(139 days)
No
The description focuses on the mechanical design and function of a balloon catheter with a scoring element and hydrophilic coating. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is intended for the "dilatation of lesions" and "treatment of obstructive lesions," which are therapeutic actions aimed at addressing a medical condition.
No
The device description indicates it is a "dilatation" catheter used to assist with "luminal expansion of stenotic arteries" and treat "obstructive lesions," which are therapeutic actions, not diagnostic.
No
The device description clearly describes a physical catheter with a balloon and scoring element, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The AngioSculpt PTA Scoring Balloon Catheter is a medical device used within the body (in vivo) to physically dilate blood vessels. It is a therapeutic device, not a diagnostic one.
- Intended Use: The intended use clearly describes a procedure performed on the patient's arteries and fistulae, not the analysis of a biological sample.
- Device Description: The description details the physical components of a catheter and balloon, not a system for analyzing biological samples.
Therefore, the AngioSculpt PTA Scoring Balloon Catheter is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The AngioSculpt PTA Scoring Balloon Catheter is intended for dilatation of lesions in the illiac, femoral, ilio-femoral, popliteal, infra popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Not for use in the coronary or neuro-vasculature.
Product codes
PNO, LIT
Device Description
The AngioSculpt PTA Scoring Balloon Catheter with HydroCross™ Coating is a standard twolumen catheter with a scoring balloon near the distal end of the catheter has a conventional nylon-blend balloon with a scoring element that wraps around the balloon. The scoring element creates focal concentrations of dilating force which minimizes balloon slippage and assists with luminal expansion of stenotic arteries. The balloon has radiopaque markers to aid in positioning the balloon in the stenosis, and is designed to provide an expandable segment of known diameter and length at a specific pressure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
illiac, femoral, ilio-femoral, popliteal, infra popliteal, 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Mechanical testing of the AngioSculpt catheter with HydroCross™ Coating was conducted in accordance with AngioScore's Risk Analysis and all applicable FDA guidance documents and relevant standards.
The following subset of bench tests were conducted to verify that design outputs met design requirements and to confirm proper function and durability. Test articles consisted of finished sterilized catheters.
- Catheter Diameter and Balloon Profile,
- Device Preparation, Deployment and Retraction
- Balloon Inflation and Deflation Time
- Catheter Bond (Tensile) Strength
- Tip Pull Strength
- Catheter Diameter and Balloon Profile (with Scoring Element)
- Torque Strength
- Pushability, Trackability and Secure Edges
- Guidewire Compatibility
- Catheter Effective Length
- Catheter Surface Appearance
- Luer Compatibility
- Coating Length
- Coating Thickness
- Coating Lubricity
- Coating Integrity
- Particulate Evaluation
- Rated Burst Pressure
- Compliance
- Device Fatigue
- Flexibility and Kink
Biocompatibility testing of predicate devices cleared under K122685 and K133998 is applicable to the 2.0-6.0mm x 100mm AngioSculpt catheters with HydroCross™ Coating; the following is a summary.
The AngioSculpt catheter with HydroCross™ Coating is categorized as an "External communicating device in contact with circulating blood with limited exposure time". The biocompatibility of the device was assessed in accordance with ISO 10993-1:2009 – Biological evaluation of medical devices, Part 1 – Evaluation and tests within a risk management process.
The biocompatibility tests listed below, except Thrombosis (in-vivo), were conducted in accordance with the provisions of the FDA GLP regulations 21 CFR Part 58. Thrombogenicity was evaluated as part of a GLP animal study.
- Cytotoxicity - MEM Elution Test using L-929 Mouse Fibroblast cells (ISO)
- Sensitization - Guinea Pig Maximization Sensitization Test
- Irritation - Intracutaneous Reactivity (Irritation) Test
- Systemic Toxicity Acute Systemic Injection Test (ISO)
- Systemic Toxicity Material Mediated Pyrogens
- Hemocompatibility - Partial Thromboplastin Time (PTT)
- Hemocompatibility - Hemolysis Direct Contact/Extract Method (ASTM)
- Hemocompatibility Direct Contact Complement Activation Testing With C3a and SC5b
- Hemocompatibility Thrombosis (in vivo)
- Genotoxicity Reverse Bacterial Mutation
- Genotoxicity - In vitro Mouse Lymphoma Assay-Extended Treatment
- Genotoxicity Rodent bone Marrow Micronucleus Assays
The biocompatibility test results confirm that the AngioSculpt catheter with HydroCross™ Coating, including the minor material changes, is non-sensitizing, non-irritating, not systemically toxic, non-hemolytic, and non-mutagenic , when evaluated under the respective test conditions. As shown in the GLP animal study, no thrombo-embolism was observed when the subject catheters were evaluated under simulated use conditions.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with the profiles overlapping each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 31, 2016
Spectranetics, Inc. Kimberley Kline Senior Manager, Regulatory Affairs 5055 Brandin Court Fremont, CA 94538
Re: K142983
Trade/Device Name: AngioSculpt® PTA Scoring Balloon Catheter with HydroCross™ Coating Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: PNO Dated: February 5, 2015 Received: February 6, 2015
Dear Ms. Kline:
This letter corrects our substantially equivalent letter of March 4, 2015.
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 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
1
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 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/ResourcesforYou/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.
Misti L. Malone -S
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with the profiles overlapping each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 31, 2016
Spectranetics, Inc. Kimberley Kline Senior Manager, Regulatory Affairs 5055 Brandin Court Fremont, CA 94538
Re: K142983
Trade/Device Name: AngioSculpt® PTA Scoring Balloon Catheter with HydroCross™ Coating Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: PNO Dated: February 5, 2015 Received: February 6, 2015
Dear Ms. Kline:
This letter corrects our substantially equivalent letter of March 4, 2015.
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 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
3
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 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/ResourcesforYou/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.
Misti L. Malone -S
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Summary for the AngioSculpt Scoring Balloon Catheter with HydroCross™ Coating
1. Submitter's Name / Contact Person
| Submitter: | Spectranetics, Inc.
5055 Brandin Court
Fremont, CA 94538 |
|-----------------|---------------------------------------------------------------------------------------------------|
| Contact Person: | Kimberley Kline
Senior Manager, Regulatory Affairs
Phone: 510-933-7989
Fax: 510-933-7994 |
February 23, 2015 Summary Preparation Date:
2. General Information
| Trade Name: | AngioSculpt® PTA Scoring Balloon Catheter with
HydroCross™ Coating |
|----------------------|-----------------------------------------------------------------------|
| Common / Usual Name: | Angioplasty catheter |
| Classification Name: | Percutaneous catheter |
| Product Codes: | LIT |
| Predicate Devices: | AngioSculpt® Scoring Balloon Catheter
(K112182/K122685/K133998) |
3. Indications for Use
The AngioSculpt PTA Scoring Balloon Catheter is intended for dilatation of lesions in the illiac, femoral, ilio-femoral, popliteal, infra popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Not for use in the coronary or neuro-vasculature.
4. Device Description
The AngioSculpt PTA Scoring Balloon Catheter with HydroCross™ Coating is a standard twolumen catheter with a scoring balloon near the distal end of the catheter has a conventional nylon-blend balloon with a scoring element that wraps around the balloon. The scoring element creates focal concentrations of dilating force which minimizes balloon slippage and assists with luminal expansion of stenotic arteries. The balloon has radiopaque markers to aid in positioning the balloon in the stenosis, and is designed to provide an expandable segment of known diameter and length at a specific pressure.
5
As shown below, the catheter has a segment which is coated with a hydrophilic coating (HydroCross™ Coating).
Image /page/5/Figure/1 description: The image shows a medical device with a long, thin tube and a handle. The tube has a transition tube with a HydroCross coating. The handle is purple and has the word "AngioScore" printed on it. The device appears to be designed for use in medical procedures.
5. Technological Characteristics
The 2.0-6.0mm x 100mm AngioSculpt catheters with HydroCross™ Coating incorporate substantially equivalent design, dimensional, and performance specifications when compared to the 510(k) cleared AngioSculpt catheters (K112182; 4.0-6.0x100/K122685; 2.0-3.5x100/K133998; 4.0-6.0x200). The following minor differences are noted:
- o The scoring element incorporates the same type of inner rings that may aid in scoring element deployment as the catheters cleared under K133998.
- The hydrophilic coating cleared under K133998 was added to the transition tube of the catheters to improve lubricity and deliverability.
- . The transition tube material was changed from Pebax 55 for manufacturability. This is the same material as cleared under K133998.
- . The inner member of the subject catheters is of the same design as the currently marketed 2.0 – 6.0mm x 100mm product; however, the middle layer of the subject catheters will consist of two material options: plexar or orevac. The inner member outer layer of the 4.0 -6.0mm x 100mm product will also consist of two material options: Pebax 6333 with black colorant or Vestamid Care ML21 2%-3% Clariant Blue (AF53676007). These materials are currently used in cleared AngioSculpt Scoring Balloon Catheters.
6. Summary of Bench Testing
Mechanical testing of the AngioSculpt catheter with HydroCross™ Coating was conducted in accordance with AngioScore's Risk Analysis and all applicable FDA guidance documents and relevant standards.
The following subset of bench tests were conducted to verify that design outputs met design requirements and to confirm proper function and durability. Test articles consisted of finished sterilized catheters.
- Catheter Diameter and Balloon Profile,
- Device Preparation, Deployment and Retraction ●
- Balloon Inflation and Deflation Time
- Catheter Bond (Tensile) Strength
- Tip Pull Strength
6
- Catheter Diameter and Balloon Profile (with Scoring Element) ●
- o Torque Strength
- Pushability, Trackability and Secure Edges
- Guidewire Compatibility ●
- Catheter Effective Length
- Catheter Surface Appearance
- Luer Compatibility
- Coating Length
- Coating Thickness
- Coating Lubricity
- Coating Integrity ●
- Particulate Evaluation
- Rated Burst Pressure
- Compliance ●
- Device Fatigue
- Flexibility and Kink
7. Summary of Biocompatibility Testing
The materials of construction for the2.0-6.0mm x 100mm AngioSculpt catheters with HydroCross™ Coating are the same materials as those of the predicate AngioSculpt catheters. Biocompatibility testing of predicate devices cleared under K122685 and K133998 is applicable to the 2.0-6.0mm x 100mm AngioSculpt catheters with HydroCross™ Coating; the following is a summary.
The AngioSculpt catheter with HydroCross™ Coating is categorized as an "External communicating device in contact with circulating blood with limited exposure time". The biocompatibility of the device was assessed in accordance with ISO 10993-1:2009 – Biological evaluation of medical devices, Part 1 – Evaluation and tests within a risk management process.
The biocompatibility tests listed below, except Thrombosis (in-vivo), were conducted in accordance with the provisions of the FDA GLP regulations 21 CFR Part 58. Thrombogenicity was evaluated as part of a GLP animal study.
- . Cytotoxicity - MEM Elution Test using L-929 Mouse Fibroblast cells (ISO)
- Sensitization - Guinea Pig Maximization Sensitization Test
- Irritation - Intracutaneous Reactivity (Irritation) Test
- Systemic Toxicity Acute Systemic Injection Test (ISO) ●
- Systemic Toxicity Material Mediated Pyrogens ●
- Hemocompatibility - Partial Thromboplastin Time (PTT)
- Hemocompatibility - Hemolysis Direct Contact/Extract Method (ASTM)
- Hemocompatibility Direct Contact Complement Activation Testing With C3a and SC5b ●
- Hemocompatibility Thrombosis (in vivo) ●
- Genotoxicity Reverse Bacterial Mutation ●
- Genotoxicity - In vitro Mouse Lymphoma Assay-Extended Treatment
- Genotoxicity Rodent bone Marrow Micronucleus Assays ●
7
The biocompatibility test results confirm that the AngioSculpt catheter with HydroCross™ Coating, including the minor material changes, is non-sensitizing, non-irritating, not systemically toxic, non-hemolytic, and non-mutagenic , when evaluated under the respective test conditions. As shown in the GLP animal study, no thrombo-embolism was observed when the subject catheters were evaluated under simulated use conditions.
8. Substantial Equivalence Comparison
The subject catheters share the same intended use, principles of operation, overall technical and functional capabilities, packaging and sterilization process, and similar design and materials as the predicate AngioSculpt catheters and are therefore substantially equivalent.
Although there are minor differences between the subject catheters and its predicate devices those differences do not raise new questions of safety or efficacy. Design verification and validation testing demonstrated adequate device performance and confirmed that no new questions of safety or effectiveness for peripheral balloon angioplasty devices were raised. The changes to the subject catheters do not affect the intended use of the device, alter the fundamental scientific technology of the device, or raise new issues of safety and effectiveness. The subject AngioSculpt PTA Scoring Balloon Catheters with HydroCross™ Coating are therefore, substantially equivalent to the predicate catheters.