(26 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts, and the device description and performance studies focus on mechanical and biological aspects.
No
A therapeutic device is used to treat or cure a disease or medical condition. This device is primarily for providing access and promoting hemostasis, which are supportive functions for diagnostic procedures, not therapeutic treatment of a disease.
No
The device is an access system for introducing other devices and promoting hemostasis. While it is indicated for use in "diagnostic femoral artery catheterization procedures," the device itself does not perform diagnostics; it facilitates the procedure where diagnostics might occur.
No
The device description explicitly states it is comprised of physical components like a sheath, anchor mechanism, shaft, and handle, indicating it is a hardware 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 clearly describes a device used in vivo (within the body) for accessing the peripheral vasculature and promoting hemostasis. IVD devices are used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description of the device components (sheath, anchor mechanism, shaft, handle) is consistent with an invasive medical device used within the body, not a laboratory instrument or reagent used for testing specimens.
- Anatomical Site: The mention of "peripheral vasculature" and "femoral artery" confirms the device's use within the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, using reagents, or providing diagnostic information based on laboratory testing.
Therefore, the Arstasis Access System is a medical device used for interventional procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Arstasisone Access 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 Arstasisone Access System is indicated for use in patients undergoing diagnostic femoral artery catheterization procedures using 5F or 6F introducer sheaths.
Product codes (comma separated list FDA assigned to the subject device)
DYB
Device Description
Arstasisone is a device that is comprised of a sheath, 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 subject device as follows: functionality, deployment and release forces, flexibility, torque loading as well as tensile, compressive and torque strengths. Biocompatibility testing was successfully conducted pursuant to ISO-10993-1, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing (1995). Prior testing included 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 reaccess, was retrospectively studied in a smaller cohort of patients.
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
§ 870.1340 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
Arstasis
... ... ... ... ... ... ... ..................................................................................................................................................
KOOKIS
510(k) SUMMARY
·
| Sponsor/Submitter: | Arstasis, Inc.
1021 Howard Avenue, Suite C
San Carlos, CA 94070 | MAR 3 0 2010 |
|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Contact Person: | Su-Mien Chong
Acting VP, Regulatory & Clinical Affairs
Phone: (650) 704-1632
Fax: (650) 594-4326 | |
| Date of Submission: | March 3, 2010 | |
| Device Trade Name: | Arstasisone 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: | Arstasis ITG Vascular Access System (K091006) | |
| Device Description: | Arstasisone is a device that is comprised of a sheath, anchor mechanism, shaft
and handle with control features. | |
| Indications for Use: | Arstasisone Access 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
Arstasisone Access System is indicated for use in patients undergoing diagnostic
femoral artery catheterization procedures using 5F or 6F introducer sheaths. | |
| Technological
Characteristics | Arstasisone is designed to create a shallow access path through the arterial wall
for the guidewire to enter the vessel lumen. | |
| Summary of
Substantial
Equivalence: | Bench testing was performed on the subject device as follows: functionality,
deployment and release forces, flexibility, torque loading as well as tensile,
compressive and torque strengths. Biocompatibility testing was successfully
conducted pursuant to ISO-10993-1, Biological Evaluation of Medical Devices
Part 1: Evaluation and Testing (1995). | |
・
·
1
Prior testing included preliminary animal studies (non GLP) and cadaver assessments , as well as clinical investigations.2 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 reaccess, was retrospectively studied in a smaller cohort of patients.
In summary, the cumulative data provided herein demonstrate that the Arstasis 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.
I The preliminary Animal Studies and Cadaver Assessments were conducted using prototypes of a similar design and configuration.
2 Clinical investigations were conducted on an earlier device version of similar design and configuration.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure, with flowing lines suggesting movement or connection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
APR 2 9 2010
Ms. Su-Mien Chong Acting Vice President, Research and Development Arstasis, Inc. 1021 Howard Avenue, Suite C San Carlos, CA 94070
Re: K100615 Trade/Device Name: Arstasis000 Access System Regulation Number: 21 CFR §870.1340 Regulation Name: Catheter, Introducer Regulatory Class: Class II (two) Product Code: DYB Dated: March 3, 2010 Received: March 4, 2010
Dear Ms. Chong:
This letter corrects our substantially equivalent letter of March 30, 2010.
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 (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general therefore, manier the act include requirements for annual registration, listing of devices, controls provisions or morice, labeling, and prohibitions against misbranding and adulteration.
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 may or subject to additions, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2 - Ms. Su-Mien Chong
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/CDRH/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/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,
Bram D. Zuckerman, MD
Director
Division of Cardiovascular Devices
Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
4
Image /page/4/Picture/0 description: The image contains the word "Arstasis" in a stylized, sans-serif font. The letters are black and have a slightly futuristic or technical appearance due to their blocky and angular design. The word is presented in a simple, straightforward manner against a white background.
APPENDIX B: INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K100615
Trade Name: Arstasis 00€ Access System
Common Name: Catheter Introducer
Indications For Use:
The Arstasis 000 Access 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 Arstasis006 Access System is indicated for use in patients undergoing diagnostic femoral artery catheterization procedures using 5F or 6F introducer sheaths.
Prescription Use V (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)
Page 1 of 1
(Posted November 13, 2003)
Dunner 2. be vision Sian-Off Division of Cardiovascular Devices
510(k) Number_K1006 | 5