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) Premarket Notification from the FDA regarding the Okami Medical SENDERO Microcatheter. It discusses the device's substantial equivalence to predicate devices based on non-clinical performance testing.

However, the document does not contain the kind of detailed information typically associated with Acceptance Criteria and Study Proof for a device like an AI/ML algorithm or software. Specifically, it lacks:

A table of acceptance criteria and reported device performance for metrics like sensitivity, specificity, or image quality (as would be seen for an AI diagnostic device).
Details on sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, or training set information. This submission is for a medical device (microcatheter), not a software or AI product.
The type of ground truth used as this applies to diagnostic/AI devices, not typically a physical catheter.

The document primarily focuses on demonstrating the physical and functional equivalence of the SENDERO Microcatheter to existing, legally marketed predicate devices through non-clinical performance testing. The acceptance criteria for this type of device are related to its physical properties, material compatibility, and functional performance, rather than diagnostic accuracy metrics.

Here's a summary of what is available in the document, framed in the context of device acceptance, even if not precisely what the prompt asked for regarding AI/ML:

1. Acceptance Criteria and Reported Device Performance (Non-Clinical Testing):

The acceptance criteria for the SENDERO Microcatheter are implicitly defined by the successful completion of various non-clinical performance tests, demonstrating its suitability for its intended use and substantial equivalence to predicate devices. The "reported device performance" is a statement that the device met these criteria.

Acceptance Criteria Category (Test per standard or internal protocol)	Reported Device Performance (as stated in the document)
Dimensional/Visual Inspection	Met suitability for intended use
Coating Thickness and Lubricity	Met suitability for intended use
Simulated Use Testing	Met suitability for intended use
Catheter Coating Integrity	Met suitability for intended use
Compatibility Testing	Met suitability for intended use
Burst Pressure Testing (per ISO 10555-1)	Met suitability for intended use
Catheter Tensile Strength (per ISO 10555-1)	Met suitability for intended use
Kink Diameter Testing	Met suitability for intended use
Torque Testing	Met suitability for intended use
Hub Testing (per ISO 594-1/2)	Met suitability for intended use
Particulate Testing	Met suitability for intended use
Flowrate Testing (per ISO 10555-1)	Met suitability for intended use
Radiopacity Testing (per ASTM F640)	Met suitability for intended use
Packaging Validation	Met suitability for intended use
Biocompatibility Testing (per ISO 10993-1):
- Cytotoxicity	Met suitability for intended use
- Sensitization	Met suitability for intended use
- Irritation	Met suitability for intended use
- Acute Systemic Toxicity	Met suitability for intended use
- Material-Mediated Pyrogenicity	Met suitability for intended use
- Hemocompatibility	Met suitability for intended use

Study Proving Device Meets Acceptance Criteria:

The study that proves the device meets the acceptance criteria is the comprehensive Non-clinical Performance Testing regimen described. The document states: "The results of the testing indicate that the SENDERO Microcatheter is substantially equivalent to the predicate device." And "The non-clinical performance data submitted in this premarket notification clearly supports the substantial equivalence of the SENDERO Microcatheter to the predicate, and demonstrates the subject device should perform as intended when used as instructed."

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

The document does not specify sample sizes for each non-clinical test. These tests are typically conducted on a defined number of device units (e.g., a certain number of catheters for burst pressure, tensile strength, etc.) according to recognized standards (like ISO or ASTM) or internal validated protocols.
Data provenance: This is a physical medical device. The data comes from laboratory testing of manufactured devices, not from patient data, so concepts like "country of origin of the data" or "retrospective/prospective" patient studies are not applicable here.

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

This is not applicable as the tests are for physical properties and biocompatibility. Ground truth is established by validated measurement techniques and adherence to engineering and scientific standards, not expert adjudication of patient data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable as this is not a diagnostic interpretation or clinical data review study.

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 is a physical medical device (microcatheter), not an AI/ML diagnostic tool.

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

Not applicable. This is not an algorithm or software.

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

For this device, "ground truth" relates to the physical and chemical properties meeting predefined specifications and standards (e.g., a specific tensile strength value, a certain flow rate, absence of cytotoxicity). It is established through validated laboratory methods and measurements.

8. The sample size for the training set:

Not applicable. This device does not involve a "training set" in the machine learning sense.

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

Not applicable.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 17, 2023

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

Re: K231600

Trade/Device Name: SENDERO Microcatheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: October 11, 2023 Received: October 12, 2023

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"

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(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).

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 OS 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,

Ariel G. Ash-
shakoor -S

Di
As
Da
-0

Digitally signed by Ariel G. Ash-shakoor -S Date: 2023.11.16 16:23:13 -05'00'

For

Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices

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Enclosure

Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K231600

Device Name

SENDERO Microcatheter

Indications for Use (Describe)

The SENDERO Microcatheter is intended for the perpheral vasculature for the infusion of diagnostic 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/4/Picture/0 description: The image shows the logo for Okami Medical. The word "Okami" is written in a large, teal, sans-serif font. The word "MEDICAL" is written in a smaller, gray, sans-serif font below the word "Okami". There is a red circle with a yellow outline on the top right of the word "Okami".

510(k) SUMMARY

Sponsor	Okami Medical, Inc.8 Argonaut, Suite 100Aliso Viejo, CA 92656USA
Contact	Jill Delsman949-446-9710jilld@okamimedical.com
Device Trade Name	SENDERO Microcatheter
Common Name	Microcatheter
Classification Name	Catheter, Percutaneous
Regulation Number	870.1250
Product Code	DQY
Predicate Device	K192625 - PG Pro Microcatheter - Product Code DQY (Primary)
Reference Device	K202797 – Drakon Microcatheter – Product Code DQO

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. Although there are slight differences between the indications for use statements of the reference predicate and the Okami SENDERO Microcatheter, the intended uses are the same. All devices are intended to deliver diagnostic (e.g. contrast media) and therapeutic agents (e.g. embolic materials such as coils or plugs) into the peripheral vasculature.

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Image /page/5/Picture/0 description: The image shows the logo for Okami Medical. The word "Okami" is written in a teal sans-serif font, with a red circle with a yellow outline above the "i". Below "Okami" is the word "MEDICAL" in a smaller, gray sans-serif font, with the registered trademark symbol next to it.

Comparison of Technological Characteristics

The Okami Medical SENDERO Microcatheter has the same or similar technological characteristics when compared to the primary and reference predicates (e.g. intended use, principle of operation, fundamental design characteristics, materials, etc.).

All devices share the same intended use and principle of operation, namely the placement of the device to the target site by percutaneous means under fluoroscopy and introduction of diagnostic and/or therapeutic agents into the peripheral vasculature.

All devices are single lumen, variable stiffness catheters with radiopaque markers on the distal end and a Luer-lock hub on the proximal end. All of the microcatheters also have hydrophilic coatings on the catheter shaft to reduce friction during navigation through the vasculature.

The subject device, primary and reference predicates are fabricated from common catheter materials of construction. While not identical, the Okami Medical SENDERO Microcatheter materials are all of the same type (e.g. polymer based hydrophilic coating, PTFE, Pebax, etc.) as the primary and reference predicates.

Each of the fundamental design characteristics of the Okami Medical SENDERO Microcatheter are also present in the primary predicate or reference predicate. Any minor design differences between the primary predicate device and the subject devices are covered by the reference device.

Non-clinical Performance Testing

Performance testing was conducted for the Okami Medical SENDERO Microcatheter to demonstrate the suitability of the device for its intended use. The results of the testing indicate that the 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)
Kink Diameter Testing
Torque Testing
Hub Testing (per ISO 594-1/2) ●
Particulate Testing
Flowrate Testing (per ISO 10555-1)
Radiopacity Testing (per ASTM F640)
Packaging Validation

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Image /page/6/Picture/0 description: The image shows the logo for Okami Medical. The word "Okami" is written in a large, teal, sans-serif font. Below "Okami" is the word "MEDICAL" in a smaller, gray, sans-serif font with the registered trademark symbol to the right. The dot of the "i" in "Okami" is a red circle with a yellow outline.

Biocompatibility Testing (per ISO 10993-1) ●
- O Cytotoxicity
- Sensitization O
- Irritation O
- Acute Systemic Toxicity O
- Material-Mediated Pyrogenicity O
- Hemocompatibility O

No clinical studies were required.

Conclusions

The SENDERO Microcatheter is substantially equivalent to the predicate in terms of intended use, principle of operation, technological characteristics, and performance characteristics. The non-clinical performance data submitted in this premarket notification clearly supports the substantial equivalence of the SENDERO Microcatheter to the predicate, and demonstrates the subject device should perform as intended when used as instructed.

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).