(184 days)
The TRUE Dilatation™ Catheter is indicated for balloon aortic valvuloplasty.
The Loma Vista Medical (LVM) TRUE Dilatation™ Catheter is a coaxial catheter with a balloon fixed at the tip used for Balloon Aortic Valvuloplasty (BAV) of the aortic valve. The effective length of the catheter is 110 cm and it has two lumens: one lumen is used to inflate and deflate the balloon and the other permits the use of a guidewire to position the catheter. The balloon inflation luer-lock hub (angled) connects to a syringe inflation device to deliver radiopaque contrast media for inflation. The guidewire luer-lock hub (straight) connects to the guidewire lumen.
Here's an analysis of the provided text regarding the acceptance criteria and the study proving the device meets them:
Device: TRUE Dilatation™ Balloon Valvuloplasty Catheter
K Number: K121083
1. Table of Acceptance Criteria and Reported Device Performance
| Test Performed | TRUE Dilatation Acceptance Criteria | TRUE Dilatation Results |
|---|---|---|
| Visual Inspection | When examined with 2.5X magnification, the external surface of the effective length of the catheter shall appear free from extraneous material, and process and surface defects. | 61 of 61 catheters passed. |
| Balloon Preparation Test | Each catheter shall be prepped per the procedure without functional difficulties or anomalies. | 61 of 61 catheters passed. |
| Diameter and Profile Test | Balloon diameter shall not deviate from stated balloon diameter by more than 1mm when inflated to 6 atm. | 61 of 61 catheters passed. |
| Balloon Distensibility | Inflated balloon diameter shall not increase more than 2% between nominal inflation pressure (3 atm) and maximum inflation pressure (6 atm). | 61 of 61 catheters passed. |
| Repeated Balloon Inflation | The balloon catheter shall not herniate or rupture after 10 inflation/deflation cycles to the maximum inflation pressure of 6 atm. | 61 of 61 catheters passed. |
| Balloon Minimum Burst Strength | The results must show statistically that with at least 95% confidence, 99.9% of the balloons will not burst at or below the maximum recommended rated burst pressure. All sizes must withstand a minimum of 6 atm. | A total of 98 samples across all device sizes tested and passed 95% confidence with 99.9% reliability. |
| Balloon Inflation / Deflation Test | The balloon shall inflate in no more than 5 seconds and deflate in no more than 10 seconds. | 60 of 60 catheters met acceptance criteria. |
| Balloon Deflatability Test | There should be no interference with balloon deflation. | As evidenced by observed deflation, 60 of 60 samples passed. |
| Tip Pull and Torque Test | Must withstand at least 10 turns without breaking. | 20 of 20 catheters passed. No reported breaks. There is only 1 shaft size. |
| Bond Strength Test | All bonds must withstand at least 15N (3.4 lbs) pull strength. | 29 of 29 samples passed. |
| Catheter Body Maximum Pressure Test | All samples must withstand 30 ATM (400 psi). | 20 of 20 catheters withstood 30 ATM. |
2. Sample Size Used for the Test Set and Data Provenance
- Bench Testing (Test Set):
- Visual Inspection, Balloon Preparation, Diameter and Profile, Balloon Distensibility, Repeated Balloon Inflation: 61 catheters.
- Balloon Minimum Burst Strength: 98 samples across all device sizes.
- Balloon Inflation/Deflation, Balloon Deflatability: 60 catheters.
- Tip Pull and Torque: 20 catheters (for the single shaft size).
- Bond Strength: 29 samples.
- Catheter Body Maximum Pressure: 20 catheters.
- In Vivo Performance Testing (Clinical Study):
- 69 devices used in 69 clinical procedures.
- Data Provenance: The document states "Two separate European clinical studies were performed." This indicates the data is from Europe and is prospective as it was collected to confirm bench test data and ensure design features meet clinical needs. Additionally, there are mentions of "European commercial launch" further supporting European provenance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Bench Testing: The document does not specify the number or qualifications of experts used to establish ground truth for the bench tests. These tests are typically performed by engineers or technicians following standardized protocols, not clinical experts for "ground truth" as might be defined in an imaging or diagnostic study.
- In Vivo Performance Testing (Clinical Study): The document does not explicitly state how many experts established the "ground truth" (clinical outcomes). However, it mentions "Data collected included device performance, procedural data, and clinical outcomes." This data would have been collected and assessed by the medical staff (e.g., cardiologists, interventional specialists) performing and monitoring the Balloon Aortic Valvuloplasty (BAV) procedures. Their specific qualifications are not detailed, but it's implied they are qualified medical professionals experienced in these procedures.
4. Adjudication Method for the Test Set
- Bench Testing: Adjudication is not applicable in the typical sense (e.g., 2+1, 3+1). These are objective physical and functional tests with predefined pass/fail criteria.
- In Vivo Performance Testing (Clinical Study): The document does not specify an adjudication method for the clinical outcomes data. It simply states that data was collected, and the results provide "objective evidence" of safe and effective use.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The provided text describes bench testing and a clinical study comparing the device's performance to a predicate device in terms of safety and effectiveness in BAV procedures, including pre-dilatation for TAVI. It does not describe an MRMC comparative effectiveness study where human readers interpret cases with and without AI assistance. Therefore, there is no effect size reported for human readers improving with AI vs. without AI assistance, as AI is not a component of this device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
No. This device is a physical medical device (catheter), not an algorithm or AI. Standalone performance studies in this context are not applicable.
7. The Type of Ground Truth Used
- Bench Testing: The ground truth for bench tests is based on objective, measurable physical and functional properties defined by engineering specifications and industry standards (e.g., balloon diameter, inflation/deflation time, burst pressure).
- In Vivo Performance Testing (Clinical Study): The ground truth for the clinical study was based on observed device performance, procedural data, and clinical outcomes during actual patient procedures. This would include direct observation by clinicians and potentially objective measurements taken during the procedure (e.g., pressure gradients, imaging results) and subsequent follow-up for adverse events. The key indicators of success were safe and effective use in BAV procedures, lack of adverse events, and successful subsequent TAVI where applicable.
8. The Sample Size for the Training Set
Not applicable. This device is a physical medical device. It does not involve machine learning or AI, and therefore, no "training set" in the computational sense is mentioned or implied.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
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OCT 1 1 202
| Revised 510(k) Summary | |
|---|---|
| Submitter: | Loma Vista Medical863A Mitten Road, Suite 100ABurlingame, CA 94010Phone: (650) 490-4747Fax: (650) 240-0761Email: paul@lomavistamedical.com |
| Contact Person: | Tiffini Diage1307 South Mary Avenue, Suite 280Sunnyvale, CA 94087Phone: (707) 799-6732Fax: (408) 462-9132Email: tdiage@namsa.com |
| Date Prepared: | 8/27/2012 |
| Trade Name: | TRUE Dilatation™ Balloon Valvuloplasty Catheter |
| Classification: | Class IIBalloon Aortic Valvuloplasty21 CFR 870.1255 |
| Product Code: | OZT |
| Predicate Device(s): | The subject device is equivalent to the following devices:NuCLEUS, 510(k) number K082776 |
| Device Description: | The Loma Vista Medical (LVM) TRUE Dilatation™ Catheter isa coaxial catheter with a balloon fixed at the tip used forBalloon Aortic Valvuloplasty (BAV) of the aortic valve. Theeffective length of the catheter is 110 cm and it has two lumens:one lumen is used to inflate and deflate the balloon and theother permits the use of a guidewire to position the catheter. Theballoon inflation luer-lock hub (angled) connects to a syringeinflation device to deliver radiopaque contrast media forinflation. The guidewire luer-lock hub (straight) connects to theguidewire lumen. |
| Indication for Use: | The TRUE Dilatation™ Catheter is indicated for balloon aorticvalvuloplasty. |
| Functional andSafety Testing: | To verify that the device design met its functional andperformance requirements, representative samples of the deviceunderwent biocompatibility, sterility, packaging integrity, andmechanical testing in accordance with ISO 10993-1 2009, ISO11135-1 2007, ASTM D4169:2009, ISO 10555-1 2009.Additional performance bench testing was performed and issummarized below. |
| In Vivo PerformanceTesting | Two separate European clinical studies were performed toconfirm bench test data, to ensure design features continue to |
| meet clinical needs, and to provide in vivo data to demonstratesafe and effective use of the TRUE Dilatation Catheter as to thepredicate device. Data collected included device performance,procedural data, and clinical outcomes. Data was collected for69 devices used in 69 clinical procedures. | |
| The data provides objective evidence that the TRUE DilatationCatheter can be used safely and effectively in BAV procedurescompared to the predicate device. In addition, the clinicalexperience confirms that the TRUE Dilatation Catheter can besuccessfully used for pre-dilatation prior to transcatheter aorticvalve implantation, in comparison to the predicate. The successof the TAVI procedure confirms that the TRUE DilatationCatheter as effective as the predicate in BAV procedures andallows for successful placement of TAVI devices. The absenceof any adverse events (0/69) indicates that the device is safe ascompared to the predicate. In addition, there have been noreports of any adverse events since the European commerciallaunch representing more than 400 TRUE procedures to date.The absence of device failures and device related adverse eventsdemonstrates the equivalency of the TRUE Dilatation Catheterto the predicate NuCLEUS device. | |
| Conclusion: | Loma Vista Medical considers the TRUE Dilatation Catheter tobe substantially equivalent to the predicate device listed above.This conclusion is based upon the devices' similarities inprinciples of operation, performance requirements, andindications for use. |
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| Test Performed | TRUE Dilatation Acceptance Criteria | TRUE Dilatation Results |
|---|---|---|
| Visual Inspection | When examined with 2.5X magnification, the external surface of the effective length of the catheter shall appear free from extraneous material, and process and surface defects. | 61 of 61 catheters passed. |
| BalloonPreparation Test | Each catheter shall be prepped per the procedure without functional difficulties or anomalies. | 61 of 61 catheters passed. |
| Diameter andProfile Test | Balloon diameter shall not deviate from stated balloon diameter by more than 1mm when inflated to 6 atm. | 61 of 61 catheters passed. |
| BalloonDistensibility | Inflated balloon diameter shall not increase more than 2% between nominal inflation pressure (3 atm) and maximum inflation pressure (6 atm). | 61 of 61 catheters passed. |
| Repeated BalloonInflation | The balloon catheter shall not herniate or rupture after 10 inflation/deflation cycles to the maximum inflation pressure of 6 atm. | 61 of 61 catheters passed. |
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| Test Performed | TRUE Dilatation Acceptance Criteria | TRUE Dilatation Results |
|---|---|---|
| Balloon MinimumBurst Strength | The results must show statistically that withat least 95% confidence,99.9% of the balloons will not burst at orbelow the maximum recommended ratedburst pressure. All sizes must withstand aminimum of 6 atm. | A total of 98 samples across alldevice sizes tested and passed 95%confidence with 99.9% reliability. |
| Balloon Inflation /Deflation Test | The balloon shall inflate in no more than 5seconds and deflate in no more than 10seconds. | 60 of 60 catheters met acceptancecriteria. |
| BalloonDeflatability Test | There should be no interference with balloondeflation. | As evidenced by observed deflation,60 of 60 samples passed. |
| Tip Pull andTorque Test | Must withstand at least 10 turns withoutbreaking. | 20 of 20 catheters passed. Noreported breaks. There is only 1shaft size. |
| Bond Strength Test | All bonds must withstand at least 15N (3.4lbs) pull strength. | 29 of 29 samples passed. |
| Catheter BodyMaximum PressureTest | All samples must withstand 30ATM (400 psi). | 20 of 20 catheters withstood 30ATM. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined serpents. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus. The seal is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002
OCT 11 2012
Loma Vista Medical c/o Ms. Tiffini Diage Regulatory Project Manager, NAMSA 1307 South Mary Avenue, Suite 280 Sunnyvale, CA 94807
Re: K121083
Trade Name: TRUE Dilatation™ Balloon Valvuloplasty Catheter Regulation Number: 21 CFR 870.1255 Regulation Name: Balloon Aortic Valvuloplasty Catheter Regulatory Class: Class II (two) Product Code: OZT Dated: August 24, 2012 Received: August 28, 2012
Dear Ms. Diage:
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 - Ms. Tiffini Diage
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 (OS) 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
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Indications for Use
510(k) Number (if known): K121083
Device Name: TRUE Dilatation Balloon Valvuloplasty Catheter
Indications For Use:
The TRUE Dilatation Balloon Valvuloplasty Catheter is indicated for balloon aortic valvuloplasty.
Over-The-Counter Use Prescription Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Division Rign-Off) Division of Cordiovascular Devices 510(k) Mumber .. K12) 083
§ 870.1255 Balloon aortic valvuloplasty catheter.
(a)
Identification. A balloon aortic valvuloplasty catheter is a catheter with a balloon at the distal end of the shaft, which is intended to treat stenosis in the aortic valve when the balloon is expanded.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The device must be demonstrated to be biocompatible.
(2) Sterility and shelf life testing must demonstrate the sterility of patient-contacting components and the shelf life of these components.
(3) Non-clinical performance evaluation must demonstrate that the device performs as intended under anticipated conditions of use, including device delivery, inflation, deflation, and removal.
(4) In vivo evaluation of the device must demonstrate device performance, including the ability of the device to treat aortic stenosis.
(5) Labeling must include a detailed summary of the device-related and procedure-related complications pertinent to the use of the device.