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).
The intended use of the AVS accessory is to control the vacuum flow in a gas scavenging apparatus.
The intended use of the modified device, as described in our labeling, has not changed as a result of the modifications.

Device Description

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.

AI/ML Overview

This 510(k) summary describes a traditional medical device (Automatic Vacuum Switch - AVS), not an AI/ML powered device. Therefore, many of the requested categories related to AI/ML device testing are not applicable. I will address the applicable criteria based on the provided document.

Acceptance Criteria and Device Performance Study for the Automatic Vacuum Switch (AVS)

This document describes the validation of the Automatic Vacuum Switch (AVS) for use as an accessory in Nitrous Oxide Sedation Systems with Dental Analgesia Gas Machines. The primary purpose of the AVS is to interlock with the analgesic gas supply, ensuring that these gases cannot be activated unless an activated scavenging system is present.

The study aimed to demonstrate the device's safety and effectiveness and its substantial equivalence to legally marketed predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance / Assessment Method
Functional Performance	Device must ensure analgesic gases cannot be turned on unless an activated scavenging system is present.	Functional Test: All finished products undergo a functional test defined in Porter's manufacturing procedure, conforming to product design specifications, prior to release.
	Control of vacuum flow in a gas scavenging apparatus.	Functional Test: Confirmed as per manufacturing procedures. Specific Testing: Included tests for delivery and vacuum flow.
Safety	No new questions of safety raised compared to predicate devices. Device is as safe as legally marketed predicate devices.	Risk Assessment: Detailed risk assessment conducted, including Failure Mode Effects Analysis (FMEA) and Hazard Analysis. Specific Testing: Backpressure, internal and external leak testing, and complete system testing. Simulated Use Testing: Performed to confirm safe operation in use scenarios.
Effectiveness	Device is as effective as legally marketed predicate devices.	Functional Test: Confirmed as per manufacturing procedures. Specific Testing: Delivery and vacuum flow, complete system testing, and simulated use testing.
Visual Inspection	Device must meet visual inspection requirements.	Visual Inspection: Conducted both in-process and on finished products, as defined in Porter's inspection procedure and conforming to product design specifications.
Compliance	Adherence to Porter Instrument Company's Document & Data Control procedure (QSP 5-1) for all procedures and records, including approvals, releases, and revisions.	All procedures and records for this product are approved, released, distributed, and revised according to QSP 5-1. (Implies compliance was met as a quality system process).

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state a specific "test set" sample size in terms of a number of devices or data points from an independent clinical study. The testing described appears to be primarily verification and validation (V&V) testing performed during the device development and manufacturing process on production units. This includes:

Manufacturing Functional Tests: Applied to "All finished products." This implies 100% inspection during manufacturing.
Design Validation Testing: Risk assessment, backpressure, delivery and vacuum flow, leak testing, system testing, and simulated use testing would have been performed on a representative sample during the design validation phase. The exact number of units or test iterations is not specified in this summary.
Data Provenance: The data is generated internally by Porter Instrument Company, Inc. and is prospective in nature (i.e., created specifically for the device's validation and ongoing manufacturing quality control). No country of origin for a clinical dataset is applicable as a clinical study is not described.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

N/A. This medical device is a mechanical accessory; its "ground truth" is based on its physical functionality and adherence to engineering specifications and safety standards rather than expert-labeled diagnostic data. Technical experts (engineers, quality assurance personnel) within Porter Instrument Co. Inc. would have defined and assessed these criteria.

4. Adjudication Method for the Test Set

N/A. Not applicable for a mechanical device undergoing V&V testing. Results would be pass/fail based on pre-defined specifications, not expert adjudication of subjective outcomes.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

N/A. This is not an AI/ML device, and no MRMC study or human reader improvement analysis was conducted or is relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

N/A. This is a traditional mechanical device; there is no "algorithm only" performance to evaluate. The device functions as intended when installed and operated correctly.

7. The type of ground truth used

The "ground truth" for the AVS is based on engineering specifications and functional requirements. This includes:

Design Specifications: Detailed parameters for backpressure, flow rates, leak tolerances, and activation logic.
Safety Standards: Compliance with relevant medical device safety standards and risk assessment outcomes (FMEA, Hazard Analysis).
Intended Use Definition: The device successfully performs its specific function as an interlock for gas scavenging systems.

8. The Sample Size for the Training Set

N/A. This is not an AI/ML device; therefore, there is no "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set was Established

N/A. Not applicable for a non-AI/ML device.

Summary

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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: 215-723-4000 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

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 (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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

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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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Regulation Number and Section

§ 868.5430 Gas-scavenging apparatus.

(a)
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.(b)
Classification. Class II (performance standards).