The CTS FloCoil Shunt is designed to help reduce blood in the operative field by temporary occlusion of the artery and to provide blood flow distal to the arteriotomy. This FloCoil Shunt is not an implant and is removed prior to completion of the anastomosis.

Device Description

The CTS FloCoil Shunt consists of coil reinforced polymer shaft with a polymer seal on each end and tapered polymer tips. The polymer seals on each end contact the vessel wall and cause occlusion of the artery proximal and distal to the arteriotomy . The FloCoil Shunt is selected according to the outer diameter of the polymer seals and is available in various sizes for various vessel diameters. There is a hole in both tapered tip ends of the FloCoil Shunt to allow for the perfusion of blood through the shunt's inner lumen and beyond the arteriotomy. A polyester thread (tether) is attached to the FloCoil Shunt in the middle of the shaft. Attached to the tether is a radiopaque tab which is used to aid insertion and removal of the FloCoil Shunt.

AI/ML Overview

The provided 510(k) summary for the CTS FloCoil™ Shunt (K970638) is for a medical device that helps reduce blood in the operative field during surgery and provides temporary blood flow. This submission is from 1997, and the information provided is characteristic of 510(k) summaries from that era, which often contained less detailed study information compared to current FDA submission requirements.

Based on the provided text, the specific details regarding the robustness of the studies (such as sample sizes, expert qualifications, and detailed statistical methodologies for acceptance criteria) are very limited. The submission focuses on functional performance testing, biocompatibility, and substantial equivalence to predicate devices rather than a rigorous performance study against quantitative acceptance criteria with specific metrics like sensitivity and specificity.

Here's an attempt to extract and describe the information based on your request, along with highlighting what is not present in the document.

Acceptance Criteria and Reported Device Performance

The document does not present a formal table of specific quantitative acceptance criteria with a corresponding "reported device performance" in terms of metrics like sensitivity, specificity, accuracy, or AUC that would be typical for an AI/algorithm-based device. Instead, the "acceptance criteria" are implied by the successful completion of functional performance testing and biocompatibility evaluation, and the "reported device performance" is a general statement of success.

Acceptance Criteria (Implied)	Reported Device Performance
Functional Performance: The Shunt would function according to its intended use instructions (i.e., help reduce blood in the operative field by temporary occlusion of the artery and provide blood flow distal to the arteriotomy).	"All testing conducted confirmed the acceptability of the CTS FloCoil Shunt to perform as intended to help reduce blood in the operative field by temporary occlusion of the artery while providing blood flow distal to the arteriotomy."
Biocompatibility: The device and its materials are safe for use in the human body as directed.	"The CTS FloCoil Shunt and Shunt materials passed the necessary biocompatibility tests."
Substantial Equivalence: The device is as safe and effective as existing predicate devices.	"The CTS FloCoil Shunt is substantially equivalent to the predicate devices with regard to intended use, function, physical characteristics, materials and sterilization method." and "All necessary testing was performed on the CTS FloCoil Shunt to ensure the product is substantially equivalent to the predicate devices and to ensure that the CTS FloCoil Shunt does not have any differences which have a significant effect on safety and effectiveness."

Study Details:

Sample size used for the test set and the data provenance:
- The document does not specify a sample size for the "test set" in terms of human subjects or distinct cases. The "Functional Performance Testing" and "Biocompatibility Evaluation" refer to testing conducted on the device itself and its materials, not on a human population in a clinical trial.
- Data provenance (country of origin, retrospective/prospective) is not applicable or specified, as no clinical study in human subjects is described. The testing appears to be lab-based or bench-top.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The "ground truth" for this device would be its physical and chemical properties and functional performance under laboratory conditions, as observed by engineers or technicians, not an expert medical consensus from a test set of medical outcomes.
Adjudication method for the test set:
- Not applicable, as no expert review or clinical case adjudication is described.
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 MRMC study was conducted or is applicable. This device is a physical surgical shunt, not an AI or imaging diagnostic tool that would involve human readers interpreting results.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For functional performance, the ground truth would be established through engineering specifications and bench testing parameters. For biocompatibility, it would be standardized laboratory tests to assess material interaction with biological systems (e.g., cytotoxicity, irritation, sensitization).
The sample size for the training set:
- Not applicable. This is not an AI/machine learning device. The concept of a "training set" doesn't apply.
How the ground truth for the training set was established:
- Not applicable.

Conclusion for this specific device (K970638):

The 510(k) summary for the CTS FloCoil™ Shunt (K970638) describes a physical medical device. The "acceptance criteria" and "study" are focused on demonstrating functional capability, material biocompatibility, and substantial equivalence to legally marketed predicate devices through bench testing and material characterization, rather than clinical performance metrics or AI algorithm validation. The questions regarding AI, expert consensus, and specific clinical study designs are not applicable to the information provided in this 1997 submission for this type of device.

Summary

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K97a638

510(k) Summary CardioThoracic Systems, Inc. CTS FloCoil™ Shunt 510(k) Notification K970638

GENERAL INFORMATION

OCT 30 1997

Manufacturer:	CardioThoracic Systems, Inc.
	10600 N. Tantau Avenue
	Cupertino, California
	(408) 342-1700
	(408) 342-1717 FAX
	Est. Reg. No. (awaiting issuance)
Contact Person:	Michael J. Billig
	Vice President, Regulatory, Quality, and Clinical Research

DEVICE DESCRIPTION

Classification:	Class II
Trade Name:	CTS FloCoil™ Shunt
Generic/Common Name:	Vascular clamp (21 CFR 870.4450)Surgical Vessel Dilator (21 CFR 870.4475)Blood Access Device and Accessories (21 CFR 876.5540)

PREDICATE DEVICES

Bio-Vascular, Inc. Flo-Rester (1)
Research Medical, Inc. Yacoubian Clamp External Coronary Artery Occluder (2)
Research Medical, Inc. Carotid Artery Shunts (3)
Research Medical, Inc. Vacu-Sponge Surgical Sponge (4)

INTENDED USE

The CTS FloCoil Shunt is designed to help reduce blood in the operative field by temporary The CTS FIOOd Brain is actery and to provide blood flow distal to the arteriotomy. This FloCoil Shunt is not an implant and is removed prior to completion of the anastomosis.

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PRODUCT DESCRIPTION

SUBSTANTIAL EQUIVALENCE

The CTS FloCoil Shunt is substantially equivalent to predicate devices currently being marketed. The marketed predicate devices are identified above. The CTS FloCoil Shunt is substantially equivalent to the predicate devices with regard to intended use, function, physical characteristics, materials and sterilization method.

All necessary testing was performed on the CTS FloCoil Shunt to ensure the product is substantially equivalent to the predicate devices and to ensure that the CTS FloCoil Shunt does not have any differences which have a significant effect on safety and effectiveness.

FUNCTIONAL PERFORMANCE TESTING

Functional testing was conducted on the CTS FloCoil Shunt to ensure that the Shunt would function according to its intended use instructions. All testing conducted confirmed the acceptability of the CTS FloCoil Shunt to perform as intended to help reduce blood in the operative field by temporary occlusion of the artery while providing blood flow distal to the arteriotomy .

BIOCOMPATIBILITY EVALUATION

The biocompatibility testing was conducted on the CTS FloCoil Shunt and Shunt materials to ensure the acceptability of the CTS FloCoil Shunt when used as directed. The CTS FloCoil Shunt and Shunt materials passed the necessary biocompatibility tests.

SUMMARY

As contained in this 510(k) summary, all necessary testing was conducted on the CTS FloCoil™ Shunt to ensure that the device is safe and effective when used in accordance to its intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is depicted in black, and the text is also in black. The logo is simple and recognizable, representing the department's role in protecting the health of all Americans.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

Mr. Michael J. Billig Vice President Requlatory, Quality and Clinical Research CardioThoracic Systems 10600 N. Tantau Avenue Cupertino, California 95014-0739

OCT 30 1997

K970638 Re : CTS MIDCAB Fixed Diameter Coronary Shunt Regulatory Class: II (Two) Product Code: DXC Dated: August 18, 1997 Received: August 21, 1997

Dear Mr. Billig:

We have reviewed your Section 510(k) 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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This letter will allow you to beqin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.qov/cdrh/dsmamain.html."

Sincerely yours,

Thomas J. Callehan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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CardioThoracic Systems, Inc. CTS FloCoil Shunt 510(k) Premarket Notification

Statement of Indications for Use

Bree L. Campese
(Division Sign-Off)

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number K970638

Regulation Number and Section

§ 870.4450 Vascular clamp.

(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).