(75 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a balloon catheter, with no mention of AI or ML capabilities.
Yes
The device is used for Percutaneous Transluminal Angioplasty (PTA) to treat obstructive lesions in arteries, which is a therapeutic intervention.
No
The device description and intended use clearly state that this is a therapeutic device used for angioplasty and post-dilatation of stents, not for diagnosis.
No
The device description clearly details a physical catheter with a balloon, lumens, guidewire compatibility, radiopaque markers, and a coating. This is a hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a procedure performed within the body (Percutaneous Transluminal Angioplasty) to treat blockages in blood vessels. This is an in vivo procedure.
- Device Description: The device is a physical catheter with a balloon designed to be inserted into blood vessels and inflated. This is a therapeutic device used directly on the patient.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used to perform tests outside the body on biological samples. This device is used inside the body for a therapeutic purpose.
N/A
Intended Use / Indications for Use
The Charger Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, popliteal, tibial, peroneal, subclavian, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
The Charger Balloon Dilatation Catheter is also indicated for post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature.
Product codes (comma separated list FDA assigned to the subject device)
LIT, DQY
Device Description
The Boston Scientific Charger™ Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter is an over-the-wire (OTW) balloon catheter with a dual lumen shaft design. One lumen marked "WIRE" is used to pass the catheter over 0.035" (0.89mm) guidewires. The second lumen marked "BALLOON" communicates with the balloon and is used to inflate and deflate the balloon during the procedure. The guidewire lumen and the balloon lumen terminate at the proximal end of the catheter in a Y-connector manifold with luer lock fittings. There are two radiopaque marker bands located under -the balloon shoulders to aid in positioning the system during the procedure. A coating is applied to the balloon to enhance insertion and withdrawal performance. The tip of the catheter is gradually tapered to facilitate advancement of the catheter through the stenosis.
The Charger™ Balloon Dilatation Catheter will be available with balloon diameters 3.0 mm to 12.0 mm, balloon lengths 20 mm to 200 mm and with shaft lengths of 40 cm, 75 cm, and 135 cm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vasculature, including iliac, femoral, popliteal, tibial, peroneal, subclavian, and renal arteries
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)
Biocompatibility testing and bench testing were performed to support a determination of substantial equivalence. The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the testing.
The following biocompatibility tests were completed on the Charger PTA Balloon Dilatation Catheter:
- MEM Elution / Cytotoxicity Guinea Pig Maximization Sensitization Intracutaneous Reactivity Acute Systemic Toxicity Materials Mediated Rabbit Pyrogen Hemolysis Direct Contact and Extract Complement Activation
- Partial Thromboplastin Time In Vitro Hemocompatibility Bacterial Mutagenicity (Ames Assay) Mouse Lymphoma Assay USP Physiochemical Latex
The following in-vitro performance tests were completed for the Charger PTA Balloon Dilatation Catheter as part of a Special 510k:
- Bond Tensile
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Mustang™ Balloon Dilatation Catheters (K103751)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
510(k) Summarv
Submitter: Boston Scientific Corporation One Scimed Place Maple Grove. MN 55311 Contact Person: Glenn Jacques Phone Number: 763-494-1152 Fax Number: 763-494-2222 Date Prepared: September 15, 2011 Device Trade Name: Charger PTA Balloon Dilatation Catheters Common Name: Percutaneous Transluminal Angioplasty Dilatation Catheter Device Classification: Class II 21 CFR 870.1250 Product Code: LIT, DQY
NOV 3 0 2011
Predicate Devices
Mustang PTA Balloon Dilatation Catheters
Device Description
The Boston Scientific Charger™ Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter is an over-the-wire (OTW) balloon catheter with a dual lumen shaft design. One lumen marked "WIRE" is used to pass the catheter over 0.035" (0.89mm) guidewires. The second lumen marked "BALLOON" communicates with the balloon and is used to inflate and deflate the balloon during the procedure. The guidewire lumen and the balloon lumen terminate at the proximal end of the catheter in a Y-connector manifold with luer lock fittings. There are two radiopaque marker bands located under -the balloon shoulders to aid in positioning the system during the procedure. A coating is applied to the balloon to enhance insertion and withdrawal performance. The tip of the catheter is gradually tapered to facilitate advancement of the catheter through the stenosis.
The Charger™ Balloon Dilatation Catheter will be available with balloon diameters 3.0 mm to 12.0 mm, balloon lengths 20 mm to 200 mm and with shaft lengths of 40 cm, 75 cm, and 135 cm.
Indications for Use
The Charger Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, popliteal, tibial, peroneal, subclavian, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
The Charger Balloon Dilatation Catheter is also indicated for post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature.
Substantial Equivalence
The Charger PTA Balloon Dilatation Catheters design, materials, manufacturing process and intended use are substantially equivalent to the predicate device Mustang™ Balloon Dilatation Catheters (K103751).
1
Comparison of Technological Characteristics
The Charger PTA Balloon Dilatation Catheter incorporates substantially equivalent device materials and design, packaging materials and design, fundamental technology, manufacturing processes, sterilization processes and intended use as those featured in the Boston Scientific predicate device Mustang™ Balloon Dilatation Catheters (K103751).
Comparison to Predicate Devices in Materials and Manufacturing 1 - RETUREA 22 - 1 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 -
| Characteristics | Mustang predicate |
|---|---|
| Manifold | Same material. Different |
| colorant. Same design | |
| serving same function | |
| Strain Relief | Same material. Same |
| design serving same | |
| function | |
| Catheter Proximal Shaft / | |
| Distal Outer | Same material. Different |
| colorant/additive. Same | |
| design serving same | |
| function | |
| Catheter Inner Shaft | Same material, different |
| colorant/additive and | |
| serving same function | |
| Bumper Tip | Same material. Different |
| colorant. Same design | |
| serving same function | |
| Balloon | Same balloon material |
| and design and serving | |
| same function and | |
| fundamental technology | |
| Balloon Bonding Method | Same bonding method |
| and function | |
| Balloon Forming | |
| Process | Same forming method |
| and function | |
| Marker Bands | Same component serving |
| same function | |
| Coating | Same coating serving |
| same function | |
| Balloon Protector | Same material and |
| similar design both | |
| serving same function. | |
| Proximal Shaft Outer | |
| Diameter | Same shaft outer |
| diameters |
2
| Comparison to Predicate Devices Characteristics | |
|---|---|
| Characteristic | Mustang predicate |
| Balloon Diameters | Same balloon diameter range serving same function |
| Balloon Lengths | Same balloon length ranges serving same function |
| Rated Burst Pressure | |
| (RBP) | Similar rated burst pressure |
| Catheter Length | Same catheter length ranges serving same function |
| Recommended | |
| Introducer Sheath | |
| Compatibility | Similar ranges and compatibilities |
| Recommended | |
| Guidewire | Same compatibility. |
| Sterilization Method | Same method. |
| SAL | Same level of assurance |
| Packaging Material | |
| and Configuration | Same design and function |
Performance Data
Biocompatibility testing and bench testing were performed to support a determination of substantial equivalence. The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the testing.
The following biocompatibility tests were completed on the Charger PTA Balloon Dilatation Catheter:
- MEM Elution / Cytotoxicity Guinea Pig Maximization Sensitization Intracutaneous Reactivity Acute Systemic Toxicity Materials Mediated Rabbit Pyrogen Hemolysis Direct Contact and Extract Complement Activation
Partial Thromboplastin Time In Vitro Hemocompatibility Bacterial Mutagenicity (Ames Assay) Mouse Lymphoma Assay USP Physiochemical Latex
3
The following in-vitro performance tests were completed for the Charger PTA Balloon Dilatation Catheter as part of a Special 510k:
Bond Tensile
Conclusion
Based on the indications for use, technological characteristics, safety and performance testing, the Charger Balloon Dilatation Catheter has been shown to be appropriate for its intended use and is considered to be substantially equivalent to the Boston Scientific Mustang™ Balloon Dilatation Catheters (K103751).
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
NOV 3 0 2011
Boston Scientific Corporation c/o Glenn Jacques One Scimed Place Maple Grove, MN 55311
Re: K112697
Trade/Device Name: Charger™ PTA Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: LIT, DQY Dated: October 28, 2011 Received: October 31, 2011
Dear Mr. Jacques:
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. 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 of ections of ecass In (FWA).
Found in the Golon SE also CE also 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.
5
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 (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 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.
Enclosure
Sincerely vours.
M. A. Hillehouse
Sin Same Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
6
| Indications for Use Statement |
|---|
| ------------------------------- |
| 510(k) Number (if known) | K112697 |
|---|---|
| Device Name | Charger™ PTA Balloon Dilatation Catheters |
| Indications for Use | The Charger Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, popliteal, tibial, peroneal, subclavian, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. |
| The Charger Balloon Dilatation Catheter is also indicated for post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature. |
| Prescription Use | X | AND/OR | Over-The-Counter Use |
|---|---|---|---|
| (Per 21 CFR 801 Subpart D) | (Per 21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| M.Y. Willelrenn | |||
|---|---|---|---|
| (Division Sign-Off) | Division of Cardiovascular Devices | Page 1 of 1 | |
| 510(k) Number | K112697 |
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