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.

Device Description

The single-use Nasal Scavenging Circuit is designed for the removal of patient expired and excess gases during conscious sedation procedures.

AI/ML Overview

This document describes a 510(k) premarket notification for a medical device called the "Nasal Scavenging Circuit." This type of submission focuses on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device, rather than proving its independent safety and effectiveness through extensive clinical trials as would be required for a Premarket Approval (PMA) application.

Therefore, the study conducted is not a traditional performance study comparing specific metrics against pre-defined acceptance criteria in the way an AI/ML device would be. Instead, the "study" is a set of non-clinical bench tests designed to show that the new device does not raise new issues of safety or effectiveness compared to its predicate.

Here's an analysis based on the provided text, addressing your specific questions to the best extent possible given the nature of a 510(k) submission for this type of device:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Implied)	Reported Device Performance
Safety: Device causes no additional safety issues for the patient.	"bench testing was performed. These tests confirmed that the device causes no additional safety issues for the patient." The device's technological characteristics, indications for use, and performance specifications are stated to be the same as the predicate device (Fraser Harlake Dental Anti-Pollution System (K833692)), implying that it performs at least as safely and effectively as the predicate. Adherence to pertinent sections of voluntary standards (NIOSH Publication No. 94-129, ISO 5356-1, ISO 5367, ANSI Z79.11-1982, CGA V-5) for design indicates meeting established safety and performance benchmarks for components and functionality.
Effectiveness: Device performs its intended function for removal of expired/excess gases.	"The indications for use, the technology, and the performance specifications are the same for the Nasal Scavenging Circuit and the predicate device." This statement is the core of the substantial equivalence claim, meaning its effectiveness is considered equivalent to the predicate. The bench testing would have demonstrated functional performance, such as gas flow, scavenging efficiency, and connection integrity, consistent with the predicate device and relevant voluntary standards, though specific numerical performance metrics are not detailed in this summary.
Substantial Equivalence: Device does not raise new issues of safety or effectiveness.	The FDA’s letter confirms that the device is "substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices," based on the provided data from the manufacturer.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not applicable in the context of human data. The "test set" consisted of physical devices subjected to non-clinical bench testing. The number of units tested is not specified in this summary.
Data Provenance: The testing was "bench testing" meaning it was conducted in a laboratory setting. The location of MINRAD Inc. (Orchard Park, New York, USA) suggests the testing likely occurred in the USA or a facility associated with the company.
Retrospective or Prospective: Not applicable for bench testing. It's a controlled experimental evaluation of the physical device's performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is a physical device being evaluated for substantial equivalence through non-clinical bench testing, not an AI/ML diagnostic device requiring expert interpretation of clinical data to establish ground truth. The "ground truth" (or performance standard) would be defined by the technical specifications of the predicate device and the relevant voluntary standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods like "2+1" typically apply to expert reviews of clinical cases (e.g., in radiology studies) where there might be disagreement among reviewers on a diagnosis or finding. This submission involves bench testing of a physical device. Performance would be an objective measurement against a standard, not a subjective interpretation requiring adjudication.

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

No. An MRMC study is not relevant for this device. This is a physical gas scavenging circuit, not an AI/ML-driven diagnostic tool that assists human readers in interpreting data.

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

Not applicable. This device is a physical product, not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this 510(k) submission is effectively the performance and safety profile of the predicate device (Fraser Harlake Dental Anti-Pollution System (K833692)) and adherence to relevant voluntary standards (e.g., NIOSH, ISO, ANSI, CGA V-5). The bench tests verify that the new device meets or is equivalent to these established engineering and safety standards.

8. The sample size for the training set

Not applicable. This device does not involve machine learning or AI, so there is no "training set."

9. How the ground truth for the training set was established

Not applicable. No training set exists for this type of device submission.

Summary

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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: (800) 832-3303 • (716) 855-1068 • Fax: (716) 855-1078

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NASAL SCAVENGING CIRCUIT PREMARKET NOTIFICATION 510(k)

9.	Voluntary standards:	Performance Standards have not been promulgated for thisdevice, however pertinent sections of the standards listedbelow were followed during the design of the device:National Institute for Occupational Safety and Health(NIOSH) Publication No. 94-129 Technical Report –Control of Nitrous Oxide in Dental Operatories International Standards Organization ISO 5356-1:2004(E) Anaesthetic and respiratory equipment –conical connectors, Part 1: Cones and sockets International Standards Organization ISO 5367:2000(E)Breathing Tubes intended for use with anaestheticapparatus and ventilators American National Standards Institute ANSI Z79.11-1982 for anesthetic equipment – scavenging systems forexcess anesthetic gases CGA V-5 – 2005 Diameter Index Safety System (DISS)(Non-interchangeable Low Pressure Connections forMedical Gas Applications)
10.	Intended use:	For Relative Analgesia [Conscious Sedation]
11.	Indication for Use:	This disposable device is to be used in conjunction withconscious sedation systems for the delivery to a patient amixture of analgesic agent and oxygen gases, or analgesic agentand air, for the removal from the treatment location of gasesexpired by the patient, and removal from the treatment locationany excess gases delivered to a patient. The device is suppliednon-sterile and latex-free.
12.	Technologicalcharacteristics:	The indications for use, the technology, and the performancespecifications are the same for the Nasal Scavenging Circuit andthe predicate device.
13.	Non-Clinical Testing	In order to verify that the Nasal Scavenging Circuit does notraise new issues of safety or effectiveness and, thus, issubstantially equivalent to the predicate device, bench testingwas performed. These tests confirmed that the device causes noadditional safety issues for the patient.

This concludes the 510(k) summary.

50 Cobham Drive • Orchard Park, New York 14127 • Tel: (800) 832-3303 • (716) 855-1068 • Fax: (716) 855-1078

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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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 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:

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)

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).