(30 days)
The JETSTREAM System is intended for use in atherectomy of the peripheral vasculature and to break apart and remove thrombus from upper and lower extremity peripheral arteries. It is not intended for use in coronary, carotid, iliac or renal vasculature.
The Jetstream Systems are rotational atherectomy catheter systems designed with either a fixed (Jetstream SC 1.85, Jetstream SC 1.6) or an expandable (Jetstream XC 2.4/3.4, Jetstream XC 2.1/3.0) cutting tip intended for use in debulking and treating vascular disease in the peripheral vasculature. Separate lumens within the Catheter allow for continuous aspiration and infusion during device use. Excised tissue, thrombus, and fluid are aspirated from the peripheral treatment site through a port in the Catheter tip to an external collection bag located on the Console. The distal portion of the Catheter also possesses infusion ports that provide continuous infusion of sterile saline during the atherectomy procedure.
The Jetstream Systems consist of two primary components: a Catheter with Control Pod and a Console, which are packaged separately. Each of these system components is described generally as follows:
- Jetstream Catheter with Control Pod: A sterile, single-use unit consisting of an electrically-driven Catheter with attached Control Pod. As with the predicate device, the modified Jetstream Catheter utilizes a differentially cutting tip and includes both aspiration and infusion capabilities and the Control Pod with Activation Handle provides a user interface with keypad controls. The unit, its electrical connectors, tubing, and aspirant collection bag are packaged in a single pouched tray.
- . PV Console: A reusable compact PV Console, with two (2) peristaltic pumps for aspiration and infusion, power supply, system controller, kevpad interface, and LED indicators for device operational status. The PV Console mounts on a standard I.V. stand and remains outside the sterile field during the procedure.
The primary modification of this 510(k) is a redesign of the Control Pod and Activation Handle, which improves the user interface. This modification applies to the entire family of Jetstream Systems.
I'm sorry, but your request cannot be fulfilled. The provided text, which is an FDA 510(k) summary for a medical device called the "Jetstream Systems," describes a physical medical device designed for atherectomy (removing plaque from arteries).
The questions you've asked, such as "A table of acceptance criteria and the reported device performance," "Sample sized used for the test set and the data provenance," "Number of experts used to establish the ground truth," and inquiries about "MRMC comparative effectiveness study," "standalone (algorithm only) performance," and "ground truth for the training set," are typical questions asked about AI/ML-based medical devices or diagnostic software, which rely on digital data and algorithmic performance.
Since the document describes a physical atherectomy catheter system, and not an AI/ML diagnostic or image analysis device, the information required to answer your questions is not present in the provided text. The testing summarized (e.g., Dimensional Verification, Heat Generation, System Reliability, Aspiration Efficiency, Electrical Safety, Biocompatibility) pertains to the physical and functional aspects of a mechanical device, not the performance of an algorithm against a ground truth dataset.
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July 27, 2020
Medrad, Inc. Brit Baird Director of Regulatory Affairs 10801 120th Avenue Ne Kirkland, Washington 98033
Re: K130637
Trade/Device Name: Jetstream XC 2.4/3.4 System Jetstream XC 2.1/3.0 System Jetstream SC 1.85 System Jetstream SC 1.6 System Regulation Number: 21 CFR 870.4875 Regulation Name: Intraluminal artery stripper Regulatory Class: Class II Product Code: MCW, QEW
Dear Brit Baird:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated April 10, 2013. Specifically, FDA is updating this SE Letter because FDA has created a new product code to better categorize your device technology.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Gregory O'Connell, OHT2: Office of Cardiovascular Devices, (301) 796-6075, Gregory.Oconnell@FDA.HHS.gov.
Sincerely,
Gregory W. O'connell -S
Digitally signed by Gregory V
O'connell -S
Date: 2020.07.27 08:05:28
-04'00'
Gregory O'Connell Assistant Director Plaque Modification Devices Team 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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 10, 2013
MEDRAD, Inc. c/o Mr. Brit Baird Director of Regulatory Affairs 9055 Evergreen Boulevard NW Minneapolis, MN 55433-8003
Re: K130637
Trade/Device Name: Jetstream XC 2.4/3.4 System Jetstream XC 2.1/3.0 System Jetstream SC 1.85 System Jetstream SC 1.6 System Regulation Number: 21 CFR 870.4875 Regulation Name: Intraluminal Artery Stripper Regulatory Class: Class II Product Code: MCW Dated: March 11, 2013 Received: March 12, 2013
Dear Mr. Baird:
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. 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. However, we remind you 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.
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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 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Matthew G. Hillebrenner
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
K130637 510(k) Number (if known): _
JETSTREAM® XC 2.4/3.4 System Device Name: JETSTREAM® XC 2.1/3.0 System JETSTREAM® SC 1.85 System JETSTREAM® SC 1.6 System
Indications for Use: The JETSTREAM System is intended for use in atherectomy of the peripheral vasculature and to break apart and remove thrombus from upper and lower extremity peripheral arteries. It is not intended for use in coronary, carotid, iliac or renal vasculature.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Matthew G. Hillebrenner
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510(k) SUMMARY
General Information:
| Date of Summary Preparation: | April 8, 2013 |
|---|---|
| Name and Address of Manufacturer: | MEDRAD, Inc.9055 Evergreen BLVD NWMinneapolis, MN 55433-8003 |
| Contact Person: | Brit BairdDirector of Regulatory AffairsPhone: 425-636-4137Fax: 425-636-4198 |
| Device Trade Names: | JETSTREAM® XC 2.4/3.4 SystemJETSTREAM® XC 2.1/3.0 SystemJETSTREAM® SC 1.85 SystemJETSTREAM® SC 1.6 System |
| Common Name: | Peripheral Atherectomy Catheter |
| Regulation Number: | 21 CFR 870.4875 |
| Regulation Name: | Intraluminal Artery Stripper |
| Regulatory Class: | Class II |
| Classification Panel: | Cardiovascular |
| Product Code: | MCW |
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Performance Standards: Performance Standards do not currently exist for these devices. None are established under Section 514.
Device Description: The Jetstream Systems are rotational atherectomy catheter systems designed with either a fixed (Jetstream SC 1.85, Jetstream SC 1.6) or an expandable (Jetstream XC 2.4/3.4, Jetstream XC 2.1/3.0) cutting tip intended for use in debulking and treating vascular disease in the peripheral vasculature. Separate lumens within the Catheter allow for continuous aspiration and infusion during device use. Excised tissue, thrombus, and fluid are aspirated from the peripheral treatment site through a port in the Catheter tip to an external collection bag located on the Console. The distal portion of the Catheter also possesses infusion ports that provide continuous infusion of sterile saline during the atherectomy procedure.
The Jetstream Systems consist of two primary components: a Catheter with Control Pod and a Console, which are packaged separately. Each of these system components is described generally as follows:
- Jetstream Catheter with Control Pod: A sterile, single-use unit consisting of an electrically-driven Catheter with attached Control Pod. As with the predicate device, the modified Jetstream Catheter utilizes a differentially cutting tip and includes both aspiration and infusion capabilities and the Control Pod with Activation Handle provides a user interface with keypad controls. The unit, its electrical connectors, tubing, and aspirant collection bag are packaged in a single pouched tray.
- . PV Console: A reusable compact PV Console, with two (2) peristaltic pumps for aspiration and infusion, power supply, system controller, kevpad interface, and LED indicators for device operational status. The PV Console mounts on a standard I.V. stand and remains outside the sterile field during the procedure.
The primary modification of this 510(k) is a redesign of the Control Pod and Activation Handle, which improves the user interface. This modification applies to the entire family of Jetstream Systems.
Indications for Use: The JETSTREAM System is intended for use in atherectomy of the peripheral vasculature and to break apart and remove thrombus from upper and lower extremity peripheral arteries. It is not intended for use in coronary, carotid, iliac or renal vasculature.
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Substantially Equivalent Devices: MEDRAD cites the following devices as the primary predicate devices for the aforementioned modification and substantial equivalence basis.
| Primary Predicate Devices | Pathway MedicalPredicate 510(k) |
|---|---|
| JETSTREAM Navitus® L System | |
| JETSTREAM Navitus® System | K122916 |
| JETSTREAM G3® SF System | |
| JETSTREAM G3® SF 1.6 System |
However, the design rationale for and device testing of the modified devices also includes references to the additional predicate devices listed in the table below:
| Other Predicate Devices | Pathway MedicalPredicate 510(k) |
|---|---|
| JETSTREAM Navitus® L System | K120242 |
| JETSTREAM G3® SF 1.6 System | K111229 |
| JETSTREAM Navitus® System | K110626 |
| JETSTREAM G3® SF System | K101334 |
| JETSTREAM G3® System | K101221 |
| JETSTREAM G3® System | K093456 |
| JETSTREAM G3® System | K092332 |
| JETSTREAM G2TM NXT System | K091509 |
| JETSTREAM Pathway PVTM Atherectomy System | K082186 |
| Pathway PVTM Atherectomy System | K081328 |
Testing Summary: To demonstrate substantial equivalence of the modified Jetstream Systems to the predicate Jetstream Systems, the technological and performance characteristics were evaluated by completion of the following testing:
- Dimensional Verification ●
- Heat Generation ●
- System Reliability/Life Test
- Aspiration Efficiency & Crossing Time
- Speed Drop – Flexibility
- Material Liberation (Guidewire Teflon and Stainless Steel)
- Rotational Speed
- Accessory Compatibility
- Infusion & Aspiration Flow Rates
- Catheter Pull
- Catheter Trackability and Pushability
- Torque to Failure
- Catheter Burst
- Cable pull ●
- Pod weight ●
- Visual/surface inspection ●
- Pod Logic ●
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- Auditory Feedback ●
- Packaging and Shelf Life
- Sterilization Validation
- Guidewire Management ●
- Electrical Safety (UL 60601-1 and EN/IEC 60601-1 (2nd Edition)) ●
- o Durability of Markings
- Power Input Test o
- Determination of Applied Parts and Accessible Parts o
- Leakage Current (Before and After Humidity) O
- Dielectric Strength Test O
- Mechanical Strength O
- O Normal Temperature Test
- Mechanical Strength and Resistance to Heat O
- Insulation o
- EMC (IEC 60601-1-2) ●
- Radiated Emissions O
- Electrostatic Discharge (ESD) O
- Radiated Immunity O
- o Magnetic Field Immunity
- Biocompatibility ●
- Cytotoxicity (MEM Elution) O
- Hemolysis (Direct Contact) O
- O Hemolysis (Extraction)
- Acute Systemic Toxicity (2 extracts saline & CSO) O
- Intracutaneous Reactivity (2 extracts saline & CSO) O
- Sensitization (Kligman Maximization method) O
- Pyrogenicity (Material Mediated) O
- Partial Thromboplastin Time (PTT) O
- o Complement Activation (C3a and SC5b-9)
The results from these tests:
- demonstrate that the technological and performance characteristics of the modified Jetstream Systems are comparable to the predicate Jetstream Systems,
- support the safety and effectiveness of the modification that is the subject of this 510(k), and
- ensure the modified devices can perform in a manner equivalent to the predicate ● Jetstream Systems with the identical intended use.
Conclusion (Statement of Equivalence): The data and information presented within this submission (including in vitro bench testing) and the similarities between the modified and predicate devices support a determination of substantial equivalence, and therefore market clearance of the modified Jetstream Systems through this 510(k) Premarket Notification.
§ 870.4875 Intraluminal artery stripper.
(a)
Identification. An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)(b)
Classification. Class II (performance standards).