The Steerable Guide Catheter consists of a Guide and a Dilator provided EtO sterile and for single use only. The Steerable Guide Catheter consists of a distal and proximal catheter shaft, a radiopaque tip ring, a handle with a steering knob, a hemostasis valve with a luer lock flush port, an atraumatic distal tip, and a Dilator with a single central lumen. The central lumen of the Guide allows for aspiration of air and infusion of fluids such as saline, and serves as a conduit during introduction and or exchange of the Dilator and ancillary devices (e.g. catheters) that have a maximum diameter of .204". The atraumatic distal tip of the Steerable Guide Catheter is radiopaque to allow visualization under fluoroscopy. The Dilator consists of a radiopaque shaft, an echogenic feature at the distal tip, a hemostasis valve with a flush port and an internal lumen designed to accept ancillary devices that have a maximum diameter of 0.035" (e.g. needles or guidewires). The Steerable Guide Catheter, Dilator and accessories are packaged in a tray enclosed in a sealed Tyvek pouch and boxed in a cardboard shelf-carton.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the "Steerable Guide Catheter." It aims to demonstrate substantial equivalence to previously marketed predicate devices. The information provided heavily focuses on regulatory compliance and comparison to predicates rather than detailed performance study results of the new device against specific acceptance criteria.

Therefore, many of the requested details about acceptance criteria and study data are not explicitly stated in the provided text. The document asserts that the new device "meets the same performance specifications as the predicate device" due to "equivalent in fundamental scientific design," but it doesn't present the acceptance criteria or a dedicated study for the new device as an individual entity.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, specific performance acceptance criteria for the new Steerable Guide Catheter (K161985) are not explicitly defined, nor are detailed quantitative performance results reported. The document states that the new device "meets the same performance specifications as the predicate device." This implies an equivalence rather than a separate set of criteria and direct test results for K161985.

Acceptance Criteria (Not explicitly stated for new device - inferred as "same as predicate")	Reported Device Performance (Not explicitly stated for new device - inferred as "meets predicate specifications")
Implied: Functional performance parameters consistent with predicate steerable guide catheters.	Implied: Device functions equivalently to predicate devices.
Implied: Material compatibility and durability consistent with predicate devices.	Implied: Materials and durability are comparable to predicate devices.
Implied: Dimensional and design specifications consistent with predicate devices.	Implied: Dimensions and design match or are within acceptable ranges of predicate devices.

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

The document does not specify a sample size for a test set or data provenance for a performance study of the new Steerable Guide Catheter (K161985). It makes a claim of equivalence to predicates without detailing newly generated test data.

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

Not applicable. The document does not describe a study involving expert assessment of generated data for the new device's performance.

4. Adjudication Method for the Test Set

Not applicable. The document does not describe a study that would require an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done according to the provided text. The submission focuses on substantial equivalence to predicate devices, not on comparative effectiveness with human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a physical medical instrument (catheter), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

Not explicitly stated in the context of performance testing for the new device. The submission relies on "technological characteristics such as design, material, and indications for use" being substantially equivalent to predicates. The "ground truth" for the submission is the regulatory acceptance of the predicate devices based on their established performance and safety profiles.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical instrument, not a machine learning model, so there is no "training set."

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

Not applicable. As above, there is no "training set" for a physical medical device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 07, 2016

Abbott Vascular Makena Mc Gowan Regulatory Affairs Associate 3200 Lakeside Drive Santa Clara, California 95054

Re: K161985

Trade/Device Name: Steerable Guide Catheter Regulation Number: 21 CFR 870.1280 Regulation Name: Steerable Catheter Regulatory Class: Class II Product Code: DRA Dated: July 18, 2016 Received: July 19, 2016

Dear Ms. Mc Gowan:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

M.A. Hilleman

for

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

510(k) Number (if known) K161985

Device Name Steerable Guide Catheter

Indications for Use (Describe)

The Steerable Guide Catheter is used for introducing various catheters into the left side of the heart through the interatrial septum.

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

The 510(k) Summary is submitted in accordance with 21 CFR §807.1280 and the requirements of the Safe Medical Device Act (SMDA) of 1990.

1.	Submitter's Name	Abbott Vascular
2.	Submitter's Address	3200 Lakeside Drive Santa Clara, CA 95054
3.	Telephone	(408) 845-0937
4.	Fax	(408) 845-3734
5.	Contact Person	Makena Mc Gowan
6.	Date Prepared	August 4, 2016
7.	Device Trade Name	Steerable Guide Catheter
8.	Device Common Name	Steerable Catheter
9.	Device Classification Name	Catheter, Steerable
10.	Predicate Device Name	K083793 Steerable Guide CatheterK091596 Steerable Guide CatheterK093866 Steerable Guide CatheterK100789 Steerable Guide CatheterK112239 Steerable Guide Catheter

11. Device Description

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12. Indication for Use

The Steerable Guide Catheter is used for introducing various cardiovascular catheters into the left side of the heart through the interatrial septum.

13. Technological Characteristics

Comparison of the new device and predicate device demonstrate that the technological characteristics such as design, material, and indications for use are substantially equivalent to the current marketed predicate device.

14. Performance Data

The Steerable Guide Catheter is equivalent in fundamental scientific design to the predicate Steerable Guide Catheter, and therefore, meets the same performance specifications as the predicate device.

15. Conclusions

The Steerable Guide Catheter has the same indications for use and technological characteristics and is substantially equivalent to the predicate device.

Regulation Number and Section

§ 870.1280 Steerable catheter.

(a)
Identification. A steerable catheter is a catheter used for diagnostic and monitoring purposes whose movements are directed by a steering control unit.(b)
Classification. Class II (performance standards).