(80 days)
Not Found
No
The description focuses on a microprocessor-controlled blower system and does not mention AI, ML, or related concepts.
Yes
The device is indicated for the "treatment of obstructive sleep apnea (OSA)", which is a medical condition. Therefore, it is a therapeutic device.
No
The device is indicated for the treatment of obstructive sleep apnea (OSA) by providing continuous positive airway pressure (CPAP), which is a therapeutic function, not a diagnostic one.
No
The device description explicitly states the system comprises a Flow Generator, patient tubing, mask, and humidifier, which are all hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of obstructive sleep apnea (OSA) by providing continuous positive airway pressure. This is a therapeutic intervention, not a diagnostic test performed on samples from the human body.
- Device Description: The device description focuses on generating and delivering air pressure to the patient's airway. It does not mention analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
- Lack of IVD Characteristics: The description lacks any mention of typical IVD components or processes, such as reagents, sample handling, analytical methods for biological markers, or diagnostic results.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The PRESTIGE CPAP system does not fit this definition.
N/A
Intended Use / Indications for Use
The PRESTIGE CPAP system is indicated for the treatment of obstructive sleep apnea (OSA) in patients weighing more than 66 lb (>30 kg). It is intended for use at home.
Product codes
73 BZD
Device Description
The PRESTIGE CPAP System is similar to the predicate devices, (S8 Prime and S7 Elite CPAP System with H2i) with a new and improved micro-processor controlled blower system that generates Continuous Positive Airway Pressure (CPAP) from 4-20 cmHo as required to maintain an "air splint" for effective treatment of OSA. The system comprises the Flow Generator, patient tubing, mask (patient interface) and humidifier.
The performance and functional characteristics of the PRESTIGE CPAP system includes all the clinician and user friendly features of the predicate devices, S8 Prime and S7 Elite CPAP System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
patients weighing more than 66 lb (>30 kg)
Intended User / Care Setting
It is intended for use at home.
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)
Design and Verification activities were performed on the PRESTIGE CPAP System as a result of the risk analysis and product requirements. All tests confirmed the product met the acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
RESMED
PRESTIGE Traditional 510(k) Premarket Notification
| Date Prepared | 10th April, 2006 | JUL 20 2006 |
|---|---|---|
| Official Contact | Dr Lionel King | |
| V.P., Quality Assurance & Regulatory Affairs | ||
| ResMed Ltd | ||
| 97 Waterloo Road | ||
| North Ryde, NSW 2113 | ||
| Australia | ||
| Tel: +61 (2) 9886 5000 | ||
| Fax: +61 (2) 9878 5517 | ||
| Classification Reference | 21 CFR 868.5905 | |
| Product Code | 73 BZD | |
| Common/Usual Name | Non continuous ventilator (IPPB). | |
| Proprietary Name | PRESTIGE CPAP System | |
| Predicate Device(s) | S8 Prime (K013909) | |
| S7 Elite (K033841) | ||
| Reason for submission | New Device |
510(k) Summary - PRESTIGE CPAP System
Intended for Use
The PRESTIGE CPAP system is indicated for the treatment of obstructive sleep apnea (OSA) in patients weighing more than 66 lb (>30 kg). It is intended for use at home.
.
1
Substantial Equivalence
The new device has the following similarities to the previously cleared predicate devices.
- ﺮ ﺍ Similar intended use
- Same operating principle ﺮ ﺍ
- Similar technologies ﺮ ﺍ
- -Same manufacturing process
Design and Verification activities were performed on the PRESTIGE CPAP System as a result of the risk analysis and product requirements. All tests confirmed the product met the acceptance criteria. ResMed has determined that the new device has not altered the safety and effectiveness of CPAP treatment of patients with Obstructive Sleep Apnoea (OSA) who weighing more than 66 lb (>30 kg). The new device complies with the applicable standards and requirements referenced in the FDA guidance documents:
- FDA Draft Reviewer Guidance for Ventilators (July 1995) r
- FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical r Devices (May 11, 2005)
- FDA Off-the-Shelf Software Use in Medical Devices (September 9,1999) ﺣ
Intended Use
The PRESTIGE CPAP system is indicated for the treatment of obstructive sleep apnea (OSA) in patients weighing more than 66 lb (>30 kg). It is intended for use at home.
Device Description
The PRESTIGE CPAP System is similar to the predicate devices, (S8 Prime and S7 Elite CPAP System with H2i) with a new and improved micro-processor controlled blower system that generates Continuous Positive Airway Pressure (CPAP) from 4-20 cmHo as required to maintain an "air splint" for effective treatment of OSA. The system comprises the Flow Generator, patient tubing, mask (patient interface) and humidifier.
The performance and functional characteristics of the PRESTIGE CPAP system includes all the clinician and user friendly features of the predicate devices, S8 Prime and S7 Elite CPAP System.
Conclusion
The PRESTIGE CPAP System is substantially equivalent to the Predicate devices.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. In the center of the seal is an emblem that resembles a stylized caduceus, a symbol often associated with medicine and healthcare. The emblem consists of a staff with a serpent entwined around it, representing healing and medicine.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 20 2006
ResMed Limited C/O Mr. David D'Cruz V.P. Clinical & Regulatory Affairs Resmed Corporation 14040 Danielson Street Poway, California 92064-6857
Re: K061200
Trade/Device Name: Prestige CPAP System Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: April 10, 2006 Received: May 1, 2006
Dear Mr. D'Cruz:
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 Eederal Register.
3
Page 2 - Mr. D'Cruz
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 vour 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 (240) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.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
4
RESMED
Indication for Use
510(k) Number (if known):
PRESTIGE CPAP System Device Name:
Indication for Use
The PRESTIGE CPAP system is indicated for the treatment of obstructive sleep apnea (OSA) in patients weighing more than 66 lb (>30 kg). It is intended for use at home.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ X Over-The-Counter Use_
(Part 21 CFR 807 Subpart C)
(Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH; Office of Device Evaluation (ODE)
Page 1 of___1
10tt April, 2006
Auy Shalom
Page 13
.....on Sign-ir)
on of Anesthesiology, General Hospital,
Cuon Control, Dental Devices
Number. K0612