(87 days)
PEMT-5 Balloon Dilatation Catheter, Courier TM Balloon Catheter
Not Found
No
The summary describes a physical medical device (a balloon dilatation catheter) and its intended use and testing. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML.
Yes
The device is indicated for percutaneous transluminal angioplasty (PTA) of arteries and treatment of obstructive lesions, which are therapeutic interventions.
No
The device is a balloon dilatation catheter used for therapeutic purposes (e.g., PTA, stent deployment/optimization) rather than for diagnosing conditions.
No
The device description clearly describes a physical catheter, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device used for therapeutic procedures (PTA, treatment of obstructive lesions, stent deployment/optimization) performed directly on the patient's body. IVDs are used to examine specimens (like blood, urine, tissue) taken from the body to provide information about a person's health.
- Device Description: The device is a catheter designed to be placed over guidewires within the body. This is consistent with an interventional medical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, using reagents, or providing diagnostic information based on laboratory testing.
Therefore, the Courier™ Balloon Dilatation Catheter is a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Courier™ Balloon Dilatation Catheter is indicated for PTA of the iliac, femoral and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae, In addition, certain sizes of the Diamond ballown catheter are indicated for stent deployment / optimization of the J&J Palmaz Biliary Stent into the biliary ducts.
Product codes
Not Found
Device Description
The proposed Courier™ Balloon Dilatation catherer is an over-the-wire catherer designed to be placed over guidewires which have outer diameters of .035" or smaller.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
iliac, femoral, and renal arteries; arteriovenous dialysis fistulae; biliary ducts
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
Functional and integrity bench testing and biocompatibility testing to the FDA guidance document, ODE Blue Book Memorandum #G95-1, May 1, 1995, Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing") were performed, and the data supported the substantial equivalence of the Courier™ Balloon Dilatation Catheter to the PEMT-5 Balloon Dilatation Catheter.
Key Metrics
Not Found
Predicate Device(s)
BSC -- PEMT-5 Balloon Dilatation Catheter, BSC -- Courier TM Balloon Catheter
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Pl qz
Medi-tech Courier™ Balloon Dilatation Catheter September 12, 1996
ATTACHMENT H
SUMMARY OF SAFETY AND EFFECTIVENESS
Pursuant to $513(i)(3)(A) of the Food, Drug, and Cosmetic Act, Boston Scientific Corporation is required to submit with this Premarket Notification either an " ... adequate summary of any information respecting safety and effectiveness or state that such information will be made available upon request of any person." Boston Scientific Corporation choose to submit a summary of information respecting safety and effectiveness. According to §513(i)(3)(B), "Any summary under subparagraph (A) respecting a device shall contain detailed information regarding data concerning adverse health effects ... "
The summary regarding the adverse health effects of the proposed Courier™ Balloon Dilatation Catheter is as follows:
| Trade Name: | Courier™ Balloon Dilatation Catheter |
|---|---|
| Manufacturer: | Boston Scientific Corporation |
| One Boston Scientific Place | |
| Natick, MA 01760 | |
| Device Generic Name: | Balloon Dilatation Catheter |
| Classification: | According to Section 13 of the Federal Food, Drug and Cosmetic Act, the |
| device classification is Class II, Performance Standards. |
Predicate Devices:
The following devices are referenced in this premarket notification as predicate devices for the Diamond™ Balloon Dilatation Catheter:
BSC -- PEMT-5 Balloon Dilatation Catheter BSC -- Courier TM Balloon Catheter
All of the devices mentioned above have been determined substantially equivalent by FDA.
Device Description:
The proposed Courier™ Balloon Dilatation catherer is an over-the-wire catherer designed to be placed over guidewires which have outer diameters of .035" or smaller.
Indications for Use:
The Courier™ Balloon Dilatation Catheter is indicated for PTA of the iliac, femoral and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae, In addition, certain sizes of the Diamond ballown catheter are indicated for stent deployment / optimization of the J&J Palmaz Biliary Stent into the biliary ducts.
1
K 963691
p292
Medi-tech Courier™ Balloon Dilatation Catheter September 12, 1996
Safety and Performance:
Functional and integrity bench testing and biocompatibility testing to the FDA guidance document, ODE Blue Book Memorandum #G95-1, May 1, 1995, Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing") were performed, and the data supported the substantial equivalence of the Courier™ Balloon Dilatation Catheter to the PEMT-5 Balloon Dilatation Catheter.
Conclusion:
Based on the Indication for Use, technological characteristics and safety and performance testing, the Courier™ Balloon Dilatation Catheter has been shown to be safe and effective for its intended use.