(399 days)
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No
The device description and performance studies focus on mechanical properties and sterilization, with no mention of AI/ML or related concepts like image processing or data analysis.
Yes.
The device is used to occlude small vessels to control bleeding, which is a therapeutic intervention aimed at treating medical conditions.
No
The device is described as being used for the "occlusion of small vessels when controlling bleeding," which is a therapeutic intervention, not a diagnostic one. The performance studies also focus on mechanical properties relevant to therapeutic use (sterilization, opening/closing, twist, MRI compatibility) rather than diagnostic accuracy.
No
The device description and performance studies clearly indicate a physical, implantable device (clips) and do not mention any software component.
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 perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states the device is a miniaturized clip used to "occlude small vessels" and "control bleeding" during surgical procedures. This is a direct intervention on the body, not a test performed on a sample outside the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Providing diagnostic information based on sample analysis.
- Reagents or assays.
The device described is a surgical instrument used for mechanical occlusion of blood vessels during surgery.
N/A
Intended Use / Indications for Use
Occlusion of small vessels as a compliment to bipolar coagulation.
Product codes
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Device Description
These devices are miniaturized versions of the currently marketed Sugita Aneurysm Clip. They are used to occlude small vessels when controlling bleeding on arteriovenous malformations or other similar venous structures.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
CHANGES DURING STERILIZATION: The sample devices were subjected to sterilization at 250°F using a 20 minute cycle. This was repeated 50 times with the closing force being measured before the first cycle and at the conclusion of the test. The change in closing force for all clips tested was less than 10%.
MULTIPLE OPENING TESTING: Sample clips were subjected to 100 openings and closings. The results showed that holding force changed less than 10%.
TWIST TESTING: Samples were subjected to a twisting motion to determine the clips ability to return to its initial configuration. All clips passed.
MRI COMPATIBILITY: Sample clips were subject to testing in a 1.5 Tessla field. The angle of deflection for the clips tested was less than 3.5°.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
FEB - 5 1997
Image /page/0/Picture/1 description: The image shows the word "MIZUHO" in white letters against a black background. The letters are bold and slightly stylized. The background is a rounded rectangle.
123 Brimbal Avenue, Beverly, MA 01915 800-699-CLIP(2547) TEL: 508-921-1718 FAX: 508-921-4003
510(k) SUMMARY
Sugita AVM Microclip
Applicant:
Mizuho America Inc. 123 Brimbal Avenue Beverly, MA 01915
Contact: Brian Connelly
Telephone: 508-921-1718 FAX: 508-921-4003
Submitted by:
Curtin & Associates International 1200 East Street Dedham, MA 02026
Contact: Donald A. Lincoln
Telephone: 617-329-1955 FAX: 617-329-2529
Date this Summary was prepared: INSERT DATE
Trade Name: Sugita AVM Microclip Common Name: AVM Clip Classification Name: Could not be determined
Legally Marketed Devices to Which Substantial Equivalence is claimed
Sundt AVM Micro Clip - K902544
1
SUGITA The leading name in neurosurgical instrumentation
1
510(k) SUMMARY-continued Sugita AVM Microclip
Description of Device: These devices are miniaturized versions of the currently marketed Sugita Aneurysm Clip. They are used to occlude small vessels when controlling bleeding on arteriovenous malformations or other similar venous structures.
Intended Use of the Device: Occlusion of small vessels as a compliment to bipolar coagulation.
Summary of Technological Characteristics: The devices are based in design upon a currently marketed spring action aneurysm clip. The material is the same, the production methods are the same, but the clip size is reduced to allow for the intended use.
Summarv of test data:
CHANGES DURING STERILIZATION: The sample devices were subjected to sterilization at 250°F using a 20 minute cycle. This was repeated 50 times with the closing force being measured before the first cycle and at the conclusion of the test. The change in closing force for all clips tested was less than 10%.
MULTIPLE OPENING TESTING: Sample clips were subjected to 100 openings and closings. The results showed that holding force changed less than 10%.
TWIST TESTING: Samples were subjected to a twisting motion to determine the clips ability to return to its initial configuration. All clips passed.
MRI COMPATIBILITY: Sample clips were subject to testing in a 1.5 Tessla field. The angle of deflection for the clips tested was less than 3.5°.