(79 days)
Not Found
No
The device description and intended use are solely focused on a physical mask for CPAP/Bi-level therapy and do not mention any software, algorithms, or data processing capabilities that would indicate AI/ML.
Yes
Explanation: The device is intended to provide an interface for the application of prescribed CPAP or Bi-level therapy. CPAP/Bi-level therapy is a medical treatment.
No
The device is a nasal mask intended to provide an interface for CPAP or Bi-level therapy. Its purpose is to deliver treatment, not to diagnose a condition.
No
The device description clearly outlines multiple physical components (mask body, cushion, headgear, etc.) and does not mention any software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide an interface for applying CPAP or Bi-level therapy. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the physical components of a mask used for delivering respiratory therapy. It does not describe any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device's function is to deliver therapy, not to perform such analysis.
N/A
Intended Use / Indications for Use
The Respironics C2 Nasal Mask is intended to provide an interface for application of prescribed CPAP or Bi-level positive airway pressure therapy.
Product codes
BZD
Device Description
The C2 Nasal Mask consists of a tubular mask body, nasal interface cradle with cushion, two nasal interface cradle adapters, two exhalation devices, elbow with swivel, single split strap headgear, headgear clips and cloth cover. Standard 22 mm flexible tubing provided with a CPAP or Bi-level device connects to the mask at the elbow with swivel.
The headgear provided with the mask is a single strap that splits to wrap around the top and back portions of the user's head. Velcro tabs at each end of the headgear are used to secure a clip that is used to fasten the headgear to the mask body. To remove the mask from the user's face, the user may slide the stretchable headgear over their head, unfasten the Velcro tabs and slide the straps through the clips that are attached to the mask, or release a clip from the mask body.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nasal
Indicated Patient Age Range
adult patients
Intended User / Care Setting
It is intended for adult patients and may be used in a home or 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)
Design verification tests were performed on the C2 Nasal Mask as a result of the risk analysis and product requirements. All tests were verified to meet the required acceptance criteria. Respironics has determined that the modifications have no impact on the safety and effectiveness of the mask. In summary, the mask described in this submittal is substantially equivalent to the predicate mask.
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
Image /page/0/Picture/1 description: The image shows a close-up, slightly angled view of a handwritten alphanumeric string. The string appears to be "K033759", with the characters written in a bold, somewhat stylized manner. The angle of the text gives it a dynamic, almost tilted appearance, and the handwriting suggests a casual or informal style.
Premarket Notification 510{k) Section 9 - 510(K) Summary
| Official Contact / Address
of Manufacturing facility | Zita A. Yurko
Manager, Regulatory Affairs
Respironics, Inc.
1001 Murry Ridge Lane
Murrysville, PA 15668 |
|---------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|
| Proprietary Name | C2 Nasal Mask |
| Common/Usual Name | Nasal mask |
| Classification Reference | 21 CFR 868.5905 |
| Classification | Class II |
| Appropriate Classification Panel | Anesthesiology Devices |
| Product Code | BZD - non-continuous ventilator |
| Predicate Devices | Worldwide Medical Technologies, Inc.
Spiritus Respiratory System (K020641) |
| Reason for submission | New Device |
Substantial Equivalence
This premarket notification submission demonstrates that the C2 Nasal Mask is substantially equivalent to the Worldwide Medical Technologies, Inc. Spiritus Respiratory System (K020641).
Design verification tests were performed on the C2 Nasal Mask as a result of the risk analysis and product requirements. All tests were verified to meet the required acceptance criteria. Respironics has determined that the modifications have no impact on the safety and effectiveness of the mask. In summary, the mask described in this submittal is substantially equivalent to the predicate mask.
1
Intended Use/Indications for Use
The Respironics C2 Nasal Mask is intended to provide an interface for application of prescribed CPAP or Bi-level positive airway pressure therapy.
Patient Population/Environment of Use
The mask is reusable and for single patient use only. It is intended for adult patients and may be used in a home or hospital/institutional environment.
Device Description
The C2 Nasal Mask consists of a tubular mask body, nasal interface cradle with cushion, two nasal interface cradle adapters, two exhalation devices, elbow with swivel, single split strap headgear, headgear clips and cloth cover. Standard 22 mm flexible tubing provided with a CPAP or Bi-level device connects to the mask at the elbow with swivel.
The headgear provided with the mask is a single strap that splits to wrap around the top and back portions of the user's head. Velcro tabs at each end of the headgear are used to secure a clip that is used to fasten the headgear to the mask body. To remove the mask from the user's face, the user may slide the stretchable headgear over their head, unfasten the Velcro tabs and slide the straps through the clips that are attached to the mask, or release a clip from the mask body.
(End of Section.)
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in capital letters.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 9 2004
Ms. Zita Yurko Regulatory Affairs Manager Respironics, Incorporated 1001 Murry Ridge Lane Murrysville, PA 15668
Re: K033759
Trade Name: C2 Nasal Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: December 1, 2003 Received: December 2, 2003
Dear Ms. Yurko:
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 Federal Register.
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
3
Page 2 - Ms. Zita Yurko
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Sections on device as described in your Section 510(k) I his letter will anow you to begin maneting your and equivalence of your device to a legally premaired notification: "The PDA miding of basification 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 If you desire specific advice for your as (301) 594-4646. Also, please note the regulation entitled, Contact the Office of Comphallso in (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general 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/dsma/dsmamain.html.
Sincerely yours,
Qiu Lin, Ph.D.
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
510(k) Number (if known): K033759
Device Name: C2 Nasal Mask
Indications for Use:
The C2 Nasal Mask is intended to provide an interface for application of prescribed CPAP or Bi-level therapy.
The mask is reusable and for single patient use only. It is intended for adult patients in a home or hospital/institutional environment.
Prescription Use_ X (Part 21 CFR 801 Subpart D) AND/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)
f.H. Wustorh
(Division Sign-Off)
Division of Desiology, General Hospital,
Infection Control, Dental Devices
510(k) Nú
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