(169 days)
No
The device description and performance testing focus on the physical characteristics and functionality of a microcatheter for delivering agents, with no mention of AI or ML capabilities.
No
The device is primarily intended for the infusion of diagnostic agents. While the description mentions that its lumen allows for the introduction of "diagnostic and therapeutic agents," its stated "Intended Use / Indications for Use" focuses solely on diagnostic agents. Therefore, its primary identified purpose is diagnostic, not therapeutic.
Yes.
The intended use explicitly states that the device is for the infusion of diagnostic agents.
No
The device description clearly outlines a physical catheter with various material and mechanical properties, and the performance studies focus on hardware-related testing.
Based on the provided information, the SENDERO Microcatheter is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the "infusion of diagnostic agents" into the peripheral vasculature. This means the device is used within the patient's body to deliver substances for diagnostic purposes, not to perform tests on samples taken from the body.
- Device Description: The description details a catheter designed for navigation and delivery within the vascular system. This is consistent with an in-vivo (within the living organism) application.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) outside of the body, which is the defining characteristic of an IVD.
Therefore, the SENDERO Microcatheter is an in-vivo diagnostic device, not an in-vitro diagnostic device.
N/A
Intended Use / Indications for Use
The SENDERO Microcatheter is intended for the peripheral vasculature for the infusion of diagnostic agents.
Product codes
DQY
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
fluoroscopic guidance
Anatomical Site
peripheral vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
- Biocompatibility Testing (per ISO 10993-1)
- Cytotoxicity
- Sensitization
- Irritation
- Acute Systemic Toxicity
- Material-Mediated Pyrogenicity
- Hemocompatibility
No clinical studies were required.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K192625 - PG Pro Microcatheter - Product Code DQY
Reference Device(s)
K202797 – Drakon Microcatheter – Product Code DQO
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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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"
1
(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
2
Enclosure
Office of Product Evaluation and Quality Center for Devices and Radiological Health
3
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 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 | K192625 - PG Pro Microcatheter - Product Code DQY (Primary) |
| Reference Device | K202797 – Drakon Microcatheter – Product Code DQO |
Device Description Summary
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.
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.
5
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
6
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.