(115 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. AXERA is indicated for use in patients undergoing diagnostic femoral artery catheterization procedures using 5F or 6F introducer sheaths.
The AXERA 2 is a device that is comprised of a latchwire, anchor mechanism, shaft and handle with control features.
The provided text describes the AXERA 2 Access System, a catheter introducer. However, it states that the device is unchanged from its predicate device (AXERA Access System, K121521) and relies on the predicate's performance data. Therefore, the details below pertain to the predicate device's testing.
There is no detailed information provided regarding specific acceptance criteria or a dedicated study documenting the predicate's performance against those criteria in a format suitable for the requested table. The document only generally states that the predicate "met all performance testing acceptance criteria."
Therefore, for aspects related to specific acceptance criteria, reported performance, sample sizes, expert involvement, and ground truth establishment, the information is synthesized from the general descriptions provided. Many fields will state "Not specified" due to the lack of granular detail in the submission for the AXERA 2 that references the predicate's testing.
Acceptance Criteria and Study for AXERA 2 Access System (Based on Predicate Device AXERA Access System K121521)
Since the AXERA 2 Access System is stated to be "unchanged for the predicate device" and its performance data relies entirely on the predicate, the acceptance criteria and study information below refer to the predicate device's testing. The submission for AXERA 2 does not provide specific numerical acceptance criteria or detailed study results for the predicate.
1. Table of Acceptance Criteria and Reported Device Performance
Note: Specific numerical acceptance criteria and reported performance values are not detailed in the provided document. The document broadly states that the predicate device met "all performance testing acceptance criteria" and "performance requirements for its intended use."
| Acceptance Criteria Category | Specific Criteria (Not Detailed) | Reported Device Performance (Not Detailed) |
|---|---|---|
| Device Functionality | Ensure proper operation. | Met |
| Deployment Forces | Heel, needle, plunger deployment forces within specified ranges. | Met |
| Release Forces | Heel release forces within specified ranges. | Met |
| Flex Conditioning | Latchwire withstands flexing without damage. | Met |
| Resistance to Damage | Latchwire integrity after flexing. | Met |
| Tensile Strength | Multiple joints (latchwire, anchor, heel, plunger, plunger tube, needle) withstand specified tensile loads. | Met |
| Compressive Strength | Handle/anchor, plunger lockout withstand specified compressive loads. | Met |
| Torque Loading | Handle/anchor withstand specified torque. | Met |
| Corrosion Resistance | Device withstands corrosion. | Met |
| Biocompatibility | Biocompatible with human tissue. | Met |
| Clinical Performance | Short-term safety and performance. | Established |
| Clinical Efficacy | Time to hemostasis, ambulation, sit up 45 degrees, discharge eligibility, actual discharge (RECITAL study). | Established |
| Long-Term Safety & Access | Ability to access and re-access. | Retrospectively studied and established |
2. Sample Size Used for the Test Set and Data Provenance
- Bench Testing: Not specified.
- Preliminary Animal Studies (non-GLP): Not specified. Prototypes of a similar design and configuration were used.
- Cadaver Assessments: Not specified. Prototypes of a similar design and configuration were used.
- Clinical Investigations: Two types of clinical evaluations were conducted:
- Short-term safety and clinical performance: "Multiple clinical evaluations" were conducted. Sample size not specified. Data provenance (country of origin) not specified. Stated as clinical investigations, implying prospective in nature.
- Long-term safety, access, and re-access: "Retrospectively studied in a smaller cohort of patients." Sample size not specified. Data provenance (country of origin) not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Not specified. The document does not mention the number or qualifications of experts for establishing ground truth in any of the testing types.
4. Adjudication Method for the Test Set
- Not specified. The document does not describe any adjudication methods used for the test sets.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC comparative effectiveness study was not done. The device is a physical catheter introducer, not an AI or imaging device where human readers would typically be involved in interpreting data with or without AI assistance. The clinical studies focused on device performance metrics in patients.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
- Not applicable. The device is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
- Bench Testing: Engineering specifications and established test methodologies.
- Preliminary Animal Studies & Cadaver Assessments: Direct observation of device interaction with biological tissue.
- Clinical Investigations (Short-term & Efficacy): Clinical outcomes (e.g., time to hemostasis, ambulation), direct observation of device performance in patients, and patient safety data.
- Clinical Investigations (Long-term): Retrospective analysis of patient outcomes and device function over time.
8. The Sample Size for the Training Set
- Not applicable. The device is a physical medical device; there is no "training set" in the context of machine learning or algorithms. The preliminary animal studies and cadaver assessments used prototypes, which could be considered an early stage of development and refinement, but not a "training set" in the computational sense.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As above, no "training set" in the computational sense. The "ground truth" for the device's design and engineering would have been based on clinical needs, engineering principles, and performance requirements for catheter introducers.
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Arstasis
SECTION 2. 510(k) SUMMARY
| Sponsor/Submitter: | Arstasis, Inc. |
|---|---|
| 740 Bay Road | |
| Contact Person: | Debra Cogan |
| Director, Quality Assurance, Regulatory & Clinical Affairs | |
| Phone: (650) 261-8073 | |
| Date of Submission: | October 4, 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 Access System (K121521) |
| Device Description: | The AXERA 2 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. AXERA is indicated for use in patientsundergoing diagnostic femoral artery catheterization proceduresusing 5F or 6F introducer sheaths. |
| TechnologicalCharacteristics | The AXERA 2 Access Device is designed to create a shallowaccess path through the arterial wall for the guidewire to enter thevessel lumen. |
| Performance Data | Device is unchanged for the predicate device. The predicate devicemet all performance testing acceptance criteria. |
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Summary of Substantial Equivalence:
There are no changes to the Indications for Use. The clinical section of the Instructions for Use was amended to include a summary of the RECITAL study results. The clinical summary includes data related to patient safety, device performance and efficacy, including time to hemostasis, time to ambulation, time to sit up 45 degrees, time to discharge eligibility and actual discharge.
Device is unchanged for the AXERA 2 Access System. Bench Testing performed for the predicate device is applicable and was not repeated for the subject AXERA 2 Access Device. All acceptance criteria for bench testing performed for the predicate device were met and test results demonstrated that the predicate device met performance requirements for its intended use. No new issues of safety or effectiveness have been raised when compared to the predicate device.
Prior bench testing of the AXERA 2 device included 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, plunger tube, needle), compressive strength (handle/anchor, plunger lockout), and torque loading (handle/anchor), corrosion resistance testing, 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 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 achievement of hemostasis.
1 The preliminary Animal Studies and Cadaver Assessments were conducted using prototypes of a similar design and configuration.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Arstasis. Inc. c/o Ms. Debra Cogan Director, Quality Assurance, Regulatory & Clinical Affairs 740 Bay Road Redwood City, CA 94063
Re: K123135
Trade Name: AXERA 2 Access System Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: December 19, 2012 Received: December 20, 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 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
JAN 2 8 2013
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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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19 21 27
Traditional 510(k)
SECTION 1. INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
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)
.g.killelea
(Division Sign-Off) Division of Cardiovascular Devices
123135 510(k) Number
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§ 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).