(76 days)
Not Found
No
The summary describes a mechanical device (a flexible polymer plug) and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
No
The device is described as a plug used with introducer sheaths to prevent blood loss, which serves an accessory function during medical procedures rather than directly treating a disease or condition.
No
The device is described as a "flexible polymer plug used to seal against blood loss" and maintain a hemostatic seal around guidewires in introducer sheaths. Its function is to prevent blood loss during a procedure, not to diagnose a condition.
No
The device description clearly states it is a "flexible polymer plug," indicating a physical hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used with introducer sheaths and guidewires to maintain a hemostatic seal. This is a mechanical function performed in vivo (within the body) during a medical procedure.
- Device Description: The description reinforces its function as a flexible polymer plug for sealing against blood loss through a hemostatic valve. This is a physical barrier function.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo during a medical procedure.
N/A
Intended Use / Indications for Use
The Gator ClipSeal Plug is intended to be used with 12F to 24F introducer sheaths to maintain a hemostatic seal around 0.035" or 0.038" guidewires.
Product codes (comma separated list FDA assigned to the subject device)
DTL
Device Description
The Gator ClipSeal Plug (GATOR) is a flexible polymer plug used to seal against blood loss through the hemostatic valve of 12F - 24F introducer sheaths. The GATOR can be used with 0.035" or 0.038" guidewires.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Technological differences in design and materials have been qualified through biomaterial assessments and verification testing, the results of which did not raise any new safety or performance questions.
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.
K073620 Guardian Hemostasis Valve (Zerusa Limited)
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.4290 Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
(a)
Identification. A cardiopulmonary bypass adaptor, stopcock, manifold, or fitting is a device used in cardiovascular diagnostic, surgical, and therapeutic applications to interconnect tubing, catheters, or other devices.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
0
510(k) Summary
Date Prepared: October 21, 2009
Submitter's Name / Contact Person
Manufacturer Vascular Solutions, Inc. 6464 Sycamore Court Minneapolis, MN 55369 USA Establishment Registration # 2134812
Contact Person
NOV - 4 2009
Loucinda Bjorklund Sr. Regulatory Affairs Associate Tel: 763-656-4300; Fax: 763-656-4253 Email: Ibjorklund@vascularsolutions.com
General Information
| Trade Name | Gator™ ClipSeal Plug |
|---|---|
| Common / Usual Name | Hemostatic plug |
| Classification Name | 870.4290 Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting |
| Class II | |
| Predicate Device | K073620 Guardian Hemostasis Valve (Zerusa Limited) |
Device Description
The Gator ClipSeal Plug (GATOR) is a flexible polymer plug used to seal against blood loss through the hemostatic valve of 12F - 24F introducer sheaths. The GATOR can be used with 0.035" or 0.038" guidewires.
Intended Use / Indications
The Gator ClipSeal Plug is intended to be used with 12F to 24F introducer sheaths to maintain a hemostatic seal around 0.035" or 0.038" guidewires.
Substantial Equivalence and Summary of Studies
The Gator ClipSeal Plug is substantially equivalent in intended use and indications to the predicate device. Technological differences in design and materials have been qualified through biomaterial assessments and verification testing, the results of which did not raise any new safety or performance questions.
1
Image /page/1/Picture/0 description: The image shows the seal of the Department of Health and Human Services. The seal features an eagle with its wings spread, and the words "Department of Health & Human Services - USA" are written around the eagle. The image is in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
NOV - 4 2009
Vascular Solutions, Inc. Ms. Loucinda Bjorklund Sr. Regulatory Affairs Associate 6464 Sycamore Court Minneapolis, MN 55369
Re: K092563
Vascular Solutions Gator ClipSeal Plug Regulation Number: 21 CFR 870.4290 Regulation Name: Cardiopulmonary Bypass adaptor, stopcock, manifold, or fitting Regulatory Class: Class II Product Code: DTL Dated: August 19, 2009 Received: August 20, 2009
Dear Ms. Bjorklund:
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 application (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
2
Page 2 - Ms. Loucinda Bjorklund
comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Duna R. Vudner
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): K092563
Device Name:
:
Gator™ ClipSeal Plug
Indications for Use:
The Gator ClipSeal Plug is intended to be used with 12F to 24F introducer sheaths to maintain a hemostatic seal around 0.035" or 0.038" guidewires.
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter
(21 CFR 801 S
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
(Posted November 13, 2003)
una R. V. Unn
Ivision Sign-Off) (Division Sign-off)
Division of Cardiovascular Devices
510(k) Number Kog