(29 days)
Not Found
No
The summary describes a physical medical device (microcatheter) used for delivering agents. There is no mention of AI, ML, image processing, or any software component that would suggest the use of such technologies. The performance studies focus on physical and material properties, not algorithmic performance.
No
The device is described as allowing "for the introduction of diagnostic and therapeutic agents," indicating it delivers therapeutic agents, but is not a therapeutic agent itself.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended for the infusion of "diagnostic and therapeutic agents."
No
The device description clearly outlines a physical catheter with a lumen, radiopaque marker, Luer-lock hub, and hydrophilic coating. The performance studies also focus on physical properties and material compatibility, not software validation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "infusion of diagnostic and therapeutic agents" into the peripheral vasculature. This describes a device used in vivo (within the body) for delivering substances, not for testing samples in vitro (outside the body).
- Device Description: The description details a catheter designed for navigation within blood vessels and delivery of agents. This is consistent with an in vivo medical device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The device's function is purely mechanical delivery.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The SENDERO Microcatheter is intended for the peripheral vasculature for the infusion of diagnostic and therapeutic 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
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
- Irritation o
- O Acute Systemic Toxicity
- Material-Mediated Pyrogenicity O
- Hemocompatibility O
Key Metrics
Not Found
Predicate Device(s)
K231600 - SENDERO Microcatheter - Product Code DQY
Reference Device(s)
Not Found
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).
0
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
2
Indications for Use
Submission Number (if known)
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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3
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
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.
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.
4
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
5
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.