The VASOVIEW System is indicated for use in minimally invasive surgery allowing access for vessel harvesting, and is primarily indicated for patients undergoing endoscopic surgery for arterial bypass. It is indicated for cutting tissue and controlling bleeding through coagulation, and for patients requiring blunt dissection of tissue including dissection of blood vessels, dissection of blood vessels of the extremities, dissection of ducts and other structures in the extraperitoneal or subcutaneous extremity and thoracic space. Extremity procedures include tissue dissection/vessel harvesting along the saphenous vein for use in coronary artery bypass grafting and peripheral artery bypass or the radial artery for use in coronary artery bypass grafting. Thoracoscopic procedures include exposure and dissection of structures external to the parietal pleura, including nerves, blood vessels and other tissues of the chest wall.

Device Description

The Harvesting Cannula has four lumens which house the Endoscope, C-Ring, distal lens washer tube and VASOVIEW Harvesting Tool for cutting and sealing of vessel branches. The C-Ring with the built in distal lens washer is independently controlled by a C-Ring Slider on the handle of the Harvesting Cannula. The C-Ring retracts the vessel and washes the distal tip of the Endoscope. The Harvesting Tool can be inserted, removed, rotated, extended, and retracted from the main Harvesting Cannula through the Tool Adapter Port.

AI/ML Overview

The provided 510(k) summary for the "Harvesting Cannula" (K132743) by MAQUET Cardiovascular LLC does not describe specific acceptance criteria or a detailed study proving the device meets them. Instead, it focuses on demonstrating substantial equivalence to a predicate device (K052274 Guidant VasoView HemoPro Endoscopic Vessel Harvesting System) based on similar intended use, operating principles, labeling, basic design, materials, sterilization processes, and packaging.

The "Safety and Performance" section broadly states that MAQUET Cardiovascular's development process required "• Performance testing" and "• Shelf life testing." It then concludes: "The results of the in-vitro tests conducted demonstrate that the functionality and performance characteristics of the device are comparable to the currently marketed Harvesting Cannula."

Without concrete performance metrics or detailed study methodologies, it's impossible to fill in most of the requested fields. However, I can extract the available information.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Characteristic	Acceptance Criteria	Reported Device Performance
Functionality	Not specified	Comparable to currently marketed Harvesting Cannula (Predicate Device)
Performance	Not specified	Comparable to currently marketed Harvesting Cannula (Predicate Device)
Shelf Life	Not specified	Successful (implicit in "Shelf life testing" completed)

Missing Information: Specific quantitative or qualitative acceptance criteria are not detailed in the document. The performance is described as "comparable" to the predicate, but specific metrics of what defines "comparable" are absent.

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

Test Set Sample Size: Not specified. The document mentions "in-vitro tests" but does not provide details on the number of devices or scenarios tested.
Data Provenance: The tests were "in-vitro," meaning conducted in a laboratory setting. The country of origin for the data is not specified, but the device owner is in the USA. The study was part of the device development process, making it a prospective assessment of the newly designed device's performance against established benchmarks (implicitly, the predicate device).

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

Not applicable. This device is a surgical instrument (Harvesting Cannula), not an diagnostic imaging or AI device that requires expert-established ground truth for its performance evaluation in the context of the provided document. Its performance would be evaluated against engineering specifications and functional requirements.

4. Adjudication Method for the Test Set

Not applicable for a device of this type and the information provided. Performance demonstration would involve engineering and functional testing, not expert adjudication of outputs.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This is a surgical instrument, not an AI or diagnostic imaging device that would typically undergo an MRMC study.

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

Not applicable. This is a physical surgical instrument, not an algorithm.

7. The type of ground truth used

For a surgical instrument like the Harvesting Cannula, "ground truth" would generally refer to adherence to design specifications, functional requirements (e.g., ability to house components, operate smoothly), material properties, and safety standards. Based on the documentation, the "ground truth" for evaluating the "functionality and performance characteristics" was the performance of the currently marketed Harvesting Cannula (the predicate device).

8. The sample size for the training set

Not applicable. This is a physical surgical instrument, not a machine learning algorithm that requires a training set.

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

Not applicable. As above, this is not an ML algorithm.

Summary of what is present:

The 510(k) summary for K132743 focuses on demonstrating substantial equivalence to a predicate device (K052274 Guidant VasoView HemoPro Endoscopic Vessel Harvesting System). The core argument is that despite minor design changes (C-Ring Tube, Blunt Tip, Scope Wash Tube length), these differences are not considered technological and do not affect the safety or effectiveness of the device.

The "Safety and Performance" section states that "Performance testing" and "Shelf life testing" were completed, and "The results of the in-vitro tests conducted demonstrate that the functionality and performance characteristics of the device are comparable to the currently marketed Harvesting Cannula." This highly generalized statement is the extent of the performance data provided in this summary. It relies on the assumption that if the new device performs "comparably" to an already cleared predicate device, it meets the necessary safety and effectiveness standards.

Summary

{0}------------------------------------------------

K132743

Harvesting Cannula

510(k) Summary

Prepared in accordance with 21 CFR Part 807.92

510(k) Number:	KXXXXXX K132743
Date Prepared:	30 August 2013
Device Owner:	MAQUET Cardiovascular LLC45 Barbour Pond DriveWayne, New Jersey 07470
Contact Personnel:	Mark Dinger
Title:	Regulatory Affairs Specialist II
Email:	mark.dinger@maquet.com
Phone:	973-709-7691
	Fax: 973-909-9954
Trade Name:	Harvesting Cannula
Device Generic Name:	Harvesting Cannula
Classification:	According to 21 CFR 878.4400 of the Federal Food, Drugand Cosmetic Act, the device classification is Class II,Product code GEI.
Predicate Device:	K052274 Guidant VasoView HemoPro Endoscopic VesselHarvesting System (SE: 21 September 2005)
Device Description:	The Harvesting Cannula has four lumens which house theEndoscope, C-Ring, distal lens washer tube andVASOVIEW Harvesting Tool for cutting and sealing ofvessel branches. The C-Ring with the built in distal lenswasher is independently controlled by a C-Ring Slider onthe handle of the Harvesting Cannula. The C-Ring retractsthe vessel and washes the distal tip of the Endoscope. TheHarvesting Tool can be inserted, removed, rotated,extended, and retracted from the main Harvesting Cannulathrough the Tool Adapter Port.

DEC 0-3 2013

{1}------------------------------------------------

Indications for Use:	The VASOVIEW System is indicated for use in minimallyinvasive surgery allowing access for vessel harvesting, andis primarily indicated for patients undergoing endoscopicsurgery for arterial bypass. It is indicated for cutting tissueand controlling bleeding through coagulation, and forpatients requiring blunt dissection of tissue includingdissection of blood vessels, dissection of blood vessels ofthe extremities, dissection of ducts and other structures inthe extraperitoneal or subcutaneous extremity and thoracicspace. Extremity procedures include tissuedissection/vessel harvesting along the saphenous vein foruse in coronary artery bypass grafting and peripheral arterybypass or the radial artery for use in coronary artery bypassgrafting. Thoracoscopic procedures include exposure anddissection of structures external to the parietal pleura,including nerves, blood vessels and other tissues of thechest wall.
TechnologicalCharacteristics	The Proposed Harvesting Cannula and the predicatedevices have the following similarities:the same intended use, the same operating principles, same labeling, incorporates the same basic design, sterilized using the same materials and processes, same materials, has same packaging. The Proposed Harvesting Cannula and the predicatedevices have the following differences:C-Ring Tube – Addition of a rib to the C-Ring Tubeas well as tube length change (to accommodate forthe C-Ring Tube Rib design). Blunt Tip – C-ring tube channel revision. Scope Wash Tube – Scope Wash Tube lengthchanged (to accommodate for new C-Ring TubeRib design). This difference is not considered a technological differenceand is substantially equivalent to the predicate devices.
Safety andPerformance:	MAQUET Cardiovascular's development process requiredthat the following activities be completed during thedevelopment of the Harvesting Cannula:
	• Performance testing• Shelf life testing
	The results of the in-vitro tests conducted demonstrate thatthe functionality and performance characteristics of thedevice are comparable to the currently marketed HarvestingCannula.
Conclusion:	Based upon the information submitted in this Traditional510(k) premarket notification, MAQUET's HarvestingCannula is substantially equivalent to the currentlymarketed Harvesting Cannula. The Harvesting Cannula issimilar to the predicate devices in the intended use and thefundamental scientific technology of the device. The designverification and validation testing established that theHarvesting Cannula is substantially equivalent as thepredicate device.

{2}------------------------------------------------

. . .

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the symbol. The text is in all caps and is relatively small compared to the caduceus symbol.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

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

December 3, 2013

Re: K132743

Trade/Device Name: Harvesting Cannula Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: September 27. 2013 Received: September 30, 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 for use stated on the May 28. 1976. the cnactment 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 rou may : merels provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH docs 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 cither 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 that I DA has into a and regulations administered by other Federal agencies. You must or any rederal states and 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

{4}------------------------------------------------

Page 2 - Mr. Mark Dinger

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 vours.

Joshua C. Nipper -S

For

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known) K132743

Device Name Harvesting Cannula

Indications for Use (Describe)

The VASOVIEW System is indicated for use in minimally invesive surgery allowing access for vessel harvesting, and is primerily indicated for patients undergoing endoscopic surgery for arterial bypass. It is indicated for cutting bleeding through coagulation, and for patients requiring blunt dissection of blood vessels, dissection of blood vessels of the extremities, dissection of ducts and other structures in the extraperity and theracies pace. Extremity procedures include tissection/vessel harvesting along the saphencus vein for use in coronary artery bypass grafting and perioteral artery bypass or the radial artery for use in coronary artery bypass grafting. Thorecossipic procedures include exposure and dissection of structures external to the parietal pleases and other tissues of the chest wall.

Type of Use (Select one or both, as applicable)

🇿 Prescription Use (Parl 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Long H. Chen A	for BSA
(Division Sign-off)Division of Surgical Devices	510(k) Number: K132743
	Digitally signed by Long H. Chen - A DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, cn=Long H. Chen - A 0.9.2342.19200300.100.1.1=1300366056 Date: 2013.12.02 08:44:22 -05'00'
FORM FDA 3881 (9/13)	Page 1 of 2

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.