(144 days)
Not Found
Not Found
No
The device description details a purely mechanical, weighted device for applying pressure, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is used to assist a vascular technician or RN in holding pressure to obtain hemostasis and alleviate stress for the user, not to treat a medical condition directly in the patient.
No
The device is described as an aid for applying pressure to the femoral artery post-catheterization to achieve hemostasis. Its purpose is to assist in a therapeutic/procedural task, not to diagnose a condition or disease.
No
The device is described as a weighted stainless steel device, indicating it is a physical hardware product, not software.
Based on the provided information, the EZ Hold device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- EZ Hold Function: The EZ Hold is a physical device used externally to apply pressure to a blood vessel (femoral artery) on the body. It does not analyze or test any biological samples.
The EZ Hold is a mechanical device used for hemostasis (stopping bleeding) after a medical procedure. Its function is entirely external and does not involve the in vitro examination of specimens.
N/A
Intended Use / Indications for Use
The EZ Hold is a weighted (1.0 and 2.0 pound) stainless steel (304) device used to assist a vascular technician or RN to hold pressure on the femoral artery post-cardiac catheriterization. Currently the technician uses either their hand or fingers to compress the artery or they use a mechanical clamp. The EZ Hold uses disks, as used with the mechanical clamps, but is held in place by the technician until hemostasis is obtained.
The EZ Hold is: 1) designed to reduce the risk for the RN of direct prolonged contact with body fluids (blood), and 2) alleviate bio-mechanical stress which occurs during traditional digital compression of the femoral artery post-cardiac catheritization. The devices work with currently marketed compatiblepressure disks (DisCo PNO-R or PNO-1 or equivalent bal and socket fit), fits the palm of the hand and is weighted to provide pressure at the site.
Product codes
DXC
Device Description
The EZ Hold is a weighted (1.0 and 2.0 pound) stainless steel (304) device. The EZ Hold uses disks, as used with mechanical clamps, and is held in place by the technician until hemostasis is obtained. The devices work with currently marketed compatiblepressure disks (DisCo PNO-R or PNO-1 or equivalent bal and socket fit), fits the palm of the hand and is weighted to provide pressure at the site.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral artery
Indicated Patient Age Range
Not Found
Intended User / Care Setting
vascular technician or RN
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850.
JAN 1 2 1998
Mr. Byron Zahler Secretary TZ Medical Incorporated 15858 S.W. Upper Boones Ferry Rd. Lake Oswego, Oregon 97035
K973132 Re : EZ Hold Device Regulatory Class: II (two) Product Code: DXC November 17, 1997 Dated: Received: November 26, 1997
Dear Mr. Zahler:
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 A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory 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.
1
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 "http://www.fda.qov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
973132
510(k) Number (if known)
Device Name:
EZ Hold
Indications For Use: 1,1
..
The EZ Hold is a weighted (1.0 and 2.0 pound) stainless steel (304) device used to assist a vascular technician or RN to hold pressure on the femoral artery post-cardiac catheriterization. Currently the technician uses either their hand or fingers to compress the artery or they use a mechanical clamp. The EZ Hold uses disks, as used with the mechanical clamps, but is held in place by the technician until hemostasis is obtained.
The EZ Hold is: 1) designed to reduce the risk for the RN of direct prolonged contact with body fluids (blood), and 2) alleviate bio-mechanical stress which occurs during traditional digital compression of the femoral artery post-cardiac catheritization. The devices work with currently marketed compatiblepressure disks (DisCo PNO-R or PNO-1 or equivalent bal and socket fit), fits the palm of the hand and is weighted to provide pressure at the site.
Th A h
(Division Sign-Off) (Division of Cardiovascular, Respiratory, and Neurological Devices 1973132 510(k) Number
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence Of CDRH, Office OF Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
Over-The-Counter Use
(Optional Format 1-2-96)