(15 days)
Not Found
No
The document does not mention AI, ML, or any related concepts, and the device description and performance studies focus on mechanical and biological aspects.
No.
The device is intended to provide access for the introduction of other devices and promote hemostasis, which are supportive functions for diagnostic procedures rather than directly treating a disease or condition.
No
The device is described as an "Access System" intended to provide access for devices into the vasculature and promote hemostasis. While it is indicated for use in patients undergoing "diagnostic femoral artery catheterization procedures," the device itself is an access tool, not a diagnostic tool that produces or processes diagnostic information.
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.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide access for introducing devices into the peripheral vasculature and to promote hemostasis. This is a therapeutic or procedural use, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a physical device (sheath, anchor mechanism, shaft, handle) used for accessing blood vessels. This is consistent with a surgical or interventional device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVDs are devices used to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Arstasis 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 Arstasis Access 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 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)
Selective bench testing was performed on the subject device as follows: functionality, torque loading, flexibility and tensile strength of the core wire assembly and sheath.
Prior bench testing included deployment forces, flexibility, tensile, compression, and torque loading, were conducted on the predicate device. 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.
In summary, the cumulative data provided herein demonstrates that the Arstasis 006 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
Arstasis
:
.
| APPENDIX A: 510(k) SUMMARY | ||
|---|---|---|
| Sponsor/Submitter: | Arstasis, Inc. | |
| 1021 Howard Avenue, Suite C | ||
| San Carlos, CA 94070 | OCT 7 2010 | |
| Contact Person: | Debra Cogan | |
| Director, Regulatory & Clinical Affairs | ||
| Phone: (650) 508-1549 x273 | ||
| Fax: (650) 594-4326 | ||
| Date of Submission: | September 20, 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: | Arstasisone Access System (K100615) | |
| 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: | Selective bench testing was performed on the subject device as | |
| follows: functionality, torque loading, flexibility and tensile | ||
| strength of the core wire assembly and sheath. | ||
| Prior bench testing included deployment forces, flexibility, tensile, | ||
| compression, and torque loading, were conducted on the predicate | ||
| device. 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 |
·
·
.
1
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 006 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/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a representation of human figures.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT 7 2010
Arstasis, Inc. c/o Ms. Su-Mien Chong Acting Vice President Research and Development 1021 Howard Avenue, Suite C San Carlos, CA 94070
Re: K102728
Trade/Device Name: Arstasis Access System Regulation Number: 21 CFR §870.1340 Regulation Name: Catheter, Introducer Regulatory Class: Class II (Two) Product Code: DYB Dated: September 20, 2010 Received: September 22, 2010
Dear Ms. Su-Mien Chong:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt have reviewed your becamined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreations) it itgang actment date of the Medical Device Amendment, or to connineres prior to May 20, 1978, the encordance with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA). and Cosmetic Act (Tier) that to hot required to the general controls provisions of the Act. of the 1 ou may, ulciclore, market the act include requirements for annual registration, listing of general controls provisions of the Provibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability adulteration. Flease note. CDICT does not ovarant must be truthful and not misleading.
3
Page 2 - Ms. Su-Mien Chong
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.
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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Duna R. Vuchner
Bram D. Zuckerman, M.D. Director
Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Special 510(k): Device Modification
APPENDIX B: INDICATIONS FOR USE STATEMENT
K102728 510(k) Number (if known):
Trade Name:
Arstasis 90€ Access System
Catheter Introducer
Common Name:
Arstasis
Indications For Use:
The Arstasis®16 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 Arstasis 000 Access 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)
Annual
(Division Sign-Off) (Division Sign-On)
Division of Cardiovascular Devices
Page [ of \
510(k) Number
(Posted November 13, 2003)
Confidential
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