(210 days)
Not Found
No
The device description and performance studies focus on the mechanical function and material properties of a titanium aneurysm clip, with no mention of AI or ML.
Yes
The device is intended for the permanent occlusion of cerebral aneurysms, which is a therapeutic intervention to treat a medical condition.
No
Explanation: This device is an aneurysm clip intended for permanent placement in the brain to occlude cerebral aneurysms. Its function is interventional/therapeutic (occlusion), not diagnostic.
No
The device description clearly states it is a "Bent titanium wire" and a "spring operated, self Closing aneurysm clip," indicating it is a physical hardware device intended for permanent placement in the brain.
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 the body (in vitro).
- Device Description and Intended Use: The description clearly states the device is a "Bent titanium wire which provides a spring operated, self Closing aneurysm clip" and its intended use is "Permanent placement in the brain for occlusion of cerebral aneurysms." This device is implanted inside the body to treat a medical condition.
Therefore, based on its function and intended use, this device is an implantable medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Permanent placement in the brain for occlusion of cerebral aneurysms. They are only to be applied with PSI clip appliers with titanium alloy jaw inserts
Product codes
HCH, HCI
Device Description
Bent titanium wire which provides a spring operated, self Closing aneurysm clip of various lengths/sizes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intracranial space, brain
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)
When used with the appropriate clip applier, as with the predicate device, the PSI Titanium Aneurysm Clip functions in the same manner as the predicate device in the occlusion of cerebral aneurysms. When used in the MRI environment, the device presents no additional risk to the patient or other personnel, is compatible with current diagnostic imaging equipment and provides substantially reduced image artifacts over cobalt-based predicate clips.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
JAN - 6 2000
SECTION 6 510(k) SUMMARY
Page 14
| Submitter Name: | Pacific Surgical Innovations, Inc. |
|---|---|
| Submitter's Address: | 360 Industrial Road |
| San Carlos, CA 94070 | |
| Contact Person: | Terry Johnston, President |
| Phone Number: | 650-802-6988 |
| Facsimile Number: | 650-802-0120 |
| Date Prepared: | April 15, 1999 |
| Device Trade Name: | PSI Titanium Aneurysm Clip |
| Device Common Name: | Aneurysm Clip |
| Classification Name: | Aneurysm Clip, 21 CFR 882.5200 |
| Predicate Device: | Aesculap Titanium Aneurysm Clip (K983758) |
| Taka Aneurysm Clip (K972750) | |
| Device Description: | Bent titanium wire which provides a spring operated, self |
| Closing aneurysm clip of various lengths/sizes. | |
| Intended Use: | Placement in the intracranial space for the occlusion of a |
| cerebral aneurysm (a balloon like sac formed on a | |
| blood vessel) to prevent it from bleeding or bursting. | |
| Placement of the clip requires the use of especially | |
| designed appliers | |
| Technological Characteristics | |
| And Comparison to Predicate | The PSI Titanium Aneurysm Clip is manufactured from |
| the same materials, to equivalent functional and | |
| dimensional specifications as the predicate clips. | |
| The material composition is titanium alloy (Ti-6Al-4V). | |
| The alloy composition and properties conform with ISO | |
| Standard 5832/3: "Implants for Surgery Metallinc | |
| Materials - Part 3: WroughtTitanium 6 - Aluminum 4 - | |
| Vanadium Alloy" and ASTM Standard F - 136: | |
| "Specification for Wrought Titanium 6AL-4V ELI Alloy | |
| for Surgical Applications". The PSI clips share similar | |
| tolerances, manufacturing controls, packaging and | |
| labeling as the predicate Taka clips. | |
| Performance Data: | When used with the appropriate clip applier, as with |
| the predicate device, the PSI Titanium Aneurysm Clip | |
| functions in the same manner as the predicate device in | |
| the occlusion of cerebral aneurysms. When used in | |
| the MRI environment, the device presents no additional | |
| risk to the patient or other personnel, is compatible with | |
| current diagnostic imaging equipment and provides | |
| substantially reduced image artifacts over cobalt-based | |
| predicate clips. | |
| Conclusion: | The Titanium Aneurysm Clip is safe and effective for it's |
| intended use and meets all regulatory requirements to be | |
| found substantially equivalent to the predicate device. |
:
1
K991959
Page 15
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name in a circular arrangement around a stylized symbol. The symbol is a representation of a human figure, with three overlapping profiles suggesting community and support. The seal is presented in black and white.
NOV 2 1 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Pacific Surgical Innovations, Inc. % Mr. Terry Johnston Vice President and General Manager 360 Industrial Road, Unit H San Carlos, California 94070
Re: K991959
Trade/Device Name: Titanium Aneurysm Clip Regulation Number: 21 CFR 882.5200 Regulation Name: Aneurysm clip Regulatory Class: II Product Code: HCH, HCI Dated: October 28, 1999 Received: November 1, 1999
Dear Mr. Johnston:
This letter corrects our substantially equivalent letter of January 6, 2000.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval (PMA). 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 -- Mr. Terry Johnston
This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally promated notification "ceresults 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), please If you doors operio as no liance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours
FOR Patat Ruma
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 13
SECTION 5
INDICATIONS FOR USE
PSI TITANIUM ANEURYSM CLIP
Device Name:
11:4
Indication for Use:
Permanent placement in the brain for occlusion of cerebral aneurysms. They are only to be applied with PSI clip appliers with titanium alloy jaw inserts
Prescription Use
OR
Over the Counter
to
(Division Sign) Off) Division of General Restor K991959 510(k) Number