(15 days)
Not Found
No
The summary describes a physical mask accessory for ventilation devices and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is intended for the "treatment of respiratory insufficiencies and obstructive sleep apnea," which classifies it as a therapeutic device.
No
The device is a mask that delivers positive airway pressure from a CPAP or bi-level device to the patient; it does not diagnose conditions.
No
The device description clearly states it is a "patient interface accessory" and describes physical components like a mask, headgear, and a 22 mm fitting, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The RespCare Hybrid AV Mask is a patient interface accessory that delivers positive airway pressure to a patient's oral and nasal passages. It is a physical interface for a ventilation device.
- Intended Use: The intended use is for treatment of respiratory insufficiencies and obstructive sleep apnea by delivering positive pressure. This is a therapeutic function, not a diagnostic one based on analyzing samples.
- Device Description: The description focuses on the physical components and how it connects to a ventilator, not on any analytical or testing capabilities.
The device's function is to facilitate the delivery of therapy, not to perform diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
The RespCare Hybrid AV Mask is intended for use by adults (> 30 kg) as a patient interface for CPAP or Bi-Level positive-pressure ventilation devices for treatment of respiratory insufficiencies and obstructive sleep apnea.
(Applies to the standard version):
For homecare applications, the Hybrid AV Mask may be reused multiple times by a single patient. For institutional applications (i.e. hospital or other clinical settings), this interface may be reused multiple times by multiple patients.
(Applies to the Disposable version): The Hybrid AV Disposable Mask is a single patient, single use interface.
Product codes (comma separated list FDA assigned to the subject device)
BZD
Device Description
The RespCare Hybrid AV Mask is a patient interface accessory to a positive pressure ventilator intended for treatment of respiratory insufficiencies and obstructive sleep apnea. The device delivers positive airway pressure from a CPAP or bi-level device to the patient's oral and nasal passages. Connection to the ventilator device is made by a standard 22 mm fitting. The mask is held in place on the face by headgear worn around the head. The device includes anti-asphyxia valve and oxygen entrainment port features.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral and nasal passages
Indicated Patient Age Range
adults (> 30 kg)
Intended User / Care Setting
Homecare applications, institutional applications (i.e. hospital or other clinical settings)
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)
Not Found
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.
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
K06224
510(k) SUMMARY Special 510(k) - RespCare Hybrid AV Mask
| Submitter's Name: | RespCare Inc. | |
|---|---|---|
| Submitter's Address: | 6601 Lyons Road, Suites B1-B4 | |
| Coconut Creek, FI 33073, USA | AUG 17 2006 | |
| Telephone Number: | (561) 208-3778 | |
| Fax Number: | (561) 892-2350 | |
| Contact Person: | Frank Pelc | |
| Date: | August 1, 2006 | |
| Proprietary Name: | RespCare Hybrid AV Mask | |
| Common/Usual Name: | Face Mask | |
| Classification: | Class II, CFR 868.5905, BZD | |
| Classification Name: | Accessory to Noncontinuous Ventilator | |
| Predicate Device: | K052227, RespCare Face Mask |
Device Description
The RespCare Hybrid AV Mask is a patient interface accessory to a positive pressure ventilator intended for treatment of respiratory insufficiencies and obstructive sleep apnea. The device delivers positive airway pressure from a CPAP or bi-level device to the patient's oral and nasal passages. Connection to the ventilator device is made by a standard 22 mm fitting. The mask is held in place on the face by headgear worn around the head. The device includes anti-asphyxia valve and oxygen entrainment port features.
Comparison to Predicate Devices
Modifications relate to providing a mask for use with systems that incorporate built-in exhalation devices. The exhalation ports are removed from the mask shell. Also, the optional male coupling adaptor is eliminated, as a female coupling is appropriate for connecting to a separate exhalation device. Labeling changes relate only to the above changes. The instructions specify that the Hybrid AV must be used with a separate exhalation device, and specify that the mask connects to a male hose fitting.
Other than these differences, the Hybrid AV Mask is essentially similar to the predicate device.
Substantial Equivalence
The information provided in this Special 510(k) demonstrates that the proposed device is substantially equivalent to the identified predicate device. The intended use and indications of the modified device are the same as the intended uses and indications as the predicate device. The modified device uses the same fundamental scientific technology as the predicate device. Changes to the design do not raise new issues of safety and effectiveness, and safety and effectiveness are verified using the same methods as reviewed in the K052227 clearance.
510(k) Summary Page 1 of 1
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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 7 2006
Mr. Frank Pelc Director, Regulatory Affairs Pespcare, Incorporated 6601 Lyons Road, Suites B1-B4 Coconut Creek, Florida 33073
Re: K062224
Trade/Device Name: RespCare Hybrid AV Mask Regulation Number: 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: August 1, 2006 Received: August 3, 2006
Dear Mr. Pelc:
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.
2
Page 2 - Mr. Pelc
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 (OS) 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 Hcalth
Enclosure
3
INDICATIONS FOR USE
510(k) Number (if known):
Device Name: RespCare Hybrid AV Mask
Indications for Use:
The RespCare Hybrid AV Mask is intended for use by adults (> 30 kg) as a patient interface for CPAP or Bi-Level positive-pressure ventilation devices for treatment of respiratory insufficiencies and obstructive sleep apnea.
(Applies to the standard version):
For homecare applications, the Hybrid AV Mask may be reused multiple times by a single patient. For institutional applications (i.e. hospital or other clinical settings), this interface may be reused multiple times by multiple patients.
(Applies to the Disposable version): The Hybrid AV Disposable Mask is a single patient, single use interface.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Cover Son
(Sign-Off)
rion of Anesthesiology, General Hospital,
ion Control, Dental Devices
) Number: K062224
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