K Number

Device Name

SPETZLER TI 100 ANEURYSM CLIP

Manufacturer

ELEKTA INSTRUMENTS, INC.

Date Cleared

1996-10-17

(346 days)

Product Code

HCH

Regulation Number

882.5200

Intended Use

The Spetzler Ti 100 Aneurysm Clips are intended for: - . Temporary occlusion of intracranial blood vessels/aneurysms - Permanent placement in the brain for occlusion of intracranial aneurysms .

Device Description

Spetzler Ti 100 Aneurysm Clips are manufactured from titanium--Certified ASTM F67-89, "Unalloyed Titanium for Surgical Implant Applications, Grade IV" (see ASTM F67-89 specifications). This grade of titanium is often referred to as "Commercially Pure Titanium," or "C. P. Titanium." The basic models are distinguished by their surface finish: natural metallic color for clips intended for permanent implantation, and blue for temporary clips. Aneurysm Clips, whether those proposed by Elekta or those manufactured or distributed by the sponsors of the predicate devices, are available in a wide variety of styles and sizes in order that all of the sizes and shapes of aneurysms can be treated. The clips are available for both temporary and permanent placement in the brain. Spetzler Ti 100 Aneurysm Clips are applied with the Elekta Titanium Nitride Coated Clip Appliers to avoid foreign metal transfer. Clips are sterilized in the Elekta Sterilization Tray.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K772200,K913765,K922272,K791978,K881911,K912456

Reference Devices

K772200,K913765,K922272,K791978,K881911,K912456

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the material properties, mechanical performance, sterilization, biocompatibility, and MR/CT compatibility of the aneurysm clips. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.

Therapeutic

Yes
The device is a Spetzler Ti 100 Aneurysm Clip, intended for temporary or permanent occlusion of intracranial blood vessels/aneurysms, which involves treating a medical condition.

Diagnostic

Explanation: The device, Spetzler Ti 100 Aneurysm Clips, is an interventional device used for temporary or permanent occlusion of intracranial blood vessels/aneurysms, not for diagnosing conditions.

SaMD (Software as a Medical Device)

The device description clearly states the device is manufactured from titanium and is a physical clip intended for surgical implantation. It is a hardware device, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is the "occlusion of intracranial blood vessels/aneurysms" and "permanent placement in the brain for occlusion of intracranial aneurysms." This is a surgical intervention performed directly on the patient's body.
Device Description: The device is a physical clip made of titanium, designed to be implanted.
Lack of In Vitro Activity: IVD devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health. This device does not perform any such analysis.

The device is a surgical implant used for a therapeutic purpose within the patient's body, which is characteristic of a medical device, but not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Spetzler Ti 100 Aneurysm Clips are intended for:

. Temporary occlusion of intracranial blood vessels/aneurysms
Permanent placement in the brain for occlusion of intracranial aneurysms .

Product codes

Not Found

Device Description

Aneurysm Clips, whether those proposed by Elekta or those manufactured or distributed by the sponsors of the predicate devices, are available in a wide variety of styles and sizes in order that all of the sizes and shapes of aneurysms can be treated. The clips are available for both temporary and permanent placement in the brain.

Spetzler Ti 100 Aneurysm Clips are applied with the Elekta Titanium Nitride Coated Clip Appliers to avoid foreign metal transfer. Clips are sterilized in the Elekta Sterilization Tray.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

MR, CT

Anatomical Site

Intracranial, Brain

Indicated Patient Age Range

Not Found

Intended User / Care Setting

User sterilizes the clips prior to use. Hospitals.

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

A study of the Spetzler Ti 100 Aneurysm Clip implanted in the brains of rabbits addresses the concern that titanium might increase the susceptibility to seizure activity. Elekta commissioned a six-month intracranial, pre-clinical implant study of 30 rabbits, divided into three groups, including 12 implanted with titanium clips, 12 implanted with the presently marketed Yasargil Phynox (cobalt chrome alloy) clips and 6 nonimplanted controls. These animals were maintained and monitored for one month (six of both groups) and six months (six of both groups) and the six negative controls. The study evaluated the substantial equivalence of the Elekta titanium clip as compared to the presently marketed Yasargil (Aescular) clip through daily monitoring, monthly EEG evaluations and Time-to-Induced-Seizure.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

1. Metallurgical/Structural Testing:

Destructive testing of a statistically determined number of clips by Laboratory Testing, Inc., Dublin. PA. Examined surfaces and cross sections at 100X and 400X, finding complete absence of imperfections.
Elekta confirmed that hospital sterilization process (270° F) had no effect on metallurgical/operational properties. Clips were sterilized in excess of 100 times, opening them with an applier every 10 cycles, and measuring closing force. Closing force remained consistent.
Corrosion test on clips confirmed they do not corrode, even under stress.
Vickers hardness measured on worked and unworked areas of the clip wire showed no statistically significant change in hardness.

2. Mechanical Performance Testing:

Elekta followed FDA's recommendation for ASTM proposed test protocol to measure closing force for each clip, recorded on the label and in the history file.
Clips placed on tubing filled with 98.6° saline solution were pulsed in excess of twenty million cycles at pressure in excess of 300 mm Hg. Results showed no leakage through the clip, no loss of blade alignment, and closing forces never went below release specifications of competitive clips.

3. Sterilization:

Elekta validated its recommended steam sterilization cycles.
Demonstrated that repeated sterilization has no effect on the mechanical properties of the clips.

4. Biocompatibility:

Six-month intracranial, pre-clinical implant study of 30 rabbits: 12 implanted with titanium clips, 12 with Yasargil Phynox (cobalt chrome alloy) clips, and 6 non-implanted controls.
- Daily monitoring, monthly EEG evaluations, and Time-to-Induced-Seizure.
- Results showed no difference in function and behavior, no difference in EEG recordings, and no statistically significant differences in seizure latency.
Study by von Holst, et al. [Acta Neurochirurgica 56:239-242 (1981)]: Implant of titanium showed no evidence of any reaction in rabbit brains, while silver showed cytoplasmic pigmentation and reactive gliosis, and tantalum showed local limited pigmentation.
Report by A. Ammar, "Tissue Compatibility of Different Intracranial Implant Materials: In-vivo and In-Vitro Studies" [Acta Neurochirurgica 72:45-59 (1984)]: Titanium showed excellent compatibility in brain implants, with "No reaction of brain tissue was observed."

5. MR Safety and Compatibility:

A study at a university characterized, mechanically tested, and magnetically evaluated Elekta titanium, Codman, Aesculap, and Sugita clips.
- Magnetic susceptibility: MP35N alloy (Codman) was 5.2 times larger, Phynox alloy (Aesculap) was 17.2 times larger, and Elgiloy (Sugita) was 15.7 times larger than Elekta's clip.
- Magnetic force in a 2 Tesla magnetic field: 14, 35, and 36 times larger for MP35N, Phynox, and Elgiloy, respectively, than for the Elekta clip.
- Hysteresis loop for Elekta clip was a shallow straight line through the origin, indicating no detectable ferromagnetism, only paramagnetism.
Another study used 1.5, 2.0, and 7.0 Tesla fields to evaluate clip displacement/deflection and image quality of Sugita, Yasargil (Aesculap), and Elekta titanium clips.
- At 1.5 and 2.0 Tesla fields, forces applied were not significant.
- At higher fields, Sugita and Aesculap clips showed unacceptable deflection (in excess of 450) compared to the titanium clip.
- Image quality: Elekta titanium clip was found to be "considerably superior in the vicinity of the clip."

6. Image artifact in MR and CT Imaging:

A university study showed significantly reduced artifact for the titanium clip in MRI and CT scans.
- MR image artifact (signal void with thin rim of hyperintensity) was 7.5 times larger for Elgiloy than Elekta and 6 times larger for Phynox.
- CT imaging streak artifact/starburst pattern sizes for Elgiloy, Phynox, and C. P. Titanium (Elekta) were in the ratios 4:3:1.
ACTA Neurochirurgica paper, "Titanium The Clips in Neurosurgery for the Elimination of Artifacts in Computer Tomography (CT)," H. von Holst, et. al., found titanium highly resistant to corrosion and not causing artifacts on CT images.
Observations at St. Vincent's Hospital in Dublin, Ireland summarized artifacts produced by Elekta (titanium), Sugita, and Aesculap clips in various MRI fields. Significant artifacts seen consistently in Sugita and Aesculap clips, while only a "s/light" artifact was seen in the Elekta titanium clip, causing almost no degradation to surrounding structures.
"Titanium Aneurysm Clip-Decreased Image Degradation in MRI and CT," Michael J. Carron, M.D., et al., presented Dr. Carron's imaging evaluations of Sugita, Aesculap, and Elekta titanium clips in CT and MRI.
- MRI artifact size 600% to 700% greater for Sugita and Aesculap clips with significant image degradation, compared to Elekta titanium clip.
- CT artifact 300% to 400% greater for Sugita and Aesculap clips with equivalent image degradation, while titanium clip had no image degradation.
Another study commissioned by Elekta studied image artifact in a dog model, comparing Spetzler Ti 100 Aneurysm Clip with a Yasargil Phynox alloy clip (Aesculap) of the same size.
- Computed Tomography: Artifact radius of titanium clip measured at 1 cm versus 3 cm for conventional clip.
- Magnetic Resonance: Artifact dimension in T1, T2 and intermediate weighted images were measured at 0.4 to 1.2 cm2 for titanium while conventional clips were at 1.0 to 3.6 cm2.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K772200,K913765,K922272, K791978,K881911, K912456

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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).

Summary

K955064

510(k) Summary of Safety and Effectiveness

OCT 17 1996

SPETZLER Ti 100 TITANIUM ANEURYSM CLIP

LEGALLY MARKETED PREDICATE DEVICES A.

The Spetzler Ti 100 Aneurysm Clip is substantially equivalent to the Yasargil Aneurysm Clips as manufactured by Aesculap AG, Tutlingen, Germany (as cleared in K772200, K913765, and K922272), the Sugita Aneurysm Clips as manufactured by Mizuho Ikakogyo Co., Ltd., Japan (as cleared in K791978 and K881911), and the Sundt Slim Line Clip as manufactured by Codman and Shurtleff, Randolph, MA (as cleared in K912456).

DEVICE DESCRIPTION B.

Spetzler Ti 100 Aneurysm Clips are applied with the Elekta Titanium Nitride Coated Clip Appliers to avoid foreign metal transfer. Clips are sterilized in the Elekta Sterilization Tray.

C. INTENDED USE

The Spetzler Ti 100 Aneurysm Clips are intended for:

. Temporary occlusion of intracranial blood vessels/aneurysms
Permanent placement in the brain for occlusion of intracranial aneurysms .

There are no differences with respect to the predicate devices for indications for use, target population, or mechanical properties.

The Spetzler Ti 100 Aneurysm Clip is safe for use with magnetic resonance (MR) devices, and produces only minimal image distortion, extending only slightly beyond the physical extent of the device. The demonstration of MR safety and compatibility is discussed below.

The Spetzler Ti 100 Aneurysm Clip is safe for use with CT imaging systems and produces significantly less image artifact than clips made from cobalt-chrome alloys such as Elgiloy (Sugita clip) or Phynox (Yasargil clip). The evaluation of the extent of clip induced artifact in CT imaging is discussed below.

The Spetzler Ti 100 Aneurysm Clip and other currently marketed clips such as the Sugita and Codman clips, are supplied to hospitals in a non-sterile package. Clips are selected for a given application and sterilized prior to use by the user. The validation of Elekta's recommended sterilization procedures is discussed below. No effect of repeated sterilization on the mechanical properties of the Elekta clips was found.

SUBSTANTIAL EQUIVALENCE SUMMARY D.

The Elekta device has the same intended use and target population as the predicate devices, and has equivalent effectiveness for its intended use. Furthermore, its new technological characteristic-the use of titanium--poses the same type of questions about safety and effectiveness as do the predicate devices.

E. NON-CLINICAL TESTING

This section summarizes the performance testing that Elekta carried out on the Spetzler Ti 100 Aneurysm Clip. This testing addressed the following issues:

(1) Mechanical and metallurgical tests to validate the structural integrity of the clips,
Mechanical performance tests to demonstrate that the clips meet their (2) specifications,
(3) Testing to validate sterilization recommendations
Biocompatibility testing, (4)
(ર) MR safety testing, and
(6) Testing to determine image artifact size for MR and CT imaging.

1. Metallurgical/Structural Testing

Elekta's specifications and tight controls were validated by the following:

Destructive testing of a statistically determined number of clips by a. the independent metallurgical laboratory, Laboratory Testing, Inc., Dublin. PA. A metallographic examination of the surfaces and cross sections, at 100X and 400X, of all stressed, worked and critical areas showed the complete absences of imperfections and defects such as cracks, voids. etc. Such metallurgical examinations will be conducted on samples from each new titanium wire delivery and each clip production lot.
Elekta has confirmed that the relatively low temperature of the b. hospital sterilization process (270° F) has absolutely no effect on the metallurgical/operational properties of the titanium clip. As distributed today, aneurysm clips are provided to the hospital nonsterile (e.g. as by Sugita and Codman). Selected clips are placed in a sterilizing tray and sterilized prior to each procedure until used. In simulating these events. Elekta sterilized the titanium clips in excess of 100 times and after each ten cycles, opened the clips with the Elekta clip applier to the maximum recommended blade opening distance and then measured the closing force per the draft ASTM standard. The closing force remained consistent for all clips.
c. Though titanium is one of the most corrosion resistant metals. Elekta commissioned a corrosion test on the clips. The results confirm that these titanium clips do not corrode, even under stress. This is further confirmed by Elekta's review of literature concerning the effects of cerebral fluids on titanium.
d. A Vickers hardness was measured on the worked and unworked areas of the clip wire. The results demonstrated no statistically significant change in hardness.

2. Mechanical Performance Testing

In evaluating the measure of closing force. Elekta has followed FDA's recommendation to use the ASTM proposed test protocol to measure each clip, prior to release for distribution. The closing force is recorded on the clip label and in the history file, by serial number.

To confirm that the Spetzler Ti 100 Aneurysm Clips retain their mechanical performance in simulated use conditions, the following study was carried out:

Clips placed on tubing filled with a 98.6° saline solution were pulsed in excess of twenty million cycles at a pressure in excess of 300 mm Hg. Using colored liquid in the tubing, the results confirm no leakage through the clip, no loss of blade alignment, and the changes in closing forces measured (double blind) never went below the release specifications of competitive clips.

3. Sterilization

Elekta has validated its recommended steam sterilization cycles. Furthermore, Elekta has demonstrated that repeated sterilization has no effect on the mechanical properties of the clips.

4. Biocompatibility

Because titanium has not been previously cleared for use in the brain in an aneurysm clip, it was incumbent upon Elekta to demonstrate that titanium is not significantly different with respect to biocompatibility properties from the cobalt-chrome allovs currently utilized in the predicate devices. This demonstration of biocompatibility includes the following studies commissioned by Elekta:

The study by von Holst, et al. [Acta Neurochirurgica 56:239-242 (1981)] found that clips made of titanium, silver, and tantalum, and implanted in

the brains of rabbits, were tolerated quite differently. The implant of titanium showed no evidence of any reaction, while the others showed cytoplasmic pigmentation and reactive gliosis (silver) and local limited pigmentation (tantalum).

The report by A. Ammar, "Tissue Compatibility of Different Intracranial Implant Materials: In-vivo and In-Vitro Studies" [Acta Neurochirurgica 72:45-59 (1984)], compared brain implants of alumina ceramics, hydroxy apatite ceramics, titanium, methylmethacrylate, Surgita aneurysm clip, silicon shunt tube, and lyophilized human dura mater (Lyo-dura). While the non-metalic implants had varying degrees of compatibility, the titanium showed excellent compatibility, while the Surgita showed fair compatibility. The report noted for the titanium implant, "No reaction of brain tissue was observed. "

Elekta commissioned a major review of the titanium toxicological literature which concluded that:

. Titanium's lack of inflammatory potential is supported by many studies. The available literature indicates that titanium does not act as an immunotoxicant.
. The scientific literature, which indicates that titanium dioxide is non-mutagenic, and the lack of reported tumors in patients with titanium implants, support the position that titanium is not genotoxic.
. The scientific literature and titanium's satisfactory use in many craniofacial implants suggest that titanium will unlikely cause adverse effects in soft tissue.
. The literature and lack of relevant observations among patients with titanium implants demonstrate that titanium dioxide does not cause adverse effects with chronic exposure and suggest that titanium will not elicit systemic effects.
. The available evidence strongly supports titanium's noncarcinogenicity.
. The limited information available on brain implantation shows that titanium does not elicit histopathology and is not associated with dissolution of the oxide layer.

ડ. MR Safety and Compatibility

In response to the risks involved in more powerful MRI systems and the continuing concern for image quality in both MRI and CT, Elekta has completed an extensive, performance evaluation of the titanium aneurysm clips:

MR Safety a.
A study carried out at a university included characterization, mechanical testing and magnetic evaluation of the Elekta titanium, Codman, Aesculap and Sugita clips.

The direct measurement of magnetic susceptibility for these clips showed that the MP35N alloy (Codman) was 5.2 times larger than for Elekta's clip, Phynox alloy (Aesculap) was 17.2 times larger, and Elgiloy (Sugita) was 15.7 times larger. The magnetic force measured in a 2 Tesla magnetic field showed that the force was 14, 35, and 36 times larger for MP35N, Phyunox, and Elgiloy, respectively, than for the Elekta clip. The results of this study demonstrate a significantly lower interaction with the magnetic field for titanium over the other clips, some of which are presently promoted as MRI safe.

Furthermore, this study evaluated the magnetization over a cycle of applied magnetic field from 4 Tesla (T) to 0 T to -4 T to 0 T and finally back to 4 T. with measurements every 0.5 T. The resulting M vs B hysteresis loop would show the extent of ferromagnetism, if any. For the Elekta clip the "hysteresis loop" was a shallow straight line through the origin, indicating no detectable ferromagnetism, only paramagnetism. Since the magnetic susceptibility of the Elekta clip is so small and paramagnetic in nature, the magnetic torque on the Elekta clip would be expected to be very small.

Another study used 1.5, 2.0 and 7.0 Tesla fields to evaluate clip displacement/deflection and image quality of the Sugita, Yasargil (Aesculap) and Elekta titanium clips. The results of this study confirm that in 1.5 and 2.0 Tesla fields the forces applied are not significant but in higher fields the Sugita and Aesculap clips show what is presently considered an unacceptable deflection (in excess of 450) as compared to the titanium clip. In image quality the Elekta titanium clip was found to be "considerably superior in the vicinity of the clip. "

b. Image artifact in MR and CT Imaging
A study carried out at a university showed significantly reduced artifact, for the titanium clip, in MRI and CT scans. In the MR image, the artifact is a signal void with a thin rim of hyperintensity. This artifact was found to be 7.5 times larger for Elgiloy than Elekta and 6 times larger for Phynox. In CT imaging clips cause a streak artifact or starburst pattern. The relative sizes of these artifacts for Elgiloy, Phynox, and C. P. Titanium (Elekta) were in the ratios, 4:3:1.

ACTA Neurochirurgica paper, "Titanium The Clips in Neurosurgery for the Elimination of Artifacts in Computer Tomography (CT)," H. von Holst, et. al., compares the artifacts caused by various intracranial implant materials with titanium (99% pure) and finds that the titanium is highly resistant to corrosion and does not cause artifacts on CT images.

Observations at St. Vincent's Hospital in Dublin, Ireland of artifacts produced by Elekta (titanium), Sugita and Aesculap clips as seen in various MRI fields, were summarized. In this paper. significant artifacts are seen consistently, in various protocols, in both the Sugita and Aesculap clips. In comparison, only a "slight" artifact is seen in the Elekta titanium clip which gives almost no degradation to the surrounding structures.

"Titanium Aneurysm Clip-Decreased Image Degradation in MRI and CT," Michael J. Carron, M.D., et al., presents Dr. Carron's (Southwest Regional Hospital, Florida) imaging evaluations of the Sugita, Aesculap and the Elekta titanium clips in both CT and MRI which were done with regard to three areas: type of artifact, relative size of artifact, degree of degradation of image. The results indicate MRI artifact size 600% to 700% greater for Sugita and Aesculap clips, with significant image degradation, as compared to the Elekta titanium clip. CT artifact is 300% to 400% greater for the Sugita and Aesculap clips with equivalent image degradation while the titanium clip was noted as having no image degradation.

Another study commissioned by Elekta studied image artifact in a dog model, comparing the Spetzler Ti 100 Aneurysm Clip with a Yasargil Phynox alloy clip (Aesculap) of the same size. The main findings were:

. Computed Tomography: Artifact radius of titanium clip measured at 1 cm versus 3 cm for conventional clip.

Magnetic Resonance: Artifact dimension in T1, T2 and . intermediate weighted images were measured at 0.4 to 1.2 cm2 for titanium while conventional clips were at 1.0 to 3.6 cm2.

F. CONCLUSIONS

Elekta has demonstrated that its testing of the Spetzler Ti 100 Aneurysm Clip and its review of the literature on the biocompatibility of titanium shows equivalent safety and effectiveness with respect to mechanical performance and biocompatibility issues, and superior performance with respect to the ancillary issues of safety and compatibility with MR and CT imaging systems.