(75 days)
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
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
This submission for the LifeSource CPAP nasal mask with pillows (K071773) is a 510(k) premarket notification. These types of submissions aim to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than proving safety and efficacy through extensive clinical trials with specific acceptance criteria in the same way a PMA (Premarket Approval) submission would.
Therefore, the study conducted here is comparative testing to demonstrate that the new device performs similarly to the predicate device, not a study against a pre-defined acceptance criterion for a novel device.
Here's a breakdown of the requested information based on the provided document:
1. A table of acceptance criteria and the reported device performance
For a 510(k) submission, "acceptance criteria" are typically demonstrating equivalence to a predicate device's performance. The "reported device performance" is the new device exhibiting similar characteristics.
| Feature / Performance Metric | Predicate Device (ADAM - K900164) Performance | Proposed Device Performance | Acceptance Criteria (Equivalence) |
|---|---|---|---|
| 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. | Same | Equivalent |
| Environment of Use | Hospital, sub-acute institutions, sleep laboratories and home | Same | Equivalent |
| Patient Population | Adult | Same | Equivalent |
| Contraindications | None | None | Equivalent |
| Single patient, Multi-use | Yes | Yes | Equivalent |
| Components | Headgear, Shell / Interface, Nasal pillows | Headgear, Shell / Interface, Nasal pillows | Equivalent |
| Dead space (Interface) | 26 ml | 26 ml | Equivalent |
| Dead space (Pillows) | 2 to 4 ml | 2 to 4 ml | Equivalent |
| Fixed leak port | Yes | Yes | Equivalent |
| Deliverable pressure range | Not provided (but typical) | Typical 3 to 18 cm H2O | Comparable (within typical range for such devices) |
| Materials | Polycarbonate, Silicone | Polycarbonate, Silicone, Biocompatibility per ISO 10993-1 | Equivalent (with added biocompatibility standard adherence) |
| Flow vs. Leak / Pressure | Not explicitly stated (implied by predicate's market clearance) | Data collected | Demonstrated to be comparable/acceptable for intended use, considering the fixed leak port and pressure range typical of predicate devices. |
| Dead space (performance) | Not explicitly stated (implied by predicate's market clearance) | Data collected | Demonstrated to be comparable/acceptable to predicate levels. |
The study proving the device meets the acceptance criteria is described as "Comparative testing for safety and efficacy." This testing specifically investigated:
- Flow vs. Leak / Pressure: This likely involved measuring the flow characteristics and leak rates at various pressure settings to ensure performance similar to the predicate and within acceptable ranges for CPAP therapy.
- Dead space: Measurements were taken to confirm the dead space volumes (26 ml for interface, 2-4 ml for pillows) are identical to the predicate device.
The premise of a 510(k) clearance is that no significant differences that affect the safety or effectiveness exist between the proposed device and the predicate. The "comparative testing" implicitly demonstrated this by showing similar performance in key areas like flow characteristics, leak, and dead space, along with material biocompatibility.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size used for the comparative testing (Flow vs. Leak / Pressure, Dead space). It also does not mention the country of origin of the data or whether the study was retrospective or prospective. Given the nature of bench testing for a medical device accessory, it's typically prospective bench testing conducted in a lab environment.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable and not provided in the document. For a physical device like a CPAP mask, "ground truth" related to expert consensus is not typically established. The performance metrics (flow, leak, dead space) are measured objectively by engineering and testing personnel, not clinical experts establishing a ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided. Adjudication methods are typically used in clinical studies where subjective assessments (e.g., image interpretation, clinical outcomes) require consensus among multiple observers. The performance testing for this device (flow, leak, dead space) is objective measurement.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI/radiology devices where human interpretation is involved. This submission is for a physical medical device (CPAP mask) and does not involve AI or human readers for diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance evaluation was not done. This device is a physical product, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the "comparative testing" of the CPAP mask, the "ground truth" for parameters like dead space and flow/leak characteristics would be based on objective physical measurements using calibrated equipment and engineering standards. It is not based on expert consensus, pathology, or outcomes data in the clinical sense.
8. The sample size for the training set
This information is not applicable and not provided. "Training set" refers to data used to train machine learning models. This submission is for a physical medical device, not a machine learning or AI system.
9. How the ground truth for the training set was established
This information is not applicable and not provided for the same reason as point 8.
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Premarket Notification 510(k) Section 5 – 510(k) Summary
LifeSource
Non-Confidential Summary of Safety and Effectiveness
Page 1 of 2 4-Sep-07
| LifeSource12621 W. 121st TerraceOverland 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), accessoryBZD - 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-levelsystems used in the treatment of adult OSA and / or ventilatorysupport. Single patient, multi-use.Environment of use – hospital, sub-acute institutions, sleeplaboratories and home |
|---|---|
| Patient Population: | Adults with OSA |
| Environment of Use: | Hospitals, Home, sub-acute care settings |
| Contraindications: | None |
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Non-Confidential Summary of Safety and Effectiveness Page 2 of 2 4-Sep-07
Comparative table:
| Features | Predicate ADAMK900164 | Proposed Device |
|---|---|---|
| Indications for use | A patient interface accessory for usewith CPAP and bi-level systemsused in the treatment of adult OSAand / or ventilatory support. | A patient interface accessory for usewith CPAP and bi-level systems used inthe treatment of adult OSA and / orventilatory support. |
| Not listed but typical of CPAPpatient 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 | HeadgearShell / InterfaceNasal pillows | HeadgearShell / InterfaceNasal pillows |
| Dead space | Interface – 26 mlPillows – 2 to 4 ml | Interface – 26 mlPillows – 2 to 4 ml |
| Fixed leak port | Yes | Yes |
| Deliverable pressurerange | Not provided | Typical 3 to 18 cm H2O |
| Materials | PolycarbonateSilicone | PolycarbonateSiliconeBiocompatibility per ISO 10993-1 |
| Comparative testingfor safety andefficacy | Flow vs. Leak / PressureDead 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.
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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.
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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
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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 / orventilatory support. Single patient, multi-use. |
| Environment of use - hospital, sub-acute institutions, sleeplaboratories 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:
§ 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).