(126 days)
Not Found
No
The description focuses on the physical components, materials, and performance testing of a pediatric CPAP mask, with no mention of AI or ML technology.
No.
The document describes a mask used to channel airflow from a CPAP or bilevel device, which are the therapeutic devices. The mask itself is an accessory that enables the therapy but does not provide therapy independently.
No
Explanation: The device is a mask for delivering continuous positive airway pressure (CPAP) or bilevel therapy, which are forms of treatment, not diagnostic procedures. Its intended use is to channel airflow to a patient, and the descriptions focus on its mechanical interface and physical characteristics, not on detecting or identifying a medical condition.
No
The device description explicitly details physical components like a mask, headgear, and connectors, and the performance studies involve bench testing of these physical attributes. There is no mention of software as a component or function of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to channel airflow noninvasively to a patient from a CPAP or bilevel device. This is a therapeutic function, not a diagnostic one.
- Device Description: The description focuses on the physical components and how they interface with the patient's nose to deliver air. There is no mention of analyzing biological samples or providing diagnostic information.
- Performance Studies: The performance studies described are bench tests related to physical and functional aspects of the mask (deadspace, assembly integrity, material safety, cleaning, pressure-flow characteristics). These are not studies related to the diagnostic accuracy of a test.
- No mention of biological samples: IVD devices typically involve the analysis of biological samples (blood, urine, tissue, etc.). This device does not interact with biological samples in a way that would provide diagnostic information.
In summary, the Pixi Pediatric mask is a medical device used for respiratory therapy, not for performing in vitro diagnostic tests.
N/A
Intended Use / Indications for Use
The Pixi Pediatric Mask channels airflow noninvasively to a patient from a continuous positive airway pressure (CPAP) or bilevel device.
The Pixi Pediatric Mask is:
• to be used by children aged between 2 and 7 for whom continuous positive airway pressure (CPAP) or bilevel therapy has been prescribed
• intended for single-patient re-use in the home environment and single-patient re-use in the hospital/institutional environment
Product codes
BZD
Device Description
The Pixi Pediatric Mask provides an interface such that airflow from a positive pressure source is directed to the patient's nose. The mask is held in place with adjustable headgear that straps the mask to the face.
The Pixi Pediatric Mask is safe when used under the conditions and purposes intended as indicated in the labeling provided with the product.
The Pixi Pediatric Mask is a prescription device supplied non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nose, Face
Indicated Patient Age Range
children aged between 2 and 7
Intended User / Care Setting
Home environment and hospital/institutional environment
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)
Non-Clinical Performance Bench testing of the physical and functional deadspace was Testing conducted on both the new and predicate devices to demonstrate that the mask design provides adequate venting. The new device has undergone assembly integrity testing to demonstrate mechanical integrity of the mask during normal use and reasonable abuse scenarios, as well as material safety testing to demonstrate biocompatibility of components. The mask has also been subjected to bench testing to validate cleaning, transport and storage conditions, and to measure the pressure-flow and flow- impedance characteristics. Use of vented nasal masks with CPAP or Bilevel therapy is Clinical Data proven technology and is well accepted by the medical community. Bench testing is sufficient to demonstrate safety and efficacy of the new device. The CO2 performance of the new device has been Performance Data demonstrated to be substantially equivalent to the predicate.
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
:!
:
Pixi Pediatric Traditional 510k
| Date Prepared | 3 August, 2010 | DEC 1 0 2010 |
|---|---|---|
| Submitter | Ms. Tracey Bullivant | |
| Official Contact | Mr. David D'Cruz - V.P. US Medical and Regulatory Affairs | |
| 9001 Spectrum Center Boulevard, San Diego, CA 92123 | ||
| Tel: (858) 836-5984 | ||
| Device Trade Name | Pixi™ Pediatric Mask | |
| Device Common Name/ | ||
| Classification Name | Vented Nasal Mask; | |
| Accessory to Noncontinuous Ventilator (IPPB) | ||
| Classification | 21 CFR 868.5905, 73 BZD (Class II) | |
| Predicate Devices | MiniMe Pediatric Mask (K090935) | |
| Description | The Pixi Pediatric Mask provides an interface such that airflow | |
| from a positive pressure source is directed to the patient's nose. | ||
| The mask is held in place with adjustable headgear that straps | ||
| the mask to the face. | ||
| The Pixi Pediatric Mask is safe when used under the conditions | ||
| and purposes intended as indicated in the labeling provided | ||
| with the product. | ||
| The Pixi Pediatric Mask is a prescription device supplied non- | ||
| sterile. | ||
| Intended Use | The Pixi Pediatric Mask channels airflow noninvasively to a | |
| patient from a continuous positive airway pressure (CPAP) or | ||
| bilevel device. | ||
| The Pixi Pediatric Mask is: | ||
| • to be used by children aged between 2 and 7 for whom | ||
| continuous positive airway pressure (CPAP) or bilevel | ||
| therapy has been prescribed | ||
| • intended for single-patient re-use in the home environment | ||
| and single-patient re-use in the hospital/institutional | ||
| environment | ||
| Technological | ||
| Characteristics | The new device provides a seal to the patient's face via a | |
| silicone elastomer interface whereas the predicate mask uses | ||
| an alternative elastomer. | ||
| Both the masks incorporate vent holes to provide continuous air | ||
| leak to flush out and minimize the amount of CO2 re-breathed | ||
| by the patient. The design of the mask components in the new | ||
| mask is such that the incorporation of these vent-holes does not | ||
| interfere with the intended performance of the mask. | ||
| Both masks connect to a conventional air delivery hose |
3 August, 2010
1
RESMED
between the mask and the positive airway-pressure source via standard conical connectors. The new device is constructed using molded plastic and silicone components and fabric / nylon headgear. All the components are fabricated using materials deemed safe (ref: ISO 10993-1). The main differences between the new device and the predicate is in the components, their design/geometry and how individual components interface with each other. Non-Clinica! Performance Bench testing of the physical and functional deadspace was Testing conducted on both the new and predicate devices to demonstrate that the mask design provides adequate venting. The new device has undergone assembly integrity testing to demonstrate mechanical integrity of the mask during normal use and reasonable abuse scenarios, as well as material safety testing to demonstrate biocompatibility of components. The mask has also been subjected to bench testing to validate cleaning, transport and storage conditions, and to measure the pressure-flow and flow- impedance characteristics. Use of vented nasal masks with CPAP or Bilevel therapy is Clinical Data proven technology and is well accepted by the medical community. Bench testing is sufficient to demonstrate safety and efficacy of the new device. The CO2 performance of the new device has been Performance Data demonstrated to be substantially equivalent to the predicate. The new device, the Pixi Pediatric mask, is substantially Substantial Equivalence equivalent to the predicate device, the MiniMe Pediatric mask: Conclusion it has the same intended use; it is intended for a subset of the patient population; ﺘ it has similar technological characteristics; ー it does not raise new questions of safety and effectiveness;
- it is at least as safe and effective. .
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image contains the words "Public Health Service" in a simple, sans-serif font. The text is black and appears against a white background. A period follows the word "Service".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
RESMED Limited C/O Mr. David D'Cruz RESMED Corporation 9001 Spectrum Center Boulevard San Diego, California 92123
Re: K102224
Trade/Device Name: Pixi™ Pediatric Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: October 18, 2010 Received: October 21, 2010
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. 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 Eederal Register.
DEC 1 0 2010
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); medical device reporting (reporting of medical device-related 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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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,
fam 2 Rossetend
for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
RESMED
Pixi Pediatric Traditional 510k
Indication for Use
DEC 1 0 2010
510{k} Number (if known): Pixi™ Pediatric Mask Device Name: Indication for Use
The Pixi Pediatric mask channels airflow noninvasively to a patient from a continuous positive airway pressure (CPAP) or bilevel device.
The Pixi Pediatric mask is:
- to be used by children aged between 2 and 7 for whom continuous positive airway pressure (CPAP) � or bilevel therapy has been prescribed
- intended for single-patient re-use in the home environment and single-patient re-use in the . hospital/institutional environment
Over-The-Counter Use AND/OR Prescription Use X (Part 21 CFR 801 Subpart D) (Part 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)
Page 1 of 1
3 August 2010
(Division Sign-Off) (Division Sign-Ult)
Division of Anesthesiology, General Hospital 14
Seneral Canated, Dental Devices Division of Anostrol, Dental Devices
1022
510(k) Number: