(173 days)
No
The device description focuses on mechanical components and procedures, with no mention of AI or ML. The "Mentions AI, DNN, or ML" section also explicitly states "Not Found".
Yes
The device is used for the non-surgical removal of emboli and thrombi from venous blood vessels, which constitutes a medical treatment for a disease or condition.
No.
The document describes a system for the "non-surgical removal of emboli and thrombi," indicating a therapeutic rather than diagnostic purpose.
No
The device description clearly outlines multiple physical components including catheters, sheaths, balloons, and accessories, indicating it is a hardware-based medical device.
Based on the provided information, the ICHOR 14F Embolectomy System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This testing is performed outside of the body (in vitro).
- ICHOR 14F Embolectomy System Function: The description clearly states that the ICHOR 14F Embolectomy System is used for the "non-surgical removal of emboli and thrombi from venous blood vessels." This is a therapeutic procedure performed inside the body (in vivo) to remove blockages.
- Lack of Specimen Analysis: There is no mention of the device analyzing any biological specimens or providing diagnostic information based on such analysis. Its purpose is mechanical removal of material from within blood vessels.
Therefore, the ICHOR 14F Embolectomy System falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
QEW
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
venous blood vessels, 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)
Non-Clinical Testing Performed
Biocompatibility Testing:
- Acute Systemic Toxicity
- Cytotoxicity
- Hemocompatibility
- complement activation
- direct and indirect hemolysis
- in vivo thrombogenicity (leveraged from GLP animal study)
- Irritation
- Material-Mediated Pyrogenicity
- Sensitization
Bench Testing:
- Accelerated Aging Testing Protocol
- Balloon characterization Testing
- balloon fatigue
- balloon inflation/deflation time
- balloon compliance
- 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.
Conclusion: The ICHOR 14F Embolectomy System is substantially equivalent to the predicate device.
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.
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 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
1
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
2
Indications for Use
510(k) Number (if known) K230743
Device Name The ICHOR 14F Embolectomy System
Indications for Use (Describe)
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.
| 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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3
510(k) Summary K230743
| Date prepared | August 31, 2023 |
|---|---|
| Name | ICHOR |
| 1900 NW 25th St. Boca Raton FL 33431 United States | |
| Contact person | Angela Mallery |
| amallery@namsa.com | |
| 763-287-3830 | |
| 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 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.
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.
4
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 | ClotTriever | |
| K182531 | ||
| Indications for Use | The ICHOR 14F Embolectomy System is | |
| indicated for the non-surgical removal of emboli | ||
| and thrombi from venous blood vessels. The | ||
| device is intended for the peripheral vasculature, | ||
| and is not intended for use in the coronary or | ||
| neurovasculature. | The ClotTriever Thrombectomy | |
| System consists of the ClotTriever | ||
| Catheter and ClotTriever Sheath. | ||
| The ClotTriever Thrombectomy | ||
| System is indicated for: | ||
| The non-surgical removal of soft | ||
| thrombi and emboli from blood | ||
| vessels. | ||
| Injection, infusion, and/or | ||
| aspiration of contrast media and | ||
| other fluids into or from a blood | ||
| vessel. | ||
| The ClotTriever Thrombectomy | ||
| System is intended for use in the | ||
| peripheral vasculature | ||
| Nitinol Funnel | ||
| (max) | 18mm | 14mm |
| Treatment Balloon | ||
| Material/Size | Pebax | |
| Diameter: 14mm / Length 15mm | No balloon, Nitinol coring element | |
| Usable Catheter | ||
| Lengths | Balloon catheter: 100cm | |
| Guide catheter: 55cm | ||
| Introducer sheath: 15cm | 105cm deployed | |
| 74cm usable | ||
| Biocompatibility | Tested to 10993-1 | Tested to 10993-1 |
| Sterilization | EO | EO |
| Packaging | Tyvek Packaging | Tyvek Packaging |
| Aspiration | ||
| Mechanism | 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 ●
5
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