(270 days)
Not Found
No
The device description and performance studies focus on mechanical components and pressure control, with no mention of AI/ML terms or data-driven analysis.
No.
The device is used for preparing and irrigating bypass grafts, which is a pre-surgical step, not a direct therapeutic intervention on a patient.
No
The device is described as a 'convenience kit indicated for controlling pressure during the preparation and irrigation of bypass grafts prior to use in bypass surgery,' focusing on mechanical functions related to graft preparation rather than diagnosing a condition or disease.
No
The device description explicitly lists physical components (pressure relief valve, bulldog clamp, etc.) that are part of the kit, indicating it is a hardware-based medical device, not software-only.
Based on the provided information, the VasoPrep Vein Preparation Kit is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "controlling pressure during the preparation and irrigation of bypass grafts prior to use in bypass surgery." This is a surgical procedure performed on a patient's tissue (bypass grafts), not a diagnostic test performed on a sample taken from the body in vitro (outside the body).
- Device Description: The components listed are surgical tools and accessories used in the preparation of the graft, not reagents, analyzers, or other items typically associated with in vitro diagnostic testing.
- Lack of Diagnostic Activity: There is no mention of analyzing biological samples, detecting markers, or providing diagnostic information about a patient's health status. The device's function is purely mechanical and procedural.
Therefore, the VasoPrep Vein Preparation Kit falls under the category of a surgical device or accessory, not an IVD.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
GBX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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:
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.
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.
1
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.
2
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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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