(9 days)
K970807, 1131.02
K970807, 1131.02
No
The description details a standard electrohydraulically operated operating table with various positioning functions, controlled by manual inputs. There is no mention of AI, ML, image processing, or data analysis capabilities.
No
The device is an operating table used for patient positioning during diagnostic examinations or surgical procedures, which is a supportive function, not a direct therapeutic intervention.
No
The device is an operating table designed for patient positioning during surgical treatment and diagnostic examinations, but it does not perform diagnostic functions itself. It supports the patient during the diagnostic examination.
No
The device description clearly details a physical operating table with electrohydraulical operation, various moving parts, and power supply components, indicating it is a hardware device with integrated software for control.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "for use during diagnostic examinations or surgical procedures to support and position a patient." This describes a device used on the patient's body for physical support and manipulation, not for testing samples from the body.
- Device Description: The description details the physical components and functions of an operating table, such as positioning movements, power sources, and table sections. This aligns with a surgical or examination support device, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process related to determining the state of a disease or condition through in vitro testing.
In summary, the device is an operating table, which is a medical device used in a clinical setting for patient care, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The device is for use during diagnostic examinations or surgical procedures to support and position a patient.
Product codes
Not Found
Device Description
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 electronydraulically
The table top is subdivided as follows: Head plate, removable back plate section, back plate, seat plate, leg plates
Each foam upholstered patient section is radiotranslucent and electrically conductive. The radiotranslucention correspond to 21 CFR 1020.30 with an Aluminium Equivalent less than 2 mm.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
K970807, 1131.02
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4960 Operating tables and accessories and operating chairs and accessories.
(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.
0
MAR I 4 1997
Summary of Safety and Effectiveness Information VII. for 510(k) Submission Mobile Operating Table 1132.01
General Information
Proprietary Name: Common Name: Classification Name: Classification: Classification Number: Intended use:
Legally marketed device Proprietary Name: Common Name: Classification Name: Classification: Classification Number:
1132.01
Mobile Operating Table Operating room table, AC - powered Class I FQQ The device is for use during diagnostic examinations or surgical procedures to support and position a patient.
Betastar 1131.02 Mobile Operating Table
Class I
.
Date of submission:
Establishment Name and Adress:
October 31, 1996
Stierten-MAQUET AG Kehlerstr. 31 76437 Rastatt / GERMANY
Contact Person: Reinhard Pfeuffer, OE Telephone: -49/7222/932-219 -49/7222/932-634 FAX:
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
$\frac{B}{Y}$
1
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 Lateral tilt movement (right / left) Leg plate movement (up/down) Back plate movement (up / down) Head plate movement (up / down) Hight adjustment
electrohydraulically electrohydraulically electrohydraulically electrohydraulically manual electronydraulically
The table top is subdivided as follows: Head plate, removable back plate section, back plate, seat plate, leg plates
Each foam upholstered patient 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 issuses 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 |