(245 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI/ML, image processing, or data-driven algorithms.
Yes
The device is described as an "ONO Retrieval device" used to "retrieve objects" within the cardiovascular system, which is a therapeutic intervention.
No
The device is described as a retrieval device used to remove foreign objects from the cardiovascular system, which is a therapeutic rather than diagnostic function.
No
The device description clearly outlines physical components such as a catheter, nitinol loops, sheath, and stop-cocks, and the performance studies include testing on physical properties like tensile strength, corrosion resistance, and fatigue, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used in the cardiovascular system to retrieve foreign objects using minimally invasive surgical procedures. This is a direct intervention within the body.
- Device Description: The description details a physical device (catheter, loops, sheath) designed for mechanical retrieval.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for a therapeutic/interventional purpose.
N/A
Intended Use / Indications for Use
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.
Product codes
MMX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cardiovascular system
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
Performance Tests (Non-Clinical): No performance standards have been established under section 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. Furthermore, histology of the surface tissue interaction and thrombogenicity were assessed and compared to the predicate.
Key Metrics
Not Found
Predicate Device(s)
K170987 Avantec Vascular Corporation Captus Vascular Retrieval System
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
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
1
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 LLC |
| 808 General Sterling Drive | |
| West Chester, PA 19382 | |
| Contact: | Tiffini Wittwer |
| Regulatory Affairs | |
| Phone: 707-799-6732 | |
| Email: twittwer@mededge.io | |
| Device Trade Name: | ONO Retrieval Device |
| Device Common Name: | Percutaneous Retrieval Device |
| Device Classification: | Device, Percutaneous Retrieval |
| Product Code: MMX | |
| 21 CFR 870.5150 | |
| Class II | |
| Review Panel: Cardiovascular Devices | |
| Predicate Device: | K170987 Avantec Vascular Corporation Captus Vascular Retrieval |
| System | |
| Description of the Device: | 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. | |
| Indication for Use: | The ONO retrieval device is intended for use in the cardiovascular |
| system to manipulate and retrieve foreign objects, including, but not | |
| limited to, guidewires, coils balloons, catheters and filters. | |
| Technological | |
| Characteristics: | A comparison of the technological characteristics of the subject device |
| and the predicate device shows the ONO Retrieval device to be | |
| substantially equivalent to the current marketed predicate device. | |
| Equivalence is based upon the product performance, design, and | |
| intended 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.
5
| | Furthermore, histology of the surface tissue interaction and
thrombogenicity were assessed and compared to the predicate. |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial Equivalence: | Based on the Indication for Use, design, safety and performance
testing, the ONO Retrieval device met the requirements for its
intended use and are substantially equivalent to the predicate
device. |
| Conclusion: | The result of all testing demonstrates that the ONO Retrieval
device is substantially equivalent to the predicate device. |