the Carina home is a pressure controlled and volume controlled (pressure regulated) ventilator. The device is intended for use with patients with a tidal volume of 100 mL upwards. It is used for patients with respiratory insufficiency, using room air (also with additional oxygen). Federal law restricts this device to sale by or on the order of a physician.

Device Description

AI/ML Overview

The provided document is a 510(k) summary for the Carina™ home ventilator. It describes the device, its intended use, and its substantial equivalence to predicate devices, but it does not contain the detailed performance study results, acceptance criteria, or ground truth information typically found in a clinical study report.

The document states: "The results of all verification and validation testing demonstrate that all system and design requirements for the Carina home device have been met. Qualification included hazard analysis, system level qualification and verification / validation tests." However, it does not provide the specifics of these tests in terms of performance metrics, acceptance criteria, sample sizes, or ground truth methods.

Therefore, many of the requested details cannot be extracted from this specific 510(k) summary. I can only provide information that is explicitly stated or can be inferred from the provided text.

Here's an attempt to answer based on the available information:

1. Table of acceptance criteria and the reported device performance

The document states that "The results of all verification and validation testing demonstrate that all system and design requirements for the Carina home device have been met." However, no specific acceptance criteria or quantitative performance metrics are reported in this summary. For example, it does not provide specific ranges for delivered tidal volume accuracy, respiratory rate accuracy, or pressure control stability that would typically be associated with a ventilator's performance and its acceptance criteria.

2. Sample sized 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 510(k) summary. The document mentions "verification and validation testing," but it does not specify the sample size of any test sets (e.g., number of patients, test conditions, etc.) or the provenance of the 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 applicable and therefore not provided in the 510(k) summary. This document pertains to a medical device (ventilator) engineering and regulatory submission, not a diagnostic algorithm that requires expert interpretation for ground truth establishment. The "ground truth" for a ventilator would typically relate to its physical performance measurements against established standards, not expert consensus on images or clinical data.

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

This information is not applicable and therefore not provided in the 510(k) summary. As stated above, this is not a diagnostic study requiring adjudication of expert opinions.

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 applicable and therefore not provided in the 510(k) summary. MRMC studies are used for evaluating diagnostic imaging systems or AI algorithms that assist human readers. The Carina home is a ventilator, not a diagnostic imaging or AI-assisted diagnostic device.

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

This information is not explicitly stated or applicable as described. The device itself is a ventilator, which operates an algorithm for controlling ventilation. Its performance is evaluated intrinsically, not as a standalone diagnostic algorithm in the context of human-in-the-loop performance. The document only mentions "system level qualification and verification / validation tests," which would inherently evaluate the device's algorithmic performance in controlling ventilation.

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

For a ventilator, the "ground truth" would typically be derived from established engineering standards, calibration measurements against highly accurate reference devices, and physiological models. The document does not specify the exact methods for ground truth establishment but implies these through references to "safety testing" and compliance with standards like IEC60601-1, IEC60601-1-2, and ASTM F1246. These standards define the acceptable performance characteristics and testing methodologies for medical devices.

8. The sample size for the training set

This information is not provided and is likely not applicable in the context of this device. Clinical studies for ventilator performance typically involve testing the device on a range of simulated lung models or, in later stages, on a limited number of patients to demonstrate safety and effectiveness. The term "training set" is generally used for machine learning algorithms, which is not the primary focus of this 510(k) for a ventilator.

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

This information is not provided and is not applicable. As mentioned above, the concept of a "training set" with established ground truth is typically associated with machine learning models, which is not the direct subject of this ventilator 510(k) summary. The ventilator's underlying control logic and algorithms are designed based on established physiological principles and engineering requirements, not "trained" on a dataset in the machine learning sense.

Summary

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510(k) Notification Carina ™home QM06_049

Kobo705

Image /page/0/Picture/2 description: The image shows the logo for Dräger Medical. The logo is in black and white, with the word "Dräger" in a bold, sans-serif font. The word "medical" is in a thinner, sans-serif font. Below the logo is the text "A Dräger and Siemens Company" in a smaller font.

510(k) Summary

acc. to 807.92

JUN 1 4 2006

Submitter'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 Monica FerranteDirector, Regulatory Affairs
	Phone: (215) 721-5400Fax: (215) 721-5425
Date submission was prepared:	2006-03-10
Device Name:
Common Name:	Ventilator
Classification Name:	Ventilator, Continuous
Regulation Number:	21 CRF 868.5895
Class:	II
Legally Marketed Device Identification:	Carina home

Device Description:

Intended Use:

The Intended use of the Canna home is round-the-clock pressure controlled and pressure regulated volume controlled ventilation of patients with respiratory insufficiency, using room air, also with additional oxygen. The Carina home is intended for use by people without medical qualifications (patients and caregivers) as well as qualified medical and technical personnel. The device is intended for use with patients with a tidal volume of 100 mL upwards. It can be used invasive and non-invasive, for both controlled and assisted ventilation. The device can be used in Home Care environments, in and out of hospital, in stationary position (lying or sitting) or in a vehicle (e.g. car).

type TEMPLATE release status RELEASED

effective date 30.09.2004

number DMS PQ2160 A4

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510(k) Notification Carina™ home QM06 049

Image /page/1/Picture/1 description: The image shows the logo for Dräger medical. The word "Dräger" is in bold, and the word "medical" is in a thinner font. Below the logo, it says "A Dräger and Siemens Company". The logo is simple and professional.

Predicate Devices:

510(k) Number	Device Name
K052554	iVent 201 Portable Ventilator
K040790	LTV 1000 Ventilator
K033008	Air Safety HEPA and non-HEPA Filters
K003068	Savina
K970839	Siemens Servo Ventilator 300A

Substantial Equivalence:

The Carina home is similar to the homecare features to he iVent 201 (K052554) and the LTV 1000 (K040790).

It incorporates a pressure regulated volume controlled ventilation mode like the PRCV mode of the Siemens Servo Ventilator 300A (K970839).

It uses an integrated HEPA filter similar to HEPA filters from Air Safety Limited (K033008).

The Carina home and the iVent 201 are both software controlled ventilators using the same operating principle and can be used for invasive as well as non invasive ventilation.

The performance data of both ventilators is comparable, with the exception of some parameters. However, for these parameters, performance data is comparable with the LTV 1000 ventilator (K040790)

Summary of Performance Testing:

Safety testing was conducted per IEC60601-1, IEC60601-1-2, ASTM F1246 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 Carina home device have been met.

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

TEMPLATE

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like symbol, with three curved lines forming the body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 4 2006

Dräger Medical, B.V. C/O Ms. Monica Ferrante Director, Regulatory Affairs Dräger Medical, Incorporated 3135 Quarry Road Telford, Pennsylvania 18969

Re: K060705

Trade/Device Name: Carina™Home Regulation Number: 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: March 10, 2006 Received: March 16, 2006

Dear Ms. Ferrante:

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 - Ms. Ferrante

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,

Chiu Lin, Ph.D.

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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INDICATIONS FOR USE STATEMENT

Indications for Use

5.10(k) Number (if known):

Device Name: Carina™home

Indications for Use:

gn-CT)
on of Anesthesiology, General Hospital,
-don Control, Dental Devices

Number: K060

Prescription Use J (Part 21 CFR 801 Subpart D)

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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)

Page 1 of 1

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template / rev.	- / -
	CVI HC USA
	Indicated Use Statement Carina home USA
reference	STD321672
revision	2
page / of	3 / 3

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).