(219 days)
The Reprocessed 3D Diagnostic Ultrasound 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. The 3D Diagnostic Ultrasound Catheter provides location information when used with the CARTO® XP EP Navigation System Version 9 or greater.
SterilMed Reprocessed 3D Diagnostic Ultrasound Catheters are specially designed catheters that provide two-dimensional imaging using an ultrasound transducer and three-dimensional location information using a location sensor. The ultrasound transducer and location sensor are at the distal tip of the catheter and can be positioned for ultrasound imaging and 3D mapping by a steering mechanism that rotates the catheter tip and provides variable deflection. 3D Diagnostic Ultrasound Catheters incorporate a hand piece, a flexible shaft and a distal tip section containing an ultrasound transducer and a location sensor. The ultrasound transducer of this device has an acoustic array that is identical to the AcuNav™ 10F Diagnostic Ultrasound Catheter. The 3D Diagnostic Ultrasound Catheter's 3D location sensor provides location information to the CARTO® XP EP Navigation System (mapping system). The 3D Diagnostic Ultrasound Catheters is 10 French with a 90 cm insertion length.
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 provided text describes the 510(k) summary for Reprocessed 3D Diagnostic Ultrasound Catheters. This document details the substantial equivalence to predicate devices and outlines functional and safety testing. However, it does not contain the specific information requested in the prompt regarding acceptance criteria and a study proving device performance in the context of AI/algorithm performance.
Here's a breakdown of why the requested information cannot be fully extracted and what can be inferred:
Why the requested information cannot be fully extracted:
- No AI/Algorithm Component: The document describes a reprocessed physical medical device (ultrasound catheters). It does not mention any artificial intelligence (AI) component, algorithm, or software that performs diagnostic analysis. The "3D location sensor" provides data to a "mapping system" (CARTO® XP EP Navigation System), but the catheter itself is the device being described, not an AI interpreting the data from it.
- Focus on Reprocessing and Substantial Equivalence: The primary purpose of this 510(k) submission is to demonstrate that the reprocessed catheters are as safe and effective as their original, new counterparts and existing predicate devices. The "studies" mentioned are focused on the safety and functionality of the reprocessed hardware (cleaning validation, sterilization, biocompatibility, mechanical reliability, electrical safety), not on the diagnostic performance of an AI model.
- Lack of Performance Metrics for AI: Consequently, there are no acceptance criteria related to sensitivity, specificity, AUC, etc., for an AI model. There's no test set, training set, or ground truth establishment relevant to AI performance.
Based on the provided text, here's what can be answered or inferred about the device and its testing, excluding AI-specific details:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a physical reprocessed device and not an AI or diagnostic algorithm in the sense implied by the prompt, the "acceptance criteria" and "performance" relate to the physical and functional integrity after reprocessing, as well as its equivalence to predicate devices.
| Acceptance Criteria Category | Description / Test | Reported Device Performance / Outcome |
|---|---|---|
| Cleaning Validation | Demonstrating that cleaning procedures effectively remove contaminants. | Process validation testing was performed to validate cleaning procedures. Specific results not detailed, but implied successful validation. |
| Sterilization Validation | Ensuring the device is sterile after reprocessing (ISO 11135, USP <71>). | Process validation testing was performed to validate sterilization procedures. Specific results not detailed, but implied successful validation according to ISO 11135 and USP <71>. |
| Biocompatibility Testing | Ensuring the reprocessed materials are safe for patient contact (ISO 10993-1). | Biocompatibility testing (ISO 10993-1) was performed. Specific results not detailed, but implied successful testing. |
| Ethylene Oxide Residuals | Measuring residual levels of ethylene oxide (if applicable) (ISO 10993-7). | Ethylene oxide residual testing (ISO 10993-7) was performed. Specific results not detailed, but implied successful testing. |
| Cleaning Residuals | Testing for residues left after the cleaning process. | Cleaning residuals testing was performed. Specific results not detailed, but implied successful testing. |
| Packaging Validation | Ensuring package integrity and sterility maintenance (ASTM D4169, ASTM F88, ASTM F2096). | Packaging validation (ASTM D4169, ASTM F88, ASTM F2096) was performed. Specific results not detailed, but implied successful validation. |
| Shelf Life Validation | Determining the period the device maintains its function and sterility. | Shelf life validation (ASTM 1980-99) was performed. Specific results not detailed, but implied successful validation. |
| Functional Performance | Verifying the proper operation of the ultrasound and 3D location sensor components. Includes aspects like ultrasound acoustic array identical to AcuNav™ 10F, and location information compatibility with CARTO® XP EP Navigation System. | Functional performance (including both the ultrasound and 3D location sensor components) was validated using bench and laboratory testing. The device is said to have an "acoustic array that is identical to the AcuNav™ 10F Diagnostic Ultrasound Catheter" and provides "location information to the CARTO® XP EP Navigation System Version 9 or greater." Implied successful performance matching predicate. |
| Mechanical Reliability | Assessing the physical durability and integrity of the catheter (e.g., steering mechanism, shaft flexibility). | Mechanical reliability was validated using bench and laboratory testing. Specific results not detailed, but implied successful validation. |
| Electrical Safety (Hipot) | Ensuring electrical insulation integrity (IEC 60601-1:2005, Clause 8.8.3). | Hipot testing (IEC 60601-1:2005, Clause 8.8.3) was performed. Specific results not detailed, but implied successful testing. |
| Electrical Safety (Defib) | Ensuring resistance to defibrillator discharge (IEC 60601-1:2005, Clause 8.5.5.1). | Defibrillation testing (IEC 60601-1:2005, Clause 8.5.5.1) was performed. Specific results not detailed, but implied successful testing. |
| Temperature Heating | Assessing temperature rise during operation (IEC 60601-2-27). | Temperature heating (IEC 60601-2-27) was performed. Specific results not detailed, but implied successful testing. |
| Substantial Equivalence | Overall conclusion that the reprocessed device is as safe and effective as the predicate devices. | The Reprocessed 3D Diagnostic Ultrasound Catheters are substantially equivalent to the Biosense Webster, Inc. SOUNDSTAR™ 3D Diagnostic Ultrasound Catheter and AcuNav™ Diagnostic Ultrasound Catheter based on functional design, materials, indications for use, and methods of construction. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size (Test Set): Not specified in terms of a "test set" for diagnostic performance, as it's not an AI/algorithm. However, representative samples of the reprocessed catheters were used for functional and safety testing. The exact number of units tested for each specific test is not provided in this summary.
- Data Provenance: Not applicable in the context of diagnostic data. The tests were performed in a laboratory/bench setting, likely in the US (where SterilMed, Inc. is located).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable: This criterion relates to diagnostic algorithms/AI. For a reprocessed physical device, "ground truth" refers to established engineering standards, material properties, and biological safety standards (e.g., ISO, ASTM, USP). The "experts" would be testing engineers, microbiologists, quality control personnel, etc., ensuring the device meets these pre-defined specifications. The document does not detail the number or specific qualifications of these personnel.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable: Adjudication methods are typically used for establishing consensus ground truth in diagnostic studies. For engineering and safety tests, the results are typically objectively measured against established pass/fail criteria or reference standards.
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 is related to diagnostic algorithms/AI. This document describes a physical medical device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No: This is related to diagnostic algorithms/AI. This document describes a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Engineering and Safety Standards: The "ground truth" for the reprocessed catheter's performance is adherence to established international and national standards for medical device safety and functionality (e.g., ISO 11135, USP <71>, ISO 10993-1 and -7, ASTM D4169, ASTM F88, ASTM F2096, ASTM 1980-99, IEC 60601-1:2005, IEC 60601-2-27), and demonstrating equivalence to the original predicate devices' performance characteristics.
8. The sample size for the training set
- Not Applicable: There is no "training set" as this is not an AI/algorithm.
9. How the ground truth for the training set was established
- Not Applicable: There is no "training set."
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AUG 1 8 2011
January 10 2011 For Reprocessed 3D Diagnostic Uhrasound Catheters
SUMMARY AND CERTIFICATION I.
STE
RILMED IN
A.
| 510(k) Summary | |
|---|---|
| Submitter: | SterilMed, Inc. |
| Contact Person: | Onya Dendinger11400 73rd Avenue NorthMaple Grove, MN 55369Ph: 763-488-3410Fax: 763-488-2051 |
| Date Prepared: | January 10, 2011 |
| Trade Name: | Reprocessed 3D Diagnostic Ultrasound Catheter |
| Classification Name: | Diagnostic Intravascular Catheter |
| Panel: | 74 |
| Classification Number: | 21 CFR § 870.1200 |
| Product Code: | OWQ, Catheter, Intravascular Ultrasound, Reprocessed |
| Class: | II |
| Predicate Devices: | The Reprocessed 3D Diagnostic Ultrasound Catheters are substantially equivalent to the Biosense Webster,Inc. SoundStar™ 3D Diagnostic Ultrasound Catheter (510(k) K070242) and the AcuNav™ DiagnosticUltrasound Catheter (510(k) K033650). |
|---|---|
| Device Description: | SterilMed Reprocessed 3D Diagnostic Ultrasound Catheters are specially designed catheters that providetwo-dimensional imaging using an ultrasound transducer and three-dimensional location information using alocation sensor. The ultrasound transducer and location sensor are at the distal tip of the catheter and can bepositioned for ultrasound imaging and 3D mapping by a steering mechanism that rotates the catheter tip andprovides variable deflection. 3D Diagnostic Ultrasound Catheters incorporate a hand piece, a flexible shaftand a distal tip section containing an ultrasound transducer and a location sensor. The ultrasound transducerof this device has an acoustic array that is identical to the AcuNav™ 10F Diagnostic Ultrasound Catheter.The 3D Diagnostic Ultrasound Catheter's 3D location sensor provides location information to the CARTO®XP EP Navigation System (mapping system). The 3D Diagnostic Ultrasound Catheters is 10 French with a90 cm insertion length. |
| Note: Only the catheter is the subject of this submission; accessories and/or any other related equipment arenot included in the scope of this submission. | |
| Intended Use: | The Reprocessed 3D Diagnostic Ultrasound Catheters are indicated for intra-cardiac and intra-luminalvisualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices inthe heart. The 3D Diagnostic Ultrasound Catheter provides location information when used with theCARTO® XP EP Navigation System Version 9 or greater. |
| Functional andSafety Testing: | Representative samples of Reprocessed 3D Diagnostic Ultrasound Catheters were tested to demonstrateappropriate functional characteristics. Process validation testing was performed to validate the cleaning andsterilization procedures as well as device packaging. In addition, the manufacturing process includes visualand validated functional testing of all products produced. |
| Summary of Non-clinical TestsConducted: | Specific non-clinical tests performed included: cleaning validation, sterilization validation (ISO 11135, USP<71>), biocompatibility testing (ISO 10993-1), ethylene oxide residual testing (ISO 10993-7), biologicaltesting, cleaning residuals, packaging validation (ASTM D4169, ASTM F88, ASTM F2096), and shelf lifevalidation (ASTM 1980-99). In addition, functional performance (including both the ultrasound and 3Dlocation sensor components) and mechanical reliability were validated using bench and laboratory testing,The testing which was performed include Hipot testing (IEC 60601-1:2005, Cause 8.8.3), defibrillationtesting (IEC 60601-1:2005, Clause 8.5.5.1), and temperature heating (IEC 60601-2-27). |
Page 1 of 2
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STERILME
Small Equipment & Instrument Repair
January 10 2011 For Reprocessed 3D Diagnostic Ultrasound Catheters
| Conclusion: | The Reprocessed 3D Diagnostic Ultrasound Catheters are substantially equivalent to the Biosense Webster, Inc. SOUNDSTAR™ 3D Diagnostic Ultrasound Catheter and AcuNav™ Diagnostic Ultrasound Catheter. |
|---|---|
| This conclusion is based upon the devices' similarities in functional design (principle of operation), materials, indications for use and methods of construction. |
Page 2 OF 2
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three curved lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
SterilMed, Inc. c/o Ms. Onya Dendinger Regulatory Affairs Manager 11400 73td Avenue North Maple Grove, MN 55369
AUG 1 8 2011
Re: K110076
Trade/Device Name: Reprocessed 3D Ultrasound Catheter (See Enclosed List) Regulatory Number: 21 CFR 870.1200 Regulation Name: Diagnostic intravascular catheter Regulatory Class: II (two) Product Code: 74 OWQ Dated: July 15, 2011 Received: July 18, 2011
Dear Ms. Dendigner:
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. Ilsting of devices, good manufacturing practice. labeling, and prohibitions against misbranding and adulteration.
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 – Ms. Onya Dendinger
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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
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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Page 3 – Ms. Onya Dendinger
DEVICE MODEL COVERED BY THIS SUBMISSION:
:
| Manufacturer | Trade Name | Description |
|---|---|---|
| Company of the considered to a comments of the considered and any and any and any and any and any and any and any and any and any and any and any and any and any and any and | Biosense Webster, Inc. SoundStar™ 3D Ultrasound Catheter SNDSTRI0 - 10 French, 90 cm length |
.
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Image /page/5/Picture/0 description: The image shows the logo for STERILMED, INC. The text below the company name indicates that they specialize in medical device reprocessing. They also offer small equipment and instrument repair services. The logo is simple and professional, with a focus on the company name.
Indications for Use
510(k) Number (if known):
KIDO76
Fe(III) TAMLs (H-TAMLs)
Device Name: Reprocessed 3D Diagnostic Ultrasound Catheters
Indications for Use:
The Reprocessed 3D Diagnostic Ultrasound 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 3D Diagnostic Ultrasound Catheter provides location information when used with the CARTO® XP EP Navigation System Version 9 or greater.
| Prescription Use | X |
|---|---|
| (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 of Cardiovascular Devices
510(k) Number k//0076
§ 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).