(76 days)
Not Found
No
The description focuses on the physical structure and utility delivery (gas, power) of a wall-mounted system, with no mention of AI/ML capabilities or data processing.
No
The device provides physical support for monitoring equipment and dispenses medical gases and electrical power but does not directly treat a medical condition or perform a therapeutic function.
No
The document describes a wall-mounted system providing physical support, storage, and dispensing of medical gases and electrical power. It does not perform any diagnostic function on a patient.
No
The device description clearly outlines physical hardware components (wall fixture, horizontal element, column, support tube, equipment carrier) and their function in providing physical support, storage, and dispensing of medical gases and electrical power. It is a physical medical device, not software-only.
Based on the provided information, the Drager Gemina System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the system provides physical support, storage, and dispensing of medical gases and electrical power. This is related to patient care infrastructure and equipment management, not the examination of specimens derived from the human body for diagnostic purposes.
- Device Description: The description details the physical components of a wall-mounted supply system. It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing specimens, diagnostic testing, or any other activities typically associated with IVD devices.
Therefore, the Drager Gemina System falls under the category of medical equipment support and supply systems, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Drager Gemina System is a nonpowered piece of durable The equipment intended to provide wall mounted physical support for medical/surgical monitoring and related equipment, storage space, and wall mounted dispensing of medical gases and electrical power required in patient care clinical settings, emergency rooms, intensive care, procedure rooms and operating rooms.
The Gemina System will be used in the same indications as other systems which provide overhead or wall mounted physical support and storage of equipment for dispensing of medical gases and electrical power.
Product codes
Not Found
Device Description
The Gemina System is a wall mounted supply system of modular design. The individual components of this modular system are wall fixture, horizontal element, column, support tube, and equipment carrier (shelf).
column contains two large terminal plates that can be The outfitted according to the individual need with various outlets for gas supply, electricity, vacuum, communications, etc.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
KA61886
Summary of Safety and Effectiveness Gemina Wall-MOunted Workplace System
INTENDED USE
Drager Gemina System is a nonpowered piece of durable The equipment intended to provide wall mounted physical support for medical/surgical monitoring and related equipment, storage space, and wall mounted dispensing of medical gases and electrical power required in patient care clinical settings, emergency rooms, intensive care, procedure rooms and operating rooms.
The Gemina System will be used in the same indications as other systems which provide overhead or wall mounted physical support and storage of equipment for dispensing of medical gases and electrical power. Another Drager System, the DVE 4000, a ceiling mounted system has previously been reviewed by FDA (K921297) .
PRODUCT DESCRIPTION
Surgical Equipment Inc. will be the distributor of the ALM Drager Gemina System in the United States. The Gemina System Dragerwerk, Aktiengesellschaft Lubeck, manufactured by is Federal Republic of Germany.
The Gemina System is a wall mounted supply system of modular design. The individual components of this modular system are wall fixture, horizontal element, column, support tube, and equipment carrier (shelf).
column contains two large terminal plates that can be The outfitted according to the individual need with various outlets for gas supply, electricity, vacuum, communications, etc.
1
SS& E Page - 2 -May 14, 1996
The Drager Gemina System is substantially equivalent in materials, design, and function to pre-enactment devices of marclare) addition as well as to other wall-mounted supply monitoring support systems currently in commercial and a distribution in the United States.
The Drager Gemina System is substantially equivalent to another Drager system, the DVE 4000, a ceiling mounted system which has previously been reviewed by FDA (K921297).
The Drager Gemina System is also substantially equivalent to the Horizon Headwall System from Hill-Rom.
Both of these systems (Gemina and Horizon) are wall mounted
systems intended to provide support for medical/surgical monitoring and related equipment and to provide physical support for wall mounted dispensing equipment of medical gases and electrical power.
of these systems are modular in design to allow for Both maximum flexibility in meeting the needs of individual users and sites.
The following charts provide a comparison of features of the Gemina System to The Horizon Headwall System:
2
SS & E Page - 3 -May 14, 1996
TABLE I
ALM Surgical
Gemina
Marketed By
Support for Medical Support for Medical Intended Use Equipment, Storage, Equipment, Storage, Electrical and Gas Electrical and Gas Support for Equipment Support for Equipment
Factory Installed Factory Installed Components Add-ons Add-ons (prefabrication) (prefabrication)
Features and Technical Specifications Quick connect or D.I.S.S. outlets. Hospital grade electrical receptacles.
Wall Mounted
Compatible Inserts
Any Manufacturer, Including Chemetron, Puritan Bennett, Ohio Med. Prod., Oxyquip.
Quick connect or D.I.S.S. outlets. Hospital grade electrical receptacles.
Wall Mounted
Horizon Headwall
Hill-Rom
Any Manufacturer, Including Chemetron, Puritan Bennett, Ohio Med. Prod., Oxyquip.
3
SS & E Page - 4 -May 14, 1996
Safety Features
the Drager systems described in this premarket notification All of are equipped with the following safety features:
- Metal edges are covered with plastic band to protect all l cables and hoses that could be enclosed from possible cutting by those edges.
- All edges are rounded. A sturdy plastic guide is provided to l quide hoses and cables to connections.
ADVERSE SAFETY AND EFFECTIVENESS INFORMATION
For correct and effective use of the Gemina System and to avoid potential safety hazards, it is essential to follow the recommendations contained in the manual provided with the device. Any use of the apparatus requires full understanding and strict observations of these instructions. The apparatus is only to be used for purposes specified here.
apparatus must be inspected and serviced by experts at The regular 6 month intervals. Care must be taken to observe the recommended maximum loads recommended in the product literature. Failure to observe the recommended maximum loads could result in injury or harm to patients and healthcare professionals.
Professional installation is required to ensure that all standards and codes for gas and power connection as well as mechanical connections are met. Failure to meet these standards could result in injury or harm to patients and healthcare personnel.