(39 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a balloon catheter. There is no mention of software, algorithms, or data processing that would indicate the presence of AI/ML.
Yes
The device is a "Balloon Dilatation Catheter" indicated for "treatment of biliary strictures," which directly relates to therapy.
No
The device description clearly states its purpose as a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter used for the treatment of biliary strictures, not for diagnosis. It is designed to dilate strictures, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly details a physical balloon catheter with lumens, a Y-connector manifold, radiopaque marker bands, and a coating, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "treatment of biliary strictures." This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The description details a physical catheter with a balloon designed to be inserted into the body to dilate a stricture. This is a medical device used for a procedure, not for testing samples outside the body.
- Anatomical Site: The anatomical site is "biliary strictures," which are within the patient's body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The device's function is purely mechanical and therapeutic.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Charger Balloon Dilatation Catheters with bailoons up to 120 mm in length are indicated for the treatment of biliary strictures.
Product codes (comma separated list FDA assigned to the subject device)
FGE
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
Biliary
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.
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
§ 876.5010 Biliary catheter and accessories.
(a)
Identification. A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.(b)
Classification. Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
0
Premarket Notification - Special 510(k) Charger™ PTA Balloon Dilatation Catheters
510(k) Summary
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 Balloon Dilatation Catheters Common Name: Percutaneous Transluminal Angioplasty Dilatation Catheter Device Classification: Class II 21 CFR 876.5010 Product Code: FGE
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 Catheters with bailoons up to 120 mm in length are indicated for the treatment of biliary strictures.
Substantial Equivalence
The Charger PTA Balloon Dilatation Catheters design, materials, manufacturing process and intended use are substantially equivalent to the predicate device Mustanny proboon Dilatation Catheters (K110122).
1
K112701
pg 2 of 4
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 (K110122).
| Comparison to Predicate Devices in Materials and Manufacturing
| A . A . A . A . A | ||
|---|---|---|
| ------------------------------------------------------------------------------------- | -- | -- |
| Characteristic | 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
K 11270)
pg 3 of 4
| 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
K112701
pg. 4 of 4
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 (K110122).
4
Image /page/4/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around it. Inside the circle is a stylized image of an eagle or bird-like figure with three lines representing its wings or feathers.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Mr. Glenn Jacques Principal, Regulatory Affairs Boston Scientific One Scimed Place MAPLE GROVE MN 55311
OCT 2 5 2011
Re: K112701
Trade/Device Name: Charger™ PTA Balloon Dilatation Catheters Regulation Number: 21 CFR$ 876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II . Product Code: FGE Dated: September 21, 2011 Received: September 28, 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 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 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 device-related
5
Page 2
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 yours,
Hubert Lemmer MD
Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use Statement
| 510(k) Number (if known) | K112701 |
|---|---|
| Device Name | Charger TM PTA Balloon Dilatation Catheters |
| Indications for Use | Charger Balloon Dilatation Catheters with balloons up to 120 mm in length are indicated for the treatment of biliary strictures. |
Prescription Use _X (Per 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use_ (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)
Aorn M Wh
(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices 510(k) Number
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