(108 days)
The SENDERO MAX Delivery Catheter is intended for the peripheral vasculature for the infusion of diagnostic and therapeutic agents.
The SENDERO MAX Delivery Catheter is a single lumen, variable stiffness catheter with a radiopaque marker on the shaped 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 guide wire, 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.
This document is a 510(k) summary for the SENDERO MAX Delivery Catheter, a medical device. It describes the device's indications for use, technological characteristics, and performance testing conducted to demonstrate its substantial equivalence to a predicate device. This type of document is a regulatory submission to the FDA, not a study report. Therefore, it does not contain the information required to answer your specific questions about acceptance criteria for an AI/CADe device or a study proving its performance.
The questions you've asked (about acceptance criteria, sample sizes, ground truth, experts, MRMC studies, standalone performance, and training sets) are typically relevant for AI/CADe devices or clinical studies used to prove the performance and safety of a device.
This document pertains to a physical medical device, specifically a catheter, not an AI or software device. The "performance testing" described (dimensional, coating, burst pressure, tensile strength, etc.) are standard engineering and material tests for physical medical devices to ensure they meet design specifications and regulatory requirements.
Therefore, it is not possible to answer your questions using the provided document because the device described is a physical catheter, not an AI/CADe device, and the document is a regulatory summary, not a clinical study report.
The document states: "No clinical studies were required." This further confirms that this submission does not contain the kind of study data you are asking about for AI/CADe performance.
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December 20, 2024
Okami Medical, Inc. Jill Delsman Vice President RA/QA 8 Argonaut, Suite 100 Aliso Viejo, California 92656
Re: K242644
Trade/Device Name: SENDERO MAX Delivery Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: August 31, 2024 Received: September 3, 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.
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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).
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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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-regulatory
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assistance/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, Digitally signed by Lydia S. Lydia S. Glaw -S Date: 2024.12.20 Glaw -S 11:21:54 -05'00' 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
Enclosure
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Indications for Use
510(k) Number (if known) K242644
Device Name SENDERO MAX Delivery Catheter
Indications for Use (Describe)
The SENDERO MAX Delivery Catheter is intended for the peripheral vasculature for the infusion of diagnostic and therapeutic agents.
X 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 teal sans-serif font. Below "Okami" is the word "MEDICAL" in a smaller, gray sans-serif font with a registered trademark symbol. To the right of the "i" in "Okami" is a red circle with a yellow outline.
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 MAX Delivery Catheter |
| Common Name | Catheter |
| Classification Name | Catheter, Percutaneous |
| Regulation Number | 870.1250 |
| Product Code | DQY |
| Predicate Device | K240384 – SENDERO Microcatheter – Product Code DQY |
| Reference Device | K140080 – Envoy Distal Access Guiding Catheter – Product Code DQY |
| 510 (k) Summary Date | December 4. 2024 |
Device Description Summary
The SENDERO MAX Delivery Catheter is a line extension of the SENDERO family of delivery catheters which includes the predicate SENDERO Microcatheter (K240384).
The SENDERO MAX Delivery Catheter is a single lumen, variable stiffness catheter with a radiopaque marker on the shaped 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 guide wire, 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 MAX Delivery Catheter 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.
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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 the word "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 MAX Delivery Catheter 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 the devices also have hydrophilic coatings on the catheter shaft to reduce friction during navigation through the vasculature.
Each of the fundamental design characteristics of the Okami Medical SENDERO MAX Delivery catheter are also present in the primary predicate or reference predicate. Any minor design differences between the primary predicate device and the subject device are covered by the reference predicate.
Non-clinical Performance Testing
Performance testing was conducted for the SENDERO MAX Delivery Catheter to demonstrate the suitability of the device for its intended use. The results of the testing indicate that the SENDERO MAX 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 80369-7)
- Particulate Testing
- Flowrate Testing (per ISO 10555-1)
- . Radiopacity Testing (per ASTM F640)
- Packaging Validation
- Biocompatibility Evaluation (per ISO 10993-1)
No clinical studies were required.
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Image /page/6/Picture/1 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.
Conclusions
The SENDERO MAX Delivery Catheter 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 MAX to the predicate, and demonstrates the subject device should perform as intended when used as instructed.
§ 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).