The SuperCross Catheter is intended to negotiate stenotic or tortuous lesions of the iliac, femoral, popliteal, tibial and renal arteries in order to facilitate placement and positioning of other catheters. The SuperCross Catheter is not intended for use in the coronary or cerebral vasculature. The SuperCross Catheter is not intended for use to dilate lesions.

Device Description

The SuperCross Catheter features a 7 French compatible hydrophilically coated stainless steel braided polyimide and polyurethane shaft, which is attached to a steerable dilator at the distal end of the device. The proximal end of the shaft is connected to a handle and rotating hemostasis valve assembly. The dilator consists of two halves. One half articulates about a hinge pin and the other half is fixed to the shaft. The dilator is actuated by a wire connected to a lever and it may be rotated 360 degrees with the control of the shaft. A guidewire lumen through the device accepts a non-polymer coated 0.018" guide wire.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device (SuperCross™ Catheter). It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study of acceptance criteria and device performance in the way one might expect for a novel AI/software medical device.

Therefore, many of the requested categories (e.g., sample sizes for test/training sets, ground truth establishment, MRMC studies, standalone performance) are not applicable or not present in this type of submission. This document details a modification to an existing device and relies on showing that the new device performs equivalently to the previously cleared predicate device, rather than proving performance against specific quantitative acceptance criteria for a novel functionality.

Here's a breakdown of the information that is available or can be inferred:

1. Table of Acceptance Criteria and Reported Device Performance

This type of 510(k) submission generally does not present specific "acceptance criteria" in a quantitative performance table like a software device. Instead, the "acceptance criteria" can be broadly understood as demonstrating "substantial equivalence" to the predicate device in terms of:

Acceptance Criteria Category (Inferred)	Reported Device Performance (Summary from Document)
Intended Use	The SuperCross Catheter has the same intended use as the predicate device (K001856): to negotiate stenotic or tortuous lesions of the iliac, femoral, popliteal, tibial and renal arteries to facilitate placement/positioning of other catheters. Not for coronary/cerebral vasculature or lesion dilation. No change to Indications for Use.
Technological Characteristics	The SuperCross Catheter has similar technological characteristics to the predicate device (K001856). It features a 7 French compatible hydrophilically coated stainless steel braided polyimide and polyurethane shaft, attached to a steerable dilator. The dilator is actuated by a wire connected to a lever and can be rotated 360 degrees. Accepts a 0.018" guidewire. (Changes from predicate are implied to be minor enough not to require new performance criteria).
Biocompatibility	Scientific testing ensured all materials are biocompatible and introduced no new adverse effects.
Physical Properties	Physical properties are appropriate for the intended use.
Safety and Effectiveness (Overall)	The device has been shown to be equivalent to the Class II predicate, implying it meets the same safety and effectiveness profiles.

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

Not Applicable. This document describes a modification to an existing physical device, not an AI/software algorithm that operates on a "test set" of data. The "testing" referred to is against physical performance and biocompatibility expectations, not a dataset in the context of AI.

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

Not Applicable. As this is not an AI/software device, there is no "ground truth" derived by experts from a test set of data.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not Applicable. See point 3.

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 is a physical catheter device, not an AI-assisted diagnostic or treatment system.

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

Not Applicable. This is a physical catheter device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not Applicable. The "ground truth" for this device's performance would be engineering specifications, material science standards, and established clinical performance of the predicate device.

8. The sample size for the training set

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

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

Not Applicable. See point 8.

Summary of the Study (as described in the document):

The study referenced in the document is primarily a "substantial equivalence" justification.

Nature of the Study: It's a submission of information demonstrating that the modified SuperCross Catheter is substantially equivalent to its previously cleared predicate device (K001856). This involves comparing:
- Intended Use: Confirmed to be identical.
- Technological Characteristics: Described device components and features, implying similarity or minor, non-impactful changes from the predicate.
- Biocompatibility: "Results of scientific testing" ensured materials are biocompatible and no new adverse effects were introduced.
- Performance Characteristics: "Results of scientific testing" ensured physical properties are appropriate for intended use. This would likely involve bench testing (e.g., tensile strength, steerability, lubricity) but specific details and acceptance ranges are not provided in this summary.

This type of submission focuses on demonstrating that the new device does not raise new questions of safety and effectiveness compared to the predicate, validating its equivalence based on design, materials, and intended function.

Summary

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Perclose, Special 510(k) Application SuperCross™ Catheter Confidential

VII. SPECIAL 510(k) SUMMARY

K014118

A.	Sponsor/Submitter:	Perclose, An Abbott Laboratories Company400 Saginaw DriveRedwood City, CA 94063Tel: (650) 474-3000Fax: (650) 474-3020
	B. Contact Person:	Sevrina CiucciRegulatory Affairs Coordinator(650) 474-3164
	C. Date of Submission:	December 12, 2001
D.	Trade (Brand) Name:	SuperCross™ Catheter
E.	Common Name:	Percutaneous Catheter
F.	Classification:	Class II
G.	Classification Name:	Percutaneous Catheter, 21 CFR Part 870.1250
H.	Product Code:	74DQY
I.	Predicate Device:	SuperCross™ Catheter (K001856)

J. Intended Use:

Device Description: K.

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L. Summary of Substantial Equivalence:

Perclose has submitted information on the indication for use, design, principle of operation, biocompatibility and performance characteristics to establish that the SuperCross Catheter is equivalent to currently marketed predicate device.

The SuperCross Catheter has the same intended use and technological characteristics as the predicate device (K001856). Results of scientific testing have ensured that all materials are biocompatible, no new adverse effects were introduced and physical properties are appropriate for the intended use.

In conclusion, the SuperCross Catheter has been shown to be equivalent to the Class II predicate, the previous generation SuperCross Catheter, on which the device is based.

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Image /page/2/Picture/1 description: The image shows a circular logo with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. Inside the circle is a stylized image of an eagle with its wings spread. The logo is black and white and appears to be a scan of a document.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 1 2002

Ms. Sevrina Ciucci Regulatory Affairs Perclose, An Abbott Laboratories Company 400 Saginaw Drive Redwood City, CA 94063

Re: K014118

Trade Name: SuperCross™ Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: DQY Dated: December 12, 2001 Received: December 14, 2001

Dear Ms. Ciucci:

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, 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.

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Page 2 - Ms. Sevrina Ciucci

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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). 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,

Odegtall
Bram D. Zuckerman, M.D.

Bram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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V. INDICATIONS FOR USE STATEMENT

Special 510(k) Number:

K014118

Device Name:

Indications for Use:

SuperCross™ Catheter The SuperCross Catheter is intended to negotiate stenotic or tortuous lesions of the iliac, femoral, popliteal, tibial and renal arteries in order to facilitate placement and positioning of other catheters. The SuperCross Catheter is not intended for use in the coronary or cerebral vasculature. The SuperCross Catheter is not intended for use to dilate lesions.

There is no change to the Indications for Use.

Division of Cardiovascular & Respiratory Devices
510(k) Number K014118

Prescription Use
(Per 21 CFR 801.109)

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).