(78 days)
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Not Found
No
The provided text does not contain any mention of AI, ML, image processing, or any other indicators of AI/ML technology. The description focuses solely on the mechanical function and intended use of a vascular occlusion system.
Yes
The device is intended to obstruct or reduce blood flow in arteries, which is a therapeutic intervention.
No
The device's intended use is to "obstruct or reduce the rate of blood flow in arteries," which is a therapeutic intervention, not a diagnostic one.
No
The device is described as a "Vascular Occlusion System" intended to obstruct or reduce blood flow in arteries. This strongly implies a physical device (e.g., a coil, plug, or other implantable/interventional component) is involved, not just software. The lack of a device description prevents definitive confirmation, but the intended use points away from a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "obstruct or reduce the rate of blood flow in arteries of the peripheral vasculature." This describes a direct intervention within the body to treat a condition, not a test performed on samples taken from the body to diagnose or monitor a condition.
- Device Description (though not found): The description of the intended use strongly suggests a physical device used within the vascular system, not a reagent, instrument, or software used for testing biological samples.
- Lack of IVD characteristics: The provided information does not mention any of the typical characteristics of an IVD, such as:
- Testing of biological samples (blood, urine, tissue, etc.)
- Diagnosis, monitoring, or screening of diseases or conditions
- Use of reagents or laboratory equipment
Therefore, the Okami Medical LOBO Vascular Occlusion System is a therapeutic device used for interventional procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Okami Medical LOBO Vascular Occlusion System is intended for use to obstruct or reduce the rate of blood flow in arteries of the peripheral vasculature. The device is not indicated for use in blood vessels where crush or bend forces are anticipated ( e.g. joint areas, superficial vasculature).
Product codes
KRD
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
peripheral vasculature
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.3300 Vascular embolization device.
(a)
Identification. A vascular embolization device is an intravascular implant intended to control hemorrhaging due to aneurysms, certain types of tumors (e.g., nephroma, hepatoma, uterine fibroids), and arteriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in neurovascular applications are also not included in this classification, see § 882.5950 of this chapter.(b)
Classification. Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 870.1(e).
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Image /page/0/Picture/0 description: The image contains 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.
April 29, 2022
Okami Medical Jill Delsman Vice President 8 Argonut Suite 100 Aliso Viejo, California 92656
Re: K220383
Trade/Device Name: LOBO Vascular Occlusion System (models LOBO-7 and LOBO-9) Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular embolization device Regulatory Class: Class II Product Code: KRD Dated: March 3, 2022 Received: March 4, 2022
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 (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 located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm 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.
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
1
device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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-reporting-mdr-howreport-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) 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 (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-DICE website 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,
Misti Malone Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K220383
Device Name
LOBO Vascular Occlusion System (models LOBO-7 and LOBO-9)
Indications for Use (Describe)
The Okami Medical LOBO Vascular Occlusion System is intended for use to obstruct or reduce the rate of blood flow in arteries of the peripheral vasculature. The device is not indicated for use in blood vessels where crush or bend forces are anticipated ( e.g. joint areas, superficial vasculature).
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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