(80 days)
Not Found
Not Found
No
The description focuses on the physical construction and materials of a guide wire, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The document states that the guide wires are intended to "facilitate the placement and enchange of PTCA balloon catheters and other therapeutic devices," indicating they are tools used with therapeutic devices, not therapeutic devices themselves.
No
The device is a guide wire intended to facilitate the placement and exchange of other therapeutic devices during angioplasty. Its function is to aid in a therapeutic procedure, not to diagnose a condition.
No
The device description clearly outlines physical components like a stainless steel core wire, PTFE coating, Pebax® sleeve, platinum spring coil, and silicone coating. This indicates a hardware-based medical device, not a software-only one.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to "facilitate the placement and enchange of PTCA balloon catheters and other therapeutic devices during angioplasty." This describes a device used in vivo (within the body) for a therapeutic procedure.
- Device Description: The description details the physical components of a guide wire used in a medical procedure, not a device designed to analyze samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed 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 SCIMED Sceptor and Sceptor Exchange PTCA Guide Wires are intended to facilitate the placement and enchange of PTCA balloon catheters and other therapeutic devices during angioplasty. The devices are provided sterile and intended for one procedure only.
Product codes
Not Found
Device Description
The Sceptor and Sceptor Exchange Guide Wires utilize common biocompatible materials and are constructed in a similar manner as currently marketed devices. The one piece stainless steel core wire has a PTFE (gray or black) coated proximal section and a tapered distal section. The distal section is surrounded by a Pebax® sleeve and platinum spring coil. The spring tip and polymer sleeve are coated with XTRA™ (silicone) coating.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Testing and evaluation of the guide wires included teflon coating adherence. Test results verified that the Sceptor and Sceptor Exchange Guide Wires met the minimum requirements and are adequate for their intended use. The Sceptor and Sceptor Exchange PTCA Guide Wires are considered to be substantially equivalent to guide wires currently marketed by SCIMED (Sceptor, Sceptor Exchange and ChoICE Guide Wires) based on a comparison of intended use, design and the results of in vitro testing and evaluation.
Key Metrics
Not Found
Predicate Device(s)
SCIMED® Sceptor™ PTCA Guide Wire, SCIMED® Sceptor™ PTCA Exchange Guide Wire, SCIMED® ChoICE™ PTCA Guide Wire
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
0
96056
510(k) Notification SCIMED Sceptor and Sceptor Exchange PTCA Guide Wire Page 3
Ar- 2 9 1996
SECTION THREE--SUMMARY OF SAFETY AND EFFECTIVENESS
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (Pursuant To Section 12 of the SAFE MEDICAL DEVICES ACT of 1990) February 8, 1996
I. General Provisions: Submitter's Name and Address:
Contact Person:
SCIMED Life Systems, Inc. One SCIMED Place Maple Grove, Minnesota 55311
Connie J. Del Toro (612) 494-2656
Classification Name:
Common or Usual Name:
Proprietary Name:
Catheter Guide Wire
PTCA Guide Wire
SCIMED® Sceptor™ Guide Wire SCIMED® Sceptor™ Exchange Guide Wire
IFE SYSTEMS, INC
II. Name of Predicate Devices:
SCIMED® Sceptor™ PTCA Guide Wire SCIMED® Sceptor™ PTCA Exchange Guide Wire SCIMED® ChoICE™ PTCA Guide Wire
III. Device Description:
The Sceptor and Sceptor Exchange Guide Wires utilize common biocompatible materials and are constructed in a similar manner as currently marketed devices. The one piece stainless steel core wire has a PTFE (gray or black) coated proximal section and a tapered distal section. The distal section is surrounded by a Pebax® sleeve and platinum spring coil. The spring tip and polymer sleeve are coated with XTRA™ (silicone) coating.
IV. Intended Use:
ﺗ
The SCIMED Sceptor and Sceptor Exchange PTCA Guide Wires are intended to facilitate the placement and enchange of PTCA balloon catheters and other therapeutic devices during angioplasty. The devices are provided sterile and intended for one procedure only.
1
510(k) Notification SCIMED Sceptor and Sceptor Exchange PTCA Guide Wire Page 4
LIFE SYSTEMS, INC.
V. Summary of Technological Characteristics:
The Sceptor and Sceptor Exchange PTCA Guide Wires utilize the same materials and method of construction as the currently marketed Sceptor and Sceptor Exchange Guide Wires. This 510(k) describes the use of an alternate proximal coating (PTFE) which is used on the currently marketed SCIMED ChoICE PTCA Guide Wire.
VI. Non-clinical Test Summary:
Testing and evaluation of the guide wires included teflon coating adherence. Test results verified that the Sceptor and Sceptor Exchange Guide Wires met the minimum requirements and are adequate for their intended use. The Sceptor and Sceptor Exchange PTCA Guide Wires are considered to be substantially equivalent to guide wires currently marketed by SCIMED (Sceptor, Sceptor Exchange and ChoICE Guide Wires) based on a comparison of intended use, design and the results of in vitro testing and evaluation.