(81 days)
No
The device description and intended use focus on physical support, storage, and dispensing of medical gases and power. There is no mention of AI or ML capabilities.
No
The device provides physical support, storage space, and dispenses medical gases and electrical power. It does not directly treat or diagnose medical conditions.
No
The device is described as providing physical support, storage, and dispensing of medical gases and electrical power. It does not mention any function related to diagnosing medical conditions.
No
The device description clearly outlines physical components such as ceiling fixtures, support systems, pendant heads, equipment carriers, terminal plates, support arms, pneumatic brakes, and a motor. This indicates it is a hardware device, not software-only.
Based on the provided text, the Drager DVE 8080 System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device provides "ceiling mounted overhead physical support for anaesthesia machines, medical/surgical monitoring and related equipment, storage space, dispensing of medical gases and electrical power required in clinical settings, emergency rooms, intensive care, procedure rooms and operating rooms." This describes a piece of equipment used to physically support and supply other medical devices and utilities within a clinical environment.
- Device Description: The description details the physical components of the system, such as ceiling fixtures, support systems, pendant heads, equipment carriers, gas outlets, electrical outlets, and support arms. These are all elements of a structural and utility delivery system, not a device that performs tests on biological samples.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
Therefore, the Drager DVE 8080 System is a piece of medical equipment used for infrastructure and support in clinical settings, not an IVD.
N/A
Intended Use / Indications for Use
8080 System is a piece of durable equipment The Drager DVE intended to provide ceiling mounted overhead physical support anaesthesia machines, medical/surgical monitoring and for and ceiling mounted related equipment, storage space, dispensing of medical gases and electrical power required in clinical settings, emergency rooms, intensive care, procedure rooms and operating rooms.
8080 will be used in the same indications as the DVE The DVE 4000 System and the DVE 8000/1/2 System and the Drager 8032E which provide physical support, storage space, and overhead,
ceiling mounted dispensing of medical gases and electrical The DVE 4000 has previously been reviewed by FDA power. (K921297). The Drager 8000/1/2 Series System and the combined DVE 8000/1/2 with DVE 4002 have been previously reviewed by FDA (K942043). The new DVE 8080 Series will be used in indications which are the same as indications for the DVE 4000, DVE 8000, for other pendant systems currently offered for DVE 8032E and commercial distribution in the United States.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
ALM Surgical Equipment Inc. will be the distributor of the Drager DVE 8080 Series in the United States. The DVE 8080 is manufactured by Dragerwerk, Aktiengesellschaft System Lubeck, Federal Republic of Germany.
The DVE 8080 Series System is a ceiling mounted overhead supply system of modular design. The individual components of any modular system are divided into four categories: ceiling fixture, support systems, pendant head or column, and equipment carrier.
The pendant column contains four terminal plates that can be outfitted according to the individual need with various outlets for gas supply, electricity, vacuum, communications, etc.
Add-on terminal boxes are available which allow the user the opportunity to meet individual equipment needs most efficiently. Add-on terminal boxes can be installed at the time of purchase or anytime afterwards.
The support system consists of either a fixed vertical support tube (DVE 8080 basic version of the series) or a single (DVE 8081) support arm or two (DVE 8082) support arms. The support arms are equipped with pneumatic brakes and are available in three combinable lengths.
The DVE 8080 Series System rotates laterally and is powered for up and down adjustment. The motor used in the DVE 8080 is an induction motor manufactured by Gefeg GmbH & Co KG. The differences between the DVE 8032E Series motor and the DVE 8080 Series motor are:
| DVE 8080 | DVE 8032E | |
|---|---|---|
| Rated voltage: | 190V/60Hz | 110V/60Hz |
| Rated Input: | 1.37A | 1.7A |
| Speed: | 3300 1/min | 103 1/min |
| P1: | 336W | 255W |
| Capacity: | - | 30u/400V |
| three-phase current | alternating current |
equipment shelf provides for better positioning of the The can be installed at time of medical devices required and purchase or added-on afterwards. Shelves are available in one standard size: 620 mm (width) by 400 mm.
Drager DVE 8080/81/82 Systems have been tested and The registered with Underwriters Laboratories (UL). All parts are Electrical accordance with the National Code. in ANSI/NFPA.
Maximum load-bearing capacities have been established for lengths of carrying arm combinations. possible numbers and These numbers have been derived from both UL testing and in-house testing.
The Drager DVE 8080 Series Systems can be used alone or in combination with the DVE 4000/1/2 Series System.
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
clinical settings, emergency rooms, intensive care, procedure rooms and operating rooms.
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Summary of Safety and Effectiveness
INTENDED USE
8080 System is a piece of durable equipment The Drager DVE intended to provide ceiling mounted overhead physical support anaesthesia machines, medical/surgical monitoring and for and ceiling mounted related equipment, storage space, dispensing of medical gases and electrical power required in clinical settings, emergency rooms, intensive care, procedure rooms and operating rooms.
8080 will be used in the same indications as the DVE The DVE 4000 System and the DVE 8000/1/2 System and the Drager 8032E which provide physical support, storage space, and overhead,
ceiling mounted dispensing of medical gases and electrical The DVE 4000 has previously been reviewed by FDA power. (K921297). The Drager 8000/1/2 Series System and the combined DVE 8000/1/2 with DVE 4002 have been previously reviewed by FDA (K942043). The new DVE 8080 Series will be used in indications which are the same as indications for the DVE 4000, DVE 8000, for other pendant systems currently offered for DVE 8032E and commercial distribution in the United States.
PRODUCT DESCRIPTION
ALM Surgical Equipment Inc. will be the distributor of the Drager DVE 8080 Series in the United States. The DVE 8080 is manufactured by Dragerwerk, Aktiengesellschaft System Lubeck, Federal Republic of Germany.
The DVE 8080 Series System is a ceiling mounted overhead supply system of modular design. The individual components of any modular system are divided into four categories: ceiling fixture, support systems, pendant head or column, and equipment carrier.
The pendant column contains four terminal plates that can be outfitted according to the individual need with various outlets for gas supply, electricity, vacuum, communications, etc.
Add-on terminal boxes are available which allow the user the opportunity to meet individual equipment needs most efficiently. Add-on terminal boxes can be installed at the time of purchase or anytime afterwards.
1
The support system consists of either a fixed vertical support tube (DVE 8080 basic version of the series) or a single (DVE 8081) support arm or two (DVE 8082) support arms. The support arms are equipped with pneumatic brakes and are available in three combinable lengths.
The DVE 8080 Series System rotates laterally and is powered for up and down adjustment. The motor used in the DVE 8080 is an induction motor manufactured by Gefeg GmbH & Co KG. The differences between the DVE 8032E Series motor and the DVE 8080 Series motor are:
| DVE 8080 | DVE 8032E | |
|---|---|---|
| Rated voltage: | 190V/60Hz | 110V/60Hz |
| Rated Input: | 1.37A | 1.7A |
| Speed: | 3300 1/min | 103 1/min |
| P1: | 336W | 255W |
| Capacity: | - | 30u/400V |
| three-phase current | alternating current |
equipment shelf provides for better positioning of the The can be installed at time of medical devices required and purchase or added-on afterwards. Shelves are available in one standard size: 620 mm (width) by 400 mm.
Drager DVE 8080/81/82 Systems have been tested and The registered with Underwriters Laboratories (UL). All parts are Electrical accordance with the National Code. in ANSI/NFPA.
Maximum load-bearing capacities have been established for lengths of carrying arm combinations. possible numbers and These numbers have been derived from both UL testing and in-house testing.
The Drager DVE 8080 Series Systems can be used alone or in combination with the DVE 4000/1/2 Series System.
RATIONALE FOR SUBSTANTIAL EQUIVALENCE
The Drager DVE 8080 Series System is substantially equivalent in materials, design, and function to pre-enactment devices of similar intended use, as well as to other pendant anaesthesia monitoring support systems currently in commercial supply and distribution in the United States.
2
The Drager DVE 8080 Series is substantially equivalent to:
-
- The DVE 8031/2 Series (K921297) and,
-
- The DVE 8032E Series (powered for vertical adjustment) (K942043)
- The AMSCO Ceiling Mounted Surgical ORBITER System, 3)
-
- The Heraeus Hanauport 810 Universal Ceiling Column
All of these systems are ceiling mounted pendant systems
intended to provide overhead support for anaesthesia machines, medical/surgical monitoring and related equipment and to provide physical support for ceiling mounted dispensing equipment of medical gases and electrical power.
All of these systems are modular in design to allow for maximum flexibility in meeting the needs of individual users and sites.
The main differences between the DVE 8080 Series System and the DVE 8032E Series System are:
- The position of the motor is changed. 1) The 8032E motor is between the end of the first arm and the beginning of the second arm. The 8080 system motor is located directly above the pendant column.
- The weight load capacity of the DVE 8080 Series (250 kg) 2) is larger than the weight load capacity of the 8032E (70 kg) .
The following charts provide a comparison of features of the DVE 8080 system to two other similar commercially marketed systems.
Table I compares the features of the DVE 8080 Series System to comparable motorized, vertically adjustable DVE 8032E the System.
Table II compares the features of the DVE 8080 Series System to the comparable motorized, vertically adjustable ORBITER system for commercial distribution by AMSCO in the United offered States.
3
TABLE I
DVE 8080
Marketed By
Intended Use
Components
ALM Surgical
Support for Medical Equipment, Storage, Electrical and Gas Support for Equipment
Factory Installed Add-ons (prefabrication)
Vertical Support Tube 2 Arms (single or double) 2 Arms (single or doubl Pendant Column Ceiling Fixture
Features and Technical 48 pre-installed Specifications
medical gas outlets and/or electrical receptacles in any combinations and of any manufacturer.
Quick connect or D.I.S.S. outlets. Hospital grade electrical receptacles.
Fully Rotational, Fully Articulated Or Fixed Height
Pendant Column
3 Combinable Lengths For Support Arms
Motor
Compatible Inserts
190 v, 60 Hz
Any Manufacturer, Including Chemetron, Puritan Bennett, Ohio Med. Prod., Oxyquip.
Allowed Vertical Movement
23.6 inches
ches
DVE 8032E
ALM Surgical
Support for Medical Equipment, Storage, Electrical and Gas Support for Equipment
Factory Installed Add-ons (prefabrication)
Vertical Support Tube Pendant Column Ceiling Fixture
24 pre-installed medical gas outlets and/or electrical receptacles in any combinations and of any manufacturer.
Quick connect or D.I.S.S. outlets. Hospital grade electrical receptacles.
Fully Rotational, Fully Articulated Or Fixed Height
Pendant Column
3 Combinable Lengths For Support Arms
110 v, 60 Hz
Any Manufacturer, Including Chemetron, Puritan Bennett, Ohio Med. Prod., Oxyquip.
23.6 inches
4
Table II
| DVE 8080 | ORBITER | |
|---|---|---|
| Marketed By | ALM Surgical | AMSCO |
| Intended Use | Structural Support for | |
| Medical, Electrical | ||
| and Gas Equipment. | ||
| Conduit for Wires, Hose. | Support for Medical | |
| Equipment, Storage, | ||
| Electrical and Gas | ||
| Support for Equipment | ||
| Components | Factory Installed | |
| Add-ons or Site | ||
| Installed | Factory Installed | |
| Add-ons | ||
| (prefabrication) | ||
| Vertical Support Tube | ||
| 2 Arms (single or double) | ||
| Pendant Column | ||
| Ceiling Fixture | Vertical Support Tube | |
| Arm (single or double) | ||
| Pendant Column | ||
| Ceiling Fixture | ||
| Features and Technical | ||
| Specifications | 48 pre-installed | |
| medical gas outlets | ||
| and/or electrical | ||
| receptacles in any | ||
| combinations and of | ||
| any manufacturer. | 12 pre-installed | |
| medical gas outlets | ||
| and/or electrical | ||
| receptacles in any | ||
| combinations and of | ||
| any manufacturer. | ||
| Quick connect or | ||
| D.I.S.S. outlets. | ||
| Hospital grade | ||
| electrical receptacles. | Quick connect or | |
| D.I.S.S. outlets. | ||
| Hospital grade | ||
| electrical receptacles. | ||
| Fully Rotational, | ||
| Fully Articulated | ||
| Height Adjustable | Fully Rotational, | |
| Fully Articulated | ||
| Height Adjustable | ||
| Pendant Column | ||
| or Head | ||
| 3 Combinable Lengths | ||
| For Support Arms | Variable Lengths, | |
| 24 to 34 inches | ||
| 3 Combinable Lengths | ||
| Premarket Notification | ||
| K831086 | ||
| Compatible Inserts | Any Manufacturer, | |
| Including Chemetron, | ||
| Puritan Bennett, Ohio | ||
| Med. Prod., Oxyquip. | Any Manufacturer, | |
| Including Chemetron, | ||
| Puritan Bennett, Ohio | ||
| Med. Prod., Oxyquip. | ||
| Motor | 190 v, 60 Hz | |
| Allowed Vertical | ||
| Movement | 23.6 inches | 28 inches |
......