(33 days)
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on mechanical aspiration and catheter technology, with no mention of AI/ML components or functions.
Yes
The device is indicated for the removal of fresh soft emboli and thrombi from vessels in the peripheral vasculature, which is a therapeutic intervention.
No
The device is described as a "Mechanical Thrombectomy System 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 explicitly states it includes a physical aspirator and catheter, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states the device is a "Mechanical Thrombectomy System and Aspirator" intended for the "removal of fresh soft emboli and thrombi from vessels in the peripheral vasculature." This is a therapeutic procedure performed directly on the patient's body, not a diagnostic test performed on a sample outside the body.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, reagents, or diagnostic results.
Therefore, the Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspirator is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspirator is indicated for the removal of fresh soft emboli and thrombi from vessels in the peripheral vasculature.
Product codes (comma separated list FDA assigned to the subject device)
QEZ
Device Description
The Subject Device includes (1) Aspire Aspirator and (1) MAX 7F - 11F Catheter. Subject Device and the Predicate are single-use, sterile, and short-term use medical devices designed to remove fresh soft emboli, debris, and thrombi from the peripheral vasculature.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vasculature
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)
Non-clinical testing in this Submission confirms the Subject Device passes simulated use tracking. simulated aspiration, and simulated thrombectomy in the peripheral vasculature with test units accelerated aged up to 3-years. Accordingly, non-clinical testing confirms the Subject Device meets specifications, intended use, demonstration of claims, and equivalence to Predicate.
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.
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). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
May 4, 2020
Control Medical Technology Shawn Fojtik President 2757 South 300 West Suite F Salt Lake City, Utah 84115
Re: K200871
Trade/Device Name: Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire Mechanical Aspirator
Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEZ Dated: March 25, 2020 Received: April 1, 2020
Dear Mr. Fojtik:
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. 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 located 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.
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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).
Sincerely,
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
2
Indications for Use
510(k) Number (if known) K200871
Device Name
Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire Mechanical Aspirator
Indications for Use (Describe)
The Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspirator is indicated for the removal of fresh soft emboli and thrombi from vessels in the peripheral vasculature.
| 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) |
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3
510(k) Summary - K200871
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 is provided.
Date Summary was Prepared
April 29, 2020
Submitter
Control Medical Technology ("Submitter") 2757 South 300 West Salt Lake City, Utah 84115 USA Phone (383) 444-2666
FDA Establishment Registration Number
3007282893
Contact
Control Medical Technology 2757 South 300 West Salt Lake City, Utah 84115 USA Shawn Fojtik Phone (383) 444-2666
Device Information
| Trade Names: | Aspire MAX 7 - 11F Mechanical Thrombectomy System an
Aspire Mechanical Aspirator |
|----------------------|-------------------------------------------------------------------------------------|
| Common Name: | Thrombectomy catheter and/or embolectomy catheter |
| Classification Name: | Embolectomy catheter |
| Product Code: | QEZ |
| Regulation: | Class II, 21 CFR 870.5150 |
Predicate Device
The Subject Device is substantially equivalent to the legally marketed Aspire MAX 5 - 6F Mechanical Thrombectomy System ("Predicate Device(s)").
| Trade Names: | Aspire MAX 5 – 6F Mechanical Thrombectomy System™ |
|---|---|
| K113757 February 22, 2012. | |
| Common Name: | Thrombectomy catheter and/or embolectomy catheter |
| Classification Name: | Embolectomy catheter |
| Product Code: | DXE |
| Regulation: | Class II, 21 CFR 870.5150 |
Reference Devices
The Subject Device references the Vascular Solutions Pronto XL 8 - 14F Thrombectomy System ("Reference K112571") and the Heraeus DuraSheath K181463 ("Reference K181463"). Reference K112571 is referenced because it is available with 8F - 14F outer diameter components and used for thrombectomy in peripheral vasculature same as the Subject Devices. Reference K181463 is
4
referenced as the catheter components in the Subject Device are the same outer dimensions, design, and indicated for use in the peripheral vasculature.
| Trade Names: | Pronto XL 8 – 14F Thrombectomy System K112571
September 27, 2011 |
|----------------------|---------------------------------------------------------------------|
| Common Name: | Thrombectomy catheter and/or embolectomy catheter |
| Classification Name: | Embolectomy catheter |
| Product Code: | DXE |
| Regulation: | Class II, 21 CFR 870.5150 |
| Trade Names: | Heraeus DuraSheath K181463 December 13, 2018 |
| Common Name: | Catheter or Sheath |
| Classification Name: | Introducer, Catheter |
| Product Code: | DYB and DRE |
| Regulation: | Class II, 21 CFR 870.1340 |
Device Description
The Subject Device includes (1) Aspire Aspirator and (1) MAX 7F - 11F Catheter. Subject Device and the Predicate are single-use, sterile, and short-term use medical devices designed to remove fresh soft emboli, debris, and thrombi from the peripheral vasculature.
Image /page/4/Figure/6 description: The image shows two medical devices, the Aspire Aspirator and the MAX 5-6F Catheter Component. The Aspire Aspirator is a handheld device with a handle and a clear cylinder. The MAX 5-6F Catheter Component is a long, thin tube with a Luer Hub at one end and a Marker Band at the other, with a length of 55 to 135cm and an outer diameter of 5F to 6F.
The Subject Device's Intended Use and Fundamental Scientific Principle are the same as the Predicate. The Predicate and Subject Device are the same in the way they are inserted into the body over a guidewire and advanced to the target arterial or venous peripheral vascular anatomy. The Subject Device and Predicate share the same core Aspirator to create thrombectomy force. MAX 7 - 11F Catheters may be connected to basic syringes and other aspiration pumps. Aspire Mechanical Aspirators may be connected to other catheters. The Subject Device does not add any new materials or manufacturing processes to the manufacturing process.
Image /page/4/Figure/8 description: The image shows the Aspire Aspirator and the MAX 7-11F Catheter Component. The Aspire Aspirator is labeled with K072299, K113757, and K131998. The catheter component has a Luer Hub and a Marker Band, and the catheter is 60 to 90 cm long and 7F to 11F OD.
Indication for Use
Indication: The Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire Mechanical Aspirator are indicated for the removal of fresh soft emboli from vessels in the peripheral vasculature. The indication and intended use are same as and substantially equivalent to the Predicate and same as other thrombectomy systems legally marketed under the DXE and QEZ product codes.
5
Predicate Comparison
| Predicate Device K113757 | Subject Device K200871 | Comments | |
|---|---|---|---|
| Device Name | Embolectomy Catheter | Embolectomy Catheter | Same as Predicate. |
| Committee | Cardiovascular | Cardiovascular | Same as Predicate. |
| FDA Product | |||
| Code | DXE | QEZ | Subject Device product code |
| updated per new FDA | |||
| thrombectomy device product | |||
| codes. | |||
| Catheter | |||
| Component | |||
| Materials | Multi-layer nylon Pebax shaft, | ||
| stainless steel wire braid, and | |||
| PTFE liner. | Multi-layer nylon Pebax shaft, | ||
| stainless steel wire coil, and | |||
| PTFE liner with thermoplastic | |||
| elastomers TPE dilator. | Subject Device and Predicate | ||
| materials are common multi-layer | |||
| catheter, metal, and liner designs. | |||
| Catheter | |||
| Component | |||
| Outer Diameters | 5F and 6F | 7F, 8F, 9F, 10F, 11F | Subject Device outer diameters |
| are larger than the Predicate | |||
| K113757, same as Reference | |||
| K181463, and smaller in outer | |||
| diameter than the largest | |||
| Reference K112571. Catheters | |||
| with outer diameters up to 14F lik | |||
| Reference K112571 are used for | |||
| thrombectomy in peripheral | |||
| vasculature. | |||
| Catheter | |||
| Component | |||
| Lengths | 55 - 135cm | 60 - 90cm | Subject Device is catheter |
| component lengths are in between | |||
| Predicate K113757 shortest and | |||
| longest catheter component | |||
| lengths. | |||
| Indication for Use | The Aspire MAX 5 – 6F | ||
| Mechanical Thrombectomy | |||
| System and Aspire Mechanical | |||
| Aspirator are indicated for the | |||
| removal of fresh soft emboli | |||
| and thrombi from vessels in | |||
| the peripheral vasculature. | The Aspire MAX 7 – 11F | ||
| Mechanical Thrombectomy | |||
| System and Aspire Mechanical | |||
| Aspirator are indicated for the | |||
| removal of fresh soft emboli | |||
| and thrombi from vessels in | |||
| the peripheral vasculature. | Subject Device is the same | ||
| indication of use as the Predicate | |||
| K113757. | |||
| Packaging | |||
| Materials | Tray, Tyvek Lid, and Box | ||
| commonly used with | |||
| interventional devices. | Tray, Tyvek Lid, and Box | ||
| commonly used with | |||
| interventional devices. | Same as Predicate. | ||
| Sterilization | Ethylene Oxide Validated in | ||
| accordance with | |||
| ANSI/AAMI/ISO 11135-1 to | |||
| achieve SAL 10-6 | Ethylene Oxide Validated in | ||
| accordance with | |||
| ANSI/AAMI/ISO 11135-1 to | |||
| achieve SAL 10-6 | Same as Predicate. | ||
| Use | Single-use, disposable | Single-use, disposable | Same as Predicate. |
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The Subiect Device is substantially equivalent to Predicate device used to remove fresh, soft thrombi/emboli from the peripheral vasculature. Substantial equivalence is based on equivalence in:
Science Fundamental Scientific Principle
| Device Construction
Design
Function | Mechanism of Action
Manufacturing |
|---------------------------------------------------|--------------------------------------|
| Device Performance
Aspiration | Single-use, disposable |
| Labeling
Indication for Use
Warnings | Instructions for Use
Box labels |
| Manufacturing
Biocompatibility | Sterilization |
Non-Clinical Testing
Non-clinical testing in this Submission confirms the Subject Device passes simulated use tracking. simulated aspiration, and simulated thrombectomy in the peripheral vasculature with test units accelerated aged up to 3-years. Accordingly, non-clinical testing confirms the Subject Device meets specifications, intended use, demonstration of claims, and equivalence to Predicate.
Clinical testing
Clinical testing is not required for the determination of substantial equivalence.
Statement of Substantial Equivalence
The Subject Device is substantially equivalent to the legally marketed Predicate based on comparison of the device classification, fundamental scientific technology, basic operating principle, indication for use, technical characteristics, packaging, and sterilization methods.
Conclusion
The Subject Device is substantially equivalent to the currently marketed Predicate based on comparison of the device classification, fundamental scientific technology, basic operating principle, indication for use, technical characteristics, packaging, and sterilization methods. Testing confirms the suitability of Subject Device for its intended use.