the Savina ventilator to include Non-Invasive Ventilation (NIV) capabilities. However, the document does NOT contain information about specific acceptance criteria or a study that details device performance against such criteria in the manner requested (e.g., accuracy, sensitivity, specificity, or objective metrics typically found in performance studies).

The document is a 510(k) Summary and a clearance letter, primarily focused on establishing substantial equivalence to predicate devices rather than proving specific performance against predefined acceptance criteria through a detailed study with objective metrics.

Therefore, most of the requested information cannot be extracted directly from the provided text.

Here is a summary of what information can be gathered and what is missing:

1. Table of acceptance criteria and reported device performance:

Acceptance Criteria	Reported Device Performance
Not specified in the document. The document focuses on "substantial equivalence" and safety/effectiveness for its intended use, rather than specific performance metrics (e.g., accuracy, reliability, latency) that would typically have acceptance criteria.	Not specified in the document. There are no quantitative performance metrics or results of a specific study to report against acceptance criteria. The document states that the device "meets its specifications and is safe and effective for its intended use," but no details on how this was measured are provided.

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

Sample size: Not specified.
Data provenance: Not specified. The document only states that "Design, development and verification of the device was performed in accordance with FDA guidance and company internal standards" and "The testing and analysis of results provide assurance that the device meets its specifications and is safe and effective." This implies testing was done, but details are absent.

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

Not applicable/Not specified. This type of information is typically related to diagnostic or interpretive devices, which this ventilator option is not. Ground truth for a ventilator would generally relate to its physical performance, safety features, and accuracy of delivered parameters, which are usually measured against physical standards or reference devices, not expert human interpretation.

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

Not applicable/Not specified. (See point 3 above).

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:

Not applicable. This device is a ventilator option, not an AI-assisted diagnostic or interpretive system involving human readers.

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

Not applicable. The device is a physical medical device (ventilator option), not an algorithm in the sense of AI or image analysis. Its "performance" would be assessed through engineering and clinical validation rather than standalone algorithm testing.

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

Not specified directly. For a ventilator, ground truth would typically refer to established engineering standards, physiological models, or direct measurements against calibrated equipment to verify the accuracy of delivered gas volumes, pressures, flow rates, alarm functionality, and safety features. Clinical outcomes might be considered for overall effectiveness but are not usually the "ground truth" for individual performance metrics.

8. The sample size for the training set:

Not applicable/Not specified. This term is typically used for AI/machine learning models. While the device underwent "design, development, and verification," the concept of a "training set" in the context of machine learning is not relevant here.

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

Not applicable/Not specified. (See point 8 above).

In summary: The provided document is a regulatory submission for 510(k) clearance, which focuses on demonstrating substantial equivalence to existing devices. It confirms that the device meets specifications and is safe and effective, but it does not provide the detailed performance study data, acceptance criteria, or specific methodologies (like sample sizes, ground truth establishment, or expert involvement) that would be found in a comprehensive clinical or performance validation study report.

Summary

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Image /page/0/Picture/0 description: The image shows the text "K013289" in a handwritten style, with the "K" being larger than the other characters. Below this, the text "NIV Option for Savina" is printed in a smaller, more formal font. A line is drawn underneath the text "NIV Option for Savina".

510(k) Summary (Section 9)

JAN 1 5 2003

Summary of Safety and Effectiveness

Applicants Name and Address

Dräger Medical AG & Co. KGaA Moislinger Allee 53-55 D-23542 Lübeck Germany

Applicants Contact Person

Mr. Ulrich Schröder Manager Regulatory Affairs

Tel. No .: 011 49 (451) 882-3648 011 49 (451) 882-4351 Fax No.:

Applicants US Contact Person

Mr James J. Brennan Director Regulatory Affairs

Tel. No.: (215) 721-5400 Fax No.: (215) 721-5412

Date the Summary was prepared

September 27, 2002

Device Name

Trade Name: Common Name: Classification Name:

NIV Option NIV Option for Dräger Intensive Care Ventilator Savina Ventilator, Continuous (per 21 CFR 868.5895)

Legally marketed device to which Substantial Equivalence is claimed

Evita 4 / Evita 2 dura with option NIV (K010093) Manufactured by Dräger Medical AG & Co. KGaA Germany. Manufactured and Distributed in the United States by Dräger Medical Inc.

Savina (K003068) Manufactured by Dräger Medical AG & Co. KGaA; Germany. Distributed in the United States by Dräger Medical İnc.

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Description of the Device

The NIV Option for Savina expands the range of available ventilation strategies to include Non-Invasive Ventilation. NIV is not a new ventilation mode but a different format to deliver ventilation to the patient. With the NIV Option activated, the user can switch the ventilator during preparation of the machine into one of two application modes: a) "Tube" application mode, b) "Mask" application mode. The "Tube" application mode corresponds to the reqular behavior of the device if the NIV option is not activated.

If the "Mask" application mode is selected, the user gains the option to configure parts of the device integrated monitoring to adapt the specific need of the mask ventilated patient.

Intended Use

Long-term Ventilator for intensive care. For patient requiring tidal volume starting at 50 ml.

Substantial Equivalence

The intended use of Savina SW 2.n with NIV Option is covered by the referenced predicate devices

Savina SW 1.n Evita 4 and Evita 2 dura SW 4.n with NIV

The technical characteristics of the NIV option do not raise new questions regarding safety or Furthermore the labelling of Savina SW 2.n with NIV provides similar effectiveness. information as the predicate devices.

Information provided in the 510(k) Premarket Notification supports the determination of substantial equivalence. Design, development and verification of the device was performed in accordance with FDA quidance and company internal standards. The testing and analysis of results provide assurance that the device meets its specifications and is safe and effective for its intended use.

In summary Dräger Medical AG & Co. KGaA has demonstrated that Savina SW 2.n including the NIV option to be safe and effective. Savina SW 2.n with NIV is considered to be substantial equivalent to currently marketed predicate devices which have been previously cleared by FDA.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features the department's symbol, which consists of three stylized human profiles facing right, arranged in a stacked formation. The profiles are connected by flowing lines, creating a sense of unity and movement. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 5 2003

-Dräger Medical AG & Company KGaA C/O Mr. James J. Brennan Director, Regulatory Affairs Drager Medical Incorporated 3135 Quarry Road Telford, Pennsylvania 18969

Re: K023289

Trade/Device Name: Savina Regulation Number: 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: December 12, 2002 Received: December 16, 2002

Dear Mr. Brennan:

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.

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Page 2 - Mr. Brennan

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 (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Sina Russo

Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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510(k) Number (if known):

Device Name:_Savina

Indications For Use:

Long-term ventilator for intensive care. For patient requiring tidal volume starting at 50 ml.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

Susan Runs

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

510(k) Number: _______________________________________________________________________________________________________________________________________________________________

011

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).