The ICHOR 7F 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 ICHOR 7F Embolectomy System is indicated for the non-surgical removal of emboli and thrombi from blood vessels. The System is intended for the peripheral vasculature (nominal size 4-10mm). The ICHOR 7F consists of four components: the Introducer Sheath, the Dilator, the Guide Catheter, and the Balloon Catheter. 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 two 1 cc syringes, two Tuohy Borst with extension lines, two three-way stopcocks, two one-way stopcocks, and one stylet.

AI/ML Overview

I am sorry, but the provided text does not contain any information about acceptance criteria or a study that proves a device meets those criteria. The document is an FDA 510(k) clearance letter and a 510(k) summary for a medical device. It outlines the device's indications for use, its components, and compares it to a predicate device. It also lists the non-clinical tests performed, but it does not provide details on the acceptance criteria for these tests nor does it present device performance data against such criteria in the format requested.

Therefore, I cannot fulfill your request to include:

A table of acceptance criteria and the reported device performance
Sample size used for the test set and the data provenance
Number of experts used to establish the ground truth for the test set and their qualifications
Adjudication method
MRMC comparative effectiveness study details
Standalone performance details
Type of ground truth used
Sample size for the training set
How the ground truth for the training set was established

Summary

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July 18, 2024

ICHOR Vascular, Inc. (ICHOR) % Brandon Woll Principal Strategy Consultant, Regulatory and R&D Namsa 400 Highway 169 South Suite 500 Minneapolis, Minnesota 55426

Re: K233917

Trade/Device Name: ICHOR 7F Embolectomy System (ICH-7F) Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEW Dated: December 12, 2023 Received: December 12, 2023

Dear Brandon Woll:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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,

Digitally signed by Gregory Gregory W. W. O'connell -S O'connell -S Date: 2024.07.18 10:43:21 -04'00'

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

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Indications for Use

510(k) Number (if known) K233917

Device Name ICHOR 7F Embolectomy System (ICH-7F)

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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Image /page/3/Picture/0 description: The image shows the text 'K233917' in a clear, sans-serif font. The text is presented in a straightforward manner, with each character distinctly visible. The number is likely an identification code or a serial number.

Image /page/3/Picture/2 description: The image shows the logo for iCHOR. The logo is in blue and orange. The text below the logo says "SAVING LIVES. SIMPLIFIED."

510(k) Summary

In accordance with the regulatory requirements of 21 CFR Part 807.92, the 510(k) Summary for the ICHOR 7F Embolectomy System is provided below.

Assigned 510(k) Number: K233917

A. Applicant Information
Applicant Name:	ICHOR
Contact Person:	Timothy Blair
Address:	1900 NW 25th St.Boca Raton, FL 33431
Telephone:	(954) 483-4525
E-mail:	tblair34@gmail.com
Correspondent Name:	NAMSA
Contact:	Adam Saltman
Address:	400 Highway 169 South, Suite 500Minneapolis, MN 55426
Telephone:	(347) 860-1872
E-mail:	asaltman@namsa.com
B. Date Prepared	17 July 2024
C. Device Name
Device Trade Name:	ICHOR 7F Embolectomy System (ICH-7F)
Common Name:	Embolectomy Catheter
Device Classification:	Peripheral Mechanical Thrombectomy with Aspiration
Regulation:	870.5150
Product Code:	QEW

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Image /page/4/Picture/2 description: The image shows the logo for iCHOR. The logo is blue and orange. The text "SAVING LIVES. SIMPLIFIED." is below the logo.

D. Predicate Device Names

Predicate Device:	ICHOR Panacea Vascular Embolectomy Catheter System
Predicate #:	K182167
Predicate Product Code:	QEW

E. Device Description Summary

The ICHOR 7F Embolectomy System is indicated for the non-surgical removal of emboli and thrombi from blood vessels. The System is intended for the peripheral vasculature (nominal size 4-10mm).

The ICHOR 7F consists of four components: the Introducer Sheath, the Dilator, the Guide Catheter, and the Balloon Catheter.

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 two 1 cc syringes, two Tuohy Borst with extension lines, two three-way ● stopcocks, two one-way stopcocks, and one stylet.

F. Intended Use/Indications for Use

G. Technological Comparison

Minor technological differences exist between the predicate and subject device; minor differences have been verified and validated through bench testing and the testing confirms these do not raise different questions of safety and effectiveness than the predicate device.

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Feature	Subject Device - ICHOR 7FEmbolectomy System (ICH-7F) - K233917	Predicate Device - TheICHOR Panacea VascularEmbolectomy CatheterSystem - K182167	Comparison
Indication for Use	The ICHOR 7FEmbolectomy System isindicated for the non-surgical removal ofemboli and thrombi fromblood vessels.The device is intended forthe peripheral vasculatureand is not intended for usein the coronary orneurovasculature.	The Panaceaembolectomy system isindicated for the non-surgical removal ofemboli and thrombi fromblood vessels.The device is intendedfor the peripheralvasculature and is notintended for use in thecoronary orneurovasculature.	Same
Regulation Number	21 CFR 870.5150	21 CFR 870.5150	Same
Regulatory Class	Class II	Class II	Same
Product Code	QEW	QEW	Same
Nitinol Funnel (max)	10.5 mm	10.5 mm	Same
Treatment BalloonMaterial/Size	Low durometer PebaxDiameter: 10 mm	Pellethane 10 mm - 12 mm	DifferentChange to balloon material anddiameter
Usable Catheter Lengths	Balloon catheter: 145 cmGuide catheter: 90 cmIntroducer Sheath 50.0 cm	150 cm	DifferentChanges to catheter length,Guide Catheter, and IntroducerSheath Length
Biocompatibility	Tested to 10993-1	Tested to 10993-1	Same
Sterilization	EO	EO	Same
Packaging	Tyvek Packaging	Tyvek Packaging	Same
Aspiration Mechanism	Syringe	Syringe	Same

H. Non-Clinical Test Summary

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:

Performance Testing
- Balloon Compliance Testing o
- Balloon Fatigue Testing O
- Balloon Inflation Testing O
- Radial Force Testing O
- Thrombus Evacuation Testing O
- Bend Radius Testing O
- Leak Testing O
- Radiopacity Testing O
- Simulated Use Testing O
- Tensile Testing O
- Torque Testing O
- O Dimension Evaluation

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Image /page/6/Picture/2 description: The image is a logo for a company called "iCHOR". The word "iCHOR" is written in blue, with the "i" having an orange dot above it. To the right of the "CH" is an orange graphic of three curved lines. Below the logo is the text "SAVING LIVES. SIMPLIFIED."

Biocompatibility Evaluations ●
- o Cytotoxicity
- Sensitization o
- Irritation o
- o Acute Systemic Toxicity
- Pyrogenicity o
- o Hemocompatibility
. Sterilization
. Packaging
. Transportation

I. Conclusion

Non-clinical testing supports substantial equivalence of the subject device to the predicate device.

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).