(29 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.
No.
The device is intended to provide access for other devices and promote hemostasis, which are supportive functions rather than direct treatment of a disease or condition.
No
The device is an access system intended for the percutaneous introduction of devices and to promote hemostasis during existing diagnostic procedures, rather than performing diagnostic functions itself. Its primary function is to facilitate access and wound closure, not to diagnose a condition.
No
The device description explicitly states it is comprised of physical components like a latchwire, anchor mechanism, shaft, handle, and control features, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for providing access for the percutaneous introduction of devices into the peripheral vasculature and promoting hemostasis. This is a direct intervention on the patient's body.
- Device Description: The description details a physical device with mechanical components (latchwire, anchor mechanism, shaft, handle).
- 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.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for a procedural purpose.
N/A
Intended Use / Indications for Use
The AXERA 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. AXERA is indicated for use in patients undergoing diagnostic femoral artery catheterization procedures using 5F or 6F introducer sheaths.
Product codes
DYB
Device Description
The AXERA 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
Bench testing of the modified AXERA device was performed for device specifications affected by the modifications described above, following sterilization of test units. All acceptance criteria were met and test results demonstrated that the modified AXERA met performance requirements for its intended use. No new issues of safety or effectiveness were raised. The following tests were performed: device functionality, deployment forces (heel, needle, plunger), release forces (heel), flex conditioning (latchwire), resistance of latchwire to damage by flexing, tensile strength of multiple joints (latchwire, anchor, heel, plunger, needle), compressive strength (handle/anchor), and torque loading (handle/anchor), and corrosion resistance testing.
Additional prior testing included tensile testing of multiple joints (plunger, plunger tube), compressive strength testing (plunger lockout), biocompatibility testing, 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
Not Found
Predicate Device(s)
AXERA Access System (K113110)
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
K12)521
Special 510(k): Device Modification
:
APPENDIX A: 510(k) SUMMARY
JUN 2 1 2012
ﺳﮯ
| Sponsor/Submitter: | Arstasis, Inc.
740 Bay Road
Redwood City, CA 94063 |
|-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Debra Cogan
Director, Quality Assurance, Regulatory & Clinical Affairs
Phone: (650) 261-8073
Fax: (650) 261-8002 |
| Date of Submission: | May 22, 2012 |
| Device Trade Name: | AXERA 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: | AXERA Access System (K113110) |
| Device Description: | The AXERA is a device that is comprised of a latchwire, anchor
mechanism, shaft and handle with control features. |
| Indications for Use: | The AXERA 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. AXERA is indicated for use in patients
undergoing diagnostic femoral artery catheterization procedures
using 5F or 6F introducer sheaths. |
| Technological
Characteristics | The AXERA Access Device is designed to create a shallow access
path through the arterial wall for the guidewire to enter the vessel
lumen. |
| Performance Data | The AXERA Access Device met all performance testing
acceptance criteria. |
| Summary of
Substantial
Equivalence: | Modifications to the AXERA Access System include changes to the
Needle Lumen Anchor (NLA) assembly to allow the Integrated
Needle to remain centered and in contact with the anchor when
deployed. Additionally, the length of the Integrated Needle is
shortened and the diameter of the Latchwire and shape of the
Latchwire latch sub-component has also been adjusted to |
1
accommodate the change to the distal end of the NLA and to improve manufacturability.
Bench testing of the modified AXERA device was performed for device specifications affected by the modifications described above, following sterilization of test units. All acceptance criteria were met and test results demonstrated that the modified AXERA met performance requirements for its intended use. No new issues of safety or effectiveness were raised. The following tests were performed: device functionality, deployment forces (heel, needle, plunger), release forces (heel), flex conditioning (latchwire), resistance of latchwire to damage by flexing, tensile strength of multiple joints (latchwire, anchor, heel, plunger, needle), compressive strength (handle/anchor), and torque loading (handle/anchor), and corrosion resistance testing.
Additional prior testing included tensile testing of multiple joints (plunger, plunger tube), compressive strength testing (plunger lockout), biocompatibility testing, 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 AXERA 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.
CONFIDENTIAL
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN 2 1 2012
Arstasis. Inc. c/o Ms. Debra Cogan Director, Quality Assurance, Regulatory & Clinical Affairs 740 Bay Road Redwood City, CA 94063
Re: K121521
Trade/Device Name: AXERA Access Systerm Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: May 22, 2012 Received: May 23, 2012
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
3
Page 2 - Ms. Debra Cogan
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/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 vours.
Bram D. Zuckerman, MD Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Arstasis
Special 510(k): Device Modification
APPENDIX B: INDICATIONS FOR USE STATEMENT
K121521 510(k) Number (if known):
Trade Name:
AXERA Access System
Catheter Introducer
Common Name:
Indications For Use:
The AXERA 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. AXERA is indicated for use in patients undergoing diagnostic femoral artery catheterization procedures using 5F or 6F introducer sheaths.
Prescription Use X . (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 | of |
|---|---|
| ------ | ---- |
(Posted November 13, 2003)
| (Division Sign-Off) | |
|---|---|
| Division: Cardiovascular Division | |
| 510(k) Number | K121541 |
(Posted Novem
CONFIDENTIAL
36