(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 G3 SE and Jetstream G3 SF Systems are atherectomy catheter devices intended for use in debulking and treating vascular disease in the peripheral vasculature. The Jetstream G3 SE System is designed with expandable cutting blades; the Jetstream G3 SF System has only a fixed diameter cutter; that is, it does not incorporate the expandable blades. Separate lumens within the Catheters 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 a 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 G3 SE and G3 SF Systems each consist of two primary components: (1) a Catheter with Control Pod and (2) a Console, which are packaged separately. Each of these system components is described generally as follows:
- Catheter with Control Pod: A sterile, single-use unit consisting of an electrically driven Catheter and Control Pod. The Catheter utilizes a differentially cutting tip and includes both aspiration and infusion capabilities. The Control Pod provides a user interface with keypad controls. The unit, its electrical connectors, tubing, and aspirant collection bag are packaged in a double-pouched tray.
- PV Console: A reusable compact Console, with two (2) peristaltic pumps for aspiration and infusion, power supply, system controller, keypad interface, and LED indicators for device operational status. The Console mounts on a standard I.V. stand and remains outside the sterile field during the procedure.
This 510(k) is for the same device most recently cleared under 510(k) K093456, but with a slightly increased catheter length and decreased catheter and tip diameter to achieve a slightly smaller crossing profile. The motor gear ratio is changed and the expandable blades are eliminated from one of the device models.
The provided document is a 510(k) summary for a medical device (Jetstream G3 SE and SF Systems), which details a manufacturer's submission for regulatory clearance based on substantial equivalence to predicate devices. It focuses on engineering and performance characteristics, but does not appear to contain information related to a study with clinical acceptance criteria involving human readers or ground truth established by experts as typically found in diagnostic accuracy studies.
Therefore, many of the requested details related to clinical performance, expert adjudicated ground truth, and multi-reader multi-case studies are not available in this document.
Here's the information that can be extracted from the provided text, along with a clarification of what is not present:
1. A table of acceptance criteria and the reported device performance
The document describes several "in vitro testing" categories but does not provide specific quantitative acceptance criteria or their corresponding performance values in a direct, tabulated format. It only states that the results "demonstrate that the technological and performance characteristics...are comparable to those of the predicate devices" and "support the safety and effectiveness of the modifications".
| Test Category | Acceptance Criteria (Not Explicitly Stated as Quantitative) | Reported Device Performance (Summary) |
|---|---|---|
| Dimensional Verification | Not explicitly stated | "comparable to those of the predicate devices" |
| Catheter Burst | Not explicitly stated | "comparable to those of the predicate devices" |
| Catheter Pull | Not explicitly stated | "comparable to those of the predicate devices" |
| System Reliability/Life | Not explicitly stated | "support the safety and effectiveness" |
| Speed Drop Flexibility | Not explicitly stated | "comparable to those of the predicate devices" |
| Accessory Compatibility | Not explicitly stated | "comparable to those of the predicate devices" |
| Infusion and Aspiration Flow Rates | Not explicitly stated | "comparable to those of the predicate devices" |
| Torque to Failure | Not explicitly stated | "comparable to those of the predicate devices" |
| Catheter Trackability and Pushability | Not explicitly stated | "comparable to those of the predicate devices" |
| Aspiration Efficiency and Crossing Time | Not explicitly stated | "comparable to those of the predicate devices" |
| Heat Generation | Not explicitly stated | "comparable to those of the predicate devices" |
| Rotational Speed | Not explicitly stated | "comparable to those of the predicate devices" |
| Guidewire and Device Wear | Not explicitly stated | "comparable to those of the predicate devices" |
| Sterilization (EO) Validation | Not explicitly stated | "support the safety and effectiveness" |
| Control Pod Logic Verification | Not explicitly stated | "support the safety and effectiveness" |
| Electrical Safety | Not explicitly stated | "support the safety and effectiveness" |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document describes "in vitro testing" (bench testing) to demonstrate substantial equivalence. These are not clinical studies with "test sets" in the diagnostic performance sense.
- Sample size used for the test set: Not specified in the document for the in vitro tests.
- Data provenance: In vitro testing; no country of origin is specified for the data, nor is it described as retrospective or prospective clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable to the provided document. The submission relies on "in vitro testing" to compare performance characteristics to predicate devices, not on a clinical ground truth established by experts for diagnostic evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable to the provided document, as it does not describe clinical testing with adjudicated ground truth.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not present and not applicable to the provided document. The device is an atherectomy catheter, not a diagnostic AI system, and the submission is for substantial equivalence based on engineering and performance characteristics.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is an atherectomy catheter (a physical medical instrument), not an algorithm or AI system. The testing performed was related to the device's physical and mechanical performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the "in vitro testing," the "ground truth" would be engineering specifications and predicate device performance, against which the new device's performance was compared. This is not clinical expert consensus, pathology, or outcomes data.
8. The sample size for the training set
This information is not applicable as the document describes performance testing of a physical medical device, not the training of a machine learning algorithm.
9. How the ground truth for the training set was established
This information is not applicable for the same reason as above (not an algorithm or AI system).
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for Pathway Medical Technologies. The logo consists of a black circle with a white, stylized mountain range inside of it. To the right of the circle, the word "PATHWAY" is written in large, sans-serif font, and below that, the words "MEDICAL TECHNOLOGIES" are written in a smaller, sans-serif font.
JUN 1 1 2010
510(k) SUMMARY
General Information: Date of Summary Preparation:
June 4, 2010
Name and Address of Manufacturer:
Pathway Medical Technologies, Inc. 10801 120th Ave NE Kirkland, Washington 98033
Contact Person:
Trade Name:
Common Name:
Regulation Number:
Regulation Name:
Regulatory Class:
Classification Panel:
Product Code:
Cyndy Adams Regulatory Affairs Sr. Manager Phone: 425-636-4047 Fax: 425-636-4001
Jetstream G3TM SE System Jetstream G3TM SF System
Peripheral Atherectomy Catheter
21 CFR 870.4875
Intraluminal Artery Stripper
Class II
Cardiovascular
MCW
{1}------------------------------------------------
Performance Standards: Performance standards do not currently exist for these devices. None are established under Section 514.
Device Description: The Jetstream G3 SE and Jetstream G3 SF Systems are atherectomy catheter devices intended for use in debulking and treating vascular disease in the peripheral vasculature. The Jetstream G3 SE System is designed with expandable cutting blades; the Jetstream G3 SF System has only a fixed diameter cutter; that is, it does not incorporate the expandable blades. Separate lumens within the Catheters 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 a 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 G3 SE and G3 SF Systems each consist of two primary components: (1) a Catheter with Control Pod and (2) a Console, which are packaged separately. Each of these system components is described generally as follows:
- Catheter with Control Pod: A sterile, single-use unit consisting of an . electrically driven Catheter and Control Pod. The Catheter utilizes a differentially cutting tip and includes both aspiration and infusion capabilities. The Control Pod provides a user interface with keypad controls. The unit, its electrical connectors, tubing, and aspirant collection bag are packaged in a double-pouched tray.
- . PV Console: A reusable compact Console, with two (2) peristaltic pumps for aspiration and infusion, power supply, system controller, keypad interface, and LED indicators for device operational status. The Console mounts on a standard I.V. stand and remains outside the sterile field during the procedure.
This 510(k) is for the same device most recently cleared under 510(k) K093456, but with a slightly increased catheter length and decreased catheter and tip diameter to achieve a slightly smaller crossing profile. The motor gear ratio is changed and the expandable blades are eliminated from one of the device models.
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.
Substantially Equivalent Devices: Pathway Medical cites the following as substantially equivalent predicate devices:
- · Jetstream G3TM System (K100462)
- · Jetstream G3TM System (K093456)
- · Jetstream G3TM System (K092332)
- · Jetstream G2TM NXT System (K091509)
{2}------------------------------------------------
Testing Summary: To demonstrate substantial equivalence of the Jetstream G3 SE and Jetstream G3 SF Systems with the predicate devices, the technological and performance characteristics were evaluated using in vitro testing as outlined below:
- . Dimensional Verification
- Catheter Burst .
- . Catheter Pull
- System Reliability/Life .
- Speed Drop Flexibility .
- Accessory Compatibility .
- Infusion and Aspiration Flow Rates .
- . Torque to Failure
- Catheter Trackability and Pushability .
- Aspiration Efficiency and Crossing Time ◆
- Heat Generation .
- Rotational Speed .
- Guidewire and Device Wear .
- Sterilization (EO) Validation .
- Control Pod Logic Verification .
- Electrical Safety .
The results from these tests:
- demonstrate that the technological and performance characteristics of the . ﺮ Jetstream G3 SE and Jetstream G3 SF Systems are comparable to those of the predicate devices.
- . support the safety and effectiveness of the modifications that are the subject of this 510(k), and
- ensure the modified devices can perform equivalently to the listed predicate . devices, which have the identical intended use.
Conclusion (Statement of Equivalence): The data and information presented within this submission and the similarities between the modified and predicate devices, support the substantial equivalence of the Jetstream G3 SE and Jetstream G3 SF Systems to the specified predicate devices. The devices have identical indications for use and equivalent technological characteristics. Bench testing supports the safety and effectiveness of the modifications that were the subject of this 510(k).
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a bird-like figure, which is the department's official emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
JUN 1 1 2010
Pathway Medical Technologies, Inc. c/o Mr. Brian Cleary Vice President of Clinical and Regulatory Affairs 10801 120th Ave NE Kirkland, WA 98033
Re: K101334
Trade/Device Name: Jetstream G3 SE & SF Systems Regulation Number: 21 CFR 870.4875 Regulation Name: Intraluminal Artery Stripper Regulatory Class: Class II (two) Product Code: MCW Dated: May 11, 2010 Received: May 12, 2010 Amended: June 4, 2010
Dear Mr. Cleary:
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. Iisting 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.
{4}------------------------------------------------
Page 2 -- Mr. Brian Cleary
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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,
W. Ward
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
510(k) Number (if known): K101334
Device Names: Jetstream G3TM SE System Jetstream G3TM SF 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, illiac 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)
W. Mac.
(Division Sign-Off) Division of Cardiovascular Devi
510(k) Number
Page of
§ 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).