The Breas PV10i CPAP System is intended to deliver Continuous Positive Airway Pressure (CPAP) therapy for the treatment of adult Obstructive Sleep Apnea (OSA).

Device Description

In the treatment of sleep disorders, CPAP is well established and common practice as a means to prevent upper airways from collapsing and therefore avoid breathing problems associated with airway collapse and obstruction. There are a number of devices legally marketed in the United States for this application, including self-adjusting CPAP systems such as the predicate ResMed Sullivan Autoset T. The self-adjusting systems accommodate pressure requirements that may vary (e.g., as patients change bodies positions or enter different sleep stages).

The Breas PV10i CPAP is similar to the predicate Breas PV100 CPAP System, but with the addition of self-adjusting pressure features. Both Breas devices are microprocessor controlled based on firmware (embedded software). Both designs incorporate pressure sensors that monitor output pressure and provide feedback to the microprocessors. The PV10i also incorporates an airflow sensor and flow signal processing means in firmware to provide self-adjusting capability.

The therapy delivered by the Breas PV10i CPAP System can be either:

1. Self-adjusting in response to variations in patient breathing patterns (CPAP "i" mode), or
1. Set to a constant pressure level (constant CPAP mode).

The primary hardware component is a blower that generates airflow. The blower assembly consists of a brushless DC motor that drives a fan, entraining ambient air through a filter and pressurizing it to provide the prescribed airflow with CPAP for the patient. The microprocessor controls the motor and hence the speed of the fan.

The PV10i pressure range is 4 - 20 cmH20. Starting pressure and self-adjusting pressure limits are settable by clinical personnel in accordance with the patient's prescription.

The CPAP airflow is delivered via a single lumen outlet tube that may be connected to various non-invasive patient interfaces, such as nasal masks. To minimize CO2 rebreathing, masks or other interfaces permitting a leak flow of at least 12 liters/minute at the minimum output pressure setting of 4 cm of H20 are recommended for use with the PV10i.

The pressure transducer incorporated in the PV10i continuously monitors output pressure to the patient and reference ambient pressure. This enables the device to automatically compensate for altitude changes.

The PV10i has an auto-switching power supply that facilitates use in conjunction with international travel (100 - 240 VAC). It can also be used with an external 12 - 24 VDC power source when AC mains line voltage is not available. This DC power source capability is not intended as a battery power back-up system for any critical treatment applications. An accessory Remote Control Module may be connected that enables clinicians to operate the PV10i without using the control and setting panels on the device itself. A PC-based software program may also be supplied that provides an optional means for clinicians to set patient parameters (e.g., start and limit pressures) and track patient compliance.

The PV10i and its accessories are not sterile. The outer dimensions of the PV10i housing are 6.3 × 4.5 × 9.3 inches, and the device weighs 3.7 pounds.

AI/ML Overview

The Breas PV10i CPAP System is intended to deliver Continuous Positive Airway Pressure (CPAP) therapy for the treatment of adult Obstructive Sleep Apnea (OSA). The studies performed aimed to demonstrate the device's efficacy and safety, particularly for its self-adjusting pressure features, and its substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes several types of testing rather than explicit, quantified acceptance criteria in a pass/fail table for each feature. However, the overarching acceptance criterion is that the device meets its stated performance specifications and demonstrates substantial equivalence to predicate devices. The reported performance indicates this criterion was met.

Acceptance Criterion (Implied)	Reported Device Performance
Non-Clinical Testing	The device passed all non-clinical tests to verify stated performance specifications and addressed all Risk Analysis issues.
Compliance with FDA Guidance	The device passed all tests for compliance with "Reviewer Guidance for Premarket Notification Submissions" (Nov 1993 draft), including Electrical Safety (IEC 601), Electromagnetic Compatibility (EMC), Mechanical Safety, Environmental, and Functional testing.
Software Validation	All device software (embedded and optional PC software) passed all tests in accordance with FDA's "Guidance for the content of Premarket Submissions for Software Contained in Medical Devices" (May 29, 1998).
Clinical Efficacy (AHI Reduction)	Three-way crossover study: No significant differences in sleep or ventilatory variables between PV10i, predicate ResMed AutoSet®T, and constant CPAP. Mean AHI for PV10i was 6.8 (compared to 4.0 for Autoset T and 1.8 for constant CPAP). Randomized treatment study: PV10i patient group showed mean AHI reduction from 55.6 initially to 6.3 after titration and 7.5 after 6 months. Comparable values for predicate AutoSet T were 56.5 -> 5.5 -> 3.6, and for predicate Goodnight 418P were 48.5 -> 4.3 -> 3.4. All self-adjusting CPAP devices were judged efficient.
Clinical Efficacy (Pressure Applied)	Three-way crossover study: PV10i applied lower mean pressure (6.7) compared to AutoSet®T (8.4) (p<0.05). Both self-titrating devices applied significantly lower mean pressure than constant CPAP (9.4) (p<0.01).
Clinical Efficacy (Patient Preference)	Three-way crossover study: Patients preferred self-adjusting CPAP pressure over constant pressure CPAP (10 vs. 1, p<0.01). Note: One patient could not be treated effectively with self-adjusting devices.
Clinical Efficacy (Epworth Sleepiness Scores & Compliance)	Randomized treatment study: Conclusions were based on these metrics, in addition to AHI. The self-adjusting CPAP devices, including PV10i, were judged efficient for home treatment. (Specific scores not detailed for PV10i, but implied to be acceptable for "efficient" judgment).
Substantial Equivalence	The device was determined to be substantially equivalent to predicate devices (Breas PV100 CPAP System K001553, ResMed Sullivan Autoset® T K970516, K970771, and K984428) based on comparable intended uses, environments of use, design, technology, and materials, with minimal differences noted. The FDA concurred with the substantial equivalence finding (K030985).

2. Sample Sizes Used for the Test Set and the Data Provenance:

Clinical Study 1 (Three-way randomized crossover study):
- Sample Size: 12 patients with symptomatic obstructive sleep apnea, of whom 11 completed all treatments.
- Data Provenance: Not explicitly stated, but clinical studies are generally considered prospective. Given the context of a 510(k) summary, it's highly likely to be prospective data collected specifically for this submission. The country of origin is not specified.
Clinical Study 2 (Randomized treatment study):
- Sample Size: Initially 100 patients with apnea-hypopnea syndrome.
- Data Provenance: Not explicitly stated, but likely prospective for the reasons above. The study included a titration night and a period of home use with follow-up after three and six months. The country of origin is not specified.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

The document does not explicitly state the number or qualifications of experts used to establish "ground truth" in the way one might for diagnostic imaging studies.

In the clinical studies, ground truth for efficacy (e.g., AHI, sleep parameters) would have been established through nocturnal polysomnography (PSG), which is the gold standard for diagnosing and assessing sleep disorders. Polysomnography results are typically interpreted by sleep physicians or sleep specialists.
The "human readers" in this context are the clinicians who would interpret the PSG data. While not explicitly mentioned, it's presumed these studies were conducted by qualified medical professionals in sleep medicine.

4. Adjudication Method for the Test Set:

Not applicable in the direct sense of adjudicating conflicting expert opinions on a specific case, as these were clinical trials assessing objective physiological parameters (like AHI) and patient outcomes. The "adjudication" would be based on statistical analysis of the measured parameters from polysomnography.

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, an MRMC study was not done. The studies were designed to compare the efficacy of the device (Breas PV10i) itself against predicate devices and conventional CPAP, rather than evaluating how human interpretation or diagnosis would improve with AI assistance.
The device being evaluated is a CPAP system, not an AI diagnostic/interpretive tool for human readers.

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

This question is less directly applicable to a CPAP device which is an active treatment rather than a diagnostic algorithm. However, the device itself operates in a "standalone" fashion in its "self-adjusting" mode, where its internal algorithm adjusts pressure based on detected patient breathing patterns.
The clinical studies evaluate the performance of this "algorithm only" (self-adjusting) mode in comparison to constant CPAP and other self-adjusting devices. For instance, the mean AHI values reported (PV10i: 6.8, AutoSet T: 4.0, constant CPAP: 1.8 in the first study, and PV10i: 7.5 after 6 months in the second study) represent the "standalone" clinical effectiveness of each device's therapy delivery (including its internal algorithms).

7. The Type of Ground Truth Used:

The primary ground truth used for evaluating efficacy was objective physiological data from nocturnal polysomnography (PSG). This includes measurements of apnea-hypopnea index (AHI), sleep parameters, and ventilatory variables.
Additional ground truth included patient-reported outcomes such as quality of life assessment, subjective preference (comfort), Epworth Sleepiness Scores, and patient compliance.

8. The Sample Size for the Training Set:

The document refers to "software algorithm validation" and mentions "firmware (embedded software)" and "airflow sensor and flow signal processing means in firmware to provide self-adjusting capability." However, it does not specify a distinct "training set" sample size for the development of these algorithms.

Typically, algorithms are developed and refined using varied data, but this summary focuses on the final validation studies. The clinical studies (12 patients and 100 patients) are presented as validation/test sets, not explicitly as training sets.
It's possible that internal testing and development involved retrospective patient data, but this information is not provided in the 510(k) summary.

9. How the Ground Truth for the Training Set was Established:

As no explicit "training set" is described for algorithm development in this document, the method for establishing its ground truth is not provided. If a training set were used, its ground truth would likely have been established similarly to the test sets, using polysomnography and other clinical assessments by qualified medical personnel.

Summary

{0}------------------------------------------------

Image /page/0/Picture/3 description: The image shows a close-up, angled view of a handwritten or printed text string. The text appears to be a combination of letters and numbers, with the sequence "K03098" clearly visible. The characters are bold and dark, contrasting with the lighter background. The angle and close proximity suggest the image is focused on highlighting this specific code or identifier.

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

Submitter:	OCT 1 5 2003Vital Signs, Inc.20 Campus RoadTotowa, NJ 07512-1200
Contact Person:	Anthony P. MartinoV. P. Quality Assurance & Regulatory AffairsPhone: (973) 790-1330, ext. 356Fax: (973) 790-4150
Summary Date:	July 16, 2003
Name of Device:	Breas PV10i CPAP System
Common Names:	CPAP SystemSelf-adjusting CPAP SystemAuto-adjusting CPAP System
Classification Name:	Non-continuous ventilator (21 CFR 868.5905)
Product Code:	73 BZD

Predicate Devices:

Breas PV100 CPAP System (K001553)

ResMed Sullivan Autoset® T (K970516, K970771, and K984428)

{1}------------------------------------------------

Device Description:

The therapy delivered by the Breas PV10i CPAP System can be either:

1. Self-adjusting in response to variations in patient breathing patterns (CPAP "i" mode), or
1. Set to a constant pressure level (constant CPAP mode).

The PV10i pressure range is 4 - 20 cmH20. Starting pressure and self-adjusting pressure limits are settable by clinical personnel in accordance with the patient's prescription.

{2}------------------------------------------------

capability is not intended as a battery power back-up system for any critical treatment applications. An accessory Remote Control Module may be connected that enables clinicians to operate the PV10i without using the control and setting panels on the device itself. A PC-based software program may also be supplied that provides an optional means for clinicians to set patient parameters (e.g., start and limit pressures) and track patient compliance.

The PV10i and its accessories are not sterile. The outer dimensions of the PV10i housing are 6.3 × 4.5 × 9.3 inches, and the device weighs 3.7 pounds.

Intended Use:

The Breas PV10i CPAP System is intended to deliver Continuous Positive Airway Pressure (CPAP) therapy for the treatment of adult Obstructive Sleep Apnea (OSA).

Comparison of Use and Technological Characteristics:

The PV10i may be used in clinical settings (e.g., hospitals, sleep laboratories, sub-acute care institutions) and home environments and must be prescribed by a physician. It is not intended for life support or life sustaining applications or for transport of critical care patients.

As compared with the cited predicate devices, the Breas PV10i CPAP System has:

Same intended uses
Same environments of use

Similar design (microprocessor-controlled blower as air source)

Same technology (software based flow signal processing means to provide self-adjusting pressure capability)

Same materials (with particular reference to the air flow pathway)

The differences that do exist are minimal and involve primarily user preference features. These features are described in labeling for the device that includes an Operator Manual.

Summary of Performance Testing:

1. Non-clinical testing was conducted to verify that the Breas PV10i CPAP System is capable of meeting its stated performance specifications and that all Risk Analysis issues have been appropriately addressed. The device passed all tests.

{3}------------------------------------------------

1. Testing was conducted to demonstrate compliance with applicable requirements in the November 1993 draft "Reviewer Guidance for Premarket Notification Submissions" published by the FDA's Division of Cardiovascular, Respiratory, and Neurological Devices. The testing included but was not limited to:
- Electrical Safety testing per IEC 601 ●
- Electromagnetic Compatibility testing (EMC testing) .
- Mechanical Safety testing .
- Environmental testing ●
- Functional testing ●

The PV10i device passed all tests.

1. All device software (the embedded software and the optional PC software) was documented and tested in accordance with the FDA's May 29, 1998 "Guidance for the content of Premarket Submissions for Software Contained in Medical Devices". The PV10i software passed all tests.
1. Two clinical studies were performed as part of the process of validating the software algorithm for the PV10i CPAP System's self-adjusting pressure features. They involved direct comparisons with predicate devices.
- In a three-way randomized crossover study involving 12 patients (of whom 11 A) completed all treatments) with symptomatic obstructive sleep apnea, the PV10i in self-adjusting mode was compared with the predicate ResMed AutoSet®T (K980721) and with conventional constant CPAP. Efficacy evaluation was based on analysis of sleep disordered breathing and sleep parameters assessed by nocturnal polysomnography. Further study outcomes were quality of life assessment and subjective preference of each device with respect to comfort.

No significant differences were noted in sleep or ventilatory variables between the devices (mean apnea-hypopnea index (AHI) 6.8, 4.0 and 1.8 with PV10i, Autoset T and constant CPAP respectively). The PV10i applied lower mean pressure (6.7) as compared with the Autoset T (8.4) (p<0.05), and both selftitrating devices applied significantly lower mean pressure as compared with constant CPAP (9.4) (p<0.01). One patient could not be treated effectively with either self-adjusting pressure device due to increased arousability from This patient was effectively treated with manually titrated CPAP. sleep. Patients preferred self-adjusting CPAP pressure over constant pressure CPAP treatment (10 vs. 1, p<0.01).

In a randomized treatment study evaluation involving initially 100 patients B) with apnea-hypopnea syndrome, four self-adjusting CPAP devices from

{4}------------------------------------------------

different manufacturers and conventional constant CPAP were compared. The study included comparison of results for a titration night and for a period of home use, with follow-up after three and six months. The self-adjusting CPAP devices included in this study were the Breas PV10i, the ResMed AutoSet®T (K980721), the Mallinckrodt GoodKnight® 418P (K993584), and the Weinmann SomnoSmart®.

Conclusions were based on apnea-hypopnea indices (AHI), Epworth sleepiness scores, and patient compliance. The PV10i patient group had a mean AHI of 55.6 initially, of 6.3 after titration and of 7.5 after 6 months. The comparable values were 56.5, 5.5 and 3.6 respectively for the predicate AutoSet T device and 48.5, 4.3 and 3.4 for the predicate Goodnight 418P. All four of the selfadjusting CPAP devices included in the study were judged to be efficient (efficacious) for home treatment.

Conclusions:

The Breas PV 10i CPAP System meets its stated performance specifications and criteria outlined in the Reviewer Guidance publications referenced above. Non-clinical test results and clinical studies demonstrate performance substantially equivalent to predicate devices. We conclude that the device is capable of operating safely in its intended environments and will be effective in fulfilling its intended use.

{5}------------------------------------------------

Image /page/5/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three swooping lines representing its body and wings. The eagle's head is facing left. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 5 2003

Mr. Anthony P. Martino Vice President of Quality Assurance & Regulatory Affairs Vital Signs, Incorporated 20 Campus Road Totowa, New Jersey 07512-1200

Re: K030985

Trade/Device Name: Breas PV10i CPAP System Regulation Number: 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: July 23, 2003 Received: July 24, 2003

Dear Mr. Martino:

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.

{6}------------------------------------------------

Page 2 - Mr. Martino

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 (301) 594-4646. 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/dsma/dsmamain.html

Sincerely vours.

Ques

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

{7}------------------------------------------------

510(k) Number:

K030982

Device Name:

Breas PV 10i CPAP System -

Indications for Use:

The Breas PV 10i CPAP System is intended to deliver Continuous Positive Airway Pressure (CPAP) therapy for the treatment of adult Obstructive Sleep Apnea (OSA).

signature

(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital, Division of Ancolnoontal Devices KO 309 B

510(k) Number:_

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

X Prescription Use (Per 21 CFR 801.109)

Over-the-Counter Use

(Optional Format 1-2-96)

Page 6

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).