The ICHOR 14F Embolectomy System is indicated for the non-surgical removal of emboli and thrombi from venous blood vessels. The System is intended for the peripheral vasculature and is not intended for use in the coronary or neurovasculature.

Device Description

The ICHOR 14F Embolectomy System is indicated for the non-surgical removal of emboli and thrombi from blood vessels. The System is intended for the peripheral venous vasculature (nominal size 8-14mm).

The System is composed of three catheters: (1) Introducer Sheath, (2) Guide Catheter, and (3) Balloon Catheter and accessories.
The outermost catheter is the Introducer Sheath, which travels to the occlusion site over the dilator. The Introducer Sheath is placed proximal to the occlusion and anchored into place by inflating the occluding balloon located at the distal tip. The balloon on the Introducer Sheath also serves to occlude flow.
The Guide Catheter, composed of the Basket Catheter telescoped within the Guide Catheter Sheath, is passed through the Introducer Sheath. When in place, the Guide Catheter Sheath, which serves as the capturing sleeve, is retracted proximally allowing a nitinol basket to expand within the vasculature proximal to the occlusion.
The Balloon Catheter is passed through the Guide Catheter and extended past the occlusion. The treatment balloon is inflated distal to the occlusion, and the Balloon Catheter is pulled proximally towards the basket until the occlusion is contained inside the basket. If desired the Guide Catheter can introduce aspiration to apply negative pressure to guide embolic material into the basket.
The accessories include a dilator, flush adapter, two 3cc syringes, a Tuohy Borst, and four extension lines with one-way stopcocks.

AI/ML Overview

The provided text is a 510(k) premarket notification for the ICHOR 14F Embolectomy System. It details the device's indications for use, its description, and a comparison to predicate and reference devices. It also lists the non-clinical testing performed to demonstrate substantial equivalence.

However, the document does not contain information about:

Acceptance criteria in tabular format with reported device performance (beyond general statements about meeting requirements).
Sample sizes used for the test set (for algorithm performance).
Data provenance (country of origin, retrospective/prospective).
Number of experts used to establish ground truth or their qualifications.
Adjudication method for the test set.
MRMC comparative effectiveness study, including effect size.
Standalone (algorithm only) performance.
Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for any specific algorithm performance claims.
Sample size for the training set (for an AI/algorithm).
How the ground truth for the training set was established.

This is because the ICHOR 14F Embolectomy System is a mechanical thrombectomy system, not an AI-powered diagnostic or therapeutic device. The "study that proves the device meets the acceptance criteria" in this context refers to the non-clinical bench testing and animal study performed to demonstrate the physical and functional aspects of the device, as well as its biocompatibility and sterilization efficacy, in comparison to existing predicate devices.

Therefore, I cannot fulfill most of the requested points as they are relevant to AI/algorithm-based medical devices, which this product is not.

Here's the information that can be extracted or inferred from the provided text, primarily regarding the non-clinical testing aspects of this mechanical device:

1. A table of acceptance criteria and the reported device performance

The document lists various tests performed, implying that acceptance criteria were met for each. However, it does not provide specific quantitative acceptance criteria or detailed reported performance results in a table. It only states that the device "met the requirements" or that testing "confirms these do not raise new questions of safety and effectiveness."

Acceptance Criteria Category	Reported Device Performance (Summary from text)
Biocompatibility	Met requirements per ISO 10993-1. (Acute Systemic Toxicity, Cytotoxicity, Hemocompatibility (o complement activation, direct and indirect hemolysis, o in vivo thrombogenicity), Irritation, Material-Mediated Pyrogenicity, Sensitization)
Bench Testing	All listed tests performed and confirm no new safety/effectiveness questions compared to predicate. (Accelerated Aging, Balloon characterization (fatigue, inflation/deflation time, compliance), Basket Durability, Basket Radial Force, Bend Radius, Hub Pressurization, Package Integrity and Bubble Leak, Radiopacity, Seal Peel, Simulated Use, Tensile Testing, Torque Strength, Visual and Dimensional)
Sterilization	Met requirements for ethylene oxide and ethylene chlorohydrin residuals per ISO 10993-7:2008/Amd1:2019; met requirements for bacterial endotoxin per AAMI/ANSI ST72:2019.
Animal Study	No adverse events, clinical observations, clinical pathology excursions, gross pathological, and histomorphological findings were evaluated that would raise new safety and effectiveness concerns compared to the comparator device at an acute timepoint.

2. Sample sizes used for the test set and the data provenance

Test Set Sample Sizes: Not specified for each individual bench test or the animal study in terms of specific numbers of devices or animals.
Data Provenance: Not explicitly stated, but typically for medical device testing, it would be conducted in controlled laboratory or GLP (Good Laboratory Practice) animal study environments. It's not "data" in the sense of patient data. The animal study was a "GLP study," implying a controlled, prospective experimental design.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable for this device type. There is no "ground truth" derived from expert image interpretation or clinical outcomes data in the context of an AI study. Mechanical device testing relies on measurable physical properties and observed biological responses.

4. Adjudication method for the test set

Not applicable. Adjudication methods are relevant for human interpretation of data, often in AI or clinical studies. This involves mechanical and biological testing.

5. 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

No. This is not an AI-assisted device. Therefore, no MRMC study was conducted or is relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No. This is not an AI algorithm.

7. The type of ground truth used

Not applicable in the context of AI. For this device, "ground truth" is established by:
- Bench Test Standards: Adherence to established engineering and material science standards (e.g., tensile strength, balloon compliance) and internal specifications.
- Biocompatibility Standards: Compliance with ISO 10993 series for biological evaluation of medical devices.
- Animal Models: Live animal physiological responses and pathological findings in a controlled GLP study setting comparing the device to a predicate/comparator.

8. The sample size for the training set

Not applicable. This device does not use an AI algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This device does not use an AI algorithm that requires a training set.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 5, 2023

Ichor Angela Mallery Regulatory 1900 NW 25th St. Boca Raton, Florida 33431

Re: K230743

Trade/Device Name: ICHOR 14F Embolectomy System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEW Dated: August 3. 2023 Received: August 3, 2023

Dear Angela 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 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,

Ariel G. Ash- Digitally signed by
Ariel G. Ash-shakoor -S
shakoor -S Date: 2023.09.05
15:45:12 -04'00'

For

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) K230743

Device Name The ICHOR 14F Embolectomy System

Indications for Use (Describe)

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)

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510(k) Summary K230743

Date prepared	August 31, 2023
Name	ICHOR1900 NW 25th St. Boca Raton FL 33431 United States
Contact person	Angela Malleryamallery@namsa.com763-287-3830
Name of Device	ICHOR 14F Embolectomy System
Common name	Embolectomy catheter
Regulation name	Peripheral Mechanical Thrombectomy With Aspiration
Classification number	21 CFR 870.5150
Product code	QEW
Regulatory class	II

	Predicate #	Predicate Trade Name	Product Code
Predicate device	K182531	The ClotTriever Thrombectomy System	QEW
	K182167	ICHOR Panacea	QEW
Reference device	K171493	MegaVac Mechanical Thrombectomy System	QEW
	K152762	Fogarty Occlusion Catheter	MJN

Device Description

Predicate and Reference

Devices

The System is composed of three catheters: (1) Introducer Sheath, (2) Guide Catheter, and (3) Balloon Catheter and accessories.
· The outermost catheter is the Introducer Sheath, which travels to the occlusion site over the dilator. The Introducer Sheath is placed proximal to the occlusion and anchored into place by inflating the occluding balloon located at the distal tip. The balloon on the Introducer Sheath also serves to occlude flow.
· The Guide Catheter, composed of the Basket Catheter telescoped within the Guide Catheter Sheath, is passed through the Introducer Sheath. When in place, the Guide Catheter Sheath, which serves as the capturing sleeve, is retracted proximally allowing a nitinol basket to expand within the vasculature proximal to the occlusion.
· The Balloon Catheter is passed through the Guide Catheter and extended past the occlusion. The treatment balloon is inflated distal to the occlusion, and the Balloon Catheter is pulled proximally towards the basket until the occlusion is contained inside the basket. If desired the Guide Catheter can introduce aspiration to apply negative pressure to guide embolic material into the basket.
· The accessories include a dilator, flush adapter, two 3cc syringes, a Tuohy Borst, and four extension lines with one-way stopcocks.

The ICHOR 14F Embolectomy System is indicated for the non-surgical removal of emboli and thrombi Indications for Use from venous blood vessels. The System is intended for the peripheral vasculature and is not intended for use in the coronary or neurovasculature.

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Comparison of Technological Characteristics with the Predicate Device

Summary of substantial

equivalence

Minor differences in the indication for use are acceptable and do not raise new questions of safety or effectiveness; the predicate had additional indications for injections and infusion of fluid; the lack of this indication does not raise additional questions.

Minor technological differences exist between the predicate and subject device; both devices are designed to capture clot with a basket and have the option to aspirate via a syringe; minor differences in dimensions have been verified and validated through bench and animal testing and the testing confirms these do not raise new questions of safety and effectiveness than the predicate device.

The reference devices were included to confirm/demonstrate the technology has similar situations FDA has encountered in the past; the reference devices are used in the identical anatomical location for the same purpose as the subject device. The ICHOR Panacea 7F uses the same basket/balloon configuration; the Mega Vac also uses a Nitinol Basket for removal of clot, the Fogarty devices use a balloon for the movement of clot. The MegaVac and Fogarty devices were the used to support the ICHOR Panacea 7F device.

Although the predicate and subject devices have different technological characteristics, all leveraged and performed design verification and validation tests confirm that these differences do not raise any new or different questions of safety or effectiveness.

Substantial Equivalence Executive Summary
	ICHOR 14F	ClotTrieverK182531
Indications for Use	The ICHOR 14F Embolectomy System isindicated for the non-surgical removal of emboliand thrombi from venous blood vessels. Thedevice is intended for the peripheral vasculature,and is not intended for use in the coronary orneurovasculature.	The ClotTriever ThrombectomySystem consists of the ClotTrieverCatheter and ClotTriever Sheath.The ClotTriever ThrombectomySystem is indicated for:The non-surgical removal of softthrombi and emboli from bloodvessels.Injection, infusion, and/oraspiration of contrast media andother fluids into or from a bloodvessel.The ClotTriever ThrombectomySystem is intended for use in theperipheral vasculature
Nitinol Funnel(max)	18mm	14mm
Treatment BalloonMaterial/Size	PebaxDiameter: 14mm / Length 15mm	No balloon, Nitinol coring element
Usable CatheterLengths	Balloon catheter: 100cmGuide catheter: 55cmIntroducer sheath: 15cm	105cm deployed74cm usable
Biocompatibility	Tested to 10993-1	Tested to 10993-1
Sterilization	EO	EO
Packaging	Tyvek Packaging	Tyvek Packaging
AspirationMechanism	Syringe	Syringe

Non-Clinical Testing Performed

Biocompatibility Testing:

Acute Systemic Toxicity ●
. Cytotoxicity
Hemocompatibility
- o complement activation
- direct and indirect hemolysis O
in vivo thrombogenicity (leveraged from GLP animal study O
Irritation
Material-Mediated Pyrogenicity .
Sensitization ●

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Bench Testing:

Accelerated Aging Testing Protocol ●
Balloon characterization Testing ●
- balloon fatigue o
- balloon inflation/deflation time o
- balloon compliance o
Basket Durability ●
Basket Radial Force Testing ●
. Bend Radius Testing
Hub Pressurization Testing
Package Integrity and Bubble Leak
. Radiopacity Testing
Seal Peel Testing ●
Simulated Use Testing
. Tensile Testing
Torque Strength Testing ●
Visual and Dimensional ●

Sterilization: The device is ethylene oxide sterilized and met the requirements for ethylene oxide and ethylene chlorohydrin residuals per ISO 10993- 7:2008/Amd1:2019; and met the requirements for bacterial endotoxin per AAMI/ANSI ST72:2019.

Animal Study: A GLP study was conducted, comparing the ICHOR 14F Embolectomy System to a comparator device at an acute timepoint. Adverse Events, clinical observations, clinical pathology excursions, gross pathological, and histomorphological finding were evaluated.

The ICHOR 14F Embolectomy System is substantially equivalent to the predicate device. Conclusion

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).