The mask ClassicStar noninvasive ventilation (NV) with standard elbow (SE) and the mask NovaStar noninvasive ventilation (N); with standard elbow (SE) are intended to provide a patient interface for application of noninvasive ventilation. The masks are to be used as an accessory to ventilators that have adequate alarms and safety systems for ventilator failure and which are intended to administer CPAP or positive pressure ventilation for treatment of respiratory failure or respiratory insufficiency. The masks are intended for use on adult patients (>30 kg/66 lbs), who are appropriate candidates for noninvasive ventilation in the hospital or institutional environment.

The mask ClassicStar NV, with standard elbow is disposable and for single patient use.

The mask NovaStar NV, with standard elbow can be used multiple times on multiple patients. Reuse, however, is limited up to 5 times.

The full face mask NovaStar, noninvasive ventilation (NV), with anti-asphyxia valve (AAV) is intended to be used with positive airway pressure devices, operating at or above 3 mbar (3 cmH2O). The mask contains exhalation ports and does not require the use of a separate exhalation device. It is intended for use on adult patients (>30 kg), who are appropriate candidates for noninvasive ventilation in the hospital, institutional and in the home environments. The mask can be used multiple times on multiple patients. Reuse, however, is limited up to 5 times.

Device Description

Within the medical device family "Noninvasive Ventilation Masks" are devices to provide a patient interface for the application of noninvasive ventilation.

The masks ClassicStar and NovaStar are Full-Face masks which cover the mouth and the nose and are available with a standard elbow (SE) or an anti-asphyxia valve (AAV). Masks with a standard elbow (SE) may only be used on ventilation devices, which incorporate adequate alarm and safety systems for ventilation failure.

A mask with an anti-asphyxia valve (AAV) incorporates the anti-asphyxia valve in the mask elbow.

The ClassicStar Masks are disposable, while the NovaStar Masks are reusable up to 5 times for multiple patients. Further differences are the headgears, which are similar in materials but differ in means of connection to the mask. The headgears are generally provided with the masks, for the reusable masks further headgears are available as optional accessory.

All noninvasive ventilation masks are available in three different sizes (S, M, L),

AI/ML Overview

The provided text is a 510(k) summary for non-invasive ventilation masks. It is a regulatory submission to the FDA for market clearance, not a scientific study reporting device performance against acceptance criteria in the way a research paper would. Therefore, much of the requested information (like specific performance metrics, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth details) is not typically found in this type of summary.

Instead, a 510(k) summary focuses on demonstrating "substantial equivalence" to legally marketed predicate devices. This typically involves showing that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness compared to the predicate. The "acceptance criteria" here are essentially the regulatory requirements for substantial equivalence, and the "study" is the overall 510(k) submission process itself, where testing (e.g., biocompatibility, materials testing, performance under simulated conditions) is conducted to ensure the device meets recognized standards and performs similarly to its predicates.

Given this context, here's an attempt to answer your questions based on the provided text, recognizing the limitations:

Acceptance Criteria and Device Performance (Based on 510(k) Submission)

The "acceptance criteria" in a 510(k) context are primarily demonstrating substantial equivalence to a predicate device in terms of intended use, technological characteristics, and safety/effectiveness. The "reported device performance" is not quantified in the typical sense of a human-AI study but rather implied through comparison to the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied from 510(k))	Reported Device Performance (Implied from 510(k))
Intended Use Equivalence: Same indications for use (patient population, environment, treatment type, ventilation mode) as predicate devices.	The masks (ClassicStar and NovaStar) are intended to provide a patient interface for noninvasive ventilation, for adult patients (>30 kg) in hospital/institutional environments. The NovaStar AAV variant also includes home environments. These uses are consistent with those of the legally marketed predicate devices (K023135, K063806, K060273).
Technological Characteristics Equivalence: Similar design, materials, and functional principles to predicate devices.	The devices are full-face masks covering mouth and nose, available with standard elbows (SE) or an anti-asphyxia valve (AAV). ClassicStar is disposable for single patient use, NovaStar is reusable up to 5 times. Available in S, M, L sizes. Materials are described as similar to headgears. The submission claims these characteristics are substantially equivalent to the predicate devices. Specific performance details (e.g., seal integrity, dead space volume) are not quantitatively reported in this summary but would have been assessed during the submission process.
Safety and Effectiveness: No new questions of safety or effectiveness are raised compared to predicate devices.	The FDA’s clearance letter (K081743) confirms that the device is "substantially equivalent ... to legally marketed predicate devices" and "does not require approval of a premarket approval application (PMA)," implying that no new questions of safety or effectiveness were raised that would prevent market clearance under general controls. Performance testing (e.g., for respiration function, materials biocompatibility) would have been conducted by the manufacturer, but specific results are not detailed in this summary.
Regulatory Compliance: Adherence to general controls (e.g., registration, listing, GMP, labeling).	The FDA letter reminds the applicant of the need to comply with all Act's requirements, including registration and listing (21 CFR Part 807), labeling (21 CFR Part 801), and good manufacturing practice (21 CFR Part 820). The market clearance itself indicates the submission met the initial regulatory hurdle.

Additional Requested Information:

Since this is a 510(k) summary for a physical medical device (masks) and not an AI/software device, many of your specific questions related to AI study design are not applicable.

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not applicable for this type of device and document. A 510(k) for a physical device like a mask does not typically involve "test sets" of data in the AI/machine learning sense. Performance is generally assessed through engineering testing (e.g., airflow resistance, dead space, seal integrity, materials biocompatibility, pressure drop) and clinical use data collection, if necessary, to demonstrate equivalence. Specific sample sizes for such tests are not detailed in this summary.
- Data Provenance: The applicant is Dräger Medical AG & Co. KG from Lübeck, Germany. Any internal testing data would likely originate from their facilities.
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)
- Not applicable. Ground truth for a physical medical device like a mask is established through objective engineering measurements, adherence to recognized standards, and, if applicable, clinical validation (though not usually required for 510(k) unless a new significant performance claim is made or equivalence is challenged). There are no "experts establishing ground truth" in the diagnostic context.
Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. This relates to diagnostic interpretation consensus, which is not relevant for a respiratory mask.
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 is a physical medical device, not an AI or diagnostic tool. MRMC studies are not relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical mask, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable in the AI/diagnostic sense. The "ground truth" for a non-invasive ventilation mask would be derived from:
  - Engineering specifications and standards: Adherence to ISO, ASTM, or other recognized standards for breathing devices (e.g., dead space, flow resistance, pressure integrity).
  - Biocompatibility testing: Ensuring materials are safe for human contact.
  - Bench testing: Actual performance measurements in a laboratory setting.
  - Clinical experience/literature: Supporting the general safety and effectiveness of non-invasive ventilation masks of similar design.
The sample size for the training set
- Not applicable. This is not an AI/machine learning device.
How the ground truth for the training set was established
- Not applicable. This is not an AI/machine learning device.

In summary: The provided document is a regulatory submission aiming for market clearance based on substantial equivalence to existing devices. It demonstrates this equivalence through a comparison of intended use and technological characteristics, implicitly supported by internal testing and adherence to recognized standards by the manufacturer. It does not provide the detailed scientific study results typically found for AI/diagnostic devices.

Summary

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510(k) Summary

Summary of Safety and Effectiveness

Applicants Name and Address:

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

Establishment Registration Number: 9611500

Contact Person:

Dr. Karin Luebbers Senior Manager Regulatory Affairs

Tel. No.: + 49 (451) 882-5367 Fax No .: + 49 (451) 882-7-5367

Applicants US Contact Person

Ms. Jovce Kilrov VP Processes, Quality & Regulatory Affairs

Tel. No .: (215) 660-2626 Fax No .: (267) 885-9989

Date submission was prepared:

2008-09-09

Device Name:

ClassicStar™, NV, Full Face Mask, SE Trade Name: Common Name: Full Face Mask, Noninvasive ventilation Trade Name: NovaStar™, NV, Full Face Mask, SE Common Name: Full Face Mask, Noninvasive ventilation NovaStar™, NV, Full Face Mask, AAV Trade Name: Common Name: Full Face Mask, Noninvasive ventilation

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Noninvasive Ventilation Masks

Classification:

Class II
Regulation No.	Device	Product Code
868.5895	Ventilator, continuous, facility use	73CBK

Legally Marketed Device to which Substantial Equivalence is claimed:

510(k) number	Trade name	Company
K023135	Image3 SE Disposable Full Face Mask	Respironics Inc.
K063806	SleepNet MoJoTM -NV Full Face Masknonvented	SleepNet Corp.
K060273	SleepNet MoJoTM Full Face Mask	SleepNet Corp.

Device Description:

Within the medical device family "Noninvasive Ventilation Masks" are devices to provide a patient interface for the application of noninvasive ventilation.

A mask with an anti-asphyxia valve (AAV) incorporates the anti-asphyxia valve in the mask elbow.

All noninvasive ventilation masks are available in three different sizes (S, M, L),

Intended Use:

ClassicStar™, NV, Full Face Mask, SE (with standard elbow), size S-L:

The mask ClassicStar noninvasive ventilation (NV) with standard elbow (SE) is intended to provide a patient interface for application of noninvasive ventilation. The mask is to he used as an accessory to ventilators that have adequate alarms and safety systems for ventilator failure and which are intended to administer CPAP or positive pressure ventilation for treatment of respiratory failure or respiratory insufficiency. It is intended for use on adult patients (>30 kg/66 lbs), who are appropriate candidates for noninvasive ventilation in the hospital or institutional environment. The mask is disposable and for single patient use. NovaStar™, NV, Full Face Mask, SE (with standard elbow), size S-L:

The mask NovaStar noninvasive ventilation (NV) with standard elbow (SE) is intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators that have adequate alarms and safety systems for ventilator

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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. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", indicating the department's name and national affiliation.

SEP 2 2 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Karin Lübbers Senior Manger Regulatory Affairs Draeger Medical AG & Co. KG 53/55 Moislinger Allee Luebeck GERMANY 23542

Re: K081743

Trade/Device Name: ClassicStar™, NV, Full Face Mask, SE NovaStar™, NV, Full Face Mask, SE NovaStarTM, NV, Full Face Mask, AAV Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: September 10, 2008 Received: September 15, 2008

Dear Ms. Lübbers:

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. Lübbers

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 (OS) 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) 276-0120. 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-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

ThAnnuele Yendms foell

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

510(k) Number (if known): K

Device Name:

ClassicStar ™, NV, Full Face Mask, SE Star TM, NV, Full Face Mask, SE
NovaStar TM, NV, Full Face Mask, AAV

Indications for Use:

The mask ClassicStar NV, with standard elbow is disposable and for single patient use.

The mask NovaStar NV, with standard elbow can be used multiple times on multiple patients. Reuse, however, is limited up to 5 times.

Prescription Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

M. The

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

Page 1 of 1

Ko81743 510(k) Number: -

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).