(75 days)
No
The summary describes a physical patient interface (nasal pillows and headgear) with features focused on fit, seal, and comfort. There is no mention of software, algorithms, data processing, or any terms related to AI/ML.
No.
Explanation: This device is a patient interface accessory for CPAP and bi-level systems, which are therapeutic devices. However, the device itself, a nasal pillow mask, is not directly therapeutic but rather a component used with a therapeutic system for treatment.
No
The device is described as a patient interface accessory (nasal pillow) for CPAP and bi-level systems used in treatment, not for diagnosis. Its features focus on comfort, seal, and position during use, and performance studies evaluate flow, leak, pressure, and dead space, all related to treatment delivery rather than diagnostictest data analysis.
No
The device description clearly outlines physical components like nasal pillows and headgear, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "A patient interface accessory for use with CPAP and bi-level systems used in the treatment of adult OSA and / or ventilatory support." This describes a device used on a patient for therapeutic purposes, not a device used to examine specimens from a patient to provide diagnostic information.
- Device Description: The description focuses on the physical components and features of a nasal pillow mask designed for comfort and fit during respiratory therapy. There is no mention of analyzing biological samples or providing diagnostic results.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Providing diagnostic information about a disease or condition
- Using reagents or assays
- Measuring biomarkers
The device is clearly a medical device used for respiratory support and treatment, falling under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
A patient interface accessory for use with CPAP and bi-level systems used in the treatment of adult OSA and / or ventilatory support. Single patient, multi-use.
Environment of use – hospital, sub-acute institutions, sleep laboratories and home
Product codes
BZD
Device Description
The proposed nasal pillow patient interface incorporates a number of features, which are designed to maximize seal and comfort, and maintain the mask in the correct position throughout use.
- . Three (3) sizes of nasal pillows to assure a good fit
- Integral fixed leak port, identical to the predicate .
- . Headgear for attachment
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
Adults with OSA
Intended User / Care Setting
Environment of use - hospital, sub-acute institutions, sleep laboratories and 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)
Comparative testing for safety and efficacy: Flow vs. Leak / Pressure, Dead space
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
Premarket Notification 510(k) Section 5 – 510(k) Summary
LifeSource
Non-Confidential Summary of Safety and Effectiveness
Page 1 of 2 4-Sep-07
| LifeSource
12621 W. 121st Terrace
| Overland Park, KS 66213 | Tel - 913-681-9201 | SEP 12 2007 |
|---|---|---|
| Official Contact: | Pamela Squire | |
| Proprietary or Trade Name: | CPAP nasal mask with pillows | |
| Common/Usual Name: | Patient interface for use with CPAP systems | |
| Classification Name: | Ventilator, non-continuous (respirator), accessory | |
| BZD - 868.5905 | ||
| Device: | CPAP nasal mask with pillows | |
| Predicate Devices: | Puritan Bennett - ADAM - K900164 |
Device Description:
The proposed nasal pillow patient interface incorporates a number of features, which are designed to maximize seal and comfort, and maintain the mask in the correct position throughout use.
- . Three (3) sizes of nasal pillows to assure a good fit
- Integral fixed leak port, identical to the predicate .
- . Headgear for attachment
| Indications for Use: | A patient interface accessory for use with CPAP and bi-level
systems used in the treatment of adult OSA and / or ventilatory
support. Single patient, multi-use.
Environment of use – hospital, sub-acute institutions, sleep
laboratories and home |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Patient Population: | Adults with OSA |
| Environment of Use: | Hospitals, Home, sub-acute care settings |
| Contraindications: | None |
1
Non-Confidential Summary of Safety and Effectiveness Page 2 of 2 4-Sep-07
Comparative table:
| Features | Predicate ADAM
K900164 | Proposed Device |
|---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | A patient interface accessory for use
with CPAP and bi-level systems
used in the treatment of adult OSA
and / or ventilatory support. | A patient interface accessory for use
with CPAP and bi-level systems used in
the treatment of adult OSA and / or
ventilatory support. |
| | Not listed but typical of CPAP
patient interface devices | |
| Environment of Use | Hospital, sub-acute institutions,
sleep laboratories and home | Same |
| Patient Population | Adult | Same |
| Contraindications | None | None |
| Single patient,
Multi-use | Yes | Yes |
| Components | Headgear
Shell / Interface
Nasal pillows | Headgear
Shell / Interface
Nasal pillows |
| Dead space | Interface – 26 ml
Pillows – 2 to 4 ml | Interface – 26 ml
Pillows – 2 to 4 ml |
| Fixed leak port | Yes | Yes |
| Deliverable pressure
range | Not provided | Typical 3 to 18 cm H2O |
| Materials | Polycarbonate
Silicone | Polycarbonate
Silicone
Biocompatibility per ISO 10993-1 |
| Comparative testing
for safety and
efficacy | | Flow vs. Leak / Pressure
Dead space |
Differences Between Other Legally Marketed Predicate Devices:
The proposed device is viewed as substantially equivalent to the predicate device, K900164.
There are no significant differences that affect the safety or effectiveness of the intended device as compared to the predicate devices.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of a stylized caduceus, which is a symbol of medicine and health. The caduceus is composed of three lines that form a stylized human figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
LifeSource C/O Mr. Paul Dryden President ProMedic, Incorporated 3460 Pointe Creek Court #102 Bonita Springs, Florida 34134
SEP 1 2 2007
Re: K071773
Trade/Device Name: CPAP Nasal Mask with Pillows Regulation Number: 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: August 27, 2007 Received: August 28, 2007
Dear Mr. Dryden:
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 proval of 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 offecting 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.
3
Page 2 - Mr. Dryden
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 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 (301) 443-6597 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
Enclosure
4
Indications for Use Statement
Page 1 of 1
| 510(k) Number: | K071773 (To be assigned) |
|---|---|
| Device Name: | CPAP Nasal mask with pillows |
| Indications for Use: | A patient interface accessory for use with CPAP and bi- |
| level systems used in the treatment of adult OSA and / or | |
| ventilatory support. Single patient, multi-use. | |
| Environment of use - hospital, sub-acute institutions, sleep | |
| laboratories and home |
Prescription Use XX (Part 21 CFR 801 Subpart D)
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)
Nul I. Page 9/10/07
(Civision Sign-Off) (Civision Sign-Old)
Division of Anesthesiology, General Hospital, Intection Control, Dental Devices
510(k) Number: