The Presto™ Inflation Device is indicated for use with angioplasty balloon dilatation catheters to create and monitor the pressure in the angioplasty balloon dilatation catheter and to deflate the angioplasty balloon dilatation catheter.

Device Description

The Presto™ Inflation Device is an ultra high pressure, large volume inflation device used to inflate, monitor pressure, and deflate angioplasty balloon dilatation catheters. It is a onepiece, 30 mL disposable inflation device rated for 40 atm with a lever-lock design that controls the piston, a manometer, and a high-pressure connecting tube with a male Luer rotating adapter. Also enclosed is a high-pressure 3-way stopcock to aid in preparation and use of the device. The manometer measures pressures ranging from 0 atm up to 40 atm in 1 atm increments. The accuracy of the manometer has been determined to be within ±1.6 ATM. These products are not made with natural rubber latex.

AI/ML Overview

The provided text describes a 510(k) summary for the Presto Inflation Device, focusing on its substantial equivalence to a predicate device. The information details the device's function, its similarities and differences to the predicate, and various performance tests conducted.

However, the document does not contain the kind of detailed information typically found in a clinical study report that would allow me to fully answer your request regarding acceptance criteria, specific test results, and experimental design (like sample sizes for test/training sets, expert qualifications, adjudication methods, or MRMC studies).

The provided text focuses on non-clinical in vitro tests to demonstrate substantial equivalence, rather than clinical efficacy or diagnostic accuracy studies. Therefore, it lacks the specific data points you're asking for in a clinical context.

Here's an attempt to answer based on the available information, noting where data is absent:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test	Acceptance Criteria (Implicit)	Reported Device Performance
Mechanical Performance	Syringe Volume	(Volume of device specified/met)	"a one-piece, 30 mL disposable inflation device"
	Rated Inflation Pressure	(Device rated for 40 atm)	"rated for 40 atm"
	Fatigue Testing	(Withstand specified cycles/pressure without failure)	"met all the predetermined acceptance criteria of design verification and validation"
	ISO Luer and Stop Cock Hub Testing	(Conform to ISO standards for luer and stopcock connections)	"met all the predetermined acceptance criteria of design verification and validation"
	Pressure Reading Accuracy (Manometer)	Within ±1.6 ATM	"accuracy of the manometer has been determined to be within ±1.6 ATM"
	Tubing Tensile Strength	(Withstand specified tensile forces)	"met all the predetermined acceptance criteria of design verification and validation"
	Syringe Barrel Graduation Markings	(Accurate and clearly readable markings)	"met all the predetermined acceptance criteria of design verification and validation"
Usability/Functionality	User Validation (Bubble Visualization)	(Ability to visualize bubbles during priming/use)	"met all the predetermined acceptance criteria of design verification and validation"
Packaging & Sterilization	Packaging (Visual Inspection, Dye Penetration, Tray Seal Tensile)	(Maintain sterility barrier, integrity, and specified seal strength)	"met all the predetermined acceptance criteria of design verification and validation"
	Shelf Life	(Viable shelf life based on accelerated aging and stability program)	"Product will have a viable shelf life based upon successful completion of testing"
	Sterilization	(Achieved and maintained sterility)	"Same method of sterilization" (as predicate, implying effective sterilization)
Biocompatibility	Cytotoxicity	(Non-cytotoxic)	"Successful testing for Cytotoxicity"
	Sensitization	(Non-sensitizing)	"Successful testing for... Sensitization"
	Intracutaneous Reactivity	(Non-reactive intracutaneously)	"Successful testing for... Intracutaneous Reactivity"
	Pyrogenicity	(Non-pyrogenic)	"pyrogenicity testing is conducted to support labeling claims"

Study Proving Acceptance Criteria:

The device meets its acceptance criteria through a series of in vitro non-clinical tests as detailed in the "Performance Data" section of the 510(k) summary. These tests were conducted using FDA Guidance Documents, recognized standards (e.g., ASTM F1980-07, ISO 10993-1:2009), and internal Risk Assessment procedures. The document states: "The results from these tests demonstrate that the technological characteristics and performance criteria of the Presto™ Inflation Device is comparable to the predicate devices and that it can perform in a manner equivalent to balloon inflation devices currently on the market with the same intended use."

Information Not Available in the Provided Text:

The following points are primarily relevant for studies involving diagnostic algorithms, AI, or clinical efficacy/safety trials with human subjects. The Presto Inflation Device is a mechanical medical device (angiographic injector), and the provided 510(k) summary focuses on demonstrating substantial equivalence through engineering and physical performance tests, rather than clinical outcomes or diagnostic accuracy. Therefore, the information for points 2-9 is not present in the document.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable / Not provided. The described tests are in vitro engineering and materials tests, not data-driven test sets in the context of AI or diagnostic algorithms.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable / Not provided. Ground truth, in this context, would be defined by engineering specifications, recognized standards, and objective measurements, not expert human interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable / Not provided. Adjudication relates to resolving disagreements in human interpretation, which is not part of these mechanical device tests.

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 / Not provided. This is relevant for AI-assisted diagnostic tools, not for a mechanical inflation device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable / Not provided. This device does not involve an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Engineering Specifications and Recognized Standards: The "ground truth" for this device's performance would be derived from its design specifications (e.g., 30ml volume, 40 atm rating), adherence to international standards (e.g., ISO, ASTM), and the results of validated physical and chemical tests (e.g., biocompatibility testing).

8. The sample size for the training set

Not applicable / Not provided. This device does not involve a training set as it is not an AI or machine learning model.

9. How the ground truth for the training set was established

Not applicable / Not provided. As there is no training set, this question is not relevant.

Summary

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

January 12, 2015

C.R. Bard, Inc. c/o Mark Job Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, MN 55313

Re: K143522

Trade/Device Name: Presto Inflation Device Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic injector and syringe Regulatory Class: Class II Product Code: MAV Dated: December 26, 2014 Received: December 29, 2014

Dear Mr. Mark Job:

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 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

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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/Resourcesfor You/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,

Melissa A. Torres -S

For Bram Zuckerman, MD Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K143522

Device Name Presto™ Inflation Device

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Presto™ Inflation Device 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: 480-638-2939

Fax: 480-449-2542

Contact: Timothy Wade, Regulatory Affairs Specialist

Date November 21, 2014

Subject Device Name:

Device Trade Name:	Presto™ Inflation Device
Common or Usual Name:	Balloon Inflation Syringe (21 CFR 870.1650;Product Code: MAV)
Classification:	Class II
Classification Panel:	Cardiovascular

Predicate Device:

SCIMED Encore Inflation Devices (K955869; cleared March 22, 1996) .
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Device Description:

Indications for Use of Device:

Comparison of Indications for Use to Predicate Devices:

The indications for use statement for the Presto™ Inflation Device is similar to the predicate device, with the addition of angioplasty for clarification purposes, and does not raise any new issues of safety and effectiveness as demonstrated through the risk analysis process. Therefore, the subject device, the Presto™ Inflation Device, is substantially equivalent to the predicate device.

Technological Comparison to Predicate Devices:

The Presto™ Inflation Device has the following similarities to the predicate device:

. Same intended use
Similar indications for use
. Same target population
Same operating principle ●
. Similar materials
. Same fundamental scientific technology

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. Similar packaging materials and configurations
. Same method of sterilization

The differences between the predicate and subject device include differences in syringe volume, rated inflation pressure reading accuracy, material composition of components, and changes in packaging configuration.

Performance Data:

To demonstrate substantial equivalence of the subject device, the Presto™ Inflation Device to the predicate device, the technological characteristics and performance criterion were evaluated. Using FDA Guidance Documents and recognized standards on non-clinical testing of medical devices and internal Risk Assessment procedures, the following in vitro tests were performed on the subject device:

. Syringe Volume
Rated Inflation Pressure .
Fatigue Testing .
ISO Luer and Stop Cock Hub Testing .
Pressure Reading .
. Tubing Tensile Strength
. User Validation (Bubble Visualization)
Syringe Barrel Graduation Markings .
Packaging .
- o Visual Inspection
- Dye Penetration o
- o Tray Seal Tensile

Product will have a viable shelf life based upon successful completion of testing performed in accordance with ASTM F1980-07, "Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices", FDA Guidance, "Shelf Life of Medical Devices", issued April 1991 and the Bard internal stability program. Additionally, biocompatibility tests were performed in accordance with ISO 10993-1: 2009, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a Risk Management Process". The Presto™ Inflation Device, when connected to an angioplasty balloon dilatation catheter, is a closed

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system and does not deliver contrast/saline to the circulatory system. Successful testing for Cytotoxicity, Sensitization and Intracutaneous Reactivity show the devices are biocompatible for their intended use. Additionally, pyrogenicity testing is conducted to support labeling claims.

The results from these tests demonstrate that the technological characteristics and performance criteria of the Presto™ Inflation Device is comparable to the predicate devices and that it can perform in a manner equivalent to balloon inflation devices currently on the market with the same intended use.

Conclusions:

The subject device, the Presto™ Inflation Device, met all the predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs. The Presto™ Inflation Device is substantially equivalent to the legally marketed predicate device.

Regulation Number and Section

§ 870.1650 Angiographic injector and syringe.

(a)
Identification. An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography.(b)
Classification. Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.