(132 days)
The iO-Flex Catheter is for continuous or intermittent preoperative, perioperative or post-operative delivery of local anesthetics and analgesics in the epidural space or near a nerve for regional anesthesia and pain management. The catheter may also be used perioperatively during open spinal procedures to irrigate, aspirate or inject a bolus of fluid or medication.
The iO-Flex Catheter is designed for use with the iO-Flex Wire.
The iO-Flex Catheter is comprised of two primary components: (1) Y-Adapter with a rotating hemostasis valve (RHV) and (2) a flexible catheter body. The Y-Adapter consists of two ports: (1) a central guidewire port with rotating hemostasis valve and (2) a side port for connection of a standard syringe for the irrigation, injection and / or aspiration of fluids at the surgical site. The central guidewire port with RHV allows for insertion of the iO-Flex Catheter over the Baxano iO-Flex Wire. The flexible catheter shaft contains external markers for depth adjustment by the clinician.
The Baxano iO-Flex Catheter underwent several non-clinical performance studies to demonstrate its functional performance and ensure it met product specifications.
1. Acceptance Criteria and Reported Device Performance:
| Assessment | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Dimensional | Met product specifications | Satisfied all dimensional requirements |
| Flexibility / Kink Resistance | Met product specifications | Satisfied all functional performance requirements |
| Leak | Met product specifications | Satisfied all functional performance requirements |
| Guidewire Compatibility | Met product specifications | Satisfied all functional performance requirements |
| Ink Adhesion | Met product specifications | Satisfied all functional performance requirements |
| Flow Rate | Met product specifications | Satisfied all functional performance requirements |
| Tensile Strength | Met product specifications | Satisfied all functional performance requirements |
| Biocompatibility (Cytotoxicity, Irritation/Acute Intracutaneous Reactivity, Acute Systemic Toxicity, Sensitization/Maximization, Pyrogenicity) | Demonstrated to be biocompatible for intended use | Demonstrated to be biocompatible for intended use |
| Ease of Introduction and Positioning (Cadaver Model) | Met product specifications | Satisfied all functional performance requirements |
| Irrigation and Injection of Fluids (Cadaver Model) | Met product specifications | Satisfied all functional performance requirements |
| Aspiration (Cadaver Model) | Met product specifications | Satisfied all functional performance requirements |
| Compatibility with Commercially-available Hemostatic Matrices (Cadaver Model) | Demonstrated ability to introduce | Validated ability to introduce |
2. Sample Size and Data Provenance:
- Bench Performance Testing: The specific sample size for each bench test (dimensional, flexibility, leak, etc.) is not explicitly stated. The nature of these tests suggests multiple units were tested to ensure consistency and reliability. Data provenance is implied to be from internal testing conducted by Baxano, Inc.
- Biocompatibility Testing: Not specified for each test, but standard procedures typically involve a sufficient number of samples to meet GLP regulations and ISO 10993-1 guidelines. Data provenance is from GLP-compliant testing conducted according to FDA and ISO standards.
- Cadaver Model Testing: Not specified, but "a cadaver model" suggests a limited number of cadavers were used for the design validation testing. The data is prospective, generated specifically for this validation.
3. Number of Experts and Qualifications for Ground Truth:
The document does not explicitly state the number or qualifications of experts used to establish a ground truth for a test set in the traditional sense of a clinical study with expert review.
- For the bench performance testing, acceptance criteria would have been established by engineering and quality assurance experts at Baxano, Inc., based on product specifications and industry standards.
- For the biocompatibility testing, ground truth was established by adherence to recognized international standards (ISO-10993-1) and FDA guidance, with testing conducted by qualified personnel in a GLP-compliant environment.
- For the cadaver model testing, "clinician" input is implied for assessing performance (e.g., ease of introduction). While not explicitly stated as "experts," these would be individuals with medical expertise in relevant spinal procedures.
4. Adjudication Method:
No formal adjudication method (like 2+1 or 3+1) is mentioned in the context of expert review for establishing ground truth, as this was not a comparative clinical trial. Performance was assessed against pre-defined engineering and biological safety specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was performed or is mentioned. This device is a catheter, and the evaluation focused on its physical and functional performance, not on interpretation by human readers.
6. Standalone Performance:
Yes, all the performance data presented (bench testing, biocompatibility, and cadaver model testing) represents the standalone performance of the iO-Flex Catheter. The tests assess the device's inherent characteristics and functionality without human-in-the-loop performance measurement.
7. Type of Ground Truth Used:
- Bench Performance Testing: Ground truth was established by adherence to pre-defined product specifications (e.g., dimensional tolerances, tensile strength values, flow rates).
- Biocompatibility Testing: Ground truth was based on the results of validated biological tests (e.g., cytotoxicity assays, irritation tests) as interpreted against the acceptance limits of the ISO 10993-1 standard.
- Cadaver Model Testing: Ground truth was based on functional observation and assessment by clinicians/testers against pre-defined performance requirements related to ease of use, fluid delivery, and compatibility.
8. Sample Size for the Training Set:
This document describes pre-market testing for a medical device (catheter), not a machine learning or AI algorithm. Therefore, there is no "training set" in the context of AI. The presented studies are validation studies for the device itself.
9. How the Ground Truth for the Training Set was Established:
As there is no AI component or training set, this question is not applicable. The device's performance was validated against established engineering, biological, and functional specifications directly.
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Image /page/0/Picture/1 description: The image shows the word "BAXANO" in a bold, sans-serif font. A stylized graphic element intersects the "X", resembling a curved line with a pointed end. The overall design is simple and modern, with a focus on the typography and the unique graphic element.
JAN 1 9 2011
510(K) SUMMARY (21 CFR 807.92) iO-Flex™ Catheter
510(k) Owner:
Baxano, Inc. 655 River Oaks Parkway San Jose, CA 95134 Tel: 408-514-2200 Fax: 408-514-2201
Contact Person:
Edward J. Sinclair Tel: 408-514-2220 E-mail: esinclair@baxano.com
Date Prepared: November 12, 2010
Trade Name: iO-Flex™ Catheter
Anesthesia Conduction Catheter Common Name:
Classification: Class II (21 CFR 868.5120)
BSO
Product Code:
I-Flow Corporation, ON-Q Introducers (K063234) Predicate Devices: B.Braun, Regional Anesthesia Catheters (K042488) Axiom Medical, Inc., MultiPurpose Wound Drain Catheter (K993592)
The iO-Flex Catheter is comprised of two primary components: (1) Device Description: Y-Adapter with a rotating hemostasis valve (RHV) and (2) a flexible catheter body. The Y-Adapter consists of two ports: (1) a central guidewire port with rotating hemostasis valve and (2) a side port for connection of a standard syringe for the irrigation, injection and / or aspiration of fluids at the surgical site. The central guidewire port with RHV allows for insertion of the iO-Flex Catheter over the Baxano iO-Flex Wire. The flexible catheter shaft contains external markers for depth adjustment by the clinician.
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| Intended Use: | The iO-Flex Catheter is for continuous or intermittent preoperative,perioperative or post-operative delivery of local anesthetics andanalgesics in the epidural space or near a nerve for regionalanesthesia and pain management. The catheter may also be usedperioperatively during open spinal procedures to irrigate, aspirate orinject a bolus of fluid or medication.The iO-Flex Catheter is designed for use with the iO-Flex Wire. |
|---|---|
| TechnologicalCharacteristics: | The Baxano iO-Flex Catheter is similar in use and has similartechnological characteristics to the I-Flow Corporation ON-QIntroducer, the B. Braun Inc. Regional Anesthesia Catheters andAxiom Medical Inc. MultiPurpose Wound Drain Catheter. Alldevices incorporate a catheter shaft and a mechanism similar to theiO-Flex Catheter Y-adapter for the irrigation, aspiration or injectionof fluids or medications. |
| Non-ClinicalPerformance Data: | Bench performance testing was conducted to demonstrate thefunctional performance of the iO-Flex Catheter and to ensure thatthe requirements of the product specification were met. iO-FlexCatheters were subjected to double ethylene oxide sterilization,environmental conditioning, and transportation testing prior toundergoing packaging, bench performance and functional testing.Bench performance testing included dimensional, flexibility / kinkresistance, leak, guide wire compatibility, ink adhesion, flow rateand tensile strength assessments. Additionally, the packaging anddevice characteristics were tested after accelerated aging to supportshelf-life labeling. The results of the bench testing demonstratedthat the iO-Flex Catheter satisfied all of the dimensional andfunctional performance requirements, which are designed to ensurethat the device is safe and effective for its intended use.To verify the biocompatibility of all components and materials forthe iO-Flex Catheter, biocompatibility testing was conductedpursuant to FDA's Guidance Document (#G95-1), Use ofInternational Standard ISO-10993-1, "Biological Evaluation ofMedical Devices Part 1: Evaluation and Testing (1995)".Biocompatibility testing was conducted in accordance with the GLPregulations using polar and nonpolar solvents. According to theFDA guidance and ISO standards, the iO-Flex Catheter, is an"external communicating device" in contact with tissue and bonefor limited exposure (<24 hour) during spinal procedures. Based onthese characteristics, the following biocompatibility tests wereconducted: Cytotoxicity, Irritation / Acute IntracutaneousReactivity, Acute Systemic Toxicity, Sensitization / Maximizationand Pyrogenicity. Based on the test results provided, the iO-FlexCatheter has been demonstrated to be biocompatible for its intendeduse. |
Design validation testing was conducted to confirm that the iO-Flex Catheter design meets the requirements of the product specification.
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Testing was conducted using a cadaver model. The following assessments were performed: Ease of introduction and positioning, guide wire compatibility, irrigation and injection of fluids as well as aspiration. The ability of the catheter to introduce commerciallyavailable hemostatic matrices was validated. The results demonstrate that the iO-Flex Catheter satisfies all of the functional performance requirements, which are designed to ensure that the device is safe and effective for its intended use.
The iO-Flex Catheter is substantially equivalent to the I-Flow Substantial Corporation ON-Q Introducers (K063224), B. Braun Regional Equivalence: Anesthesia Catheters (K042488), and the Axiom Medical MultiPurpose Wound Drain Catheter (K993592) in terms of its intended use / indications for use, as well as technological characteristics and principles of operation.
The iO-Flex Catheter has the same indications for use and fundamental scientific technology as the predicate devices. Based upon the indications for use, technological characteristics and performance test results, iO-Flex Catheter does not raise any new questions of safety or effectiveness.
Baxano, Inc. has determined based on bench performance, Conclusions: biocompatibility and cadaver studies that the iO-Flex Catheter conforms to its design specifications and is substantially equivalent to the predicate devices.
Any statement regarding "substantial equivalence" made in this 510(k) submission and summary only relates to whelher the product addressed in this submission may be lawfully marketed without premarket approval or reclassification, and is not interpreted as un admission or any other type of evidence in any patent proceeding, including patent infringement, litigation or proceeding before any Patent Office. The present submission and statements therein therefore should not be construed as affecting or relating to the scope of any patent application, or to whether the product addressed in this submission, or its use, may be considered indistinct, from a patentability perspective, from any of the other devices referenced in this filing.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of three wavy lines, which are positioned to the right of the text. The text is arranged in a circular pattern around the left side of the graphic. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Edward J. Sinclair Vice President, Clinical, Regulatory and Quality affairs Baxano, Incorporated 655 River Oaks Parkway San Jose. California 95134
JAN 1-9 2011
Re: K102594
Trade/Device Name: Baxano iO-Flex Catheter Regulation Number: 21 CFR 868.5120 Regulation Name: Anesthesia Conduction Catheter Regulatory Class: II Product Code: BSO Dated: December 13, 2010 Received: December 14, 2010
Dear Mr. Sinclair:
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.
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Page 2- Mr. Sinclair
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Rh for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: Baxano iO-Flex Catheter
Indications For Use:
The iO-Flex Catheter is for continuous or intermittent preoperative, perioperative or postoperative delivery of local anesthetics and analgesics in the epidural space or near a nerve for regional anesthesia and pain management. The catheter may also be used perioperatively during open spinal procedures to irrigate, aspirate or inject a bolus of fluid or medication.
The iO-Flex Catheter is designed for use with the iO-Flex Wire.
Prescription Use V (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital Division of Anesthouselongy.
Infection Control, Dental Devicesage 1 of 1
KIS 2594
510(k) Number: CONFIDENTIAL
Baxano, Inc.
Page 5-2
§ 868.5120 Anesthesia conduction catheter.
(a)
Identification. An anesthesia conduction catheter is a flexible tubular device used to inject local anesthetics into a patient and to provide continuous regional anesthesia.(b)
Classification. Class II (performance standards).