The subject Cables (VASOVIEW HEMOPRO Extension Cable, VASOVIEW HEMOPRO 2 Extension Cable, Bipolar Extension Cable, Fixed Distance and Active Return Cord) are accessories to the VASOVIEW Endoscopic Vessel Harvesting System. They are supplied non-sterile and must be sterilized prior to each.

Device Description

The VASOVIEW HEMOPRO Extension Cable (P/N VH-3030), is a reusable cable designed for use with the VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System and the VASOVIEW HEMOPRO Power Supply. The Extension Cable is supplied non-sterile and must be sterilized prior to each use.

The VASOVIEW HEMOPRO 2 Extension Cable (P/N VH-4030), is a reusable cable designed for use with the VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System and the VASOVIEW HEMOPRO Power Supply and the HEMOPRO 2 Adapter Cable. The Extension Cable is supplied non-sterile and shall be sterilized prior to each use. The Extension Cable connects to the VASOVIEW HEMOPRO Power Supply via the Adapter Cable.

The Active/Return extension cord with banana plugs (P/N 1838), is a reusable cord designed for use with the VASOVIEW Endoscopic Vessel Harvesting System VV6 Pro/VV7. Each cord is supplied non-sterile and must be sterilized prior to each use.

The Bipolar Extension Cable, Fixed Distance (P/N 2838) is a reusable cable designed for use with the VASOVIEW Endoscopic Vessel Harvesting System VV6 Pro /VV7. Each cable is supplied non-sterile and must be sterilized prior to each use.

AI/ML Overview

Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets those criteria:

Device: VASOVIEW HEMOPRO Extension Cable, VASOVIEW HEMOPRO 2 Extension Cable, Bipolar Extension Cable, Fixed Distance, and Active Return Cord (accessories to the VASOVIEW Endoscopic Vessel Harvesting System)

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria with corresponding performance results in a quantitative manner as one might expect for a clinical study on diagnostic accuracy or efficacy. Instead, it describes a series of performance qualifications and verifications undertaken to demonstrate substantial equivalence to predicate devices, particularly regarding reprocessing methods.

The "acceptance criteria" here are implied to be the successful completion and passing of these performance qualifications, demonstrating that the proposed cables perform equivalently or better in terms of safety and functionality under the specified reprocessing conditions.

Acceptance Criteria (Implied)	Reported Device Performance
Compliant with expanded cleaning methods:	All listed cleaning methods were successfully qualified.
- Manual Cleaning Process Performance Qualification	Performance Qualification successful.
- Manual with Ultrasonic Cleaning Process Performance Qualification	Performance Qualification successful.
- Automated Washer With Alkaline Detergent Cleaning Process Performance Qualification	Performance Qualification successful.
- Automated Washer with Enzyme Detergent Cleaning Process Performance Qualification	Performance Qualification successful.
Compliant with expanded reprocessing (sterilization) methods:	All listed sterilization methods were successfully qualified.
- Thermal Disinfection Performance Qualification	Performance Qualification successful.
- Complex Product Family Sterizone VP4 Sterilization Process Performance Qualification	Performance Qualification successful.
- Complex Product Family Steris® V-Pro™ 1 Plus Hydrogen Peroxide Sterilization Process Performance Qualification	Performance Qualification successful.
- Complex Product Family Ethylene Oxide Sterilization Process Performance Qualification	Performance Qualification successful.
- Complex Product Family Steam Sterilization Process Performance Qualification	Performance Qualification successful.
Demonstrate biocompatibility (cytotoxicity, sensitization, irritation, systemic toxicity) for residuals from new cleaning methods.	MEM Elution Cytotoxicity Testing for Enzymatic Detergent Residuals Performance Qualification successful. MEM Elution Cytotoxicity Testing for Alkaline Detergent Residuals Performance Qualification successful.
Human Factors Usability Validation	Validation successful.

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

The document does not specify exact sample sizes for each "Performance Qualification" test. These are typical engineering and laboratory tests, not clinical trials. The "test set" would refer to the physical devices (cables) subjected to the various cleaning and sterilization cycles. It's common for such tests to use a statistically representative number of devices to demonstrate reproducibility and worst-case scenarios, but specific numbers are not provided.

The data provenance is from laboratory testing (likely internal to the manufacturer or conducted by contract labs), rather than clinical data from a specific country, retrospective or prospective.

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

This type of testing (performance qualification for cleaning, sterilization, and biocompatibility of medical device accessories) typically does not involve human experts establishing a "ground truth" in the way a clinical study with medical image interpretation would. Instead, highly trained laboratory personnel, quality engineers, and microbiologists follow standardized protocols (e.g., ISO, AAMI standards) to perform the tests and interpret the results against predefined acceptance criteria from those standards. The "ground truth" is defined by the objective pass/fail criteria of these validated testing methods. Therefore, no information on the number or qualifications of "experts" for ground truth establishment in this context is provided or expected.

4. Adjudication method for the test set

Not applicable. Adjudication methods like "2+1" or "3+1" are used in clinical studies where multiple human readers interpret data, and discrepancies need to be resolved. For laboratory performance testing of device reprocessing, results are generally objective and determined by validated methodologies, not subjective interpretation requiring "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

No. This is not an AI-assisted diagnostic device, nor is it a device that requires human interpretation of medical cases. Therefore, an MRMC study is not relevant to this submission.

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

No. This device is an accessory to an electrosurgical system, not an algorithm or an AI-powered device.

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

The "ground truth" for the performance qualifications is based on objective measurements and pass/fail criteria derived from recognized industry standards (e.g., ISO 10993-1 for biocompatibility, and validated cleaning/sterilization protocols). For instance, a cleaning qualification's ground truth would be the measurable reduction of protein, hemoglobin, or other contaminants below a specified threshold, as determined by laboratory assays. Biocompatibility ground truth is determined by the absence of cytotoxic effects in cell cultures or adverse reactions in animal models, according to standard test methods.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI-based device, so there is no training set in that sense.

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

Not applicable. No training set as described in the context of AI/ML.

Summary

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 17, 2019

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

Re: K191947

Trade/Device Name: VASOVIEW HEMOPRO Extension Cable, VASOVIEW HEMOPRO 2 Extension Cable, Bipolar Extension Cable, Fixed Distance, and Active Return Cord Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: July 19, 2019 Received: July 22, 2019

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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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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 and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4. Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K191947

Device Name

VASOVIEW HEMOPRO Extension Cable, VASOVIEW HEMOPRO 2 Extension Cable, Bipolar Extension Cable, Fixed Distance and Active Return Cord

Indications for Use (Describe)

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

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

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510(k) Summary

Prepared in accordance with 21 CFR Part 807.92

510(k) Number:	K191947
Date Prepared:	16 Sept 2019
Device Owner:	MAQUET Cardiovascular, LLC.45 Barbour Pond DriveWayne NJ 07470United States of America
Contact Personnel:	Mr. Mark Dinger
Title:	Sr. Regulatory Affairs Specialist
Email:	mark.dinger@getinge.com
Phone:	973-709-7691Fax: 973-909-9954
Trade Name:	VASOVIEW HEMOPRO Extension Cable,VASOVIEW HEMOPRO 2 Extension Cable,Bipolar Extension Cable, Fixed Distance andActive Return Cord
Device Generic Name:	Electrosurgical cutting and coagulation device and accessories
Classification:	Class IIGEI; Electrosurgical cutting and coagulation device andaccessories, 21 CFR 878.4400
Predicate Device:	(K153194) VASOVIEW HEMOPRO Endoscopic VesselHarvesting System (SE: 19 April 2016)(K101274) VASOVIEW HEMOPRO 2 Endoscopic VesselHarvesting System (SE: 11 June 2010)(K091733) VASOVIEW 6 PRO Endoscopic Vessel HarvestingSystem (SE: 28 August 2009)
Device Description:	The VASOVIEW HEMOPRO Extension Cable (P/N VH-3030), isa reusable cable designed for use with the VASOVIEWHEMOPRO Endoscopic Vessel Harvesting System and theVASOVIEW HEMOPRO Power Supply. The Extension Cable issupplied non-sterile and must be sterilized prior to each use.

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	The VASOVIEW HEMOPRO 2 Extension Cable (P/N VH-4030),is a reusable cable designed for use with the VASOVIEWHEMOPRO 2 Endoscopic Vessel Harvesting System and theVASOVIEW HEMOPRO Power Supply and the HEMOPRO 2Adapter Cable. The Extension Cable is supplied non-sterile andshall be sterilized prior to each use. The Extension Cable connectsto the VASOVIEW HEMOPRO Power Supply via the AdapterCable.
	The Active/Return extension cord with banana plugs (P/N 1838), isa reusable cord designed for use with the VASOVIEW EndoscopicVessel Harvesting System VV6 Pro/VV7. Each cord is suppliednon-sterile and must be sterilized prior to each use.
	The Bipolar Extension Cable, Fixed Distance (P/N 2838) is areusable cable designed for use with the VASOVIEW EndoscopicVessel Harvesting System VV6 Pro /VV7. Each cable is suppliednon-sterile and must be sterilized prior to each use.
Indications for Use:	The subject Cables (VASOVIEW HEMOPRO Extension Cable,VASOVIEW HEMOPRO 2 Extension Cable, Bipolar ExtensionCable, Fixed Distance and Active Return Cord) are accessories tothe VASOVIEW Endoscopic Vessel Harvesting System. They aresupplied non-sterile and must be sterilized prior to each.
TechnologicalCharacteristics	The Proposed Cables and the predicate devices have the followingsimilarities:the same intended use, the same operating principles, incorporates the same basic design and materials, has same packaging.
	The Proposed Cables and the predicate devices have the followingdifferences:Added clarity to the Manual Cleaning method and added thefollowing cleaning methods to provide more flexibilitycapability to the end user. Manual Cleaning with Sonication Automated Cleaning with Alkaline detergent Automated Cleaning with Enzymatic detergent Combined Automated Washing / Thermal High LevelDisinfectant (in a washer/disinfecter). Expanded method in one modality and removed a method in

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another modality for sterilization.

TABLE 1: SUBSTANTIAL EQUIVALENCE TABLE

TABLE 1: SUBSTANTIAL EQUIVALENCE TABLE
	(K153194) VASOVIEW HEMOPRO Endoscopic Vessel Harvesting
Description	System (SE: 19 April 2016)(K101274) VASOVIEW HEMOPRO 2 Endoscopic VesselHarvesting System (SE: 11 June 2010)(K091733) VASOVIEW 6 PRO Endoscopic VesselHarvesting System (SE: 28 August 2009)	Proposed Cables
Product Code	GEI	Same as Predicate
Regulation No.	21 CFR 878.4400 Electrosurgical cutting and coagulation device andaccessories	Same as Predicate
Biocompatibility	Materials are reasonably safe and effective for limited duration of anexternal communicating device for tissue/bone/dentin accordance withinternational standards ANSI/AAMI/ISO 10993-1Cytotoxicity Sensitization Irritation (including intracutaneous reactivity) Systemic Toxicity	Same as Predicate
Sterility	Sold non-sterile	Same as Predicate
Verification	Performance Testing	Same as Predicate
Indications For Use	The VASOVIEW System is indicated for use in minimally invasivesurgery allowing access for vessel harvesting, and is primarily indicatedfor patients undergoing endoscopic surgery for arterial bypass. It isindicated for cutting tissue and controlling bleeding throughcoagulation, and for patients requiring blunt dissection of tissueincluding dissection of blood vessels, dissection of blood vessels of theextremities, dissection of ducts and other structures in theextraperitoneal or subcutaneous extremity and thoracic space.Extremity procedures include tissue dissection/vessel harvesting alongthe saphenous vein for use in coronary artery bypass grafting andperipheral artery bypass or the radial artery for use in coronary arterybypass grafting. Thoracoscopic procedures include exposure anddissection of structures external to the parietal pleura, including nerves,blood vessels and other tissues of the chest wall.	The subject Cables(VASOVIEW HEMOPROExtension Cable,VASOVIEW HEMOPRO 2Extension Cable, BipolarExtension Cable, FixedDistance and Active ReturnCord) are accessories to theVASOVIEW EndoscopicVessel Harvesting System.They are supplied non-sterile and must be sterilizedprior to each.
Target Population	Primarily, patients with cardiovascular disease undergoing surgery,including cardiac and peripheral bypass surgery	Same as Predicate
Anatomical Sites	Blood vessels, blood vessels of the extremities, the saphenous vein andthe radial artery, structures in the extraperitoneal or subcutaneousextremity and thoracic space, nerves, blood vessels and other tissues ofthe chest wall.	Same as Predicate
Use Location(hospital, homeambulance, ect.)	Hospital	Same as Predicate
Device Description	The VASOVIEW HEMOPRO Extension Cable (P/N VH-3030) is areusable cable designed for use with the VASOVIEW HEMOPROEndoscopic Vessel Harvesting System and the VASOVIEWHEMOPRO Power Supply. The Extension Cable is supplied non-sterileand must be sterilized prior to each use.The VASOVIEW HEMOPRO 2 Extension Cable (P/N VH-4030) is areusable cable designed for use with the VASOVIEW HEMOPRO 2Endoscopic Vessel Harvesting System and the VASOVIEWHEMOPRO Power Supply and the HEMOPRO 2 Adapter Cable. TheExtension Cable is supplied non-sterile and shall be sterilized prior toeach use. The Extension Cable connects to the VASOVIEWHEMOPRO Power Supply via the Adapter Cable.The Active/Return extension cord with banana plugs (P/N 1838), is areusable cord designed for use with the VASOVIEW Endoscopic VesselHarvesting System Each cord is supplied non-sterile and must besterilized prior to each use.The Bipolar Extension Cable, Fixed Distance (P/N 2838) is a reusablecable designed for use with the VASOVIEW Endoscopic VesselHarvesting System. Each cable is supplied non-sterile and must besterilized prior to each use.	Same as Predicate
Cleaning Methods	CleaningManual Ultrasonic	•Added Clarity to ManualCleaning method•Manual Cleaning withSonication•Automated Cleaning withAlkaline detergent•Automated Cleaning withEnzymatic detergent•Combined AutomatedWashing / Thermal HighLevel Disinfectant (in awasher/disinfecter).
ReprocessingMethods	Sterilization:Steam Ethylene Oxide Steris System 1 Sterrad 100S, NX & 100 NX	Sterilization:Steam Ethylene Oxide Sterrad 100S, NX &100 NX Steris VPRO

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The differences are not considered a technological difference and are substantially equivalent to the predicate device.

Safety and Performance: MAQUET Cardiovascular, LLC., development process required that the following activities be completed during the development of the Cables:

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Performance testing

Complex Product Family Manual Cleaning Process Performance Qualification
Complex Product Family Manual with Ultrasonic Cleaning Process PerformanceQualification
Complex Product Family Automated Washer With Alkaline Detergent CleaningProcess Performance Qualification
Complex Product Family Automated Washer with Enzyme Detergent CleaningProcess Performance Qualification
Complex Product Family Thermal Disinfection Performance Qualification
Human Factors Usability Validation - Endoscope
Complex Product Family MEM Elution Cytotoxicity Testing for EnzymaticDetergent Residuals Performance Qualification
Complex Product Family MEM Elution Cytotoxicity Testing for Alkaline DetergentResiduals Performance Qualification
Complex Product Family Sterizone VP4 Sterilization Process PerformanceQualification
Complex Product Family Steris® V-Pro™ 1 Plus Hydrogen Peroxide SterilizationProcess Performance Qualification
Complex Product Family Ethylene Oxide Sterilization Process PerformanceQualification
Complex Product Family Steam Sterilization Process Performance Qualification

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.