(120 days)
Not Found
No
The description focuses on mechanical aspiration and saline delivery, with no mention of AI/ML terms or functions.
Yes
The device is intended to "remove/aspirate fluid and break-up soft emboli and thrombus from the peripheral vasculature," which directly treats a medical condition.
No
The device is designed for thrombectomy (removal/aspiration of fluid and breakdown of soft emboli and thrombus) and delivery of diagnostics/therapeutics, but not for diagnosing medical conditions.
No
The device description clearly outlines multiple hardware components including a catheter, pump set, suction tubing, saline drive unit, and accessory cart.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to remove/aspirate fluid and break up thrombus from the peripheral vasculature and to infuse/deliver diagnostics or therapeutics. This is a therapeutic and interventional procedure performed directly on the patient's body.
- Device Description: The device description details a system for physically removing material from the patient's blood vessels. It involves a catheter, pump, and collection system. This is consistent with a medical device used for treatment, not for analyzing samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.) in vitro (outside the body) to provide diagnostic information. The device's function is to physically interact with the patient's vasculature.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The JETi AIO Peripheral Thrombectomy System is intended to:
- remove/aspirate fluid and break-up soft emboli and thrombus from the peripheral vasculature, and
- subselectively infuse/deliver diagnostics or therapeutics with or without vessel occlusion.
Product codes
QEZ
Device Description
The JETi All In One (AIO) Peripheral Thrombectomy System consists of one aspiration catheter, which is connected to the JETi Pump Set and JETi AIO Suction Tubing, one JETi AIO Peripheral Saline Drive Unit (SDU), and an Accessory Cart. A Non-Sterile Accessory Device is supplied. In use, thrombus enters the distal catheter tip via the suction force provided by the JETi AIO SDU internal vacuum pump. The peripheral SDU and pump set deliver a stream of sterile saline through the secondary lumen to break up and dilute the thrombus within the catheter. The diluted thrombus and saline are drawn back through the primary lumen and deposited into the disposable collection canister. No high pressure saline is injected into the patient during normal operation. The peripheral SDU, a height adjustable cart, a height adjustable canister mount, an IV pole, basket, and cart handle are contained on an accessory cart.
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
Prescription Use (Part 21 CFR 801 Subpart D)
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 performed pursuant to Walk Vascular's risk analysis. All data met the acceptance criteria and fell within pre-determined product specifications and external standard requirements. The following testing was performed to support the determination of substantial equivalence:
Design validation SDU life cycle Software validation 60601-1 Product and electrical safety
No pre-clinical or clinical data were generated to establish substantial equivalence. Bench data are considered adequate to support a determination of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
November 17, 2020
Walk Vascular, LLC Paul Gasser Medical Device RA/QA Consultant 17171 Daimler Street Irvine, California 92614
Re: K201998
Trade/Device Name: JETi AIO Peripheral Thrombectomy System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEZ Dated: October 9, 2020 Received: October 13, 2020
Dear Paul Gasser:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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 (QS) 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 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,
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) K201998
Device Name JETi AIO Peripheral Thrombectomy System
Indications for Use (Describe) The JETi AIO Peripheral Thrombectomy System is intended to:
- remove/aspirate fluid and break-up soft emboli and thrombus from the peripheral vasculature, and
- subselectively infuse/deliver diagnostics or therapeutics with or without vessel occlusion.
| 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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3
Traditional 510(k) Summary
| Submitter: | Walk Vascular, LLC
17171 Daimler Street
Irvine, CA 92614
USA |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Brad Culbert
VP, Engineering
Walk Vascular LLC
Telephone: 949-752-9642
Fax: 949-752-9658
Email: bsculbert@yahoo.com |
| Date Summary Prepared: | July 10, 2020 |
| Device Trade Name: | JETI AIO Peripheral Thrombectomy System |
| Common Name: | Embolectomy/Thrombectomy Catheter |
| Classification Name: | Embolectomy Catheter (21 CFR 870.5150) |
| Product Code: | QEZ |
| Predicate Device: | JETi 88 Peripheral Thrombectomy System
(510(k) K183403) |
Device Description:
The JETi All In One (AIO) Peripheral Thrombectomy System consists of one aspiration catheter, which is connected to the JETi Pump Set and JETi AIO Suction Tubing, one JETi AIO Peripheral Saline Drive Unit (SDU), and an Accessory Cart. A Non-Sterile Accessory Device is supplied. In use, thrombus enters the distal catheter tip via the suction force provided by the JETi AIO SDU internal vacuum pump. The peripheral SDU and pump set deliver a stream of sterile saline through the secondary lumen to break up and dilute the thrombus within the catheter. The diluted thrombus and saline are drawn back through the primary lumen and deposited into the disposable collection canister. No high pressure saline is injected into the patient during normal operation. The peripheral SDU, a height adjustable cart, a height adjustable canister mount, an IV pole, basket, and cart handle are contained on an accessory cart.
4
Indications for Use:
The JETi AIO Peripheral Thrombectomy System is intended to:
- remove/aspirate fluid and break-up soft emboli and thrombus from the peripheral vasculature, and
- subselectively infuse/deliver diagnostics or therapeutics with or without vessel occlusion.
Statement of Equivalence:
The subject device and the predicate share the same intended use and have similar technological characteristics.
Key differences between the subject and predicate devices are reflected in the following table.
| Design Features | Predicate JETi 88 Peripheral
Thrombectomy System | Subject JETi AIO Peripheral
Thrombectomy System |
|----------------------------------------|----------------------------------------------------------------|----------------------------------------------------|
| Catheter | | |
| Catheter working length
(cm) | 100 | Same |
| Catheter connections and
location | Multi-port Luer adapter on the
proximal end of the catheter | Same |
| Pump Set | | |
| Saline input tube length
(feet) | 6 | Same |
| Saline Drive Unit | | |
| IEC 60601-1-2 edition
complied with | 4th | Same |
| On/off control | Foot pedal | Handheld controller |
| Method to stop flow | Pinch valve | Handheld controller |
| Pinch valve control | Mode button | N/A |
| Aspiration method | Vacuum pump | Same, but internal to unit |
| Location | Mounted on cart outside sterile field | Same |
| Vacuum sensor connector | Standard RJ45 | Same |
| Accessory Stand | | |
| Height adjustable | No | Yes |
| Sterile Accessory Kit | Present | Replaced with suction tubing |
| Non-Sterile Accessory Device | Present | Modified to accommodate internal pump |
The JETi AIO Peripheral Thrombectomy System is substantially equivalent to the predicate device.
5
Summary of Non-Clinical Performance Data:
Device evaluation consisted of in vitro testing performed pursuant to Walk Vascular's risk analysis. All data met the acceptance criteria and fell within pre-determined product specifications and external standard requirements. The following testing was performed to support the determination of substantial equivalence:
Design validation SDU life cycle Software validation 60601-1 Product and electrical safety
Biocompatibility Testing:
Biocompatibility testing was not conducted, as the catheter and pump set materials are identical to the predicate device.
Sterilization Testing:
Sterilization testing was not conducted, as the catheter and pump set designs are comparable to the predicate device.
Transportation and Shelf Life Testing:
Transportation and shelf life testing was not conducted on the catheter and pump set, as the catheter and pump set are comparable to the predicate device. Shelf life testing was conducted for the SDU.
The data from the in vitro testing above supports the substantial equivalence of the subject device to the predicate device.
Summary of Pre-Clinical and Clinical Data:
No pre-clinical or clinical data were generated to establish substantial equivalence. Bench data are considered adequate to support a determination of substantial equivalence.
Summary:
Based on the intended use, and in vitro performance information provided in this premarket notification, the JETi AIO Peripheral Thrombectomy System is substantially equivalent to the predicate device.