(31 days)
Not Found
No
The device description details a mechanical compression system with a manual pump and digital manometer, with no mention of AI or ML components or functions.
Yes
The device is used for compression of the femoral artery or vein after vessel cannulation and for ultrasound-guided compression repair of a femoral artery pseudoaneurysm, which are therapeutic interventions.
No
The device is used for compression and hemostasis of the femoral artery or vein after cannulation or for pseudoaneurysm repair, which are therapeutic and procedural uses, not diagnostic.
No
The device description clearly outlines physical components such as an arch, a sterile pneumatic pressure dome, an integrated pump with a digital manometer, and a belt, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the compression of the femoral artery or vein after vessel cannulation and for ultrasound-guided compression repair of a femoral artery pseudoaneurysm. This is a therapeutic and mechanical intervention performed directly on the patient's body.
- Device Description: The device is a mechanical system that applies external pressure to a blood vessel. It does not involve the examination of specimens derived from the human body (like blood, urine, tissue, etc.) to provide information about a physiological state, health, disease, or congenital abnormality.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on in vitro testing.
In summary, the FemoStop Femoral Compression System is a medical device used for hemostasis and repair through mechanical compression, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
FemoStop™ Femoral Compression System is indicated for use in the compression for the femoral artery or vein after vessel cannulation, and in ultrasounded-guided compression repair of a femoral artery pseudoaneurysm.
Product codes (comma separated list FDA assigned to the subject device)
DXC
Device Description
This combination of FemoStop™ Femoral Compression is called FemoStop™ Gold and consists of an arch with a sterile pneumatic pressure dome, an integrated pump with a digital manometer and a belt. The pressure dome, the vessel punp with a digital manometer and a belt. The pressure dome is placed over the vessel puncture site in the groin. The belt is placed around the patient. The dome applies mechanical pressure over the vessel puncture site to induce hemostasis. The dome pneumatic pressure in the dome in emiliate site to induce hemostasis. The pneumatic pressure in the dome is applica and regulated by a manual pump and displayed on a manometer. The arch and belt provide counter pressure for the dome.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral artery or vein (groin)
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)
The modified device has the same fundamental technological characteristics as the predicate device. The software modification does not affect the intended use, operating principle, technology or manufacturing process. The following tests and quality assurance measures were applied to the development of the modified software:
- Software validation, including black-box testing. .
- Application of risk management according to ISO 14971:2007 Medical Devices-. Application of risk management to medical devices.
The subject version of FemoStop™ Gold functioned as intended and conformed to the required specifications. No new issues of safety and effectiveness have been raised. Thus, the subject FemoStop™ Gold version is considered substantially equivalent to the predicate device.
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.
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
§ 870.4450 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
KITO193 alo82
Attachment 6
510(k) Summary
FEB 2 4 2011
Submitter information: St. Jude Medical Systems AB Palmbladsgatan 10 Box 6350, SE-751 35 Uppsala,SWEDEN Phone:(+46) 18161000
Contact:
Katrin Svensson 2
Date Prepared:
January 17, 2010
Proprietary Name:
Registration name:
Vascular Clamp
DXC
Predicate Devices:
Product Code
K024107 FemoStop® HD Femoral Compression System K062033 BP101 Digital Blood Pressure Monitor K080206 FemoStop™ Femoral Compression System
FemoStop™ Femoral Compression System
Description of the Device: This combination of FemoStop™ Femoral Compression is called FemoStop™ Gold and consists of an arch with a sterile pneumatic pressure dome, an integrated pump with a digital manometer and a belt. The pressure dome,
the vessel punp with a digital manometer and a belt. The pressure dome is placed over the vessel puncture site in the groin. The belt is placed around the patient. The dome applies mechanical pressure over the vessel puncture site to induce hemostasis. The dome
pneumatic pressure in the dome in emiliate site to induce hemostasis. The pneumatic pressure in the dome is applica and regulated by a manual pump and displayed on a manometer. The arch and belt provide counter pressure for the dome.
Indication for Use of the Device: FemoStop™ Femoral Compression System is indicated for use in the compression for the femoral artery or vein after vessel cannulation, and in ultrasounded-guided compression repair of a femoral artery pseudoaneurysm.
Technical Characteristics: The technical characteristics of the actual FemoStop™ are identical to the predicate FemoStop™ Femoral Compression System. The main modification is that this version will be supplied without a hemostatic dressing and that the software in the manometer has been updated. The software modification consists of a 10 second activation delay and inclusion of additional error codes.
1
K110193. pg 2 of 2
Substantial Equivalence and performance data: The modified device has the same fundamental technological characteristics as the predicate device. The software modification does not affect the intended use, operating principle, technology or manufacturing process. The following tests and quality assurance measures were applied to the development of the modified software:
- Software validation, including black-box testing. .
- Application of risk management according to ISO 14971:2007 Medical Devices-. Application of risk management to medical devices.
The subject version of FemoStop™ Gold functioned as intended and conformed to the required specifications. No new issues of safety and effectiveness have been raised. Thus, the subject FemoStop™ Gold version is considered substantially equivalent to the predicate device.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
St. Jude Medical Systems AB c/o Ms. Katrin Svensson Regulatory Affairs Officer Palmbladsgatan 10 Uppsala, Sweden SE-751 35
FEB 2 4 2011
Re: K110193
Trade/Device Name: FemoStop™ Gold Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II Product Code: DXC Dated: January 21, 2011 Received: January 24, 2011
Dear Ms. Svensson:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
3
Page 2 - Ms. Katrin Svensson
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 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/CDRH0ffices/ucm11.5809.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,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and · Radiological Health
Enclosure
4
Attachment 2
Indications for Use Statement
510(k) Number (if known):
FemoStop™ Gold Device Name:
Indications For Use: FemoStop Femoral Compression System is indicated for use in the compression of the femoral artery or vein after vessel cannulation and in ultrasound-guided compression repair of a femoral artery pseudoaneurysm.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
W.M.
Page 1 of
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K110193