(154 days)
The Reprocessed 3D Diagnostic Ultrasound eco Catheters are indicated for intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart. When used with compatible Carto® 3 EP Navigation Systems (version 2.3 and higher) the reprocessed 3D Diagnostic Ultrasound eco Catheters provide location information.
Sterilmed Reprocessed 3D Diagnostic Ultrasound eco Catheters are specially designed catheters that provide two-dimensional imaging using an ultrasound transducer and three-dimensional location sensor. They are IntraCardiac Echo (ICE) Catheters with acoustic array and magnetic location sensor equivalent to the currently cleared SoundStar eco 8F G Ultrasound Catheter, and SoundStar eco 8F Ultrasound Catheters 510(k) K140318. The magnetic location sensor (providing location information to the CARTO® 3 EP Navigation System) and an ultrasound transducer (acquiring real time ultrasound images) are embedded in the catheter tip. The Reprocessed 3D Diagnostic Ultrasound Catheters, when connected to the corresponding Ultrasound Systems, will provide real-time integration of the ultrasound images with CARTO® 3 electromagnetic acquired maps.
The document describes the acceptance criteria and the study conducted to demonstrate the substantial equivalence of reprocessed 3D Diagnostic Ultrasound eco Catheters to new (OEM) devices.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Test) | Reported Device Performance | Result |
|---|---|---|
| Mechanical Reliability | ||
| Joint Bond Strength (SM5653/5840) | Tensile strength of device joints confirmed reprocessing has no effect. | Pass |
| Torsional Strength (SM5652/5842) | Torsional strength of flexible tip and shaft sections confirmed reprocessing has no effect. | Pass |
| Flexation Fatigue (SM5604/5827) | Flexation through maximum range of deflection (100 times) confirmed reprocessing has no effect. | Pass |
| Deflection Fatigue (SM5605/5823) | Deflection in simulated use model (multiple times) confirmed reprocessing has no effect. | Pass |
| Tip Buckling (SM4091/5923) | Force required to cause tip buckling ensured reprocessing had no effect. | Pass |
| Sensor/System Functionality | ||
| CCS Check (SM5523/5822) | Calibration check confirmed reprocessing has no effect on device's ability to maintain sensor location. | Pass |
| Auto ID (SM5800/5830) | Reprocessed devices continue to be identified as Soundstar eco 8F catheters. | Pass |
| EEPROM Reset Verification (SM5802/5841) | EEPROM can be effectively reset and continue to function as intended. | Pass |
| AMCS Acoustic Verification (SM5522/5828) | Acoustic Manual Calibration System functions for reprocessed devices. | Pass |
| Safety | ||
| Thrombogenicity Testing (SM6020/6828) | Reprocessed devices do not cause any new risk of thrombus formation. | Pass |
| Biocompatibility Testing (ISO 10993-1) | Data demonstrates no risk presented by reprocessed catheters. | Pass |
| EM Compatibility (IEC 60601-1:2005 A1:2012) | Compliance to defibrillation protection (peak differential signal < 1 volt). | Pass |
| Current Leakage (SM5831) | 100% in-process inspection via Hi-pot (1500VDC) for electrical insulation. | Pass |
| Functionality (In-process) | 100% in-process inspection for functionality. | Pass |
| Total emitted acoustic power (IEC 61161:2013) | Verified and documented (SM5826). | Pass |
| Cleaning Validation | Performed to validate cleaning procedures. | Pass |
| Sterilization Validation (ISO 11135, USP <71>) | Performed to validate sterilization procedures. | Pass |
| Ethylene Oxide Residual Testing (ISO 10993-7) | Performed. | Pass |
| Packaging Validation (ASTM D4169, F88, F2096) | Performed. | Pass |
| Shelf Life Validation (ASTM 1980-99) | Performed. | Pass |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the specific sample size for each individual test within the "Verification Testing" or "Summary of Non-Clinical Tests Conducted" sections. It refers to "representative samples of reprocessed devices" for functional characteristics testing. Other tests like "100% in-process inspected" indicate testing of every reprocessed device during manufacturing.
Data Provenance: The data is generated internally by Sterilmed, Inc. as part of their reprocessing validation. It is retrospective in the sense that it evaluates the performance of reprocessed devices after the reprocessing procedure has been applied. The country of origin of the data is the USA (Maple Grove, MN).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This section is not applicable as the described tests are primarily physical, electrical, chemical, and functional performance benchmarks against defined standards and specifications, rather than a clinical study requiring expert interpretation of medical images or data for ground truth establishment. The "ground truth" here is the established performance parameters of the original (OEM) device and relevant industry standards.
4. Adjudication Method for the Test Set:
This is not applicable as the tests performed are objective, quantitative measurements against predefined pass/fail criteria, not subjective assessments 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:
This is not applicable. The document describes the validation of reprocessed medical devices (catheters), not an AI algorithm or a study involving human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This is not applicable. The document describes the validation of reprocessed medical devices (catheters), not an algorithm.
7. The Type of Ground Truth Used:
The ground truth used for these tests is based on:
- Performance specifications of the original (OEM) devices: The reprocessed devices are compared to the performance characteristics of the Biosense Webster SoundStar eco 8F and eco 8F G Ultrasound Catheters (K140318).
- Industry Standards: Compliance with various ISO, ASTM, USP, and IEC standards (e.g., ISO 11135, USP <71>, ISO 10993-1, ISO 10993-7, ASTM D4169, ASTM F88, ASTM F2096, ASTM 1980-99, IEC 60601-1:2005 A1:2012, IEC 61161:2013).
- Internal Specifications: Criteria established by Sterilmed, Inc. for functional performance, cleaning, and sterilization.
8. The Sample Size for the Training Set:
This is not applicable. The document describes the validation of reprocessed medical devices, not a machine learning model that would require a training set. The "process validation testing" for cleaning and sterilization procedures are internal validation processes, not machine learning training.
9. How the Ground Truth for the Training Set Was Established:
This is not applicable, as there is no training set mentioned in the context of machine learning. The "ground truth" for the processes mentioned (cleaning, sterilization) is established through rigorous scientific testing and adherence to recognized industry standards to ensure the reprocessed devices meet safety and efficacy requirements.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Public Health Service
November 21, 2016
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Sterilmed. Inc. Neelu Gibson Senior Director, Regulatory Affairs 5010 Cheshire Parkway, Suite 2 Plymouth, Minnesota 55446
Re: K161700
Trade/Device Name: Reprocessed 3D Diagnostic Ultrasound eco Catheters (See attached list of models) Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: OWO Dated: October 7, 2016 Received: October 11, 2016
Dear Neelu Gibson:
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
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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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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.
Mucha Jellman
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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K161700
Models intended for reprocessing
| OriginalManufacturer | OEMModelNumber | ReprocessedProduct Code | Description |
|---|---|---|---|
| Biosense Webster,Inc. | 10439011 | R10439011 | SoundStar® eco DiagnosticUltrasound Catheter, 8F, 90 cmlength. For use with Siemensultrasound systems. |
| Biosense Webster,Inc. | 10439236 | R10439236 | SoundStar® eco DiagnosticUltrasound Catheter, 8F, 90 cmlength. For use with GE ultrasoundsystems. |
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Indications for Use
510(k) Number (if known) K161700
Device Name
Reprocessed 3D Diagnostic Ultrasound eco Catheters
Indications for Use (Describe)
The Reprocessed 3D Diagnostic Ultrasound eco Catheters are indicated for intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart. When used with compatible Carto® 3 EP Navigation Systems (version 2.3 and higher) the reprocessed 3D Diagnostic Ultrasound eco Catheters provide location information.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------------------------------ | ----------------------------------------------------------------------------------- |
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Image /page/4/Picture/0 description: The image shows the logo for Sterilmed. The logo consists of a stylized, partially-formed circle on the left, with the word "STERILMED" in all caps to the right of the circle. The circle is silver on the top and green on the bottom. The word "STERILMED" is in a simple, sans-serif font.
| Submitter and Manufacturer: | Neelu GibsonSterilmed, Inc.5010 Cheshire Parkway, Suite 2Plymouth, MN 55446 |
|---|---|
| Manufacturing Facility Address: | 11400 73rd Avenue NorthMaple Grove, MN 55369 |
| Primary Contact: | Neelu GibsonSterilmed, Inc.Tel: 908-705-3160Fax: 763-488-3350Email: ngibson9@its.jnj.com |
| Date of Submission: | 21 May, 2016 |
| Trade Name: | Reprocessed 3D Diagnostic Ultrasoundeco Catheters |
| Regulation Name: | Diagnostic Intravascular Catheter |
| Device Classification: | Class II |
| Product Code: | OWQ |
510(k) Summary - K161700
| PredicateDevice: | Biosense Webster, Inc.: SoundStar eco 8F G Ultrasound Catheter, and SoundStareco 8F Ultrasound Catheter (510(k) K140318) |
|---|---|
| Secondary /ReferencePredicates | Sterilmed Inc: Reprocessed 3D Ultrasound Diagnostic Catheter (510(k) K110076)Sterilmed Inc: Reprocessed Ivus Imaging Catheter (510(k) K043453) |
| DeviceDescription: | Sterilmed Reprocessed 3D Diagnostic Ultrasound eco Catheters are speciallydesigned catheters that provide two-dimensional imaging using an ultrasoundtransducer and three-dimensional location sensor. |
| They are IntraCardiac Echo (ICE) Catheters with acoustic array and magneticlocation sensor equivalent to the currently cleared SoundStar eco 8F G UltrasoundCatheter, and SoundStar eco 8F Ultrasound Catheters 510(k) K140318. Themagnetic location sensor (providing location information to the CARTO® 3 EPNavigation System) and an ultrasound transducer (acquiring real time ultrasoundimages) are embedded in the catheter tip. | |
| The Reprocessed 3D Diagnostic Ultrasound Catheters, when connected to thecorresponding Ultrasound Systems, will provide real-time integration of theultrasound images with CARTO® 3 electromagnetic acquired maps. | |
| Note: Only the catheter is the subject of this submission. Accessories and/or anyother related equipment are not included in the scope of this submission. The tablebelow lists the specific model numbers that are the subject of this submission. |
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| OriginalManufacturer | OEMModelNumber | ReprocessedProductCode | Description |
|---|---|---|---|
| Biosense Webster,Inc. | 10439011 | R10439011 | SoundStar® eco DiagnosticUltrasound Catheter, 8F, 90 cmlength. For use with Siemensultrasound systems. |
| Biosense Webster,Inc. | 10439236 | R10439236 | SoundStar® eco DiagnosticUltrasound Catheter, 8F, 90 cmlength. For use with GE ultrasoundsystems. |
| Indications forUse: | The Reprocessed 3D Diagnostic Ultrasound eco Catheters are indicated for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy andphysiology as well as visualization of other devices in the heart. When used withcompatible Carto® 3 EP Navigation Systems (version 2.3 and higher) thereprocessed 3D Diagnostic Ultrasound eco Catheters provide location information. | ||
| TechnologicalCharacteristics: | The Reprocessed 3D Diagnostic Ultrasound eco Catheters are identical to thepredicate devices in design, materials of construction, and intended use. There areno changes to the clinical applications, patient population, performancespecifications, or method of operation. | ||
| Functional andSafety Testing: | Representative samples of reprocessed devices were tested to demonstrateappropriate functional characteristics.Process validation testing was performed to validate the cleaning and sterilizationprocedures as well as device packaging. In addition, the manufacturing processincludes visual and validated functional testing of all products produced.Where appropriate prior validation testing of previously cleared Reprocessed 3DDiagnostic Ultrasound eco Catheter K110076 and Reprocessed AcuNav ImagingCatheter K043453 was utilized for the same reprocessing procedures, equipment,sterile barrier and sterilization processing. The Reprocessed 3D DiagnosticUltrasound eco Catheters are reprocessed no more than three (3) times. Each deviceis marked and tracked through each reprocessing cycle. After the device hasreached the maximum number of reprocessing cycles (3), the device is rejectedfrom further reprocessing. Reprocessing is performed only by the manufacturerSterilmed, Inc. | ||
| Summary ofNon-ClinicalTestsConducted: | Specific non-clinical tests performed included: cleaning validation, sterilizationvalidation (ISO 11135, USP <71>), biocompatibility testing (ISO 10993-1),ethylene oxide residual testing (ISO 10993-7), packaging validation (ASTMD4169, ASTM F88, ASTM F2096), and shelf life validation (ASTM 1980-99). Inaddition, functional performance (including both the ultrasound and 3D locationsensor components) and mechanical reliability were validated using bench andlaboratory testing. |
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| Catheters perform as originally intended. | |
|---|---|
| Conclusion: | Sterilmed concludes that the Reprocessed 3D Diagnostic Ultrasound ecoCatheters are safe, effective, and substantially equivalent to the predicatedevices, Biosense Webster, Inc. SoundStar eco 8F and eco 8F G UltrasoundCatheters (K140318), as described in this premarket notification submission.The Reprocessed 3D Diagnostic Ultrasound eco Catheters are substantiallyequivalent to the listed predicate devices with respect to their indications foruse (intended use) and technical characteristics. The information and dataprovided in this 510(k) submission identify no new safety or effectivenessissues. |
| VerificationTesting | Description | Pass/Fail |
|---|---|---|
| Joint BondStrength(SM5653/5840) | Test measured tensile strength of device joints toconfirm reprocessing has no effect on device. | Pass |
| Torsional Strength(SM5652/5842) | Test measured the torsional strength of the flexible tipand shaft sections to confirm reprocessing has no effecton device. | Pass |
| Flexation Fatigue(SM5604/5827) | Test measured flexation through maximum range ofdeflection 100 times to confirm that reprocessing has noeffect on device. | Pass |
| Deflection Fatigue(SM5605/5823) | Testing measured deflection in a simulated usemodel through full articulation multiple times toconfirm that reprocessing has no effect on device. | Pass |
| Tip buckling(SM4091/5923) | Testing measured force required to cause tipbuckling, to ensure reprocessing has effect ondevice. | Pass |
| CCS check(SM5523/5822) | Calibration check testing confirmed thatreprocessing has no effect on device's ability tomaintain sensor location. | Pass |
| Auto ID(SM5800/5830) | Testing confirmed that reprocessed devices continueto be identified as Soundstar eco 8F catheters | Pass |
| EEPROM resetverification(SM5802/5841) | Testing confirmed that EEPROM can be effectivelyreset and continue to function as intended onreprocessed devices. | Pass |
| AMCS AcousticVerification(SM5522/5828) | Testing confirmed that Acoustic Manual CalibrationSystem functions for reprocessed devices. | Pass |
| ThrombogenicitytestingSM6020/6828 | Testing confirmed that reprocessed devices do notcause any new risk of thrombus formation. | Pass |
Summary of Performance Testing
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Biocompatibility testing .
Biocompatibility data demonstrates that there is no risk presented by Reprocessed SoundStar eco 8F and eco 8F G Ultrasound Catheters.
- Electromagnetic compatibility (EMC) testing was performed by Sterilmed per IEC 60601-1:2005 AI:2012 3nd Edition Medical electrical equipment - Part 1 General requirements for basic safety and essential performance were the defibrillation, leakage current and functional testing.
Defibrillation
Test report SM 5839 documents the defibrillation protection compliance to the IEC 60601-1:2005 Clause 8.5.5.1 for defibrillation protection testing. IEC 60601-1:2005 Clause 8.5.5.1 for defibrillation protection testing defines a peak value of the differential signal (Yl -Y2) to be less than 1 volt (passing the test). Voltage reading over 1 volt is considered a fail.
Current Leakage and Functional Test
To mitigate the concerns of possible damage to the device due to reprocessing the devices are:
- 100% in-process inspected for electrical insulation via Hi-pot (high potential) . testing, in which each device is subjected to 1500VDC, and electrical leakage is monitored. Reference test report SM5831
- 100% in-process inspected for functionality. ●
IEC 60601-1-2:2007
No physical changes or parts replacement is conducted by Sterilmed during the reprocessing. The devices are unchanged and are identical to the OEM devices as evidenced in functional tests SM5828 - AMCS Check - SoundStar eco 8F within Error! Reference source not found..
IEC 61161:2013
Total emitted acoustic power of ultrasonic transducers was verified and documented in SM5826.
Summary
The Reprocessed 8F Catheters and their predicate devices, the OEM 8F Catheters, have the same intended use and indications for use and fundamental scientific technology. Based on performance testing for the Reprocessed 8F Catheters against the OEM devices discussed above, Sterilmed concludes that the Reprocessed 8F catheters are safe, effective, and substantially equivalent to the predicate OEM 8F catheters.
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).