Distal Access torque devices are used to maneuver quide wires in the coronary and peripheral vasculature during interventional or diagnostic procedures. Distal Access torque devices are not intended for use in the neurovasculature.

Device Description

The Distal Access Torque Device (Predict / Spinr Controller) is a single-use hand-held manually operated high-performance torque device / controller used to maneuver difficult-to-grasp devices including quidewires during interventional or diagnostic procedures. The Predict's design allows for predictable and controllable rotation of a device clockwise with counterclockwise return to its original orientation. Clockwise and counterclockwise rotations are manually controlled so the Predict rotates the same number of rotations in one direction as the other. Similar to the predicates, the user manually advances and retracts the Predict torque device forward and backward to introduce or remove the connected device from the body. Also, identical to the predicates, the Predict may be connected to a device already in the body. Same as the predicates, a device, including a guidewire, is loaded into the Predict 0.014 - 0.039" by inserting the proximal end of the device into the distal end of the Predict's cap. The Predict locks down on the device when the user rotates the collet cap clockwise, forcing the industry standard designed collet to grip onto the device is released when the user rotates the cap counterclockwise to loosen the collet's grip on the device. Once a device is connected, the Predictably rotates devices between 3 and 5 times clockwise and counterclockwise as per the labeled number of rotation is manually controlled by the user's finger, thumb and hand. Also, identical to predicates, the Predict does not use electrical power or software.

AI/ML Overview

This document is primarily a 510(k) summary for the Distal Access Torque Device (Predict or Spinr). It details the device's description, indications for use, and a comparison to predicate devices, focusing on demonstrating substantial equivalence. The document does not contain an acceptance criteria table or information typically found in an independent study report, such as specific performance metrics and their acceptance limits.

However, based on the provided text, I can infer some criteria and the general nature of the "study" (non-clinical testing) conducted.

Here's an attempt to answer your request based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a formal table of acceptance criteria with specific numerical limits and corresponding performance results. Instead, it lists attributes evaluated and states: "The Predict subject device met all predetermined acceptance criteria identified in test protocols created to evaluate conformance with the relevant requirements of the above listed standards, guidance documents, and in-house protocols demonstrating that identified potential risks and hazards have been acceptably controlled and that the safety and/ or performance of the new device are equivalent to those of the cited predicate device(s)."

Here's a table based on the evaluated attributes and the general statement about meeting acceptance criteria:

Acceptance Criteria (Inferred from Evaluated Attributes)	Reported Device Performance
Axial wire retention force	Met acceptance criteria
Collet release (ease of release)	Met acceptance criteria
Collet slip torque	Met acceptance criteria
Cap dimensions	Met acceptance criteria
Collet insertion force	Met acceptance criteria
Rotational speed	Met acceptance criteria
Comparative torque (vs. predicate)	Met acceptance criteria
Screw rotations	Met acceptance criteria
Wire pull (force to remove wire)	Met acceptance criteria
Spring force and dimensions	Met acceptance criteria
Slider length and sleeve view port	Met acceptance criteria
Axial force and wire movement (vs. predicate)	Met acceptance criteria
Collet slip torque (comparison to predicate)	Met acceptance criteria
Evaluation of collet grip strength under simulated use	Met acceptance criteria
Package seal strength and integrity	Met acceptance criteria
Biocompatibility (Cytotoxicity, Sensitization, Acute Systemic Toxicity, Pyrogenicity, Hemocompatibility)	Met acceptance criteria

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

The document mentions "Verification and validation tests" and "in-house protocols" for testing of the Predict device. However, it does not specify sample sizes for any of the tests conducted.

Data Provenance: The data is from "in-house protocols" and "nonclinical tests" conducted by Distal Access, LLC. The country of origin is not explicitly stated, but the company address is in Park City, UT, USA. The data is retrospective in the sense that the tests were performed on finished devices to support the 510(k) submission, not as part of a prospective clinical trial.

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

This information is not provided in the document. The tests appear to be engineering and laboratory-based performance tests, not human-reader-based assessments where "ground truth" established by experts would typically be relevant.

4. Adjudication Method for the Test Set

This information is not applicable as the tests are non-clinical engineering and performance evaluations, not diagnostic assessments requiring adjudication of human interpretations.

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

No, an MRMC comparative effectiveness study was not done. This device is a manual torque device, not an AI-assisted diagnostic tool.
The concept of human readers improving with AI vs without AI assistance is not applicable to this type of medical device.

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

No, a standalone algorithm performance study was not done. This device is a mechanical tool operated by a human, not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical performance and safety tests were established by engineering specifications, regulatory standards (e.g., ISO 10993, ANSI/AAMI/ISO 11135-1, ASTM F88, ASTM F1980-07), and internal design protocols. For instance, a test for "axial wire retention force" would have a defined minimum force that the device must withstand before the wire slips, and successfully meeting this force would be the "ground truth" for that attribute.

8. The Sample Size for the Training Set

This information is not provided and is not applicable. The device is a mechanical tool, not an AI system that requires a "training set" of data.

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

This information is not applicable as there is no "training set" for this type of device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of a human figure, represented by three overlapping profiles facing to the right. The profiles are black and the background is white.

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

December 10, 2014

Distal Access. LLC c/o Mr. Mark Job Regulatory Technology Services LLC 1394 25th Street NW Buffalo, MN 55313

Re: K141054

Trade/Device Name: Distal Access Torque Device or Controller (Predict or Spinr) Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: November 24, 2014 Received: November 25, 2014

Dear Mr. Job:

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. Iisting 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

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device-related adverse events) (21 CFR 803); 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.

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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 yours,

Melissa A. Torres -S

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)

K141054

Device Name

Distal Access Torque Device or Controller (Predict or Spinr)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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5. 510(k) Summary

510(k) Number K141054

GeneralProvisions	Date of Preparation:	December 8, 2014
	Submitter Name:	Shawn P. Fojtik
	Sponsor:	Distal Access, LLC
	Address:	5010 Heuga Court, Park City, UT 84098-8514
	Telephone/	Phone (435) 602-9640
	Fax No.:	(954) 457-8038
	Email	fojtik@post.harvard.edu
	Contact Name:	Shawn P. Fojtik
	Contact Company:	Distal Access, LLC
	Address:	5010 Heuga Court, Park City, UT 84098-8514 USA
	Telephone/	(435) 602-9640
	Fax No.:	(954) 457-8038
	Email:	fojtik@post.harvard.edu
SubjectDevice	Trade Name:	Distal Access Torque Device or Controller (Predict or Spinr)
	Common Name:	Torque device / controller
	Classification Name:	Catheter Guide Wire (accessory)(74DQX; 21 CFR § 870.1330)
PredicateDevices	Trade Name:	Pin Vise torque device
	Common Name:	Torque device / controller
	Classification Name:	Catheter, Percutaneous (accessory)(74DQY; 21 CFR § 870.1250)
	Manufacturer:	Merit Medical Systems, Inc.
	Premarket Notification:	K936032 December 17, 1993
	Trade Name:	VSI torque device
	Common Name:	Torque device / controller
	Classification Name:	Catheter Guide Wire (accessory)(74DQX; 21 CFR § 870.1330)
	Manufacturer:	Vascular Solutions, Inc.
	Premarket Notification:	K100093 April 30,2010

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Predict Torque Device

Device Description

Manually rotating, spinning, and torqueing wires, guidewires, catheters, and other devices are common during interventional and diagnostic procedures. The Distal Access Torque Device (Predict / Spinr Controller) is a single-use hand-held manually operated high-performance torque device / controller used to maneuver difficult-to-grasp devices including quidewires during interventional or diagnostic procedures.

The Predict's design allows for predictable and controllable rotation of a device clockwise with counterclockwise return to its original orientation. Clockwise and counterclockwise rotations are manually controlled so the Predict rotates the same number of rotations in one direction as the other. Similar to the predicates, the user manually advances and retracts the Predict torque device forward and backward to introduce or remove the connected device from the body. Also, identical to the predicates, the Predict may be connected to a device already in the body.

Same as the predicates, a device, including a guidewire, is loaded into the Predict 0.014 - 0.039" by inserting the proximal end of the device into the distal end of the Predict's cap. The Predict locks down on the device when the user rotates the collet cap clockwise, forcing the industry standard designed collet to grip onto the device is released when the user rotates the cap counterclockwise to loosen the collet's grip on the device.

Once a device is connected, the Predictably rotates devices between 3 and 5 times clockwise and counterclockwise as per the labeled number of rotation is manually controlled by the user's finger, thumb and hand. Also, identical to predicates, the Predict does not use electrical power or software.

Similar to predicate devices, industry standard components and materials are used:

Medical grade polycarbonate (Makrolon) sleeve, grip, body, screw, slider, and cap components. -
Stainless steel spring. -
Industry standard collet design. -
ISO 10993 compliant medical grade Loctite adhesive and NuSil Lubricant. -

Predicts do not add any new materials or manufacturing processes to molding or assembly.

Indication for Use

Guidance Documents

Verification and validation tests have been performed in accordance with the FDA's Design Control requirements identified in 21 CFR §820.30. The following guidance documents and standards were used in conjunction with in-house protocols to determine that the new Predict device is substantially equivalent to the predicated device(s):

ISO 10993-1:2009, Biological Evaluation of Medical Devices Part-1: Evaluation and Testing ANSI/AAMI/ISO 11135-1:2007, Sterilization of health care products- Ethylene oxide- Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices

AAMI ISO TIR 11135-2:2008, Sterilization of health care products- Ethylene oxide - Part 2: Page 2 of 4 Section 5 510k Summary

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Guidance on the application of ANSI/AAMI/ISO 11135-1

ANSI/AAMI/ ISO 11607-1: (2006)/(R)2010. Packaging for terminally sterilized medical devices- Part 1: Requirements for materials, sterile barrier systems and packaging systems ANSI/AAMI/ ISO 11607-2: (2006)/(R)2010, Packaging for terminally sterilized medical devices- Part 2: Validation requirements for forming, sealing, and assembly processes ASTM F88, Standard Test Method for Seal Strength of Flexible Barrier Materials ASTM F 1980-07. Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices (Sterility)

Testing

In addition, the following attributes were evaluated in accordance with test protocols to determine the relative performance of the new Predict device with the predicate torque devices:

Axial wire retention force;
Collet release testing;
Collet slip torque;
Cap dimensions;
. Collet insertion force;
. Rotational speed;
. Comparative torque testing:
. Screw rotations;
Wire pull tests;
. Spring force and dimensions:
Slider length and sleeve view port test;
. Rotational speed test:
Comparative torque tests;
. Axial force and wire movement versus predicate;
Collet slip torque comparison to predicate;
. Evaluation of collet grip strength under simulated use;
. Package seal strength and integrity.
. Biocompatibility: Cytotoxicity, Sensitization, Acute Systemic Toxicity, Pyrogenicity, and Hemocompatibility.

The Predict subject device met all predetermined acceptance criteria identified in test protocols created to evaluate conformance with the relevant requirements of the above listed standards, guidance documents, and in-house protocols demonstrating that identified potential risks and hazards have been acceptably controlled and that the safety and/ or performance of the new device are equivalent to those of the cited predicate device(s).

Clinical testing.

Not required for this device.

Summary of Substantial Equivalence

Based on a comparison of labeling, including intended and indicated uses, of the new and predicate devices: results of performance and safety tests: and an acceptable biological and toxicological risk associated with the use of the Predict torque device; Distal Access concludes that its new torque devices perform as well as or better than, the identified predicate devices, and can therefore be considered substantially equivalent.

Page 3 of 4 Section 5 510k Summary

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The conclusions drawn from the nonclinical tests demonstrate that the Predict device is substantial equivalent to the legally marketed Merit Pin Vice and VSI torque devices.

Regulation Number and Section

§ 870.1330 Catheter guide wire.

(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.