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 System with integrated Insufflator DPIS 2000 (the "DPIS 2000 System") consists of the following 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.

AI/ML Overview

The provided text is a 510(k) summary for the SurgiQuest AirSeal® Optical Trocar & Cannula System with integrated Insufflator DPIS 2000. It describes the device, its indications for use, and some of the testing performed to demonstrate its safety and effectiveness.

However, the document does not contain specific acceptance criteria values or detailed study results (like sample sizes, ground truth establishment, expert qualifications, or MRMC study details) that would allow for a comprehensive answer to your request regarding acceptance criteria and performance studies. The "TESTING" section briefly mentions the device's ability to create and maintain a port of entry, maintain pneumoperitoneum, and aid in smoke evacuation, but it doesn't quantify these abilities with specific metrics or acceptable ranges.

The only specific performance detail mentioned is related to sterilization:

Sterilization: Achieves a Sterility Assurance Level (SAL) of 10-6 in accordance with ISO 11137:2006 and AAMI TIR 27:2001.

Therefore, based only on the provided text, a complete table of acceptance criteria and device performance as requested, along with details about sample sizes, experts, adjudication, and specific study types (like MRMC or standalone), cannot be fully generated.

Here's what can be extracted and what is missing, based solely on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Stated or Implied)	Reported Device Performance (from text)
Sterility	Achieves a Sterility Assurance Level (SAL) of 10-6.
Pneumoperitoneum Maintenance	Tested to show its ability to maintain adequate pneumoperitoneum during laparoscopic surgery.
Smoke Evacuation	Tested to show its ability to aid in the evacuation of smoke.
Port of Entry creation/maintenance	Tested to show its ability to create and maintain a port of entry during simulated laparoscopic surgery.

Note: The acceptance criteria for pneumoperitoneum maintenance, smoke evacuation, and port of entry are descriptive ("adequate," "aid in," "ability to create and maintain") rather than quantifiable metrics with specific thresholds. The document does not provide the numerical results or the specific acceptance thresholds for these aspects beyond stating that they were tested successfully.

2. Sample size used for the test set and the data provenance

Sample size for test set: Not specified in the provided text.
Data provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective). The testing is generally referred to as "simulated laparoscopic surgery."

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

Not specified in the provided text. The testing mentioned in the document appears to be primarily laboratory/technical testing rather than human-expert-driven ground truth establishment for a diagnostic algorithm.

4. Adjudication method for the test set

Not applicable/Not specified in the provided text. (No diagnostic algorithm or expert review for ground truth described).

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/Not specified in the provided text. This is a medical device (trocar and insufflator), not an AI-assisted diagnostic tool.

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

Not applicable/Not specified in the provided text. This is a medical device, not an algorithm. The device itself performs functions.

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

For Sterility: Established based on compliance with ISO 11137:2006 and AAMI TIR 27:2001 standards.
For Functional Performance (Pneumoperitoneum, Smoke Evacuation, Port of Entry): The text implies that the ground truth was based on the device's ability to perform these functions during "simulated laparoscopic surgery" in a manner deemed "adequate" or successful. No further details on how "adequacy" or "success" were quantitatively defined and measured are provided.

8. The sample size for the training set

Not applicable/Not specified in the provided text. There is no mention of a "training set" as this device is not an AI/machine learning solution.

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

Not applicable/Not specified in the provided text. No training set is mentioned.

Summary

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SurgiQuest, Inc. , Modified SurgiQuest AirSeal® Optical Trocar & Cannula System with integrated Insufflator DPIS 2000 Special 510(k) Notification

XI. 510(k) SUMMARY OF SAFETY & EFFECTIVENESS

2012

SUBMITTER	SurgiQuest, Inc.333 Quarry RoadMilford, CT 06460	JUL
CONTACT PERSON	Daniel DonovanSr. Director of Operations - SurgiQuest, Inc.
DATE PREPARED	February 24, 2012
CLASSIFICATION	Endoscope and accessories under 21 C.F.R. 876.1500;Laparoscopic Insufflator under 21 C.F.R. 884.1730Product Code: GCJ and HIFClass: II
COMMON NAME	Disposable Endoscopic Trocar and Cannula;Carbon Dioxide Insufflator for Laparoscopy
PROPRIETARY NAMEPREDICATEDEVICE(S)	SurgiQuest AirSeal® iFS (Name subject to change)SurgiQuest AirSeal® Optical Trocar & Cannula System withintegrated Insufflator DPIS2000SurgiQuest, Inc. (Orange, CT)K103692
DEVICE DESCRIPTION	The SurgiQuest AirSeal® Optical Trocar & Cannula Systemwith integrated Insufflator DPIS 2000 (the "DPIS 2000System") consists of the following major components: (1) atrocar, (2) a cannula, (3) tube sets, and (4) a micro-processorcontrolled insufflation, recirculation and filtration unit (the"DPIS 2000 Unit"). The cannula, trocar and tube sets aresterile, single-use products. The DPIS 2000 Unit is non-sterile and reusable.
INDICATIONS FORUSE	The SurgiQuest AirSeal Optical Trocar & Cannula Systemwith integrated Insufflator DPIS 2000 (the "DPIS 2000System") is intended for use in diagnostic and/or therapeuticendoscopic procedures to distend the peritoneal cavity byfilling it with gas, to establish and maintain a path of entryfor endoscopic instruments, and to evacuate surgical smoke.The trocar of the DPIS 2000 System is indicated for use withor without visualization.
TESTING	The device has been tested to show its ability to create andmaintain a port of entry during simulated laparoscopic surgery.It has also been tested to show its ability to maintain adequatepneumoperitoneum during the course of laparoscopic surgeryand to aid in the evacuation of smoke.
	Sterility validation is in accordance with ISO 11137:2006
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6/20/2012

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SurgiQuest, Inc.

Modified SurgiQuest AirSeal® Optical Trocar & Cannula System with integrated Insufflator DPIS 2000 Special 510(k) Notification

Sterilization of Health Care Products -- Radiation -- Part 1: Requirements for Development, Validation and Routine Control of a Sterilization Process For Medical Devices and AAMI TIR 27:2001, Sterilization of Healthcare Products -Radiation Sterilization - Substantiation of 25kGY as a Sterilization Dose - Method VD Max

A Sterility Assurance Level (SAL) of 10-6 is achieved.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings outstretched, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circle around the eagle. The eagle is depicted in black, and the text is also in black. The logo is simple and recognizable, and it is often used on official documents and websites related to the Department of Health & Human Services.

· Public Health Service

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

Surgiquest, Incorporated % Mr.Daniel Donovan Senior Director of Operations 333 Quarry Road Milford, Connecticut 06460

3 2012 JUL

Re: K121336

Trade/Device Name: Modified 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: June 18, 2012

Received: June 22, 2012

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/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 yours,

Eunel Keith

ForMark 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

510(k) Number (if known): K121336

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

Indications For Use:

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

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R. O'aide forman

Page 1 of 1

(Division Sign-Of (Division Sign-On)
Division of Surgical, Orthopedic, Avishorative Devices

510(k) Number K121336

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.