The Micro Guide Catheter ELITE accessory is to be used with the Frontrumer® CTO Catheter. The Frontrumer® CTO Catheter is intended to facilitate the intraluminal placement of conventional guide wires beyond stenotic lesions (including chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention.

Device Description

The Micro Guide Catheter ELITE is a 6F sheath compatible catheter designed to navigate and place guidewires in the peripheral vasculature and to provide additional support for the Frontrunner® CTO Catheter. The Frontrunner® CTO Catheter is indicated to facilitate the intraluminal placement of conventional guidewires beyond the stenotic lesions (including chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention. The Micro Guide Catheter ELITE is a single lumen torqueable tube containing a PTFE inner liner that is surrounded by a stainless steel braid, which is further encompassed by a polymer jacket, and features a final external hydrophilic coating. The proximal end utilizes a molded hub with a luer fitting for flushing, with winged tabs designed to facilitate maneuvering and torqueing in the vasculature, while the distal tip contains a radiopaque marker band for visibility under fluoroscopy. The Micro Guide Catheter ELITE is available in various configurations and several lengths. The Micro Guide Catheter ELITE is provided sterile (by EO) and is intended for single use only.

AI/ML Overview

The provided document is a 510(k) summary for the Micro Guide Catheter ELITE. It outlines the device description, intended use, and comparison to a predicate device, along with performance data. However, it does not explicitly present acceptance criteria in a table format with reported device performance for specific clinical or diagnostic metrics as one would expect for an AI/ML powered device.

Instead, the document details various types of performance tests conducted to demonstrate substantial equivalence to a predicate device. For the purpose of answering your request, I will interpret "acceptance criteria" as the successful completion and meeting of specifications for each listed performance test, and "reported device performance" as the documented successful outcome of these tests.

It's important to note that this device is a physical medical device (catheter), not an AI/ML-powered diagnostic tool. Therefore, many of your specific questions regarding AI/ML study design (ground truth, expert consensus, MRMC studies, training sets, etc.) are not applicable in this context.

Here's an attempt to structure the information based on your request, with a focus on how the provided document does address performance and testing, and explicitly stating where information requested for AI/ML devices is not present or not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test/Evaluation	Acceptance Criteria (Implicit)	Reported Device Performance
Biocompatibility	In vitro Cytotoxicity	Meet ISO 10993-1 & GLP Req.	Successfully passed
	In vitro Hemolysis	Meet ISO 10993-1 & GLP Req.	Successfully passed
	USP <661> Containers	Meet ISO 10993-1 & GLP Req.	Successfully passed
	Extraction Testing	Meet ISO 10993-1 & GLP Req.	Successfully passed
Device Dimensional & Functional Testing	Dimensional	Meet specifications	Verified
	Tensile	Meet specifications	Verified
	Leak	Meet specifications	Verified
	Coating Integrity	Meet specifications	Verified
	Lubricity	Meet specifications	Verified
	Stiffness and Pushability	Meet specifications	Verified
	Kink	Meet specifications	Verified
	Torque Strength & Transmission	Meet specifications	Verified
	Corrosion Resistance	Meet specifications	Verified
	Particulate	Meet specifications	Verified
	Simulated Use	Meet specifications	Verified
Packaging & Sterilization	Bioburden	Meet specifications	Verified
	EO Residuals	Meet specifications	Verified
	Bacterial Endotoxin	Meet specifications	Verified
Animal Study	Radiopacity	Equivalent to predicate	Scored successfully
	Rotation	Maintained/Improved	Scored successfully
	Advancement	Maintained/Improved	Scored successfully
	Retraction	Maintained/Improved	Scored successfully
	Vessel Damage/Perforation	No increase in risk	No evidence of tissue damage or perforation

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

Test Set Sample Size:
- Animal Study: Two animals were used. Within each animal, four devices were evaluated (2 test articles, 2 control articles). This gives a total of 4 uses of the test device (Micro Guide Catheter ELITE) across two animals.
- Other Testing (Biocompatibility, Dimensional, Functional, Packaging/Sterilization): The document does not specify the exact number of units or samples used for each of these in vitro/bench tests. It mentions "finished and sterilized catheters" for biocompatibility.
Data Provenance:
- Animal Study: Prospective, conducted in a porcine model. The country of origin is not specified but it was a GLP (Good Laboratory Practice) study.
- Biocompatibility & Other Tests: Likely lab-based (in vitro/bench) testing of manufactured devices. Provenance (country of origin) not specified. These were not human data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. This is a physical medical device, not an AI/ML diagnostic device requiring expert interpretation for ground truth establishment. The "ground truth" for its performance is determined by physical measurements, chemical analyses, and biological responses in animal models.

4. Adjudication Method for the Test Set

Not applicable. There was no expert adjudication in the context of diagnostic interpretation. For the animal study, evaluation was done by the study investigators.

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

No. This type of study is relevant for diagnostic devices, especially those using AI, to assess reader performance. It does not apply to a physical catheter.

6. Standalone (Algorithm Only) Performance Study

No. This applies to AI/ML algorithms, not physical medical devices.

7. Type of Ground Truth Used

Physical/Chemical Measurements and Biological Observations:
- For biocompatibility: Adherence to ISO standards and observed biological responses (cytotoxicity, hemolysis, etc.).
- For dimensional/functional: Engineering specifications and measurements.
- For packaging/sterilization: Measured levels of contaminants or residuals against safety limits.
- For animal study: Direct observation of device performance (radiopacity, rotation, advancement, retraction) and gross pathological evaluation of tissues for damage.

8. Sample Size for the Training Set

Not applicable. This device does not involve an AI/ML algorithm that requires a training set. The device design and testing are based on engineering principles and preclinical evaluations.

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

Not applicable. As there is no AI/ML training set, there is no ground truth related to it.

Summary

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

November 14, 2014

Cordis Corporation Dr. Michelle Ragozzino Rodgers Sr. Regulatory Affairs Specialist 6500 Paseo Padre Pkwy. Fremont, CA 94555

Re: K140438

Trade/Device Name: Micro Guide Catheter ELITE Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: PDU Dated: October 9, 2014 Received: October 10, 2014

Dear Dr. Rodgers.

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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,

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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Indications for Use

510(k) Number (if known) K140438

Device Name Micro Guide Catheter ELITE

Indications for Use (Describe)

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

☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

-SUBMITTER

Cordis Corporation, a Johnson & Johnson Company 6500 Paseo Padre Parkway Fremont, CA 94555

Contact Person: Michelle Ragozzino Rodgers, Ph.D. (510) 248-2450 Tel: Fax: (510) 248-2533

Date Prepared: October 9, 2014

II. DEVICE

Name of Device: Micro Guide Catheter ELITE Common Name: Percutaneous catheter Classification Name: Catheter for Crossing Total Occlusions (21 CFR §870.1250) Requlatory Class: Class II Product Code: PDU

III. PREDICATE DEVICE

Micro Guide Catheter XP, previously cleared under K082143 This predicate has not been the subject of a recall.

No reference devices were used in this submission.

IV. DEVICE DESCRIPTION

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fluoroscopy. The Micro Guide Catheter ELITE is available in various configurations and several lengths.

The Micro Guide Catheter ELITE is provided sterile (by EO) and is intended for single use only.

V. INDICATIONS FOR USE

The Micro Guide Catheter ELITE accessory is to be used with the Frontrunner® CTO Catheter. The Frontrunner® CTO Catheter is intended to facilitate the intraluminal placement of conventional guide wires beyond stenotic lesions (including chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The subject Micro Guide Catheter ELITE is identical in intended use to the predicate Micro Guide Catheter XP. No change was made to the operating principle or control mechanism. At a high level, the subject and predicate devices are based on the following same technological elements:

Catheter-Facilitates placement of and provides support to Frontrunner® XP CTO ● Catheter
Use of marker bands and radiopaque materials for fluoroscopic visualization of catheter . tip
6F Sheath compatibility
Use of hydrophilic coating for distal lubricity to advance through lesion
Use of a standard male luer fitting for flush port ●
EO sterilized, single use device ●

The changes to the subject device relative to the predicate are limited to minor modifications to the catheter shaft and tip and an improved packaging design. The following technological differences exist between the subject and the predicate devices:

. Modified shaft
Distal tip shape
Packaging size reduction and associated packaging material change ●

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VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination:

Biocompatibility Testing

Biocompatibility evaluation for the Micro Guide Catheter ELITE (subject device) leveraged the existing biocompatibility test data qenerated for the Micro Guide Catheter XP (predicate device). Supplemental biocompatibility testing to support the Micro Guide Catheter ELITE was performed on finished and sterilized catheters in compliance with U.S. Food and Drug Administration Good Laboratory Practice (GLP) requlations set forth in 21 CFR Part 58 and per ISO 10993-1:2009/Cor 1:2010 Biological evaluation of medical devices - Part 1. Supplemental Biocompatibility testing included the following tests:

o In vitro Cytotoxicity - MEM Elution
o In vitro Hemolysis - ASTM Extract & Direct Contact
o USP <661> Containers - Plastics, Physicochemical Tests

Extraction testing was also conducted on the Micro Guide Catheter ELITE.

Device Dimensional and Functional Testing

Dimensional
o Tensile
o Leak
Coating integrity
Lubricity
Stiffness and pushability o
Kink
Torque strength and torque transmission
Corrosion resistance
Particulate ●
o Simulated use

Packaging and Sterilization

Bioburden
EO residuals ●
Bacterial Endotoxin ●

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Animal Study

Cordis conducted a GLP animal study to evaluate the performance of Micro Guide Catheter Elite under simulated conditions in a porcine model. Two animals were utilized for the acute evaluations in the peripheral vasculature. Four devices (2 test articles and 2 control articles) were evaluated in each animal and scored for radiopacity and the ability to rotate, advance and retract the devices. No procedure-related complications or deaths were reported. Evaluation arteries were grossly evaluated in situ, and following excision, they were longitudinally cut and evaluated for signs of damage or trauma. There was no evidence of tissue damage or perforation. This study demonstrated that the angled tip and added stiffness of the Micro Guide Catheter ELITE relative to the predicate device does not increase the risk of vessel damage or perforation.

VIII. CONCLUSIONS

The subject Micro Guide Catheter ELITE is the same in basic design and identical intended use as the legally marketed predicate, Micro Guide Catheter XP. The minor modifications made to the catheter shaft and tip and improved packaging design for Micro Guide Catheter ELITE product family do not alter the fundamental scientific technology of the device's operating principles, mechanism of action, or the indication for the use of device. The design modifications made to the Micro Guide Catheter ELITE were verified and validated through a series of tests ensuring that the subject catheter meets the specifications and that the performance and functionality are substantially equivalent to the predicate device. The Micro Guide Catheter ELITE continues to meet all previous performance specifications, and none of the critical clinical performance parameters have changed. The modifications do not raise new questions of safety and effectiveness. Micro Guide Catheter ELITE can be used according to its intended use and in an equivalent manner to the predicate device.

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).