The BreatheX Nasal Interface System is an accessory intended for use with devices that deliver Continuous Positive Airway Pressure (CPAP) and bi-level positive airway pressure in treating adult patients.

Device Description

The BreatheX Nasal Interface System has been designed for use as an accessory with commonly marketed CPAP units. The device consists of a plastic manifold with integral exhaust port, nasal mask cushion, a set of nasal pillows, adjustable headgear straps, and an interface tube with a 22mm fitting.

The Nasal Interface System allows a patient to use either the nasal pillows or nasal mask cushion interchangeably. The lightweight construction of the device is designed to maximize patient comfort.

The device is labeled for single patient use.

AI/ML Overview

The Hoffman Laboratories BreatheX™ Nasal Interface System is a CPAP device accessory. The provided document does not detail specific quantitative acceptance criteria or a formal study proving the device met such criteria in the way one might expect for a diagnostic or therapeutic medical device involving clinical outcomes.

Instead, the submission focuses on demonstrating substantial equivalence to already legally marketed predicate devices through non-clinical testing and comparison of technological characteristics.

Here's an breakdown of the information requested, based on the provided text:

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

Acceptance Criteria Category	Specific Criteria (Implicitly based on predicate devices and standards)	Reported Device Performance
Environmental Performance	Compliance with standards for temperature, humidity, shock, vibration, moisture ingress.	"The BreatheX Nasal Interface System passed all of the tests."
Static Performance	Comparable dead space to predicate devices.	"The device met specified requirements and was comparable to the applicable specifications of the predicate devices."
Dynamic Performance	Comparable pressure-flow characteristics to predicate devices.	"The device met specified requirements and was comparable to the applicable specifications of the predicate devices."
Sound Output Level	Comparable sound output level to predicate devices.	"The device met specified requirements and was comparable to the applicable specifications of the predicate devices."
Biocompatibility	Materials comply with biocompatibility requirements for intended use.	"The materials utilized in the device comply with biocompatibility requirements appropriate for the intended use."
Risk & Hazard Analysis	Residual risks acceptable for intended use.	"Risk and Hazard analyses were performed, and the results of the analyses demonstrated that the residual risks were acceptable for the intended use."
Technological Equivalence	Similar technological characteristics as predicate devices (e.g., rigid plastic manifold, soft silicone rubber seal, head straps, integral exhaust port).	"The BreatheX Nasal Interface device utilizes similar technological characteristics as the predicate devices... Like the predicate devices, the manifold... has an integral exhaust port..."

2. Sample sized used for the test set and the data provenance

Sample Size: Not specified quantitatively. The "tests" mentioned are likely engineering and bench tests, not involving human subjects. For example, "dead space" or "pressure-flow characteristics" would be measured on a single or a small number of device units.
Data Provenance: The tests were conducted internally by Hoffman Laboratories, LLC. "Laboratory and standards compliance tests" are mentioned, suggesting controlled lab environments. No country of origin for data is stated beyond the company's location in Chatsworth, CA, USA. The data is retrospective in the sense that it was collected prior to the 510(k) submission.

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

This information is not applicable and not provided. The "ground truth" for this type of device (a CPAP accessory) in a 510(k) submission is typically based on engineering specifications, industry standards, and comparison to predicate devices, rather than expert interpretation of clinical data.

4. Adjudication method for the test set

Not applicable and not provided. As mentioned above, this is not a 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

No MRMC study was conducted. This device is not an AI-powered diagnostic or therapeutic tool that would involve human readers or AI assistance.

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

No standalone algorithm performance study was done. This device does not involve an algorithm.

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

The "ground truth" for the non-clinical tests was based on engineering specifications, industry standards (e.g., for environmental testing), and predefined performance characteristics that were considered acceptable or comparable to the predicate devices. For example, the "specified requirements" for dead space and pressure-flow characteristics served as the ground truth against which the device's performance was measured. Biocompatibility requirements per relevant standards also acted as ground truth.

8. The sample size for the training set

Not applicable. This device is not an AI or machine learning system, so there is no training set.

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

Not applicable, as there is no training set.

Summary

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K061099

AUG 1 1 2006

Summary of Safety and Effectiveness in accordance with 21 CFR 807.92

Company Name: Hoffman Laboratories, LLC 9305 Eton Ave Chatsworth CA 91311

Contact: Keith Bosecker, President

Phone: 818-341 4131

Fax: 818-341 4135

Email: keith_bosecker@hoffmanlaboratories.com

Summary Date: April 14, 2006

Trade Name: Hoffman Laboratories BreatheX™ Nasal Interface System

Common Name: CPAP Device Accessory

Common Classification/Name: Ventilator, non-continuous, non-life supporting

Product Code(s): 21 CFR 868.5905 BZD

Class: Class II

Predicate Devices:

510K Number: K031883 ●
Manufacturer: SensorMedics Corporation (VIASYS) .
Lyra Nasal Interface . Trade Name:
510K Number: K050359 .
Manufacturer: ResMed Limited .
Ultra Mirage II Mask Trade Name: ●

Reason for Submission: New Device

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Description of Device

The Nasal Interface System allows a patient to use either the nasal pillows or nasal mask cushion interchangeably. The lightweight construction of the device is designed to maximize patient comfort.

The device is labeled for single patient use.

Intended Use

The BreatheX Nasal Interface System is intended for use as accessory device to CPAP machines in the treatment of obstructive sleep apnea (OSA).

The BreatheX Nasal Interface System is for use on adult spontaneously breathing (non-ventilator dependant) patients at home or in the sleep clinic.

Indications for Use

Caution: Federal law restricts this device to sale by or on the order of a physician.

Technology

The BreatheX Nasal Interface device utilizes similar technological characteristics as the predicate devices. All devices utilize a rigid plastic manifold with a soft silicone rubber seal to the area around the nose or the nasal passages. All devices are attached to the patient's head using flexible adjustable straps.

Like the predicate devices, the manifold of the BreatheX Nasal Interface System has an integral exhaust port which continuously vents a portion of the CPAP treatment air in order to minimize the rebreathing of expired gases.

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Non-Clinical Tests Submitted:

The device was tested in accordance with applicable standards for medical device environmental temperature and humidity, shock and vibration, and moisture ingress. The BreatheX Nasal Interface System passed all of the tests.

Static and dynamic performance testing was conducted in comparison with the predicate devices for dead space, pressure-flow characteristics and sound output level. The device met specified requirements and was comparable to the applicable specifications of the predicate devices.

The materials utilized in the device comply with biocompatibility requirements appropriate for the intended use.

Risk and Hazard analyses were performed, and the results of the analyses demonstrated that the residual risks were acceptable for the intended use.

Clinical Tests Submitted: None

Conclusions

The function of the BreatheX Nasal Interface System is substantially equivalent to the predicate devices. Laboratory and standards compliance tests are provided to support the safety and performance of the device.

As described above, all of the testing demonstrates that the Hoffman Laboratories BreatheX Nasal Interface System is as safe and effective and performs in a manner equivalent to the predicate nasal interface devices.

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Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined lines representing the branches of government. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the caduceus. The seal is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 1 2006

Mr. Keith Bosecker President Hoffman Laboratories, LLC 9305 Eton Avenue Chatsworth, California 91311

Re: K061099

Trade/Device Name: Hoffman Laboratories BreatheXTM Nasal Interface System Regulation Number: 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: August 3, 2006 Received: August 7, 2006

Dear Mr. Bosecker:

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. Bosecker

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 vour 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/cdrlv/industry/support/index.html.

Sincerely yours,

Smitte Y. Michie Davis

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):

Hoffman Laboratories BreatheX™ Nasal Interface System Device Name:

Indications for use:

Caution: Federal law restricts this device to sale by or on the order of a physician.

Prescription Use __ × (Part 21 CFR 801 Subpart D) AND / OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sua Rump

ion of Anestheaningy General Hospital, Control, Dental Devices

) Number. K061099

Page 1 of _1 _

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).