The VasoPrep Vein Preparation Kit is a sterilized convenience kit indicated for controlling pressure during the preparation and irrigation of bypass grafts prior to use in bypass surgery.

Device Description

The VasoPrep Vein Preparation Kit is a convenience kit that consists of a pressure relief valve, bulldog clamp, vessel cannula and introducer, stopcock, syringes, extension tube, vein cup and drapes used in the preparation of bypass grafts prior to use in bypass surgery.

AI/ML Overview

The provided text describes a medical device, the VasoPrep Vein Preparation Kit, and its 510(k) summary for FDA clearance. It details the device's intended use and substantial equivalence to predicate devices, along with mentions of performance and biocompatibility testing. However, the text does not include specific quantitative acceptance criteria or detailed study results that would typically be required to answer the questions about device performance in the requested format.

Therefore, I cannot populate the table or answer most of the specific questions about the study design as the information is not present in the provided document.

Here's a breakdown of what can be extracted and what is missing:

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

Acceptance Criteria	Reported Device Performance
Valve cracking pressure meets safety requirements	"Results of in-vitro testing, including valve cracking pressure... demonstrate that the VasoPrep Vein Preparation Kit is safe and effective for its intended use." (Specific values not provided)
System leakage within acceptable limits	"Results of in-vitro testing, including... system leakage, demonstrate that the VasoPrep Vein Preparation Kit is safe and effective for its intended use." (Specific values not provided)
Biocompatibility meets ISO 10993-1	"The materials used in the VasoPrep Vein Preparation Kit meet the requirements of ISO 10993-1 in accordance with FDA Guidance Memo G-95." (No specific test results beyond compliance confirmation)

Missing Information for Table: The document explicitly states that in-vitro testing was performed for "valve cracking pressure" and "system leakage" to demonstrate safety and effectiveness. However, it does not provide the specific numerical acceptance criteria for these parameters (e.g., "valve cracking pressure must be within X to Y mmHg") nor does it provide the numerical results (e.g., "valve cracking pressure was Z mmHg"). It only states that the device "demonstrates" safety and effectiveness.

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

Sample size for test set: Not specified. The document mentions "in-vitro testing" but doesn't provide details on the number of samples or trials performed.
Data provenance: "in-vitro testing" is stated, meaning it was conducted in a lab environment. No information on country of origin or whether it was retrospective/prospective is provided, as these are typically applicable to human or animal studies, not purely in-vitro device performance tests.

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

This question is not applicable as the "test set" described is for in-vitro device performance (e.g., pressure and leakage), not for diagnostic accuracy or interpretation by experts. Ground truth in this context would likely be defined by engineering specifications and measurements.

4. Adjudication method for the test set

This question is not applicable for the same reasons as #3. Adjudication methods are relevant for subjective interpretations, whereas these tests are objective measurements.

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, an MRMC comparative effectiveness study was not done. This device is a physical medical kit used in surgery, not a diagnostic imaging or AI-assisted interpretation device, so such a study would not be relevant.

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

Not applicable. This is a physical medical kit, not an algorithm or AI device.

7. The type of ground truth used

The ground truth for the performance tests (valve cracking pressure, system leakage) would be based on engineering specifications and direct measurements. For biocompatibility, the ground truth is compliance with ISO 10993-1 standards.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" in the context of machine learning or algorithms. Its performance is evaluated through direct physical and material testing.

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

Not applicable for the same reason as #8.

Summary

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510(K) SUMMARY

This summary of 510(k)-safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Date Prepared: February 28, 2014

510(k) number: K131659

Applicant Information:

VasoPrep Surgical LLC 55 Madison Avenue, Suite 400 Morristown, NJ 07960

Contact Person

Robert J. Chin Ph.D. Phone Number: (650) 593-5225

Device Information:

VasoPrep Vein Preparation Kit Trade Name: 878.4200 Classification: Classification Name (Code): Irrigation Catheter (GBX)

Physical Description:

Intended Use:

The VasoPrep Vein Preparation Kit is a sterilized convenience kit indicated for controlling pressure during the preparation and irrigation of bypass grafts prior to use in bypass surgery.

Equivalent Device:

The VasoPrep Vein Preparation Kit is substantially equivalent in intended use and/or method of operation to the DMC Saphenous Vein Distension System (K000704) and the Vasoshield Pressure Controlling Syringe (K082725).

Test Results:

Performance

Results of in-vitro testing, including valve cracking pressure and system leakage, demonstrate that the VasoPrep Vein Preparation Kit is safe and effective for its intended use.

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Biocompatibility

The materials used in the VasoPrep Vein Preparation Kit meet the requirements of ISO 10993-1 in accordance with FDA Guidance Memo G-95.

Summary:

Based on the intended use, product, performance, sterilization and biocompatibility information provided in this notification, the subject device has been shown to be substantially equivalent to the currently marketed predicate devices identified.

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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 consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all caps and is written in a sans-serif font.

Public Health Service

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

March 3, 2014

VasoPrep Surgical c/o Dr. Robert Chin Regulatory Consultant 55 Madison Avenue, Suite 400 Morristown, NJ 07960

Re: K131659

Trade/Device Name: VasoPrep Vein Preparation Kit Regulation Number: 21 CFR 878.4200 Regulation Name: Introduction/Drainage Catheter and Accessories Regulatory Class: Class II Product Code: GBX Dated: January 17, 2014 Received: January 24, 2014

Dear Dr. Chin:

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.

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

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Page 2 - Robert J. Chin, PhD

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,

FDA

for Bram Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K131659

Device Name: VasoPrep Vein Preparation Kit

Indications for Use:

The VasoPrep Vein Preparation Kit is a sterilized convenience kit indicated for controlling pressure during the preparation and irrigation of bypass grafts prior to use in bypass surgery.

Prescription Use × (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Regulation Number and Section

§ 878.4200 Introduction/drainage catheter and accessories.

(a)
Identification. An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions. Examples include irrigation and drainage catheters, pediatric catheters, peritoneal catheters (including dialysis), and other general surgical catheters. An introduction/drainage catheter accessory is intended to aid in the manipulation of or insertion of the device into the body. Examples of accessories include adaptors, connectors, and catheter needles.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.