The Cordis 7F Hydrolyser Thrombectomy Catheter system consists of a 7F Catheter and an Accessory Kit. The 7F Catheter is a 65 - 100 cm dual lumen catheter which consists of an injection lumen that allows for saline to be injected and an exhaust lumen that allows for the fluid to be transported into a collection bag.

AI/ML Overview

The provided documents are for a 510(k) submission for the Cordis 7F Hydrolyser Thrombectomy Catheter. This is a medical device, not an AI or software device, so many of the requested fields regarding AI/ML device performance and ground truth establishment are not applicable.

Based on the provided text, here's what can be extracted:

Device Name: Cordis 7F Hydrolyser Thrombectomy Catheter
Predicate Device: Cordis 7F Hydrolyser Thrombectomy Catheter (65 cm length)
Indications for Use: The 7F Hydrolyser is indicated to percutaneously remove soft, newly formed (≤ 5 days old) thrombus from dialysis shunts.

Acceptance Criteria and Study for Cordis 7F Hydrolyser Thrombectomy Catheter

For this medical device, the acceptance criteria are generally focused on demonstrating substantial equivalence to a legally marketed predicate device, primarily through performance and safety testing. The "study" in this context refers to the pre-clinical testing mentioned to confirm equivalence.

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance / Method of Confirmation
Substantial Equivalence	Device performs in a manner similar to or better than the predicate device for its indicated use.	Confirmed through pre-clinical testing, demonstrating equivalence to the Cordis 7F Hydrolyser Thrombectomy Catheter (65 cm length). The 510(k) was a "Line Extension," indicating modifications (e.g., increased length to 100 cm) did not alter fundamental function or safety.
Biocompatibility	All materials in contact with body fluids must be biocompatible.	All materials used are biocompatible (stated in the Summary of Safety and Effectiveness).
Functional Performance	Ability to percutaneously remove soft, newly formed (≤ 5 days old) thrombus from dialysis shunts.	Verified by pre-clinical testing (implied by "equivalence confirmed through pre-clinical testing"). Specific metrics like thrombus removal efficiency, time, or complete removal percentage are not detailed in these summary documents but would have been part of the underlying test reports.
Safety	No new safety concerns compared to the predicate device.	Verified by pre-clinical testing and biocompatibility assessments. The FDA's substantial equivalence determination implies acceptable safety.
Design and Materials	Catheter design (dual lumen, injection/exhaust lumen) and materials meet specifications and are consistent with the predicate device or justified modifications.	Device described as a "7F Catheter," "dual lumen," with an "injection lumen" and "exhaust lumen," consistent with the Hydrolyser technology. "All materials used... are biocompatible."

2. Sample size used for the test set and the data provenance

Sample Size: Not specified in the provided documents. "Pre-clinical testing" typically involves a series of in-vitro and/or in-vivo studies with a defined number of test articles and possibly animal models, but the exact sample sizes are not detailed here.
Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The testing would have been conducted by the manufacturer (Cordis Corp.) or its designated testing facilities.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable for this type of medical device submission. "Ground truth" in the context of AI/ML or diagnostic imaging studies refers to verifiable clinical truth, established by experts. For a physical medical device like a thrombectomy catheter, "ground truth" relates to physical and functional performance measurements obtained through engineering tests and biological assessments. Testing would be performed by qualified engineers, technicians, and potentially veterinarians/surgeons (for animal studies), but the "number of experts" for ground truth establishment as defined for AI is not relevant.

4. Adjudication method for the test set

Not applicable for this type of medical device. Adjudication methods (e.g., 2+1, 3+1) are used for resolving disagreements among multiple human readers when establishing ground truth for diagnostic studies; this is not relevant for the performance testing of a thrombectomy catheter.

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

Not applicable. This device is a physical medical device, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical medical device, not an AI algorithm.

7. The type of ground truth used

For this device, the "ground truth" would be established through a combination of:

Engineering Measurements: Quantifiable physical properties and performance characteristics (e.g., flow rates, force measurements, material properties, catheter flexibility, thrombus removal efficiency in in-vitro models).
Biological Assessments: Biocompatibility testing (e.g., cytotoxicity, sensitization, irritation studies as per ISO 10993 standards).
Pre-clinical In-vivo Studies (if conducted): Performance and safety observations in animal models to simulate thrombus removal, with "truth" established by direct observation, pathological analysis of tissues, or imaging results.

The documents state "The equivalence was confirmed through pre-clinical testing," which broadly covers these types of ground truth.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/ML device.

Summary

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October 8, 2021

Cordis Corp. Ariel MacTavish Senior Regulatory Affairs Associate 14201 N.w.60th Ave. Miami Lakes, Florida 33014

Re: K990805

Trade/Device Name: Cordis 7F Hydrolyser Thrombectomy Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEZ

Dear Ariel MacTavish:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated March 15, 1999. Specifically, FDA is updating this SE Letter because FDA has created a new product code to better categorize your device technology.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Gregory O'Connell, OHT2: Office of Cardiovascular Devices, (301) 796-6075, Gregory. Oconnell(a)FDA.HHS.gov.

Sincerely,

Digitally signed by Gregory W. Gregory W. O'connell 5 O'connell -S Date: 2021.10.08 10:43:35 -04'00'

Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 5 1999

Ariel MacTavish, RAC Senior Regulatory Affairs Associate Cordis Corporation 14201 N.W. 60th Avenue Miami Lakes, FL 33014

Re: K990805 Trade Name: Modification to 7F Hydrolyser Thrombectomy Catheter Requlatory Class: II Product Code: DXE Dated: March 10, 1999 March 11, 1999 Received:

Dear Ms. MacTavish:

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 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). 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 to A substantially equivalent determination assumes compliance with 895. 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 regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to

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Page 2 - Ms. Ariel MacTavish

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 requlations.

This letter will allow you to begin 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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4586. 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 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.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

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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Attachment 2

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Indications for Use Statement

510(k) Number (if known)	K990805
Device Name	Cordis 7F Hydrolyser Thrombectomy Catheter
Indications for Use	The 7F Hydrolyser is indicated to percutaneously remove soft, newly formed (≤ 5 days old) thrombus from dialysis shunts.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ch. To. Am. Awn

(Division Sign-O Division of Cardiovas and Neurological De 510(k) Number

Cordis 7F Hydrolyser Line Extension Special 510(k) March, 1999

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Attachment 4

Summary of Safety and Effectiveness

GeneralProvisions	The name of the device is:
	Proprietary Name	Common or Usual Name
	Cordis 7F Hydrolyser Thrombectomy Catheter(65 – 100 cm length)	Embolectomy Catheter
Name ofPredicateDevices	The device is substantially equivalent to:• Cordis 7F Hydrolyser Thrombectomy Catheter (65 cm length)
Classification	Class II.
PerformanceStandards	Performance standards have not been established by the FDA under section514 of the Food, Drug and Cosmetic Act.
Indications forUse	The 7F Hydrolyser is indicated to percutaneously remove soft, newly formed(≤ 5 days old) thrombus from dialysis shunts.
DeviceDescription	The Cordis 7F Hydrolyser Thrombectomy Catheter system consists of a 7FCatheter and an Accessory Kit.
	The 7F Catheter is a 65 - 100 cm dual lumen catheter which consists of aninjection lumen that allows for saline to be injected and an exhaust lumen thatallows for the fluid to be transported into a collection bag.
Biocompatibility	All materials used in the Cordis 7F Hydrolyser Thrombectomy Catheter arebiocompatible.
Summary ofSubstantialEquivalence	The Cordis 7F Hydrolyser Thrombectomy Catheter is substantially equivalentto the predicate device. The equivalence was confirmed through pre-clinicaltesting.
Cordis 7F Hydrolyser Line ExtensionSpecial 510(k)March, 1999		16

Regulation Number and Section

§ 870.5150 Embolectomy catheter.

(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).