EZ HOLD 1 LBS., EZ HOLD 2 LBS

K973132 · Tz Medical, Inc. · DXC · Jan 12, 1998 · Cardiovascular

Device Facts

• Record ID: K973132
• Device Name: EZ HOLD 1 LBS., EZ HOLD 2 LBS
• Applicant: Tz Medical, Inc.
• Product Code: DXC · Cardiovascular
• Decision Date: Jan 12, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4450
• Device Class: Class 2

Intended 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.

Device Story

EZ Hold is a handheld, weighted (1.0 or 2.0 lb) stainless steel device used in clinical settings post-cardiac catheterization. It functions as an ergonomic interface between the clinician's hand and a standard pressure disk (e.g., DisCo PNO-R/PNO-1). The clinician holds the device against the femoral artery site to maintain compression until hemostasis is achieved. By providing weight and a palm-fitting form factor, it reduces the clinician's physical effort and minimizes direct contact with patient blood. It replaces or supplements traditional manual digital compression, reducing bio-mechanical stress for the operator.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Constructed of 304 stainless steel. Weighted design (1.0 and 2.0 lbs). Features a ball-and-socket interface compatible with standard pressure disks (e.g., DisCo PNO-R/PNO-1). Handheld, non-powered, manual device.

Indications for Use

Indicated for use by vascular technicians or RNs to assist in applying manual pressure to the femoral artery site following cardiac catheterization to achieve hemostasis.

Regulatory Classification

Identification

A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.

Reference Devices

• DisCo PNO-R
• DisCo PNO-1

Submission Summary (Full Text)

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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.

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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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

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Concurrence Of CDRH, Office OF Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)