(84 days)
Not Found
Not Found
No
The provided 510(k) summary does not contain any mention of AI, ML, or related concepts, nor does it describe functionalities typically associated with these technologies (like image processing or complex data analysis beyond basic follow-up).
Yes.
The device is used in conjunction with CPAP systems for the follow-up of obstructive sleep apnea patients, which directly relates to the treatment and management of a medical condition.
No
The device is used for "follow up" of patients, which implies monitoring or management of an already diagnosed condition, rather than identifying or characterizing a disease.
Unknown
The provided 510(k) summary is incomplete and lacks a device description, making it impossible to determine if the device is software-only or includes hardware components.
Based on the provided information, it is highly unlikely that the DeVilbiss SmartLink System is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the system is for the "follow up of obstructive sleep apnea patients weighing above 30 kg on nasal CPAP therapy." This describes a system used for monitoring and managing a patient's therapy, not for performing tests on samples taken from the body (which is the core definition of an IVD).
- Lack of IVD Characteristics: The provided information does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing diagnostic information based on laboratory tests
In summary, the DeVilbiss SmartLink System appears to be a system for monitoring and managing CPAP therapy, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The DeVilbiss SmartLink System can only be used in conjunction with the DV51 and DV54 Series CPAP Systems for follow up of obstructive sleep apnea patients weighing above 30 kg on nasal CPAP therapy.
Product codes
BZD
Device Description
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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
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Indicated Patient Age Range
Not Found
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
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
OCT 2 8 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Joseph E. Olsavsky Vice President-Global Quality & Regulatory Affairs DeVilbiss Healthcarc 100 DeVilbiss Drive Somerset, Pennsylvania 15501
Re: K082209
Trade/Device Name: DeVilbiss DV5M Smartlink System Regulation Number: 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: October 9, 2008 Received: October 10, 2008
Dear Mr. Olsavsky:
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.
1
Page 2 - Mr. Olsavsky
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,
Thannelis-Led-and-forein
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
2
Indications for Use
510(k) Number: (if known): K082209
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use: The DeVilbiss SmartLink System can only be used in conjunction with the DV51 and DV54 Series CPAP Systems for follow up of obstructive sleep apnea patients weighing above 30 kg on nasal CPAP therapy.
Prescription Use ਮ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
L. Hilliard
(Division) Sign-Off) Division of Anesthesiology. General Hospital Infection Control, Dental Devices
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510(k) Number: Ko 82209