(111 days)
Not Found
No
The provided text describes a patient interface (mask) for CPAP/Bi-Level devices. It details the physical components, intended use, and predicate devices. There is no mention of AI, ML, image processing, or any data-driven algorithms that would typically indicate the presence of AI/ML technology.
Yes
The device is intended for the treatment of respiratory insufficiencies and obstructive sleep apnea, which are medical conditions, thus making it a therapeutic device.
No
The Utopia is described as a "patient interface accessory" for CPAP or Bi-Level positive-pressure ventilation devices, delivering positive airway pressure. Its intended use is for "treatment of respiratory insufficiencies and obstructive sleep apnea," not for diagnosing these conditions.
No
The device description clearly states it is a "patient interface accessory" that delivers positive airway pressure and includes physical components like a mask, forehead pad, headgear, exhalation port, anti-asphyxia valve, and oxygen entrainment port. These are hardware components, not software.
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 a patient interface for delivering positive pressure ventilation for respiratory insufficiencies and obstructive sleep apnea. This is a therapeutic application, not a diagnostic one.
- Device Description: The device description focuses on delivering air pressure to the patient's airways. It does not mention any components or functions related to analyzing biological samples (blood, urine, tissue, etc.) which is the core of IVD devices.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to facilitate the delivery of therapy, not to perform diagnostic tests.
N/A
Intended Use / Indications for Use
The Utopia is intended for use by adults (> 30 kg) as a patient interface for currently-marketed CPAP or bi-level positive pressure flow generators for treatment of respiratory insufficiencies and obstructive sleep apnea.
For homecare applications, the Utopia may be reused multiple times by a single patient. For in-homecare applications (i.e. hospital or other clinical settings), this interface may be reused multiple times by multiple patients.
The Utopia Disposable is a single patient, single use interface.
Product codes (comma separated list FDA assigned to the subject device)
BZD
Device Description
The Utopia 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 a forehead pad and headgear worn around the head. The device includes exhalation port. 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; in-homecare 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
K 0522 49
DEC 7 2005
510(k) SUMMARY
| Submitter's Name: | RespCare Inc. |
|---|---|
| Submitter's Address: | 6601 Lyons Road, Suites B1-B4 |
| Coconut Creek, FI 33073, USA | |
| Telephone Number: | (561) 208-3778 |
| Fax Number: | (954) 727-8479 |
| Contact Person: | Frank Pelc |
| Date: | August 17, 2005 |
| Proprietary Name: | Utopia |
| Common/Usual Name: | Face Mask |
| Classification: | Class II, CFR 868.5905, BZD |
| Classification Name: | Accessory to Noncontinuous Ventilator |
| Predicate Devices: | K030822 -- Hans Rudolph 7600 Vmask |
| K040506 - Fisher & Paykel HC431 | |
| K002465 - Respironics PerformaTrak |
Device Description
The Utopia 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 a forehead pad and headgear worn around the head. The device includes exhalation port. anti-asphyxia valve, and oxygen entrainment port features.
Comparison to Predicate Devices
The Utopia is essentially similar to the legally marketed predicate interfaces listed above in function, intended use, materials, and features.
Both the proposed device and the predicates are intended to be used as a patient interface for currently-marketed CPAP or Bi-Level positive-pressure ventilation devices for treatment of respiratory insufficiencies and obstructive sleep apnea. The Utopia is offered in single use and multiple patient, multiple use versions. Predicate examples are offered for both single and multiple use for comparison.
Like the predicate masks, the Utopia delivers non-invasive positive airway pressure from a CPAP or bi-level flow generator to the patient's oral and nasal passages. The Utopia provides a seal against the face as it is held in place with a headgear worn around the head similar to the predicates.
Exhalation ports are provided on the mask shell. An anti-asphyxia valve is provided as a safety feature in case of low pressure delivery from the ventilator device. Accessory ports for oxygen entrainment are provided. Each of these features is comparable to predicates mentioned above. Materials used in the Utopia are comparable to the predicates as well.
1
Substantial Equivalence
The Utopia is equivalent to the predicate devices in intended use, environment of use, patient population, and frequency of use. Its basic method of operation and design is also equivalent to the predicates, as described in the comparison above. Materials information and functional testing relative to the intended use of the Utopia show that it is as safe and effective as the predicate devices.
As such, it is RespCare's conclusion that the Utopia is substantially equivalent to the predicate devices.
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three wavy lines, which are meant to represent the human form.
DEC 7 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Frank Pelc Director, Regulatory Affairs and Quality Compliance Respeare, Incorporated 6601 Lyons Road, Suites B1-B4 Coconut Creek, Florida 33073
Re: K052249
Trade/Device Name: Utopia Regulation Number: 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: November 3, 2005 Received: November 4, 2005
Dear Mr. Pelc:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave revers 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 mensiale continered prior station been reclassified in accordance with the provisions of Amendinens, or to actriced Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvin applied.com (1) he Act. The general controls provisions of the Act include controls provided 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 (1 Nr), it may of badyos to another of Federal Regulations, Title 21, Parts 800 to 898. In your device ear or routersh further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Pelc
Please be advised that FDA's issuance of a substantial equivalence determination does not I least to advised that 1 Dr. e tormination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. or the Act of any I ederal the Act's requirements, including, but not limited to: registration 1 od intiles comply was 807); labeling (21 CFR Part 801); good manufacturing practice and fisting (21 es result in the quality systems (QS) regulation (21 CFR Part 820); and if requirences as tectronic 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) This fetter will anon your be of a finding of substantial equivalence of your device to a premaired predicated 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), rr you desire it the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You entriod, "Wherehalled" information on your responsibilities under the Act from the Inter 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,
Suttie y. Michie ond
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
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INDICATIONS FOR USE
510(k) Number (if known):
Device Name: Utopia
Indications for Use:
The Utopia is intended for use by adults (> 30 kg) as a patient interface for currently-marketed CPAP The Glopia is mendou for accoby adults ( obstructive sleep apnea.
(Applies to the standard version):
(Applies to the standard version);
For homecare applications, the Utopia may be reused multiple times by a single patient. For i of nomeoure applications (i.e. hospital or other clinical settings), this interface may be reused multiple times by multiple patients.
(Applies to the Disposable version): The Utopia Disposable 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)
W. Mela for A. Graham
v. Genoral Hospital.
Page 1 of
Number: K 052277