The Short Port Blunt Tip Trocar (BTT) is used to provide a port of access for insertion of endoscopic instruments into an incision site. The device consists of a main body with a Balloon on the distal end, a Balloon inflation port, an Endoscope seal on the proximal end, and an external port with a one-way valve for gas insufflation. It also includes a Cannula seal to allow insertion of the Harvesting Cannula. The balloon minimizes leakage and secures the port. A 30 cc syringe is provided for inflation/deflation of the Balloon.

AI/ML Overview

The provided text details a 510(k) premarket notification for a medical device, the MAQUET Cardiovascular Short Port Blunt Tip Trocar (BTT), rather than an AI/ML software device. Therefore, the information requested for AI/ML device acceptance criteria and study particulars is not present in the document.

The document discusses the substantial equivalence of the Short Port BTT to predicate devices based on:

Intended Use: Same
Operating Principles: Same
Sterilization: Same materials and processes
Packaging: Same

Differences noted:

Material change from Latex balloon (implying the new device does not use Latex, though not explicitly stated as such, it's inferred from the "Revision of Latex content statement").
Labeling change regarding Latex content.
Change from "converter door" to "Cannula Seal and 7mm O Seal."

The document states that these differences are "not considered a technological difference and is substantially equivalent to the predicate devices."

The "study" mentioned is the development process and testing conducted to demonstrate substantial equivalence, not an AI/ML specific study. The results of these in-vitro tests are cited as demonstrating that "the functionality and performance characteristics of the device are comparable to the currently marketed Short Port BTT."

Therefore, I cannot populate the table or answer the specific questions about AI/ML device acceptance criteria and studies, as this document pertains to a traditional medical device (trocar) and not an AI/ML product.

However, I can extract information relevant to a traditional medical device submission based on the provided text:

Acceptance Criteria and Reported Device Performance (Traditional Medical Device Context):

Acceptance Criteria (Demonstrated Equivalence)	Reported Device Performance (Demonstrated Equivalence)
Same intended use	Yes, same intended use.
Same operating principles	Yes, same operating principles.
Same sterilization methods and materials	Yes, sterilized using the same materials and processes.
Same packaging	Yes, has same packaging.
Functionality comparable to predicate	Functionality and performance characteristics proven comparable through in-vitro tests.

Missing Information (for AI/ML context, not applicable here):

Sample size for the test set and data provenance: Not applicable. The "test set" here refers to in-vitro performance tests of the physical device.
Number of experts used to establish ground truth & qualifications: Not applicable.
Adjudication method: Not applicable.
Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
Standalone (algorithm only) performance: Not applicable.
Type of ground truth used: Not applicable. The ground truth here is the performance of the predicate device for comparison in physical tests.
Sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary

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MAQUET Cardiovascular Premarket Notification Traditional 510(k) ﮯ Short Port Blunt Tip Trocar (BTT)

GETINGE GROUP

APR 1 1 2013

· Short Port Blunt Tip Trocar 510(k) Summary

Prepared in accordance with 21 CFR Part 807.92

510(k) Number:	K130121
Date Prepared:	8 April 2013
Device Owner:	MAQUET Cardiovascular LLC45 Barbour Pond DriveWayne, New Jersey 07470
Contact Personnel:Title:Email:Phone:	Mark DingerRegulatory Affairs Specialist IImark.dinger@maquet.com973-709-7691Fax: 973-807-1658
Trade Name:	Short Port Blunt Tip Trocar
Device Generic Name:	Trocar Port
Primary Classification:	According to 21 CFR 876.1500 of the Federal Food, Drugand Cosmetic Act, the device classification is Class II,Primary Product Code GCJ, and Secondary Product CodeGEI.
Predicate Device:	K992353 Blunt Tip Trocar Port (SE: 30 July 1999)
Device Description:	The Short Port Blunt Tip Trocar (BTT) is used to provide aport of access for insertion of endoscopic instruments intoan incision site. The device consists of a main body with aBalloon on the distal end, a Balloon inflation port, anEndoscope seal on the proximal end, and an external portwith a one-way valve for gas insufflation. It also includes aCannula seal to allow insertion of the Harvesting Cannula.The balloon minimizes leakage and secures the port. A 30cc syringe is provided for inflation/deflation of the Balloon.
Indications for Use:	This product has applications for surgery in the saphenousvein, or radial artery for establishment of a port of entry forendoscopic instruments.

ત્ત્વનું

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ETINGE GRO

Technological Characteristics

The Proposed Short Port Blunt Tip Trocar and the predicate devices have the following similarities:

the same intended use. 0
the same operating principles. O
sterilized using the same materials and processes, O
has same packaging. O

The Proposed Short Port Blunt Tip Trocar and the predicate devices have the following differences:

Material change: From Latex balloon. o
Labeling change: Revision of Latex content o statement.
Change converter door to Cannula Seal and 7mm O Seal.

This difference is not considered a technological difference and is substantially equivalent to the predicate devices.

MAQUET Cardiovascular's development process required that the following activities be completed during the development of the Short Port BTT:

. Performance testing
. Biocompatibility testing
Sterility testing .
Shelf life testing .

The results of the in-vitro tests conducted demonstrate that the functionality and performance characteristics of the device are comparable to the currently marketed Short Port BTT.

Based upon the information submitted in this Traditional 510(k) premarket notification. MAOUET's Short Port BTT is substantially equivalent to the currently marketed Short Port BTT. The Short Port BTT is similar to the predicate devices in the intended use and the fundamental scientific technology of the device. The design verification and validation testing established that the Short Port BTT is substantially equivalent as the predicate device.

Safety and Performance:

Conclusion:

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

April 11, 2013

MAQUET Cardiovascular LLC % Mr. Mark Dinger Regulatory Affairs Specialist II 45 Barbour Pond Drive Wayne, New Jersey 07470

Re: K130121

Trade/Device Name: Short Port Blunt Tip Trocar Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: March 21, 2013 Received: March 27, 2013

Dear Mr. Dinger:

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. Ilsting 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.

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

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Page 2 - Mr. Mark Dinger

CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/ResourcesforYou/Industry/default.htm.

Sincerely yours, FOR

Peter Dikumm -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K130121

Device Name: Short Port Blunt Tip Trocar (BTT)

Indications For Use:

This product has applications for surgery in the saphenous vein, or radial artery for establishment of a port of entry for endoscopic instruments.

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Joshua C. Nipper -S

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

For

(Division Sign-Off)

Division of Surgical Devices

K130121 510(k) Number

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.