(100 days)
Not Found
No
The summary describes a mechanical device for vascular access and hemostasis, with no mention of AI, ML, image processing, or data-driven decision making. The performance studies focus on mechanical properties and clinical outcomes, not algorithmic performance.
Yes
The device is intended to provide access for the percutaneous introduction of devices and to promote hemostasis, which describes a medical intervention to treat or manage a physiological condition.
No
The device is described as an access system for percutaneous introduction of devices and to promote hemostasis during femoral artery catheterization procedures. It facilitates a diagnostic procedure but is not itself performing a diagnostic function.
No
The device description explicitly states it is comprised of physical components (latchwire, anchor mechanism, shaft, handle) and the performance studies involve bench testing of these physical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device used for the percutaneous introduction of devices into the peripheral vasculature and to promote hemostasis. This is a surgical/interventional procedure performed directly on the patient's body.
- Device Description: The device is described as a physical system with mechanical components (latchwire, anchor mechanism, shaft, handle). This is consistent with a surgical or interventional device.
- 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, etc.) to provide information for diagnosis, monitoring, or compatibility testing. The device's function is entirely focused on accessing and managing the vascular system in vivo.
IVD devices are used outside the body to analyze biological samples. This device is used inside the body during a medical procedure.
N/A
Intended Use / Indications for Use
The System is intended to provide access for the percutaneous introduction of devices into the peripheral vasculature and to promote hemostasis at the arteriotomy site as an adjunct to manual compression. The System is indicated for use in patients undergoing diagnostic femoral artery catheterization procedures using 5F or 6F introducer sheaths.
Product codes
DYB
Device Description
Arstasisone is a device that is comprised of a latchwire, anchor mechanism, shaft and handle with control features.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vasculature, femoral artery
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)
Bench testing was performed on the Latchwire Device following sterilization of test units. Parameters tested include functionality testing, deployment forces, corrosion resistance, compression and torque loading, flexibility and tensile strength. Tensile testing for the 19 gauge Access Needle was performed following gamma radiation. Arstasisone met all performance testing acceptance criteria.
Additional prior testing included biocompatibility testing pursuant to ISO-10993-1, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing (1995), preliminary animal studies (non-GLP) and cadaver assessments, as well as clinical investigations. Multiple clinical evaluations were conducted. The short term safety and clinical performance of the device were established. The long term safety, as well as the ability to access and re-access, was retrospectively studied in a smaller cohort of patients.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Arstasisone Access System (K102728)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).
0
K103143 page 1 of 2
ત્વદ્યકાર
Special 510(k): Device Modification
FEB - 2 2011
APPENDIX A: 510(k) SUMMARY
| Sponsor/Submitter: | Arstasis, Inc.
1021 Howard Avenue, Suite C
San Carlos, CA 94070 |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Debra Cogan
Director, Regulatory & Clinical Affairs
Phone: (650) 508-1549 x273
Fax: (650) 594-4326 |
| Date of Submission: | October 22, 2010 |
| Device Trade Name: | Arstasisone Latchwire Access System |
| Common Name: | Catheter Introducer |
| Device Classification: | Class II |
| Regulation Number: | 21 CFR 870.1340 |
| Classification Name: | Catheter Introducer |
| Product Code: | DYB |
| Predicate Device: | Arstasisone Access System (K102728) |
| Device Description: | Arstasisone is a device that is comprised of a latchwire, anchor
mechanism, shaft and handle with control features. |
| Indications for Use: | The System is intended to provide access for the percutaneous
introduction of devices into the peripheral vasculature and to
promote hemostasis at the arteriotomy site as an adjunct to manual
compression. The System is indicated for use in patients
undergoing diagnostic femoral artery catheterization procedures
using 5F or 6F introducer sheaths. |
| Technological
Characteristics | Arstasisone Latchwire device is designed to create a shallow access
path through the arterial wall for the guidewire to enter the vessel
lumen. |
| Performance Data | Arstasisone met all performance testing acceptance criteria. |
| Summary of
Substantial
Equivalence: | Bench testing was performed on the Latchwire Device following
sterilization of test units. Parameters tested include functionality
testing, deployment forces, corrosion resistance, compression and
torque loading, flexibility and tensile strength.
Tensile testing for the 19 gauge Access Needle was performed
following gamma radiation. |
CONFIDENTIAL
1
Special 510(k): Device Modification
Additional prior testing included biocompatibility testing pursuant to ISO-10993-1, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing (1995), preliminary animal studies (non-GLP) and cadaver assessments, as well as clinical investigations.1 Multiple clinical evaluations were conducted. The short term safety and clinical performance of the device were established. The long term safety, as well as the ability to access and re-access, was retrospectively studied in a smaller cohort of patients.
In summary, the cumulative data provided herein demonstrates that the Arstasis " Latchwire Access System is substantially equivalent to its predicate in providing access to the arterial lumen and facilitating the introduction and placement of devices into the peripheral vasculature and achievement of hemostasis.
1 The preliminary Animal Studies and Cadaver Assessments were conducted using prototypes of a similar design and configuration.
2
Image /page/2/Picture/11 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and features an abstract eagle design in the center. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged around the perimeter of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002
Arstasis, Inc. c/o Debra Cogan Director, Regulatory & Clinical Affairs 740 Bay Rd Redwood City, CA 94063
FEB - 2 201
.
Re: K103143
Trade/Device Name: Arstasis °°° Latchwire Access System Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter introducer Regulatory Class: Class II (two) Product Code: DYB Dated: January 25, 2011 Received: January 26, 2011
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.
:
.
3
Page 2 – Ms. Debra Cogan
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/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/ReportalProblem/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/Resourcesfor You/Industry/default.htm.
Sincerely yours
Bram D. Zuckerman, M.D.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
APPENDIX B: INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Trade Name:
Arstasisone Latchwire Access System
Common Name:
Indications For Use:
Arstasis
Latchwire Access Syste
Catheter Introducer
The System is intended to provide access for the percutaneous introduction of devices into the peripheral vasculature and to promote hemostasis at the arteriotomy site as an adjunct to manual compression. The System is indicated for use in patients undergoing diagnostic femoral artery catheterization procedures using 5F or 6F introducer sheaths.
Prescription Use (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 OF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| -------------------------------------------------------- |
(Division Sign-Off)
Page of
vision Sign Off) 510(k) Number
(Posted November 13, 2003)
CONFIDENTIAL