UTOPIA

K052249 · Respcare, Inc. · BZD · Dec 7, 2005 · Anesthesiology

Device Facts

• Record ID: K052249
• Device Name: UTOPIA
• Applicant: Respcare, Inc.
• Product Code: BZD · Anesthesiology
• Decision Date: Dec 7, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 clinical 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.

Device Story

Utopia is a patient interface (mask) for CPAP or bi-level ventilators; delivers positive airway pressure to oral and nasal passages. Device features include forehead pad, headgear for secure facial seal, exhalation port, anti-asphyxia valve, and oxygen entrainment port. Connects to ventilators via standard 22 mm fitting. Used in home or clinical settings; operated by patients or healthcare providers. Provides non-invasive ventilation support to treat respiratory insufficiency and obstructive sleep apnea; benefits patient by maintaining airway patency.

Clinical Evidence

No clinical data. Substantial equivalence is based on functional testing and comparison of materials and design to legally marketed predicate devices.

Technological Characteristics

Patient interface mask with forehead pad and headgear. Features include 22 mm standard ventilator connection, exhalation port, anti-asphyxia valve, and oxygen entrainment port. Available in single-use (disposable) and multi-use versions. Materials are comparable to predicate masks. Non-powered, passive device.

Indications for Use

Indicated for adults (> 30 kg) requiring CPAP or bi-level positive-pressure ventilation for respiratory insufficiency or obstructive sleep apnea.

Regulatory Classification

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.

Predicate Devices

• Hans Rudolph 7600 Vmask (K030822)
• Fisher & Paykel HC431 (K040506)
• Respironics PerformaTrak (K002465)

Submission Summary (Full Text)

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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-B4<br>Coconut Creek, FI 33073, USA |
| Telephone Number: | [phone] |
| Fax Number: | [phone] |
| 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<br>K040506 - Fisher & Paykel HC431<br>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.

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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 [phone]. 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 [phone] or [phone] 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.

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Number: K 052277