(154 days)
No
The summary describes a reprocessed ultrasound catheter with a location sensor. There is no mention of AI or ML in the intended use, device description, or performance studies. The focus is on the reprocessing and functional equivalence to the original device.
No
The device is described as a "diagnostic" ultrasound catheter used for "intra-luminal visualization" and providing "location information," indicating its purpose is to aid in diagnosis or navigation rather than to directly treat a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "indicated for intra-luminal visualization of cardiac and great vessel anatomy and physiology," which is a diagnostic purpose. Additionally, the device's name itself includes "Diagnostic Ultrasound."
No
The device description explicitly states it is a catheter with embedded hardware components (ultrasound transducer and magnetic location sensor).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart." This describes a device used within the body for imaging and navigation, not for testing samples outside the body to diagnose conditions.
- Device Description: The description details an "IntraCardiac Echo (ICE) Catheter" with an ultrasound transducer and magnetic location sensor. This is a device designed for direct interaction with internal anatomy.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on these samples to provide diagnostic information. The device provides real-time imaging and location information in vivo.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / Indications for Use
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.
Product codes
OWO, OWQ
Device Description
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. Note: Only the catheter is the subject of this submission. Accessories and/or any other related equipment are not included in the scope of this submission.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Cardiac and great vessel anatomy
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Functional and Safety Testing: Representative samples of reprocessed devices were tested to demonstrate appropriate functional characteristics. Process validation testing was performed to validate the cleaning and sterilization procedures as well as device packaging. In addition, the manufacturing process includes visual and validated functional testing of all products produced. Where appropriate prior validation testing of previously cleared Reprocessed 3D Diagnostic Ultrasound eco Catheter K110076 and Reprocessed AcuNav Imaging Catheter K043453 was utilized for the same reprocessing procedures, equipment, sterile barrier and sterilization processing. The Reprocessed 3D Diagnostic Ultrasound eco Catheters are reprocessed no more than three (3) times. Each device is marked and tracked through each reprocessing cycle. After the device has reached the maximum number of reprocessing cycles (3), the device is rejected from further reprocessing. Reprocessing is performed only by the manufacturer Sterilmed, Inc.
Specific non-clinical tests performed included: cleaning validation, sterilization validation (ISO 11135, USP ), biocompatibility testing (ISO 10993-1), ethylene oxide residual testing (ISO 10993-7), packaging validation (ASTM D4169, ASTM F88, ASTM F2096), and shelf life validation (ASTM 1980-99). In addition, functional performance (including both the ultrasound and 3D location sensor components) and mechanical reliability were validated using bench and laboratory testing. Catheters perform as originally intended.
Verification Testing:
- Joint Bond Strength (SM5653/5840): Test measured tensile strength of device joints to confirm reprocessing has no effect on device. (Pass)
- Torsional Strength (SM5652/5842): Test measured the torsional strength of the flexible tip and shaft sections to confirm reprocessing has no effect on device. (Pass)
- Flexation Fatigue (SM5604/5827): Test measured flexation through maximum range of deflection 100 times to confirm that reprocessing has no effect on device. (Pass)
- Deflection Fatigue (SM5605/5823): Testing measured deflection in a simulated use model through full articulation multiple times to confirm that reprocessing has no effect on device. (Pass)
- Tip buckling (SM4091/5923): Testing measured force required to cause tip buckling, to ensure reprocessing has effect on device. (Pass)
- CCS check (SM5523/5822): Calibration check testing confirmed that reprocessing has no effect on device's ability to maintain sensor location. (Pass)
- Auto ID (SM5800/5830): Testing confirmed that reprocessed devices continue to be identified as Soundstar eco 8F catheters. (Pass)
- EEPROM reset verification (SM5802/5841): Testing confirmed that EEPROM can be effectively reset and continue to function as intended on reprocessed devices. (Pass)
- AMCS Acoustic Verification (SM5522/5828): Testing confirmed that Acoustic Manual Calibration System functions for reprocessed devices. (Pass)
- Thrombogenicity testing SM6020/6828: Testing confirmed that reprocessed devices do not cause any new risk of thrombus formation. (Pass)
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: 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.
Conclusion: Sterilmed concludes that the Reprocessed 3D Diagnostic Ultrasound eco Catheters are safe, effective, and substantially equivalent to the predicate devices, Biosense Webster, Inc. SoundStar eco 8F and eco 8F G Ultrasound Catheters (K140318), as described in this premarket notification submission. The Reprocessed 3D Diagnostic Ultrasound eco Catheters are substantially equivalent to the listed predicate devices with respect to their indications for use (intended use) and technical characteristics. The information and data provided in this 510(k) submission identify no new safety or effectiveness issues.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
1
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
2
K161700
Models intended for reprocessing
| Original
Manufacturer | OEM
Model
Number | Reprocessed
Product Code | Description |
|---------------------------|------------------------|-----------------------------|--------------------------------------------------------------------------------------------------------------------|
| Biosense Webster,
Inc. | 10439011 | R10439011 | SoundStar® eco Diagnostic
Ultrasound Catheter, 8F, 90 cm
length. For use with Siemens
ultrasound systems. |
| Biosense Webster,
Inc. | 10439236 | R10439236 | SoundStar® eco Diagnostic
Ultrasound Catheter, 8F, 90 cm
length. For use with GE ultrasound
systems. |
3
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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4
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 Gibson
Sterilmed, Inc.
5010 Cheshire Parkway, Suite 2
Plymouth, MN 55446 |
|---------------------------------|----------------------------------------------------------------------------------------------------------|
| Manufacturing Facility Address: | 11400 73rd Avenue North
Maple Grove, MN 55369 |
| Primary Contact: | Neelu Gibson
Sterilmed, Inc.
Tel: 908-705-3160
Fax: 763-488-3350
Email: ngibson9@its.jnj.com |
| Date of Submission: | 21 May, 2016 |
| Trade Name: | Reprocessed 3D Diagnostic Ultrasound
eco Catheters |
| Regulation Name: | Diagnostic Intravascular Catheter |
| Device Classification: | Class II |
| Product Code: | OWQ |
510(k) Summary - K161700
| Predicate
Device: | Biosense Webster, Inc.: SoundStar eco 8F G Ultrasound Catheter, and SoundStar
eco 8F Ultrasound Catheter (510(k) K140318) |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Secondary /
Reference
Predicates | Sterilmed Inc: Reprocessed 3D Ultrasound Diagnostic Catheter (510(k) K110076)
Sterilmed Inc: Reprocessed Ivus Imaging Catheter (510(k) K043453) |
| Device
Description: | 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. |
| | Note: Only the catheter is the subject of this submission. Accessories and/or any
other related equipment are not included in the scope of this submission. The table
below lists the specific model numbers that are the subject of this submission. |
5
Image /page/5/Picture/0 description: The image shows the logo for STERILMED. The logo features a stylized, partially circular graphic on the left, with the word "STERILMED" in a sans-serif font to the right of the graphic. The graphic is two-toned, with the upper portion in silver and the lower portion in green.
| Original
Manufacturer | OEM
Model
Number | Reprocessed
Product
Code | Description |
|---------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|--------------------------------------------------------------------------------------------------------------------|
| Biosense Webster,
Inc. | 10439011 | R10439011 | SoundStar® eco Diagnostic
Ultrasound Catheter, 8F, 90 cm
length. For use with Siemens
ultrasound systems. |
| Biosense Webster,
Inc. | 10439236 | R10439236 | SoundStar® eco Diagnostic
Ultrasound Catheter, 8F, 90 cm
length. For use with GE ultrasound
systems. |
| Indications for
Use: | The Reprocessed 3D Diagnostic Ultrasound eco Catheters are indicated for intra-
cardiac and 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. | | |
| Technological
Characteristics: | The Reprocessed 3D Diagnostic Ultrasound eco Catheters are identical to the
predicate devices in design, materials of construction, and intended use. There are
no changes to the clinical applications, patient population, performance
specifications, or method of operation. | | |
| Functional and
Safety Testing: | Representative samples of reprocessed devices were tested to demonstrate
appropriate functional characteristics.
Process validation testing was performed to validate the cleaning and sterilization
procedures as well as device packaging. In addition, the manufacturing process
includes visual and validated functional testing of all products produced.
Where appropriate prior validation testing of previously cleared Reprocessed 3D
Diagnostic Ultrasound eco Catheter K110076 and Reprocessed AcuNav Imaging
Catheter K043453 was utilized for the same reprocessing procedures, equipment,
sterile barrier and sterilization processing. The Reprocessed 3D Diagnostic
Ultrasound eco Catheters are reprocessed no more than three (3) times. Each device
is marked and tracked through each reprocessing cycle. After the device has
reached the maximum number of reprocessing cycles (3), the device is rejected
from further reprocessing. Reprocessing is performed only by the manufacturer
Sterilmed, Inc. | | |
| Summary of
Non-Clinical
Tests
Conducted: | Specific non-clinical tests performed included: cleaning validation, sterilization
validation (ISO 11135, USP ), biocompatibility testing (ISO 10993-1),
ethylene oxide residual testing (ISO 10993-7), packaging validation (ASTM
D4169, ASTM F88, ASTM F2096), and shelf life validation (ASTM 1980-99). In
addition, functional performance (including both the ultrasound and 3D location
sensor components) and mechanical reliability were validated using bench and
laboratory testing. | | |
6
Image /page/6/Picture/0 description: The image shows the logo for STERILMED. The logo features a stylized, circular graphic on the left, with the word "STERILMED" in a simple, sans-serif font to the right of the graphic. The graphic is two-toned, with the top portion in silver and the bottom portion in green.
| Catheters perform as originally intended. | |
|---|---|
| Conclusion: | Sterilmed concludes that the Reprocessed 3D Diagnostic Ultrasound eco |
| Catheters are safe, effective, and substantially equivalent to the predicate | |
| devices, Biosense Webster, Inc. SoundStar eco 8F and eco 8F G Ultrasound | |
| Catheters (K140318), as described in this premarket notification submission. | |
| The Reprocessed 3D Diagnostic Ultrasound eco Catheters are substantially | |
| equivalent to the listed predicate devices with respect to their indications for | |
| use (intended use) and technical characteristics. The information and data | |
| provided in this 510(k) submission identify no new safety or effectiveness | |
| issues. |
| Verification
Testing | Description | Pass/
Fail |
|------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|
| Joint Bond
Strength
(SM5653/5840) | Test measured tensile strength of device joints to
confirm reprocessing has no effect on device. | Pass |
| Torsional Strength
(SM5652/5842) | Test measured the torsional strength of the flexible tip
and shaft sections to confirm reprocessing has no effect
on device. | Pass |
| Flexation Fatigue
(SM5604/5827) | Test measured flexation through maximum range of
deflection 100 times to confirm that reprocessing has no
effect on device. | Pass |
| Deflection Fatigue
(SM5605/5823) | Testing measured deflection in a simulated use
model through full articulation multiple times to
confirm that reprocessing has no effect on device. | Pass |
| Tip buckling
(SM4091/5923) | Testing measured force required to cause tip
buckling, to ensure reprocessing has effect on
device. | Pass |
| CCS check
(SM5523/5822) | Calibration check testing confirmed that
reprocessing has no effect on device's ability to
maintain sensor location. | Pass |
| Auto ID
(SM5800/5830) | Testing confirmed that reprocessed devices continue
to be identified as Soundstar eco 8F catheters | Pass |
| EEPROM reset
verification
(SM5802/5841) | Testing confirmed that EEPROM can be effectively
reset and continue to function as intended on
reprocessed devices. | Pass |
| AMCS Acoustic
Verification
(SM5522/5828) | Testing confirmed that Acoustic Manual Calibration
System functions for reprocessed devices. | Pass |
| Thrombogenicity
testing
SM6020/6828 | Testing confirmed that reprocessed devices do not
cause any new risk of thrombus formation. | Pass |
Summary of Performance Testing
7
Image /page/7/Picture/0 description: The image shows the logo for STERILMED. The logo features a stylized, circular graphic on the left, with the word "STERILMED" in a combination of bold and light gray text to the right. The circular graphic appears to be a stylized recycling symbol, with the top half in silver and the bottom half in green.
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.