(29 days)
The MicroTract Access System is intended to allow the use of a .018" guidewire with a .035" or .038" guidewire compatible dilator up to 23cm in overall length.
The MicroTract Access System contains a 20 gauge Access Needle, a 0.018" Guidewire, and a Dilator Adapter. The Dilator Adapter is a sterile, single use device that is hollow and has a tapered increase in outer diameter on one end. This shape allows the Adapter to fill the excess space between .018" guidewires and dilators with larger inner diameters.
The provided text is a 510(k) summary for the MicroTract Access System, a medical device. It describes the device, its indications for use, and a summary of performance data used to demonstrate substantial equivalence to predicate devices.
However, the document does not contain the level of detail requested regarding specific acceptance criteria, study methodologies (like sample sizes for test/training sets, data provenance, expert qualifications, or adjudication methods), or outcomes of a multi-reader multi-case (MRMC) comparative effectiveness study or standalone algorithm performance.
The "Performance Data" section in the summary is very high-level and states: "The MicroTract Access System was subjected to tensile testing to demonstrate that it met ISO11070-1998 specifications for dilators. The System also underwent testing for dimensional specifications, design verification and validation including insertion forces and useability as assessed on a simulated clinical bench model."
This statement confirms that some performance testing was conducted, but it doesn't provide the detailed acceptance criteria or study results in the format requested.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer the specific questions about sample sizes, ground truth establishment, expert involvement, or MRMC studies for this device based on the information provided. The document focuses on demonstrating substantial equivalence through general performance testing rather than a detailed AI-related study or clinical trial.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 7, 2015
Arstasis, Inc. Debra Cogan Regulatory Consultant 6500 Kaiser Drive Suite 120 Fremont, CA, 94555
Re: K151877
Trade/Device Name: MicroTract Access System Regulation Number: 21 CFR 870.1310 Regulation Name: Vessel dilator for percutaneous catheterization Regulatory Class: II Product Code: DRE Dated: July 7, 2015 Received: July 9, 2015
Dear Ms. Cogan:
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 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.
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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/Resourcesfor You/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,
Bram D. Zuckerman -S
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
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SECTION 1. INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
| Trade Name: | MicroTract Access System |
|---|---|
| Common Name: | dilator, vessel, for percutaneous catheterization |
| Indications For Use: | The MicroTract Access System is intended to allow the use of a.018" guidewire with a .035" or .038" guidewire compatible dilatorup to 23cm in overall length. |
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 Center for Devices and Radiological Health (CDRH)
Page 1 of 1
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SECTION 2. 510(k) SUMMARY
| Sponsor/Submitter: | Arstasis, Inc.650 Kaiser RdFremont, CA 94555 |
|---|---|
| Contact Person: | Debra CoganRegulatory ConsultantPhone: (408) 515-0820 |
| Date of Submission: | Fax: (650) 508-1567July 7, 2015 |
| Device Trade Name: | MicroTract Access System |
| Common Name: | Dilator Adapter |
| Device Classification: | Class II |
| Regulation Number: | 21 CFR 870.1310 |
| Classification Name: | dilator, vessel, for percutaneous catheterization |
| Product Code: | DRE |
| Primary PredicateDevice: | Arstasis Dilator Adapter (K103421) |
| Secondary PredicateDevice: | AXERA RX Access System (K140287) |
| Device Description: | The MicroTract Access System contains a 20 gauge Access Needle, a0.018" Guidewire, and a Dilator Adapter. The Dilator Adapter is a sterile,single use device that is hollow and has a tapered increase in outerdiameter on one end. This shape allows the Adapter to fill the excessspace between .018" guidewires and dilators with larger inner diameters. |
| Indications for Use: | The MicroTract Access System is intended to allow the use of a .018"guidewire with a .035" or .038" guidewire compatible dilator up to 23cmin overall length. |
| TechnologicalCharacteristics | The MicroTract Dilator Adapter is a polyethylene bump extrusion that fitsinto a .035"-.038" compatible vessel dilator with an internal diametersized to 0.018" guidewire. The Access Needle is a 20 gauge diameterneedle made of stainless steel. The guidewire is 0.018" diameter made ofNitinol with a Tungsten coil. |
| Performance Data | The MicroTract Access System was subjected to tensile testing todemonstrate that it met ISO11070-1998 specifications for dilators. TheSystem also underwent testing for dimensional specifications, designverification and validation including insertion forces and useability asassessed on a simulated clinical bench model. |
| Summary ofSubstantialEquivalence: | The MicroTract Access System is substantially equivalent to the predicatedevice as confirmed through performance testing. |
§ 870.1310 Vessel dilator for percutaneous catheterization.
(a)
Identification. A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.(b)
Classification. Class II (performance standards).