The SurgiQuest AirSeal ® Optical Trocar & Cannula System with integrated Insufflator DPIS 2000 (the "DPIS 2000 System") is intended for use in diagnostic and/or therapeutic endoscopic procedures to distend the peritoneal cavity by filling it with gas, to establish and maintain a path of entry for endoscopic instruments and to evacuate surgical smoke. The trocar of the DPIS 2000 System is indicated for use with or without visualization.

Device Description

The SurgiQuest AirSeal® Optical Trocar & Cannula Device Description: System with integrated Insufflator DPIS 2000 (the "DPIS System") consists of of the following 2000 major components: (1) a trocar, (2) a cannula, (3) tube sets, and (4) a micro-processor controlled insufflation, recirculation and filtration unit (the "DPIS 2000 Unit"). The cannula, trocar and tube sets are sterile, single-use products. The DPIS 2000 Unit is non-sterile and reusable.

The DPIS 2000 Unit is designed to function in one of three (3) separate modes of operation: (a) Insufflation Mode; (b) AirSeal Mode; or (c) Smoke Evacuation Mode.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on what is present and noting what is absent for a comprehensive understanding:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text describes various tests and standards met by the device, rather than explicit "acceptance criteria" presented as quantitative thresholds. However, we can infer the performance statements from what was tested and validated.

Acceptance Criteria (Inferred from testing)	Reported Device Performance
Pneumoperitoneum Maintenance: Ability to create and maintain pneumoperitoneum in all operating modes (Insufflation, AirSeal, Smoke Evacuation).	"Bench test results demonstrate that the DPIS 2000 System is safe and effective in creating and maintaining pneumoperitoneum in all three modes."
Sterility Assurance Level (SAL): SAL of ≤ 10-6.	"A sterility assurance level (SAL) is ≤ 10-6 achieved."
Ethylene Oxide and Ethylene Chlorohydrin Residuals: EO < 5 mg / 10 days, ECH < 5 mg / 10 days remained on the tube set.	"Residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) data shows that the limit of EO < 5 mg / 10 days and ECH < 5 mg / 10 days that remain on the tube set will not be exceeded."
Biocompatibility: Meet standards for cytotoxicity, irritation, and delayed type hypersensitivity.	Biocompatibility testing performed in accordance with ISO 10993-5, ISO 10993-10, and ISO 10993-12. (Implies compliance with these standards.)
Material/Product Integrity: Packaging and product integrity maintained.	"Package and product integrity were tested in accordance with ISO11607-1, Packaging for Terminally Sterilized Medical Devices and ASTM-F-1980-02, Standard for Accelerated Aging of Sterile Medical Device Packages." (Implies compliance with these standards.)
Electrical Safety: Comply with general requirements for medical electrical equipment safety.	Tested in accordance with IEC 60601-1 and IEC 60601-1-2. (Implies compliance with these standards.)
Quality Management System: Compliance with relevant quality management standards.	"The DPIS 2000 Unit has been developed in accordance with 21 CFR 820, ISO 13485:2003 & ISO 14971:2007"
Substantial Equivalence: Same intended use, indication for use, operating principles, and design features as predicate devices.	Stated that the system is "substantially equivalent to the Substantial AirSeal Predicate Device (K071571, K083211, K092504) Equivalence: and to the Insufflation Predicate Device (K063367)."

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

Sample Size: The document does not specify the sample sizes used for any of the individual bench tests (e.g., pneumoperitoneum, sterility, biocompatibility, packaging). It only states that these tests were performed.
Data Provenance: The data is from "bench tests" performed by the manufacturer, SurgiQuest, Inc., in Orange, CT, USA. It is retrospective in the sense that the tests were conducted prior to the 510(k) submission, but it's not clinical data (prospective or retrospective patient data).

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

This information is not applicable as the device is a medical instrument (trocar, cannula, insufflator), not an AI/software device that requires expert-established ground truth for a test set. The validation relies on established engineering, biological, and sterility standards.

4. Adjudication Method for the Test Set

This information is not applicable for the same reason as point 3. Testing involves compliance with predefined standards and measurements, not subjective expert 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

Not applicable. This device is hardware (trocar, cannula, insufflator) and does not involve AI or human readers for diagnostic interpretation. Therefore, an MRMC study and AI assistance effect size are irrelevant.

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

Not applicable. This device is hardware and does not have a "standalone algorithm" performance to report.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on established engineering standards, biological safety standards (biocompatibility), and sterilization efficacy standards. For example, a sterility assurance level (SAL) of ≤ 10-6 is an industry-accepted "ground truth" for terminal sterilization. Similarly, the limits for residual ethylene oxide are defined by standards. For functional performance (pneumoperitoneum), the "ground truth" is whether the system performs as intended without significant issues on a test bench.

8. The Sample Size for the Training Set

Not applicable. This device is hardware and does not have a "training set" in the context of an AI/machine learning model. The development of the device would involve engineering design and iterative testing, but not a formally defined "training set" in the sense of AI.

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

Not applicable. As per point 8, there is no training set for this type of medical device submission.

Summary

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K/03692

MAY 25 2011

510(k) SUMMARY OF SAFETY & EFFECTIVENESS

Submitter:	SurgiQuest, Inc.12 Cascade Blvd. - Suite 2BOrange, CT 06477
Contact Person:	Daniel DonovanSr. Dir., Operations
	Phone: (203) 799-2400 Ext. 202Fax: (203) 799-2401e-mail: ddonovan@surgiquest.com
Date Prepared:	December 10, 2010
Trade Name:	SurgiQuest AirSeal® Optical Trocar & Cannula Systemwith integrated Insufflator DPIS 2000(Trade name subject to change)
Common Name:	Disposable Endoscopic Trocar and Cannula;Carbon Dioxide Insufflator for Laparascopy
Classification Name:	Endoscope and accessories under 21 C.F.R. 876.1500;Laparoscopic Insufflator under 21 C.F.R. 884.1730
Regulatory Class:	II
Product Code:	GCJ and HIF
Predicate Devices:	SurgiQuest AirSeal Optical Trocar & Cannula System,SurgiQuest, Inc., K071571
	AirSeal Optical Trocar & Cannula System, SurgiQuest,Inc., K083211
	SurgiQuest AirSeal Optical Trocar & Cannula SystemSurgiQuest, Inc., K092504
	45L High Core Insufflator F114W.O.M. World of Medicine AG, K063367

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The DPIS 2000 Unit is designed to function in one of three (3) separate modes of operation: (a) Insufflation Mode; (b) AirSeal Mode; or (c) Smoke Evacuation Mode.

The SurgiQuest AirSeal® Optical Trocar & Cannula Intended Use: System with integrated Insufflator DPIS 2000 (the "DPIS 2000 System") is intended for use in diagnostic and/or therapeutic endoscopic procedures to distend the peritoneal cavity by filling it with gas, to establish and maintain a path of entry for endoscopic instruments and to evacuate surgical smoke. The trocar of the DPIS 2000 System is indicated for use with or without visualization.

The DPIS 2000 System is substantially equivalent to the Substantial AirSeal Predicate Device (K071571, K083211, K092504) Equivalence: and to the Insufflation Predicate Device (K063367). Specifically, the proposed device has the same intended use and the same indication for use as the Predicate Devices. In addition, the DPIS 2000 System and the Predicate Devices use the same or similar basic operating principles and incorporate the same or similar basic design features. Finally, biocompatibility, sterility, packaging and bench testing demonstrate the safety and effectiveness of the proposed device.

Bench test results demonstrate that the DPIS 2000 System is safe and effective in creating and maintaining pneumoperitoneum in all three modes.

The DPIS 2000 Unit has been developed in accordance with 21 CFR 820, ISO 13485:2003 & ISO 14971:2007

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and will be tested in accordance with IEC 60601-1. General Requirements for Medical Electrical Equipment -Part 1: General Requirements for Safety and IEC60601-1-2, Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests.

Gamma sterility validation has been performed (and will be in the case of the Smoke Evacuation Tube Set) in accordance with ISO 11137 Sterilization of health care products - Radiation, Part 1 - Part 3 and AAMI TIR 27, Healthcare Products: Sterilization of Radiation Sterilization - Substantiation of 25kGY as a Sterilization Dose - Method VD Max. ETO sterility validation has been performed ISO 11135-1, Sterilization of health care products -Ethylene Oxide - Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices; and ISO 10993-7, Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide sterilization residuals. Residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) data shows that the limit of EO < 5 mg / 10 days and ECH < 5 mg / 10 days that remain on the tube set will not be exceeded.

A sterility assurance level (SAL) is ≤ 10- achieved. The foregoing sterility validation testing will be performed on the Smoke Evacuation Tube Set.

Package and product integrity were tested in accordance with ISO11607-1, Packaging for Terminally Sterilized Medical Devices and ASTM-F-1980-02, Standard for Accelerated Aging of Sterile Medical Device Packages. ISO 11137 -2, Sterilization of health care products --Radiation -- Part 2: Establishing the sterilization dose.

Finally, biocompatibility testing has been performed on the cannula, the optical trocar, the blunt tipped trocar including fixation device and the AirSeal® Tube Set (and will be in the case of the Smoke Evacuation Tube Set) in accordance with ISO 10993-5, Biological Evaluation of Medical Devices - Part 5: Tests for InVitro Cytotoxicity; ISO 10993-10, Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Delayed Type

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Hypersensitivity; and ISO 10993-5:2009, Biological Evaluation of Medical Devices - Part 12: Sample Preparation and Reference Material.]

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the circumference. Inside the circle is a stylized image of an eagle or bird-like figure with outstretched wings, rendered in a simple, abstract design.

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

SurgiQuest, Inc. % Mr. Daniel Donovan Sr. Director of Operations 12 Cascade Boulevard, Suite 2B Orange, Connecticut 06477

MAY 25 2011

Re: K103692

Trade/Device Name: SurgiQuest AirSeal® Optical Trocar & Cannula System with Integrated Insufflator DPIS 2000 Regulation Number: 21 CFR 884.1730 Regulation Name: Laparoscopic insufflator Regulatory Class: Class II Product Code: HIF, GCJ Dated: May 18, 2011 Received: May 19, 2011

Dear Mr. Donovan:

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. Daniel Donovan

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/CDRHQffices/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark A. Millan

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATMENT

510(k) Number (if known): K/03692

Device Name: SurgiQuest AirSeal® Optical Trocar & Cannula System with integrated Insufflator DPIS 2000

Indications for Use:

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)

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)

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(Division Sign-Off Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K103692

Regulation Number and Section

§ 884.1730 Laparoscopic insufflator.

(a)
Identification. A laparoscopic insufflator is a device used to facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it.(b)
Classification. (1) Class II (performance standards).(2) Class I for tubing and tubing/filter kits which include accessory instruments that are not used to effect intra-abdominal insufflation (pneumoperitoneum). The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.