(235 days)
Not Found
No
The summary describes a mechanical headrest system for surgical positioning and imaging compatibility. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML. The testing focuses on mechanical and imaging compatibility properties.
No
The device is a mechanical support system used for cranial stabilization during surgery, not a therapeutic device that treats or cures a medical condition.
No
This device is a mechanical support system used for cranial stabilization and positioning during surgery, particularly when intra-operative imaging is used. It does not perform any diagnostic functions like detecting, analyzing, or interpreting medical conditions or diseases.
No
The device description explicitly lists physical components such as Skull Clamp, Skull Pins, Parallelogram Adaptor, and Headplate, and the performance studies focus on the mechanical and material properties of these components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes a mechanical support system for cranial and spine surgery, providing rigid skeletal fixation or noninvasive head positioning/stabilization during surgery, especially when intra-operative imaging is used. This is a surgical device, not a diagnostic one.
- Device Description: The description details the physical components of a headrest system used for positioning a patient's head during neurosurgery. This aligns with a surgical support device.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Input Imaging Modality: While the device is designed to be compatible with various imaging modalities (MR, CT, X-Ray, Angiography), it is not performing the imaging or analyzing the images for diagnostic purposes. It is a physical support system used in conjunction with imaging.
- Performance Studies: The performance studies focus on the mechanical integrity, compatibility with imaging systems (ensuring it doesn't interfere), and biocompatibility of the device itself. There are no studies related to diagnostic accuracy, sensitivity, specificity, etc., which are typical for IVDs.
In summary, the DORO LUCENT Headrest System is a surgical support device designed to facilitate procedures and imaging during cranial and spine surgery. It does not perform any in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The DORO LUCENT radiolucent/MRI Compatible Headrest System with Skull Pins are components of a mechanical support system, which is used in cranial and spine surgery when rigid skeletal fixation is required for cranial stabilization and when intra-operative imaging is used.
The DORO LUCENT radiolucent/MRI Compatible Headrest System with noninvasive head positioning or noninvasive cranial stabilization device are components of a mechanical support system, which is used in cranial and spine surgery when noninvasive head positioning or noninvasive cranial stabilization is required and when intra-operative imaging is used.
The DORO LUCENT Headrest System provides an interface for accessories like retractor systems, navigation adaptors or other items.
Product codes
HBL
Device Description
The DORO LUCENT® iXI and iMRI Headrest System ensures an adequate positioning of a patient's head for neurosurgery. Additional intra-operative imaging can be performed.
The DORO LUCENT® iXI and iMRI Headrest System consists of the following: Skull Clamp, Skull Pins, Parallelogram Adaptor and Headplate. The Parallelogram Adaptor is used to connect the Skull Clamp (including Skull Pins) or the Headplate to the OR-Table/ Transfer Board.
Additional accessories like the Adjusting wrench and Transfer Collision Indicator supports the performance of the Headrest System.
These special Headrest Systems are developed for selected OR-Table/ MRI scanner combinations. They are separated in following sets:
- . 4003.200 DORO LUCENT® Headrest System TRUMPF for SIEMENS Aera/Skyra MRI Systems
- 4003.300 DORO LUCENT® iMRI Headrest System MAQUET for SIEMENS/PHILIPS/GE ●
- . 4003.500 DORO LUCENT® iXI Headrest System
By the use of the Navigation Adaptors the performance of the Headrest System is supplemented. The intra-operative navigation is feasible because of the provided interface to the navigation device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MR-, CT-, X-Ray- and Angiography-Imaging
Anatomical Site
cranial and spine
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
The devices have been tested as a system and single device.
DORO LUCENT® iXI and iMRI Headrest System
- Static load: Pass - The System supports the static load plus the additional safety factor without mechanical failure.
- MR-Compatibility: Pass - The system is MR compatible as it does not impair the function of the MRI system.
- CT/Angio-Compatibility: Pass - The system is CT/Angio compatible, as there wasn't any new or additional shadowing on the image.
- X-Ray-Compatibility: Pass - The system is X-Ray compatible, as there wasn't any new or additional shadowing on the image.
DORO LUCENT® Skull Clamp
- Static load (Latching teeth mechanism): Pass - The interface must withstand the static load over the defined duration without damage or malfunction.
- Torque (Rocker Arm): Pass - The Rocker Arm must withstand the torque without damaging, opening or malfunction of the Open-Lock mechanism.
DORO LUCENT® Skull Pins
- Mechanical stability (scratch test): Pass - The Skull Pin withstands an applied radial force when an axial force is applied.
- MR-Compatibility: Pass - The item is MR conditional.
- Sterility: Pass - The tests show that the item is packaged sterile and stays sterile for the shelf life.
- Biocompatibility: Pass - The item is biocompatible.
DORO LUCENT® Headplate
- Static load: Pass - The Headplate supports the static load plus safety factor without mechanical failure.
- Biocompatibility: Pass - The item is biocompatible.
Testing confirmed that the performance of the DORO LUCENT® iXI and iMRI Headrest System meets the product specification of the device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.4460 Neurosurgical head holder (skull clamp).
(a)
Identification. A neurosurgical head holder (skull clamp) is a device used to clamp the patient's skull to hold head and neck in a particular position during surgical procedures.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Pro Med Instruments GmbH Sandra Untenberger Regulatory Affairs Manager Boetzinger Str. 38 Freiburg, 79111 DE
Re: K191740
Trade/Device Name: DORO LUCENT iXI and iMRI Headrest System Regulation Number: 21 CFR 882.4460 Regulation Name: Neurosurgical Head Holder (Skull Clamp) Regulatory Class: Class II Product Code: HBL Dated: January 17, 2020 Received: January 22, 2020
Dear Sandra Untenberger:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance)and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For Matthew Krueger Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K191740
Device Name
DORO LUCENT® iXI and iMRI Headrest System
Indications for Use (Describe)
The DORO LUCENT radiolucent/MRI Compatible Headrest System with Skull Pins are components of a mechanical support system, which is used in cranial and spine surgery when rigid skeletal fixation is required for cranial stabilization and when intra-operative imaging is used.
The DORO LUCENT radiolucent/MRI Compatible Headrest System with noninvasive head positioning or noninvasive cranial stabilization device are components of a mechanical support system, which is used in cranial and spine surgery when noninvasive head positioning or noninvasive cranial stabilization is required and when intra-operative imaging is used.
The DORO LUCENT Headrest System provides an interface for accessories like retractor systems, navigation adaptors or other items.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/2 description: The image shows the logo for "pro med instruments". The logo is in blue and consists of the letters "pmi" in a stylized font. The "p" is lowercase and has a curved shape. The "m" and "i" are also lowercase and connected. Above the "mi" is a blue circle. To the right of the "p" is the text "pro med instruments" in a smaller font.
| DATE OF APPLICATION: | 14.05.2019 |
|---|---|
| APPLICANT: | pro med instruments GmbH |
| Bötzinger Straße 38 | |
| 79111 Freiburg im Breisgau | |
| Germany | |
| Tel: +49 (0) 761 384 222 10 | |
| Fax: +49 (0) 761 384 222 81 | |
| E-Mail: pmi@pmisurgical.com |
CONTACT PERSON:
Name: Sandra Untenberger Position: Regulatory Affairs Tel.: +49 761 384 222 45 E-Mail: ra@pmisurgical.com
4
Image /page/4/Picture/2 description: The image shows the logo for Pro Med Instruments. The logo is primarily blue and features a stylized letter 'p' connected to the letters 'mi'. To the right of the 'mi' is the text 'pro med instruments' in a smaller, sans-serif font. The overall design is modern and clean.
1 Device Name
| Trade Name: | DORO LUCENT® iXI and iMRI Headrest System |
|---|---|
| Common Name: | Neurosurgical Head Holder (Skull Clamp) |
| Device Classification Name: | Holder, head, neurosurgical (Skull Clamp) |
Classification / Product Code 2
DORO LUCENT® iXI and iMRI Headrest System can be classified according to following device name and product code:
| Device | Regulation
Description | Regulation
Medical
Specialty | Review
Panel | Product
Code | Regulation
Number | Device
Classification |
|-------------------------------------------------|-----------------------------------------------|------------------------------------|-----------------|-----------------|----------------------|--------------------------|
| Holder, head,
neurosurgical
(Skull Clamp) | Neurosurgical
head holder
(Skull Clamp) | Neurology | Neurology | HBL | 882.44602 | 2 |
Predicate Device / Reference Device က
| Device | Predicate Device | 510(k)
Number | 510(k) Holder |
|-------------------------------------------------|-------------------------------------------------------------------------------|------------------|--------------------------|
| DORO LUCENT® iXI
and iMRI Headrest
System | DORO RADIOLUCENT HEADREST
SYSTEM ( ALSO MRI-
COMPATIBLE) AND COMPONENTS | K063494 | pro med instruments GmbH |
ব Device Description
The DORO LUCENT® iXI and iMRI Headrest System ensures an adequate positioning of a patient's head for neurosurgery. Additional intra-operative imaging can be performed.
The DORO LUCENT® iXI and iMRI Headrest System consists of the following: Skull Clamp, Skull Pins, Parallelogram Adaptor and Headplate. The Parallelogram Adaptor is used to connect the Skull Clamp (including Skull Pins) or the Headplate to the OR-Table/ Transfer Board.
Additional accessories like the Adjusting wrench and Transfer Collision Indicator supports the performance of the Headrest System.
These special Headrest Systems are developed for selected OR-Table/ MRI scanner combinations. They are separated in following sets:
- . 4003.200 DORO LUCENT® Headrest System TRUMPF for SIEMENS Aera/Skyra MRI Systems
- 4003.300 DORO LUCENT® iMRI Headrest System MAQUET for SIEMENS/PHILIPS/GE ●
- . 4003.500 DORO LUCENT® iXI Headrest System
By the use of the Navigation Adaptors the performance of the Headrest System is supplemented. The intra-operative navigation is feasible because of the provided interface to the navigation device.
5
Image /page/5/Picture/2 description: The image shows the logo for "pro med instruments". The logo is in blue and consists of the letters "pmi" in a stylized font. The letters "pro med instruments" are written in a smaller font to the right of the letters "pmi".
5 Intended Use
The DORO LUCENT radiolucent/MRI Compatible Headrest System with Skull Pins are components of a mechanical support system, which is used in cranial and spine surgery when rigid skeletal fixation is required for cranial stabilization and when intra-operative imaging is used.
The DORO LUCENT radiolucent/MRI Compatible Headrest System with noninvasive head positioning or noninvasive cranial stabilization device are components of a mechanical support system, which is used in cranial and spine surgery when noninvasive head positioning or noninvasive cranial stabilization is required and when intra-operative imaging is used.
The DORO LUCENT Headrest System provides an interface for accessories like retractor systems, navigation adaptors or other items.
Technological Characteristics 6
The Technological Characteristics of DORO LUCENT® iXI and iMRI Headrest System are the same as the Technological Characteristics of the predicate device.
| | pro med instruments GmbH
DORO LUCENT® iXI and iMRI Headrest
System
(New Device) | pro med instruments GmbH
DORO RADIOLUCENT HEADREST SYSTEM
(ALSO MRI-COMPATIBLE) AND
COMPONENTS
(Predicate Device) |
|-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | DORO LUCENT® iXI and iMRI Headrest
System | DORO RADIOLUCENT HEADREST SYSTEM
(ALSO MRI-COMPATIBLE) AND
COMPONENTS |
| Regulation
Number | 882.4460 | 882.4460 |
| Class | 2 | 2 |
| Code | HBL | HBL |
| 510(k)
number | --- | K063494 |
| | pro med instruments GmbH | pro med instruments GmbH |
| | DORO LUCENT® iXI and iMRI Headrest
System
(New Device) | DORO RADIOLUCENT HEADREST SYSTEM
( ALSO MRI-COMPATIBLE) AND
COMPONENTS
(Predicate Device) |
| Indication
for use | The DORO LUCENT radiolucent/MRI
Compatible Headrest System with Skull Pins
are components of a mechanical support
system, which is used in cranial and spine
surgery when rigid skeletal fixation is required
for cranial stabilization and when intra-
operative imaging is used.
The DORO LUCENT radiolucent/MRI
Compatible Headrest System with noninvasive
head positioning or noninvasive cranial
stabilization device are components of a
mechanical support system, which is used in
cranial and spine surgery when noninvasive
head positioning or noninvasive cranial
stabilization is required and when intra-
operative imaging is used.
The DORO LUCENT Headrest System provides
an interface for accessories like retractor
systems, navigation adaptors or other items. | The Radiolucent/ MRI Compatible Skull
Clamp Headrest System with Skull Pins
The DORO® Radiolucent/ MRI Compatible
Skull Clamp Headrest System with Skull Pins
are components of a mechanical support
system which is used in head and neck
surgery when rigid skeletal fixation is required
for cranial stabilization and when
intra-operative CT or MR Imaging is used.
The Radiolucent/ MRI Compatible
Horseshoe Headrest System
The DORO® Radiolucent/ MRI Compatible
Horseshoe Headrest System are components
of a mechanical support system which is used
in head and neck surgery when non-invasive
head support is required and when intra-
operative CT or MR Imaging is used.
The Radiolucent/ MRI Compatible Halo
System
The DORO® Radiolucent/ MRI Compatible
Halo System is a system of radiolucent halo
rings of varying size and styles that may be
used in neurosurgical applications as an arm
rest during head and neck surgery when
intra-operative CT or MR Imaging is required. |
| Principles of
operation | Mechanical support system | Mechanical support system |
| Method of
cranial
stabilization | Rigid skeletal fixation or noninvasive
stabilization | Rigid skeletal fixation or secured noninvasive
stabilization |
| Method of
cranial
fixation | Three-point fixation in prone, supine or lateral
position | Three-point fixation in prone, supine, lateral
or sitting position |
| Method of
noninvasive
stabilization | Pad for prone or supine positioning | Non-invasive gel pad for prone or supine
positioning |
| Intraoperati
ve imaging | MR-, CT-, X-Ray- and Angiography-Imaging | MR-, CT- and X-Ray Imaging |
| reprocessing | Manual cleaning and disinfection between
uses;
single-use pins | Manual cleaning and disinfection between
uses;
single-use pins |
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Image /page/6/Picture/2 description: The image shows the logo for "pro med instruments". The logo is in blue and consists of the letters "p", "m", and "i". The letters are stylized and connected to each other. The words "pro med instruments" are written in a smaller font to the right of the letters.
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Image /page/7/Picture/2 description: The image shows the logo for "pro med instruments". The logo is in blue and features the letters "pmi" in a stylized font. The words "pro med instruments" are written in a smaller font to the right of the letters "pmi".
| | pro med instruments GmbH
DORO LUCENT® iXI and iMRI
Headrest System
(New Device) | pro med instruments GmbH
DORO RADIOLUCENT HEADREST
SYSTEM ( ALSO MRI-
COMPATIBLE) AND
COMPONENTS
(Predicate Device) |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | DORO® Skull Clamp radiolucent
for DORO LUCENT®
Parallelogram Adaptors | DORO® Skull Clamp Radiolucent |
| Sterility | Nonsterile | Nonsterile |
| Type of head fixation | 3 point fixation | 3 point fixation |
| Shape/ general design | U-shape | U-shape |
| Adjustment for various head
sizes | Extension assembly is adjustable | Extension assembly is adjustable |
| Clamping force | Max. 360 N/ 80 lbs | Max. 360 N/ 80 lbs |
| Load range | Max. 12.5 kg/ 27.5 lbs | Max. 12.5 kg/ 27.5 lbs |
| Interface for accessories | Quick-Rail® | Quick-Rail® |
| Imaging modality | radiolucent,
MR conditional (≤ 3T) | radiolucent,
MR safe |
| Patient contact components/
materials | None | None |
| Materials: | polymers, glass, composites, metal
coating | polymers, composites |
| | | |
| | DORO LUCENT® Headplate | DORO® Adult Horsehoe
Headrest Radiolucent without
Extension bar
combined with
DORO® Horseshoe Gel Pads
(left & right) |
| Sterility | Nonsterile | Nonsterile |
| Type of head fixation | Noninvasive | Noninvasive |
| Shape/ general design | Headplate base plate with foam pad | Horseshoe shaped base with gel-
pads |
| Load range | Max. 12.5 kg/ 27.5 lbs | Max. 12.5 kg/ 27.5 lbs |
| Imaging modality | radiolucent,
MR conditional (≤ 3T) | radiolucent,
MR safe |
| Materials: | Polymers, composites | Polymers |
| | | |
| | DORO LUCENT® Disposable
Skull Pins, Adult, sterile | DORO® Radiolucent Disposable
Skull Pins, Ceramic, Adult |
| Sterility | SAL 10-6 by gamma radiation | SAL 10-6 by ethylene oxide |
| Frequency of use | Single use | Single use |
| Packaging | Sterile blister pack | Sterile blister pack |
| Shape/ general design | Pin tip injected with plastic | Pin tip injected with plastic |
| Imaging modality | radiolucent,
MR conditional (≤ 3T, SAR≤
4W/kg) | radiolucent,
MR safe |
| Materials: | Polymers, composites | Polymers |
| | DORO LUCENT® Parallelogram
Adaptor Trumpf for Siemens
Aera/Skyra MRI systems | DORO® Swivel Adaptor
Radiolucent
combined with
DORO® Transitional Member
Radiolucent (short and/or long) |
| Sterility | Nonsterile | Nonsterile |
| Shape/ general design | A device that interfaces to the Skull
Clamp on one side and the Transfer
Board on the other, which is fixed
to the OR-Table. The joint system
in the parallelogram design
combined with the joint for height
adjustment, allows for the
positioning adjustment in all
degrees of freedom. | Different rods with interfaces to the
Skull Clamp on one side and the
OR-Table on the other side. The
rods are connected with screws,
wherein the positioning adjustment
can be realized. The Swivel Adaptor
is rotatable in his length axis. |
| Flexibility/ degrees of freedom | Linear axis (x): cranial/caudal-
direction
Linear axis (y): Lateral
Linear axis (z): upwards/
downwards
Rotation axes: around x-, y- and z-
axis | Linear axis (x): cranial/caudal-
direction
Linear axis (y): Lateral
Linear axis (z): upwards/
downwards
Rotation axes: around x-, y- and z-
axis |
| Load range | 12.5 kg/ 27.5 lbs | 12.5 kg/ 27.5 lbs |
| Interface OR-table | 6 screws (M8) for attaching the
adaptor on the Transfer Board
(Trumpf OR-Table) | Starburst with screw (M16) |
| Interface Skull Clamp/ Head
plate | Starburst with thread (M16) | Starburst with screw (M16) |
| Imaging modality | radiolucent,
MR conditional (≤ 3T) | radiolucent,
MR safe |
| Materials: | Polymers, composites, metal | Polymers, composite |
| | | |
| | DORO LUCENT® iMRI
Parallelogram Adaptor Maquet | DORO® Swivel Adaptor
Radiolucent
combined with
DORO® Transitional Member
Radiolucent (short and/or long) |
| Sterility | Nonsterile | Nonsterile |
| Shape/ general design | A device that interfaces to the Skull
Clamp on one side and the Transfer
Board on the other, which is fixed
to the OR-Table. The joint system
in the parallelogram design
combined with the joint for height
adjustment, allows for the
positioning adjustment in all
degrees of freedom. | Different rods with interfaces to the
Skull Clamp on one side and the
OR-Table on the other side. The
rods are connected with screws,
wherein the positioning adjustment
can be realized. The Swivel Adaptor
is rotatable in his length axis. |
| Flexibility/ degrees of freedom | Linear axis (x): cranial/caudal-
direction
Linear axis (y): Lateral
Linear axis (z): upwards/
downwards
Rotation axes: around x-, y- and z-
axis | Linear axis (x): cranial/caudal-
direction
Linear axis (y): Lateral
Linear axis (z): upwards/
downwards
Rotation axes: around x-, y- and z-
axis |
| Load range | 12.5 kg/ 27.5 lbs | 12.5 kg/ 27.5 lbs |
| Interface OR-table | 4 screws (M18) for attaching the
adaptor on the Transfer Board
(Maquet OR-Table) | Starburst with screw (M16) |
| Interface Skull Clamp/ Head
plate | Starburst with thread (M16) | Starburst with screw (M16) |
| Imaging modality | radiolucent,
MR safe | radiolucent,
MR safe |
| Materials: | Polymers, composites | Polymers, composites |
| | DORO LUCENT® IXI
Parallelogram Adaptor Maquet | DORO® Swivel Adaptor
Radiolucent
combined with
DORO® Transitional Member
Radiolucent (short and/or long) |
| Sterility | Nonsterile | Nonsterile |
| Shape/ general design | A device that interfaces to the Skull
Clamp on one side and the Transfer
Board on the other, which is fixed
to the OR-Table. The joint system
in the parallelogram design
combined with the joint for height
adjustment, allows for the
positioning adjustment in alldegrees of freedom. | Different rods with interfaces to the
Skull Clamp on one side and the
OR-Table on the other side. The
rods are connected with screws,
wherein the positioning adjustment
can be realized. The Swivel Adaptor
is rotatable in his length axis. |
| Flexibility/ degrees of freedom | Linear axis (x): cranial/caudal-
direction
Linear axis (y): Lateral
Linear axis (z): upwards/
downwards
Rotation axes: around x-, y- and z-
axis | Linear axis (x): cranial/caudal-
direction
Linear axis (y): Lateral
Linear axis (z): upwards/
downwards
Rotation axes: around x-, y- and z-
axis |
| Load range | 11 kg/ 24.25 lbs | 12.5 kg/ 27.5 lbs |
| Interface OR-table | Slim plate with lateral rails to insert
the adaptor in the Transfer Board
(Maquet OR-Table) and clamping
mechanism to protect pulling out
the adaptor. | Starburst with screw (M16) |
| Interface Skull Clamp/ Head
plate | Starburst with thread (M16) | Starburst with screw (M16) |
| Imaging modality | radiolucent,
MR safe | radiolucent,
MR safe |
| Materials | Polymers, composites | Polymers, composites |
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Image /page/8/Picture/2 description: The image shows the logo for "pro med instruments". The logo is primarily blue. The letters "pmi" are stacked on top of each other on the left side of the logo, with the words "pro med instruments" written in a smaller font to the right of the letters.
9
Image /page/9/Picture/2 description: The image shows the logo for Pro Med Instruments. The logo is primarily blue and features a stylized lowercase 'p' that transitions into the letters 'mi'. To the right of the 'mi' is the text 'pro med instruments' in a smaller font size.
10
Image /page/10/Picture/2 description: The image shows the logo for Pro Med Instruments. The logo is primarily blue and features the letters 'pmi' in a stylized font. The 'p' is lowercase and has a curved shape, while the 'm' and 'i' are connected and slightly smaller, positioned above the words 'pro med instruments' in a smaller, sans-serif font. A blue circle is positioned above the 'i'.
6.1 Summary of Technological Characteristics
The above listed Technological Characteristics show that the DORO LUCENT® iXI and iMRI Headrest System, and the DORO Radiolucent Headrest System (also MRI-compatible) and components are substantially equivalent. Therefore safety and effectiveness can be ensured for these items.
7 Performance Data
The devices have been tested as a system and single device. Tests were performed and the results are shown in the table below.
| Test | Result |
|---|---|
| DORO LUCENT® iXI and iMRI Headrest System | |
| Static load | |
| Verifies the ability of the system to sustain a | |
| certain load with an additional safety factor. | Pass |
| The System supports the static load plus the | |
| additional safety factor without mechanical failure. | |
| MR-Compatibility | |
| Verifies the MR- Compatibility of the system. | Pass |
| The system is MR compatible as it does not impair | |
| the function of the MRI system. | |
| CT/Angio-Compatibility | |
| Verifies the CT/Angio- Compatibility of the | |
| system. | Pass |
| The system is CT/Angio compatible, as there | |
| wasn't any new or additional shadowing on the | |
| image. | |
| X-Ray-Compatibility | |
| Verifies the X-Ray- Compatibility of the system. | Pass |
| The system is X-Ray compatible, as there wasn't | |
| any new or additional shadowing on the image. | |
| DORO LUCENT® Skull Clamp | |
| Static load (Latching teeth mechanism) | |
| Verifies the ability of the Skull Clamp to sustain a | |
| certain load with an additional safety factor. | Pass |
| The interface must withstand the static load over | |
| the defined duration without damage or | |
| malfunction. | |
| Torque (Rocker Arm) | |
| Verifies the ability of the skull clamp to resist | |
| applied torque while in use. | Pass |
| The Rocker Arm must withstand the torque | |
| without damaging, opening or malfunction of the | |
| Open-Lock mechanism. | |
| DORO LUCENT® Skull Pins | |
| Mechanical stability (scratch test) | |
| Verifies the mechanical shear stability of the Skull | |
| Pin. | Pass |
| The Skull Pin withstands an applied radial force | |
| when an axial force is applied. | |
| MR-Compatibility | |
| Verifies the MR- Compatibility of the pin. | Pass |
| The item is MR conditional. | |
| Sterility | |
| Verifies the sterility of the pin. | Pass |
| The tests show that the item is packaged sterile | |
| and stays sterile for the shelf life. | |
| Biocompatibility | |
| Verifies the biocompatibility of the pin. | Pass |
| The item is biocompatible. | |
| DORO LUCENT® Headplate | |
| Static load | |
| Verifies the ability of the Headplate to sustain a | |
| certain load with an additional safety factor. | Pass |
| The Headplate supports the static load plus safety | |
| factor without mechanical failure. | |
| Biocompatibility | |
| Verifies the biocompatibility of the Headplate. | Pass |
| The item is biocompatible. |
11
Image /page/11/Picture/2 description: The image shows the logo for "pro med instruments". The logo is in blue and consists of the letters "pmi" in a stylized font. The words "pro med instruments" are written in a smaller font to the right of the letters "pmi". The logo is simple and modern.
Testing confirmed that the performance of the DORO LUCENT® iXI and iMRI Headrest System meets the product specification of the device.
Substantial Equivalence Summary / Conclusion 8
The DORO LUCENT® iXI and iMRI Headrest System and components are used as support to stabilize a patient's head during neurosurgical operative procedures.
device is comparable in design, construction, intended use and performance This characteristics to the predicate devices.
Based on available 510(k) information herein provided, DORO LUCENT® iXI and iMRI Headrest System and components are considered substantially equivalent to the predicate device in terms of intended use, technology and performance specifications. There are no differences between the devices which may raise new issues concerning safety or effectiveness.