(24 days)
Not Found
No
The summary describes a mechanical surgical device and does not mention any AI or ML components or functionalities.
No
The device is described as an anastomotic device used in CABG procedures to create a sutureless connection between the aorta and a venous graft. This is an surgical instrument for creating a connection, not directly treating a disease or condition in a therapeutic manner.
No
The device is described as an "Aortic Anastomotic Device" intended to create a sutureless proximal anastomosis during CABG procedures, which is a surgical tool, not a diagnostic one.
No
The device description clearly describes a physical medical device (CorLink™ Aortic Anastomotic Device and C-Punch device) used in surgical procedures, not a software-only application.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for creating a sutureless proximal anastomosis between the Aorta and a venous graft conduit during CABG procedures. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as being used in a surgical setting to create an opening in the aorta.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples (blood, tissue, etc.) outside of the body to diagnose a condition, monitor treatment, or screen for diseases.
IVD devices are used to examine specimens obtained from the human body to provide information for diagnosis, monitoring, or screening. This device is a surgical tool used in vivo (within the living body).
N/A
Intended Use / Indications for Use
The ByPass CorLink™ Aortic Anastomotic Device (CorLink™ AAD) is intended to be used in CABG procedures for creating a sutureless proximal anastomosis between the Aorta and a venous graft conduit.
Product codes (comma separated list FDA assigned to the subject device)
FZP, NCA
Device Description
This 510(k) notification describes a device intended for use in Coronary Artery Bypass Grafting procedures for creating a rapid sutureless proximal anastomosis between a grafted vessel and the aorta. The C-Punch device is intended for creating the aortotomy in which the implanted device will be deployed.
The C-Punch device is equivalent to the Linear Punch already cleared as a component of the CorLink AAD (K011589) with respect to intended use, materials and performance of the aortotomy. The major difference between the two systems is the method by which the punch creates the aortotomy. The Linear Punch creates an aortotomy by insertion of the punch tip to the aortic wall and retraction of the punch tip against the cutting tube. The cut piece of the aortic wall is contained within the cutting tube. The C-Punch achieves the same aortotomy sizes and quality by insertion of a central needle and cutting/coring the tissue by rotating the punch device clockwise and counterclockwise. The cut piece of the aortic wall is contained within the cutting/coring tube.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Aorta
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)
Information on risk analysis of the modifications and performance testing provided in the application demonstrates equivalence to the predicate device with respect to performance.
Based on the performance data gathered, the device modifications do not raise any new questions of safety or effectiveness.
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
§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.
0
8 2002 MAR
510(k) Summary of Safety and Effectiveness ByPass LTD, CorLinkTM Automated Anastomotic System 510(k) Number KO20470
This 510(k) notification is submitted by ByPass LTD.3 Hasadnaot St.Herzelia B 46728 Israel
The contact person is Amir Loshakove, General Manager.
This 510(k) notification describes a device intended for use in Coronary Artery Bypass Grafting procedures for creating a rapid sutureless proximal anastomosis between a grafted vessel and the aorta. The C-Punch device is intended for creating the aortotomy in which the implanted device will be deployed.
The C-Punch device is equivalent to the Linear Punch already cleared as a component of the CorLink AAD (K011589) with respect to intended use, materials and performance of the aortotomy. The major difference between the two systems is the method by which the punch creates the aortotomy. The Linear Punch creates an aortotomy by insertion of the punch tip to the aortic wall and retraction of the punch tip against the cutting tube. The cut piece of the aortic wall is contained within the cutting tube. The C-Punch achieves the same aortotomy sizes and quality by insertion of a central needle and cutting/coring the tissue by rotating the punch device clockwise and counterclockwise. The cut piece of the aortic wall is contained within the cutting/coring tube.
Information on risk analysis of the modifications and performance testing provided in the application demonstrates equivalence to the predicate device with respect to performance.
Based on the performance data gathered, the device modifications do not raise any new questions of safety or effectiveness.
Based on the information provided the modification of the CorLink™ AAD to include the C-Punch is substantially equivalent to the cleared CorLink™ AAD using the Linear Punch with respect to intended use, technological characteristics, and performance.
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or bird with three overlapping wing-like shapes. The bird is facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 8 2002
ByPass, Ltd. c/o Jonathan Kahan Hogan and Hartson 555 Thirteenth Street, N.W. Washington, D.C. 20004 -1109
Re: K020470
Trade Name: CorLink™ AAD Regulation Number: 878.4300; 878.4300 Regulation Name: Implantable Clip; Aortic Stapling Device Regulatory Class: II Product Code: FZP, NCA Dated: February 19, 2002 Received: February 20, 2002
Dear Mr. Kahan:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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.
2
Page 2 – Mr. Jonathan S. Kahan
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Miriam C. Provoort
for Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
INDICATIONS FOR USE ENCLOSURE
| 510(k) Number (if known): | K020470 |
|---|---|
| Device Name: | CorLink™ Automated Anastomotic Device |
| Indications for Use: | The ByPass CorLink™ Aortic Anastomotic Device (CorLink™ AAD) is intended to be used in CABG procedures for creating a sutureless proximal anastomosis between the Aorta and a venous graft conduit. |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-off) Division of General and Restorative Devices
510(k) Number K020470
Prescription Use
(Per 21 CFR 801.109)
OR
Over the Counter Use
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K620470
Page 4 of 39