(335 days)
No
The document describes a mechanical atherectomy system with pumps and a controller, but there is no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is intended for use in atherectomy and to break apart and remove thrombus, which are therapeutic interventions.
No
The JETSTREAM System is intended for atherectomy, which is a therapeutic procedure to remove blockages from blood vessels, not to diagnose a condition.
No
The device description clearly outlines hardware components including a catheter with a cutting tip, a control pod, and a console with pumps and a power supply. The 510(k) is for a modification related to an optional procedure supply (atherectomy lubricant), not a software change.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "atherectomy of the peripheral vasculature and to break apart and remove thrombus for upper and lower extremity peripheral arteries." This describes a surgical procedure performed in vivo (within the body), not a test performed in vitro (outside the body) on biological samples to diagnose a condition.
- Device Description: The description details a mechanical system with a cutting tip, aspiration, and infusion capabilities designed to physically remove material from blood vessels. This is consistent with a surgical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory testing.
Therefore, the JETSTREAM System is a surgical device, specifically an atherectomy system, and not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The JETSTREAM System is intended for use in atherectomy of the the peripheral vasculature and to break apart and remove thrombus for upper and lower extremity peripheral arteries. It is not intended for use in coronary, carotic, iliac or renal vasculature.
Product codes (comma separated list FDA assigned to the subject device)
MCW, QEW
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 identical 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, keypad 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 purpose of this 510(k) is to add atherectomy lubricant as an optional procedure supply listed within the Instructions for Use (IFU). This modification applies to the entire family of JETSTREAM Systems.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vasculature, upper and lower extremity peripheral arteries
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)
Testing Summary: To demonstrate substantial equivalence of the subject JETSTREAM Systems to the predicate JETSTREAM Systems, the technological and performance characteristics were evaluated by completion of the following testing:
- System Reliability/Life Test
- Aspiration Efficiency & Crossing Time ●
- Material Liberation (Guidewire Teflon and Stainless Steel) ●
- Rotational Speed ●
- Accessory Compatibility
- Infusion & Aspiration Flow Rates ●
- Catheter Translation Over Guidewire (Aggressive Thrombus Test ● & Guidewire Challenge Blood Test)
- Catheter Aspiration Clogging Test
- Tip Cutting (Aorta Strip Test and Lumen Size Test)
- Cytotoxicity (this was done on Rotaglide alone, ViperSlide alone, Rotaglide ● exposed to the device and ViperSlide exposed to the device)
- Hemolysis (this was done on Rotaglide alone, ViperSlide alone, Rotaglide ● exposed to the device and ViperSlide exposed to the device)
- Acute Toxicity (this was done on Rotaglide alone, ViperSlide alone, Rotaglide ● exposed to the device and ViperSlide exposed to the device)
- FTIR Testing and analysis (this was done on Rotaglide alone, ViperSlide . alone, Rotaglide exposed to the device and ViperSlide exposed to the device)
The results from these tests:
- demonstrate that the technological and performance characteristics of the subject . 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 subject devices can perform in a manner equivalent to the predicate JETSTREAM Systems with the identical intended use.
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.
K122916, K120242, K111229, K110626, K101334, K101221, K093456, K092332, K091509, K082186, K081328
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
§ 870.4875 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).
0
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July27, 2020
Medrad, Inc. George Lucas Senior Regulatory Affairs Associate 8880 Evergreen Blvd. Nw Minneapolis, Minnesota 55433
Re: K133023
Trade/Device Name: JETSTREAM XC 2.4/3.4 JETSTREAM XC 2.1/3.0 JETSTREAM SC 1.85 JETSTREAM SC 1.6 Regulation Number: 21 CFR 870.4875 Regulation Name: Intraluminal artery stripper Regulatory Class: Class II Product Code: MCW, QEW
Dear George Lucas:
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 August 27, 2014. 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 W. O'connell -S Date: 2020.07.27 08:20:47 -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
1
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 27, 2014
Bayer Medical Care, Inc. Mr. George Lucas Senior Regulatory Affairs Associate 8880 Evergreen Blvd. NW Minneapolis, MN 55433-8003
Re: K133023 Trade/Device Name: Jetstream Systems Regulation Number: 21 CFR 870.4875 Regulation Name: Intraluminal Artery Stripper Regulatory Class: Class II Product Code: MCW Dated: July 21, 2014 Received: July 22, 2014
Dear Mr. Lucas,
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. 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 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
2
the quality systems (OS) 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 Industry and Consumer Education 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. 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
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 Industry and Consumer Education 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.
Kenneth J. Cavanaugh -S
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
510(k) Number (if known) K133023
Device Name
JETSTREAM® XC 2.4/3.4; JETSTREAM® XC 2.1/3.0; JETSTREAM® SC 1.85; JETSTREAM® SC 1.6
Indications for Use (Describe)
The JETSTREAM System is intended for use in atherectomy of the the peripheral vasculature and to break apart and remove thrombus for upper and lower extremity peripheral arteries. It is not intended for use in coronary, carotic, iliac or renal vasculature.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(k) SUMMARY
General Information:
| Date of Summary Preparation: | August 26, 2014 | |
|---|---|---|
| Name and Address of Manufacturer: | Bayer Medical Care Inc. | |
| 9055 Evergreen Blvd NW | ||
| Minneapolis, MN 55433-8003 | ||
| Contact Person: | George Lucas | |
| Senior Regulatory Affairs Associate | ||
| Phone: 763-717-1163 | ||
| Fax: 763-780-2227 | ||
| Device Trade Names: | JETSTREAM® XC 2.4/3.4 System | |
| JETSTREAM® XC 2.1/3.0 System | ||
| JETSTREAM® SC 1.85 System | ||
| JETSTREAM® 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 |
5
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 identical 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, keypad 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 purpose of this 510(k) is to add atherectomy lubricant as an optional procedure supply listed within the Instructions for Use (IFU). 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.
6
Substantially Equivalent Devices: Bayer Medical Care cites the following devices as the primary predicate devices for the aforementioned modification and substantial equivalence basis.
| Primary Predicate Devices | MEDRAD Predicate
510(k) |
|------------------------------|----------------------------|
| JETSTREAM® XC 2.4/3.4 System | K130637 |
| JETSTREAM® XC 2.1/3.0 System | |
| JETSTREAM® SC 1.85 System | |
| JETSTREAM® SC 1.6 System | |
However, the design rationale for and device testing of the subject devices also includes references to the additional predicate devices listed in the table below:
| Other Predicate Devices | MEDRAD/Pathway |
|---|---|
| Medical Predicate 510(k) | |
| JETSTREAM Systems (XC and SC family) | K122916 |
| 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 subject JETSTREAM Systems to the predicate JETSTREAM Systems, the technological and performance characteristics were evaluated by completion of the following testing:
- System Reliability/Life Test
- Aspiration Efficiency & Crossing Time ●
- Material Liberation (Guidewire Teflon and Stainless Steel) ●
- Rotational Speed ●
- Accessory Compatibility
- Infusion & Aspiration Flow Rates ●
- Catheter Translation Over Guidewire (Aggressive Thrombus Test ● & Guidewire Challenge Blood Test)
- Catheter Aspiration Clogging Test
- Tip Cutting (Aorta Strip Test and Lumen Size Test)
- Cytotoxicity (this was done on Rotaglide alone, ViperSlide alone, Rotaglide ● exposed to the device and ViperSlide exposed to the device)
- Hemolysis (this was done on Rotaglide alone, ViperSlide alone, Rotaglide ● exposed to the device and ViperSlide exposed to the device)
- Acute Toxicity (this was done on Rotaglide alone, ViperSlide alone, Rotaglide ● exposed to the device and ViperSlide exposed to the device)
Bayer Medical Care Inc.
7
-
FTIR Testing and analysis (this was done on Rotaglide alone, ViperSlide . alone, Rotaglide exposed to the device and ViperSlide exposed to the device)
The results from these tests: -
demonstrate that the technological and performance characteristics of the subject . 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 subject 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 subject and predicate devices support a determination of substantial equivalence, and therefore market clearance of the subject JETSTREAM Systems through this 510(k) Premarket Notification.