(89 days)
Intended 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).
Not Found
This FDA 510(k) clearance letter for the Okami Medical LOBO Vascular Occlusion System primarily deals with the substantial equivalence determination of a medical device based on its indications for use, without detailing specific performance studies against acceptance criteria in the manner that would be expected for a novel AI/ML-based device.
Therefore, many of the requested elements for an AI/ML device (e.g., sample sizes for training/test sets, expert qualifications, MRMC studies, ground truth establishment) are not applicable to the content provided in this 510(k) letter.
However, I can extract the relevant information from the document as it pertains to the device and its intended use, and indicate where the requested information is absent.
Device Name: Okami Medical LOBO Vascular Occlusion System
Regulation Name: Vascular Embolization Device
Regulatory Class: Class II
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).
Here's an attempt to answer your questions based solely on the provided text, acknowledging that much of the detailed study information for AI/ML devices is not present.
1. A table of acceptance criteria and the reported device performance
The provided document, a 510(k) clearance letter, does not contain specific acceptance criteria or reported device performance in a measurable format like sensitivity, specificity, accuracy, or other quantitative metrics. The basis for clearance in a 510(k) is "substantial equivalence" to a predicate device, meaning the new device is as safe and effective as a legally marketed device. Performance data, if submitted, would have been part of the 510(k) submission but are not typically detailed in the clearance letter itself.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in this document. The 510(k) clearance is based on substantial equivalence to a predicate device, implying that the device performs as intended and is as safe and effective as the predicate. | Not specified in this document. Performance data (e.g., occlusion rates, complication rates) would have been part of the manufacturer's submission but are not summarized here. |
2. Sample sizes used for the test set and the data provenance
- Sample Size (Test Set): Not mentioned in this document.
- Data Provenance (e.g., country of origin, retrospective/prospective): Not mentioned in this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as this is a physical medical device (vascular occlusion system), not an AI/ML diagnostic or image analysis device that requires expert-established ground truth for performance evaluation in the context of an AI model.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as this is a physical medical device, not an AI/ML device requiring expert adjudication of ground truth for performance evaluation.
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
This information is not applicable as this is a physical medical device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as this is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For a device like a vascular occlusion system, performance data would likely involve outcomes data from preclinical studies (e.g., animal models) and potentially clinical studies (human trials), focusing on aspects like successful occlusion, patency of collateral vessels, complication rates, and device integrity. However, the specific type and details of ground truth/performance verification are not provided in this clearance letter.
8. The sample size for the training set
This information is not applicable as this is a physical medical device, not an AI/ML model that undergoes training.
9. How the ground truth for the training set was established
This information is not applicable as this is a physical medical device, not an AI/ML model.
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October 30, 2019
Okami Medical Rebecca Pine Official Correspondent 8 Argonaut, Suite 100 Aliso Viejo, California 92656
Re: K192083
Trade/Device Name: Okami Medical LOBO Vascular Occlusion System Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II Product Code: KRD Dated: September 27, 2019 Received: September 30, 2019
Dear Rebecca Pine:
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 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.
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
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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 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-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-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,
For
Misti Malone 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) K192083
Device Name
Okami Medical LOBO Vascular Occlusion System
Indications for Use (Describe)
Intended 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).
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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§ 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).