(82 days)
Not Found
No
The device description and summary of performance studies focus on mechanical components and bench testing, with no mention of AI, ML, or related concepts.
No
Justification: The device's intended use is for securing sutures for soft tissue approximation, which is a mechanical function to hold tissues together, not to treat or cure a disease or medical condition itself.
No
The device is described as a system for permanent securing of surgical suture for soft tissue approximation, indicating a therapeutic or surgical function rather than a diagnostic one. It is used to crimp a clip around sutures, which is a physical manipulation for repair, not for identifying a disease or condition.
No
The device description clearly outlines physical components: a stainless steel suture clip and an applier with a handle, shaft, and rod. It also mentions the system is provided sterile and the applier is disposable. These are all hardware components, not software.
Based on the provided information, the Influence Clip System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "permanent securing of two strands of surgical suture for soft tissue approximation in open or laparoscopic surgical procedures." This describes a surgical procedure performed on the patient's body, not a test performed on a sample taken from the patient's body.
- Device Description: The device description details a mechanical system for crimping a clip onto sutures during surgery. It does not involve analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
In summary, the Influence Clip System is a surgical device used to facilitate a surgical procedure, not a diagnostic test performed on a sample.
N/A
Intended Use / Indications for Use
The Influence Clip System is indicated for permanent securing of two strands of surgical suture for soft tissue approximation in open or laparoscopic surgical procedures.
Product codes
79FZP
Device Description
The Influence Clip System has two components, a suture clip and an applier. To fixate sutures, the stainless steel clip is inserted into the applier. Two strands of suture are threaded through the clip and the applier inserted into the trocar (if a laparoscopic procedure is performed). The applier's handle is then tightly squeezed which causes a rod within the applier's shaft to crimp the clip around the sutures. The sutures' ends are cut close to the clip (alternative version of applier with suture cutter may be used). The system is provided sterile and the applier is disposable, for single patient use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
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
Bench testing has demonstrated that the device is safe and effective and that its performance is substantially equivalent to a 510(k)-cleared device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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
JUL 28 1998
510(k) Summary of Safety and Effectiveness Influence, Inc.'s Influence Clip System 510(k) Number ________________________________________________________________________________________________________________________________________________________________ 1981631
Submitter's Name:
Peter A. Bick. M.D., President and CEO Influence, Inc. 71 Stevenson Street, Suite 1120 San Francisco, California 94105 Telephone: 415-546-7700 / Fax: 415-546-7744
Device:
Trade name: Influence Clip System Classification Name: Implantable Clip Product Code: 79FZP
Predicate Devices:
United States Surgical Corporation's Auto Suture Suture Closure (K954853), Innovasive Devices, Inc.'s Y-Knot Suture Clip (K973313), and Howmedica, Inc.'s Dall-Miles Cable Grip System (K900926).
Indication for Use:
The Influence Clip System is indicated for permanent securing of two strands of surgical suture for soft tissue approximation in open or laparoscopic surgical procedures.
Device Description:
The Influence Clip System has two components, a suture clip and an applier. To fixate sutures, the stainless steel clip is inserted into the applier. Two strands of suture are threaded through the clip and the applier inserted into the trocar (if a laparoscopic procedure is performed). The applier's handle is then tightly squeezed which causes a rod within the applier's shaft to crimp the clip around the sutures. The sutures' ends are cut close to the clip (alternative version of applier with suture cutter may be used). The system is provided sterile and the applier is disposable, for single patient use.
Technological Characteristics and Performance:
All materials used in the Influence Clip System are either commonly used in medical applications or have been proven to be biocompatible through
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biocompatibility testing. Bench testing has demonstrated that the device is safe and effective and that its performance is substantially equivalent to a 510(k)-cleared device.
510(k) Notification for the Influence Clip System
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Image /page/2/Picture/1 description: The image contains the words "Public Health Service" in a simple, bold font. The text is arranged on a single line, with each word clearly legible. The overall impression is clean and straightforward, suggesting an official or institutional context.
Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized design of three human profiles facing right, arranged in a stacked formation. The profiles are connected and form a single, abstract shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the top and left side of the profile design.
JUL 28 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Peter A. Bick. M.D. President and CEO Influence, Inc. 71 Stevenson Street, Suite 1120 San Francisco, California 94105
Re: K981631 Trade Name: Influence Clip System Regulatory Class: II Product Code: FZP Dated: May 4, 1998 Received: May 7, 1998
Dear Dr. Bick:
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 (OS) 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.
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.
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Page 2 - Dr. Peter Bick
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,
Cella M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
| 510(k) Number (if known): | K981631 |
|---|---|
| --------------------------- | --------- |
Device Name:
Indications for Use:
Influence Clip System, consisting of the Influence Clip System Applier and Influence Clip System Suture Clip
The Influence Clip System is intended for permanent securing of two strands of surgical suture for soft tissue approximation in open or laparoscopic surgical procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-off) Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices 510(k) Number _ . . OR Over the Counter Use__________________________________________________________________________________________________________________________________________________________ Prescription Use (Per 21 CFR 801.109) 2948167 vik) Number
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