(235 days)
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 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.
The provided FDA 510(k) summary describes a medical device, the DORO LUCENT® iXI and iMRI Headrest System. This document focuses on the substantial equivalence of the new device to a predicate device rather than presenting a clinical study to evaluate diagnostic performance with a human-in-the-loop or standalone algorithm. Therefore, many of the requested criteria related to AI/algorithm performance and clinical study details are not applicable or not present in this submission.
Here's the information that can be extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally demonstrated through "Pass" results in various performance tests.
| Acceptance Criteria (Test) | Reported Device Performance |
|---|---|
| DORO LUCENT® iXI and iMRI Headrest System | |
| Static load: Ability to sustain a certain load with an additional safety factor. | Pass |
| MR-Compatibility: Does not impair the function of the MRI system. | Pass |
| CT/Angio-Compatibility: No new or additional shadowing on the image. | Pass |
| X-Ray-Compatibility: No new or additional shadowing on the image. | Pass |
| DORO LUCENT® Skull Clamp | |
| Static load (Latching teeth mechanism): Ability to sustain a certain load with an additional safety factor without damage/malfunction. | Pass |
| Torque (Rocker Arm): Ability to resist applied torque without damaging, opening, or malfunction of the Open-Lock mechanism. | Pass |
| DORO LUCENT® Skull Pins | |
| Mechanical stability (scratch test): Withstands an applied radial force when an axial force is applied. | Pass |
| MR-Compatibility: MR conditional. | Pass |
| Sterility: Packaged sterile and stays sterile for shelf life. | Pass |
| Biocompatibility: Biocompatible. | Pass |
| DORO LUCENT® Headplate | |
| Static load: Ability to sustain a certain load with an additional safety factor without mechanical failure. | Pass |
| Biocompatibility: Biocompatible. | Pass |
2. Sample size used for the test set and the data provenance
This is a physical medical device (headrest system), not an AI/software device. The "test set" here refers to the physical units of the device and its components undergoing engineering and materials testing. The document does not specify the exact number of units or components tested for each criterion. The provenance of the data is from pro med instruments GmbH, the manufacturer, and the tests were likely conducted internally or by accredited third-party labs. The study is a prospective testing of manufactured devices against pre-defined engineering and safety standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth for a physical device's performance often relates to instrumented measurements (e.g., force, torque, imaging artifacts) and material properties, not expert consensus as would be used for diagnostic imaging algorithms.
4. Adjudication method for the test set
Not applicable. Adjudication methods like "2+1" or "3+1" are used in clinical studies for diagnostic accuracy, where expert opinions need to be reconciled. For device performance testing, results are quantitative or pass/fail based on pre-defined specifications.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device.
7. The type of ground truth used
The ground truth for this device's performance is based on engineering specifications, material science, sterility standards, and regulatory requirements (e.g., MRI compatibility standards). For example, "MR-Compatibility" is verified against established standards for how metallic or non-metallic objects interact with MRI fields. "Static load" is verified against a specified weight with a safety factor.
8. The sample size for the training set
Not applicable. This is a physical medical device and does not involve AI/machine learning training sets.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for an AI algorithm, no ground truth needs to be established for it.
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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
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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
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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
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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 | RegulationDescription | RegulationMedicalSpecialty | ReviewPanel | ProductCode | RegulationNumber | DeviceClassification |
|---|---|---|---|---|---|---|
| Holder, head,neurosurgical(Skull Clamp) | Neurosurgicalhead 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® iXIand iMRI HeadrestSystem | DORO RADIOLUCENT HEADRESTSYSTEM ( 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.
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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 HeadrestSystem(New Device) | pro med instruments GmbH--DORO RADIOLUCENT HEADREST SYSTEM(ALSO MRI-COMPATIBLE) ANDCOMPONENTS(Predicate Device) | |
|---|---|---|
| Device Name | DORO LUCENT® iXI and iMRI HeadrestSystem | DORO RADIOLUCENT HEADREST SYSTEM(ALSO MRI-COMPATIBLE) ANDCOMPONENTS |
| RegulationNumber | 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 HeadrestSystem(New Device) | DORO RADIOLUCENT HEADREST SYSTEM( ALSO MRI-COMPATIBLE) ANDCOMPONENTS(Predicate Device) | |
| Indicationfor use | The DORO LUCENT radiolucent/MRICompatible Headrest System with Skull Pinsare components of a mechanical supportsystem, which is used in cranial and spinesurgery when rigid skeletal fixation is requiredfor cranial stabilization and when intra-operative imaging is used.The DORO LUCENT radiolucent/MRICompatible Headrest System with noninvasivehead positioning or noninvasive cranialstabilization device are components of amechanical support system, which is used incranial and spine surgery when noninvasivehead positioning or noninvasive cranialstabilization is required and when intra-operative imaging is used.The DORO LUCENT Headrest System providesan interface for accessories like retractorsystems, navigation adaptors or other items. | The Radiolucent/ MRI Compatible SkullClamp Headrest System with Skull PinsThe DORO® Radiolucent/ MRI CompatibleSkull Clamp Headrest System with Skull Pinsare components of a mechanical supportsystem which is used in head and necksurgery when rigid skeletal fixation is requiredfor cranial stabilization and whenintra-operative CT or MR Imaging is used.The Radiolucent/ MRI CompatibleHorseshoe Headrest SystemThe DORO® Radiolucent/ MRI CompatibleHorseshoe Headrest System are componentsof a mechanical support system which is usedin head and neck surgery when non-invasivehead support is required and when intra-operative CT or MR Imaging is used.The Radiolucent/ MRI Compatible HaloSystemThe DORO® Radiolucent/ MRI CompatibleHalo System is a system of radiolucent halorings of varying size and styles that may beused in neurosurgical applications as an armrest during head and neck surgery whenintra-operative CT or MR Imaging is required. |
| Principles ofoperation | Mechanical support system | Mechanical support system |
| Method ofcranialstabilization | Rigid skeletal fixation or noninvasivestabilization | Rigid skeletal fixation or secured noninvasivestabilization |
| Method ofcranialfixation | Three-point fixation in prone, supine or lateralposition | Three-point fixation in prone, supine, lateralor sitting position |
| Method ofnoninvasivestabilization | Pad for prone or supine positioning | Non-invasive gel pad for prone or supinepositioning |
| Intraoperative imaging | MR-, CT-, X-Ray- and Angiography-Imaging | MR-, CT- and X-Ray Imaging |
| reprocessing | Manual cleaning and disinfection betweenuses;single-use pins | Manual cleaning and disinfection betweenuses;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 iMRIHeadrest System(New Device) | pro med instruments GmbH--DORO RADIOLUCENT HEADRESTSYSTEM ( ALSO MRI-COMPATIBLE) ANDCOMPONENTS(Predicate Device) | |
|---|---|---|
| DORO® Skull Clamp radiolucentfor 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 headsizes | 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, metalcoating | polymers, composites |
| DORO LUCENT® Headplate | DORO® Adult HorsehoeHeadrest Radiolucent withoutExtension barcombined withDORO® 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® DisposableSkull Pins, Adult, sterile | DORO® Radiolucent DisposableSkull 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® ParallelogramAdaptor Trumpf for SiemensAera/Skyra MRI systems | DORO® Swivel AdaptorRadiolucentcombined withDORO® Transitional MemberRadiolucent (short and/or long) | |
| Sterility | Nonsterile | Nonsterile |
| Shape/ general design | A device that interfaces to the SkullClamp on one side and the TransferBoard on the other, which is fixedto the OR-Table. The joint systemin the parallelogram designcombined with the joint for heightadjustment, allows for thepositioning adjustment in alldegrees of freedom. | Different rods with interfaces to theSkull Clamp on one side and theOR-Table on the other side. Therods are connected with screws,wherein the positioning adjustmentcan be realized. The Swivel Adaptoris rotatable in his length axis. |
| Flexibility/ degrees of freedom | Linear axis (x): cranial/caudal-directionLinear axis (y): LateralLinear axis (z): upwards/downwardsRotation axes: around x-, y- and z-axis | Linear axis (x): cranial/caudal-directionLinear axis (y): LateralLinear axis (z): upwards/downwardsRotation 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 theadaptor on the Transfer Board(Trumpf OR-Table) | Starburst with screw (M16) |
| Interface Skull Clamp/ Headplate | 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® iMRIParallelogram Adaptor Maquet | DORO® Swivel AdaptorRadiolucentcombined withDORO® Transitional MemberRadiolucent (short and/or long) | |
| Sterility | Nonsterile | Nonsterile |
| Shape/ general design | A device that interfaces to the SkullClamp on one side and the TransferBoard on the other, which is fixedto the OR-Table. The joint systemin the parallelogram designcombined with the joint for heightadjustment, allows for thepositioning adjustment in alldegrees of freedom. | Different rods with interfaces to theSkull Clamp on one side and theOR-Table on the other side. Therods are connected with screws,wherein the positioning adjustmentcan be realized. The Swivel Adaptoris rotatable in his length axis. |
| Flexibility/ degrees of freedom | Linear axis (x): cranial/caudal-directionLinear axis (y): LateralLinear axis (z): upwards/downwardsRotation axes: around x-, y- and z-axis | Linear axis (x): cranial/caudal-directionLinear axis (y): LateralLinear axis (z): upwards/downwardsRotation 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 theadaptor on the Transfer Board(Maquet OR-Table) | Starburst with screw (M16) |
| Interface Skull Clamp/ Headplate | Starburst with thread (M16) | Starburst with screw (M16) |
| Imaging modality | radiolucent,MR safe | radiolucent,MR safe |
| Materials: | Polymers, composites | Polymers, composites |
| DORO LUCENT® IXIParallelogram Adaptor Maquet | DORO® Swivel AdaptorRadiolucentcombined withDORO® Transitional MemberRadiolucent (short and/or long) | |
| Sterility | Nonsterile | Nonsterile |
| Shape/ general design | A device that interfaces to the SkullClamp on one side and the TransferBoard on the other, which is fixedto the OR-Table. The joint systemin the parallelogram designcombined with the joint for heightadjustment, allows for thepositioning adjustment in alldegrees of freedom. | Different rods with interfaces to theSkull Clamp on one side and theOR-Table on the other side. Therods are connected with screws,wherein the positioning adjustmentcan be realized. The Swivel Adaptoris rotatable in his length axis. |
| Flexibility/ degrees of freedom | Linear axis (x): cranial/caudal-directionLinear axis (y): LateralLinear axis (z): upwards/downwardsRotation axes: around x-, y- and z-axis | Linear axis (x): cranial/caudal-directionLinear axis (y): LateralLinear axis (z): upwards/downwardsRotation 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 insertthe adaptor in the Transfer Board(Maquet OR-Table) and clampingmechanism to protect pulling outthe adaptor. | Starburst with screw (M16) |
| Interface Skull Clamp/ Headplate | 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.
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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.
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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 loadVerifies the ability of the system to sustain acertain load with an additional safety factor. | PassThe System supports the static load plus theadditional safety factor without mechanical failure. |
| MR-CompatibilityVerifies the MR- Compatibility of the system. | PassThe system is MR compatible as it does not impairthe function of the MRI system. |
| CT/Angio-CompatibilityVerifies the CT/Angio- Compatibility of thesystem. | PassThe system is CT/Angio compatible, as therewasn't any new or additional shadowing on theimage. |
| X-Ray-CompatibilityVerifies the X-Ray- Compatibility of the system. | PassThe system is X-Ray compatible, as there wasn'tany 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 acertain load with an additional safety factor. | PassThe interface must withstand the static load overthe defined duration without damage ormalfunction. |
| Torque (Rocker Arm)Verifies the ability of the skull clamp to resistapplied torque while in use. | PassThe Rocker Arm must withstand the torquewithout damaging, opening or malfunction of theOpen-Lock mechanism. |
| DORO LUCENT® Skull Pins | |
| Mechanical stability (scratch test)Verifies the mechanical shear stability of the SkullPin. | PassThe Skull Pin withstands an applied radial forcewhen an axial force is applied. |
| MR-CompatibilityVerifies the MR- Compatibility of the pin. | PassThe item is MR conditional. |
| SterilityVerifies the sterility of the pin. | PassThe tests show that the item is packaged sterileand stays sterile for the shelf life. |
| BiocompatibilityVerifies the biocompatibility of the pin. | PassThe item is biocompatible. |
| DORO LUCENT® Headplate | |
| Static loadVerifies the ability of the Headplate to sustain acertain load with an additional safety factor. | PassThe Headplate supports the static load plus safetyfactor without mechanical failure. |
| BiocompatibilityVerifies the biocompatibility of the Headplate. | PassThe item is biocompatible. |
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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.
§ 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).