(192 days)
Not Found
No
The device description details a purely mechanical system for applying pressure, with no mention of software, algorithms, or any components that would suggest AI/ML capabilities. The "Mentions AI, DNN, or ML" field is also explicitly marked as "Not Found".
Yes
The device is used for hemostasis management following catheterization, which is a therapeutic intervention aimed at stopping bleeding.
No
The device is used for compression of the femoral artery or vein following catheterization for hemostasis management, which is a therapeutic rather than diagnostic function.
No
The device description clearly outlines multiple physical components including an arch, pneumatic pressure dome, connector tube, stopcock, belt locks, and a woven belt, indicating it is a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The described device is a mechanical compression system used externally on the patient's body to apply pressure to a blood vessel (femoral artery or vein) after a procedure. It does not analyze any biological samples taken from the patient.
- Intended Use: The intended use is "compression of the femoral artery or vein following catheterization," which is a physical intervention, not a diagnostic test.
The device is a therapeutic/hemostatic device, not a diagnostic one.
N/A
Intended Use / Indications for Use
The femoral compression system is indicated for the compression of the femoral artery or vein following catheterization.
Product codes
NMF,DXC
Device Description
The femoral compression device is used to provide compression of the femoral artery for hemostasis management after catheterization. The device is comprised of an arch with an attached sterile pneumatic pressure dome, connector tube, stopcock and belt locks. A woven belt is used to secure the device onto the patient. In use, the belt is placed under and around the patient's hips and the arch is placed over the patient's groin with the dome atop the puncture site. The belt is attached to the arch via the adjustable belt locks and is tightened. A pneumatic pump and manometer are attached to the stopcock connector. The user controls the mechanical pressure applied to the puncture site by increasing or decreasing air pressure applied to the dome. The arch and belt absorb and distribute the opposing force from the dome. Vanguard receives previously used compression devices from healthcare facilities; cleans, inspects, tests, repackages and sterilizes the devices; and returns them to the healthcare facility.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral artery or vein
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
Decontamination and cleaning, sterilization validations and functional/performance and biocompatibility testing demonstrates that the reprocessed devices perform as intended and are safe and effective.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, composed of three parallel lines forming a serpentine shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus. The seal is presented in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 2004
Vanguard Medical Concepts, Inc. c/o Ms. Heather Crawford Director of Regulatory Affairs 5307 Great Oak Drive Lakeland, FL 33815
Re: K011832 - Supplemental Validation Submission Vanguard Reprocessed Femoral Compression Device Regulation Number: 21 CFR 870.4450 Regulation Name: Clamp, Vascular Regulatory Class: II (2) Product Code: NMF Dated: September 18, 2001 Received: September 24, 2001
Dear Ms. Crawford:
The above-referenced premarket notification (510(k)) was cleared by the Office of Device Evaluation (ODE) on December 21, 2001. We have received your supplemental validation data as required for reprocessed single-use devices by the Medical Device User Fee and Modernization Act of 2002. After reviewing your supplemental validation data, we have determined the devices listed in the enclosure accompanying this letter are 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 these devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (PMA) they 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 898. In addition, FDA may publish further announcements concerning your devices in the Federal Register.
1
Page 2 - K011832
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your devices comply 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 applicable 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.
The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in classification for your devices and thus, permits you to legally market the devices. This letter will allow you to continue marketing the devices listed in the enclosure accompanying this letter.
If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at 240-276-0120 (DOEB). 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 Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
B. Bimmima for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
2
Attachment 1
USCI ® C.R. Bard®, Inc. / RADI Medical Systems AB Model Number: 017500
OEM Trade Name: FemoStop® Femoral Compression System
3
Indications for Use
510(k) Number:
Device Name: Yanguard Reprocessed Femoral Compression Device
Indications for Use:
The femoral compression system is indicated for the compression of the femoral artery or vein following catheterization.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use V (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Y. Oele Mch
Division of Cardiovascular & Respiratory Devices
510(k) Number K011832
iv
4
DEC 21 2001
510(k) Summary of Safety & Effectiveness
| Submitter | Vanguard Medical Concepts, Inc.
5307 Great Oak Drive
Lakeland, FL 33815 |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Mr. Mike Sammon, Ph.D.
Director, Research and Development
(863) 683-8680, extension 228
(801) 327-3339 (facsimile)
mikes@safe-reuse.com |
| Date | June 14, 2001 |
| Device | Trade Names: Vanguard Reprocessed Femoral Compression Device
⇒ USCI® C. R. Bard®, Inc., RADI Medical Systems AB FemoStop®
Femoral Compression SystemCommon Name: Femoral compression device, groin compressorClassification: 21 CFR 870.4450 - Vascular Clamp – Class IIProduct Code DXC |
| Predicate
Device | USCI® C. R. Bard®, Inc., RADI Medical Systems AB FemoStop® Femoral
Compression System legally marketed under 510(k) premarket notification
K983471 |
| Indications for
Use | The femoral compression system is indicated for the compression of the
femoral artery or vein following catheterization. |
| Contra-
indications | Femoral compression presents a significant risk for deep vein thrombosis in
patients with severe peripheral vascular disease. Femoral artery or vein grafts
are also at significant risk for damage with use of this device. |
| | Continued on next page |
USCI and Bard are registered trademarks of C.R. Bard, Inc. FemoStop is a registered trademark of RADI Medical Systems AB
5
510(k) Summary of Safety & Effectiveness, Continued
| Device
Description | The femoral compression device is used to provide compression of the
femoral artery for hemostasis management after catheterization. The device
is comprised of an arch with an attached sterile pneumatic pressure dome,
connector tube, stopcock and belt locks. A woven belt is used to secure the
device onto the patient. |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | In use, the belt is placed under and around the patient's hips and the arch is
placed over the patient's groin with the dome atop the puncture site. The belt
is attached to the arch via the adjustable belt locks and is tightened. A
pneumatic pump and manometer are attached to the stopcock connector. The
user controls the mechanical pressure applied to the puncture site by
increasing or decreasing air pressure applied to the dome. The arch and belt
absorb and distribute the opposing force from the dome. |
| | Vanguard receives previously used compression devices from healthcare
facilities; cleans, inspects, tests, repackages and sterilizes the devices; and
returns them to the healthcare facility. |
| Technological
Characteristics | The Vanguard reprocessed compression device is essentially identical to
the currently marketed OEM compression device. No changes are made to
the currently marketed device's specifications and they possess the same
technological characteristics. Biocompatibility and performance/functional
testing demonstrate that the devices are equivalent and continue to be safe and
effective for their intended use. |
| Test Data | Decontamination and cleaning, sterilization validations and
functional/performance and biocompatibility testing demonstrates that the
reprocessed devices perform as intended and are safe and effective. |
| Conclusion | Based on the information provided herein and the 510(k) "Substantial
Equivalence" Decision Making Process Chart, we conclude that the Vanguard
reprocessed femoral compression device is substantially equivalent to the
predicate device, the OEM compression device, USCI® C. R. Bard®, Inc.,
RADI Medical Systems AB FemoStop® Femoral Compression System,
under the Federal Food, Drug and Cosmetic Act. |