(151 days)
Not Found
No
The device description and performance studies focus on mechanical aspiration and standard catheter components, with no mention of AI/ML or related concepts.
Yes
The device is indicated for "removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature," which directly treats a medical condition.
No.
The device is an Aspiration Catheter and Aspirator indicated for the removal of fresh, soft emboli and thrombi, which is a therapeutic function, not a diagnostic one.
No
The device description clearly outlines physical components like catheters, aspirators, and syringes, and the testing performed is focused on the physical properties and performance of these hardware components. There is no mention of software as a component or its function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature. This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device is a catheter and aspirator designed for physical removal of material from within blood vessels.
- Mechanism of Action: The device works by physically aspirating (sucking out) the emboli and thrombi.
- Lack of In Vitro Testing: The device is not used to test samples (like blood, tissue, etc.) outside of the body to provide diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used for direct intervention and removal of material from within the body.
N/A
Intended Use / Indications for Use
The Aspire RX-LP6 Aspiration Catheter and Aspirator are indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature.
Product codes (comma separated list FDA assigned to the subject device)
QEZ, DXE
Device Description
An "Aspire RX-LP6 Aspiration Catheter" includes (1) RX-LP6 Aspiration Catheter and (1) Aspire Aspirator 30ml.
- Aspire RX-LP6 Aspiration Catheters (RX-LP6 Aspiration Catheter and Aspire Aspirator): 6F -Guide Cath compatible rapid exchange catheter with 4.8mm long distal aspiration opening, 1.0mm wide distal and 1.1mm wide proximal aspiration lumen, 0.054" outer diameter (OD) single lumen aspiration shaft, and removable stylet.
- Aspire Aspirator 30ml. -
Aspire RX-LP6 Aspiration Catheters are single-use, sterile, short-term use, and non-pyrogenic medical devices designed for use with piston syringes to remove fresh, soft emboli and thrombi from the peripheral and coronary vasculature. The Aspire RX-LP6 Aspiration Catheter operating and scientific principle is the same as predicate devices. The catheter is inserted into the body over a guidewire and through a sheath or guide catheter to the target anatomy. A syringe is then connected to the catheter and the aspiration is manually created with the syringe.
Similar to predicate devices, industry standard intravascular catheter components and materials are used:
- -Clear proximal polycarbonate female luer lock,
- Stainless steel core wire. -
- Clear Main Shafts, -
- Embedded platinum iridium radiopaque marker, -
- Clear polycarbonate barrel piston syringe. -
Aspire RX-LP6 Aspiration Catheters do not add any new materials, or manufacturing processes to the manufacturing process.
Same as predicates, all RX-LP6 Aspiration Catheters may be connected to piston syringes including the Aspire Mechanical Aspirator. Aspirators may be connected to other catheters to aspirate fluids and thrombus.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessels in the coronary and peripheral vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Aspire RX-LP6 Aspiration Catheters are single-use devices intended for use by physician's experienced and trained in diagnostic and interventional procedures.
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)
Non-Clinical Testing:
- A. General: Visual and surface inspection; Corrosion resistance testing; Dimensional inspection.
- B. Integrity and compatibility: Guidewire compatibility testing; Catheter radiopacity testing; Catheter force at break catheter tensile strength integrity testing; Catheter force at break bonds tensile strength integrity testing; Catheter kink testing; Catheter torque testing; Catheter tracking simulated anatomy testing as part of aspiration testing.
- C. Aspiration testing: RX-LP6 Aspiration Catheters and predicates with low viscosity aspirants; RX-LP6 Aspiration Catheters and predicates with high viscosity aspirants; Blood aspiration; Thrombus aspiration; In-vivo aspiration.
- D. Biocompatibility: Cytotoxicity Minimal Essential Media (MDM) Elution ANSI/AAMI/ISO -10993-5; Acute Systemic Toxicity ISO 10993-11; Pyrogen Material Mediated USP ; LAL Endotoxin Test USP ; Intracutaneous Reactivity ISO 10993-10; Maximization Sensitization Test ISO 10993-10; Hemocompatibility Hemolysis ASTM Direct Contact ISO 10993-4.
- E. Particulate: Validated particulate testing confirmed subject devices passed with scores significantly below an established minimum national standard.
Subject devices passed all biocompatible tests.
Non-clinical testing confirms the Aspire RX-LP6 Aspiration Catheters and Aspirator passes all testing and meets specifications. Specific tests confirm functionality in the intended use, safety, demonstration of claims, and equivalence to predicate devices plus compliance with ISO recognized standards.
Clinical testing: Not applicable.
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.
Xpress-Way RX Catheter K121301, Export XT Aspiration Catheters K061958, Pronto V3 Aspiration Catheter K063371
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.
Not Found
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
§ 870.5150 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 the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two parts: the Department of Health and Human Services logo on the left and the FDA acronym and full name on the right. The Department of Health and Human Services logo is a stylized representation of a human figure, while the FDA acronym and full name are written in blue, with the acronym in a blue square.
July 27, 2020
Control Medical Technology, LLC % Mark Job Third Party Official Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114
Re: K131998
Trade/Device Name: Aspire Rx-LP6 Aspiration Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEZ
Dear Mark Job:
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 November 26, 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
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
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized depiction of three human profiles facing to the right, layered on top of each other. The profiles are rendered in a simple, flowing line style.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 26, 2013
Control Medical Technology, LLC c/o Regulatory Technology Services, LLC Mr. Mark Job 1394 25th Street, NW Buffalo, MN 55313
Re: K131998
Trade/Device Name: ASPIRE RX-LP6 Aspiration Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: DXE Dated: October 29, 2013 Received: October 30, 2013
Dear Mr. Job:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
2
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/Resourcesfor You/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,
M.A. Hillebrand
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
4. Indication for Use Statement
510(k) Number: K131998
Device Name: Aspire RX-LP6 Aspiration Catheter
Indications for Use:
The Aspire RX-LP6 Aspiration Catheter and Aspirator are indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
M.A. Hillebrand
4
5. 510(k) Summary
In accordance with the Safe Medical Devices Act (SMDA) of 1990 and Title of the Code of Federal Regulations Part 807 (21 CFR $807), and in particular $807.92, the following summary of safety and effectiveness information is provided.
Date Summary was Prepared
November 19, 2013
Submitter
Control Medical Technology 136 Heber Avenue, Suite 101 PO Box 681013 Park City, UT 84068 Phone (954) 534-9345
FDA Establishment Registration Number
3007282893
Contact
President Control Medical Technology 136 Heber Avenue, Suite 101 PO Box 681013 Park City, UT 84068 Phone (954) 534-9345
Device Information
| Trade Name: | Aspire RX-LP6 Aspiration Catheter |
|---|---|
| Common Name: | Embolectomy or aspiration catheter and aspirator |
| Classification Name: | Embolectomy catheter |
| Product Code: | DXE |
| Regulation: | Class II, 21 CFR 870.5150 |
Predicate Devices
Aspire RX-LP6 Aspiration Catheters are substantially equivalent to the Medtronic Export Aspiration Catheters, Vascular Solutions Pronto Extraction Catheters, Lumen - Volcano Xtract Aspiration Catheters, and other predicate devices.
| Trade Names: | Xpress-Way RX Catheter K121301 July 30, 2012 |
|---|---|
| Export XT Aspiration Catheters K061958 September 5, 2006 | |
| Pronto V3 Aspiration Catheter K063371 Mar 30, 2009 | |
| Common Name: | Embolectomy or aspiration catheter and piston syringe |
| Classification Name: | Embolectomy catheter |
| Product Code: | DXE |
| Regulation: | Class II, 21 CFR 870.5150 |
5
Device Description
An "Aspire RX-LP6 Aspiration Catheter" includes (1) RX-LP6 Aspiration Catheter and (1) Aspire Aspirator 30ml.
- Aspire RX-LP6 Aspiration Catheters (RX-LP6 Aspiration Catheter and Aspire Aspirator): 6F -Guide Cath compatible rapid exchange catheter with 4.8mm long distal aspiration opening, 1.0mm wide distal and 1.1mm wide proximal aspiration lumen, 0.054" outer diameter (OD) single lumen aspiration shaft, and removable stylet.
- Aspire Aspirator 30ml. -
Aspire RX-LP6 Aspiration Catheters are single-use, sterile, short-term use, and non-pyrogenic medical devices designed for use with piston syringes to remove fresh, soft emboli and thrombi from the peripheral and coronary vasculature. The Aspire RX-LP6 Aspiration Catheter operating and scientific principle is the same as predicate devices. The catheter is inserted into the body over a guidewire and through a sheath or guide catheter to the target anatomy. A syringe is then connected to the catheter and the aspiration is manually created with the syringe.
Similar to predicate devices, industry standard intravascular catheter components and materials are used:
- -Clear proximal polycarbonate female luer lock,
- Stainless steel core wire. -
- Clear Main Shafts, -
- Embedded platinum iridium radiopaque marker, -
- Clear polycarbonate barrel piston syringe. -
Aspire RX-LP6 Aspiration Catheters do not add any new materials, or manufacturing processes to the manufacturing process.
Same as predicates, all RX-LP6 Aspiration Catheters may be connected to piston syringes including the Aspire Mechanical Aspirator. Aspirators may be connected to other catheters to aspirate fluids and thrombus.
Indications, Intended Use and Contraindications
Indication: "The Aspire RX-LP6 Aspiration Catheter and Aspirator are indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature."
Intended Use: Aspire RX-LP6 Aspiration Catheters are single-use devices intended for use by physician's experienced and trained in diagnostic and interventional procedures. Techniques for placement of vascular sheaths, catheters, and guidewires may be used.
Contraindications: "The RX-LP6 Aspiration Catheter is contraindicated in: vessels -
- -LAL Endotoxin Test USP
- Intracutaneous Reactivity ISO 10993-10 -
- -Maximization Sensitization Test ISO 10993-10
- Hemocompatibility Hemolysis ASTM Direct Contact ISO 10993-4 -
Subject devices passed all biocompatible tests.
- E. Particulate: Validated particulate testing confirmed subject devices passed with scores significantly below an established minimum national standard.
8
Clinical testing
Not applicable.
Statement of Equivalence
Aspire RX-LP6 Aspiration Catheters are substantially equivalent to the currently marketed Pronto. Export, and Xpress-Way aspiration systems based on comparison of the device classification, basic operating principle, indication for use, intended use, technical characteristics, packaging, and sterilization methods.
Conclusion
Aspire RX-LP6 Aspiration Catheters are substantially equivalent to the currently marketed Pronto. Export, and Xtract catheters based on comparison of the device classification, basic operating principle, indication for use, intended use, technical characteristics, packaging, and sterilization methods. Testing confirms the suitability of Aspiration Catheters and Aspirator for its intended use.
The conclusions drawn from the nonclinical tests that demonstrate that Aspire RX-LP6 Aspiration Catheters is as safe, as effective, and performs at least as safely and effectively as the legally marketed device identified as predicated devices in this section.