The SENDERO Microcatheter is a single lumen, variable stiffness catheter with a radiopaque marker on the distal end and a Luer-lock hub on the proximal end. A hydrophilic coating on the catheter shaft reduces friction during navigation through the vasculature. The device is delivered to the target location using standard interventional techniques (e.g. use of guidewire, guide catheter, etc.) under fluoroscopic guidance. Once at the target location, the lumen of the device allows for the introduction of diagnostic and therapeutic agents into the peripheral vasculature.

AI/ML Overview

The provided text is a 510(k) summary for the SENDERO Microcatheter, a medical device. This document describes the device, its intended use, comparison to a predicate device, and the non-clinical performance testing conducted to demonstrate substantial equivalence.

However, the request asks for information typically associated with a study proving that an AI/Software as a Medical Device (SaMD) meets acceptance criteria, including details about a test set, expert ground truth establishment, MRMC studies, standalone performance, and training set information.

The provided FDA 510(k) summary for the SENDERO Microcatheter does NOT contain information about an AI/SaMD, nor does it describe a study involving human readers, expert adjudication, or AI performance metrics.

The SENDERO Microcatheter is a physical medical device (a microcatheter) used for infusion, and its clearance relies on non-clinical performance testing (e.g., mechanical testing, biocompatibility) to demonstrate substantial equivalence to a predicate device.

Therefore, I cannot fulfill the request as the necessary information regarding AI/SaMD acceptance criteria and study details (test set, ground truth experts, MRMC, training set, etc.) is not present in the provided text.

The document explicitly states: "No clinical studies were required." This further indicates that the type of study described in the prompt (involving human readers, AI performance, etc.) was not conducted for this device's regulatory clearance.

Summary

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March 8, 2024

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Okami Medical, Inc. Jill Delsman Official Applicant 8 Argonaut. Suite 100 Aliso Viejo, California 92656

Re: K240384

Trade/Device Name: SENDERO Microcatheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: February 6, 2024 Received: February 8, 2024

Dear Jill Delsman:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Samuel G. Raben -S

Lydia Glaw Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

Submission Number (if known)

K230384

Device Name

SENDERO Microcatheter

Indications for Use (Describe)

The SENDERO Microcatheter is intended for the peripheral vasculature for the infusion of diagnostic and therapeutic agents.

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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Image /page/3/Picture/1 description: The image shows the logo for Okami Medical. The word "Okami" is written in a teal sans-serif font, with the "i" dotted with a red circle with a yellow outline. Below the word "Okami" is the word "MEDICAL" in a smaller, gray sans-serif font, with the registered trademark symbol next to it.

510(k) SUMMARY

Sponsor	Okami Medical, Inc.
	8 Argonaut, Suite 100
	Aliso Viejo, CA 92656
	USA
Contact	Jill Delsman
	949-446-9710
	jilld@okamimedical.com
Device Trade Name	SENDERO Microcatheter
Common Name	Microcatheter
Classification Name	Catheter, Percutaneous
Regulation Number	870.1250
Product Code	DQY
Predicate Device	K231600 - SENDERO Microcatheter - Product Code DQY
510 (k) Summary Date	March 1, 2024

Device Description Summary

Intended Use / Indications for Use

The SENDERO Microcatheter is intended for the peripheral vasculature for the infusion of diagnostic and therapeutic agents.

Indications for Use Comparison

The indication for use statement between the primary predicate and the subject device is identical.

Comparison of Technological Characteristics

The modified SENDERO Microcatheter is substantially equivalent to the predicate device with respect to intended use, principle of operation, and fundamental design characteristics.

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Image /page/4/Picture/1 description: The image shows the logo for Okami Medical. The word "Okami" is in a teal sans-serif font, with the "i" having a red circle with a gold outline above it. Below "Okami" is the word "MEDICAL" in a smaller, gray sans-serif font, with the registered trademark symbol to the right.

Only minor modifications have been made to the SENDERO Microcatheter materials and construction including a change in polyamide material specification, design enhancement of the catheter braid, increase in opacity of the marker band, increase in minimum catheter inside dimension and an update to the Luer-lock hub for compliance with ISO 80369-7 requirements, as well as labeling updates for maximum pressure specification.

The minor differences between the predicate and the subject device do not raise new or different questions of safety and effectiveness in comparison to the predicate device. These modifications have been addressed through design control activities, including a risk assessment to determine the verification and validation activities required to demonstrate the acceptability and substantial equivalence of any minor differences in technological characteristics between the predicate and subject device. Results of the verification and validation activities met the predefined acceptance criteria, demonstrating the subject device is substantially equivalent in terms of intended use, principle of operation, technological characteristics, and performance characteristics to the SENDERO Microcatheter cleared under K231600.

Non-clinical Performance Testing

A risk analysis based on the principles of ISO 14971 was performed to assess the impact of the modifications to the SENDERO Microcatheter. Performance testing, as outlined below, was conducted to demonstrate the subject device met the same performance criteria established for the predicate device. The results of the testing indicate that the modified SENDERO Microcatheter is substantially equivalent to the predicate device.

Performance testing included:

Dimensional/Visual Inspection
Coating Thickness and Lubricity
Simulated Use Testing ●
Catheter Coating Integrity
Compatibility Testing
Burst Pressure Testing (per ISO 10555-1)
Catheter Tensile Strength (per ISO 10555-1)
Catheter Tip Strength
Kink Diameter Testing
Torque Testing
Hub Testing (per ISO 80369-7)
Flowrate Testing (per ISO 10555-1)
Radiopacity Testing (per ASTM F640)
Particulate Testing
Biocompatibility Testing (per ISO 10993-1)
- o Cytotoxicity
- o Sensitization

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SENDERO Microcatheter

Image /page/5/Picture/1 description: The image is a logo for Okami Medical. The word "Okami" is written in a teal sans-serif font, with the "i" dotted with a red circle with a yellow outline. Below the word "Okami" is the word "MEDICAL" in a smaller, gray sans-serif font, with the registered trademark symbol to the right.

Irritation o
O Acute Systemic Toxicity
Material-Mediated Pyrogenicity O
Hemocompatibility O

No clinical studies were required.

Conclusions

The modified SENDERO Microcatheter is substantially equivalent to the predicate device in terms of intended use, principle of operation, technological characteristics, and performance characteristics.

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).