MINRAD INC. NASAL SCAVENGING CIRCUIT

K072255 · Minrad, Inc. · CBN · Oct 18, 2007 · Anesthesiology

Device Facts

• Record ID: K072255
• Device Name: MINRAD INC. NASAL SCAVENGING CIRCUIT
• Applicant: Minrad, Inc.
• Product Code: CBN · Anesthesiology
• Decision Date: Oct 18, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5430
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For Relative Analgesia [Conscious Sedation]

Device Story

Single-use Nasal Scavenging Circuit designed for conscious sedation procedures. Device connects to conscious sedation systems to deliver medical gases (analgesic agent/oxygen or air) to patients. Simultaneously functions to scavenge and remove patient-expired gases and excess/unused gases from the treatment environment. Used in clinical settings by healthcare providers. Benefits include reduction of environmental exposure to waste anesthetic gases during sedation.

Clinical Evidence

Bench testing only. Testing verified performance against NIOSH Publication No. 94-129, ISO 5356-1:2004(E), ISO 5367:2000(E), ANSI Z79.11-1982, and CGA V-5-2005 standards to ensure safety and effectiveness.

Technological Characteristics

Single-use, non-sterile, latex-free gas scavenging apparatus. Conforms to ISO 5356-1 (conical connectors), ISO 5367 (breathing tubes), ANSI Z79.11 (scavenging systems), and CGA V-5 (DISS connections). Mechanical design for gas delivery and removal.

Indications for Use

Indicated for use in conjunction with conscious sedation systems for the delivery of analgesic agent and oxygen or air to patients, and for the removal of expired, excess, and unused gases from the treatment location. Prescription use only.

Regulatory Classification

Identification

A gas-scavenging apparatus is a device intended to collect excess anesthetic, analgesic, or trace gases or vapors from a patient's breathing system, ventilator, or extracorporeal pump-oxygenator, and to conduct these gases out of the area by means of an exhaust system.

Predicate Devices

• Fraser Harlake Dental Anti-Pollution System (K833692)

Submission Summary (Full Text)

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## NASAL SCAVENGING CIRCUIT PREMARKET NOTIFICATION 510(k)

ULL 1 8 2007

Image /page/0/Picture/2 description: This document is a 510(k) summary for MINRAD Inc. It includes the owner's name, address, contact information, preparation date of August 10th, 2007, device name (Nasal Scavenging Circuit), common name (Gas Scavenging Apparatus), product classification, predicate device (Fraser Harlake Dental Anti-Pollution System (K833692)), and a description of the device. The single-use Nasal Scavenging Circuit is designed for the removal of patient expired and excess gases during conscious sedation procedures.

i0 Cobham Drive • Orchard Park, New York 14127 • Tel: [phone] • [phone] • Fax: [phone]

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# NASAL SCAVENGING CIRCUIT PREMARKET NOTIFICATION 510(k)

| 9. | Voluntary standards: | Performance Standards have not been promulgated for this<br>device, however pertinent sections of the standards listed<br>below were followed during the design of the device:<br>National Institute for Occupational Safety and Health<br>(NIOSH) Publication No. 94-129 Technical Report –<br>Control of Nitrous Oxide in Dental Operatories International Standards Organization ISO 5356-1:<br>2004(E) Anaesthetic and respiratory equipment –<br>conical connectors, Part 1: Cones and sockets International Standards Organization ISO 5367:2000(E)<br>Breathing Tubes intended for use with anaesthetic<br>apparatus and ventilators American National Standards Institute ANSI Z79.11-<br>1982 for anesthetic equipment – scavenging systems for<br>excess anesthetic gases CGA V-5 – 2005 Diameter Index Safety System (DISS)<br>(Non-interchangeable Low Pressure Connections for<br>Medical Gas Applications) |
|-----|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 10. | Intended use: | For Relative Analgesia [Conscious Sedation] |
| 11. | Indication for Use: | This disposable device is to be used in conjunction with<br>conscious sedation systems for the delivery to a patient a<br>mixture of analgesic agent and oxygen gases, or analgesic agent<br>and air, for the removal from the treatment location of gases<br>expired by the patient, and removal from the treatment location<br>any excess gases delivered to a patient. The device is supplied<br>non-sterile and latex-free. |
| 12. | Technological<br>characteristics: | The indications for use, the technology, and the performance<br>specifications are the same for the Nasal Scavenging Circuit and<br>the predicate device. |
| 13. | Non-Clinical Testing | In order to verify that the Nasal Scavenging Circuit does not<br>raise new issues of safety or effectiveness and, thus, is<br>substantially equivalent to the predicate device, bench testing<br>was performed. These tests confirmed that the device causes no<br>additional safety issues for the patient. |

This concludes the 510(k) summary.

50 Cobham Drive • Orchard Park, New York 14127 • Tel: [phone] • [phone] • Fax: [phone]

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines forming its body and head. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circle around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

#### OCT 1 8 2007

Mr. John McNeirney Vice President and Chief Technical Officer MINRAD, Incorporated 50 Cobham Drive Orchard Park, New York 14127

Re: K072255

Trade/Device Name: Nasal Scavenging Circuit Regulation Number: 21 CFR 868.5430 Regulation Name: Gas-Scavenging Apparatus Regulatory Class: II Product Code: CBN Dated: October 12, 2007 Received: October 15, 2007

Dear Mr. McNeirney:

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. McNeirney

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 yours,

Sandite Y. Michie DMD.

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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### NASAL SCAVENGING CIRCUIT PREMARKET NOTIFICATION 510(k)

Additional information per 510(k) response letter received August 31, 2007 from Dr. Chiu Lin: ISSUE 1, ATTACHMENT 1 K072255

#### 4.0 Indications for Use Statement

# Indications for Use

510(k) Number (if known):

Device Name: Nasal Scavenging Circuit

Indications for Use:

The single-use Nasal Scavenging Circuit is intended to be used in conjunction with a conscious sedation system for the delivery of medical gases to the patient, and for the removal of expired, excess and unused gases from the treatment location.

Mirt Thilal

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

07 2255 510(k) Number:

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)