AUTOMATIC VACUUM SWITCH (AVS) MODEL NUMBER AVS 5000

K981754 · Porter Instrument Co., Inc. · CBN · Jun 16, 1998 · Anesthesiology

Device Facts

• Record ID: K981754
• Device Name: AUTOMATIC VACUUM SWITCH (AVS) MODEL NUMBER AVS 5000
• Applicant: Porter Instrument Co., Inc.
• Product Code: CBN · Anesthesiology
• Decision Date: Jun 16, 1998
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5430
• Device Class: Class 2

Intended Use

For control of vacuum flow in a gas scavenging apparatus, used as an accessory in Porter Instrument Company's Nitrous Oxide Sedation Systems with Dental Analgesia Gas Machines (flowmeters).

Device Story

The Automatic Vacuum Switch (AVS) is an accessory for dental nitrous oxide sedation systems. It functions as an interlock mechanism to ensure that analgesic gas flow is only enabled when the vacuum-based gas scavenging system is active. The device monitors the status of the scavenging system and controls the vacuum flow accordingly. It is intended for use in dental clinical settings by dental professionals. By preventing gas delivery without active scavenging, the device reduces the risk of occupational exposure to waste anesthetic gases, thereby enhancing safety for the dental staff.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including functional testing, visual inspection, backpressure testing, delivery and vacuum flow testing, internal and external leak testing, and simulated use testing. A detailed risk assessment, including Failure Mode Effects Analysis (FMEA) and Hazard Analysis, was performed.

Technological Characteristics

The AVS is a mechanical/pneumatic interlock switch designed for integration with dental gas flowmeters. It operates as a vacuum-controlled valve to regulate gas scavenging flow. The device is subject to internal manufacturing procedures and quality control standards (QSP 5-1). It is a non-electronic, accessory-level component.

Indications for Use

Indicated for use as an accessory to dental nitrous oxide sedation systems to control vacuum flow in gas scavenging apparatuses, ensuring analgesic gases cannot be activated unless the scavenging system is operational.

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

• Double Mask (K761140)
• Clean Air Pollution Reduction System (K802067)

Submission Summary (Full Text)

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## JUN 16 1998

## 510(k) Summary of Safety and Effectiveness In accordance with SMDA '90

May 15, 1998

Porter Instrument Co., Inc 245 Township Line Road PO Box 907 Hatfield PA 19440-0907

Stephen D. Loeffler, Manager of Engineering and Quality Contact: Telephone: [phone] Automatic Vacuum Switch, dental Common/Usual Product Name:

Porter Instrument Company, Inc., Trade/Proprietary Name: Automatic Vacuum Switch (AVS)

Classification Name:

Anesthesiology Non-classified* Accessory to § 868.5430 Gas scavenging apparatus. Class 2

Substantial Equivalence1 to:

| 510(k) # | Name | Applicant |
|----------|--------------------------------------|-----------------------------|
| K761140 | Double Mask | Fraser Sweatman |
| K802067 | Clean Air Pollution Reduction System | Porter Instrument Co., Inc. |

Device Description:

In accordance with section 510(k) for the Federal Food, Drug, and Cosmetic Act, Porter Instrument Company, Inc. intends to introduce into interstate commerce the Automatic Vacuum Switch (AVS) device. The automatic interlock switch (AVS) is a device intended to assure that analgesic gases cannot be turned on unless an activated scavenging system is present.

Porter Instrument Company, Inc. 510(k) for the Automatic Vacuum Switch

Porter Instrument Company, Inc. - 510(k) Submission for the Automatic

Attachment # 11.01

¹ The term "substantially equivalent" as use herein is intended to be a determination of substantial equivalence from an FDA -regulatory point of view under the Federal Food, Drug, and Cosmetic Act and relates to the fact that the product can be marketed without premarket approval or reclassification. These products may be considered distinct from a patient point of view. The term "substantially equivalent" is not applicable to and does not diminish any patient claims related to this product or the technology used to manufacture the product.

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#### Intended Use

For control of vacuum flow in a gas scavenging apparatus, used as an accessory in Porter Instrument Company's Nitrous Oxide Sedation Systems with Dental Analgesia Gas Machines (flowmeters).

### Substantial Equivalence

The Automatic Vacuum Switch (AVS) is substantially equivalent, in comparison to the legally marketed device, because it:

- . has the same intended use as the predicate device; and
- has different technological characteristics, and
- the information submitted to FDA; .
- does not raise new questions of safety and effectiveness, and ・
- demonstrates that the Automatic Vacuum Switch (AVS) is as safe and as effective as the legally marketed device

Different technological characteristics include, but are not limited to, changes in materials, design, energy sources, and principles of operation.

Porter Instrument Company's claim of substantial equivalence does not mean the compared devices are identical but that the substantial equivalence is established with respect to: intended use, design, energy used or delivered, materials, performance, safety, effectiveness, labeling, biocompatibility, standards, and other applicable characteristics.

#### Safety and Effectiveness

1. 3

All finished products are function tested and must meet all required specifications before release to distribution. A range of tests is required for release, which include, but are not limited to; a functional test and a visual inspection (both in process and finished product).

The function test and the visual inspection are defined in both Porter's manufacturing procedure and inspection procedure. These documents are established test procedures, which conform to the product design specifications.

All procedures and records for this product are approved, released, distributed and revised according to Porter Instrument Company's Document & Data Control procedure QSP 5-1.

Qualification of the Automatic Vacuum Switch (AVS) included a detailed risk assessment, which attended to a Failure Mode Effects Analysis and a Hazard Analysis. Additional testing covered: backpressure, delivery and vacuum flow, internal and external leak testing, complete system testing and simulated use testing.

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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 image of an eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the eagle in a circular fashion.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 16 1998

Mr. Stephen D. Loeffler Porter Instrument Company, Inc. 245 Township Line Road P.O. Box 907 Hatfield, PA 19440-0907

K981754 Re: Trade Name: Automatic Vacuum Switch (AVS) Regulatory Class: Unclassified Product Code: 73 CBN May 15, 1998 Dated: Received: May 18, 1998

Dear Mr. Loeffler:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: . General ... . (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Stephen D. Loeffler

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Thomas J. Callalon

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

11

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# Statement of Indications for Use

The intended use of the AVS accessory is to control the vacuum flow in a gas scavenging apparatus.

Special 510(k) statement: The intended use of the modified device, as described in our labeling, has not changed as a result of the modifications.

Wolf Sepulveda MD
(Division Sign-Off)

Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number_ E

Page 7 of 61 Porter Instrument Company, Inc. - 510(k) Submission for the Automatic Vacuum Switch

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