The Outback Catheter is intended to facilitate placement and positioning of catheters within the peripheral vasculature. The Outback Catheter is not intended for use in the coronary or cerebral vasculature.

Device Description

The Outback catheter features a 6 Fr. steel-braided polyimide and polyurethane shaft through which a single-lumen steel-braided polyimide guide is housed. The guide is extendable and steerable from the tip of the catheter shaft, and features a radiopaque multi-beveled guide tip allowing for visualization under fluoroscopy. A radiopaque index on the catheter shaft is oriented to the steerable guide tip. The proximal end of the Outback Catheter features a rotating hemostasis valve through which the guide is extended and retracted via a rotational handle mechanism.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called the "Outback™ Catheter." This type of submission is for demonstrating substantial equivalence to a predicate device, rather than proving that a device meets specific acceptance criteria through a highly structured study with performance metrics in the way that an AI/ML device submission would.

Therefore, the requested information, such as "acceptance criteria," "reported device performance," "sample size for the test set," "number of experts used to establish ground truth," "adjudication method," "MRMC study," "standalone performance," "type of ground truth," and "sample size for the training set" are not applicable to this 510(k) submission.

The document does not contain any information about a study designed to prove the device meets specific performance acceptance criteria in the context of an AI/ML device. Instead, it focuses on demonstrating substantial equivalence to a previously marketed predicate device.

Here's a breakdown of what the document does state in relation to demonstrating equivalence:

1. Acceptance Criteria and Reported Device Performance:

Not applicable. The document does not define specific performance acceptance criteria for the Outback™ Catheter that would be met through a quantitative study with reported metrics like sensitivity, specificity, etc.
Instead, the document states: "Results of [costs were introduced] and physical properties are appropriate for the intended use." This refers to internal testing of the device's physical and functional properties to ensure it performs as expected for its intended use, but not against pre-defined clinical performance acceptance criteria.

2. Sample Size Used for the Test Set and Data Provenance:

Not applicable. This information is not relevant to a 510(k) for demonstrating substantial equivalence of a physical medical device. There is no "test set" of data in the AI/ML sense.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

Not applicable. No ground truth establishment by experts for a test set is mentioned.

4. Adjudication Method:

Not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. This type of study is not mentioned as it's typically for assessing the impact of AI on human reader performance, which isn't the focus of this 510(k).

6. Standalone (Algorithm Only) Performance:

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

7. Type of Ground Truth Used:

Not applicable.

8. Sample Size for the Training Set:

Not applicable.

9. How the Ground Truth for the Training Set Was Established:

Not applicable.

Key takeaway from the document:

The basis for clearance is "substantial equivalence" to the predicate device (Outback™ Catheter (K001577)). The argument is that the new device has "the same intended use and technological characteristics as the Outback Catherer has the battle of scientific testing have ensured that all the predicate device (18001977)." This means the manufacturer performed tests to confirm that the materials, design, and function are comparable to the predicate and suitable for its intended use, rather than a clinical trial to establish new performance metrics against a defined ground truth.

Summary

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JAN 11 2002

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

K014117

VII. SPECIAL 510(K) SUMMARY

	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:	Outback™ 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:	Outback™ Catheter (K001577)

J. Intended Use:

K. Device Description:

L. Summary of Substantial Equivalence:

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

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The Outback Catheter has the same intended use and technological characteristics as the Outback Catherer has the battle of scientific testing have ensured that all the predicate device (18001977). Results of costs were introduced and physical properties are appropriate for the intended use.

In conclusion, the Outback Catheter has been shown to be equivalent to the Class II
n is he conce In conclusion, the Outback Catheter has over the count of the device is based.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with a double-stranded snake winding around a staff. The seal is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The image is in black and white.

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: K014117 Trade Name: Outback™ Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: DOY 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 r that FDA has made a determination that your device complies with other requirements of the Act that I Dr has intatutes and regulations administered by other Federal agencies. You must or any I coclar sunated and regerments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFR Part 8077, adoling (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) I mis letter will and in yours of substantial equivalence of your device to a legally promatics noticated 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 additionally 21 21 1 594-4646. 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 Oivision 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,

Deeda Telke

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:

Device Name:

Indications for Use:

There is no change to the Indications for Use.

Prescription Use
(Per 21 CFR 801.109)

KO14117

Outback™ 0.035" Catheter

Division of Cardiovascular & Respiratory Devices
510(k) Number B014117

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).