(20 days)
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. The System is indicated for use in patients undergoing diagnostic femoral artery catheterization procedures using 5F or 6F introducer sheaths.
The AXERA is a device that is comprised of a latchwire, anchor mechanism, shaft and handle with control features.
The provided text describes a Special 510(k) for a device modification of the AXERA Access System. It focuses on engineering and performance testing to demonstrate substantial equivalence, rather than a clinical study evaluating diagnostic performance with AI. Therefore, most of the requested information regarding acceptance criteria, sample size, ground truth, and expert evaluation for an AI-based study is not available in the provided document.
Here's a breakdown of what can be extracted based on the given text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Device Functionality | Met acceptance criteria |
| Deployment Forces (heel, needle, plunger) | Met acceptance criteria |
| Release Forces (heel) | Met acceptance criteria |
| Flex Conditioning (latchwire) | Met acceptance criteria |
| Tensile Strength (multiple joints: latchwire, anchor, heel, plunger, needle) | Met acceptance criteria |
| Compressive Strength (handle/anchor) | Met acceptance criteria |
| Torque Loading (handle/anchor) | Met acceptance criteria |
| Corrosion Resistance | Met acceptance criteria (from prior testing) |
| Biocompatibility | Met acceptance criteria (from prior testing) |
2. Sample size used for the test set and the data provenance
- Test Set Size: Not specified for each individual test. The document states "test units" were used but does not provide a specific number for each test or overall.
- Data Provenance: The testing was "bench testing," meaning it was conducted in a laboratory setting. There is no information regarding country of origin or whether it was retrospective or prospective in the context of human data, as no human data was primary to this specific modification submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. The "ground truth" for this device modification was based on engineering specifications and physical performance measurements, not expert human interpretation for an AI system.
4. Adjudication method for the test set
- Not applicable. The testing described is physical performance testing against predetermined engineering specifications, not a subjective evaluation requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This was not an AI-based study. It was a device modification submission based on bench testing.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a manual catheter introducer system, not an AI algorithm.
7. The type of ground truth used
- The "ground truth" was derived from engineering specifications and objective physical measurements (e.g., forces, strengths, flexibility) established for the device's intended function.
8. The sample size for the training set
- Not applicable. No training set for an AI algorithm was involved.
9. How the ground truth for the training set was established
- Not applicable. No training set for an AI algorithm was involved.
Summary of the Study Proving Device Meets Acceptance Criteria:
The study described is primarily a bench testing evaluation for a device modification to the AXERA Access System. The modifications included changing the needle material from nitinol to stainless steel, a minor change in the Needle Lumen Anchor (NLA) geometry and manufacturing process, and the addition of marking holes.
The study aimed to confirm that these modifications did not adversely affect the device's performance characteristics. A series of engineering tests were conducted on the modified AXERA device, including:
- Device functionality
- Deployment forces (heel, needle, plunger)
- Release forces (heel)
- Flex conditioning (latchwire)
- Tensile strength of multiple joints (latchwire, anchor, heel, plunger, needle)
- Compressive strength (handle/anchor)
- Torque loading (handle/anchor)
Additionally, prior testing results for corrosion resistance, flex conditioning, tensile testing, compressive strength, and biocompatibility were referenced as also having met acceptance criteria. Preliminary animal studies (non-GLP) and cadaver assessments, along with clinical investigations, were also mentioned as part of the broader evaluation history of the AXERA system, though not specifically for this modification.
The conclusion was that "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." This indicates that the device's performance after modification remained consistent with its original design and intended use, and therefore demonstrated substantial equivalence to the predicate device.
{0}------------------------------------------------
Arstasis
NOV - 9, 2011 K113110 page 1 of 2
Special 510(k): Device Modification
APPENDIX A: 510(k) SUMMARY
| Sponsor/Submitter: | Arstasis, Inc.740 Bay StRedwood City, CA 94063 |
|---|---|
| Contact Person: | Debra CoganDirector, Regulatory & Clinical AffairsPhone: (650) 261-8073Fax: (650) 261-8002 |
| Date of Submission: | October 19, 2011 |
| 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: | Latchwire Access Device/AXERA (K103143) |
| Device Description: | The AXERA is a device that is comprised of a latchwire, anchormechanism, shaft and handle with control features. |
| Indications for Use: | The AXERA Access System is intended to provide access for thepercutaneous introduction of devices into the peripheral vasculatureand to promote hemostasis at the arteriotomy site as an adjunct tomanual compression. The System is indicated for use in patientsundergoing diagnostic femoral artery catheterization proceduresusing 5F or 6F introducer sheaths. |
| TechnologicalCharacteristics | The AXERA device is designed to create a shallow access paththrough the arterial wall for the guidewire to enter the vessel lumen.The modified device continues to have the same technologicalcharacteristics as that of the predicate. Modifications includechanging the needle material from nitinol to stainless steel, a minorchange in the Needle Lumen Anchor (NLA) geometry andmanufacturing process to accommodate the stiffer stainless steelmaterial, and the addition of marking holes enhance user feedbackof blood mark. |
| Performance Data | The AXERA device met all performance testing acceptancecriteria. |
{1}------------------------------------------------
K113110 page 2 of 2
Arstasis
Summary of
Equivalence:
Substantial
Special 510(k): Device Modification
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), tensile strength of multiple joints (latchwire, anchor, heel, plunger, needle), compressive strength (handle/anchor), and torque loading (handle/anchor).
Additional prior testing included corrosion resistance testing. flex conditioning, tensile testing of multiple joints, compressive strength testing, biocompatibility testing, preliminary animal studies (non-GLP) and cadaver assessments, as well as clinical investigations.1 Multiple clinical evaluations were conducted.
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.
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 shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name, "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA," arranged in a circular pattern around a stylized eagle-like emblem. The emblem is a simple, abstract design of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans and provide essential human services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
NOV - 9 2011
Arstasis. Inc. c/o Debra Cogan 740 Bay Rd. Redwood City, CA 94063
Re: K113110
Trade/Device Name: AXERA Access System Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter introducer Regulatory Class: Class II (two) Product Code: DYB Dated: October 19, 2011 Received: October 20, 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.
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
{3}------------------------------------------------
Page 2 - Ms. Debra Cogan
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,
$\mu$
/
Br
Di
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:
AYERA Access System
Common Name:
Indications For Use:
AXERA Access System
Catheter Introducer
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. 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) | |
|---|---|
| Division of Cardiovascular Devices | |
| 510(k) Number | K113112 |
Page 1 of 1(Posted November 13, 2003)
CONFIDENTIAL
§ 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).