MOBILE OPERATING TABLE 1132.01

K970807 · Stierlen-Maquet AG · GDC · Mar 14, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K970807
• Device Name: MOBILE OPERATING TABLE 1132.01
• Applicant: Stierlen-Maquet AG
• Product Code: GDC · General, Plastic Surgery
• Decision Date: Mar 14, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4960
• Device Class: Class 1
• Attributes: 3rd-Party Reviewed

Intended Use

The device is for use during diagnostic examinations or surgical procedures to support and position a patient.

Device Story

Mobile operating table for patient support and positioning during surgery or diagnostics. Electrohydraulically operated system; controlled via hand control box, IR-transmitter, foot switch, or manual override. Powered by rechargeable batteries. Features include Trendelenburg/reverse Trendelenburg, lateral tilt, leg plate, back plate, and height adjustment; head plate adjustment is manual. Table top consists of radiotranslucent, electrically conductive, foam-upholstered sections. Used in operating rooms by surgical staff. Benefits include precise patient positioning and radiotranslucency for intraoperative imaging.

Clinical Evidence

Bench testing only. Compliance with IEC 601-1, EN 60601-1 (UL 2601), IEC 601-1-2, and prEN 50115. Radiotranslucency verified to meet 21 CFR 1020.30 (Aluminium Equivalent < 2 mm).

Technological Characteristics

Electrohydraulical system; battery-powered with built-in charger. Radiotranslucent, electrically conductive foam-upholstered sections. Complies with IEC 601-1, EN 60601-1, IEC 601-1-2, prEN 50115, DIN EN ISO 29001, and DIN EN ISO 46001. Radiotranslucency < 2 mm Aluminium Equivalent per 21 CFR 1020.30.

Indications for Use

Indicated for patients requiring support and positioning during diagnostic examinations or surgical procedures.

Regulatory Classification

Identification

Operating tables and accessories and operating chairs and accessories are AC-powered or air-powered devices, usually with movable components, intended for use during diagnostic examinations or surgical procedures to support and position a patient.

Predicate Devices

• Betastar 1131.02

Submission Summary (Full Text)

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MAR 14 1997
K970807

# VII. Summary of Safety and Effectiveness Information for 510(k) Submission Mobile Operating Table 1132.01

## General Information

| Proprietary Name: | 1132.01 |
| --- | --- |
| Common Name: | Mobile Operating Table |
| Classification Name: | Operating room table, AC - powered |
| Classification: | Class I |
| Classification Number: | FQO |
| Intended use: | The device is for use during diagnostic examinations or surgical procedures to support and position a patient. |

## Legally marketed device

| Proprietary Name: | Betastar 1131.02 |
| --- | --- |
| Common Name: | Mobile Operating Table |
| Classification Name: | - |
| Classification: | Class I |
| Classification Number: | - |
| Date of submission: | October 31, 1996 |
| --- | --- |
| Establishment Name and Address: | Stierlen-MAQUET AG
Kehlerstr. 31
76437 Rastatt / GERMANY
Contact Person: Reinhard Pfeuffer, OE
Telephone: -49/7222/932-219
FAX: -49/7222/932-634 |

Establishment Registration Number: 8010652

Safety and Effectiveness Information supporting the Substantial Equivalence Determination

## Performance Standards

The device complies with
- IEC 601-1 respectively EN 60601-1 (UL 2601)
- Medical Electrical Equipment Part I,
- General Requirements for Safety
- IEC 601-1-2, prEN 50115
- Medical Electrical Equipment Part II,
- Particular Requirements for the Safety of Operating Tables

The design, manufacturing and quality control of the device comply with:
- DIN EN ISO 29001
- DIN EN ISO 46001

510(k) Notification - Mobile Operating Table 1132.01 - Stierlen MAQUET AG
30

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# Technological Characteristics and the intended use of the device

The operating table has been designed to fulfil the special requirements for patient positioning during surgical treatment. The side rails are provided for fitting additional parts. Before positioning the patient the device has to be covered with sheets. It is an electrohydraulical operated system which can be controlled by means of a hand control box, IR-transmitter, foot switch or with the override. Power is supplied by batteries, which can be recharged by a built-in battery charger. The operating table has the following functions:

| Trendelenburg / reverse Trendelenburg positioning | electrohydraulically |
| --- | --- |
| Lateral tilt movement (right / left) | electrohydraulically |
| Leg plate movement (up/down) | electrohydraulically |
| Back plate movement (up / down) | electrohydraulically |
| Head plate movement (up / down) | manual |
| Hight adjustment | electrohydraulically |

The table top is subdivided as follows:

Head plate, removable back plate section, back plate, seat plate, leg plates

Each foam upholstered patient supporting section is radiotranslucent and electrically conductive. The radiotranslucention correspond to 21 CFR 1020.30 with an Aluminium Equivalent less than 2 mm.

The development of the design considers the latest issues of applicable regulations. The following table shows in detail which regulations were applied.

| Applied Standards | 1132.01 | 1131.02 |
| --- | --- | --- |
| IEC 601-1 respectively EN 60601-1 (UL 2601) | yes | yes |
| IEC 601-1-2 | yes | yes |
| prEN 50115 | yes | no |
| Design, manufacturing and quality control of the device comply with: DIN EN ISO 29001, DIN EN ISO 46001 | yes | no |

510(k) Notification - Mobile Operating Table 1132.01 - Stierlen MAQUET AG