(57 days)
Not Found
No
The document describes extension cables and cords for an endoscopic vessel harvesting system. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML functionality. The performance studies focus on cleaning, sterilization, usability, and cytotoxicity, not algorithmic performance.
No
The device is described as an accessory cable used with an endoscopic vessel harvesting system, which is a surgical tool. The cable itself does not directly treat or diagnose a disease or condition.
No
The device is an accessory (cables) for an endoscopic vessel harvesting system, which is used for surgical procedures, not for diagnostic purposes.
No
The device description explicitly states that the devices are "reusable cables" and "cord," which are physical hardware components. There is no mention of software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that these cables are accessories to the VASOVIEW Endoscopic Vessel Harvesting System. This system is used for surgical procedures (harvesting blood vessels).
- Device Description: The descriptions detail cables designed to connect components of a surgical system.
- Anatomical Site: The anatomical sites mentioned are related to surgical procedures (blood vessels, tissues, etc.).
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or treatment.
IVD devices are specifically designed for testing biological samples outside the body to provide diagnostic or other health-related information. This device is part of a surgical system used within the body.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
GEI
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.
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
Hospital
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)
Performance testing:
Complex Product Family Manual Cleaning Process Performance Qualification
Complex Product Family Manual with Ultrasonic Cleaning Process Performance Qualification
Complex Product Family Automated Washer With Alkaline Detergent Cleaning Process Performance Qualification
Complex Product Family Automated Washer with Enzyme Detergent Cleaning Process Performance Qualification
Complex Product Family Thermal Disinfection Performance Qualification
Human Factors Usability Validation - Endoscope
Complex Product Family MEM Elution Cytotoxicity Testing for Enzymatic Detergent Residuals Performance Qualification
Complex Product Family MEM Elution Cytotoxicity Testing for Alkaline Detergent Residuals Performance Qualification
Complex Product Family Sterizone VP4 Sterilization Process Performance Qualification
Complex Product Family Steris® V-Pro™ 1 Plus Hydrogen Peroxide Sterilization Process Performance Qualification
Complex Product Family Ethylene Oxide Sterilization Process Performance Qualification
Complex Product Family Steam Sterilization Process Performance Qualification
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
§ 878.4400 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.
0
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.
1
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
2
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)
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.
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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3
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 Drive | |
| Wayne NJ 07470 | |
| United States of America | |
| Contact Personnel: | Mr. Mark Dinger |
| Title: | Sr. Regulatory Affairs Specialist |
| Email: | mark.dinger@getinge.com |
| Phone: | 973-709-7691 |
| Fax: 973-909-9954 | |
| Trade Name: | VASOVIEW HEMOPRO Extension Cable, |
| VASOVIEW HEMOPRO 2 Extension Cable, | |
| Bipolar Extension Cable, Fixed Distance and | |
| Active Return Cord | |
| Device Generic Name: | Electrosurgical cutting and coagulation device and accessories |
| Classification: | Class II |
| GEI; Electrosurgical cutting and coagulation device and | |
| accessories, 21 CFR 878.4400 | |
| Predicate Device: | (K153194) VASOVIEW HEMOPRO Endoscopic Vessel |
| Harvesting System (SE: 19 April 2016) | |
| (K101274) VASOVIEW HEMOPRO 2 Endoscopic Vessel | |
| Harvesting System (SE: 11 June 2010) | |
| (K091733) VASOVIEW 6 PRO Endoscopic Vessel Harvesting | |
| System (SE: 28 August 2009) | |
| 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. |
4
| | 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. |
| Indications for Use: | 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. |
| Technological
Characteristics | The Proposed Cables and the predicate devices have the following
similarities:
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 following
differences:
Added clarity to the Manual Cleaning method and added the
following cleaning methods to provide more flexibility
capability to the end user. Manual Cleaning with Sonication Automated Cleaning with Alkaline detergent Automated Cleaning with Enzymatic detergent Combined Automated Washing / Thermal High Level
Disinfectant (in a washer/disinfecter). Expanded method in one modality and removed a method in |
5
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 Vessel | ||
| Harvesting System (SE: 11 June 2010) | ||
| (K091733) VASOVIEW 6 PRO Endoscopic Vessel | ||
| Harvesting System (SE: 28 August 2009) | Proposed Cables | |
| Product Code | GEI | Same as Predicate |
| Regulation No. | 21 CFR 878.4400 Electrosurgical cutting and coagulation device and | |
| accessories | Same as Predicate | |
| Biocompatibility | Materials are reasonably safe and effective for limited duration of an | |
| external communicating device for tissue/bone/dentin accordance with | ||
| international standards ANSI/AAMI/ISO 10993-1 | ||
| Cytotoxicity 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 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. | 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. | ||
| 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 and | |
| the radial artery, structures in the extraperitoneal or subcutaneous | ||
| extremity and thoracic space, nerves, blood vessels and other tissues of | ||
| the chest wall. | Same as Predicate | |
| Use Location | ||
| (hospital, home | ||
| ambulance, ect.) | Hospital | Same as Predicate |
| 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 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. Each cable is supplied non-sterile and must be
sterilized prior to each use. | Same as Predicate |
| Cleaning Methods | Cleaning
Manual Ultrasonic | •Added Clarity to Manual
Cleaning method
•Manual Cleaning with
Sonication
•Automated Cleaning with
Alkaline detergent
•Automated Cleaning with
Enzymatic detergent
•Combined Automated
Washing / Thermal High
Level Disinfectant (in a
washer/disinfecter). |
| Reprocessing
Methods | Sterilization:
Steam Ethylene Oxide Steris System 1 Sterrad 100S, NX & 100 NX | Sterilization:
Steam Ethylene Oxide Sterrad 100S, NX &
100 NX Steris VPRO |
6
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:
7
Performance testing
| Complex Product Family Manual Cleaning Process Performance Qualification |
|---|
| Complex Product Family Manual with Ultrasonic Cleaning Process Performance |
| Qualification |
| Complex Product Family Automated Washer With Alkaline Detergent Cleaning |
| Process Performance Qualification |
| Complex Product Family Automated Washer with Enzyme Detergent Cleaning |
| Process Performance Qualification |
| Complex Product Family Thermal Disinfection Performance Qualification |
| Human Factors Usability Validation - Endoscope |
| Complex Product Family MEM Elution Cytotoxicity Testing for Enzymatic |
| Detergent Residuals Performance Qualification |
| Complex Product Family MEM Elution Cytotoxicity Testing for Alkaline Detergent |
| Residuals Performance Qualification |
| Complex Product Family Sterizone VP4 Sterilization Process Performance |
| Qualification |
| Complex Product Family Steris® V-Pro™ 1 Plus Hydrogen Peroxide Sterilization |
| Process Performance Qualification |
| Complex Product Family Ethylene Oxide Sterilization Process Performance |
| Qualification |
| Complex Product Family Steam Sterilization Process Performance Qualification |