(91 days)
Not Found
No
The 510(k) summary describes a mechanical clip system and appliers, with no mention of software, algorithms, or any technology that would typically incorporate AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
Yes
The device is used to occlude an intracranial aneurysm to prevent it from bleeding or bursting, which is a therapeutic intervention.
No
The device is an aneurysm clip system used to occlude an intracranial aneurysm, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly states it is a "Clip System" and describes physical components like "clips" and "appliers," indicating it is a hardware medical device.
No, 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, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The SCANLAN® Heifetz Aneurysm Elgiloy® Clip System is a surgical implant used inside the body to physically occlude an aneurysm. It does not involve testing or analyzing biological specimens.
Therefore, based on the provided information, this device falls under the category of a surgical implant or device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
SCANLAN® Heifetz Aneurysm Elgiloy® Clip System provides standard clips and appliers used to occlude an intracranial aneurysm to prevent it from bleeding or bursting.
Product codes
Not Found
Device Description
The SCANLAN® Heifetz Aneurysm Elgiloy Clip System is a device used to occlude an intractanial aneurysm (a balloonlike sac formed on a blood vessel) to prevent bleeding or bursting.) The SCANLAN® Heifetz Aneurysm Elgiloy® Clip System is sold non-sterile. Descriptions of each clip size and shape are provided in the brochure. Appliers are available in five sizes and are described in the accompanying brochure (See Appendix A. ) A schematic for a representative clip size is provided in Appendix B.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intracranial aneurysm
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5200 Aneurysm clip.
(a)
Identification. An aneurysm clip is a device used to occlude an intracranial aneurysm (a balloonlike sac formed on a blood vessel) to prevent it from bleeding or bursting.(b)
Classification. Class II (performance standards).
0
510(k) Summarv
SUBMITTER:
Submitted on behalf of:
SCANLAN® International One Scanlan Plaza St. Paul, MN 55107 612-298-0997 Telephone:
Official Correspondent:
Ken Blake Vice President Research & Development
DATE SUMMARY PREPARED: 1-22-96
SCANLAN® Heifetz Aneurysm Elgiloy® Clip System TRADE NAME:
Aneurysm Clip & Applier System COMMON NAME:
SUBSTANTIALLY EQUIVALENT TO: Weck Heifetz Aneurysm Clip & Applier System
DESCRIPTION of the DEVICE:
The SCANLAN® Heifetz Aneurysm Elgiloy Clip System is a device used to occlude an intractanial aneurysm (a balloonlike sac formed on a blood vessel) to prevent bleeding or bursting.) The SCANLAN® Heifetz Aneurysm Elgiloy® Clip System is sold non-sterile. Descriptions of each clip size and shape are provided in the brochure. Appliers are available in five sizes and are described in the accompanying brochure (See Appendix A. ) A schematic for a representative clip size is provided in Appendix B.
INDICATIONS FOR USE:
SCANLAN® Heifetz Aneurysm Elgiloy® Clip System provides standard clips and appliers used to occlude an intracranial aneurysm to prevent it from bleeding or bursting.
CLINICAL INFORMATION and SAFETY and EFFECTIVENESS:
SCANLAN® Heifetz Aneurysm Elgiloy Clip System is substantially equivalent to the Weck Heifetz Aneurysm Clips system (clips and appliers) that are represented in part by K790413. Note that the Weck system (additional clip sizes and shapes) is also a pre-amendment device. There are no substantial differences in materials, designs or performance, in so far as can be determined, between the Weck brand of Heifetz Aneurysm clips and appliers and the Scanlan International products