(278 days)
Not Found
Not Found
No
The description focuses on standard CPAP/BPAP modes and a minimum breathing rate function, with no mention of AI or ML algorithms for pressure adjustment, patient monitoring, or other functions.
Yes.
The device is intended for the treatment of Obstructive Sleep Apnea (OSA) and applies positive airway pressure, which directly indicates a therapeutic function.
No
The device is described as being "intended for the treatment of Obstructive Sleep Apnea (OSA)", indicating a therapeutic rather than diagnostic purpose. Its modes of operation (CPAP, BPAP, and minimum breathing rate) are all for delivering therapy, not for diagnosing conditions.
No
The device description, while not explicitly provided, strongly implies a hardware component (CPAP/BPAP machine) that delivers positive airway pressure. The software likely controls this hardware.
Based on the provided information, the Silenzio Delta is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the treatment of Obstructive Sleep Apnea (OSA) by applying positive airway pressure. This is a therapeutic intervention, not a diagnostic test performed on in vitro samples.
- Device Description: While the description is "Not Found," the intended use clearly describes a device that delivers air pressure to a patient's airway.
- No mention of in vitro samples: There is no indication that the device analyzes blood, urine, tissue, or any other biological sample outside of the body.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. The Silenzio Delta's function is to treat a condition by physically supporting the airway.
N/A
Intended Use / Indications for Use
The Silenzio Delta is intended for the treatment of Obstructive Sleep Apnea (OSA) in adult patients 30 kg and over.
Silenzio Delta has three modes of operation. In CPAP mode,treatment is carried out by applying a continuous positive airway pressure through a nasal mask. In the BPAP mode, the pressure during expiration is lower than during inspiration, as prescribed by the physician. In a third mode, a minimum breathing rate can be set between 0 to 25 BrPM. The operation is identical as in BPAP mode, but if the patient fails to make an inspiratory effort within the interval set by the minimum BrPM control, the device will cycle to the pressure support level to deliver the breath to the patient based on the minimum BrPM setting.
The Silenzio Delta can be used to administer oxygen by using external oxygen tank and bleeding oxygen into the patient circuit. This therapy is not metered or otherwise regulated. Patient monitoring must be performed to ensure effective administration of oxygen therapy.
Product codes
73 BZD
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
airway
Indicated Patient Age Range
adult patients
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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.
Not Found
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)
Not Found
§ 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/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. The bottom half of the circle contains a stylized image of a caduceus, a symbol often associated with medicine and healthcare. The caduceus consists of a staff with two snakes coiled around it, topped by a pair of wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 17 1998
Mr. Gregg Gaskins Nidek Medical Products, Inc. 3949 Valley East Industrial Drive Birmingham, AL 35217
Re: K980551 Silenzio Delta Continuous Positive Airway Pressure System Regulatory Class: II (two) Product Code: 73 BZD Dated: August 14, 1998 Received: August 19, 1998
Dear Mr. Gaskins:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
1
Page 2 - Mr. Gregg Gaskins
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 yours,
Thomas J. Callahan, Ph.D.
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
K980551 510(k) Number:
Silenzio Delta Continuous Positive Airway Pressure System. Device Name:
Indications For Use:
The Silenzio Delta is intended for the treatment of Obstructive Sleep Apnea (OSA) in adult patients 30 kg and over.
Silenzio Delta has three modes of operation. In CPAP mode,treatment is carried out by applying a continuous positive airway pressure through a nasal mask. In the BPAP mode, the pressure during expiration is lower than during inspiration, as prescribed by the physician. In a third mode, a minimum breathing rate can be set between 0 to 25 BrPM. The operation is identical as in BPAP mode, but if the patient fails to make an inspiratory effort within the interval set by the minimum BrPM control, the device will cycle to the pressure support level to deliver the breath to the patient based on the minimum BrPM setting.
The Silenzio Delta can be used to administer oxygen by using external oxygen tank and bleeding oxygen into the patient circuit. This therapy is not metered or otherwise regulated. Patient monitoring must be performed to ensure effective administration of oxygen therapy.
Mark Kramer
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number_K980551
/ Prescription Use