(29 days)
Not Found
No
The description focuses on mechanical components and their function in facilitating guidewire use, with no mention of AI/ML terms or capabilities.
No.
The device is an access system intended to facilitate the use of specific guidewires and dilators, not to treat a disease or condition itself. It's a tool for procedural access, not a therapeutic intervention.
No
The device description and intended use indicate it is an access system designed to facilitate the use of guidewires and dilators, which are interventional tools, not diagnostic ones. The performance studies focus on mechanical specifications (tensile testing, dimensional specifications, insertion forces, usability), not diagnostic accuracy.
No
The device description explicitly lists physical components: a 20 gauge Access Needle, a 0.018" Guidewire, and a Dilator Adapter. This indicates it is a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a system for accessing a body lumen using guidewires and dilators. This is a procedure performed in vivo (within the body) for medical intervention.
- Device Description: The components (needle, guidewire, dilator adapter) are all tools used for accessing and navigating within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or treatment.
IVD devices are specifically designed to be used in vitro (outside the body) to analyze biological samples. This device is clearly intended for use in vivo.
N/A
Intended Use / 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 23cm in overall length.
Product codes (comma separated list FDA assigned to the subject device)
DRE
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
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.
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.
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
§ 870.1310 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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are rendered in a dark color, creating a sense of depth and unity. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
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.
1
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
2
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 dilator | |
| up 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
3
SECTION 2. 510(k) SUMMARY
| Sponsor/Submitter: | Arstasis, Inc.
650 Kaiser Rd
Fremont, CA 94555 |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Debra Cogan
Regulatory Consultant
Phone: (408) 515-0820 |
| Date of Submission: | Fax: (650) 508-1567
July 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 Predicate
Device: | Arstasis Dilator Adapter (K103421) |
| Secondary Predicate
Device: | AXERA RX Access System (K140287) |
| Device Description: | 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. |
| 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 23cm
in overall length. |
| Technological
Characteristics | The MicroTract Dilator Adapter is a polyethylene bump extrusion that fits
into a .035"-.038" compatible vessel dilator with an internal diameter
sized to 0.018" guidewire. The Access Needle is a 20 gauge diameter
needle made of stainless steel. The guidewire is 0.018" diameter made of
Nitinol with a Tungsten coil. |
| Performance Data | 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. |
| Summary of
Substantial
Equivalence: | The MicroTract Access System is substantially equivalent to the predicate
device as confirmed through performance testing. |