The PTA-Duo PTA Balloon Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the femoral, iliac, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This catheter is not for use in coronary arteries.

Device Description

The PTA-Duo PTA Balloon Catheter is designed for dilation of peripheral vessels in the arterial system and native or synthetic arteriovenous dialysis fistulae in the treatment of obstructive lesions. The PTA-Duo PTA Balloon Catheter is a 0.035" guide-wire compatible, non-compliant, high pressure balloon catheter with a proprietary valve system which allows distal injection of contrast media without the need to remove the guidewire. By providing an angioplasty balloon with distal contrast injection capability. the user is able to treat obstructive lesions within the arteriovenous dialysis fistulae without having to lose guidewire position to visualize the result.

AI/ML Overview

This document describes the design verification and validation of the PTA-Duo PTA Balloon Catheter through various tests.

1. Table of Acceptance Criteria and Reported Device Performance:

The provided text details various tests performed and concludes that the device "met all predetermined acceptance criteria" and "all test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the PTA-Duo PTA Balloon Catheter met the established specifications necessary for consistent performance during its intended use." However, specific quantitative acceptance criteria or detailed numerical results for each test are not explicitly provided in the given text.

Below is a table summarizing the types of tests mentioned. Without specific acceptance values from the document, we can only state that the device met those unstated criteria.

Category	Test Performed	Reported Performance
Biocompatibility	ISO MEM Elution Assay	Met established specifications; materials are non-toxic and non-sensitizing.
	ASTM Hemolysis Assay	Met established specifications; materials are non-toxic and non-sensitizing.
	Complement Activation C3a and SC5b-9 Assay	Met established specifications; materials are non-toxic and non-sensitizing.
	Partial Thromboplastin Time	Met established specifications; materials are non-toxic and non-sensitizing.
	Four Hour Thromboresistance Evaluation	Met established specifications; materials are non-toxic and non-sensitizing.
	Materials Mediated Rabbit Pyrogen	Met established specifications; materials are non-toxic and non-sensitizing.
	ISO Guinea Pig Maximization Sensitization	Met established specifications; materials are non-toxic and non-sensitizing.
	ISO Acute Systemic Injection Test	Met established specifications; materials are non-toxic and non-sensitizing.
	ISO Intracutaneous Reactivity Test	Met established specifications; materials are non-toxic and non-sensitizing.
	Pyrogen (LAL) Chromogenic	Met established specifications; materials are non-toxic and non-sensitizing.
In-Vitro Performance	Balloon Crossing Profile	Met established specifications necessary for consistent performance.
	Catheter Shaft Diameter	Met established specifications necessary for consistent performance.
	Guidewire Lumen Diameter	Met established specifications necessary for consistent performance.
	Catheter Shaft Markings	Met established specifications necessary for consistent performance.
	Balloon Working Length	Met established specifications necessary for consistent performance.
	Balloon Rated Burst Pressure	Met established specifications necessary for consistent performance.
	Balloon Compliance/Outer Diameter	Met established specifications necessary for consistent performance.
	Balloon Inflation/Deflation Time	Met established specifications necessary for consistent performance.
	Balloon Fatigue	Met established specifications necessary for consistent performance.
	Catheter Body Burst Strength	Met established specifications necessary for consistent performance.
	Catheter Bond and Tip Pull Strength	Met established specifications necessary for consistent performance.
	Catheter Torque Strength	Met established specifications necessary for consistent performance.
	Contrast Media Flow Rate	Met established specifications necessary for consistent performance.
	Simulated Use/Flexibility/Kink	Met established specifications necessary for consistent performance.
	Radiopacity	Met established specifications necessary for consistent performance.
In-Vivo Performance	Angioplasty procedure on synthetic AV grafts (ovine)	Vessel and organ response comparable between test and control device treatments. Met established specifications.

2. Sample Size Used for the Test Set and Data Provenance:

Test Set Sample Size:
- Biocompatibility: Not specified for each test, but standard models like guinea pigs and rabbits are mentioned.
- In-Vitro Performance: Not specified, but generally involves multiple samples of the manufactured device.
- In-Vivo Testing: "ovine specimens" (sheep) with synthetic arteriovenous access grafts. The exact number of specimens is not provided, but it states "test and control comparator groups," implying more than one animal.
Data Provenance: The studies were internal company studies ("Hotspur Technologies, Inc.") and conducted in accordance with "21 CFR Part 58 'Good Laboratory Practices for Nonclinical Laboratory Studies'." The country of origin is not explicitly stated, but the company address is in Mountain View, CA, USA, and the submission is to the US FDA. This indicates US-based studies. The studies are prospective in nature for device verification.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

Not applicable. The tests performed are primarily bench (in-vitro) and animal (in-vivo) studies focused on the physical and biological performance of the device itself, rather than diagnostic interpretation requiring human experts to establish ground truth. Physical measurements, chemical analyses, and histological examinations establish the "ground truth" for device performance.

4. Adjudication Method for the Test Set:

Not applicable for this type of device performance testing. Ground truth is established by objective measurements and scientific analysis, not by expert consensus adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that rely on human interpretation of outputs (e.g., medical images) and AI assistance. This document describes the validation of a physical medical device (balloon catheter) where performance is measured objectively.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Not applicable. This device is a physical medical instrument, not an algorithm or AI system.

7. The Type of Ground Truth Used:

Biocompatibility: Ground truth was established by laboratory assays measuring cellular response, immune response, and material interactions with biological systems according to ISO and ASTM standards.
In-Vitro Performance: Ground truth was established by direct physical measurements (e.g., diameter, length, pressure, time) and engineering tests (e.g., fatigue, burst strength, torque).
In-Vivo Testing: Ground truth was established by surgical observation, post-survival observation, and histological examination of vessel and organ response in ovine specimens, comparing the test device to controls.

8. The Sample Size for the Training Set:

Not applicable. This document pertains to the verification and validation of 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 there is no training set for a physical medical device.

Summary

{0}------------------------------------------------

K10104/7

CONFIDENTIAL

Hotspur Technologies, Inc. 510(k) Notification: PTA-Duo PTA Balloon Catheter

SECTION 5.0: 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

A. Submitter Information
Submitter's Name:	Hotspur Technologies, Inc.
Address:	880 Maude Ave., Suite AMountain View, CA 94043	JUL 1 3 2010
Telephone:	650-969-3150
Fax:	408-608-1597
Contact Person:	Eric Ankerud, Executive Vice President Clinical, Regulatory,Quality
Date of Preparation:	July 6, 2010

B. Subject Device

Trade Name: Common/Usual Name: Classification Name:

PTA-Duo PTA Balloon Catheter Balloon Catheter Catheter, Angioplasty, Peripheral, Transluminal/Percutaneous Catheter (21 CFR 870.1250, Product Code LIT)

C. Predicate Device Name(s)

Trade Name(s):

Vaccess PTA Balloon Dilation Catheter, K073472

D. Device Description:

E. Intended Use:

F. Summary of Similarities and Differences in Technological Characteristics, Performance and Intended Use:

The proposed PTA-Duo PTA Balloon Catheter and the predicate Vaccess PTA Balloon Dilation Catheter intended use. Both are indicated for treatment of obstructive lesions by high pressure have the same dilation in the arterial system and of native or synthetic arteriovenous dialysis fistulae.

The proposed PTA-Duo PTA Balloon Catheter and the Vaccess PTA Balloon Dilation Catheter contain an inflatable non-compliant balloon for dilation of obstructive lesions. The usable length of the proposed PTA-Duo PTA Balloon Catheter is 55 cm whereas the usable length of the predicate Bard Vaccess Balloon Dilation Catheter is 50cm. The proposed device and predicate device are substantially equivalent in terms of intended use, fundamental scientific technology, target population, operating principles, and method of sterilization.

{1}------------------------------------------------

G. Performance Data:

Biocompatibility testing on the proposed PTA-Duo PTA Balloon Catheter has been completed. The biocompatibility test results show that the materials used in the design and manufacture of the components of the proposed device are non-toxic and non-sensitizing to biological tissues consistent with its intended use. The following Biocompatibility tests were completed:

ISO MEM Elution Assay .
ASTM Hemolysis Assay .
Complement Activation C3a and SC5b-9 Assay .
. Partial Thromboplastin Time
Four Hour Thromboresistance Evaluation .
Materials Mediated Rabbit Pyrogen .
ISO Guinea Pig Maximization Sensitization .
ISO Acute Systemic Injection Test .
ISO Intracutaneous Reactivity Test .
Pyrogen (LAL) Chromogenic .

The proposed PTA-Duo PTA Balloon Catheter was evaluated using the following in-vitro performance bench testing to confirm the performance characteristics as compared to the predicate device:

Balloon Crossing Profile .
. Catheter Shaft Diameter
. Guidewire Lumen Diameter
. Catheter Shaft Markings
Balloon Working Length .
Balloon Rated Burst Pressure
Balloon Compliance/ Outer Diameter .
. Balloon Inflation/Deflation Time
. Balloon Fatigue
. Catheter Body Burst Strength
. Catheter Bond and Tip Pull Strength
. Catheter Torque Strength
Contrast Media Flow Rate .
Simulated Use/Flexibility/Kink .
Radiopacity �

In-vivo testing was completed and conducted in accordance with 21 CFR Part 58 "Good Laboratory Practices for Nonclinical Laboratory Studies". Synthetic arteriovenous access grafts were surgically placed in ovine specimens and allowed to mature. Following graft maturation, a simulated angioplasty procedure was performed on test and control comparator groups. Post procedure animals were survived and observed for a predetermined period. Post survival, vessel and organ histology was completed to compare vessel and organ response to the test and control device treatments.

All test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the PTA-Duo PTA Balloon Catheter met the established specifications necessary for consistent performance during its intended use.

H. Conclusions:

The PTA-Duo PTA Balloon Catheter met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, test protocols, and/or customer inputs. The PTA-Duo PTA Balloon Catheter is substantially equivalent to the legally marketed predicate device and does not raise any new safety or effectiveness questions.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name in a circular arrangement around a stylized emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with a bird-like design incorporated into it.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

JUL 1 8 2010

Hotspur Technologies, Inc. c/o Eric Ankerud Executive Vice President, Clinical Regulatory and Quality 880 Maude Avenue, Suite A Mountain View, CA 94043

Re: K101047

Trade/Device Name: PTA-Duo PTA Balloon Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT Dated: July 6, 2010 Received: July 7, 2010

Dear Mr. Ankerud:

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. However, we remind you 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

{3}------------------------------------------------

Page 2 - Mr. Ankerud

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 devicerelated 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/ReportaProblem/default.htmi 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.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm263366.htm

Sincerely yours.

Duma R. Lahner

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

Enclosure

{4}------------------------------------------------

SECTION 4.0: INDICATIONS FOR USE STATEMENT

510(k) Number:

Device Name:

K101047

PTA-Duo PTA Balloon Catheter

Indication For Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duma R. Vihner

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_K10 \ D47

Regulation Number and Section

§ 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).