(71 days)
Not Found
No
The device description and performance studies focus on mechanical compression and reprocessing validation, with no mention of AI or ML. The device is manually controlled.
Yes
The device is intended for use in the compression of the femoral artery or vein after catheterization, which is a therapeutic intervention to control bleeding.
No
The device is intended for the mechanical compression of a femoral artery or vein after catheterization to stop bleeding, which is a therapeutic rather than a diagnostic function.
No
The device description clearly outlines physical components such as an arch, pneumatic pressure dome, connection tubing, and belt. The performance studies also focus on testing of these physical components and processes like cleaning and sterilization, indicating it is a hardware-based device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "compression of the femoral artery or vein after catheterization." This is a mechanical action applied to the patient's body.
- Device Description: The device is described as applying "mechanical pressure over the spot where there is bleeding." This is a physical intervention.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) in vitro (outside the body) to provide information for diagnosis, monitoring, 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 purely mechanical compression applied externally to the patient.
N/A
Intended Use / Indications for Use
The Reprocessed Femoral Compression Device is intended for use in the compression of the femoral artery or vein after catheterization.
Product codes
NMF, DXC
Device Description
The femoral compression device consists of an arch with a sterile pneumatic pressure dome and a connection tubing and belt. The device is applied on the patient with the dome over the femoral artery or vein and the belt around the patient. A sterile wound dressing is to be placed between the device and the patient making the device a "non-patient contacting device". The user controls the inflation of the dome by increasing or decreasing the pressure with a connected, manual pump (not provided). The dome applies a mechanical pressure over the spot where there is bleeding, while the arch and belt absorb and evenly distribute the opposite force from the dome. Only the femoral compression device is the subject of this submission; the integrated pump with a manometer is not included in the scope of this submission.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Specific non-clinical tests performed included: cleaning validation, sterilization validation (ISO 11135, USP ), biocompatibility testing (ISO 10993-1), ethylene oxide residual testing (ISO 10993-7), packaging validation (ASTM D4169, ASTM F88, ASTM F1929, ASTM F2096), and shelf life validation (ASTM 1980-07). In addition, validation of functional performance (bench testing) was performed through simulated use, visual inspection, fatigue testing, and function testing. Performance testing shows the reprocessed femoral compression device to perform as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
APR - 3 2012
Image /page/0/Picture/2 description: The image contains two lines of text. The first line says "Medical Device Reprocessing". The second line says "Small Equipment & Instrument Repair".
510(K) PREMARKET NOTIFICATION SUBMISSION 20 JANUARY 2012 For Reprocessed Femoral Compression Devices
II. SUMMARY AND CERTIFICATION
510(k) Summary A.
SterilMed, Inc.
Contact Person:
Submitter:
Jason Skramsted 11400 73td Avenue North Maple Grove, MN 55369 Phone: 763-488-3483 Fax: 763-488-4491
| Date Prepared: | 20 January 2012 |
|---|---|
| Trade Name: | Reprocessed Femoral Compression Device |
| Classification Name: | Clamp, Vascular, Reprocessed |
| Classification Number: | Class II, 21 CFR 870.4450 |
| Product Code: | NMF |
| Predicate
Devices: | The reprocessed femoral compression device is substantially equivalent to the SterilMed Femoral Compression
Device (K012574) with secondary substantial equivalence to the St. Jude Medical FemoStop™ Gold Femoral
Compression System(K080206). |
|---------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
Description: | The femoral compression device consists of an arch with a sterile pneumatic pressure dome and a connection
tubing and belt. The device is applied on the patient with the dome over the femoral artery or vein and the belt
around the patient. A sterile wound dressing is to be placed between the device and the patient making the
device a "non-patient contacting device". The user controls the inflation of the dome by increasing or
decreasing the pressure with a connected, manual pump (not provided). The dome applies a mechanical pressure
over the spot where there is bleeding, while the arch and belt absorb and evenly distribute the opposite force
from the dome. Only the femoral compression device is the subject of this submission; the integrated pump with
a manometer is not included in the scope of this submission. |
| Intended
Use: | The Reprocessed Femoral Compression Device is intended for use in the compression of the femoral artery or
vein after catheterization. |
| Functional
and Safety
Testing: | Representative samples of reprocessed femoral compression devices were tested to demonstrate appropriate
functional characteristics. Process validation testing was performed to validate the cleaning and sterilization
procedures as well as device packaging. In addition, the manufacturing process includes visual and validated
functional testing of all products produced. |
| Summary of
Non-clinical
Tests
Conducted: | Specific non-clinical tests performed included: cleaning validation, sterilization validation (ISO 11135, USP
), biocompatibility testing (ISO 10993-1), ethylene oxide residual testing (ISO 10993-7), packaging
validation (ASTM D4169, ASTM F88, ASTM F1929, ASTM F2096), and shelf life validation (ASTM 1980-
07). In addition, validation of functional performance (bench testing) was performed through simulated use,
visual inspection, fatigue testing, and function testing. Performance testing shows the reprocessed femoral
compression device to perform as intended. |
| Conclusion: | The reprocessed femoral compression device is substantially equivalent to SterilMed's Femoral Compression
Device with secondary substantial equivalence to the St. Jude Medical's FemoStop™ Gold Femoral
Compression System. This conclusion is based upon the devices' similarities in functional design (principles of
operation), materials, indications for use and methods of construction. |
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
APR - 3 2012
SterilMed. Inc. c/o Mr. Jason Skramsted Regulatory Affairs Specialist 11400 73rd Avenue North Maple Grove, MN 55369
Re: K120204
Trade/Device Name: Reprocessed Femoral Compression Device Regulation Number: 21 CFR 870.4450 Regulation Name: Clamp, Vascular, Reprocessed Regulatory Class: Class II Product Code: NMF, DXC Dated: January 20, 2012 Received: January 23, 2012
Dear Mr. Skramsted:
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 in microsite
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, include 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
2
Page 2 - Mr. Jason Skramsted
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 r Rase be devised alat I bermination that your device complies with other requirements of the Act that I Dri has intatutes and regulations administered by other Federal agencies. You must or any I oderal 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 Of K Fart 607); ideeinig (21 CFR 803); good manufacturing practice requirements as set de rice-related adverse overse) (QS) regulation (2) CFR Part 820); and if applicable, the electronic form in the quality systems (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 800) ), please 11 you desire specific ad resolved by Centers Offices/CDRH/CDRHOffices/ucm115809.htm for go to map. Power Radiological Health's (CDRH's) Office of Compliance. Also, please the Concertified, "Misbranding by reference to premarket notification" (21CFR Part note the regulations 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 Tou may of amall 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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
M. A. Hillemann
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Medical Device Reprocessing
Small Equipment & Instrument Repair
510(K) PREMARKET NOTIFICATION SUBMISSION 20 JANUARY 2012 For Reprocessed Femoral Compression Devices
Indications for Use
510(k) Number (if known):
Device Name: Reprocessed Femoral Compression Device
Indications for Use:
The Reprocessed Femoral Compression Device is intended for use in the compression of the femoral artery or vein after catheterization.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
M.A. Killebrew
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number K120204