Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and intended use clearly define the Provent Nasal Cannula as a passive component for transmitting pressure signals, with no mention of data processing, analysis, or any AI/ML related terms.

Therapeutic

No

The device is indicated for transmitting respiratory airflow signals between a therapy device and pressure transducers during sleep studies, not for providing therapy itself.

Diagnostic

No

Explanation: The device is a nasal cannula, which is an accessory used to transmit respiratory airflow signals to pressure transducers during sleep studies. It does not independently diagnose any condition. Its function is to facilitate the collection of data for diagnostic purposes, but it is not a diagnostic device itself.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components (bifurcated tube, luer lock connector, filter, component to hold tubes) and how it is worn, indicating it is a hardware device.

IVD (In Vitro Diagnostic)

Based on the provided information, the Provent Nasal Cannula is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Provent Nasal Cannula Function: The Provent Nasal Cannula's intended use is to transmit respiratory airflow signals between a medical device (Provent Professional Sleep Apnea Therapy device) and a physiologic recorder. It is a component used during a sleep study to facilitate the measurement of physiological signals (airflow pressure).
No Sample Analysis: The device does not analyze any biological samples from the patient. It is a conduit for physical signals (airflow pressure).

Therefore, the Provent Nasal Cannula falls under the category of a medical device used for monitoring or therapy, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Provent Nasal Cannula is indicated for the transmission of respiratory airflow signals between the Provent Professional Sleep Apnea Therapy device and the pressure transducers used with physiologic recorders during sleep studies.

Product codes

MNR

Device Description

The Provent Nasal Cannula was developed to transmit pressure signals from the Provent Professional Sleep Apnea Therapy device to a pressure transducer of a physiologic recorder during sleep evaluations. The Provent Nasal Cannula is specifically designed to attach the Provent Professional Sleep Apnea Therapy (Provent PSAT, K071560) device to standard pressure transducers.

The Provent Nasal Cannula is essentially identical to standard nasal cannulae except for its custom connection to the Provent PSAT. The Provent Nasal Cannula is comprised of the same design elements as a standard nasal cannula:

a bifurcated tube with a luer lock connector,
an anti-microbial filter at one end, and
a component to hold the tubes in the correct location near the nostrils at the other end.

The Provent nasal cannula is worn in the same way as the standard nasal cannulae, with the proximal ends held in place in the path of nasal airflow and the tubing routed over the ears and under the chin.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Nasal, nostrils

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Bench data were submitted to support the 510(k) Notification. The bench testing demonstrated that the device is safe and effective for its intended use.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K051313, K984431, K971501, K053063

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 868.2375 Breathing frequency monitor.

(a)
Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.(b)
Classification. Class II (performance standards).

Summary

0

Korogrz3

:AUG - 7 2008

510(K) SUMMARY

| 510(k) Applicant: | Ventus Medical, Inc.
1301 Shoreway Rd., Suite 340
Belmont, CA 94002
(650) 632-4199 (phone)
(650) 632-4198 (fax) |

-------------------	-----------------------------------------------------------------------------------------------------------------------------

Cindy Domecus. R.A.C. (US & EU) Contact: Domecus Consulting Services LLC (650) 343-4813

Date Summary Prepared: July 17, 2008

Provent™ Nasal Cannula Name of Device:

Nasal Cannula Common Name:

Classification Name: Breathing Frequency Monitor (21 CFR 868.2375, Product Code MNR)

Predicate Device: Predicate devices included in the 510(k) Notification are as follows: K051313. Salter Labs Bi-NAPS Nasal Airflow and Snore Transducer K984431. Braebon Medical Ultima Airflow Sensor

K971501, Bio-logic Airflow Pressure Transducer K053063, Pro-Flow Multipurpose Cannula

Device Description:

The Provent Nasal Cannula was developed to transmit pressure signals from the Provent Professional Sleep Apnea Therapy device to a pressure transducer of a physiologic recorder during sleep evaluations. The Provent Nasal Cannula is specifically designed to attach the Provent Professional Sleep Apnea Therapy (Provent PSAT, K071560) device to standard pressure transducers.

The Provent Nasal Cannula is essentially identical to standard nasal cannulae except for its custom connection to the Provent PSAT. The Provent Nasal Cannula is comprised of the same design elements as a standard nasal cannula:

1. a bifurcated tube with a luer lock connector,
1. an anti-microbial filter at one end, and
1. a component to hold the tubes in the correct location near the nostrils at the other end.

4-1

1

The Provent nasal cannula is worn in the same way as the standard nasal cannulae, with the proximal ends held in place in the path of nasal airflow and the tubing routed over the ears and under the chin.

Indications for Use:

The Provent Nasal Cannula is indicated for the transmission of respiratory airflow signals between the Provent Professional Sleep Apnea Therapy device and the pressure transducers used with physiologic recorders during sleep studies.

Comparison to Predicate Devices:

The table below shows a comparison the Provent Nasal Cannula to its predicates.

| | Provent
Nasal
Cannula | Salter Labs
BI-NAPS
Nasal Airflow
and Snore
Transducer | Biologic
Airflow
Pressure
Transducer | Braebon
Medical Ultima
Airflow
Sensor | Pro-Flow
Multipurpos
e Cannula |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
for Use | The Provent
Nasal
Cannula is
indicated for
the
transmission
of respiratory
airflow
signals
between the
Provent
Professional
Sleep Apnea
Therapy
device and
the pressure
transducers
used with
physiologic
recorders
during sleep
studies. | The Salter
Labs Airflow
Pressure
Transducer is
a reusable
device
intended for
use during
sleep disorder
studies to
detect
respiratory
airflow and
snoring for
recording onto
a
polysomnogra
phy recorder
via nasal
pressure
changes. | The Bio-logic
Airflow
Pressure
Transducer is
indicated for
use during
sleep disorder
studies to
detect
respiratory
airflow for
recording on a
physiological
recorder. It is a
battery-
powered
device, with a
disposable
nasal cannula
which attaches
to the patient
and plugs into
the input of the
Airflow
Pressure
Transducer
device. | The Ulitma
Airflow
Pressure
Sensor is
intended for
use during
sleep disorder
studies as a
qualitative
measure of
respiratory
airflow ... A
disposable
nasal cannula
with a 0.2-
micron
hydrophobic
filter attaches
to the patient
and connects
to the input of
the Ultima
Airflow
Pressure
Sensor. | Intended for
use for
simultaneous detection
of
respiratory
airflow and
sampling, or
delivery, of
gases, such
as EtCO2 or
oxygen |
| Product
Code | MNR | MNR | MNR | BZQ | CCK |
| Purpose | Carry nasal
airflow
signals | Carry and
process nasal
airflow signals | Carry and
process nasal
airflow signals | Carry and
process nasal
airflow signals | Carry nasal
airflow
signals and
sample or
deliver gas |

2

| | Provent
Nasal
Cannula | Salter Labs
BI-NAPS
Nasal Airflow
and Snore
Transducer | Biologic
Airflow
Pressure
Transducer | Braebon
Medical Ultima
Airflow
Sensor | Pro-Flow
Multipurpos
e Cannula |
|--------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|------------------------------------------------------------------------|------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Interface
with nasal
air flow | Two open
tubing ends
which attach
to the
Provent
Professional
Sleep Apnea
Therapy
device,
which, in turn
enters the
nares | Two open
tubing ends on
nasal prongs
which enter
the nares | Two open
tubing ends on
nasal prongs
which enter the
nares | Two open
tubing ends on
nasal prongs
which enter the
nares | Two open
tubing ends
on nasal
prongs
which enter
the nares |
| Cannula
interface
with
pressure
transducer | Single Luer
fitting | Single Luer
fitting | Single Luer
fitting | Single Luer
fitting | One Luer
fitting for
each
purpose
(one for
airflow
monitoring
and one for
gas
delivery/sam
pling) |
| Method of
pressure
signal
transmissio
n | Hollow
tubing | Hollow tubing | Hollow tubing | Hollow tubing | Hollow
tubing |
| Reuse | Single use,
disposable | Cannula
portion is
single use,
disposable | Cannula
portion is single
use, disposable | Cannula
portion is single
use, disposable | Single use,
disposable |

Table 4-1. Comparison of the Provent Nasal Cannula with predicate devices

Performance Data:

Bench data were submitted to support the 510(k) Notification. The bench testing demonstrated that the device is safe and effective for its intended use.

3

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ventus Medical, Incorporated C/O Ms. Cindy Domecus Principal Domecus Consulting Services LLC 1301 Shoreway Road, Suite 340 Belmont, California 94002

AUG - 7 2008

Re: K080983

Trade/Device Name: Provent™ Nasal Cannula Regulation Number: 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: II Product Code: MNR Dated: July 17, 2008 Received: July 21, 2008

Dear Ms. Domecus:

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 vour 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.

4

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 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,

Clare

Chiu S. Lin, Ph. D Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

5

INDICATIONS FOR USE

510(k) Number (if known):

Device Name: Provent™ Nasal Cannula

Indications for Use:

The Provent Nasal Cannula is indicated for the transmission of respiratory airflow signals between the Provent™ Professional Sleep Apnea Therapy device and the pressure transducers used with physiologic recorders during sleep studies.

Prescription Use × 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)

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

510(k) Number: K080983

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