WEINMANNcompact is for the treatment of Obstructive Sleep Apnea (OSA) in adult patients (>30kg). The device delivers a fixed treatment pressure within the range of 4 to 20 cmH2O. (Fooly). The oction action and click 2) is indicated for the humidification and warming of air from the WEINMANNcompact flow generator device. The WEINMANNcompact and WEINMANNclick 2 are for home and hospital use.

Device Description

The WEINMANNcompact is a microprocessor controlled blower-based device that generates a Continuous Positive Airway Pressure (CPAP) from 4 to 20 cmH2O for the treatment of Obstructive Sleep Apnea (OSA). The system includes the flow generator, patient tubing, external power supply, and an optional heated humidifier WEINMANNclick 2. A radial compressor draws in ambient air via a filter and conveys it to the unit outlet. From here the air flows through the hose system and the mask to the patient. The WEINMANNcompact has one mode of operation (CPAP fixed-pressure mode). In this mode the flow generator provides a single fixed-pressure as set by the clinician. A softstart automatic system is installed to help the patient fall asleep more easily. The optional breath humidifier WEINMANNclick 2 can be snapped onto the therapy unit at the front. The air from the flow generator is directed over a water surface in the humidifier, which functions according to the pass-over principle.

AI/ML Overview

The provided text is a 510(k) summary for the WEINMANNcompact CPAP device. It details the device's technical characteristics and claims substantial equivalence to predicate devices. However, it does not contain detailed information about specific acceptance criteria or a dedicated study that proves the device meets those criteria in the way typically found for a new, non-equivalent device or a device with new performance claims.

The document states: "Design verification testing was performed based on risk analysis and product requirements to ensure that the WEINMANNcompact met its specifications. All tests were verified to meet acceptance criteria. Biocompatibility testing was performed to verify the equivalent safety of the materials of the device." This is a general statement and does not provide the specific details requested in your prompt.

Therefore, many of your requested fields cannot be filled from the provided text.

Here's how I can address your request based on the available information, with clear indications where information is not present:

Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

The provided 510(k) summary for the WEINMANNcompact indicates that the device's acceptance criteria are based on its specifications, and these were verified through "Design verification testing" and "Biocompatibility testing." The core of the submission is a claim of substantial equivalence to existing predicate devices (ResMed S7 Elite CPAP System and WEINMANNcomfort 2). This means the device is considered safe and effective because its technological characteristics and intended use are the same or very similar to legally marketed devices.

The "study" to prove the device meets acceptance criteria primarily consists of demonstrating that the WEINMANNcompact shares the "same intended use, same operating principle, same technology, [and] same manufacturing process" as its predicates. Any minor differences (e.g., external power supply) were deemed not to affect safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (as inferred)	Reported Device Performance (as inferred)
Intended Use	Treatment of Obstructive Sleep Apnea (OSA) in adult patients (>30kg) via fixed CPAP pressure. Humidification and warming of air for optional humidifier. For home and hospital use.	Same as predicate devices. Meets specified intended use.
Pressure Range	Delivers fixed therapy pressure within 4 to 20 cmH2O.	Meets specified pressure range.
Operating Principle	Microprocessor controlled blower-based device, radial compressor, softstart automatic system.	Same as predicate devices. Functions as a CPAP device.
Technology	Blower-based CPAP technology.	Same as predicate devices.
Manufacturing Process	Standard manufacturing process for CPAP devices.	Same as predicate devices.
Safety and Effectiveness	Equivalent to predicate devices, not adversely affected by minor changes (e.g., external power supply).	Design verification testing and biocompatibility testing performed to ensure safety and effectiveness. "All tests were verified to meet acceptance criteria."
Biocompatibility	Materials are biocompatible and safe.	Biocompatibility testing performed to verify equivalent safety of materials.

Detailed Information (where available or explicitly not present in the document):

Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document primarily refers to "design verification testing" and "biocompatibility testing" without providing specific sample sizes for these tests. In the context of substantial equivalence, formal clinical trials with human subjects and specific test set sizes for performance evaluation against a gold standard are often not required if technological characteristics are demonstrably equivalent.
- Data Provenance: Not specified. (e.g., country of origin, retrospective or prospective).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the submission. For a 510(k) based on substantial equivalence, the "ground truth" is often established by adherence to recognized standards and engineering specifications rather than expert consensus on specific device output measurements against a clinical truth.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not provided in the submission. The submission focuses on technical verification rather than human-read decision-making requiring adjudication.
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:
- No, an MRMC comparative effectiveness study was not conducted. This type of study is relevant for AI-assisted diagnostic or interpretive devices, which the WEINMANNcompact (a CPAP therapeutic device) is not. There is no AI component mentioned for human assistance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This question is not applicable as the device is a medical therapy device (CPAP), not an algorithm for diagnosis or interpretation. The device operates independently to deliver a set pressure.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the WEINMANNcompact's performance appears to be its adherence to established engineering specifications for CPAP devices and its capability to deliver pressure within the stated range (4-20 cmH2O). For biocompatibility, the ground truth would be established by international standards (e.g., ISO 10993). However, specific details are not provided.
The sample size for the training set:
- This information is not applicable as there is no mention of a "training set" in the context of machine learning or AI for this device. The device operates based on predefined engineering and thermodynamic principles.
How the ground truth for the training set was established:
- This information is not applicable as there is no "training set."

Summary

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Image /page/0/Picture/0 description: The image shows the logo for WEINMANN medical technology. The logo is in black and white, with the word "WEINMANN" in large, bold letters. Below the logo, the words "medical technology" are written in a smaller font. Above the logo, the words "page 1 of 2" are written in a smaller font. Below the words "medical technology", the number "K07 2009" is written in a larger font.

5. 510(k) Summary

WEINMANNcompact

November 26, 2007

DEC 1 4 2007

Submitter Information:

Weinmann Gerate für Medizin GmbH+Co. KG Kronsaalsweg 40 22525 Hamburg / Germany

Submitter's Name:	Dr. Ralf Egenolf
Phone:	011 49 40 54 70 2 - 370
Fax:	011 49 40 54 70 2 - 468

Device Name:

Proprietary name:	WEINMANNcompact
Common Name:	CPAP Device

Noncontinuous ventilator Classification Name:

Device Classification:

21 CFR 868.5905, Class II, Product Code BZD

Predicate Device Equivalence:

Substantial equivalence is claimed to ResMed S7 Elite CPAP System, cleared for commercial distribution per K013909 and WEINMANNcomfort 2, cleared for commercial distribution (since the original submittal) per K071163.

Device Description:

The system includes the flow generator, patient tubing, external power supply, and an optional heated humidifier WEINMANNclick 2.

A radial compressor draws in ambient air via a filter and conveys it to the unit outlet. From here the air flows through the hose system and the mask to the patient.

The WEINMANNcompact has one mode of operation (CPAP fixed-pressure mode). In this mode the flow generator provides a single fixed-pressure as set by the clinician. A softstart automatic system is installed to help the patient fall asleep more easily.

The optional breath humidifier WEINMANNclick 2 can be snapped onto the therapy unit at the front. The air from the flow generator is directed over a water surface in the humidifier, which functions according to the pass-over principle.

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Image /page/1/Picture/0 description: The image shows the logo for WEINMANN medical technology. The logo is in black and white, with the word "WEINMANN" in large, bold letters. Below the word "WEINMANN" are the words "medical technology" in a smaller font. There are two diagonal lines between the two N's in WEINMANN.

Intended Use:

Comparison of Technological Characteristics

The WEINMANNcompact has the same technological characteristics as the predicate devices.

The new device has the following similarities to the previously cleared predicate devices:

Same intended use .
Same operating principle .
Same technology .
Same manufacturing process .

The new device differs to Resmed S7 Elite CPAP System in having an external power supply. This change, as well as other minor changes, does not affect safety and effectiveness.

Summary of Device Testing:

Design verification testing was performed based on risk analysis and product requirements to ensure that the WEINMANNcompact met its specifications. All tests were verified to meet acceptance criteria. Biocompatibility testing was performed to verify the equivalent safety of the materials of the device.

Conclusion:

Based on the above, we concluded that the WEINMANNcompact is substantially equivalent to the legally marketed predicate devices and is safe and effective for its intended use, and performs as well as or better than the predicate devices.

End of section.

r + +

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a stylized caduceus, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OEC 1 4 2007

Dr. Ralf Egenolf Head of Quality Management and Regulatory Affairs Department Weinmann Gerate fur Medizin GmbH + Company KG Kronsaalsweg 40 Hamburg GERMANY 22525

Re: K072009

Trade/Device Name: WEINMANNcompact Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: November 26, 2007 Received: November 29, 2007

Dear Dr. Egenolf:

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 - Dr. Egenolf

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) 276-0115. 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,

Cintan, U.d.d. ter
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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4. Indications for Use Statement

510(k) Number (if known): K072009

Device Name: __ WEINMANNcompact

Indications For Use:

WEINMANNcompact is for the treatment of Obstructive Sleep Apnea (OSA) in adult patients (>30kg). The device delivers a fixed therapy pressure within the range of 4 to 20 cmH2O. The ( - only). THO done CEINMANNclick 2) is indicated for the humidification and warming of air optional namian (vice to the generator device. The WEINMANNcompact and WEINMANNclick 2 are for home and hospital use.

Prescription Use × (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Min Vuchul

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

510(k) Number: K072009

Page 5 of 47

Regulation Number and Section

§ 868.5905 Noncontinuous ventilator (IPPB).

(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).