(121 days)
Not Found
No
The summary does not mention any AI or ML terms, image processing, or describe any training or test sets related to AI/ML model development. The testing described is focused on mechanical and functional performance.
Yes.
The device is intended to provide access for the percutaneous introduction of devices into the peripheral vasculature and promote hemostasis, which are therapeutic actions.
No
The AXERA Access System is intended to provide access for the introduction of devices and promote hemostasis during existing diagnostic procedures, rather than performing diagnosis itself.
No
The device description explicitly states it is comprised of physical components (latchwire, anchor mechanism, shaft, handle with control features) and the performance studies describe bench testing and simulated use testing on a physical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide access for the introduction of devices into the peripheral vasculature and promote hemostasis. This is a procedural device used in vivo (within the body) during a medical procedure.
- Device Description: The description details a mechanical device with a latchwire, anchor mechanism, shaft, and handle. This is consistent with a surgical or interventional device, not a diagnostic test performed on biological samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The AXERA Access System is a tool used during a medical procedure, not a diagnostic test.
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 (comma separated list FDA assigned to the subject device)
DYB
Device Description
The AXERA 2 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
Bench testing of the modified AXERA 2 Access System was performed for device specifications affected by the modifications described above, following sterilization of test units. The following tests were performed: device functionality, flex conditioning (Latchwire), Latchwire resistance to flexing, tensile strength of Latchwire to Anchor (parallel and non-parallel), tensile strength of Latchwire distal coil to core wire, and tensile strength of Latchwire proximal coil, latch, and core wire. Simulated use testing was performed on a cadaveric model and confirmed safety of the modified tip shape.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The AXERA 2 Access Device met all performance testing acceptance criteria.
Bench testing of the modified AXERA 2 Access System was performed for device specifications affected by the modifications described above, following sterilization of test units. The following tests were performed: device functionality, flex conditioning (Latchwire), Latchwire resistance to flexing, tensile strength of Latchwire to Anchor (parallel and non-parallel), tensile strength of Latchwire distal coil to core wire, and tensile strength of Latchwire proximal coil, latch, and core wire. Simulated use testing was performed on a cadaveric model and confirmed safety of the modified tip shape.
Additional prior bench testing of the AXERA 2 device included accessory functionality, deployment forces (heel, needle, plunger), release forces (heel), flex conditioning (guidewire), tensile strength of multiple joints (anchor, heel, plunger, plunger tube, needle, guidewire, dilator adapter), access needle integrity, compressive strength (handle/anchor, plunger lockout), and torque loading (handle/anchor), corrosion resistance testing, guidewire resistance to fracture, guidewire resistance to flexing, 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 (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.
AXERA 2 Access System (K123135), Prelude Sheath Introducer (K070159), Pinnacle Introducer Sheath (K984260), Avanti Catheter Sheath Introducer (K945616)
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
Image /page/0/Picture/0 description: The image shows a series of lines radiating from a central point. The lines vary in thickness, with some being quite bold and others being thin and faint. The overall impression is one of perspective, as if the lines are converging towards a vanishing point in the distance.
SECTION 2. 510(k) SUMMARY
Arstesss
K123618 p.1 of 2
MAR 2 4 2013
| Sponsor/Submitter: | Arstasis, Inc. |
|---|---|
| 740 Bay Road | |
| Contact Person: | Debra Cogan |
| Director, Quality Assurance, Regulatory & Clinical Affairs | |
| Phone: (650) 261-8073 | |
| Date of Submission: | November 21, 2012 |
| Device Trade Name: | AXERA 2 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 2 Access System (K123135) manufactured by Arstasis, |
| Inc., Prelude Sheath Introducer (K070159) manufactured by Merit | |
| Medical Systems, Inc .; Pinnacle Introducer Sheath (K984260) | |
| manufactured by Terumo Medical Corporation; and Avanti | |
| Catheter Sheath Introducer (K945616) manufactured by Cordis | |
| Corporation. | |
| Device Description: | The AXERA 2 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 2 Access Device is designed to create a shallow |
| access path through the arterial wall for the guidewire to enter the | |
| vessel lumen. |
1
Performance Data
The AXERA 2 Access Device met all performance testing acceptance criteria.
Summary of Substantial Equivalence:
Modifications to the AXERA 2 Access System consist of changes to the Latchwire, including change to the length of the latchwire, process changes for manufacturing the latchwire, and modifications to the shape of the tip. These design modifications both streamline manufacturing and provide the Physician with the option of using a shorter device to gain arterial access.
There are no changes to the Indications for Use or procedural steps resulting from the changes described within this submission.
Bench testing of the modified AXERA 2 Access System was performed for device specifications affected by the modifications described above, following sterilization of test units. The following tests were performed: device functionality, flex conditioning (Latchwire), Latchwire resistance to flexing, tensile strength of Latchwire to Anchor (parallel and non-parallel), tensile strength of Latchwire distal coil to core wire, and tensile strength of Latchwire proximal coil, latch, and core wire. Simulated use testing was performed on a cadaveric model and confirmed safety of the modified tip shape.
Additional prior bench testing of the AXERA 2 device included accessory functionality, deployment forces (heel, needle, plunger), release forces (heel), flex conditioning (guidewire), tensile strength of multiple joints (anchor, heel, plunger, plunger tube, needle, guidewire, dilator adapter), access needle integrity, compressive strength (handle/anchor, plunger lockout), and torque loading (handle/anchor), corrosion resistance testing, guidewire resistance to fracture, guidewire resistance to flexing, 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 data provided herein demonstrate that the AXERA 2 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 promoting hemostasis as an adjunct to manual compression.
1 The preliminary Animal Studies and Cadaver Assessments were conducted using prototypes of a similar design and configuration.
2
Image /page/2/Picture/1 description: The image is a logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol, composed of three curved lines, which is positioned to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The text is in all capital letters and is evenly spaced around the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 24, 2013
Arstasis. Inc. c/o Ms. Debra Cogan Director, Ouality Assurance, Regulatory and Clinical Affairs 740 Bay Road Redwood City, CA 94063
Re: K123618
Device Name: AXERA 2 Access System Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: February 12, 2013 Received: February 13, 2013
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
3
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,
Matthew G. Hillebrenner
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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SECTION 1. INDICATIONS FOR USE STATEMENT
| 510(k) Number (if known): | K123618 |
|---|---|
| Trade Name: | AXERA 2 Access System |
| Common Name: | Catheter Introducer |
| 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)
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