The JETi™ Hydrodynamic Thrombectomy System is intended to remove/aspirate fluid and break-up soft emboli and thrombus from the peripheral vasculature, including deep vein thrombosis (DVT), and to sub-selectively infuse/deliver diagnostics or therapeutics with or without vessel occlusion.

Device Description

The JETi™ Hydrodynamic Thrombectomy System (JETi HTS) is a hydro-mechanical aspiration system intended for the removal of intravascular thrombus. The system is comprised of the JETi™ Catheter, JETi™ Pump Set, JETi™ Saline Drive Unit (SDU), JETi™ Accessory Cart, JETi™ Suction Tubing, and JETi™ Non-sterile Canister Set. The JETi Hydrodynamic Thrombectomy System is designed to continuously aspirate thrombotic material into the JETi Catheter, where a high-pressure stream of saline within the catheter tip macerates the thrombus as it is aspirated.

AI/ML Overview

Here's an analysis of the provided text, focusing on acceptance criteria and the supporting study, structured as requested:

1. Table of Acceptance Criteria and Reported Device Performance

Criterion Type	Acceptance Criteria	Reported Device Performance
Primary Effectiveness	At least 75% reduction in modified Marder Score from pre-JETi venogram to final venogram (per core laboratory assessment), with a one-sided 97.5% lower confidence limit comparing to a performance goal of 64%.	Achieved in 84.5% (93/110) limbs, with a one-sided 97.5% lower confidence limit of 76.4%, which compares favorably to the performance goal of 64% (p value < 0.0001). The primary effectiveness endpoint was met.
Primary Safety	Composite of JETi-related major adverse events up to 30 days post-JETi (per CEC adjudication) should be less than 10%.	1.7% (2/116) (95% CI, 0.21%, 6.09%). This rate is less than the acceptance criterion of 10%. The primary safety endpoint was met.
Secondary Outcomes (Implied)	Improved treated vessel patency and compressibility, Villalta post-thrombotic syndrome score, leg pain, and quality of life at 30 days. (While not explicitly stated as "acceptance criteria," these are reported as positive outcomes that support the device's effectiveness.)	All were improved at 30 days.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size (Clinical Testing - JETi Registry):
- Total registered subjects in the registry: 260
- Subjects treated for lower extremity (LE) DVT (analysis population for effectiveness and safety): 116
- Limbs evaluated for the primary effectiveness endpoint: 110
- Subjects evaluated for the primary safety endpoint: 116
Data Provenance: Prospective, multi-center study conducted in the United States (US) and Europe.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document mentions "core laboratory assessment" for the primary effectiveness endpoint (Marder Score reduction) and "CEC adjudication" (Clinical Events Committee adjudication) for the primary safety endpoint (major adverse events).
The number and specific qualifications of the experts within the core laboratory and CEC are not specified in the provided text.

4. Adjudication Method for the Test Set

Effectiveness Endpoint: "core laboratory assessment"
Safety Endpoint: "CEC adjudication"
The specific adjudication method (e.g., 2+1, 3+1, none) used by the core laboratory or CEC is not detailed in the provided text.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, an MRMC comparative effectiveness study was NOT done. The clinical study described (JETi Registry) is a "prospective, single-arm, multicenter study" focused on the performance of the JETi HTS alone. It does not compare the device's performance with and without AI assistance or against human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The JETi™ Hydrodynamic Thrombectomy System is a physical medical device (a thrombectomy system). It does not appear to be an AI/algorithm-based device, so the concept of "standalone algorithm performance" is not applicable here. The study assesses the performance of the device in treating thrombosis.

7. The Type of Ground Truth Used

Effectiveness Endpoint: Modified Marder Score from pre-JETi venogram to final venogram, assessed by a core laboratory. This suggests a standardized, expert-driven assessment of imaging data.
Safety Endpoint: JETi-related major adverse events, adjudicated by a Clinical Events Committee (CEC). This indicates expert consensus based on clinical event reporting.

8. The Sample Size for the Training Set

Not applicable. The provided document describes a clinical study for a physical medical device (JETi™ Hydrodynamic Thrombectomy System), not an AI algorithm. Therefore, there is no "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As mentioned above, this is a physical medical device, not an AI algorithm.

Summary

FDA 510(k) Clearance Letter - JETi™ Hydrodynamic Thrombectomy System

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.07.05

April 4, 2025

Abbott Medical
Fiona Pu
Manager, Regulatory Affairs
3200 Lakeside Drive
Santa Clara, California 95054

Re: K243549
Trade/Device Name: JETi™ Hydrodynamic Thrombectomy System
Regulation Number: 21 CFR 870.5150
Regulation Name: Embolectomy catheter
Regulatory Class: Class II
Product Code: QEZ, KDQ, FOX
Dated: March 4, 2025
Received: March 4, 2025

Dear Fiona Pu:

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"

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K243549 - Fiona Pu Page 2

(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).

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 QS 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 (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-reporting-combination-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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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).

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K243549 - Fiona Pu Page 3

Sincerely,

GREGORY W. O'CONNELL -S
Digitally signed by GREGORY W. O'CONNELL -S
Date: 2025.04.04 14:49:22 -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

Enclosure

Page 4

Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Submission Number (if known)	K243549
Device Name	JETi™ Hydrodynamic Thrombectomy System

Indications for Use (Describe)

The JETi™ Hydrodynamic Thrombectomy System is intended to remove/aspirate fluid and breakup soft emboli and thrombus from the peripheral vasculature, including deep vein thrombosis (DVT), and to subselectively infuse/deliver diagnostics or therapeutics with or without vessel occlusion.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Traditional 510(k) Pre-market Notification Page 1 of 3

ATTACHMENT 011-04

510(K) SUMMARY

510(k) Summary Per 21 CFR §807.92

510(k) Number	K243549
Date Prepared	November 15, 2024
Submitter Name & Address	Abbott Medical3200 Lakeside DriveSanta Clara, CA 95054
Contact Person	Fiona Pu408-748-4990
Alternative Contact Person	Claire Elkins408-845-0625
Proprietary/Trade Name	JETi™ Hydrodynamic Thrombectomy System
Common/Usual Name	Embolectomy/Thrombectomy Catheter
Classification Name	Embolectomy Catheter (21 CFR 870.5150, Product Code QEZ)Infusion stand (21 CFR 880.6990, Product Code FOX)Vacuum-powered body fluid suction apparatus (21 CFR 880.6740, Product Code KDQ)
Predicate Device	Predicate device: ZelanteDVT Thrombectomy System, K202218Reference device: JETi Hydrodynamic Thrombectomy System, K232458
Device Description	The JETi™ Hydrodynamic Thrombectomy System (JETi HTS) is a hydro-mechanical aspiration system intended for the removal of intravascular thrombus. The system is comprised of the JETi™ Catheter, JETi™ Pump Set, JETi™ Saline Drive Unit (SDU), JETi™ Accessory Cart, JETi™ Suction Tubing, and JETi™ Non-sterile Canister Set. The JETi Hydrodynamic Thrombectomy System is designed to continuously aspirate thrombotic material into the JETi Catheter, where a high-pressure stream of saline within the catheter tip macerates the thrombus as it is aspirated.
Indications for Use/Intended Use	The JETi™ Hydrodynamic Thrombectomy System is intended to remove/aspirate fluid and break-up soft emboli and thrombus from the peripheral vasculature, including deep vein thrombosis (DVT), and to sub-selectively infuse/deliver diagnostics or therapeutics with or without vessel occlusion.
Comparison to Predicate Device	The JETi Hydrodynamic Thrombectomy System (JETi HTS) is substantially equivalent to the predicate ZelanteDVT Thrombectomy

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Traditional 510(k) Pre-market Notification Page 2 of 3

ATTACHMENT 011-04

System (K202218). Although the Indications for Use statement of the subject device is not identical to the predicate device, the differences do not alter the intended therapeutic use of the device and do not affect the safety and effectiveness of the device relative to the predicate. Both the JETi HTS and predicate device have the same intended use: removal of thrombi or emboli from and infusion of fluids into the peripheral vasculature including DVT.

The technological principle for both the subject and predicate device is based on a clot fragmentation mechanism, which uses aspiration and a jet with fluid delivery features. Although JETi HTS and predicate device have different clot fragmentation mechanism and catheter size offering, the different technological characteristics between the subject device and predicate do not raise different questions of safety and effectiveness.

Summary on Non-Clinical Testing	Non-clinical testing was not required to support the update to the Indications for Use. The JETi HTS (K232458) is used as a reference device to account for differences in the technological features between the predicate ZelanteDVT Thrombectomy System and the JETi HTS. JETi HTS (K232458) is identical in design, technological, and performance characteristics to the subject device.
Summary on Clinical Testing	The JETi Registry collected real-world data on the safety, performance, and clinical benefits of the JETi HTS System for the treatment of thrombosis in the peripheral vasculature. It is a prospective, single-arm, multicenter study that registered 260 subjects treated for thrombosis in the peripheral vasculature from 27 sites in the United States (US) and Europe. Subjects were treated for arterial, venous, or arteriovenous thromboses and are followed for 12 months, with data collection at baseline, during the procedure, discharge, 30-day, and 12-month visits. This was a standard of care all-comers registry, and there were no restrictions on presenting thrombus location in the peripheral vasculature or onset of signs and symptoms.A total of 116 registered subjects were treated for lower extremity (LE) DVT. Subject mean age was 56.6 ± 18.5 years, with the youngest subject being 18 and oldest subject being 85 years old. The majority, 55.2% (64/116), were under 65 years old. The split between male 50.0% (58/116) and female 50.0% (58/116) subjects was even. Of the analysis population, 50.9% (59/116) identified as Caucasian, 6.9% (8/116) identified as Black; 1.7% (2/116) identified as American Indian or Alaskan Native; 31.9% (37/116) of subjects declined to disclose or did not disclose their race information due to Europe's

Summary on Non-Clinical Testing

Non-clinical testing was not required to support the update to the Indications for Use. The JETi HTS (K232458) is used as a reference device to account for differences in the technological features between the predicate ZelanteDVT Thrombectomy System and the JETi HTS. JETi HTS (K232458) is identical in design, technological, and performance characteristics to the subject device.

Summary on Clinical Testing

The JETi Registry collected real-world data on the safety, performance, and clinical benefits of the JETi HTS System for the treatment of thrombosis in the peripheral vasculature. It is a prospective, single-arm, multicenter study that registered 260 subjects treated for thrombosis in the peripheral vasculature from 27 sites in the United States (US) and Europe. Subjects were treated for arterial, venous, or arteriovenous thromboses and are followed for 12 months, with data collection at baseline, during the procedure, discharge, 30-day, and 12-month visits. This was a standard of care all-comers registry, and there were no restrictions on presenting thrombus location in the peripheral vasculature or onset of signs and symptoms.A total of 116 registered subjects were treated for lower extremity (LE) DVT. Subject mean age was 56.6 ± 18.5 years, with the youngest subject being 18 and oldest subject being 85 years old. The majority, 55.2% (64/116), were under 65 years old. The split between male 50.0% (58/116) and female 50.0% (58/116) subjects was even. Of the analysis population, 50.9% (59/116) identified as Caucasian, 6.9% (8/116) identified as Black; 1.7% (2/116) identified as American Indian or Alaskan Native; 31.9% (37/116) of subjects declined to disclose or did not disclose their race information due to Europe's

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Traditional 510(k) Pre-market Notification Page 3 of 3

ATTACHMENT 011-04

local regulation. Self-identification of ethnicity of the subjects were 10.3% (12/116) as Hispanic or Latino, 59.5% (69/116) as non-Hispanic or Latino, 30.2% (35/116) as declined or non-disclosed due to Europe's local regulations.

Treatment strategy, including the use of adjunctive therapy, was per investigator's discretion. The majority of patients in the registry (66.1% of limbs) were not treated with any adjunctive interventional device(s) (CDT or other thrombectomy device).

The primary effectiveness endpoint, defined as at least 75% reduction in modified Marder Score from pre-JETi venogram to final venogram, per core laboratory assessment, was achieved in 84.5% (93/110) limbs, with a one-sided 97.5% lower confidence limit of 76.4% comparing to a performance goal of 64% with a p value of < 0.0001. The primary effectiveness endpoint of the JETi Registry was met. Primary effectiveness endpoint was comparable when the JETi system was used with or without adjunctive interventional device(s); with at least 75% thrombus reduction achieved in 86.8% and 83.3% of limbs, respectively.

The primary safety endpoint, defined as the composite of JETi-related major adverse events up to 30 days post-JETi per CEC adjudication, was 1.7% (2/116) (95% CI, 0.21%, 6.09%). The rate of 1.7% (2/116) is less than the acceptance criterion of 10%. The primary safety endpoint of the JETi Registry was met.

Treated vessel patency and compressibility, Villalta post-thrombotic syndrome score, leg pain, and quality of life were all improved at 30 days.

Statement of Equivalence	The proposed changes to the Indications for Use, namely adding the specific use for DVT, is supported by the clinical data presented and thus, has been shown to not raise new or different questions of safety and effectiveness relative to the predicate, therefore, it can be concluded that the JETi HTS is substantially equivalent 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).