(219 days)
Not Found
No
The device description focuses on mechanical components and procedures, with no mention of AI or ML. The performance studies are standard engineering and biocompatibility tests, not related to algorithmic performance.
Yes
The device is designed for the non-surgical removal of emboli and thrombi from blood vessels using mechanical means (basket, balloon, aspiration), which directly treats a medical condition.
No
The device is an embolectomy system intended for the "non-surgical removal of emboli and thrombi from blood vessels," indicating a therapeutic rather than diagnostic purpose.
No
The device description clearly outlines multiple physical components (Introducer Sheath, Dilator, Guide Catheter, Balloon Catheter, syringes, stopcocks, stylet) and describes their mechanical function in removing emboli and thrombi. There is no mention of software as a component or its function.
Based on the provided information, the ICHOR 7F Embolectomy System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is the "non-surgical removal of emboli and thrombi from blood vessels." This describes a therapeutic intervention performed within the patient's body (in vivo).
- Device Description: The description details a system of catheters and balloons designed to physically remove blockages from blood vessels. This is a mechanical, interventional device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens outside of the body (in vitro), such as blood, tissue, or other bodily fluids, for diagnostic purposes.
IVD devices are used to perform tests on samples taken from the body to provide information for diagnosis, monitoring, or screening. The ICHOR 7F Embolectomy System is a medical device used for treatment, not diagnosis.
N/A
Intended Use / Indications for Use
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 in the coronary or neurovasculature.
Product codes
QEW
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.
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:
- 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
- Biocompatibility Evaluations ●
- o Cytotoxicity
- Sensitization o
- Irritation o
- o Acute Systemic Toxicity
- Pyrogenicity o
- o Hemocompatibility
- . Sterilization
- . Packaging
- . Transportation
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.
Not Found
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and 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.
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).
1
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
2
Indications for Use
510(k) Number (if known) K233917
Device Name ICHOR 7F Embolectomy System (ICH-7F)
Indications for Use (Describe)
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 in the coronary or neurovasculature.
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 500 |
| Minneapolis, 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
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.
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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Image /page/5/Picture/1 description: The image shows the logo for Ichor. The logo is blue and orange. The text below the logo says "SAVING LIVES. SIMPLIFIED."
| Feature | Subject Device - ICHOR 7F
Embolectomy System (ICH-
7F) - K233917 | Predicate Device - The
ICHOR Panacea Vascular
Embolectomy Catheter
System - K182167 | Comparison |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| Indication for Use | 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. | 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. | 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 Balloon
Material/Size | Low durometer Pebax
Diameter: 10 mm | Pellethane 10 mm - 12 mm | Different
Change to balloon material and
diameter |
| Usable Catheter Lengths | Balloon catheter: 145 cm
Guide catheter: 90 cm
Introducer Sheath 50.0 cm | 150 cm | Different
Changes to catheter length,
Guide Catheter, and Introducer
Sheath 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.