MINISPACER DUAL-SPRAY MDI ADAPTER WITH 22MM (OR 15MM) OD / 22MM OD/ID CONNECTIONS / 15MM ID CONNECTIONS

K102658 · Thayer Medical Corp. · CAF · Dec 10, 2010 · Anesthesiology

Device Facts

• Record ID: K102658
• Device Name: MINISPACER DUAL-SPRAY MDI ADAPTER WITH 22MM (OR 15MM) OD / 22MM OD/ID CONNECTIONS / 15MM ID CONNECTIONS
• Applicant: Thayer Medical Corp.
• Product Code: CAF · Anesthesiology
• Decision Date: Dec 10, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Dual Spray MINISPACER® MDI adapter is a single patient, disposable device for dispensing pressurized metered dose inhaler (pMD)) medication ito a breathing circuit, as prescribed by a physician or other licensed health care practitioner. The device is indicated for patients on a breathing circuit, for whom aerosol medication has been prescribed, in short term and long term critical care environments. The device is intended for sale by or on the order of a physician.

Device Story

MiniSpacer Dual Spray MDI Adapter is a single-patient, disposable device; facilitates delivery of pressurized metered dose inhaler (pMDI) medication into a breathing circuit. Used in critical care environments; operated by clinicians. Device connects to breathing circuit; allows pMDI actuation into airflow; ensures medication delivery to patient. Benefits include efficient aerosol administration for patients already on mechanical ventilation or breathing support.

Clinical Evidence

Bench testing only.

Technological Characteristics

Single-patient, disposable MDI adapter. Designed for integration into breathing circuits. Mechanical device; no electronic components, software, or energy source.

Indications for Use

Indicated for patients on a breathing circuit requiring aerosolized pMDI medication in short or long-term critical care environments. Prescription only.

Regulatory Classification

Identification

A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.

Submission Summary (Full Text)

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. James M. Strickland Chief Executive Officer Thayer Medical Corporation 4575 South Palo Verde Road. Suite 337 Tucson, Arizona 85714-1961

# DFC 1 0 2010

Re: K102658

Trade/Device Name: MiniSpacer® Dual Spray MDI Adapter Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: November 9, 2010 Received: November 10, 2010

Dear Mr. Strickland:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

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Page 2- Mr. Strickland

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 (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.

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/MedicalDevices/Safety/ReportaProblem/default.htm 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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

for

Anthony D. Watson, B.S., M.S., M.B.A. 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

### 510(k) Number (if known):

DEC 1 0 2010

Device Name: MiniSpacer® Dual Spray MDI Adapter

### Indications For Use:

The Dual Spray MINISPACER® MDI adapter is a single patient, disposable device for dispensing pressurized metered dose inhaler (pMD)) medication ito a breathing circuit, as prescribed by a physician or other licensed health care practitioner.

The device is indicated for patients on a breathing circuit, for whom aerosol medication has been prescribed, in short term and long term critical care environments.

The device is intended for sale by or on the order of a physician.

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 Deylee Eva

(Division Sign-Off)
Division of Anesthesiology, General Hospital
Division of Anesthesiology, General Devices (Division Sign-Off) Division of Anesthesisters

510(k) Number: