LogoFDA 510(k) Search
K Number
K122367
Device Name
BARD PTV DILATATION CATHETER
Manufacturer
C.R. BARD, INC.
Date Cleared
2012-11-02

(88 days)

Product Code
OMZ
Regulation Number
870.1250
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Bard PTV Dilatation Catheters are recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve. - A patient with isolated pulmonary stenosis . - A patient with valvular pulmonary stenosis with other minor congenital heart . disease that does not require surgical intervention.
Device Description
The Bard 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 0.035" guidewire and is available in 75 and 100 cm working lengths. 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.
More Information

K102473, K120971

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 or ML.

Yes

The device is a dilatation catheter used for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve, which is a medical procedure to treat pulmonary stenosis, indicating a therapeutic purpose.

No

The device is a balloon catheter used for Percutaneous Transluminal Valvuloplasty (PTV) to treat pulmonary stenosis, which is a therapeutic intervention rather than 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. There is no mention of software as the primary or sole component.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve in patients with pulmonary stenosis. This is a therapeutic procedure performed in vivo (within the body) to treat a medical condition.
  • Device Description: The device is a balloon catheter designed to be inserted into the body to dilate a narrowed valve. This is a medical device used for intervention, not for testing samples in vitro (outside the body).
  • Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.

IVD devices are specifically designed for testing samples in vitro to provide diagnostic information. This device is a therapeutic device used in vivo.

N/A

Intended Use / Indications for Use

The Bard PTV Dilatation Catheters are recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve.

  • A patient with isolated pulmonary 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

(T.tre Bard 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 0.035" guidewire and is available in 75 and 100 cm working lengths. 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Pulmonary 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)

To demonstrate substantial equivalence of the subject device, the Bard PTV Dilatation Catheter, to the predicate devices, the technological characteristics and performance criterion 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:

  • . Catheter Shaft Length
  • Inflation Time .
  • Simulated Use Deflation Time .
  • Removal Deflation Time .
  • Trackability .

The following in vitro tests were leveraged from the predicate device, the Atlas® PTA Balloon Dilatation Catheter:

  • Tip Length .
    Balloon Outer Diameter .
  • Balloon Working Length .
  • Catheter Shaft Outer Diameter .
  • Catheter Shaft Inner Diameter .
  • Tip Visibility .
  • . Catheter Shaft Visibility
  • . Marker Band Visibility
  • Tip Morphology .
  • Tip Tensile .
  • Joint Tensile .
  • Catheter Elongation .
  • Nominal (Operating) Pressure .
  • Rated Burst Pressure .
  • Balloon Burst Mode .
  • Fatigue .
  • Catheter Shaft Leaks .
  • Catheter Shaft Burst .
  • Balloon Distensibility .
  • Marker Band Alignment .
  • Sheath Compatibility t
  • Equipment Interface .
  • Media Interaction .
  • Pouch Tensile Strength .

The results from these tests demonstrate that the technological characteristics and performance criteria of the Bard 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 similar intended use.

Summary of Performance Testing:

  • Visual Inspection: Inspection of the device for damage is completed prior to any testing for informational purposes. Contamination of the device is covered in biocompatibility section 15. During testing no abnormalities were observed, which was confirmed through functional testing of the device. Result: PASS.
  • Balloon Preparation Test: The specification for the subject device states that the catheter's guidewire lumen must be flushable with saline utilizing a 10mL syringe or equivalent. All results showed the subject device passed the specified criteria. Result: PASS.
  • Diameter and Profile Test: The specification for the subject device is +.04/-.03mm across all diameters. When calculated for the smallest balloon size (12mm) a +/- 10% change in labeled diameter equates to +/-1.2mm. All results showed the subject device passed the specified criteria, which is more robust than the Mullins-X predicate device criteria. Result: PASS.
  • Mechanical Integrity (Nominal Burst Pressure): All results showed the subject device passed the sped criteria, which is more robust than the Mullins-X predic device criteria, because the labeled rated burst pressu are hi. Result: PASS.
  • Balloon Distensibility (as stated in Ta tigue): The specification for the subject device is ≤ 5% across iameters. .Il results showed the subject device passed the s riteria which is more robust than the Mullins-X pre evice criteria. Result: PASS.
  • Balloon Inflatability Test: Deflation (as stated in Table 7). The balloon's ability to deflate is evaluated during deflation testing. Any abnormalities during testing are documented. During testing no abnormalities during deflation were observed and all samples were able to be fully deflated. Result: PASS.
  • Tip Pull and Torque Test: Tip Tensile (as stated in Table 7). The tip specification for the subject device is different than the Mullins-X predicate device in that it follows ISO10555-1; specifically, the tip is tested for tensile strength. The tip tensile specification for the subject device states that the catheter must withstand a minimum tensile force of 2 pounds-force. All results showed the subject device passed the specified criteria from the ISO standard. Result: PASS.
  • Bond-Strength Test: Joint Tensile (as stated in Table 7). The bond strength specification for the subject device states that the catheter must withstand a minimum tensile force of 5 pounds-force. All results showed the subject device passed the specified criteria, which is more robust than the Mullins-X predicate device criteria. Result: PASS.
  • Catheter Body Maximum Pressure Test: Catheter Shaft Leak and Catheter Shaft Burst (as stated in Table 7). The highest rated burst pressure for Atlas Gold is 18atm, and as a safety factor the proposed specification was set to +5atm above the highest rated burst pressure (23atm minimum). All results showed the subject device passed the specified criteria. Result: PASS.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

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.

K102473, K120971

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

§ 870.1250 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

K122367

Bard PTV Dilatation Catheter 2 2012 NOV 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: 480-379-2841

Fax: 480-449-2546

Contact: Erin Fox, Regulatory Affairs Specialist II

August 1, 2012 Date

Subject Device Name:

Device Trade Name:Bard 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:

  • Mullins-X PTV Catheter (K102473; cleared December 9, 2010) .
  • Atlas® PTA Balloon Dilatation Catheter (K120971, cleared April 19, 2012) .

Image /page/0/Picture/18 description: The image shows the word "BARD" in a stylized, blocky font. The letters are outlined in black, giving them a bold and distinct appearance. The font style is geometric and somewhat angular, making the word visually striking.

1

Device Description:

(T.tre Bard 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 0.035" guidewire and is available in 75 and 100 cm working lengths. 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.

| Attribute | Bard PTV Dilatation Catheter
Product Offering |
|--------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|
| Balloon Diameter
(mm) | 12, 14, 16, 18, 20, 22, 24, 26 |
| Balloon Length
(cm) | 2, 4, 6 |
| Catheter Shaft
Lengths (cm) | 75, 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 Bard PTV Dilatation Catheters are recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve.

  • . A patient with isolated pulmonary 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 stylized, blocky font. The letters are outlined in black, giving them a bold and distinct appearance. The overall design is simple yet eye-catching, with a focus on readability and a modern aesthetic.

2

Comparison of Indications for Use to Predicate Devices:

The indication for use statement for the Bard 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 Bard PTV Dilatation Catheter, is substantially equivalent to the predicate device.

Technological Comparison to Predicate Devices:

The Bard PTV Dilatation Catheter has the following similarities to the predicate devices:

  • Same intended use (Mullins-X PTV Catheter) .
  • Same indications for use (Mullins-X PTV Catheter) .
  • Same target population (Mullins-X PTV Catheter) .
  • Same fundamental scientific technology (both predicates) .
  • Same operating principle (both predicates) .
  • . Same packaging materials and configuration (Atlas® PTA Balloon Dilatation Catheter)
  • . Same sterility assurance level and method of sterilization (Atlas® PTA Balloon Dilatation Catheter)

Performance Data:

To demonstrate substantial equivalence of the subject device, the Bard PTV Dilatation Catheter, to the predicate devices, the technological characteristics and performance criterion 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:

  • . Catheter Shaft Length
  • Inflation Time .
  • Simulated Use Deflation Time .
  • Removal Deflation Time .
  • Trackability .

The following in vitro tests were leveraged from the predicate device, the Atlas® PTA Balloon Dilatation Catheter:

Bard Peripheral Vascular, Inc.

Image /page/2/Picture/22 description: The image shows the word "BARD" in a bold, sans-serif font. The letters are all capitalized and appear to be outlined. The font style gives the word a modern and somewhat geometric appearance.

3

  • Tip Length .
    Balloon Outer Diameter .

  • Balloon Working Length .

  • Catheter Shaft Outer Diameter .

  • Catheter Shaft Inner Diameter .

  • Tip Visibility .

  • . Catheter Shaft Visibility

  • . Marker Band Visibility

  • Tip Morphology .

  • Tip Tensile .

  • Joint Tensile .

  • Catheter Elongation .

  • Nominal (Operating) Pressure .

  • Rated Burst Pressure .

  • Balloon Burst Mode .

  • Fatigue .

  • Catheter Shaft Leaks .

  • Catheter Shaft Burst .

  • Balloon Distensibility .

  • Marker Band Alignment .

  • Sheath Compatibility t

  • Equipment Interface .

  • Media Interaction .

  • Pouch Tensile Strength .

The results from these tests demonstrate that the technological characteristics and performance criteria of the Bard 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 similar intended use. The following table provides a detailed summary of performance testing completed on the subject device, as compared to the corresponding performance testing completed on the predicate Mullins-X PTV Catheter.

Image /page/3/Picture/28 description: The image shows the word "BARD" in a stylized, outlined font. The letters are bold and connected, giving the word a solid, block-like appearance. The overall design is simple and eye-catching.

4

Page 97

Traditional 510(k)
Bard PTV Dilatation Catheter

Summary of Performance Testing

.

| Predicate
Mullins-X Test | Predicate Mullins-X
Acceptance Criteria | Test
Performed
on Subject
Device? | Subject Bard PTV Dilatation Catheter
Acceptance Criteria | Test
Result |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|
| Visual
Inspection | The catheters shall be free from
contamination, discoloration, and any
form of damage that could impact the
proper functioning of the device. | YES | Inspection of the device for damage is completed prior to
any testing for informational purposes. Contamination of the
device is covered in biocompatibility section 15.

During testing no abnormalities were observed, which was
confirmed through functional testing of the device (described
below). | PASS |
| Balloon
Preparation Test | Each catheter shall be prepped per
the procedure without functional
difficulties or anomalies. | YES | Media Interaction (as stated in Table 7)

The specification for the subject device states that the
catheter's guidewire lumen must be flushable with saline
utilizing a 10mL syringe or equivalent. Though worded
differently, the specification of the subject device is similar to
the Mullins-X predicate device, as they both ensure no
anomalies are noted during simulated use.

All results showed the subject device passed the specified
criteria. | PASS |
| Diameter and
Profile Test | The balloon diameter at rated burst
pressure shall be within +/- 10% of the
labeled balloon diameter and the
samples should fit through the
selected introducer with no problems. | YES | Balloon Outer Diameter (as stated in Table 7)

The specification for the subject device is +.04/-.03mm
across all diameters. When calculated for the smallest
balloon size (12mm) a +/- 10% change in labeled diameter
equates to +/-1.2mm.

All results showed the subject device passed the specified
criteria, which is more robust than the Mullins-X predicate
device criteria. | PASS |

Bard Peripheral Vascular, Inc

: .

BARD

5

aditional 510(k)
ard PTV Dilatation Cathe

Page 98

PASS PASS PASS PASS sults showed the subject device passed the specif
a, and no breaks were seen.
I Burst Pressure (as stated in Table 7) All results showed the subject device passed the spec
criteria, which is more robust than the Mullins-X predic
device criteria, because the labeled rated burst pressu
are hi esults showed the subject device passed the spe The specification for the subject device is ≤ 5% acro
iameters. .Il results showed the subject device passed the s
riteria which is more robust than the Mullins-X pre
evice criteria. specification for the subject device states that that the the states that the states that the states that the states of the states of the be
sure is greater than the Mullinspecification for the subject device states th
ter must be capable of withstanding 20 cyc
on to ≥ labeled rated burst pressure. ation and Deflation (as stated in Tab oon Distensibility (as stated in Ta tigue (as stated in Table criteria ્ટર્ટ ES ES ES e results must show statistically
in at least 95% confidence, at least and the more of the bearth and the more of the more of burnst pressure. results must demonstrate that
on diameter is within + k & Mithin + K BP
abeled diameter is within + K BP
not be significantly increased by and bed
easingly higher pressuress. tion achieved
ss than 12 seconds and def
eved in less than 20 second o breaks allowe Balloon inflation
Deflation
Test Balloon Minimur
Burst Strength Repeated
Balloon Inflation
(Balloon Fatigu
Test) Balloon
Distensibilit

BARI

Peripheral Vascular

6

Page 99

Traditional 510(k)
Bard PTV Dilatation Catheter

...

← ←

:

:

| Balloon
Inflatability Test, | There should be no interference with
balloon deflation | YES | Deflation (as stated in Table 7) | PASS |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| | The balloon's ability to deflate is evaluated during deflation
testing as mentioned above. Any abnormalities during
testing are documented. | | | |
| | During testing no abnormalities during deflation were
observed and all samples were able to be fully deflated. | | | |
| Tip Pull.and.
Torque Test, | Must withstand at least 10 turns
without breaking | YES | Tip Tensile (as stated in Table 7) | PASS |
| | The tip specification for the subject device is different than
the Mullins-X predicate device in that it follows ISO10555-1;
specifically, the tip is tested for tensile strength. The tip
tensile specification for the subject device states that the
catheter must withstand a minimum tensile force of 2
pounds-force. | | | |
| | All results showed the subject device passed the specified
criteria from the ISO standard. | | | |
| Bond-Strength
Test | All bonds must withstand at least 3 lbs
of pull strength. | YES | Joint Tensile (as stated in Table 7) | PASS |
| | The bond strength specification for the subject device states
that the catheter must withstand a minimum tensile force of
5 pounds-force. | | | |
| | All results showed the subject device passed the specified
criteria, which is more robust than the Mullins-X predicate
device criteria. | | | |
| Catheter Body
Maximum
Pressure Test | All samples must withstand 30 ATM
(400psi). | YES | Catheter Shaft Leak and Catheter Shaft Burst (as stated
in Table 7) | PASS |
| | | | The highest rated burst pressure for Atlas Gold is 18atm,
and as a safety factor the proposed specification was set to
+5atm above the highest rated burst pressure (23atm
minimum). Though the value is less than the Mullins-X
specification, it is adequate for the labeled burst pressure of
the subject device. | |
| | | | All results showed the subject device passed the specified
criteria. | |

.

.. :

.

Bard Peripheral Vascular, Inc

. '

BARID

7

Traditional 510(k) Traditional 510(k)
Bard Prv Dilatation Cathete

。 2017/07/14

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រៀង ក្រុងប្រជាជាងមួយម៉ែត្រីជួរប៉ុន្តែព្រឹមពីមួយ Vascular, Inc

ﺮ ﺗﻢ ﺗﻌﻠﻴﻤﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ

.

—

.

. .

8

Conclusions:

The subject device, the Bard 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 Bard PTV Dilatation Catheter is substantially equivalent to the legally marketed predicate devices, the Mullins-X PTV Catheter and the Atlas® PTA Balloon Dilatation Catheter.

Image /page/8/Picture/5 description: The image shows the word "BARD" in a bold, sans-serif font. The letters are outlined in black, giving them a distinct and prominent appearance. The overall design is simple and clean, focusing on the clarity and readability of the word.

9

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002

NOV 2 2012

Bard Peripheral Vascular, Inc. c/o Ms. Erin Fox Regulatory Affairs Specialist C. R. Bard 1625 West Third Street Tempe, AZ 85281

Re: K122367

Trade/Device Name: Bard PTV Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Pulmonary Valvuloplasty Catheter Regulatory Class: Class II Product Code: OMZ Dated: August 2, 2012 Received: August 5, 2012

Dear Ms. Fox:

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.

10

Page 2 - Ms. Erin Fox

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 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/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,

Aus Hille

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

11

Indications for Use

510(k) Number (if known):

Device Name: Bard PTV Dilatation Catheter

Indications for Use: The Bard PTV Dilatation Catheters are recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve.

  • A patient with isolated pulmonary 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)

Mskiel

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number K122367

Image /page/11/Picture/16 description: The image shows the word "BARD" in a bold, sans-serif font. The letters are outlined in black, and the interior of the letters is white. The letters are evenly spaced and appear to be in a slightly condensed style. The overall impression is a clean and modern design.

Bard Peripheral Vascular, Inc.