(114 days)
Not Found
No
The device description and intended use describe a physical mask for CPAP/Bi-Level therapy, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is described as a non-invasive patient interface for CPAP or Bi-Level Ventilator treatment, which are therapeutic modalities for respiratory conditions.
No
The device is a full face mask designed to deliver pressurized gases (CPAP or Bi-Level Ventilator treatment) to patients, not to diagnose a condition. The diagnosis is made by a physician prior to the device's use.
No
The device description clearly outlines physical components like a silicone seal, headgear straps, a swivel adaptor, and exhaust holes, 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:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The F&P Simplus™ Full Face Mask is a non-invasive patient interface used to deliver pressurized gases for CPAP or Bi-Level Ventilator treatment. It directly interacts with the patient's respiratory system, not with specimens taken from the body.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, chemical reactions, or diagnostic testing performed on bodily fluids or tissues.
Therefore, the F&P Simplus™ Full Face Mask is a medical device used for respiratory support, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The F&P Simplus™ Full Face Mask is intended to be used by individuals who have been diagnosed by a physician as requiring CPAP or Bi-Level Ventilator treatment. The F&P Simplus™ Full Face Mask is intended for Single Patient Adult Use in the home and Multiple Patient Adult Use in the hospital or other clinical setting where proper disinfection of the device can occur between patient uses.
Product codes (comma separated list FDA assigned to the subject device)
BZD
Device Description
The F&P Simplus™ Full Face Mask is a non-invasive patient interface. The mask includes a silicone seal which covers the nose and mouth of a patient and is held in place by adjustable headgear straps. The mask connects to a single breathing tube via a swivel adaptor to receive pressurized gases. The gases delivered to the patient may be humidified and/or oxygen enriched. The exhaust holes on the mask housing allow exhaled air to be flushed out while the system is in operation.
An oxygen pressure port accessory is available to be used with the device for oxygen therapy and/or gas monitoring.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nose and mouth
Indicated Patient Age Range
Adult
Intended User / Care Setting
Single Patient Adult Use in the home and Multiple Patient Adult Use in the hospital or other clinical setting where proper disinfection of the device can occur between patient uses.
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)
Testing of the F&P Simplus™ Full Face Mask was compared to the predicate K040506 Flexifit™ Series HC431 Full Face Mask for performance and K121597 Eson Nasal Mask for biocompatibility. These tests demonstrate substantial equivalence of the F&P Simplus™ Full Face Mask to the two aforementioned predicate masks.
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.
K040506 Flexifit™ Series HC431 Full Face Mask, K121597 Eson Nasal Mask
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
Section 5 - 510(k) Summary
JUN 0 5 2013
| CARDER COLLECTION COLLECTION COLLECTION COLLECTION COLLECTION CONTRACT COLLECTION CONTRACT COLLECTION CONTRACT COLLECTION CONTRACT COLLECTION CONTRACT COLLECTION CONTRACT COL
A-444400
AND ALL
| And And And And Andred American |
|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
.
LEBERES
Advisorial
.
|
15 Maurice Paykel Place, East Tamaki P O Box 14 348, Panmure Auckland, New Zealand Telephone: +64 9 574 0100 Facsimile: +64 9 574 0148 Website: www.fphcare.com
| Date Prepared | 7 February 2013 |
|---|---|
| Contact Person | Sue Cho |
| Contact Details | Address: 15 Maurice Paykel Place, East Tamaki |
| PO Box 14 348, Panmure | |
| Auckland, New Zealand | |
| Telephone: +64 9 574 0100 | |
| Fax: +64 9 574 0148 | |
| Trade Name | F&P Simplus™ Full Face Mask |
| Common Name | Full Face Mask |
| Classification Name | Non continuous ventilator IPPB |
| (21 CFR § 868.5905, product code BZD) | |
| Predicate Devices | K040506 Flexifit™ Series HC431 Full Face Mask, Fisher & |
| Paykel Healthcare - for performance | |
| K121597 Eson Nasal Mask, Fisher & Paykel Healthcare - for | |
| material biocompatibility |
1
Device Description 5.1
The F&P Simplus™ Full Face Mask is a non-invasive patient interface. The mask includes a silicone seal which covers the nose and mouth of a patient and is held in place by adjustable headgear straps. The mask connects to a single breathing tube via a swivel adaptor to receive pressurized gases. The gases delivered to the patient may be humidified and/or oxygen enriched. The exhaust holes on the mask housing allow exhaled air to be flushed out while the system is in operation.
An oxygen pressure port accessory is available to be used with the device for oxygen therapy and/or gas monitoring.
5.2 Intended Use
The F&P Simplus™ Full Face Mask is intended to be used by individuals who have been diagnosed by a physician as requiring CPAP or Bi-Level Ventilator treatment. The F&P Simplus™ Full Face Mask is intended for Single Patient Adult Use in the home and Multiple Patient Adult Use in the hospital or other clinical setting where proper disinfection of the device can occur between patient uses.
5.3 Technological Characteristics Comparison
The F&P Simplus™ Full Face Mask has the following similarities to the previously cleared Fisher & Paykel Healthcare Flexifit™ Series HC431 Full Face Mask:
- Similar intended use. -
- -Both masks deliver CPAP gases through the nose and mouth.
The key differences between the two masks are that the F&P Simplus™ Full Face Mask:
- -Has a permanently attached ball elbow rather than a detachable swivel elbow.
- Is smaller in size with under lip design as opposed to the under chin design. -
- -Has a modified non-rebreathing valve design.
- Has a modified headgear clip design. -
- -Has a modified design and location of exhaust holes.
5.4 Non-Clinical Tests
Testing of the F&P Simplus™ Full Face Mask was compared to the predicate K040506 Flexifit™ Series HC431 Full Face Mask for performance and K121597 Eson Nasal Mask for biocompatibility. These tests demonstrate substantial equivalence of the F&P Simplus™ Full Face Mask to the two aforementioned predicate masks. Copies of test reports are included in Appendix A.
The F&P Simplus™ Full Face Mask has been tested to the following standards:
- . ISO 17510-2:2007 Sleep Apnea Breathing Therapy - Part 2: Masks and Applications Accessories
- ISO 10993-1:2009 Biological Evaluation of Medical Devices Part 1: Evaluation and . Testing Within a Risk Management Process
2
Conclusion ર.5
The comparison of features, performance, and intended use demonstrate that the F&P Simplus™ Full Face Mask is substantially equivalent to the predicate K040506 Flexifit Series HC431 Full Face Mask for performance and K121597 Eson Nasal Mask for biocompatibility.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 5, 2013
Fisher & Paykel Healthcare, Limited Ms. Sue Cho 15 Maurice Paykel Place, East Tamaki P.O. Box 14 348, Panmure Auckland, New Zealand 2013
Re: K130328
Trade/Device Name: F&P Simplus™ Full Face Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: March 6. 2013 Received: March 7, 2013
Dear Ms. Cho:
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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
4
Page 2 - Ms. Cho
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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Tejashri Purohit-Sheth, M.D.
Clinical Deputy Director
DAGRID
FOR
Kwame Ulmer, M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Section 4 - Indications for Use Statement
510(k) Number:
Device Name:
F&P Simplus™ Full Face Mask
Indications for Use:
The F&P Simplus™ Full Face Mask is intended to be used by individuals who have been diagnosed by a physician as requiring CPAP or Bi-Level Ventilator treatment. The F&P Simplus™ Full Face Mask is intended for Single Patient Adult Use in the home and Multiple Patient Adult Use in the hospital or other clinical setting where proper disinfection of the device can occur between patient uses.
Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
1=HIF+S
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
(Division Sign-Off)
Division of Anesthesloiogy, General Hospital Division of Ancolnosters
510(k) Number
Anva