(91 days)
Not Found
No
The description focuses on mechanical components and surgical procedures, with no mention of AI or ML terms or functionalities.
No
The device is described as a surgical tool for tissue dissection and vessel harvesting, primarily used during bypass surgeries, rather than directly treating a disease or condition for therapeutic purposes.
No
The device is described as a surgical tool for tissue cutting, coagulation, and blunt dissection, primarily used for vessel harvesting in bypass grafting, not for diagnosis.
No
The device description clearly details physical components like a Harvesting Cannula, lumens, an Endoscope, a C-Ring, and a Harvesting Tool, indicating it is a hardware-based medical device used in surgical procedures.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical device used for minimally invasive procedures, specifically for vessel harvesting, tissue cutting, coagulation, and blunt dissection. This is a direct surgical intervention on the patient's body.
- Device Description: The description details a system with cannulas, tools for cutting and sealing, and mechanisms for manipulating tissue and providing visualization. These are all components of a surgical instrument.
- 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 screening.
IVD devices are used outside the body to analyze samples and provide diagnostic information. This device is used inside the body to perform surgical procedures.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
GEI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessel harvesting (saphenous vein for use in coronary artery bypass grafting and peripheral artery bypass, radial artery for use in coronary artery bypass grafting), extraperitoneal or subcutaneous extremity and thoracic space, chest wall, arteries, ducts.
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)
MAQUET Cardiovascular's development process required that the following activities be completed during the development of the Harvesting Cannula: Performance testing, Shelf life testing. 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.
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
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 LLC |
| 45 Barbour Pond Drive | |
| Wayne, 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, Drug |
| and Cosmetic Act, the device classification is Class II, | |
| Product code GEI. | |
| Predicate Device: | K052274 Guidant VasoView HemoPro Endoscopic Vessel |
| Harvesting System (SE: 21 September 2005) | |
| 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. |
DEC 0-3 2013
1
| 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. |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological
Characteristics | The Proposed Harvesting Cannula and the predicate
devices 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 predicate
devices have the following differences:
C-Ring Tube – Addition of a rib to the C-Ring Tube
as well as tube length change (to accommodate for
the C-Ring Tube Rib design). Blunt Tip – C-ring tube channel revision. Scope Wash Tube – Scope Wash Tube length
changed (to accommodate for new C-Ring Tube
Rib design). This difference is not considered a technological difference
and is substantially equivalent to the predicate devices. |
| Safety and
Performance: | MAQUET Cardiovascular's development process required
that the following activities be completed during the
development of the Harvesting Cannula: |
| | • Performance testing
• Shelf life testing |
| | 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. |
| Conclusion: | Based upon the information submitted in this Traditional
510(k) premarket notification, MAQUET's Harvesting
Cannula is substantially equivalent to the currently
marketed Harvesting Cannula. The Harvesting Cannula is
similar to the predicate devices in the intended use and the
fundamental scientific technology of the device. The design
verification and validation testing established that the
Harvesting Cannula is substantially equivalent as the
predicate device. |
2
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. . .
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 |