The AS3700 Anesthesia Delivery System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation.

The AS3700 is intended for use by licensed clinicians, for patients requiring anesthesia within a health care facility, and can be used in both adult and pediatric populations.

Device Description

The AS3700 Anesthesia Delivery System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation.

AI/ML Overview

The provided text describes a 510(k) summary for the AS3700 Anesthesia Delivery System. This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study with specific acceptance criteria and performance metrics for a diagnostic or AI-driven device.

Therefore, many of the requested elements (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) are not applicable or cannot be extracted from this document.

However, I can extract the information relevant to how the device's performance was evaluated for its 510(k) clearance, which is primarily through compliance with recognized standards.

Here's the closest representation based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Standard/Requirement	Reported Device Performance
Safety	IEC 60601-1:1988+A1:1991+A2:1995	Compliant
	IEC 60601-1-4:2000	Compliant
	IEC 60601-1-8:2006	Compliant
	IEC 60601-2-13:2003	Compliant
	IEC 62366:2007 (Usability)	Compliant
	ISO10993-1: 2003 (Biocompatibility)	Compliant
	ISO 14971:2007 (Risk Management)	Compliant
	ISO 15223:2000 (Symbols)	Compliant
	ISO 5356-1:2004 (Anesthetic & Respiratory Equipment)	Compliant
	ISO 21647:2004 (Respiratory Gas Monitors)	Compliant
	CGA V-1:2005 (Compressed Gas Cylinders)	Compliant
	CGA V-5:2008	Compliant
	ASTM F1101-90:2003 (Anesthesia Systems)	Compliant
	CEN EN 980:1996 +A1:1999+A2:2001 (Symbols)	Compliant
Performance	Performance specifications equivalent to predicate devices	Compliant
	Risk analysis developed and hazards mitigated	Documented
Software	IEC 62304: 2006	Verified and Validated
Electromagnetic Compatibility (EMC)	IEC 60601-1-2:2007	Compliant

Study Proving Device Meets Acceptance Criteria:

The document states that "The AS3700 Anesthesia Delivery System has been tested and found to be in compliance with recognized safety, performance and electromagnetic compatibility standards." This implies a series of engineering verification and validation tests were conducted to ensure the device met the requirements of each listed standard. It also mentions a "risk analysis has been developed to identify potential hazards and document the mitigation of the hazards" and that "The device's software has been verified and validated in accordance with the appropriate test requirements."

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

Not applicable/Not provided: This is an engineering safety and performance validation, not a clinical study involving human data or a machine learning evaluation. The "test set" would refer to the physical device and its components undergoing testing against engineering standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable/Not provided: Ground truth in this context refers to the defined specifications within the listed industry standards, which are established by expert consensus within standards bodies, not by individual clinical experts for a specific test set. The engineers conducting the tests would be qualified in medical device testing and regulatory compliance.

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

Not applicable/Not provided: This pertains to clinical diagnostic studies involving reader interpretations, not engineering compliance testing.

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

Not applicable: This device is an anesthesia delivery system, not an AI-powered diagnostic or assistive tool.

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

Not applicable: This device operates with human input (licensed clinicians) and is not a standalone algorithm.

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

Engineering Standards and Specifications: The "ground truth" for this device's performance is adherence to the technical specifications outlined in the various IEC, ISO, CGA, and ASTM standards listed. These standards represent established best practices and safety requirements for anesthesia delivery systems.

8. The sample size for the training set

Not applicable: This is not a machine learning or AI device that requires a training set.

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

Not applicable: This is not a machine learning or AI device that requires a training set.

Summary

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K102471 FEB 1 1 2011

510(k) Summary AS3700 Anesthesia Delivery System

This 510(k) Summary is provided in accordance with the requirements of 21 CFR 807.92.

Date:	December 21, 2010
Submitter:	Mindray DS USA, Inc.800 MacArthur Blvd.Mahwah, NJ 07430Contact: Russell OlsenDirector, Quality Assurance and Regulatory AffairsTelephone: 201-995-8391Facsimile: 201-995-8605
Device Trade Name:	AS3700 Anesthesia Delivery System
Common Name:	Anesthesia Delivery
Device Classification:	§868.1560- BSZ - Gas Machine, Anesthesia
Predicate Devices:	AS3000 Anesthesia Delivery System /Mindray DS USA, Inc -K080175Avance / GE Datex-Ohmeda - K081844
Device description:	The AS3700 Anesthesia Delivery System is a device used toadminister to a patient, continuously or intermittently, a generalinhalation anesthetic and to maintain a patient's ventilation.
Indications for Use:	The AS3700 Anesthesia Delivery System is a device used toadminister to a patient, continuously or intermittently, a generalinhalation anesthetic and to maintain a patient's ventilation.The AS3700 is intended for use by licensed clinicians, for patientsrequiring anesthesia within a health care facility, and can be usedin both adult and pediatric populations.

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Technological Comparison to Predicate Devices:

The AS3700 is equivalent to predicated devices respecting indications for use, basic operation, performance specifications and energy supply.

Relative to the predicate devices, the AS3700 incorporates a 15" LCD touch screen and the use of digital flow meters. The predicate Avance incorporates similar technology. The AS3000 support a separate display and traditional mechanical flow meters.

The AS3700 and the predicate Avance support equivalent ventilation modes: VCV, PCV, PCV, PCV- VG, SIMV-PC, SIMV- PC and PS. The predicate AS3000 supports VCV, PCV, SIMV-PC, and PS.

The AS3700 and both predicate devices are indicated for use in adult and pediatric populations. The AS3700 provides default ventilation parameter settings for adults and two pediatric populations defined as child and small child. The predicate AS3000 provides default setting for adults and the pediatric population defined as child. The predicate Avance provides default settings based on patient weight.

Summary of Performance Testing:

The AS3700 Anesthesia Delivery System has been tested and found to be in compliance with recognized safety, performance and electromagnetic compatibility standards.

A risk analysis has been developed to identify potential hazards and document the mitigation of the hazards. The device's software has been verified and validated in accordance with the appropriate test requirements.

The AS3700 has been tested and found to be in compliance with the following safety, performance and electromagnet compatibility standards:

IEC 60601-1:1988+A1:1991+A2:1995 .
IEC 60601-1-2:2007 .
IEC 60601-1-4:2000 .
IEC 60601-1-8:2006 ●
IEC 60601-2-13:2003 .
IEC 62304: 2006 o

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IEC 62366:2007 .
ISO10993-1: 2003 .
ISO 14971:2007 .
ISO 15223:2000 .
ISO 5356-1:2004 .
ISO 21647:2004 .
CGA V-1:2005 .
CGA V-5:2008 .
ASTM F1101-90:2003 .
CEN EN 980:1996 +A1:1999+A2:2001 .

Conclusion:

Based on the description, technological comparison, performance testing and the supporting documentation, the AS3700 Anesthesia Delivery System is considered substantially equivalent to the predicate devices.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

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

Mr. Russell Olsen Vice President, Quality Assurance and Regulatory Affairs Mindray DS USA, Incorporated 800 MacArthur Boulevard Mahwah, New Jersey 07430

FEB 1 1 201

Re: K102471

Trade/Device Name: AS3700 Anesthesia Delivery System Regulation Number: 21 CFR 868.5160 Regulation Name: Gas Machine for Anesthesia or Analgesia Regulatory Class: II Product Code: BSZ Dated: February 10, 2011 Received: February 11, 2011

Dear Mr. Olsen:

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. Olsen

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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

for

Anthony 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):

Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The AS3700 Anesthesia Delivery System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation.

The AS3700 is intended for use by licensed clinicians, for patients requiring anesthesia within a health care facility, and can be used in both adult and pediatric populations.

ਮ Prescription Use (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 Device Evaluation (ODE)

(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
Page 1 of 1
K102471

510(k) Number:

Regulation Number and Section

§ 868.5160 Gas machine for anesthesia or analgesia.

(a)
Gas machine for anesthesia —(1)Identification. A gas machine for anesthesia is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The device may include a gas flowmeter, vaporizer, ventilator, breathing circuit with bag, and emergency air supply.(2)
Classification. Class II (performance standards).(b)
Gas machine for analgesia —(1)Identification. A gas machine for analgesia is a device used to administer to a patient an analgesic agent, such as a nitrous oxide-oxygen mixture (maximum concentration of 70 percent nitrous oxide).(2)
Classification. Class II (performance standards).