(91 days)
KMA-339
Not Found
No
The device description and intended use clearly indicate a mechanical bracket for supporting medical injectors, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" section also explicitly states "Not Found".
No
The device is described as an accessory for supporting angiographic injectors, not as a device with a therapeutic effect itself.
No
The device is described as an accessory for supporting angiographic injectors. Its function is mechanical support, not to diagnose medical conditions or provide diagnostic information.
No
The device description clearly describes a physical bracket (hardware) intended to support medical injectors. There is no mention of software as the primary component or function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an accessory for supporting angiographic injectors. This is a mechanical support function for a medical device used in a clinical setting, not for testing samples taken from the human body.
- Device Description: The description focuses on the physical characteristics and function of the bracket in relation to supporting injectors and attaching to table rails. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
- Reagents, calibrators, or controls
The device is a physical accessory used in a medical procedure, not a diagnostic test performed on a sample.
N/A
Intended Use / Indications for 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.
Product codes
DXT
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Medrad Universal T-rail Table Bracket, catalog number KMA-339
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1650 Angiographic injector and syringe.
(a)
Identification. An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography.(b)
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.
0
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 (412) 767-2400, ext. 3536 (412) 767-8899 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
. :
(412) 767-2400 .'
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:
KMA-350 Universal Adjustable
Table Bracket | Predicate Device:
KMA-339 Universal Table Bracket |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|
| Intended Use | 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. (These Medrad
angiographic injectors are intended to
be used to deliver intravenous
contrast medium into humans for
angiographic diagnostic procedures.) | An accessory for supporting Medrad
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
7/8 to 1-1/8 inches high | From 1/8 to ½ inches thick and
7/8 to 1-1/4 inches wide |
| Electrical Isolation | Yes (The bracket is isolated from the
injector head via a plastic bushing at
the injector head collar.) | Same |
1
1
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
2
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 (301) 594-4586. 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" (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 (800) 638-2041 or (301) 443-6597 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
3
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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
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)