(30 days)
The True Dilatation Catheter is indicated for balloon aortic valvuloplasty.
The 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. The balloon functions by connecting an inflation device to the angled luer lock and injecting contrast/sailine into the inflation lumen; which inflates the balloon on the distal end of the catheter. The inflation device plunger is pulled back to deflate the balloon and it can then be withdrawn into the introducer for removal.
The provided text is a 510(k) summary for the True Dilatation Balloon Valvuloplasty Catheter. It describes the device, its intended use, and the functional and safety testing performed to demonstrate its equivalence to a predicate device.
Acceptance Criteria and Device Performance Study
The document does not detail specific quantitative acceptance criteria or a dedicated study that proves the device meets these criteria in the way one might expect for an AI/ML device. Instead, it focuses on demonstrating substantial equivalence to a previously cleared predicate device (True Dilatation Balloon Valvuloplasty Catheter, 510(k) number K121083).
The "study" in this context is the range of Functional and Safety Testing outlined, which serves to verify that the device design met its functional and performance requirements. The acceptance criteria for these tests would implicitly be the successful completion of each test without failure and within specified parameters, demonstrating that the device functions as intended and is safe.
Here's a breakdown of what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document does not provide explicit "acceptance criteria" with numerical thresholds for performance metrics. Instead, it describes "performance requirements" that were met through testing. The "reported device performance" is the successful completion of these tests.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility in accordance with ISO 10993-1 2009 | Device underwent biocompatibility testing. (Successful) |
| Sterility in accordance with ISO 11135-1 2007 | Device underwent sterility testing. (Successful) |
| Packaging integrity in accordance with ASTM D4169:2009 | Device underwent packaging integrity testing. (Successful) |
| Mechanical testing in accordance with ISO 10555-1 2009 | Device underwent mechanical testing. (Successful) |
| Dimensional verification of inflated balloon | Performed. (Successful, specific values not given) |
| Simulated use for access to annulus, inflation, re-sheathing, and withdrawal | Performed. (Successful) |
| Inflation and deflation time | Performed. (Successful, specific values not given) |
| Rupture, herniation, and leaking | Performed. (Successful, no rupture, herniation, or leaking) |
| Compatibility with introducer | Performed. (Successful) |
| Diameter Variation over Operating Pressure Range (20-26mm) | <2% (This is a specific performance metric reported) |
Note on "Acceptance Criteria": For a physical medical device, especially for a 510(k) based on substantial equivalence, the "acceptance criteria" are generally that the device performs functionally and safely at least as well as the predicate device, and meets relevant international standards. The listed tests are how this is demonstrated.
The subsequent questions (2-9) are typically relevant for AI/ML device submissions, which involve data provenance, ground truth establishment, and clinical study designs. This document describes a traditional medical device (balloon catheter), and therefore, most of these questions are not applicable based on the provided text.
Here's why and what can be said:
2. Sample Size Used for the Test Set and Data Provenance
- Not applicable in the context of AI/ML. This document describes a physical medical device (catheter). The "test set" refers to samples of the device itself undergoing various physical and chemical tests (e.g., biocompatibility, sterility, mechanical).
- Sample Size: Not explicitly stated for each test, but "representative samples of the device" were used.
- Data Provenance: Not applicable in the AI/ML sense. The "data" comes from laboratory and physical testing of device samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. There is no "ground truth" in the clinical data sense for this type of device submission. The "ground truth" for physical characteristics and performance is established by standardized testing methods and material science. Experts would be involved in designing and conducting these tests (e.g., metrology, materials science, sterility assurance professionals), but their roles are not detailed as clinical "ground truth" experts.
4. Adjudication Method for the Test Set
- Not applicable. Adjudication is typically for clinical endpoints or image interpretations. For physical device testing, results are usually definitive (pass/fail, within/outside spec).
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
- Not applicable. This is a physical medical device, not an AI/ML diagnostic tool involving human readers or interpretation of medical cases.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
- Not applicable in the AI/ML sense. For this device, the "ground truth" for its performance is established by:
- Compliance with recognized international standards (e.g., ISO, ASTM).
- Physical measurements and characterizations (e.g., balloon diameter variation, inflation/deflation time).
- Results of controlled laboratory tests (e.g., biocompatibility assays, sterilization validation).
- Comparison to the performance characteristics of the legally marketed predicate device.
8. The Sample Size for the Training Set
- Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As above, no training set for an AI/ML algorithm is involved.
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| 510(k) Summary | |
|---|---|
| Submitter: | Loma Vista Medical |
| 863A Mitten Road, Suite 100A | |
| Burlingame, CA 94010 | |
| Phone: (650) 490-4747 | |
| Fax: (480) 449-2546Email: chris.timmons@crbard.com | |
| Contact Person: | Tiffini Diage |
| 1307 South Mary Avenue, Suite 280Sunnyvale, CA 94087 | |
| Phone: (707) 799-6732 | |
| Fax: (408) 462-9132 | |
| Email: tdiage@namsa.com | |
| Date Prepared: | 12/20/2013 |
| Trade Name: | True Dilatation Balloon Valvuloplasty Catheter |
| Classification: | Class IIBalloon Aortic Valvuloplasty21 CFR 870.1250 |
| Product Code: | OZT |
| Predicate Device(s): | The subject device is equivalent to the following devices:True Dilatation Balloon Valvuloplasty Catheter, 510(k) numberK121083 |
| Device Description: | The True Dilatation Catheter is a coaxial catheter with a balloonfixed at the tip used for Balloon Aortic Valvuloplasty (BAV) ofthe aortic valve. The effective length of the catheter is 110 cmand it has two lumens: one lumen is used to inflate and deflatethe balloon and the other permits the use of a guidewire toposition the catheter. The balloon inflation luer-lock hub(angled) connects to a syringe inflation device to deliverradiopaque contrast media for inflation. The guidewire luer-lockhub (straight) connects to the guidewire lumen. The balloonfunctions by connecting an inflation device to the angled luerlock and injecting contrast/sailine into the inflation lumen;which inflates the balloon on the distal end of the catheter. Theinflation device plunger is pulled back to deflate the balloon andit can then be withdrawn into the introducer for removal. |
| Indication for Use: | The True Dilatation Catheter is indicated for balloon aorticvalvuloplasty. |
| TechnologicalCharacteristics: | The True Dilatation Balloon Valvuloplasty Catheter in thissubmission is identical to the previously cleared device. Thetechnical characteristics are the identical. The only changebeing made in this submission is the addition of the 26mm |
| Balloon Length | 4.5cm |
| Materials | Shaft: Pebax |
| Balloon: Polymer composite | |
| Image Band: Platinum | |
| Recommended Inflation Pressure | 3-6 ATM |
| Diameter Variation over Operating Pressure Range | 20mm: <2%22mm: <2%24mm: <2%26mm: <2% |
| Marker Band Locations | 1 at proximal balloon shoulder1 at distal balloon shoulder |
| Sterilization Method | Ethylene Oxide |
| Functional and Safety 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. Thefollowing mechanical tests were performed:● Dimensional verification of inflated balloon● Simulated use for access to annulus, inflation, re-sheathing, and withdrawal● Inflation and deflation time● Rupture, herniation, and leaking● Compatibility with introducer |
| Conclusion: | Loma Vista Medical considers the True Dilatation Catheter to besubstantially equivalent to the predicate device listed above.This conclusion is based upon the devices' similarities inprinciples of operation, performance requirements, and |
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around it. Inside the circle is an abstract symbol that resembles a stylized caduceus, a traditional symbol of medicine, with a staff and two snakes.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 20, 2015
Bard Peripheral Vascular Inc. Ms. Tiffini Diage Medical Research Manager NAMSA 863A Mitten Road, Suite 100A Burlingame, CA 94010
Re: K133569
Trade/Device Name: True Dilation Balloon Valvuloplasty Catheter Regulation Number: 21 CFR 870.1255 Regulation Name: Balloon Aortic Valvuloplasty Regulatory Class: Class II Product Code: OZT Dated: November 18, 2013 Received: November 25, 2013
Dear Ms. Diage:
This letter corrects our substantially equivalent letter of December 20, 2013.
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
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Page 2 - Ms. Tiffini Diage
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 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" (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 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 yours.
Nicole G. Ibrahim -S
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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Appendix S: Indications for Use
Indications for Use Statement
510(k) Number: K133569
Device Name: True Dilatation Balloon Valvuloplasty Catheter
Indications for Use:
The True Dilatation Balloon Valvuloplasty Catheter is indicated for balloon aortic valvuloplasty.
Prescription Use X (21 CFR 801 Subpart D)
AND/OR
い
Over-The-Counter Use (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)
M.A.Silliman
Loma Vista Medical
Page 58 of 61 Special 510(k) for the True Dilatation Balloon Valvuloplasty Catheter
§ 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.