(90 days)
Not Found
No
The summary describes a mechanical device (balloon catheter) and its performance testing, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is a therapeutic device because its intended use is for Percutaneous Transluminal Angioplasty (PTA) to treat obstructive lesions in arteries and dialysis fistulae, which is a treatment to restore blood flow.
No
The document describes the PTA-Duo PTA Balloon Catheter as a device designed for "Percutaneous Transluminal Angioplasty" and "dilation of peripheral vessels" to "treat obstructive lesions." This indicates a therapeutic function, not a diagnostic one. While it allows for distal injection of contrast media to "visualize the result," this visualization is part of guiding the therapeutic procedure, not for initial diagnosis.
No
The device description clearly describes a physical balloon catheter with a proprietary valve system, which is a hardware component. The performance studies also focus on the physical properties and biological interactions of the device materials and design.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used within the body for a therapeutic procedure (Percutaneous Transluminal Angioplasty). IVDs are used outside the body to examine specimens (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a physical catheter with a balloon designed to be inserted into blood vessels. This is consistent with an interventional device, not a diagnostic test performed on a sample.
- Performance Studies: The performance studies focus on the physical and biological interactions of the device within the body (biocompatibility, in-vitro bench testing of physical properties, in-vivo testing in animals). IVD performance studies would focus on the accuracy and reliability of the test results obtained from analyzing specimens.
The PTA-Duo PTA Balloon Catheter is a therapeutic medical device used for angioplasty, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
LIT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral, iliac, and renal arteries, native or synthetic arteriovenous dialysis fistulae
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
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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 A | |
| Mountain 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:
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.
E. Intended Use:
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.
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:
PTA-Duo PTA Balloon Catheter
Indication For Use:
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.
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