(238 days)
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No
The summary describes a mechanical irrigation system with no mention of AI, ML, image processing, or data analysis capabilities.
No
Explanation: The device is an irrigation system used to infuse sterile irrigant solution and allow visualization during surgical procedures. It does not directly treat or mitigate a disease or condition, which is the primary function of a therapeutic device.
No
Explanation: The device is described as an irrigation system used to infuse sterile irrigant solution to allow visualization during a procedure, not to diagnose a condition. Its purpose is procedural, not diagnostic.
No
The device description explicitly states it is composed of biocompatible plastics and includes physical components like a valve controller, tubing, introducer sheaths, and connections, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "irrigate vascular tissue intraoperatively" and "infuse sterile irrigant solution into a vein to allow visualization of the valve destruction process during vein preparation for in-situ vascular bypass." This describes a surgical procedure involving direct interaction with the patient's body for therapeutic or procedural purposes.
- Device Description: The device is described as an "irrigation system" composed of tubing, sheaths, and connections for infusing and draining solutions. This aligns with devices used in surgical or medical procedures, not for analyzing samples outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze samples (like blood, urine, tissue, etc.) in vitro (outside the living body) to provide information about a patient's health status, diagnosis, or treatment.
IVD devices are specifically designed to perform tests on samples taken from the body to provide diagnostic or other health-related information. This device's function is to facilitate a surgical procedure.
N/A
Intended Use / Indications for Use
Like other, commercially available vascular irrigation sets and intravascular administration sets, the GORE irrigation system is intended to irrigate vascular tissue intraoperatively.
This includes use of the GORE irrigation system to infuse sterile irrigant solution into a vein to allow visualization of the valve destruction process during vein preparation for in-situ vascular bypass.
Product codes
79 FPA
Device Description
The GORE irrigation system is composed of biocompatible plastics consistent with those used in other commercially available irrigation systems and intravascular administration sets. All tissue and fluid-path materials will be documented as suitable for intended use per international standards and FDA guidances, prior to commercial distribution and clinical use.
The GORE irrigation system consists of a valve controller, tubing with introducer sheaths, and connections for infusion and drainage of irrigant solution into and from the clamped vein. As the same types of biocompatible plastics used in other irrigation sets will be used in the GORE irrigation set, and all materials used in the GORE irrigation set will be appropriately characterized and tested for biocompatibility, no new issues regarding materials are raised by the GORE device. As the GORE irrigation set operates in a manner similar to other commercially available irrigation sets, and surgical users are very familiar with the use of irrigation sets during vein preparation for in-situ bypass, there are no new issues regarding the technological characteristics or use of the GORE device.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
vascular tissue, vein
Indicated Patient Age Range
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Intended User / Care Setting
surgical users
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.
0
Image /page/0/Picture/0 description: The image shows the logo for GORE. The logo has the word "GORE" in bold, block letters. Above and to the right of the word is a black shape that resembles a stylized arrow. Below the word "GORE" are the words "Creative Technologies Worldwide" in a smaller font.
DRE & ASSOCIATES, INC
1505 NORTH FOURTH STREET . P.O. BOX 3000 . FLAGSTAFF, ARIZONA
K 964067
UN - 5 1997
PREMARKET NOTIFICATION SUMMARY
Intravascular administration set
| 1. | Applicant : | W. L. Gore and Associates, Inc.
1505 N. Fourth Street
P.O. Box 3000
Flagstaff, Arizona 86003-3000 |
|----|--------------------|------------------------------------------------------------------------------------------------------------|
| 2. | Applicant Device : | GORE Irrigation System |
Irrigation system Common Name :
Classification Name :
Predicate Device : 3.
For the purposes of demonstrating the premarket clearance of other, similarly-classified, devices, GORE cited FDA-issued 510k's.
Applicant Device Description : 4.
The GORE irrigation system is composed of biocompatible plastics consistent with those used in other commercially available irrigation systems and intravascular administration sets. All tissue and fluid-path materials will be documented as suitable for intended use per international standards and FDA guidances, prior to commercial distribution and clinical use.
The GORE irrigation system consists of a valve controller, tubing with introducer sheaths, and connections for infusion and drainage of irrigant solution into and from the clamped vein. As the same types of biocompatible plastics used in other irrigation sets will be used in the GORE irrigation set, and all materials used in the GORE irrigation set will be appropriately characterized and tested for biocompatibility, no new issues regarding materials are raised by the GORE device. As the GORE irrigation set operates in a manner similar to other commercially available irrigation sets, and surgical users are very familiar with the use of irrigation sets during vein preparation for in-situ bypass, there are no new issues regarding the technological characteristics or use of the GORE device.
1
【官网】
- Like other commercially available vascular irrigation 5. Intended Use : sets and intravascular administration sets, the GORE irrigation system is intended to irrigate vascular tissue intraoperatively. This includes use for infusion of sterile irrigant solution into a vein to allow visualization of pertinent intravascular structures, venous valves and tributary sites, during vein preparation for in-situ vascular bypass.
ਂ. Technological Characteristics :
As the GORE irrigation set is structured similarly and operates in a manner similar to other commercially available irrigation sets, and surgical users are very familiar with the use of irrigation sets during vein preparation for insitu bypass, there are no new issues regarding the technological characteristics or use of the GORE device.
For the past two decades, GORE-TEX Medical Products have been used in more than 4,000,000 clinical applications for a broad range of indications. This extensive clinical history demonstrates that GORF is capable of ensuring that its devices possess the requirite structural, biocompatibility and mechanical characteristics to function safely and effectively.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Dawn Lopez Requlatory Affairs Associate W.L. Gore & Associate, Inc. Medical Products Division 3750 West Kiltie Lane P.O. Box 900 Flagstaff, Arizona 86002-0900
JUN - 5 1997
Re: % K964067 GORE Irrigation Set Requlatory Class: II (Two) Product Code: 79 FPA Dated: March 6, 1997 Received: March 7, 1997
Dear Ms. Lopez:
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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 - Ms. Dawn Lopez
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) 594-4648. 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"dsmo@fdadr.cdrh.fda.gov."
Sincerely yours,
Thomas J. Callahon
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Set Intravascular Inrigation 800. 5440 +PA
INDICATIONS FOR USE
| 510k Number (if known): | K 964067 |
|---|---|
| Device Name: | Core Irrigation System |
Indications for Use:
Like other, commercially available vascular irrigation sets and intravascular administration sets, the GORE irrigation system is intended to irrigate vascular tissue intraoperatively.
This includes use of the GORE irrigation system to infuse sterile irrigant solution into a vein to allow visualization of the valve destruction process during vein preparation for in-situ vascular bypass.
Concurrence of CDRH, Office of Device Evaluation (ODE):
Bata L. Campbell
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number K964067
Prescription Use: X (per 21 CFR 801.109)
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Over the Counter Use: ________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)