(109 days)
Not Found
No
The summary describes a mechanical device (balloon catheter with a valve system and embolectomy coil) and its performance is evaluated through biocompatibility and in-vitro/in-vivo testing, with no mention of AI or ML.
Yes
The device is indicated for removing embolic material and dilating stenosis to treat obstructive lesions within synthetic arteriovenous dialysis fistulae, which are therapeutic actions.
No
Explanation: The device is a PTA balloon catheter intended for de-clotting and treating stenosis. Its purpose is interventional (therapeutic) rather than diagnostic.
No
The device description clearly states it is a "PTA Balloon Catheter" and details its physical components and mechanical functions (guide-wire compatible, valve system, embolectomy coil). The performance studies also focus on biocompatibility and physical performance characteristics of a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Function: The PTA-Plus PTA Balloon Catheter is a surgical device used inside the body (specifically within synthetic arteriovenous dialysis fistulae) to physically remove thrombus and dilate stenosis. It is a therapeutic device, not a diagnostic one.
- Intended Use: The intended use clearly describes a procedure performed on the patient, not a test performed on a sample from the patient.
The information provided confirms it's an interventional device used for treatment within the body.
N/A
Intended Use / Indications for Use
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.
Product codes
LIT, DXE
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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-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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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/Percutaneous | |
| Catheter (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, K901625 | |
| BARD Vaccess PTA Balloon Dilation Catheter, K073472 |
D. 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.
E. Intended Use:
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.
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
1
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:
PTA-Plus PTA Balloon Catheter
Device Name:
Indication For Use:
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.
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)
Mirro ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘ
(Division Sign-Off) (Division Olgh Olyn Olyn Scular Devices
510(k) Number_KIOO8AZ