(83 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a balloon catheter, with no mention of AI or ML.
Yes
The device is a PTV (Percutaneous Transluminal Valvuloplasty) Dilatation Catheter, which is explicitly described for use in a medical procedure to treat pulmonary valve stenosis.
No
This device is a balloon catheter used for Percutaneous Transluminal Valvuloplasty (PTV) to dilate the pulmonary valve, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly outlines a physical balloon catheter with hardware components like a balloon, catheter shaft, radiopaque markers, and luer-lock hubs. The performance studies also focus on physical characteristics and mechanical testing of the hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve." This is a therapeutic procedure performed in vivo (within the body) to treat a medical condition (pulmonary valve stenosis).
- Device Description: The description details a balloon catheter designed for mechanical intervention within the body. It describes components like a guidewire, balloon, and inflation lumen, all consistent with a device used for a medical procedure.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze samples and provide diagnostic information. This device is used in vivo for a therapeutic intervention.
N/A
Intended Use / Indications for Use
The Vida PTV Dilatation Catheter is recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve in the following:
- A patient with isolated pulmonary valve stenosis .
- A patient with valvular pulmonary stenosis with other minor congenital heart . disease that does not require surgical intervention.
Product codes (comma separated list FDA assigned to the subject device)
OMZ
Device Description
The Vida PTV Dilatation Catheter is a high performance balloon catheter consisting of an over-the-wire catheter with a balloon fixed at the distal tip. The proprietary, noncompliant, low profile balloon is designed to provide consistent balloon diameters and lengths even at high pressures. Two radiopaque markers delineate the working length of the balloon and aid in balloon placement. The coaxial catheter includes an atraumatic tip to facilitate advancement of the catheter to and through the valve. The over-the-wire catheter is compatible with .035" quidewire and is available in 100 cm working length. The proximal portion of the catheter includes a female luer-lock hub connected to the inflation lumen, and a female luer-lock hub connected to the guidewire lumen. Packaged with every product is a profile reducing sheath that is positioned over the balloon for protection before use. A re-wrapping tool is also provided on the catheter shaft. This product is not manufactured with any latex.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pulmonary valve, heart
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)
To demonstrate substantial equivalence of the subject device to the predicate devices, its technological characteristics and performance criteria were evaluated. Using FDA Guidance Documents on non-clinical testing of medical devices and internal Risk Assessment procedures, the following in vitro tests were performed on the subject device:
- Visual Inspection
- Media Interaction (i.e. Balloon Preparation Test)
- Catheter Shaft Length
- Trackability
- Inflation/Deflation Time (i.e. Balloon Inflation/Deflation Test, and Balloon Inflatability Test)
The following in vitro tests were leveraged from the predicate Atlas Gold PTA Dilatation Catheter:
- Tip Length
- Balloon Outer Diameter (i.e. Diameter and Profile Test)
- Balloon Working Length
- Catheter Shaft Outer Diameter
- Catheter Shaft Inner Diameter
- Tip Visibility
- Catheter Shaft Visibility
- Marker Band Visibility
- Tip Morphology
- Tip Tensile (i.e. Tip Pull and Torque Test, and Bond Strength Test)
- Balloon to Shaft Tensile
- Hub to Shaft Tensile
- Catheter Shaft Elongation
- Balloon Nominal (Operating) Pressure
- Rated Burst Pressure (i.e. Balloon Minimum Burst Strength)
- Balloon Burst Mode
- Fatigue (i.e. Repeated Balloon Inflation)
- Catheter Shaft Leaks (i.e. Catheter Body Maximum Pressure Test)
- Catheter Shaft Burst (i.e. Catheter Body Maximum Pressure Test)
- Balloon Distensibility
- Marker Band Alignment
- Sheath Compatibility
- Equipment Interface
- Visual Inspection of Packaging
- Dye Penetration
- Pouch Tensile Strength
The results from these tests demonstrate that the technological characteristics and performance criteria of the Vida PTV Dilatation Catheter are substantially equivalent to the predicate devices, and that it can perform in a manner equivalent to devices currently on the market for the same intended use.
Summary of Performance Testing:
Visual Inspection, Acceptance Criteria: The catheters shall be free from contamination, discoloration, and any form of damage that could impact the proper functioning of the device.
Media Interaction (i.e. Balloon Preparation Test), Acceptance Criteria: Each catheter shall be prepped per the procedure without any functional difficulties or anomalies. Guidewire lumen must be flushable (saline appears at distal end when injected from proximal end) with 5 ml of saline utilizing a 10-ml syringe or equivalent.
Catheter Shaft Length, Acceptance Criteria: 100 +/- 3 cm
Trackability, Acceptance Criteria: Using the IDTE, the trackability into an appropriately-sized 23-cm Cordis Avanti introducer or B.Braun Intradyn 23-cm (sheath sizes >= 12 Fr.) and through a worst-case pulmonary valve model should have forces
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
0
K 131002
Page 111
JUL 0 2 2013
Vida PTV Dilatation Catheter 510(k) Summary 21 CFR 807.92
- As required by the Safe Medical Devices Act of 1990, coded under Section 513, Part (I)(3)(A) of the Food, Drug and Cosmetic Act, a 510(k) summary upon which substantial equivalence determination is based is as follows:
Submitter Information:
| Applicant: | Bard Peripheral Vascular, Inc |
|---|---|
| 1625 West 3rd Street | |
| Tempe, Arizona 85281 |
Phone: 480-350-6012
Fax: 480-449-2546
Contact: Aaron Conovaloff, Regulatory Affairs Associate
Date April 9, 2013
Subject Device Name:
| Device Trade Name: | Vida PTV Dilatation Catheter |
|---|---|
| Common or Usual Name: | Pulmonary (Pulmonic) Valvuloplasty |
| Catheters/Percutaneous Valvuloplasty | |
| Catheter (21 CFR 870.1250, Product Code | |
| OMZ) | |
| Classification: | Class II |
| Classification Panel: | Cardiovascular |
Predicate Devices:
- Bard PTV Dilatation Catheter (K122367; cleared November 2, 2012) .
- Atlas Gold PTA Dilatation Catheter (K122984, cleared October 22, 2012) .
Bard Peripheral Vascular, Inc.
Image /page/0/Picture/18 description: The image shows the word "BARD" in a stylized, outlined font. The letters are bold and have a geometric design, with sharp angles and straight lines. The overall appearance is modern and somewhat abstract due to the font choice.
1
Device Description:
The Vida PTV Dilatation Catheter is a high performance balloon catheter consisting of an over-the-wire catheter with a balloon fixed at the distal tip. The proprietary, noncompliant, low profile balloon is designed to provide consistent balloon diameters and lengths even at high pressures. Two radiopaque markers delineate the working length of the balloon and aid in balloon placement. The coaxial catheter includes an atraumatic tip to facilitate advancement of the catheter to and through the valve. The over-the-wire catheter is compatible with .035" quidewire and is available in 100 cm working length. The proximal portion of the catheter includes a female luer-lock hub connected to the inflation lumen, and a female luer-lock hub connected to the guidewire lumen. Packaged with every product is a profile reducing sheath that is positioned over the balloon for protection before use. A re-wrapping tool is also provided on the catheter shaft. This product is not manufactured with any latex.
| Attribute | Vida PTV Dilatation Catheter
Product Offering |
|--------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|
| Balloon Diameter
(mm) | 12, 14, 16, 18, 20, 22, 24, 26 |
| Balloon Length
(cm) | 2, 4, 6 |
| Catheter Shaft
Length (cm) | 100 |
| Introducer Sheath
Compatibility
(compatible
balloon sizes,
diameter (mm) x
length (cm)) | 7F: (12x 2,4,6; 14x 2,4)
8F: (14x 6; 16x 2,4,6; 18x 2,4)
9F: (18x 6; 20x 2,4)
10F: (22x 2,4; 24x 2,4)
12F: (26x 2,4) |
Indications for Use of Device:
The Vida PTV Dilatation Catheter is recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve in the following:
- A patient with isolated pulmonary valve stenosis .
- A patient with valvular pulmonary stenosis with other minor congenital heart . disease that does not require surgical intervention.
Image /page/1/Picture/10 description: The image shows the word "BARD" in a bold, outlined font. The letters are large and spaced closely together. The overall impression is of a simple, yet impactful design.
2
Comparison of Indications for Use to Predicate Devices:
The indications for use statement for the Vida PTV Dilatation Catheter does not raise any new issues of safety and effectiveness as demonstrated through the risk analysis process based on the proposed indications for use statement as compared to the predicate devices. Therefore, the subject device, the Vida PTV Dilatation Catheter, is substantially equivalent to the predicate devices.
Technological Comparison to Predicate Devices:
The Vida PTV Dilatation Catheter has the following similarities to the predicate device. the Bard PTV Dilatation Catheter (clearance to market via K122367 on November 2. 2012):
- . Same intended use
- Same indications for use .
- . Same target population
- Same operating principle .
- . Same fundamental scientific technology
- . Same sterility assurance level and method of sterilization
The Vida PTV Dilatation Catheter has the following similarities to the predicate device, the Atlas Gold PTA Dilatation Catheter (clearance to market via K122984, on October 22, 2012):
- . Same operating principle
- . Same fundamental scientific technology
- Same packaging materials and configurations .
- . Same sterility assurance level and method of sterilization
Performance Data:
To demonstrate substantial equivalence of the subject device to the predicate devices, its technological characteristics and performance criteria were evaluated. Using FDA Guidance Documents on non-clinical testing of medical devices and internal Risk Assessment procedures, the following in vitro tests were performed on the subject device:
- . Visual Inspection
Image /page/2/Picture/21 description: The image shows the word "BARD" in a bold, sans-serif font. The letters are outlined in black, giving them a hollow appearance. The font style is consistent throughout the word, with each letter having a uniform thickness and design.
3
Traditional 510(k) Vida PTV Dilatation Catheter
- Media Interaction (i.e. Balloon Preparation Test) ●
- Catheter Shaft Length .
- Trackability .
- Inflation/Deflation Time (i.e. Balloon Inflation/Deflation Test, and Balloon . Inflatability Test)
The following in vitro tests were leveraged from the predicate Atlas Gold PTA Dilatation Catheter:
- Tip Length .
- Balloon Outer Diameter (i.e. Diameter and Profile Test) .
- Balloon Working Length .
- Catheter Shaft Outer Diameter .
- · Catheter Shaft Inner Diameter .
- . Tip Visibility
- Catheter Shaft Visibility .
- . Marker Band Visibility
- Tip Morphology .
- Tip Tensile (i.e. Tip Pull and Torque Test, and Bond Strength Test) .
- Balloon to Shaft Tensile .
- Hub to Shaft Tensile .
- Catheter Shaft Elongation .
- Balloon Nominal (Operating) Pressure �
- Rated Burst Pressure (i.e. Balloon Minimum Burst Strength) .
- . Balloon Burst Mode
- � · Fatigue (i.e. Repeated Balloon Inflation)
- Catheter Shaft Leaks (i.e. Catheter Body Maximum Pressure Test) .
- . Catheter Shaft Burst (i.e. Catheter Body Maximum Pressure Test)
- Balloon Distensibility ●
- Marker Band Alignment .
- Sheath Compatibility .
- Equipment Interface ●
- Visual Inspection of Packaging .
- Dye Penetration
4
Pouch Tensile Strength .
The results from these tests demonstrate that the technological characteristics and performance criteria of the Vida PTV Dilatation Catheter are substantially equivalent to the predicate devices, and that it can perform in a manner equivalent to devices currently on the market for the same intended use. The following table provides a detailed summary of performance testing completed on the subject device.
Image /page/4/Picture/5 description: The image shows the word "BARD" in a stylized, outlined font. The letters are bold and sans-serif, with a slight three-dimensional effect created by the outline. The overall impression is a clean and modern design.
5
| Test Performed | Acceptance Criteria | Vida |
|---|---|---|
| Visual Inspection | The catheters shall be free from contamination, discoloration, and any form of | |
| damage that could impact the proper functioning of the device. | ||
| Media Interaction (i.e. | ||
| Balloon Preparation Test) | Each catheter shall be prepped per the procedure without any functional | |
| difficulties or anomalies. | ||
| Guidewire lumen must be flushable (saline appears at distal end when injected | ||
| from proximal end) with 5 ml of saline utilizing a 10-ml syringe or equivalent. | ||
| Catheter Shaft Length | $100 \pm 3$ cm | |
| Trackability | Using the IDTE, the trackability into an appropriately-sized 23-cm Cordis | |
| Avanti introducer or B.Braun Intradyn 23-cm (sheath sizes ≥ 12 Fr.) and | ||
| through a worst-case pulmonary valve model should have forces ≤ 700 gF. | ||
| Inflation/Deflation Time | ||
| (i.e. Balloon | ||
| Inflation/Deflation Test, | ||
| and Balloon Inflatability | ||
| Test) | Inflation Time | |
| Inflation achieved ≤ 20 seconds using | ||
| 25:75 contrast: saline ratio. | ||
| Simulated Use Deflation Time | ||
| Deflation achieved ≤ 20 seconds using | ||
| 25:75 contrast:saline ratio. | ||
| Removal Deflation Time | ||
| Deflation time ≤ 90 seconds with 25:75 | ||
| contrast:saline ratio. |
Summary of Performance Testing
Bard Peripheral Vascular, Inc.
6
Conclusions:
The subject device, the Vida PTV Dilatation Catheter, met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs. The Vida PTV Dilatation Catheter is substantially equivalent to the legally marketed predicate devices, the Bard PTV Dilatation Catheter and the Atlas Gold PTA Dilatation Catheter.
Image /page/6/Picture/5 description: The image shows the word "BARD" in a bold, sans-serif font. The letters are outlined in black, with a white fill. The letters are slightly stylized, with the "A" having a pointed top and the "R" having a curved leg. The word is centered and takes up most of the frame.
7
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/7/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the department's name around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 2, 2013
Aaron Conovaloff, Ph.D. Regulatory Affairs Associate Bard Peripheral Vascular, Inc. 1625 West 3rd Street Tempe, AZ 85281
Re: K131002
Trade/Device Name: Vida ™ PTV Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Pulmonary Valvuloplasty Catheters Regulatory Class: Class II Product Code: OMZ Dated: April 26, 2013 Received: April 29, 2013
Dear Dr. Conovaloff:
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. Isting 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
8
Page 2 - Aaron Conovaloff, Ph.D.
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 Small Manufacturers. International and Consumer Assistance at its tollfree 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/ReportalProblem/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.
MZtillehem
for Bram D. Zuckerman, M.D.
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
9
Indications for Use
510(k) Number (if known): K131002
Device Name: Vida PTV Dilatation Catheter
Indications for Use: The Vida PTV Dilatation Catheter is recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve in the following:
- A patient with isolated pulmonary valve stenosis .
- A patient with valvular pulmonary stenosis with other minor congenital heart ● disease that does not require surgical intervention.
Prescription Use X (Part21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21CFR 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. Hillemann
Bard Peripheral Vascular, Inc.
Image /page/9/Picture/15 description: The image shows the word "BARD" in a stylized, bold font. Each letter is outlined with a thick black border, giving it a distinct and prominent appearance. The font style is unique, with sharp angles and geometric shapes forming the letters.