The Hybrid NE Mask 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 failure, and which are intended to administer positive pressure ventilation. The mask will be offered in a disposable version and a multiuse version. It is intended for use on adult patients (>30 kg), who are appropriate candidates for noninvasive ventilation.

(Applies to the standard version):

For homecare applications, the Hybrid NE Mask may be reused multiple times by a single patient. For institutional applications (i.e. hospital or other clinical settings), this interface may be reused multiple times by multiple patients.

(Applies to the Disposable version): The RespCare Hybrid NE Mask Disposable is a single patient, single use interface.

Device Description

A specialized interface for Non-Invasive Ventilation. It will be modeled after the RespCare Face Mask (K052227), with intentional exhalation features removed for use with ventilators equipped with an active safety valve.

AI/ML Overview

This K062019 submission describes a medical device, the RespCare Hybrid NE Mask, and its substantial equivalence to predicate devices, rather than presenting a study demonstrating its performance against specific acceptance criteria. Therefore, the information typically requested for a performance study (acceptance criteria, sample sizes, expert ground truth, etc.) is not present in this document.

The document is a 510(k) summary for a new medical device submission to the FDA. The purpose of a 510(k) is to demonstrate that the new device is "substantially equivalent" to a legally marketed predicate device. This is done by comparing the new device's intended use, technological characteristics, and safety and effectiveness information to those of the predicate. It does not typically involve a clinical study with detailed performance metrics and acceptance criteria in the way a PMA (Pre-Market Approval) submission might.

Here's an breakdown of why the requested information isn't available based on the provided text, and what is available:

1. A table of acceptance criteria and the reported device performance:

Not Applicable. The document explicitly states, "Materials information and functional testing relative to the intended use of the RespCare Hybrid NE Mask show that it is as safe and effective as the predicate devices." This is a summary statement of the testing performed to demonstrate substantial equivalence, but it does not specify quantitative acceptance criteria or detailed performance results in the format requested. The detailed functional testing data and acceptance criteria would have been included in the full 510(k) submission, but are not part of this publicly available summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not Applicable. No human clinical study or "test set" in the context of an algorithm's performance is described. The "functional testing" mentioned would likely refer to bench testing (e.g., flow resistance, sealing capabilities) rather than patient 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):

Not Applicable. No "ground truth" establishment by experts is mentioned, as there is no diagnostic or interpretive task being performed by the device that would require such validation.

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

Not Applicable. No test set or expert adjudication is described.

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. The device is a face mask for ventilation, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study is irrelevant.

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

Not Applicable. This is a physical medical device (a mask), not an algorithm.

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

Not Applicable. As a face mask, the concept of "ground truth" as it applies to diagnostic devices or algorithms is not relevant. The "ground truth" for a mask would be its physical properties and performance against engineering standards (e.g., seal integrity, pressure drop).

8. The sample size for the training set:

Not Applicable. The device is a physical product and does not involve machine learning or a "training set."

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

Not Applicable. No training set is used.

Summary of what is presented in the provided document:

The provided document, K062019, is a 510(k) summary for the RespCare Hybrid NE Mask. It focuses on demonstrating substantial equivalence to existing predicate devices, rather than presenting a performance study with specific acceptance criteria.

Key information from the document:

Device Name: RespCare Hybrid NE Mask
Intended Use: "The Hybrid NE Mask 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 failure, and which are intended to administer positive pressure ventilation. The mask will be offered in a disposable version and a multiuse version. It is intended for use on adult patients (>30 kg), who are appropriate candidates for noninvasive ventilation."
Predicate Devices:
- K030515 – Hans Rudolph 7500 Vmask
- K023135 - Respironics Image3 SE
Basis for Substantial Equivalence: The document states the device is "essentially similar to the legally marketed predicate interfaces listed above in function, intended use, materials, and features." The essential difference is identified as "the shape of the interface." It further clarifies equivalence in "intended use, environment of use, patient population, and frequency of use," and that its "basic method of operation and design is also equivalent to the predicates."
Evidence of Safety and Effectiveness: "Materials information and functional testing relative to the intended use of the RespCare Hybrid NE Mask show that it is as safe and effective as the predicate devices." (Note: specific details of this testing, including acceptance criteria, are not provided in this summary but would be in the full submission).

This submission is purely for regulatory clearance based on substantial equivalence to existing devices, meaning it relies on the safety and effectiveness established for the predicate devices.

Summary

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K062019

510(k) SUMMARY

Submitter's Name:	RespCare Inc.
Submitter's Address:	6601 Lyons Road, Suites B1-B4Coconut Creek, FI 33073, USA
Telephone Number:	(561) 208-3778
Fax Number:	(954) 727-8479
Contact Person:	Frank Pelc
Date:	July 14, 2006
Proprietary Name:	RespCare Hybrid NE Mask
Common/Usual Name:	Face Mask
Classification:	Class II, CFR 868.5895, CBK
Classification Name:	Accessory to Continuous Ventilator
Predicate Devices:	K030515 – Hans Rudolph 7500 VmaskK023135 - Respironics Image3 SE

Device Description

Comparison to Predicate Devices

The RespCare Hybrid NE Mask is essentially similar to the legally marketed predicate interfaces listed above in function, intended use, materials, and features. The essential difference between the RespCare face mask and the predicate devices is the shape of the interface.

Both the proposed device and the predicates are intended to be used as a patient interface for non-invasive ventilation devices. Each are designed to be suitable for use with ventilators equipped with an active safety valve. Each deliver non-invasive ventilation to the patient's oral and nasal passages and provide a seal against the face as it is held in place with a headgear worn around the head. Each provide accessory ports for pressure monitoring or supplemental oxygen, and connect to the ventilator device via a standard 22 mm fitting.

Substantial Equivalence

The RespCare Hybrid NE Mask is equivalent to the predicate devices in intended use, environment of use, patient population, and frequency of use. Its basic method of operation and design is also equivalent to the predicates, as described in the comparison above. Materials information and functional testing relative to the intended use of the RespCare Hybrid NE Mask show that it is as safe and effective as the predicate devices.

As such, it is RespCare's conclusion that the RespCare Hybrid NE Mask is substantially equivalent to the predicate devices.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is a stylized symbol of three human figures connected by flowing lines, representing the department's mission to protect the health of all Americans.

AUG 1 7 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Frank Pelc Director, Regulatory Affairs and Quality Compliance Innomed Technologies, Incorporated /RespCare, Incorporated 6601 Lyons Road, Suites B1-B4 Coconut Creek, Florida 33073

Re: K062019

Trade/Device Name: Hybrid NE Mask Regulation Number: 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: July 14, 2006 Received: July 17, 2006

Dear Mr. Pelc:

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 8010 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Pelc

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 regencies. 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 monufacturing prectice 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/cdrl/industry/support/index.html.

Sincerely vours.

Chia 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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SECTION 7: INDICATIONS FOR USE

510(k) Number (if known): K062019

Device Name: Hybrid NE Mask

Indications for Use:

(Applies to the standard version):

(Applies to the Disposable version): The RespCare Hybrid NE Mask Disposable is a single patient, single use interface.

Prescription Use X (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)

Cilia Sndliom

: Humber

of Anesthesiology, General Hospital

Page 1 of

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).