(184 days)
NuCLEUS, K082776
Not Found
No
The summary describes a mechanical balloon catheter and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is indicated for "balloon aortic valvuloplasty," which is a medical procedure performed to treat a medical condition (aortic valve stenosis), directly aligning with the definition of a therapeutic device.
No
The device is a therapeutic balloon catheter used for balloon aortic valvuloplasty, a treatment procedure, not for diagnosis.
No
The device description clearly describes a physical catheter with a balloon, lumens, and hubs, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Function: The TRUE Dilatation™ Catheter is a medical device used inside the body during a surgical procedure (Balloon Aortic Valvuloplasty). It is used to physically dilate the aortic valve.
- Intended Use: The intended use clearly states "balloon aortic valvuloplasty," which is a therapeutic procedure performed on a patient.
The device description and intended use clearly indicate that this is an invasive medical device used for treatment, not for diagnostic testing of samples outside the body.
N/A
Intended Use / Indications for Use
The TRUE Dilatation™ Catheter is indicated for balloon aortic valvuloplasty.
Product codes (comma separated list FDA assigned to the subject device)
OZT
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
aortic valve
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: To verify that the device design met its functional and performance requirements, representative samples of the device underwent biocompatibility, sterility, packaging integrity, and mechanical testing in accordance with ISO 10993-1 2009, ISO 11135-1 2007, ASTM D4169:2009, ISO 10555-1 2009. Additional performance bench testing was performed and is summarized below.
In Vivo Performance Testing: Two separate European clinical studies were performed to confirm bench test data, to ensure design features continue to meet clinical needs, and to provide in vivo data to demonstrate safe and effective use of the TRUE Dilatation Catheter as to the predicate device. Data collected included device performance, procedural data, and clinical outcomes. Data was collected for 69 devices used in 69 clinical procedures. The data provides objective evidence that the TRUE Dilatation Catheter can be used safely and effectively in BAV procedures compared to the predicate device. In addition, the clinical experience confirms that the TRUE Dilatation Catheter can be successfully used for pre-dilatation prior to transcatheter aortic valve implantation, in comparison to the predicate. The success of the TAVI procedure confirms that the TRUE Dilatation Catheter as effective as the predicate in BAV procedures and allows for successful placement of TAVI devices. The absence of any adverse events (0/69) indicates that the device is safe as compared to the predicate. In addition, there have been no reports of any adverse events since the European commercial launch representing more than 400 TRUE procedures to date. The absence of device failures and device related adverse events demonstrates the equivalency of the TRUE Dilatation Catheter to the predicate NuCLEUS device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Key Metrics are presented in table format for "Functional and Safety Testing" and include a pass rate for each test.
- Visual Inspection: 61 of 61 catheters passed.
- Balloon Preparation Test: 61 of 61 catheters passed.
- Diameter and Profile Test: 61 of 61 catheters passed.
- Balloon Distensibility: 61 of 61 catheters passed.
- Repeated Balloon Inflation: 61 of 61 catheters passed.
- Balloon Minimum Burst Strength: A total of 98 samples across all device sizes tested and passed 95% confidence with 99.9% reliability.
- Balloon Inflation / Deflation Test: 60 of 60 catheters met acceptance criteria.
- Balloon Deflatability Test: As evidenced by observed deflation, 60 of 60 samples passed.
- Tip Pull and Torque Test: 20 of 20 catheters passed. No reported breaks.
- Bond Strength Test: 29 of 29 samples passed.
- Catheter Body Maximum Pressure Test: 20 of 20 catheters withstood 30 ATM.
Key Metrics for "In Vivo Performance Testing":
- Absence of any adverse events (0/69)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
NuCLEUS, 510(k) number K082776
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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OCT 1 1 202
| Revised 510(k) Summary | |
|---|---|
| Submitter: | Loma Vista Medical |
| 863A Mitten Road, Suite 100A | |
| Burlingame, CA 94010 | |
| Phone: (650) 490-4747 | |
| Fax: (650) 240-0761 | |
| Email: paul@lomavistamedical.com | |
| Contact Person: | Tiffini Diage |
| 1307 South Mary Avenue, Suite 280 | |
| Sunnyvale, CA 94087 | |
| Phone: (707) 799-6732 | |
| Fax: (408) 462-9132 | |
| Email: tdiage@namsa.com | |
| Date Prepared: | 8/27/2012 |
| Trade Name: | TRUE Dilatation™ Balloon Valvuloplasty Catheter |
| Classification: | Class II |
| Balloon Aortic Valvuloplasty | |
| 21 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 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. | |
| Indication for Use: | The TRUE Dilatation™ Catheter is indicated for balloon aortic |
| valvuloplasty. | |
| Functional and | |
| Safety Testing: | To verify that the device design met its functional and |
| performance requirements, representative samples of the device | |
| underwent biocompatibility, sterility, packaging integrity, and | |
| mechanical testing in accordance with ISO 10993-1 2009, ISO | |
| 11135-1 2007, ASTM D4169:2009, ISO 10555-1 2009. | |
| Additional performance bench testing was performed and is | |
| summarized below. | |
| In Vivo Performance | |
| Testing | Two separate European clinical studies were performed to |
| confirm bench test data, to ensure design features continue to | |
| meet clinical needs, and to provide in vivo data to demonstrate | |
| safe and effective use of the TRUE Dilatation Catheter as to the | |
| predicate device. Data collected included device performance, | |
| procedural data, and clinical outcomes. Data was collected for | |
| 69 devices used in 69 clinical procedures. | |
| The data provides objective evidence that the TRUE Dilatation | |
| Catheter can be used safely and effectively in BAV procedures | |
| compared to the predicate device. In addition, the clinical | |
| experience confirms that the TRUE Dilatation Catheter can be | |
| successfully used for pre-dilatation prior to transcatheter aortic | |
| valve implantation, in comparison to the predicate. The success | |
| of the TAVI procedure confirms that the TRUE Dilatation | |
| Catheter as effective as the predicate in BAV procedures and | |
| allows for successful placement of TAVI devices. The absence | |
| of any adverse events (0/69) indicates that the device is safe as | |
| compared to the predicate. In addition, there have been no | |
| reports of any adverse events since the European commercial | |
| launch representing more than 400 TRUE procedures to date. | |
| The absence of device failures and device related adverse events | |
| demonstrates the equivalency of the TRUE Dilatation Catheter | |
| to the predicate NuCLEUS device. | |
| Conclusion: | Loma Vista Medical considers the TRUE Dilatation Catheter to |
| be substantially equivalent to the predicate device listed above. | |
| This conclusion is based upon the devices' similarities in | |
| principles of operation, performance requirements, and | |
| indications 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. |
| 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. |
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:
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| Test Performed | TRUE Dilatation Acceptance Criteria | TRUE Dilatation Results |
|---|---|---|
| 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. |
:
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3
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
5
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