CPAP MASK

K071915 · Arcimed Laboratories, LLC · BZD · May 14, 2008 · Anesthesiology

Device Facts

• Record ID: K071915
• Device Name: CPAP MASK
• Applicant: Arcimed Laboratories, LLC
• Product Code: BZD · Anesthesiology
• Decision Date: May 14, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

A patient interface, face mask, for use with CPAP and bilevel systems used in the treatment of adult (>30 kg) OSA and / or ventilatory support. Two styles (with exhalation port and without exhalation port). Single use only < 24 hours.

Device Story

Patient interface face mask for CPAP/bi-level systems; used in hospitals, home, and sub-acute care settings. Features adhesive foam seal to maintain position on patient face; available in medium size; offered in vented (integral fixed leak port) and non-vented styles. Non-vented models require external circuit with anti-asphyxia valve (AAV). Device connects to CPAP/bi-level tubing; provides interface for airflow delivery. Healthcare providers or patients use device to treat OSA or provide ventilatory support. Benefits include secure seal, patient comfort, and reduced CO2 rebreathing compared to predicates.

Clinical Evidence

Bench testing only. Evaluated dead space (91 ml), exhaust flow rates across pressures (3-40 cm H2O), pressure drop/resistance to flow (0.35 cm H2O @ 50 lpm), and CO2 rebreathing (0.06% EtCO2). Anti-asphyxia valve activation demonstrated to be equivalent to predicates.

Technological Characteristics

Patient interface mask consisting of shell, foam, and adhesive seal. Single-use, medium size. Vented and non-vented configurations. Requires external anti-asphyxia valve for non-vented use. Technical performance: 91 ml dead space; flow resistance 0.35 cm H2O @ 50 lpm; CO2 rebreathing 0.06% EtCO2.

Indications for Use

Indicated for adult patients (>30 kg) with obstructive sleep apnea (OSA) or requiring ventilatory support. For use with CPAP and bi-level systems. Single-use only (<24 hours).

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

• ResMed Quattro Full Face Mask (K063122)
• Advanced Warming Adhesive mask (K950771)
• Respironics Full face mask (K002465)

Submission Summary (Full Text)

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K071915 Page 1 of 3

# MAY 1 4 2008

## Non-Confidential Summary of Safety and Effectiveness

Page 1 of 3 7-May-08

| ARCimed Laboratories, LLC<br>85 Oak Street<br>Weston, MA 02493 | Tel - 781-237-4544 |
|----------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Official Contact: | Robert W. Daly, Managing Member |
| Proprietary or Trade Name: | ARCimed CPAP mask |
| Common/Usual Name: | Patient interface for use with CPAP systems |
| Classification Name: | Ventilator, non-continuous (respirator), accessory<br>BZD - 868.5905 |
| Device: | ARCimed CPAP mask |
| Predicate Devices: | ResMed - Quattro Full Face Mask - K063122<br>Advanced Warming - Adhesive mask - K950771<br>Respironics Full face mask - K002465 |

#### Device Description:

The proposed patient interface face mask incorporates a number of features, which are designed to maximize seal and comfort, and maintain the mask in the correct position throughout use.

- Adhesive foam to seal to the patient face .
- . One size - medium
- Models with and without Integral fixed leak (exhalation) port .

| Indications for Use: | A patient interface, face mask, for use with CPAP and bi-level systems used in the treatment of adult (>30 kg) OSA and / or ventilatory support. Two styles (with exhalation port and without exhalation port). | |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| | Single use only < 24 hours. | |
| Patient Population: | Adults (>30 kg) with OSA | |
| Environment of Use: | Hospitals, Home, sub-acute care settings | |

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K071915 Page 2 of 3

# Non-Confidential Summary of Safety and Effectiveness

Comparative table:

| Features | Predicates | Proposed Device |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | ResMed Quattro<br>Full Face Mask - K063122<br>Advanced Warming -<br>Adhesive Mask - K950771<br>Respironics Full face mask –<br>K002465 | ARCimed CPAP mask |
| Indications for use | A patient interface for use with<br>CPAP and bi-level systems used<br>in the treatment of adult (> 30<br>kg) OSA and / or ventilatory<br>support.<br><br>Anesthesia face mask with<br>adhesive seal (Advanced<br>Warming - K950771) | A patient interface for use with<br>CPAP and bi-level systems used in<br>the treatment of adult (>30 kg) OSA<br>and / or ventilatory support. |
| Environment of<br>Use | Home, Hospital, Sub-acute<br>Institutions | Same |
| Patient Population | Adult | Same |
| Contraindications | None | None |
| Disposable, single<br>patient use | No – multi-use – K063122<br>Yes – K950771 | Yes |
| Components | Shell<br>Cushion<br>Adhesive seal (K950771) | Shell<br>Foam<br>Adhesive seal |
| Dead space | 203 ml (K063122) | 91 ml |
| Fixed leak port | ResMed Quattro K063122 | |
| Exhaust Flow<br>range | Pressure / Flow (lpm)<br>3 cm H2O / 17.8 lpm<br>10 cm H2O / 31.5 lpm<br>20 cm H2O / 42.6 lpm<br>30 cm H2O / 51.7 lpm<br>40 cm H2O / 60.1 lpm | Pressure / Flow (lpm)<br>3 cm H2O / 19.9 lpm<br>10 cm H2O / 33.3 lpm<br>20 cm H2O / 47.1 lpm<br>30 cm H2O / 58.0 lpm<br>40 cm H2O / 67.8 lpm<br>Pass / fail +/- 15% |

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K071915 Page 3 of 3

#### Non-Confidential Summary of Safety and Effectiveness Page 3 of 3 7-May-08

| Features | Predicates | Proposed Device |
|---------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | ResMed Quattro<br>Full Face Mask - K063122<br>Advanced Warming –<br>Adhesive Mask - K950771<br>Respironics Full face mask –<br>K002465 | ARCimed CPAP mask |
| Vented and<br>Non-vented styles<br>requires anti-<br>asphyxia valve in<br>the circuit | Yes – ResMed – K063122<br><br>Offer a mask with optional anti-asphyxia valve | Vented and Non-vented models<br>requires attachment to a circuit with<br>anti-asphyxia valve incorporated<br>demonstrated to activate AAV valve<br>equivalent to predicates<br><br>Should be used with AAV with<br>minimum opening pressures of < 3 cm H2O |
| Pressure Drop<br>(Resistance to<br>flow) | ResMed – K063122<br>0.59 cm H2O @ 50 lpm<br>1.2 cm H2O @ 100 lpm | 0.35 cm H2O @ 50 lpm<br>0.81 cm H2O @ 100 lpm |
| CO2 rebreathing<br>Measured change<br>from baseline | ResMed – K063122<br>0.25% EtCO2 | 0.06% EtCO2 |
| Adhesive as a seal | Advanced Warming – K950771<br>Offers a tight seal<br>No performance requirements<br>other have will remain attached<br>to patient's face | We are claiming no performance<br>requirements other than the mask<br>will seal and remain attached to the<br>patient's face. |

### Differences Between Other Legally Marketed Predicate Devices:

The proposed device is viewed as substantially equivalent to the predicate devices, K950771, K002465, and K063122.

There are no significant differences that affect the safety or effectiveness of the intended device as compared to the predicate devices.

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Image /page/3/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" arranged around the perimeter. Inside the circle is a stylized eagle-like symbol with flowing lines, representing the department's mission related to health and human well-being.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 4 2008

ARCimed Laboratories LLC C/O Mr. Paul E. Dryden President ProMedic, Incorporated 24301 Woodsage Drive Bonita Springs, Florida 34134-2958

Re: K071915

Trade/Device Name: ARCimed CPAP Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: May 8, 2008 Received: May 9, 2008

Dear Mr. Dryden:

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.

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#### Page 2 - Mr. Dryden

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 (QS) 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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

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

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#### Indications for Use Statement

Page 1 of 1

510(k) Number: K071915 (To be assigned)

Device Name: ARCimed CPAP mask

Indications for Use: A patient interface, face mask, for use with CPAP and bilevel systems used in the treatment of adult (>30 kg) OSA and / or ventilatory support. Two styles (with exhalation port and without exhalation port).

Single use only < 24 hours.

Prescription Use XX (Part 21 CFR 801 Subpart D) 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)

signature

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K671915