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 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.

AI/ML Overview

The provided text describes the 510(k) submission for "The ICHOR Panacea Vascular Embolectomy Catheter System." It focuses on demonstrating substantial equivalence to a predicate device through in vitro testing. However, the document does not provide the detailed information required for the questions regarding acceptance criteria and a study proving a device meets those criteria, specifically concerning AI/algorithm performance.

Here's why and what's missing:

This device is a physical medical device (catheter system), not an AI/algorithm-based diagnostic or therapeutic device. The questions posed are highly relevant to AI/ML medical devices where performance metrics like sensitivity, specificity, AUC, etc., are crucial, and the "ground truth" establishment, expert adjudication, and human reader comparative studies are standard.
The "testing" mentioned is for a physical device. The "Summary of Testing" section lists various in vitro tests (e.g., "Balloon performance and dimensions," "Tensile testing," "Clot capture," "Biocompatibility," "Sterilization," "Animal testing"). These are standard for clearing a physical medical device and ensure its mechanical properties, safety, and functionality. They are not about the performance of an AI algorithm.
There is no mention of "acceptance criteria" in the context of an AI's diagnostic performance. The "acceptance criteria" referred to in the document would be pre-determined specifications for the physical properties and performance of the catheter (e.g., balloon burst pressure, tensile strength limits, successful clot removal percentage in an in vitro model).
No "study" is described that involves human readers, ground truth established by experts, or AI performance metrics. The document states "All data met the acceptance criteria and fell within pre-determined product specifications and industry standard requirements," referring to the physical tests.
No data provenance, sample sizes for AI test/training sets, or expert qualifications are discussed. These concepts are not applicable to the premarket notification for this physical device.

Therefore, I cannot answer the questions based on the provided text, as the text describes the submission for a physical medical device and not an AI/ML-driven device.

To answer your questions, I would need a 510(k) summary or clinical study report for an AI-based medical device that performs a diagnostic or prognostic task.

Summary

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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)

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 RdSuite 220AToledo OH 43615
Contact Person:	Angela Mallery400 Highway 169 South, Suite 500,Minneapolis, MN 55426Phone: (763) 287-3830amallery@namsa.com
Summary	December 20, 2018
Preparation DateDevice Name	The ICHOR Panacea Vascular Embolectomy Catheter System
DeviceClassification:	Embolectomy CatheterDXE21 CFR 870.5150
Intended Use:	The Panacea embolectomy system is indicated for the non-surgicalremoval of emboli and thrombi from blood vessels. The device isintended for the peripheral vasculature, and is not intended for use inthe coronary or neurovasculature.
Contraindications:	None
Device Description	The fundamental mechanism of action is temporary vessel occlusioncombined with mechanical balloon embolectomy and aspirationthrough a guide catheter. The sheath provides vessel access. Theocclusion balloon catheter is intended for temporary vessel occlusionand the guide catheter functions to remove emboli and thrombi. Thedevices are provided sterile, non-pyrogenic, and intended for singleuse only.
Predicate Device:	MegaVac (K171493)
Reference Devices:	Fogarty Occlusion Catheter (K152762)Penumbra Embolectomy Aspiration System (K160533)
SubstantialEquivalenceInformation	The device is substantially equivalent to the predicate devicesregarding its similar intended use, design, function, materials andsterilization method. In accordance with risk analysis and according tointernational standards, verification testing was conducted.
	The subject and predicate/reference devices are considered equivalent,the device has the equivalent intended use as the predicate; ThePanacea and the predicate both have the ability to capture clot in aNitinol basket, and have the option to aspirate with a syringe; Thedesign of the subject device and the predicate devices are substantiallyequivalent with only minor differences to the type of material, sizes,and dimensions; While the predicate does not use a balloon as anocclusive element (using a Nitinol basket instead) the reference device(Fogarty) does use an occlusive balloon; The Panacea and thepredicate both are intended to treat the same disease and are used inthe same patient population.
	ICHOR asserts when comparing the Panacea and the predicate; thedifferences in technology do not raise different questions of safety andeffectiveness and that the device is substantially equivalent to a legallymarketed device," respectively
	The device and the predicate both occlude the vessel in order tocapture clot, the device uses a Pellethane balloon and a Nitinol basketwhereas the predicate uses a coated Nitinol basket and a Nitinolelement 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) doesuse an occlusive balloon.
	There are minor differences in dimensions between the Panacea andMegaVac Systems, these can be attributed to the MegaVac systemshave 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.

Regulation Number and Section

§ 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).