UNIVERSAL ADJUSTABLE T-RAIL TABLE BRACKET

K984418 · Medrad, Inc. · DXT · Mar 11, 1999 · Cardiovascular

Device Facts

• Record ID: K984418
• Device Name: UNIVERSAL ADJUSTABLE T-RAIL TABLE BRACKET
• Applicant: Medrad, Inc.
• Product Code: DXT · Cardiovascular
• Decision Date: Mar 11, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1650
• Device Class: Class 2

Intended Use

The Universal Adjustable T-Rail Table Bracket is intended to be used as an accessory for supporting Medrad Mark IV, Mark V, and Mark V Plus Angiographic injectors and other Medrad injectors of similar weight and post size.

Device Story

Universal Adjustable T-Rail Table Bracket (KMA-350) serves as mechanical support accessory for Medrad angiographic injectors (Mark IV, V, V Plus). Device mounts to clinical table rails (1/4 to 1/2 inch thick). Key features include adjustable height (12-17 inches) and non-disassembly mounting mechanism. Provides electrical isolation between injector head and table via plastic bushing. Used in clinical settings by medical staff to stabilize injectors during contrast delivery procedures.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Mechanical table bracket; height-adjustable (12-17 inches); mounts to table rails 1/4 to 1/2 inch thick; includes plastic bushing for electrical isolation between injector head and bracket.

Indications for Use

Indicated for supporting Medrad Mark IV, Mark V, and Mark V Plus Angiographic injectors and similar weight/post-size injectors used to deliver intravenous contrast medium into humans for angiographic diagnostic procedures.

Regulatory Classification

Special Controls

*Classification.* Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Predicate Devices

• Medrad Universal T-rail Table Bracket (KMA-339)

Submission Summary (Full Text)

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# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

Submitter's Name: Submitter's Address: Telephone Number: Fax Number: Contact Person: Date:

Proprietary Name: Common Name: Classification: Classification Name: Medrad Inc. One Medrad Drive, Indianola, PA 15051 USA [phone], ext. 3536 [phone] Frank Pelc December 9, 1998

Universal Adjustable T-Rail Table Bracket Table Bracket 74 DXT Injector and Syringe, Angiographic

Predicate Device:

Medrad Universal T-rail Table Bracket, catalog number KMA-339

### Medrad, Inc.

One Medrad Drive

Indianola, PA 15051-0780

. :

[phone] .'

Substantial Equivalence - The Universal Adjustable T-Rail Table Bracket, catalog number KMA-350, is substantially equivalent to Medrad's Universal T-Rail Table Bracket, catalog number KMA-339, a pre-amendment device. Both products have the same intended use to support Medrad Mark IV, Mark V, and Mark V Plus Angiographic Injectors and other Medrad injectors of similar weight (22 lbs. for the Mark IV, 19 lbs. for the Mark V Plus) and post size. Both fit on table rails from ¼ to ½ inches thick and 7/8 to 1-1/8 inches high. The primary differences are that the design of the proposed KMA-350 Table Bracket is modified to allow the bracket height to be adjusted; and that the KMA:350 Table Bracket can be secured to a table rail without needing to be disassembled.

A table comparing the characteristics of both table brackets is provided below.

# Comparison Table

| | Proposed Device:<br>KMA-350 Universal Adjustable<br>Table Bracket | Predicate Device:<br>KMA-339 Universal Table Bracket |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|
| Intended Use | An accessory for supporting Medrad<br>Mark IV, Mark V, and Mark V Plus<br>Angiographic injectors and other<br>Medrad injectors of similar weight and<br>post size. (These Medrad<br>angiographic injectors are intended to<br>be used to deliver intravenous<br>contrast medium into humans for<br>angiographic diagnostic procedures.) | An accessory for supporting Medrad<br>Angiographic Injectors. |
| Dimensions (Height) | 12 to 17 inches | 17-3/8 inches |
| Height Adjustable | Yes (5 inches) | No |
| Table Rail Size | From ¼ to ½ inches thick and<br>7/8 to 1-1/8 inches high | From 1/8 to ½ inches thick and<br>7/8 to 1-1/4 inches wide |
| Electrical Isolation | Yes (The bracket is isolated from the<br>injector head via a plastic bushing at<br>the injector head collar.) | Same |

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 11 1999

Mr. Frank Pelc Regulatory Affairs Coordinator Medrad Inc. One Medrad Drive Indianola, PA 15051

Re : K984418 Trade Name: Universal Adjustable T-Rail Table Bracket Requlatory Class: II Product Code: DXT Dated: February 18, 1999 February 19, 1999 Received:

Dear Mr. Pelc:

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 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). 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 895. A substantially equivalent determination assumes compliance with 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 regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this

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Page 2 - Mr. Frank Pelc

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 requlations.

This letter will allow you to beqin 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 diaqnostic 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" (21CFR 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.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Sincerely yours,

Thomas J. Callahon

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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## INDICATION FOR USE

510(k) Number: K984418

Device Name: Universal Adjustable T-Rail Table Bracket

Indications for Use/Intended Use:

The Universal Adjustable T-Rail Table Bracket is intended to be used as an accessory for supporting Medrad Mark IV, Mark V, and Mark V Plus Angiographic injectors and other Medrad injectors of similar weight and post size.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Chrtyluth for TTC

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Dev. 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

✓

OR

Over-The-CounterUse _

(Optional Format 1-2-96)