(111 days)
The Utopia is intended for use by adults (> 30 kg) as a patient interface for currently-marketed 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 Utopia may be reused multiple times by a single patient. For non-homecare 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.
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.
This 510(k) Premarket Notification (K052249) describes the Utopia Face Mask, an accessory to a noncontinuous ventilator. The submission focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study with specific acceptance criteria and performance metrics for a novel technology.
Therefore, many of the requested sections (Table of acceptance criteria and reported device performance, sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, type of ground truth, training set size, and how training set ground truth was established) are not applicable or available in this document.
The document details the device description, comparison to predicate devices, and the FDA's decision regarding substantial equivalence. It confirms the Utopia mask is "substantially equivalent to the legally marketed predicate interfaces listed above in function, intended use, materials, and features." This implies that the device meets the safety and effectiveness standards established by the predicate devices through similar design and materials.
Here's a breakdown of the available information relevant to your request:
1. Table of Acceptance Criteria and Reported Device Performance:
- Not applicable. This submission doesn't define specific numerical acceptance criteria (e.g., a certain percentage of efficacy or specific measurement ranges) or report novel performance data against such criteria. Instead, it relies on demonstrating substantial equivalence to existing legally marketed predicate devices. The "performance" is implicitly tied to being as safe and effective as the predicates.
2. Sample Size Used for the Test Set and Data Provenance:
- Not applicable. There is no mention of a "test set" in the context of new performance data or clinical trials to prove device effectiveness. The submission relies on a comparison of the Utopia's design, materials, and intended use against predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable. As there is no "test set" requiring ground truth establishment through expert review for novel performance, this information is not present.
4. Adjudication Method for the Test Set:
- Not applicable. No test set requiring expert adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
- Not applicable. This device is a face mask, not an AI-powered diagnostic tool. MRMC studies are not relevant to its regulatory pathway.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Not applicable. This device is a physical medical device (face mask), not a software algorithm.
7. The Type of Ground Truth Used:
- Not applicable. No new "ground truth" derived from expert consensus, pathology, or outcomes data for performance evaluation is mentioned. The ground truth for this submission is essentially the established safety and effectiveness of the predicate devices based on their legal marketing and performance history.
8. The Sample Size for the Training Set:
- Not applicable. This device is a physical medical device and does not involve machine learning or a "training set."
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As there is no training set, this information is not relevant.
Summary of the Study/Evidence Presented:
The "study" in this context is a comparison to predicate devices to establish substantial equivalence.
- Methodology: The submitter (RespCare Inc.) conducted an analysis comparing the Utopia face mask to three legally marketed predicate devices: K030822 (Hans Rudolph 7600 Vmask), K040506 (Fisher & Paykel HC431), and K002465 (Respironics PerformaTrak).
- Basis for Equivalence: The comparison highlighted similarities in:
- Function: Delivers positive airway pressure from CPAP or bi-level devices.
- Intended Use: Patient interface for treating respiratory insufficiencies and obstructive sleep apnea.
- Environment of Use: Homecare and hospital/clinical settings.
- Patient Population: Adults (> 30 kg).
- Frequency of Use: Single-use and multiple-use versions (matching predicates).
- Basic Method of Operation and Design: Provides a seal, held by headgear, includes exhalation ports, anti-asphyxia valve, and oxygen entrainment ports.
- Materials: Stated to be comparable to predicates.
- Conclusion: RespCare Inc. concluded that the Utopia is "substantially equivalent to the predicate devices" because "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." (Note: The submission states that functional testing was done but does not provide details or results of that testing in this document).
- FDA Decision: The FDA reviewed the submission and determined that the device is substantially equivalent to legally marketed predicate devices. This determination implies that the FDA agreed with RespCare's assessment that the Utopia mask meets the necessary safety and effectiveness standards, as demonstrated by its similarity to already approved devices.
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K 0522 49
DEC 7 2005
510(k) SUMMARY
| Submitter's Name: | RespCare Inc. |
|---|---|
| Submitter's Address: | 6601 Lyons Road, Suites B1-B4Coconut 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 VmaskK040506 - Fisher & Paykel HC431K002465 - 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.
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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.
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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
§ 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).