(73 days)
Not Found
Not Found
No
The summary describes a physical medical device (a nasal cannula) and contains no mention of AI, ML, or any software-based analytical capabilities.
No
The device is an accessory to positive pressure ventilation devices, not a therapeutic device itself.
No
The text indicates that the device is an "accessory to positive pressure ventilation devices for patients suffering from Obstructive Sleep Apnea requiring positive airway pressure therapy". This describes a therapeutic device, not a diagnostic one. It assists in treatment, it does not diagnose a condition.
No
The device description clearly identifies the device as a "Ventlab Nasal CPAP Cannula," which is a physical accessory to a ventilation device, not a software-only product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as an accessory to positive pressure ventilation devices for treating Obstructive Sleep Apnea. This is a therapeutic application, not a diagnostic one.
- Device Description: The description simply names the device as a "Nasal CPAP Cannula," which is consistent with a respiratory therapy device.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in the body
- Providing information for diagnosis, monitoring, or screening
IVDs are used to perform tests on samples taken from the human body to provide information about a person's health. This device is used to deliver positive airway pressure directly to the patient.
N/A
Intended Use / Indications for Use
The Ventlab Nasal CPAP Cannula is an accessory to positive pressure ventilation devices for patients suffering from Obstructive Sleep Apnea requiring positive airway pressure therapy (i.e., CPAP, BiLevel).
Product codes
BZD
Device Description
Ventlab Nasal CPAP Cannula
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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).
0
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "HUMAN SERVICES - USA" are written in a circular fashion above the symbol. The word "DEPARTMENT" is written in a circular fashion below the symbol.
JUN 0 3 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Robert M. Kelly Director Regulatory Affairs Quality Assurance Ventlab Corporation 2934 Highway 601 North Mocksville, North Carolina 27028
Re: K040726
Trade/Device Name: Ventlab Nasal CPAP Cannula Regulation Number: 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: March 18, 2004 Received: March 25, 2004
Dear Mr. Kelly:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your becares were is substantially equivalent (for the reletenced above and nave actemmed are to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Interstate conmiseree pror to thay been reclassified in accordance with the provisions of Amendinents, on to devrees mat narvic Act (Act) that do not require approval of a premarket the rederal Pood, Drug, that Cosments , therefore, market the device, subject to the general approval appreation (1 MIT). " The general controls provisions of the Act include controls provisions of the First - Insting 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 (FMA), it may of subject to sach additions, Title 21, Parts 800 to 898. In the Close of your device can be found in the Could of Postering your device in the Federal Register.
1
Page 2 - Mr. Kelly
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA s issualice of a subscriptions with other requirements
mean that FDA has made a determination that your device with other Federal agencies mean that FDA has made a decemmanon that your and regulations and more of the Act of the Act or registrative of the Act or any rederal statutes and regirations, including, but not limited to: registration
You must comply with all the Act stars and a cold meanufacturing practice You must comply with an the Act 3 requirements increat 801); good manufacturing practice
and listing (21 CFR Part 807); labeling (21 CFR Part 801); and i and listing (21 CFR Part 807), labelling (21 CFR Part 803), 3561 Part 820); and if requirements as set forth in the quality systems (QS) regulars (Sections 531-542 of the Act);
applicable, the electronic product radiation control provisions (Sections 531-54 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k)
The Children and Charles of Charles of volusions of your device to a I his letter will anow you to begin manced.ing your device of your device to a premarket notification. The PDA Inding of otobalized of rour 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), If you desire specific advice for your device of the same . Also, please note the regulation please contact the Office of Comphance are (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act its tall f may obtail other general miormation on your resp.
Division of Small Manufacturers, International and Consumer Assistance at its toll-free Division of Binasa 2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
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
2
Indications for Use:
unknown 510k Number :
Applicant: Ventlab Corporation
Device Name: Ventlab Nasal CPAP Cannula
The Ventlab Nasal CPAP Cannula is an accessory to positive pressure The Ventiab Nasal CPAP Califical is an aboooory to people Sleep Apnea requiring
ventilation devices for patients suffering from Obstructive Sleep Apnea requiring
Posts for p ventifation device to: paint therapy (i.e., CPAP, BiLevel).
Federal (USA) law restricts this device to sale by or on the order of a physician.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _____________________________________________________________________________________________________________________________________________________________
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
Cuy Sylvorn
(Division Sign-Off Division of Anesthesiology, General Hospital, Infection Control, Denta 510(k) Number