MINIME PEDIATRIC MASK

K090935 · Sleepnet Corporation · BZD · Jul 1, 2009 · Anesthesiology

Device Facts

• Record ID: K090935
• Device Name: MINIME PEDIATRIC MASK
• Applicant: Sleepnet Corporation
• Product Code: BZD · Anesthesiology
• Decision Date: Jul 1, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The MiniMe™ Pediatric Mask is intended to provide an interface for application of CPAP or bi-level therapy. It is intended for patients > 2 years old and < 12 years old. The MiniMe Pediatric Mask is intended for single patient, multi-use in the home environment and multiple patients, multi-use in the hospital/ institutional environment.

Device Story

MiniMe™ Pediatric Mask serves as patient interface for CPAP or bi-level therapy; designed for pediatric patients aged 2-12 years. Device features vent holes for fixed leak or operates without vents when used with circuits containing anti-asphyxia valves. Reusable mask intended for single-patient home use or multi-patient hospital/institutional use. Clinicians or caregivers apply mask to patient; device facilitates delivery of prescribed positive airway pressure therapy. Benefits include non-invasive respiratory support for pediatric population. Performance verified via pressure vs. flow/leak and internal volume/dead space testing.

Clinical Evidence

Bench testing only. Comparative performance testing conducted, including pressure vs. flow/leak and internal volume/dead space testing, to demonstrate substantial equivalence to predicate devices.

Technological Characteristics

Reusable pediatric mask interface; includes vent holes for fixed leak or non-vented configuration for use with anti-asphyxia valve circuits. Materials identical to predicate devices. No electronic components or software.

Indications for Use

Indicated for patients aged > 2 years and < 12 years requiring CPAP or bi-level therapy via a patient interface mask.

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

• Respironics ComfortGel (K073600 / K954207)
• Respironics ComfortLite2 (K053352)
• Airway Development Clarissa (K032922)
• ResMed Kidsta (K060105)
• SleepNet MiniMe (K013306)

Submission Summary (Full Text)

{0}------------------------------------------------

K090935

510(k) Summary Page 1 of 2 18-Jun-09

JUL - 1 2009

| SleepNet Corporation | |
|----------------------------|-----------------------------------------------------------------------------|
| 5 Merrill Industrial Drive | Tel - 603-758-6625 |
| Hampton, NH 03842 | Fax - 603-758-6699 |
| Official Contact: | Jennifer Kennedy - Director of Quality |
| Proprietary or Trade Name: | MiniMe™ Pediatric Mask |
| Common/Usual Name: | Patient interface |
| Classification Code/Name: | BZD - accessory for ventilator, non-continuous (respirator)<br>CFR 868.5905 |
| Device: | MiniMe™ Pediatric Mask |
| Predicate Devices: | K073600 / K954207 - Respironics ComfortGel |
| | K053352 - Respironics ComfortLite2 |
| | K032922 -- Airway Development Clarissa |
| | K060105 - ResMed Kidsta |
| | K013306 - SleepNet MiniMe |

### Device Description:

The SleepNet MiniMe™ Pediatric Mask with vent holes for a fixed leak during use and without vent holes when used with a patient circuit that incorporates its own anti-asphyxia valve,

It is single patient, multi-use or multi-patient, reusable.

#### Indications for Use:

The MiniMe™ Pediatric Mask is intended to provide an interface for application of CPAP or bilevel therapy. It is intended for patients > 2 years old and < 12 years old. The MiniMe Pediatric Mask is intended for single patient, multi-use in the home environment and multiple patients, multi-use in the hospital/ institutional environment.

Patient Population: For patients aged > 2 years and < 12 years old

Environment of Use: Home or hospital / institutional environments.

The MiniMeTM is viewed as substantially equivalent to the predicate devices because:

#### Indications -

- Identical to predicates K954207, K053352 .
#### Patient Population -

- Similar to K032922 and K060105 fits between these populations with no new risks .

{1}------------------------------------------------

# 510(k) Summary Page 2 of 2 18-Jun-09

# Technology -

- Identical technology to SleepNet MiniMeTM K013306 ◆
### Materials -

- The materials in patient contact identical to predicate devices .
### Environment of Use -

- · Identical to predicates SleepNet K013306, Respironics K954207 and K053352
### Differences -

There are no differences between the predicates and the proposed device. We are only changing the indications for use.

### Comparative Performance

We have performed comparative performance testing including -- Pressure vs. Flow / leak and Internal volume / dead space testing.

The results demonstrated that the devices were substantially equivalent.

{2}------------------------------------------------

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

#### Public Health Service

JUL - 1 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

ProMedicm, Incorporated C/O Paul E. Dryden President SleepNet Corporation 24301 Woodsage Drive Bonita Springs, Florida 34134-2958

Re: K090935

Trade/Device Name: MiniMeTM Pediatric Mask Regulation Number: 21 CFR 868 5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: June 18, 2009 Received: June 19, 2009

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 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.

{3}------------------------------------------------

# 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 yours,

Susan Runner, D.D.S., M.A.

Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

## Enclosure

{4}------------------------------------------------

# Indications for Use Statement

Page 1 of 1

510(k) Number:

K090935

Device Name:

MiniMe™ Pediatric Mask

Indications for Use:

The MiniMe™ Pediatric Mask is intended to provide an interface for application of CPAP or bi-level therapy. It is intended for patients > 2 years old and < 12 years old.

The MiniMe Pediatric Mask is intended for single patient, multi-use in the home environment and multiple patients, multi-use in the hospital/ institutional environment.

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)

Susan Ginse

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

510(k) Number: K090935