(99 days)
The CorLink AAS is indicated for creation of an anastomosis between a venous graft conduit and the aorta for coronary artery bypass grafting (CABG). The Coring punch component penetrates the aorta and cuts a circumferential aortotomy in which the implanted device will be deployed.
This 510(k) notification describes the CorLink™ Automated Anastomotic Device indicated for creation of an anastomosis between a venous graft conduit and the aorta for coronary artery bypass grafting. The Coring punch device is intended for creating the aortotomy in which the implanted device will be deployed. The major differences between the two systems are: 1. The Piercing Tip and the Tissue Grabber are in one piece in the modified coring punch 2. Tissue Grabber button was replaced by an automatic Tissue Grabber activation button component 3. The Tissue Grabber in the modified coring punch contains 3 barbs instead of 2 as in the 510k cleared coring punch design 4. The Cylinder Cutting Edge diameter will range from 2.5 mm to 3.6 mm and from 2.9 mm to 4.0 mm in the 2.0 mm and 4.0 mm size kits (in 0.1 mm increments each), respectively. 5. The modified coring punch is single use only, whereas the 510(k) cleared coring punch was for single patient use.
This 510(k) summary does not contain information typically found in a clinical study report or a detailed validation study. Instead, it focuses on demonstrating substantial equivalence to a predicate device based on modifications to a component. Therefore, much of the requested information regarding acceptance criteria, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies is not present.
However, based on the provided text, here's what can be extracted and inferred:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly list quantitative "acceptance criteria" for the modified device's performance in the typical sense (e.g., a specific percentage success rate or a measurement tolerance). Instead, the criterion for acceptance is substantial equivalence to the predicate device in terms of performance, intended use, and technological characteristics.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device in performance. | "Information on risk analysis of the modifications and performance testing provided in the application demonstrates equivalence to the predicate device with respect to performance." |
| Modifications do not raise new questions of safety or effectiveness. | "Based on the performance data gathered, the device modifications do not raise any new questions of safety or effectiveness." |
| Intended Use | "The Coring punch device is intended for creating the aortotomy in which the implanted device will be deployed." (Consistent with predicate AAS component, K020470) |
| Technological Characteristics (Punch mechanism improvement) | "The improvement in the punch mechanism does not require any design, structural, or dimensional changes to the Handle, the Inserter, Sizer and the Implant." (Suggests the improved punch performs its function without negatively impacting other parts.) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The document mentions "performance testing" and "performance data gathered" but does not give specific numbers of tests or samples.
- Data Provenance: Not explicitly stated. The company is ByPass LTD, located in Herzelia B, Israel. The testing would presumably have been conducted by the manufacturer or a contract lab. Whether this was retrospective or prospective (in terms of design changes vs. new testing) isn't detailed, but the "performance testing provided in the application" suggests specific tests were conducted for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not provided in the 510(k) summary. The nature of the device (a surgical tool for creating an aortotomy) suggests "ground truth" would be established through direct observation of the punch's function and the resulting aortotomy in a controlled environment (e.g., animal models, cadaveric studies, or bench testing on tissue models), rather than through expert consensus on diagnostic images.
4. Adjudication Method for the Test Set
- Not applicable/Not specified. Adjudication methods like 2+1 or 3+1 are typically used in clinical trials or diagnostic studies where multiple readers interpret data. This is a device modification submission focused on mechanical function/performance.
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. This is not an AI-assisted diagnostic device, and thus, an MRMC study comparing human readers with and without AI assistance is not relevant or mentioned.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This is a physical surgical device, not an algorithm.
7. The Type of Ground Truth Used
- The document implies that the ground truth for "performance testing" would relate to the successful creation of the aortotomy, its size, minimal tissue trauma, and integration with the implanted device. This would likely be assessed through direct physical measurement and visual inspection (e.g., histology, dimensional analysis) of the results of the punch's action on tissue. The text mentions the diameter range for the cutting edge, suggesting precise dimensional requirements.
8. The Sample Size for the Training Set
- Not applicable. This is a modification to a physical device, not a machine learning algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no "training set" in the context of an AI algorithm. For the initial design and iteration of the device, engineering specifications and testing would have guided its development.
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MAR 3 1 2004
510(k) Summary of Safety and Effectiveness ByPass LTD, CorLink™ Automated Anastomotic System 510(k) Number_K033979
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 the CorLink™ Automated Anastomotic Device indicated for creation of an anastomosis between a venous graft conduit and the aorta for coronary artery bypass grafting. The Coring punch device is intended for creating the aortotomy in which the implanted device will be deployed.
The Coring punch device is equivalent to the punch already cleared as a component of the CorLinkTM AAS (K020470) with respect to intended use. The major differences between the two systems are:
l. The Piercing Tip and the Tissue Grabber are in one piece in the modified coring punch
- Tissue Grabber button was replaced by an automatic Tissue Grabber activation button component
The Tissue Grabber in the modified coring punch contains 3 barbs instead of 2 3. as in the 510k cleared coring punch design
- The Cylinder Cutting Edge diameter will range from 2.5 mm to 3.6 mm and from 2.9 mm to 4.0 mm in the 2.0 mm and 4.0 mm size kits (in 0.1 mm increments each), respectively.
The modified coring punch is single use only, whereas the 510(k) cleared 5. coring punch was for single patient use.
The improvement in the punch mechanism does not require any design, structural, or dimensional changes to the Handle, the Inserter, Sizer and the Implant.
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™ AAS to include the Coring punch is substantially equivalent to the cleared CorLink™MAAS using the punch with respect to intended use, technological characteristics, and performance.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 3 1 2004
By-Pass Makafim Ltd. c/o Mr. Jonathan S. Kahan Hogan and Hartson 555 13th Street NW Washington, DC 20004-1109
Re: K033979
CorLinkTM Automated Anastomotic System - Coring punch modification Regulation Number: 21 CFR 870.4300 Regulation Name: Implantable Clip Regulatory Class: Class II (two) Product Code: FZP Dated: December 22, 2003 Received: December 23, 2003
Dear Mr. Kahan:
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. Ilsting 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.
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Page 2 - Mr. Jonathan S. Kahan
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. 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), please contact the Office of Compliance at (301) 594-4646. 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) you may obtain. 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,
R. Lochner
Bram D. 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 ENCLOSURE
| 510(k) Number (if known): | K033979 |
|---|---|
| Device Name: | CorLink™ Automated Anastomotic System - Coring punch modification |
| Indications for Use: | The CorLink AAS is indicated for creation of an anastomosis between a venous graft conduit and the aorta for coronary artery bypass grafting (CABG). The Coring punch component penetrates the aorta and cuts a circumferential aortotomy in which the implanted device will be deployed. |
Prescription Use (Per 21 CFR 801.109)
OR
Over the Counter Use__________________________________________________________________________________________________________________________________________________________
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Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-off) Division of General and Restorative Devices
510(k) Number_ K 033979
§ 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.