(245 days)
The Onocor ONO Retrieval device is indicated for use in the cardiovascular system to retrieve objects using minimally invasive surgical procedures include retrieval of intravascular foreign objects such as coils, balloons, catheters, guidewires and/or filters within the cardiovascular system. This device is not intended for use in the coronary arteries or neurovasculature.
The ONO Retrieval device is constructed of 12 Fr stainless steel reinforced catheter, a series of braided nitinol loops forming a basket, a peel away sheath, inner catheter and stop-cocks. The peel away sheath is advanced to compress the nitinol basket for introduction and then removed. The ONO is compatible with up to a 7 Fr manipulation device or snare and with 12Fr to 26 Fr retrieval sheaths. The ONO has a working length of 86 cm.
The provided text is a 510(k) summary for the ONO Retrieval Device and does not contain information related to software or AI performance metrics. Therefore, it is not possible to describe acceptance criteria or a study proving device performance in the context of an AI/software device using the provided input.
The document discusses performance tests for a physical medical device (a retrieval catheter), including:
- Dimensional Testing
- Tensile Strength
- Corrosion Resistance
- Catheter Kink Testing
- Torque Strength
- Simulated Use
- Radiopacity
- Design Validation Testing and Summative Usability Testing
- Distribution Testing
- Fatigue
- Biocompatibility Testing (Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Material Mediated Pyrogenicity, Hemolysis, Thrombogenicity, Complement Activation)
- Pre-clinical study in a porcine model comparing subject and predicate devices for retrieval of foreign objects and assessment of histology and thrombogenicity.
The document states that these tests were conducted "to meet the acceptance criteria that were determined to demonstrate substantial equivalence," but it does not explicitly list the acceptance criteria values or the reported device performance for these tests. It only makes a general statement that the device was shown to meet them and is substantially equivalent to the predicate device.
To answer the requested points, the following information is not present in the provided text:
- A table of acceptance criteria and the reported device performance: The document lists types of tests but does not provide specific criteria values or performance results.
- Sample size used for the test set and the data provenance: For the pre-clinical study, it mentions "a porcine model" but not the number of animals or the origin of the data. For other performance tests, no sample sizes are given.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as this is a physical device and not an AI/software testing scenario for ground truth against expert interpretation.
- Adjudication method for the test set: Not applicable.
- 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: Not applicable, as this is not an AI/software device.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI/software device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth in the context of AI/software performance is not relevant here. For the physical device, performance was assessed through engineering tests and an animal study.
- The sample size for the training set: Not applicable, as this is not an AI/software device using a training set.
- How the ground truth for the training set was established: Not applicable.
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May 23, 2022
Onocor Vascular LLC Tiffini Wittwer Regulatory Affairs 808 General Sterling Drive West Chester, Pennsylvania 19382
Re: K212988
Trade/Device Name: ONO Retrieval Device Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: MMX Dated: April 14, 2022 Received: April 19, 2022
Dear Tiffini Wittwer:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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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 (OS) 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 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,
Gregory O'Connell 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) K212988
Device Name ONO Retrieval Device
Indications for Use (Describe)
The Onocor ONO Retrieval device is indicated for use in the cardiovascular system to retrieve objects using minimally invasive surgical procedures include retrieval of intravascular foreign objects such as coils, balloons, catheters, guidewires and/or filters within the cardiovascular system. This device is not intended for use in the coronary arteries or neurovasculature.
| 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) | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | ||
| Prescription Use (Part 21 CFR 801 Subpart D) | ||||
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
K212988
| Date Prepared: | May 20, 2022 |
|---|---|
| Company: | Onocor LLC808 General Sterling DriveWest Chester, PA 19382 |
| Contact: | Tiffini WittwerRegulatory AffairsPhone: 707-799-6732Email: twittwer@mededge.io |
| Device Trade Name: | ONO Retrieval Device |
| Device Common Name: | Percutaneous Retrieval Device |
| Device Classification: | Device, Percutaneous RetrievalProduct Code: MMX21 CFR 870.5150Class IIReview Panel: Cardiovascular Devices |
| Predicate Device: | K170987 Avantec Vascular Corporation Captus Vascular RetrievalSystem |
| Description of the Device: | The ONO Retrieval device is constructed of 12 Fr stainless steelreinforced catheter, a series of braided nitinol loops forming a basket, apeel away sheath, inner catheter and stop-cocks. The peel away sheathis advanced to compress the nitinol basket for introduction and thenremoved. The ONO is compatible with up to a 7 Fr manipulation deviceor snare and with 12Fr to 26 Fr retrieval sheaths. The ONO has aworking length of 86 cm. |
| Indication for Use: | The ONO retrieval device is intended for use in the cardiovascularsystem to manipulate and retrieve foreign objects, including, but notlimited to, guidewires, coils balloons, catheters and filters. |
| TechnologicalCharacteristics: | A comparison of the technological characteristics of the subject deviceand the predicate device shows the ONO Retrieval device to besubstantially equivalent to the current marketed predicate device.Equivalence is based upon the product performance, design, andintended use. The ONO Retrieval device and the predicate devices have |
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similar materials of construction, dimensional specifications, designs, and sterilization process.
Performance Tests No performance standards have been established under section (Non-Clinical): 514, performance standards, of the Food, Drug and Cosmetic Act for these devices. A series of testing was conducted in accordance with protocols based on requirements outlined in guidance and industry standards and the below were shown to meet the acceptance criteria that were determined to demonstrate substantial equivalence.
The following tests were performed under the specified testing parameters to support the ONO Retrieval device substantial equivalence.
Performance Testing, including:
- Dimensional Testing ●
- Tensile Strength ●
- Corrosion Resistance ●
- Catheter Kink Testing ●
- Torque Strength ●
- Simulated Use
- Radiopacity ●
- Design Validation Testing and Summative Usability Testing
- Distribution Testing ●
- Fatigue
Biocompatibility Testing, including:
- Cytotoxicity (ISO 10993-5)
- Sensitization (ISO 10993-10)
- Intracutaneous Reactivity (ISO 10993-10) ●
- Acute Systemic Toxicity (ISO 10993-11) ●
- Material Mediated Pyrogenicity (ISO 10993-11)
- Hemolysis (ISO 10993-4)
- Thrombogenicity (ISO 10993-4)
- Complement Activation (ISO 10993-4)
A pre-clinical study was performed in a porcine model comparing the subject and predicate devices. Retrieval of various foreign objects from the vascular system was performed to demonstrate that the device is appropriate with the stated indications.
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| Furthermore, histology of the surface tissue interaction andthrombogenicity were assessed and compared to the predicate. | |
|---|---|
| Substantial Equivalence: | Based on the Indication for Use, design, safety and performancetesting, the ONO Retrieval device met the requirements for itsintended use and are substantially equivalent to the predicatedevice. |
| Conclusion: | The result of all testing demonstrates that the ONO Retrievaldevice is substantially equivalent to the predicate device. |
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).