(133 days)
No
The summary describes a mechanical device for embolectomy and aspiration, with no mention of AI, ML, image processing, or data-driven decision making.
Yes
The device is described as an "embolectomy system" indicated for "non-surgical removal of emboli and thrombi from blood vessels," which directly implies treatment of a medical condition.
No
The device description states its purpose is for "non-surgical removal of emboli and thrombi," indicating a therapeutic rather than diagnostic function.
No
The device description clearly outlines physical components like a sheath, occlusion balloon catheter, and guide catheter, indicating it is a hardware-based medical 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 the device is for the "non-surgical removal of emboli and thrombi from blood vessels." This is a therapeutic procedure performed directly on the patient's body.
- Mechanism of Action: The description details a mechanical process involving temporary vessel occlusion, balloon embolectomy, and aspiration. This is a physical intervention, not a test performed on a sample taken from the body.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform such tests on specimens.
The device is a medical device used for a therapeutic intervention within the patient's vasculature.
N/A
Intended Use / Indications for Use
The Panacea embolectomy system is indicated for the non-surgical removal of emboli and thrombi from blood vessels. The device is intended for the peripheral vasculature, and is not in the coronary or neurovasculature.
Product codes (comma separated list FDA assigned to the subject device)
DXE
Device Description
The fundamental mechanism of action is temporary vessel occlusion combined with mechanical balloon embolectomy and aspiration through a guide catheter. The sheath provides vessel access. The occlusion balloon catheter is intended for temporary vessel occlusion and the guide catheter functions to remove emboli and thrombi. The devices are provided sterile, non-pyrogenic, and intended for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Device evaluation consisted of in vitro testing and supports the substantial equivalence to the predicate device. All data met the acceptance criteria and fell within pre-determined product specifications and industry standard requirements. The following is a list of tests that were performed:
- RX Balloon Catheter Embolectomy Sheath testing
- Balloon performance and dimensions
- Dimensions
- Leak testing
- Tensile testing
- Marker Band Fluoro Opacity
- Balloon inflation and deflation time
- Balloon durability
- Biocompatibility
- Sterilization
- Packaging
- Transportation and Shelf life
- Seal and package integrity testing
- Animal testing
- Guide Catheter testing
- Dimensions
- Funnel durability
- Funnel radial force
- Marker band fluro opacity
- Kink resistance
- Tensile strength
- Dilator testing
- Dimensions
- Kink resistance
- Tensile strength
- System testing
- Full system testing
- Torque strength testing
- Clot capture
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 21, 2018
ICHOR Vascular, Inc. % Ms. Angela Mallery Principal Product Development Strategist, Regulatory NAMSA 400 Highway 169 South, Suite 500 Minneapolis, MN 55426
Re: K182167
Trade/Device Name: The ICHOR Panacea Vascular Embolectomy Catheter System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: DXE Dated: November 30, 2018 Received: December 3, 2018
Dear Ms. Mallery:
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 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely. Date: / 2018.12.21 Eleni Whatley 09:21:13 -05'00' For | Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K182167
Device Name
The ICHOR Panacea Vascular Embolectomy Catheter System
Indications for Use (Describe)
The Panacea embolectomy system is indicated for the non-surgical removal of emboli and thrombi from blood vessels. The device is intended for the peripheral vasculature, and is not in the coronary or neurovasculature.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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TRADITIONAL 510(K) SUMMARY
K182167: The ICHOR Panacea Vascular Embolectomy Catheter System
| Submitter: | ICHOR Vascular Inc.
2865 N Reynolds Rd
Suite 220A
Toledo OH 43615 |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Angela Mallery
400 Highway 169 South, Suite 500,
Minneapolis, MN 55426
Phone: (763) 287-3830
amallery@namsa.com |
| Summary | December 20, 2018 |
| Preparation Date
Device Name | The ICHOR Panacea Vascular Embolectomy Catheter System |
| Device
Classification: | Embolectomy Catheter
DXE
21 CFR 870.5150 |
| Intended Use: | The Panacea embolectomy system is indicated for the non-surgical
removal of emboli and thrombi from blood vessels. The device is
intended for the peripheral vasculature, and is not intended for use in
the coronary or neurovasculature. |
| Contraindications: | None |
| Device Description | The fundamental mechanism of action is temporary vessel occlusion
combined with mechanical balloon embolectomy and aspiration
through a guide catheter. The sheath provides vessel access. The
occlusion balloon catheter is intended for temporary vessel occlusion
and the guide catheter functions to remove emboli and thrombi. The
devices are provided sterile, non-pyrogenic, and intended for single
use only. |
| Predicate Device: | MegaVac (K171493) |
| Reference Devices: | Fogarty Occlusion Catheter (K152762)
Penumbra Embolectomy Aspiration System (K160533) |
| Substantial
Equivalence
Information | The device is substantially equivalent to the predicate devices
regarding its similar intended use, design, function, materials and
sterilization method. In accordance with risk analysis and according to
international standards, verification testing was conducted. |
| | The subject and predicate/reference devices are considered equivalent,
the device has the equivalent intended use as the predicate; The
Panacea and the predicate both have the ability to capture clot in a
Nitinol basket, and have the option to aspirate with a syringe; The
design of the subject device and the predicate devices are substantially
equivalent with only minor differences to the type of material, sizes,
and dimensions; While the predicate does not use a balloon as an
occlusive element (using a Nitinol basket instead) the reference device
(Fogarty) does use an occlusive balloon; The Panacea and the
predicate both are intended to treat the same disease and are used in
the same patient population. |
| | ICHOR asserts when comparing the Panacea and the predicate; the
differences in technology do not raise different questions of safety and
effectiveness and that the device is substantially equivalent to a legally
marketed device," respectively |
| | The device and the predicate both occlude the vessel in order to
capture clot, the device uses a Pellethane balloon and a Nitinol basket
whereas the predicate uses a coated Nitinol basket and a Nitinol
element to achieve the same outcome. |
| | While the predicate does not use a balloon as an occlusive element
(using a Nitinol basket instead) the reference device (Fogarty) does
use an occlusive balloon. |
| | There are minor differences in dimensions between the Panacea and
MegaVac Systems, these can be attributed to the MegaVac systems
have a broader indication for use. |
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5
Summary of Testing:
Device evaluation consisted of in vitro testing and supports the substantial equivalence to the predicate device. All data met the acceptance criteria and fell within pre-determined product specifications and industry standard requirements. The following is a list of tests that were performed:
- RX Balloon Catheter Embolectomy Sheath testing .
- . Balloon performance and dimensions
- Dimensions ●
- Leak testing ●
- Tensile testing
- Marker Band Fluoro Opacity ●
- Balloon inflation and deflation time
- Balloon durability
- Biocompatibility
- Sterilization
- . Packaging
- . Transportation and Shelf life
- Seal and package integrity testing
- Animal testing
- . Guide Catheter testing
- Dimensions
- Funnel durability
- Funnel radial force ●
- Marker band fluro opacity
- Kink resistance
- Tensile strength
- Dilator testing ●
- . Dimensions
- Kink resistance ●
- . Tensile strength
- System testing ●
- Full system testing .
- Torque strength testing ●
- Clot capture ●
Conclusion:
As described in this 510(k) Summary, the device is substantially equivalent to the predicate based on a comparison of intended uses and the results of in-vitro testing.