The Siemens Koordinat Angiographic X-ray Table family is intended to support and position patients for Angiographic examinations, Angiographic interventional techniques where an X-ray translucent tabletop is required, and for use during surgery where an X-ray translucent tabletop is required.

Device Description

The Koordinat Table family is a modification to an existing floor mounted X-ray table for angiographic examinations and interventions, and surgery. The modified Koordinat table is based on knowledge and experience gained with the predecessor model, the Koordinat M Table. The Koordinat M was described in the 510(k) Submitted on 4/30/95 with the number K951176.

AI/ML Overview

The provided text is a 510(k) summary for the Siemens Koordinat Angiographic and Operating Room Model X-Ray Table Family. It details the device's intended use and substantial equivalence to predicate devices. However, it does not contain information about acceptance criteria or specific studies demonstrating device performance against such criteria.

Here's why and what information is missing based on your request:

Type of Device: The device is an X-ray table, which is a physical piece of equipment for patient positioning, not a medical device that produces diagnostic results (like an AI algorithm for image analysis). Therefore, the provided text focuses on hardware specifications and substantial equivalence, not performance metrics like sensitivity, specificity, or accuracy that would be relevant for an AI or diagnostic device.
Focus of 510(k) Summary: A 510(k) summary primarily demonstrates that a new device is "substantially equivalent" to a legally marketed predicate device. This often involves comparing technological characteristics, intended use, and safety/effectiveness profiles, rather than presenting detailed clinical trial data with acceptance criteria for quantitative performance metrics.

Therefore, for your specific numbered points, the information is largely absent from the provided text:

A table of acceptance criteria and the reported device performance: Not present. The text describes the device's function and technical characteristics, but no quantitative performance metrics or acceptance criteria are listed.
Sample sized used for the test set and the data provenance: Not applicable/not present. This is a hardware device; there isn't a "test set" of data in the sense you're referring to for AI or diagnostic devices.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not present.
Adjudication method for the test set: Not applicable/not present.
If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable/not present. This device is not an AI for image interpretation.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable/not present.
The type of ground truth used: Not applicable/not present.
The sample size for the training set: Not applicable/not present.
How the ground truth for the training set was established: Not applicable/not present.

Summary of available information related to performance/equivalence:

Device Description: The Koordinat Table family is a modification of an existing floor-mounted X-ray table.
Technological Characteristics Comparison: The new Koordinat Table has "the same technological characteristics" as the predicate Koordinat M table. The primary difference highlighted is a change from analog to CAN bus interface for reporting and controlling table movements in the higher-end models.
Predicate Devices: The new models are deemed substantially equivalent to the Koordinat M Table (K951176), OP/PTCA-System 1520 (K883613), Synchra Tilt (K940696), and 90/50 Mobile Imaging Table (K884531). This substantial equivalence implies that the new device meets the same safety and effectiveness standards as these previously cleared devices.
Intended Use: "intended to support and position patients for Angiographic examinations, Angiographic interventional techniques where an X-ray translucent tabletop is required, and for use during surgery where an X-ray translucent tabletop is required."

In essence, the "study" demonstrating the device meets "acceptance criteria" in this context is the 510(k) submission itself, which argues and validates substantial equivalence to existing, legally marketed predicate devices. The "acceptance criteria" are implicitly met if the device fundamentally performs its intended function (patient support and positioning) in a manner that is as safe and effective as the predicate devices, despite minor technological updates.

Summary

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DEC 21 1999

K993947

Attachment 11

510 (k) Summary

Koordinat Angiographic and Operating Room Model X-Ray Table Family

Submitted by: Siemens Medical Systems, Inc. 186 Wood Ave South Iselin, NJ 08830

November 22, 1999

This 510(k) Summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92.

1. Contact Person

Ms Alicia Juergensen Phone: (908) 321-3243 Fax: (908)321-4841

2. Device Name and Classification:

Trade Name:

Classification Name: Classification Panel: CFR Section: Device Class:

Koordinat Angiographic and Operating Room Model X-Ray Table Family Angio X-Ray System Accessory Radiology 21 CFR §892.1600 Class II

3. Intended Use:

4. Substantial Equivalence:

The new Koordinat OR models are substantially equivalent to the following device in commercial distribution:

Koordinat M Table, K951176 cleared on 4/30/95 . Siemens Medical Systems, Inc.
. OP/PTCA-System 1520, K883613 cleared on 9/15/88 Maquet
Synchra Tilt, K940696 cleared on Philips
t 90/50 Mobile Imaging Table, K884531 cleared on1/11/89 Beta Medical System

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5. Device Description

Summary of Technological Characteristics of the Principal Device as Compared with the 6. Predicate Device

The Kordinat Table has the same technological characteristics as the predicate Koordinat M table. Like the Koordinat M the Koordinat OR family can be connected to several existing angiographic xray systems (i.e. Angiostar Plus and Multistar Plus).

The difference is demonstrated in the higher two models which will no longer utilize analog interface but will provide a CAN bus interface to report table position to the angiographic x-ray system. Table movements will also be controlled via the CAN bus interface.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the perimeter of the circle. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 1 1999

Alicia Juergensen Technical Specialist

Regulatory Affairs

Iselin, NJ 08830

Siemens Medical Systems, Inc.

186 Wood Avenue South

Re:

Kooridinat OR, AXIUM, AXIOM OR Angiographic and Operating Room Model X-Ray Table Family Dated: November 19, 1999 Received: November 22, 1999 Regulatory class: II 21 CFR 892.1600/Procode: 90 IZI

Dear Ms. Juergensen:

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.

K993947

If vour 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 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 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.

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 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"(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/dsma/dsmamain.html".

Sincerely yours,
Dan Stet

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive. Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Attachment 1

Indications for Use

K993947 510(k) Number (if known):

Device Name: __ Koordinat Angiographic X-Ray Table____________________________________________________________________________________________________________________________

Indications for Use:

The Siemens Koordinat Angiographic X-ray Table family is intended to support and position patients for I he ordinations, Angiographic interventional techniques where an X-ray translucent tabletop is required, and for use during surgery where an X-ray translucent tabletop is required.

Concurrence of the CDRH, Office of Device Evaluation (ODE)

Prescription Use (per 21 CFR 801.109)
OR Over-The-Counter Use

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number	K993947

Regulation Number and Section

§ 892.1600 Angiographic x-ray system.

(a)
Identification. An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.