(134 days)
P820009
No
The summary describes a physical medical device (aneurysm clips) made of titanium alloy, focusing on its material properties, mechanical performance, and compatibility with imaging modalities. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is an implantable medical device used for permanent or temporary occlusion of cerebral blood vessels, which serves a mechanical function rather than delivering therapeutic energy or substance.
No
This device is a surgical implant (aneurysm clip) used for occluding cerebral aneurysms, not for diagnosing a condition.
No
The device description clearly states the device is a physical implant made from titanium alloy, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "implantation for permanent occlusion of cerebral aneurysms" and "temporary occlusion of cerebral blood vessels." This describes a surgical implant used directly on the patient's body.
- Device Description: The description details the material (titanium alloy) and physical characteristics of a surgical clip.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide diagnostic information. IVDs are used to perform tests in vitro (in glass, or outside the living organism).
The information provided describes a surgical implant, not a diagnostic device used for testing samples.
N/A
Intended Use / Indications for Use
The Sugita Titanium Aneurysm Clips of the permanent type are indicated for implantation for permanent occlusion of cerebral aneurysms. The temporary type are indicated for temporary occlusion of cerebral blood vessels.
Product codes (comma separated list FDA assigned to the subject device)
HCH
Device Description
The Sugita Titanium Aneurysm Clip is made from the titanium alloy Ti6AI4V. This alloy was chosen for the new clip because of its excellent compatibility with magnetic resonance imaging (MRI) devices. Titanium and its alloys cause much less artifact and are subject to much smaller magnetomechanical effects than other clips materials such as the cobalt-chrome alloys or stainless steel. Ti6Al4V also has excellent mechanical properties.
The Sugita Titanium Aneurysm Clips are available in 55 models of various shapes and sizes. These shapes and sizes are identical to the corresponding models of the Sugita Elgiloy clips.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cerebral aneurysms, cerebral blood vessels
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The data show that after 500 openings and closings, the Mizuho Titanium Aneurysm Clips on average retain 98.5% of their original closing force (using the ASTM measurement technique). This compares with 97.1% for the Yasargil Titanium Clips. The MR safety and compatibility summary in Section IV demonstrates that the clip is safe for use in the MR environment up to 10 T, and that the artifact on MR images up to 1.5 T does not extend significantly beyond the region occupied by the clip. Streak artifact on CT images is minimal, much less than is seen with cobalt-chromium alloy clips.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
P820009
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
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KQ90202
510(k) Summary
Sugita Titanium Aneurysm Clip
Common/Classification Name: Intracerebral Aneurysm Clip, 21 CFR 882.5200
Mizuho America, Inc. 123 Brimbal Avenue Beverly, MA 01915
978-921-1718 978-921-4003 (FAX)
Contact: Jon Macomber, Prepared: April 14, 1999
LEGALLY MARKETED PREDICATE DEVICES A.
The Sugita Titanium Aneurysm Clip is substantially equivalent to the Aesculap Titanium Aneurysm Clip which was cleared by FDA as K970050 on November 26, 1997. It is also substantially equivalent in some characteristics to the Sugita (Elgiloy) Aneurysm Clip, cleared for marketing under P820009 as a Class III device and reclassified into Class II on May 18, 1983, and to the Spetzler Ti-100 Titanium Aneurysm Clip cleared by FDA as K955064 on October 17, 1996.
DEVICE DESCRIPTION B.
The Sugita Titanium Aneurysm Clip is made from the titanium alloy This alloy was chosen for the new clip because of its Ti6AI4V. excellent compatibility with magnetic resonance imaging (MRI) Titanium and its alloys cause much less artifact and are devices. subject to much smaller magnetomechanical effects than other clips materials such as the cobalt-chrome alloys or stainless steel. Ti6Al4V also has excellent mechanical properties.
The Sugita Titanium Aneurysm Clips are available in 55 models of various shapes and sizes. These shapes and sizes are identical to the corresponding models of the Sugita Elgiloy clips.
C. INTENDED USE
The Sugita Titanium Aneurysm Clips of the permanent type are indicated for implantation for permanent occlusion of cerebral aneurysms. The temporary type are indicated for temporary occlusion
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K990202
of cerebral blood vessels.
SUBSTANTIAL EQUIVALENCE SUMMARY D.
The Sugita Titanium Aneurysm Clip is a medical device, and it has similar indications for use statement as the legally marketed Sugita Aneurysm Clip. However, the differences in indications statements do not change the intended therapeutic use. The Sugita Titanium Aneurysm Clip has the same technological characteristics and is made from the same material as the Aesculap Titanium Clip. For most of the characteristics, this premarket notification will describe the characteristics of the Sugita Titanium Aneurysm Clip in sufficient detail to assure substantial equivalence. One characteristic, mechanical properties, may not be precise enough to ensure so laboratory data are submitted equivalence, herein which demonstrate that the Sugita Titanium Aneurysm Clip is substantially equivalent to the predicate device with regard to mechanical properties.
E. TECHNOLOGICAL CHARACTERISTICS
The Sugita Titanium Aneurysm Clip is made from the titanium alloy The 55 models manufactured in the titanium alloy are Ti6AI4V. identical to the corresponding Sugita Elgiloy models in shape and size.
F. TESTING
As is discussed in detail elsewhere in this 510(k), the data show that after 500 openings and closings, the Mizuho Titanium Aneurysm Clips on average retain 98.5% of their original closing force (using the ASTM measurement technique). This compares with 97.1% for the Yasargil Titanium Clips. The MR safety and compatibility summary in Section IV demonstrates that the clip is safe for use in the MR environment up to 10 T, and that the artifact on MR images up to 1.5 T does not extend significantly beyond the region occupied by the clip. Streak artifact on CT images is minimal, much less than is seen with cobalt-chromium alloy clips.
G. CONCLUSIONS
The 510(k) decision algorithm brings us to a determination of Substantial Equivalence, as defined in the Federal Food, Drug, and Cosmetic Act.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 4 1999
Mizuho America, Inc. c/o T. Whit Athey, Ph.D. Senior Consultant C.L. McIntosh & Associates, Inc. 12300 Twinbrook Parkway, Suite 625 Rockville, Maryland 20852
Re: K990202
Trade Name: Sugita Titanium Aneurysm Clip Regulatory Class: II Product Code: HCH Dated: April 15, 1999 Received: April 15, 1999
Dear Dr. Athey:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - T. Whit Athey, Ph.D.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
STATEMENT OF INDICATIONS FOR USE
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Sugita Titanium Aneurysm Clip Device Name:
Indications For Use:
The Sugita Titanium Aneurysm Clips of the permanent type are indicated for implantation for permanent occlusion of cerebral aneurysms. The temporary type are indicated for temporary occlusion of cerebral blood vessels.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
põlluf
Sign-Off) 11:11:11 City 1 General Restorative Dev ت 510(K) Number _