(78 days)
Not Found
Not Found
No
The device description and performance studies focus on the mechanical function of a titanium clip for occlusion, with no mention of AI/ML, image processing, or data-driven performance metrics.
Yes
The device is intended for the "Temporary or Permanent Occlusion of Blood Vessels," which is a direct therapeutic intervention to control bleeding or stop blood flow.
No
Explanation: The device description states its purpose is to "occlude an intracranial blood vessel, stop bleeding, or hold tissue or mechanical device in place in a patient." This indicates a therapeutic function (treatment), not a diagnostic one.
No
The device description clearly states it is a "Bent titanium wire," indicating a physical hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens from the human body (like blood, urine, or tissue) outside of the body to provide information about a person's health. This device is a physical implant used inside the body to occlude blood vessels.
- The description clearly states the device is a "Bent titanium wire that is forcibly closed to occlude an intracranial blood vessel... in a patient." This is a surgical implant, not a diagnostic tool that analyzes samples.
- The intended use is "Temporary or Permanent Occlusion of Blood Vessels." This is a therapeutic or interventional use, not a diagnostic one.
The information provided describes a surgical clip used for hemostasis (stopping bleeding) or securing tissue/devices within the body. This falls under the category of a surgical implant or device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Pacific Surgical Innovations, Inc. Titanium Micro-Ligation Hemostatic Clip is designed for temporary or permanent implantation for use in ligating blood vessels. The clip has applications in many surgical procedures including where hemostasis is required or radiographic marking is necessary, in general or intracranial procedures.
Product codes
FZP
Device Description
Bent titanium wire that is forcibly closed to occlude an intracranial blood vessel, stop bleeding, or hold tissue or mechanical device in place in a patient. Especially designed to prevent slippage when properly applied.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intracranial 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)
When used with the appropriate clip applier, as used with the predicate device, the PSI hemostasis clip functions in the same manner as the predicate device in occluding blood vessels.
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.
Vitalitec International Titanium Hemostatic Clip, Spetzler Titanium Aneurysm Clip
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows a stylized text graphic with the words "KAHIOOZ" in bold, black brushstroke-like letters. Below the word, centered horizontally, is the text "Page 12" in a smaller, simpler font. The overall impression is that of a title or heading, possibly for a document or publication.
SECTION 6 510(k) SUMMARY
Submitter Name:
Submitter's Address:
Contact Person:
Phone Number:
Facsimile Number:
Date Prepared:
Device Trade Name:
Device Common Name:
Classification Name:
Predicate Device:
Device Description:
Intended Use:
Pacific Surgical Innovations, Inc.
360 Industrial Road, Unit H San Carlos, CA 94070
Terry Johnston, President
650-802-6988
650-802-0120
March 12, 1999
PSI Titanium Micro-Ligation Hemostatic Clip
Micro-Ligation Hemostatic Clip
Implanted Malleable Clip
Vitalitec International Titanium Hemostatic Clip Spetzler Titanium Aneurysm Clip
Bent titanium wire that is forcibly closed to occlude an intracranial blood vessel, stop bleeding, or hold tissue or mechanical device in place in a patient. Especially designed to prevent slippage when properly applied.
The Pacific Surgical Innovations, Inc. Titanium Micro-Ligation Hemostatic Clip is designed for temporary or permanent implantation for use in ligating blood vessels. The clip has applications in many surgical procedures including where hemostasis is required or radiographic marking is necessary, in general or intracranial procedures.
1
Page 13
.
| Technological Characteristics
and Comparison to Predicate | The PSI Titanium Micro-Ligation Hemostasis Clip
is manufactured from the same materials, meeting
the same standards and dimensional specifications
and manufactured by the same contract manu-
facturer as the predicate hemostasis clip. |
|--------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance Data: | When used with the appropriate clip applier, as
used with the predicate device, the PSI hemostasis
clip functions in the same manner as the predicate
device in occluding blood vessels. |
| Conclusion: | The PSI Titanium Micro-Ligation Hemostatic
Clip is safe and effective for its intended use and
meets all regulatory requirements to be found
substantially equivalent to the predicate device. |
.
:
2
Public Health Service
JUN 11 1999
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Terry Johnston President Pacific Surgical Innovations, Inc. 360 Industrial Road, Unit H San Carlos, California 94070
Re: K991002
Trade Name: Titanium Micro-Ligation Hemostatic Clip Regulatory Class: II Product Code: FZP Dated: March 19, 1999 Received: March 25, 1999
Dear Mr. Johnston:
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 (OS) 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.
3
Page 2 - Mr. Terry Johnston
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
Page 11
SECTION 5
INDICATIONS FOR USE
PSI Titanium Micro-Ligation Hemostatic Clip
Temporary or Permanent Occlusion of Blood Vessels Including Intracranial Blood Vessels
bcollefa
(Division Sign-Off) Division of General Restorative Devices 510(k) Number -
Prescription ! !s: (Per 21 CFR 801.109)
X