(88 days)
PEMT-5 Balloon Dilatation Catheter, Ultra-thin™ Diamond Balloon Catheter
Not Found
No
The 510(k) summary describes a physical medical device (a balloon dilatation catheter) and its intended use and performance testing. There is no mention of software, algorithms, image processing, AI, ML, or any related concepts that would indicate the incorporation of AI/ML technology. The performance studies focus on bench testing and biocompatibility, typical for this type of device.
Yes
The device is used for medical interventions (PTA, treatment of obstructive lesions, stent deployment/optimization) in various anatomical sites, indicating its therapeutic purpose.
No
Explanation: The "Intended Use / Indications for Use" section states that the device is indicated for "PTA (Percutaneous Transluminal Angioplasty) of the iliac, femoral and renal arteries and for the treatment of obstructive lesions...". This describes a therapeutic, rather than a diagnostic, function.
No
The device description clearly states it is a "Balloon Dilatation Catheter," which is a physical medical device, not software. The performance studies also focus on bench testing and biocompatibility, typical for hardware devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that the Diamond™ Balloon Dilatation Catheter is an over-the-wire catheter used for procedures performed within the body (PTA of arteries, treatment of fistulae, stent deployment in biliary ducts). It is a therapeutic and interventional device, not a device that analyzes samples outside the body.
The information provided focuses on the physical characteristics and intended use for treating conditions within the patient's body, which is characteristic of an in vivo medical device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Diamond™ Balloon Dilatation Catheter is indicated for PTA of the iliac, femoral and renal arteries and for the treatment of obstructive lesions of naive or synthetic arteriovenous dialysis fistulae. In addition, certain sizes of the Diamond balloon 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 Diamond™ Balloon Dilatation catheter is an over-the-wire catheter 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, 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 (according 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 Ultra-thin™ Diamond™ Balloon Dilatation Catheter to the PEMT-5 Balloon Dilatation Catheter.
Key Metrics
Not Found
Predicate Device(s)
PEMT-5 Balloon Dilatation Catheter, Ultra-thin™ Diamond 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
Ka63397
Nov 25 1996
Medi-tech Ultra-thin™ Diamond™ Balloon Dilatation Catheter
August 28, 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 Diamond™ Balloon Dilatation Catheter is as follows:
| Trade Name: | Diamond™ 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 -- Ultra-thin™ Diamond Balloon Catheter
All of the devices mentioned above have been determined substantially equivalent by FDA.
Device Description:
The proposed Diamond™ Balloon Dilatation catheter is an over-the-wire catheter designed to be placed over guidewires which have outer diameters of .035" or smaller.
Indications for Use:
The Diamond™ Balloon Dilatation Catheter is indicated for PTA of the iliac, femoral and renal arteries and for the treatment of obstructive lesions of naive or synthetic arteriovenous dialysis fistulae. In addition, certain sizes of the Diamond balloon catheter are indicated for stent deployment / optimization of the J&J Palmaz Biliary Stent into the biliary ducts.
1
K96 3397
P2072
Medi-tech Ultra-thin™ Diamond™ Balloon Dilatation Catheter
August 28, 1996
Safety and Performance:
Functional and integrity bench testing and biocompatibility testing (according 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 Ultra-thin™ Diamond™ 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 Diamond™ Balloon Dilatation Catheter has been shown to be safe and effective for its intended use.