The ICHOR Panacea Vascular Embolectomy Catheter System

K182167 · Ichor Vascular, Inc. · QEW · Dec 21, 2018 · Cardiovascular

Device Facts

• Record ID: K182167
• Device Name: The ICHOR Panacea Vascular Embolectomy Catheter System
• Applicant: Ichor Vascular, Inc.
• Product Code: QEW · Cardiovascular
• Decision Date: Dec 21, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

System for non-surgical removal of emboli/thrombi from peripheral vasculature; utilizes temporary vessel occlusion combined with mechanical balloon embolectomy and aspiration via guide catheter. Components include sheath for vessel access, occlusion balloon catheter, and guide catheter for clot removal. Operated by physicians in clinical settings. Device captures clot using Nitinol basket and Pellethane balloon; aspiration performed via syringe. Output is physical removal of thrombus; aids clinical decision-making by restoring blood flow. Benefits patient through minimally invasive clot extraction.

Clinical Evidence

Bench testing only. Evaluation included in vitro testing (balloon performance, dimensions, leak, tensile, inflation/deflation time, durability, biocompatibility, sterilization, packaging, shelf life, guide catheter/dilator testing, and system-level torque/clot capture) and animal testing. All results met pre-determined acceptance criteria and product specifications.

Technological Characteristics

Materials: Pellethane (balloon), Nitinol (basket). Components: Occlusion balloon catheter, guide catheter, sheath, dilator. Energy: Mechanical. Connectivity: None. Sterilization: Sterile, non-pyrogenic. Single-use.

Indications for Use

Indicated for non-surgical removal of emboli and thrombi from peripheral blood vessels. Not for coronary or neurovasculature use.

Regulatory Classification

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.

Predicate Devices

• MegaVac (K171493)

Reference Devices

• Fogarty Occlusion Catheter (K152762)
• Penumbra Embolectomy Aspiration System (K160533)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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) | |
|--------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| <div> <span>X</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span></span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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# TRADITIONAL 510(K) SUMMARY

K182167: The ICHOR Panacea Vascular Embolectomy Catheter System

| Submitter: | ICHOR Vascular Inc.<br>2865 N Reynolds Rd<br>Suite 220A<br>Toledo OH 43615 |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Angela Mallery<br>400 Highway 169 South, Suite 500,<br>Minneapolis, MN 55426<br>Phone: [phone]<br>[e-mail] |
| Summary | December 20, 2018 |
| Preparation Date<br>Device Name | The ICHOR Panacea Vascular Embolectomy Catheter System |
| Device<br>Classification: | Embolectomy Catheter<br>DXE<br>21 CFR 870.5150 |
| Intended Use: | The Panacea embolectomy system is indicated for the non-surgical<br>removal of emboli and thrombi from blood vessels. The device is<br>intended for the peripheral vasculature, and is not intended for use in<br>the coronary or neurovasculature. |
| Contraindications: | None |
| Device Description | The fundamental mechanism of action is temporary vessel occlusion<br>combined with mechanical balloon embolectomy and aspiration<br>through a guide catheter. The sheath provides vessel access. The<br>occlusion balloon catheter is intended for temporary vessel occlusion<br>and the guide catheter functions to remove emboli and thrombi. The<br>devices are provided sterile, non-pyrogenic, and intended for single<br>use only. |
| Predicate Device: | MegaVac (K171493) |
| Reference Devices: | Fogarty Occlusion Catheter (K152762)<br>Penumbra Embolectomy Aspiration System (K160533) |
| Substantial<br>Equivalence<br>Information | The device is substantially equivalent to the predicate devices<br>regarding its similar intended use, design, function, materials and<br>sterilization method. In accordance with risk analysis and according to<br>international standards, verification testing was conducted. |
| | The subject and predicate/reference devices are considered equivalent,<br>the device has the equivalent intended use as the predicate; The<br>Panacea and the predicate both have the ability to capture clot in a<br>Nitinol basket, and have the option to aspirate with a syringe; The<br>design of the subject device and the predicate devices are substantially<br>equivalent with only minor differences to the type of material, sizes,<br>and dimensions; While the predicate does not use a balloon as an<br>occlusive element (using a Nitinol basket instead) the reference device<br>(Fogarty) does use an occlusive balloon; The Panacea and the<br>predicate both are intended to treat the same disease and are used in<br>the same patient population. |
| | ICHOR asserts when comparing the Panacea and the predicate; the<br>differences in technology do not raise different questions of safety and<br>effectiveness and that the device is substantially equivalent to a legally<br>marketed device," respectively |
| | The device and the predicate both occlude the vessel in order to<br>capture clot, the device uses a Pellethane balloon and a Nitinol basket<br>whereas the predicate uses a coated Nitinol basket and a Nitinol<br>element to achieve the same outcome. |
| | While the predicate does not use a balloon as an occlusive element<br>(using a Nitinol basket instead) the reference device (Fogarty) does<br>use an occlusive balloon. |
| | There are minor differences in dimensions between the Panacea and<br>MegaVac Systems, these can be attributed to the MegaVac systems<br>have a broader indication for use. |

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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.