The reprocessed steerable introducer devices are indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.

Device Description

The reprocessed steerable introducer consists of a steerable sheath and plastic dilator, which is indicated for introducing various cardiovascular catheters including the left side of the heart through the interatrial septum. The device is always delivered over a guidewire. The steerable introducer device enters through the right femoral vein and is guided into the right atrium of the heart. A knob on the introducer handle dictates the amount and direction of curl at the distal tip of the sheath. The shaft of the introducer is filled with radiopaque material so the device can be seen using fluoroscopy. A guidewire pokes through the septum into the left atrium and a tapered dilator enlarges the hole. The dilator is then removed allowing the introduction of a catheter.

The device is an 8.5F asymmetrical bi-directional steerable introducer with a varying amount of curl (small, medium or large) at the distal tip and a useable length of 61 or 71 cm. The proximal end of the device sheath is fitted with a hemostasis valve to minimize blood loss during catheter insertion and/or exchange over a guidewire. A side port with three-way stopcock is provided for air or blood aspiration, fluid infusion, blood sampling, and pressure monitoring. A handle is equipped with a rotating collar to deflect the large curl 90 degrees in the counterclockwise direction and 180 degrees in the clockwise direction. The sheath is filled with radiopaque material for visualization under fluoroscopy.

AI/ML Overview

The provided document is a 510(k) premarket notification letter from the FDA to Sterilmed, Inc. for a Reprocessed Steerable Introducer. This document is not a study report that includes details about acceptance criteria and device performance in the context of an AI/ML medical device.

The content focuses on demonstrating substantial equivalence of the reprocessed device to legally marketed predicate devices, rather than on the performance of a novel AI/ML algorithm. Therefore, many of the requested details about acceptance criteria, study design, expert ground truth, and AI performance metrics are not applicable to this document.

However, I can extract the information that is relevant to the device's functional and safety performance, as established for its substantial equivalence claim, even though it doesn't involve AI.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document outlines performance testing intended to show that the reprocessed device performs similarly to the new predicate device. While specific numerical acceptance criteria values are not explicitly listed in the submission summary, the intent is that the reprocessed device meets the functional and safety standards expected of the original, new device.

Performance Test Category	Acceptance Criteria (Implied)	Reported Device Performance (Summary)
Mechanical/Functional	Devices operate as intended, meeting design specifications of the original device.	"Functional testing has shown the reprocessing does not affect the performance of the devices." The reprocessed devices are "identical in form, fit, functionality and intended use as the predicate devices."
Cap Retention		Similar to predicate device
Shaft Deflection and Flexation		Similar to predicate device
Joint Strength		Similar to predicate device
Leak		Similar to predicate device
Shaft Torque		Similar to predicate device
Stiffness		Similar to predicate device
Distribution		Similar to predicate device
Torque Response		Similar to predicate device
Dimensional Verification	Dimensions match original device specifications.	Similar to predicate device
Systems Use	Device functions correctly in its intended system.	Similar to predicate device
Biocompatibility	Meets ISO 10993-1 standards for short-duration blood contact (<24 hours).	All tests (Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Acute Systemic Toxicity, Hemocompatability, Thrombogenicity, Chemical Pyrogens, Hemolysis, Immune Response) were conducted and met the standards.
Sterilization	Sterile to a Sterility Assurance Level (SAL) of 10-6.	Achieved by ethylene oxide sterilization.

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

Test Set Sample Size: The document does not specify the exact sample size for each performance test. It mentions that "the device was tested" and "functional testing has shown."
Data Provenance: The testing was conducted by Sterilmed, Inc. as part of their premarket notification submission to the FDA. The nature of this document suggests the data is prospective for the reprocessed device, generated specifically for this submission to demonstrate substantial equivalence. The country of origin of the data is implied to be the USA (Plymouth, MN, where Sterilmed is located).

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

This information is not applicable as this submission relates to a reprocessed medical device and its physical/functional characteristics, not an AI/ML algorithm requiring expert ground truth for classification or prediction. The "ground truth" here is the performance of the new, predicate device and established engineering/biocompatibility standards.

4. Adjudication method for the test set:

Not applicable. There is no expert adjudication process described, as the evaluation is based on objective measurements against engineering specifications and regulatory standards for device performance.

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 document is about a physical medical device (steerable introducer), not an AI/ML system. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed or described.

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

Not applicable. This document is about a physical medical device, not an AI/ML algorithm.

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

The "ground truth" for the reprocessed device is its ability to meet the established performance specifications and safety profiles of the original, new predicate devices (St. Jude Agilis™ NxT Steerable Introducers, K061363 and K081645), as well as relevant international standards (e.g., ISO 10993-1 for biocompatibility) and regulatory requirements. This is an engineering and materials science-based ground truth, not an expert consensus or pathology-based one.

8. The sample size for the training set:

Not applicable. This document is about a reprocessed physical device, not an AI/ML system that utilizes a training set.

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

Not applicable. As there is no AI/ML training set, the concept of establishing ground truth for it does not apply.

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 consists of a stylized caduceus symbol, which features a staff with a serpent entwined around it. To the left of the symbol, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion.

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

March 23, 2016

Sterilmed, Inc. % Ming Chew Regulatory Consultant Libra Medical Inc. 8401 63rd Avenue North, Suite 63 Brooklyn Park, Minnesota 55428

Re: K152090

Trade/Device Name: Reprocessed Steerable Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: PNE Dated: February 25, 2016 Received: February 26, 2016

Dear Ming Chew:

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 (OS) 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 yours,

Kenneth J. Cavanaugh -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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Page 3 - Ming Chew

Attachment

The following models are included in the clearance of K152090:

G408318 G408319 408309 408310 G408324

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Image /page/3/Picture/0 description: The image shows the text "K152090" at the top, followed by a logo with the text "STERILMED.". Below the logo, the text "24 JULY 2015" is displayed. The logo features a circular design with green and gray colors, suggesting a medical or sterilization-related theme. The text is clear and legible, indicating a label or informational graphic.

5. INDICATIONS FOR USE STATEMENT
DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration	Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See PRA Statement below.
Indications for Use
510(k) Number ( if known )	K152090
Device Name	Reprocessed Steerable Introducers
Indications for Use ( describe )
The reprocessed steerable introducer devices are indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.
Type of Use ( select one or both, as applicable )
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (Part 21 CFR 801 Subpart C )
CONTINUE ON A SEPARATE PAGE IF NEEDED
This section applies only to requirements of the Paperwork Reduction Act of 1995DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden to:
Department of Health and Human ServicesFood and Drug AdministrationOffice of Chief Information OfficerPaperwork Reduction Act (PRA) StaffPRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Image /page/4/Picture/0 description: The image shows the Sterilmed logo, which includes a green and silver circular design with the word "STERILMED" in gray text. Below the logo, the text "23 MARCH 2016" is displayed in a simple, sans-serif font. The text is likely a date associated with the logo or the image itself. The overall design is clean and professional.

1. 510(K) SUMMARY

1.1 ADMINISTRATIVE INFORMATION

1.1.1 Sponsor

Patricia Kaufman Sterilmed, Inc. 5010 Cheshire Parkway N, Suite 2 Plymouth, MN 55446

Tel: (763) 488-3211 Fax: (763) 488-2050 Email: tschrater@sterilmed.com

1.1.2 Primary Contact

Ming Cheng Chew Regulatory Consultant Libra Medical, Inc. 8401 73rd Ave North, Suite 63 Minneapolis, MN 55428 Tel: 763-232-3701 Fax: 763-477-6357 Email: mcchew@libramed.com

1.1.3 Secondary Contact

Julie Bodmer Regulatory Consultant Libra Medical, Inc. 8401 73rd Ave North, Suite 63 Minneapolis, MN 55428 Tel: 612-910-3412 Fax: 763-477-6357 Email: jbodmer@libramed.com

1.2 DEVICE NAME

Reprocessed Steerable Introducer Trade Name Common Name Steerable Introducer Classification Name Reprocessed Catheter Introducer Classification II PNE Primary Product Code

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Image /page/5/Picture/0 description: The image shows the Sterilmed logo, which includes a stylized symbol with a green and silver color scheme. The text "STERILMED" is written in a simple, sans-serif font next to the symbol. Below the logo, the date "23 MARCH 2016" is printed in a larger, serif font.

Secondary Product Code DYB

1.3 DEVICE DESCRIPTION OVERVIEW

Note: The guidewire is not included in the scope of this submission as it is purchased off-theshelf (K935170) and packaged with the reprocessed devices. Only the steerable sheath and plastic dilator are subject in this submission. In this submission references to the "device(s)" refers to both the sheath and dilator.

1.4 INDICATIONS FOR USE

The Reprocessed Steerable Introducer is indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.

TECHNOLOGY OVERVIEW 1.5

The device is an 8.5F asymmetrical bi-directional steerable introducer with a varying amount of curl (small, medium or large) at the distal tip and a useable length of 61 or 71 cm. The proximal end of the device sheath is fitted with a hemostasis valve to minimize blood loss during catheter insertion and/or exchange over a guidewire. A side port with three-way stopcock is provided for air or blood aspiration, fluid infusion, blood sampling, and pressure monitoring. A handle is equipped with a rotating collar to deflect the large curl 90 ° in the counterclockwise direction and 180° in the clockwise direction. The sheath is filled with radiopaque material for visualization under fluoroscopy.

1.6 PERFORMANCE TESTING OVERVIEW

The reprocessed steerable introducer devices are substantially equivalent to the new unreprocessed predicate devices (K061363 and K081645) in that the reprocessed devices are the same as the new un-reprocessed predicate devices in terms of form, fit, function, and intended use. No animal or clinical testing was conducted for this premarket notification submission. Physical and performance testing included:

Cap Retention
Shaft Deflection and Flexation
Joint Strength
Leak ●

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Image /page/6/Picture/0 description: The image shows the Sterilmed logo, which includes a stylized green and silver arrow. The text "STERILMED" is written in a simple, sans-serif font to the right of the arrow. Below the logo, the date "23 MARCH 2016" is written in a larger, serif font.

Shaft Torque ●
Stiffness ●
Distribution ●
Torque Response ●
Dimensional Verification ●
Systems Use ●

In addition, the device was tested for biocompatibility per ISO 10993-1 for short duration contact with blood (<24 hours). Biocompatibility testing included:

Cytotoxicity
Sensitization ●
Irritation/Intracutaneous Reactivity ●
Acute Systemic Toxicity
Hemocompatability ●
Thrombogenicity
Chemical Pyrogens
Hemolysis ●
Immune Response

The device is sterilized by ethylene oxide to an SAL 10-6 level. These performances are similar to that described by the predicate device.

1.7 SUBSTANTIAL EQUIVALENCE

Sterilmed's reprocessed steerable introducer devices are substantially equivalent to the predicate devices, St. Jude Agilis"14 NxT Steerable Introducers. There are no changes to the clinical applications, patient population, performance specifications, or method of operation. The reprocessing does not change the design or function of the device, but restores the performance characteristics of a used device. After reprocessing, the devices are identical in form, fit, functionality and intended use as the predicate devices (K061363 and K081645).

1.8 CONCLUSION

The reprocessed steerable introducer devices have identical indications for use and technological characteristics as the predicate devices. Functional testing has shown the reprocessing does not affect the performance of the devices, nor the safety of the devices. Therefore, the reprocessed steerable introducer devices and the predicate devices are substantially equivalent.

Regulation Number and Section

§ 870.1340 Catheter introducer.

(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).