(91 days)
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.
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.
This document describes a 510(k) submission for the Medrad Universal Adjustable T-Rail Table Bracket (KMA-350), seeking substantial equivalence to the predicate device, Medrad Universal T-Rail Table Bracket (KMA-339). The submission focuses on comparing the new device's characteristics to the predicate and highlighting its modified design for adjustability and ease of attachment.
Here's an analysis of the provided information, framed by your requested criteria:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria here are implicitly defined by the characteristics of the predicate device, as the submission aims for substantial equivalence. The "device performance" refers to the new device's characteristics.
| Criterion (Feature) | Acceptance (Predicate Device KMA-339) | Reported Device Performance (Proposed Device KMA-350) |
|---|---|---|
| Intended Use | Accessory for supporting Medrad Angiographic Injectors. | Accessory for supporting Medrad Mark IV, Mark V, and Mark V Plus Angiographic injectors and other Medrad injectors of similar weight and post size. |
| Dimensions (Height) | 17-3/8 inches | 12 to 17 inches |
| Height Adjustable | No | Yes (5 inches) |
| Table Rail Size Compatibility | From 1/8 to ½ inches thick and 7/8 to 1-1/4 inches wide | From ¼ to ½ inches thick and 7/8 to 1-1/8 inches high |
| Electrical Isolation | Same (isolated from injector head via plastic bushing) | Yes (The bracket is isolated from the injector head via a plastic bushing at the injector head collar.) |
Study Proving Device Meets Acceptance Criteria:
The document describes a substantial equivalence determination study. This type of study does not involve traditional clinical trials or performance testing against acceptance criteria in the same way a new, novel device might. Instead, it relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device.
The study presented here is a design comparison and functional assessment against a predicate device.
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for Test Set: Not applicable in the traditional sense of a human subject or data-driven 'test set'. The "test set" here comprises the design specifications and physical characteristics of the proposed KMA-350 device, which are then compared to the predicate KMA-339. There are no patient data or image sets involved.
- Data Provenance: The data provenance is from Medrad Inc.'s internal design and manufacturing specifications for both the proposed KMA-350 and the predicate KMA-339. This is retrospective in the sense that the predicate device is already on the market, and its specifications are established. The new device's specifications are part of its development process.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. "Ground truth" in this context would be the established specifications and performance of the predicate device, and the design intent/specifications of the proposed device. This is determined by the manufacturer's engineering and design teams, not by independent experts establishing a "ground truth" for a test set in the clinical or AI sense.
4. Adjudication Method for the Test Set
Not applicable. There is no adjudication method in the sense of resolving discrepancies in expert opinions, as no such opinions are being solicited for a clinical or image-based test set. The comparison is objective, based on physical and functional specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This device is a mechanical bracket for supporting an injector. MRMC studies are typically used for diagnostic devices (e.g., imaging software) where human readers interpret medical cases.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
Not applicable. This device is a mechanical accessory, not an algorithm.
7. Type of Ground Truth Used
The "ground truth" for this substantial equivalence submission is essentially the established specifications, intended use, and performance of the predicate device (KMA-339), as well as the design and engineering specifications of the new device (KMA-350). These are objective engineering parameters and manufacturer-defined intended uses.
8. Sample Size for the Training Set
Not applicable. There is no "training set" as this is a mechanical device, not an AI or machine learning application.
9. How the Ground Truth for the Training Set Was Established
Not applicable, for the same reasons as point 8.
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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 (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 AdjustableTable Bracket | Predicate Device:KMA-339 Universal Table Bracket | |
|---|---|---|
| Intended Use | An accessory for supporting MedradMark IV, Mark V, and Mark V PlusAngiographic injectors and otherMedrad injectors of similar weight andpost size. (These Medradangiographic injectors are intended tobe used to deliver intravenouscontrast medium into humans forangiographic diagnostic procedures.) | An accessory for supporting MedradAngiographic 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 and7/8 to 1-1/8 inches high | From 1/8 to ½ inches thick and7/8 to 1-1/4 inches wide |
| Electrical Isolation | Yes (The bracket is isolated from theinjector head via a plastic bushing atthe 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 (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
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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)
§ 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.