The PTA-Plus PTA Balloon Catheter is indicated for use within synthetic arteriovenous dialysis fistulae to remove embolic material (thrombus/debris) and dilate stenosis for treatment of obstructive lesions.

Device Description

The proposed PTA-Plus PTA Balloon Catheter is designed for de-clotting and treating stenosis in synthetic dialysis grafts. It is an .035" guide-wire compatible, PTA balloon catheter with a proprietary valve system which allows injection of contrast and an embolectomy coil for mechanical removal of thrombus.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Hotspur Technologies, Inc. PTA-Plus PTA Balloon Catheter, based on the provided document:

1. Acceptance Criteria and Reported Device Performance

The document states that the PTA-Plus PTA Balloon Catheter met "all predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance documents, test protocols, and/or customer inputs." However, it does not provide a specific table or list of quantitative acceptance criteria values alongside the device's reported performance for each criterion. Instead, it broadly lists the types of tests performed and concludes that the device successfully met the established specifications.

Therefore, the table below reflects the categories of tests conducted and the general performance outcome as stated in the submission. Specific numerical values for acceptance criteria or performance are not detailed in the provided text.

Acceptance Criteria Category	Reported Device Performance
Biocompatibility Testing	Materials are non-toxic and non-sensitizing, consistent with intended use.
- ISO MEM Elution Assay	Met established specifications.
- Materials Mediated Rabbit Pyrogen	Met established specifications.
- ASTM Hemolysis Assay	Met established specifications.
- Complement Activation C3a and SC5b-9 Assay	Met established specifications.
- Partial Thromboplastin Time	Met established specifications.
- Four Hour Thromboresistance Evaluation	Met established specifications.
- ISO Guinea Pig Maximization Sensitization	Met established specifications.
- ISO Acute Systemic Injection Test	Met established specifications.
- ISO Intracutaneous Reactivity Test	Met established specifications.
- Pyrogen (LAL) Chromogenic	Met established specifications.
In-vitro Performance Bench Testing	The device confirmed performance characteristics compared to predicate devices and met established specifications.
- Balloon Crossing Profile	Met established specifications.
- Catheter Shaft Diameter	Met established specifications.
- Guidewire Lumen Diameter	Met established specifications.
- Catheter Shaft Markings	Met established specifications.
- Balloon Working Length	Met established specifications.
- Balloon Rated Burst Pressure	Met established specifications.
- Balloon Compliance/Outer Diameter	Met established specifications.
- Balloon Inflation/Deflation Time	Met established specifications.
- Balloon Fatigue	Met established specifications.
- Catheter Body Burst Strength	Met established specifications.
- Catheter Bond and Tip Pull Strength	Met established specifications.
- Catheter Torque Strength	Met established specifications.
- Contrast Media Flow Rate	Met established specifications.
- Adherent Clot Removal	Met established specifications.
- Simulated Use/Flexibility/Kink	Met established specifications.
- Radiopacity	Met established specifications.
In-vivo Animal Model Testing	The device showed vessel and organ response comparable to control device treatments, meeting established specifications.

2. Sample Size for Test Set and Data Provenance

Sample Size for Test Set: The document does not specify a numerical sample size for the in-vitro or in-vivo tests. For the in-vivo testing, it mentions "ovine specimens" and "test and control comparator groups" but no specific number of animals.
Data Provenance:
- In-vitro testing: Performed internally ("in-vitro").
- In-vivo testing: Conducted using an animal model (ovine specimens). The study was performed "in accordance with 21 CFR Part 58 'Good Laboratory Practices for Nonclinical Laboratory Studies'," which suggests a controlled, prospective study design. There's no mention of the country of origin, but given the submission to the FDA, it's likely U.S.-based or conducted under U.S. regulatory standards.

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

This information is not provided in the document. The device's performance was evaluated through physical, chemical, and animal testing rather than human interpretation or expert-established ground truth in the context of diagnostic performance.

4. Adjudication Method for the Test Set

This information is not applicable as the evaluation involved physical/chemical bench testing and animal studies, not human adjudication of results.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable. The device is a medical instrument (balloon catheter), not an AI-assisted diagnostic tool.

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

This information is not applicable. The device is a medical instrument, not an algorithm. The "standalone" performance here would refer to its physical and functional attributes, which were tested in-vitro and in-vivo.

7. The type of ground truth used

Biocompatibility: Established by adherence to ISO and ASTM standards and specific assay results (e.g., non-toxic, non-sensitizing, non-pyrogenic).
In-vitro Performance: Established by engineering specifications, comparative performance to predicate devices (which themselves met established safety and efficacy profiles), and adherence to predefined test protocols (e.g., balloon burst pressure, inflation/deflation times).
In-vivo Performance: Established by surgical implantation outcomes, observation of animal specimens, and post-survival vessel and organ histology, comparing responses to test and control devices. The ground truth here is the physiological response and histological findings in the ovine model.

8. The sample size for the training set

This information is not provided. The concept of a "training set" is typically associated with machine learning or AI models, which is not applicable to this physical medical device. The "training" for this device would refer to its design and manufacturing processes, which are not detailed in terms of a data set.

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

This information is not applicable for the same reasons as point 8.

Summary

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K/0084/2

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

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

A. Submitter Information
Submitter's Name:	Hotspur Technologies, Inc.	JUL 12 2010
Address:	880 Maude Ave., Suite A
	Mountain View, CA 94043
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:	PTA-Plus PTA Balloon Catheter
Common/Usual Name:	Balloon Catheter
Classification Name:	Catheter, Angioplasty, Peripheral, Transluminal/PercutaneousCatheter (21 CFR 870.1250, Product Code LIT)Catheter, Embolectomy (21 CFR 870.5150, Product Code DXE)
C. Predicate Device Name(s):
Trade Name(s):	Edwards Fogarty Adherent Clot Catheter, K901625BARD 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-Plus PTA Balloon Catheter ("PTA-Plus") and the predicate Fogarty Adherent Clot Catheter have the same intended use. Both are indicated for removal of emboli from synthetic arteriovenous fistula. The predicate Fogarty Adherent Clot Catheter is also indicated for removal of emboli from native vessels in the arterial system. The proposed PTA-Plus and the predicate Bard Vaccess PTA Balloon Dilation Catheter have the same intended use. Both are indicated for treatment of obstructive lesions by dilation of the stenosis of synthetic arteriovenous dialysis fistula.

The proposed PTA-Plus PTA Catheter has similar technological characteristics as the predicate devices. The proposed PTA-Plus combines the features of the two predicate devices into one device. The proposed PTA-Plus and the Bard Vaccess PTA Balloon Dilation Catheter contain an inflatable non-compliant balloon for dilation of stenosis. The proposed PTA-Plus and the Fogarty Adherent Clot Catheter both have a coil which is expanded by manual control of the proximal handle/cable for embolectomy. The usable length of the proposed PTA-Plus PTA Balloon Catheter is 55 cm whereas the usable length of the

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predicate Fogarty Adherent Clot Catheter is 80 cm and the predicate Bard Vaccess Balloon dilation Catheter is 50cm or 80cm. The proposed device and predicate devices are substantially equivalent in terms of intended use, fundamental scientific technology, target population, operating principles, and method of sterilization.

G. Performance Data:

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

The proposed PTA-Plus PTA Balloon Catheter was tested in-vitro and in an in-vivo animal model to confirm the performance characteristics as compared to the predicate devices. The following in-vitro performance bench testing was completed for the PTA-Plus PTA Balloon Catheter:

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 .
. Adherent Clot Removal
Simulated Use/Flexibility/Kink .
Radiopacity .

In-vivo testing for the PTA-Plus PTA Balloon Catheter was completed 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 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-Plus PTA Balloon Catheter met the established specifications necessary for consistent performance during its intended use. .

H. Conclusions:

The PTA-Plus PTA Balloon Catheter met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance documents, test protocols, and/or customer inputs. The PTA-Plus PTA Balloon Catheter is substantially equivalent to the legally marketed predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

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

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

(JUL 1 2 2010

Re: K100842

PTA-Plus PTA Balloon Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: DXE, 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.

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Page 2 - Mr. Eric Ankerud

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 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.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 vours.

R. beames

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

Enclosure

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SECTION 4.0: INDICATIONS FOR USE STATEMENT

510(k) Number:

K100842

PTA-Plus PTA Balloon Catheter

Device Name:

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)

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(Division Sign-Off) (Division Olgh Olyn Olyn Scular Devices

510(k) Number_KIOO8AZ

Regulation Number and Section

§ 870.5150 Embolectomy catheter.

(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).