This table is intended for use in a diagnostic x-ray system to support patients during general purpose radiological procedures in the horizontal, vertical and trendelenburg positions.

Device Description

The Legacy/Legacy-D table is a patient support providing angulation to +/- 90 degrees and tabletop motion in the longitudinal and lateral directions. It includes an integrated table bucky and a spot film/fluoroscopic tower. The new bucky has the same function as the older version.

AI/ML Overview

This submission, K973039, describes the GE Legacy/Legacy-D Radiologic Table. This is a device for patient support during diagnostic x-ray procedures and as such, does not require a study with acceptance criteria.

Here's a breakdown based on the provided documents:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Safety: Device is as safe as other diagnostic x-ray tables of similar design.	"The design of the Legacy/Legacy-D raises no new questions of safety or effectiveness."
Effectiveness/Performance: Device performs as well as other diagnostic x-ray tables of similar design.	"In the opinion of GE Medical Systems the Legacy/Legacy-D is as safe, and performs as well as other diagnostic x-ray tables of similar design having the same intended uses."
Intended Uses: Supports patients during general purpose radiological procedures in horizontal, vertical, and trendelenburg positions.	"This table is intended for use in a diagnostic x-ray system to support patients during general purpose radiological procedures in the horizontal, vertical and trendelenburg positions."
Substantial Equivalence: Substantially equivalent to currently marketed radiologic tables that comply with the same or equivalent standards.	"Legacy/Legacy-D Radiologic Table is substantially equivalent to currently marketed radiologic tables that comply with the same or equivalent standards and have the same intended uses."

2. Sample Size Used for the Test Set and Data Provenance:

Not applicable. This is a 510(k) submission for a non-AI/diagnostic device, and no specific test set or clinical study data is presented to prove performance based on a sample size. The equivalence is asserted based on design and intended use compared to predicate devices.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable. No ground truth was established for a test set in the context of a performance study for this device.

4. Adjudication Method for the Test Set:

Not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. This is not an AI-powered diagnostic device, and therefore, no MRMC study was conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This device does not involve an algorithm or AI.

7. The Type of Ground Truth Used:

Not applicable. Performance for this device is based on its mechanical and functional specifications, compared to predicate devices, not on diagnostic accuracy against a ground truth.

8. The Sample Size for the Training Set:

Not applicable. This device does not involve machine learning or a training set.

9. How the Ground Truth for the Training Set was Established:

Not applicable.

Summary of the Study (or basis for clearance):

The GE Legacy/Legacy-D Radiologic Table obtained 510(k) clearance by demonstrating substantial equivalence to existing, legally marketed diagnostic x-ray tables. The "study" in this context is the comparison of the new device's design, materials, and intended use against predicate devices. The manufacturer's conclusion is that the device "is as safe, and performs as well as other diagnostic x-ray tables of similar design having the same intended uses" and that its design "raises no new questions of safety or effectiveness." The FDA's review agreed with this assessment, confirming substantial equivalence and allowing the device to proceed to market. There was no clinical trial or performance study with acceptance criteria in the traditional sense for this type of medical device clearance.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined within a circle. There are three decorative swirls around the circle, one at the top and two at the bottom.

GE Medical Systems K973039

OCT 16 1997

SUMMARY OF SAFETY AND EFFECTIVENESS

August 13, 1997

This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.87(h)

IDENTIFICATION OF THE SUBMITTER:

Larry A. Kroger Phone - (414) 544-3894 FAX - (414) 544-3863

Legacy/Legacy-D Radiologic Table IDENTIFICATION OF THE PRODUCT:

General Electric Co. Manufactured by: Medical Systems Division 3000 North Grandview Blvd. Waukesha, WI 53188

MARKETED DEVICE:

Legacy/Legacy-D Radiologic Table is substantially equivalent to currently marketed radiologic tables that comply with the same or equivalent standards and have the same intended uses.

DEVICE DESCRIPTION:

INDICATIONS FOR USE:

This table is intended for use in a diagnostic x-ray system to support patients during general purpose radiological procedures in the horizontal, vertical and trendelenburg positions.

CONCLUSIONS:

In the opinion of GE Medical Systems the Legacy/Legacy-D is as safe, and performs as well as other diagnostic x-ray tables of similar design having the same intended uses. The design of the Legacy/Legacy-D raises no new questions of safety or effectiveness.

{1}------------------------------------------------

Image /page/1/Picture/2 description: The image shows the logo for the Department of Health & Human Services (HHS) in the USA. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.

OCT 1 6 1997

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Larry A. Kroger, Ph.D. Regulatory Affairs Program Manager GE Medical Systems, Inc. P.O. Box 414 Milwaukee. WI 53201

Re: K973039

Legacy/Legacy-D Table (Diagnostic X-Ray Table) Dated: August 13, 1997 Received: August 14, 1997 Regulatory class: II 21 CFR 892.1980/Procode: 90 IXR

Dear Dr. Kroger:

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, 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 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 Regulations, Title 21, Parts , 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 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 Radiation Control provisions, or other Federal laws or regulations.

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) 594-4613. Additionally, for question 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.gov/cdrh/dsmamain.html".

Sincerely yours,

h.7.liau Yu

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

1973039 510(k) Number (if known):

Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

This table is intended for use in a diagnostic x-ray system to support patients during general purpose radiological procedures in the horizontal, vertical and trendelenburg positions.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David le. Seymore

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K973039

Prescription Use_ (Per 21 CFR 801.109)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 892.1980 Radiologic table.

(a)
Identification. A radiologic table is a device intended for medical purposes to support a patient during radiologic procedures. The table may be fixed or tilting and may be electrically powered.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.