(82 days)
The DORO LUCENT® Skull clamp is part of a mechanical support system, which is used during head or neck surgery. The product can be used in an intra-operative setting for CT and X-ray imaging.
The DORO LUCENT® Skull clamp Pediatric Set is part of a mechanical support system, which is used during head or neck surgery. The product can be used in an intra-operative setting for CT and X-ray imaging. The target patient population includes children over 5 years of age.
The DORO LUCENT® Skull Clamp ensures an adequate positioning of a patient's head and provides rigid fixation for neurosurgery. The device is suitable for intra-operative X-ray and CT based imaging procedures.
The DORO LUCENT® Skull Clamp consists of a fixed arm, an adjustable arm and modular pin holders. Thus, using the DORO LUCENT® Skull Clamp Pediatric Set, the skull clamp can be configured as three-pin or four-pin pediatric set up.
The provided text describes the 510(k) clearance for the DORO LUCENT® Skull Clamp and DORO LUCENT® Skull Clamp Pediatric Set. However, it does not contain information about a study based on AI/ML or any performance testing related to software or AI. The tests mentioned are for mechanical performance, usability, and reprocessing of the physical device.
Therefore, for aspects related to AI/ML device performance, such as sample size for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for training, the information is not available in the provided document.
Here's a breakdown of what is available based on the mechanical device performance testing:
Device: DORO LUCENT® Skull Clamp (1101.001) and DORO LUCENT® Skull Clamp Pediatric Set (1101.040)
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria / Benchmark (Implicit) | Reported Device Performance |
|---|---|---|
| Maximum Load Test (System Test) | The skull clamp must be capable of resisting the forces imposed by the patient and surgeon when in use and in locked position without movement in any connection, joint and/or plastic deformation. | Pass. The skull clamp is capable of withstanding the given force without movement in any connection, joint and/or plastic deformation. |
| Usability | The usability of the skull clamp must be given. | Pass. The usability of the skull clamp is given. |
| Static load (Latching teeth mechanism) | The skull clamp must be able to withstand a maximum static load for a given duration without signs of permanent deformation, fracture, or breakage. | Pass. The skull clamp withstands a static load for the given duration without signs of permanent deformation, fracture, or breakage. |
| Creep | The skull clamp must maintain the applied maximum force without a force deviation from the initially applied load by a defined value. | Pass. The skull clamp can maintain the applied maximum force without a force deviation from the initially applied load by a defined value. |
| Pin force accuracy | The skull clamp force delivery component must be verified at each force level throughout its range to deliver the stated force within the actual setting. | Pass. The skull clamp force delivery component is verified at each force level throughout its range to deliver the stated force within the actual setting. |
| Torque load resistance | The skull clamp must withstand a defined torque for a given amount of time without deformation or any structural failures. | Pass. The skull clamp withstands a defined torque for a given amount of time without deformation or any structural failures. |
| CT Evaluation | The skull clamp must produce fewer artifacts than the set benchmark for adequate imaging results. | Pass. The skull clamp produces fewer artifacts than the set benchmark as defined in the test report. |
| Reprocessing | Reprocessing must be validated according to specified standards (ANSI/AAMI ST98:2022, DIN EN ISO 17664-1:2021, DIN EN ISO 17664-2:2021, AAMI TIR 12: 2020) including accumulation of residue, cleaning effectiveness, and disinfection effectiveness. | Pass. The test data shows the reprocessing of DORO LUCENT® Skull Clamp is validated and a test report in support of the statement is provided. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated for each test. For mechanical/physical performance tests, the "sample size" typically refers to the number of units tested. The document indicates "Tests were performed and the results are shown in the table below," implying a sufficient number of tests were conducted to confirm performance.
- Data Provenance: Not specified in terms of country of origin or retrospective/prospective for these physical device tests. These are likely internal laboratory tests conducted by the manufacturer.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Not applicable. This device is a mechanical skull clamp, not an AI/ML diagnostic device requiring expert interpretation for ground truth. The "ground truth" for these tests is the physical measurement and observation of the device's performance against defined engineering and safety standards.
4. Adjudication Method for the Test Set:
- Not applicable. See point 3.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. This type of study is relevant for AI/ML diagnostic tools being compared to human performance, which is not the case for this mechanical device.
6. Standalone (Algorithm Only) Performance:
- Not applicable. There is no algorithm or software for standalone performance in this mechanical device.
7. Type of Ground Truth Used:
- Engineering and Safety Standards/Specifications: The ground truth for these tests is established by the device's design specifications and compliance with relevant industry standards (e.g., for mechanical strength, CT compatibility, and reprocessing).
8. Sample Size for the Training Set:
- Not applicable. This is a mechanical device, not an AI/ML product developed through a training process with a data set.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. See point 8.
{0}------------------------------------------------
April 24, 2024
Image /page/0/Picture/1 description: The image contains two logos. On the left is the Department of Health and Human Services logo. On the right is the Food and Drug Administration logo. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Pro Med Instruments GmbH Rabel Talpur Regulatory Affairs Specialist Bötzinger Straße 86 Freiburg, Baden-württemberg 79111 Germany
Re: K240319
Trade/Device Name: DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040) Regulation Number: 21 CFR 882.4460 Regulation Name: Neurosurgical Head Holder (Skull Clamp) Regulatory Class: Class II Product Code: HBL Dated: February 2, 2024 Received: February 2, 2024
Dear Rabel Talpur:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
{1}------------------------------------------------
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-emitting products, including information about labeling regulations, please see Device Advice (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.
Digitally signed by Adam D. Adam D. Pierce -S Date: 2024.04.24 Pierce -S 13:21:24 -04'00'
Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional
{2}------------------------------------------------
and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Indications for Use
510(k) Number (if known) K240319
Device Name DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040)
Indications for Use (Describe)
The DORO LUCENT Skull clamp is part of a mechanical support system, which is used during head or neck surgery. The product can be used in an intra-operative setting for CT and X-ray imaging.
The DORO LUCENT Skull clamp Pediatric Set is part of a mechanical support system, which is used during head or neck surgery. The product can be used in an intra-operative setting for CT and X-ray imaging. The target patient population includes children over 5 years of age.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{4}------------------------------------------------
510(k) Summary K240319
{5}------------------------------------------------
Device Information: 1
| Category | Comments |
|---|---|
| Sponsor: | pro med instruments GmbHBötzinger Straße 8679111 Freiburg im BreisgauGermanyTel: + 49 (0) 761 384 222 10Fax: +49 (0) 761 384 222 81E-Mail: regulatoryaffairs@blackforestmedical.com |
| Correspondent Contact Information | Name: Rabel TalpurPosition: Regulatory Affairs SpecialistTel.: + 49 (0) 761 384 222 67E-Mail: regulatoryaffairs@blackforestmedical.com |
| Device Common Name: | Neurosurgical head holder (skull clamp) |
| Device Regulation & Name | 882.4460, Neurosurgical head holder (skull clamp) |
| Classification & Product Code:510(K) Number: | Device Classification: IIProduct Code: HBL510(K) Number: K240319 |
| Device Proprietary Name: | DORO LUCENT® Skull Clamp |
2 Predicate Device Information:
| Predicate Device | DORO LUCENT® iXI and iMRI Headrest System |
|---|---|
| Predicate Device Manufacturer: | pro med instruments GmbH |
| Predicate Device Common Name: | Neurosurgical head holder (skull clamp) |
| Predicate Device Premarket Notification # | K191740 |
| Predicate Device Classification & Name | Device Class: IIHolder, head, neurosurgical (Skull Clamp) |
| Predicate Device Classification & Product Code: | Device Class: IIProduct Code: HBL |
ന Reference Device Information:
| Reference Device | DORO® Headrest System |
|---|---|
| Reference Device Manufacturer: | pro med instruments GmbH |
| Reference Device Common Name: | Neurosurgical head holder (skull clamp) |
| Reference Device Premarket Notification # | K001808 |
{6}------------------------------------------------
pro med instruments GmbH
DORO LUCENT® Skull Clamp - K240319
| Reference Device Classification & Name | Device Class: IINeurosurgical head holder (skull clamp) |
|---|---|
| Reference Device Classification & Product Code: | Device Class: IIProduct Code: HBL |
Date Summary Prepared ব
24.04.2024
Device Description ട
The DORO LUCENT® Skull Clamp ensures an adequate positioning of a patient's head and provides rigid fixation for neurosurgery. The device is suitable for intra-operative X-ray and CT based imaging procedures.
Image /page/6/Picture/7 description: The image shows a medical device called a DORO head holder. The device is black and blue and has a U-shape. The DORO logo is visible on the bottom of the device.
Figure 1: DORO LUCENT® Skull Clamp (REF: 1101.001)
The DORO LUCENT® Skull Clamp consists of a fixed arm, an adjustable arm and modular pin holders. Thus, using the DORO LUCENT® Skull Clamp Pediatric Set, the skull clamp can be configured as three-pin or four-pin pediatric set up.
Image /page/6/Picture/10 description: The image shows three different views of a blue and black mechanical part. The first view shows the part from the side, with a cylindrical body and two curved black arms extending from the center. The second view shows a similar part, but with a different end and the arms in a slightly different position. The third view shows a bolt with a large, ridged head and a threaded shaft, with the word "Start" printed on the side.
Figure 2: DORO LUCENT® Skull Clamp pediatric Set (REF: 1101.040)
{7}------------------------------------------------
Indications for Use e
The DORO LUCENT® Skull clamp is part of a mechanical support system, which is used during head or neck surgery. The product can be used in an intra-operative setting for CT and X-ray imaging.
The DORO LUCENT® Skull clamp Pediatric Set is part of a mechanical support system, which is used during head or neck surgery. The product can be used in an intra-operative setting for CT and X-ray imaging. The target patient population includes children over 5 years of age.
| Characteristic | pro med instruments GmbHDORO LUCENT® Skull Clamp(K240319) | pro med instruments GmbHDORO LUCENT® iXI and iMRIHeadrest System(K191740) | Impact onSubstantialEquivalence |
|---|---|---|---|
| Company | pro med instruments GmbH | pro med instruments GmbH | SubstantiallyEquivalent |
| RegulationNumber | 882.4460 | 882.4460 | SubstantiallyEquivalent |
| Product Code | HBL | HBL | SubstantiallyEquivalent |
| Intended Use | The DORO LUCENT® Skull clampis part of a mechanical supportsystem, which is used during heador neck surgery. The product canbe used in an intra-operativesetting for CT and X-ray imaging. | The DORO LUCENT radiolucent/MRICompatible Headrest System withSkull Pins are components of amechanical support system, which isused in cranial and spine surgerywhen rigid skeletal fixation is requiredfor cranial stabilization and whenintra-operativeimaging is used.The DORO LUCENT radiolucent/MRICompatible Headrest System withnoninvasive headpositioning or noninvasive cranialstabilization device are components ofa mechanical support system, which isused in cranial and spine surgerywhen noninvasive head positioning ornoninvasive cranial stabilization isrequired and when intra-operativeimaging is used.The DORO LUCENT Headrest Systemprovides an interface for accessorieslike retractor systems, navigationadaptors or other items. | SubstantiallyEquivalent |
| Characteristic | pro med instruments GmbHDORO LUCENT® Skull Clamp(K240319) | pro med instruments GmbHDORO LUCENT® iXI and iMRIHeadrest System(K191740) | Impact onSubstantialEquivalence |
| Indications forUse | The DORO LUCENT® Skull clampis part of a mechanical supportsystem, which is used during heador neck surgery. The product canbe used in an intra-operativesetting for CT and X-ray imaging.The DORO LUCENT® Skull clampPediatric Set is part of amechanical support system, whichis used during head or necksurgery. The product can be usedin an intra-operative setting for CTand X-ray imaging. The targetpatient population includeschildren over 5 years of age. | The DORO LUCENT radiolucent/MRICompatible Headrest System withSkull Pins are components of amechanical support system, which isused in cranial and spine surgerywhen rigid skeletal fixation is requiredfor cranial stabilization and whenintra-operative imaging is used.The DORO LUCENT radiolucent/MRICompatible Headrest System withnoninvasive head positioning ornoninvasive cranial stabilizationdevice are components of amechanical support system, which isused in cranial and spine surgerywhen noninvasive head positioning ornoninvasive cranial stabilization isrequired and when intra-operativeimaging is used.The DORO LUCENT Headrest Systemprovides an interface for accessoriesLike retractor systems, navigationadaptors or other items. | SubstantiallyEquivalent |
| Technology | Cranial fixation | Cranial fixation | SubstantiallyEquivalent |
| Features: | |||
| Principles ofoperation | Mechanical support system | Mechanical support system | SubstantiallyEquivalent |
| Method ofcranialstabilization | Rigid skeletal fixation | Rigid skeletal fixation or securednoninvasive stabilization | SubstantiallyEquivalent |
| Method ofcranialfixation | Three- and Four-point fixation inprone, supine or lateral position | Three-point fixation in prone, supine,lateral or sitting position | SubstantiallyEquivalent |
| Intra-operativeimaging | CT-, X-Ray Imaging | MR-, CT-, X-Ray- and Angiography-Imaging | SubstantiallyEquivalent |
| reprocessing | Automated cleaning anddisinfection between uses | Manual cleaning and disinfectionbetween uses | SubstantiallyEquivalent |
7 Comparison of the Technological Characteristics
{8}------------------------------------------------
pro med instruments GmbH
DORO LUCENT® Skull Clamp - K240319
7.1 Summary of Supporting Data
The above-listed Technological Characteristics show that the DORO LUCENT® Skull Clamp, and the DORO LUCENT® iXI and iMRI Headrest System are substantially equivalent.
{9}------------------------------------------------
Discussion of Performance Testing ထ
Tests were performed and the results are shown in the table below.
| Test | Result |
|---|---|
| DORO LUCENT® Skull Clamp | |
| Maximum Load Test (System Test) | Pass |
| Verifies the skull clamp can resist the forces imposed by thepatient and the surgeon when in use and in locked position. | The skull clamp is capable to withstand givenforce without movement in any connection,joint and/or plastic deformation. |
| Usability | Pass |
| Verifies if the usability of the skull clamp is given. | The usability of skull Clamp is given |
| Static load (Latching teeth mechanism) | Pass |
| Verifies the ability of the skull clamp to withstand maximumstatic load. | The skull clamp withstands a static load forgiven duration without signs of permanentdeformation, fracture, or breakage. |
| Creep | Pass |
| Verifies the mechanical integrity of the Skull Clamp and itsability to withstand constant loading over time without asignificant loss of clamping force. | The skull clamp can maintain the appliedmaximum force without a force deviation fromthe initially applied load by a defined value. |
| Pin force accuracy | Pass |
| Verifies the force delivery component to ensure the forcereadings are accurate and depict the actual force applied. | The skull clamp force delivery component isverified at each force level throughout its rangeto deliver the stated force within the actualsetting. |
| Torque load resistance | Pass |
| Verifies skull clamp can withstand rotational movement whenin use and locked position without impacting the lockingmechanism. | The skull clamp withstands a defined torque forgiven amount of time without deformation orany structural failures. |
| CT Evaluation | Pass |
| Verifies that the skull clamp does not affects the CT images ina negative way and produce less artifacts according to the setbenchmark for adequate imaging result. | The skull Clamp produces less artefacts thanthe set benchmark as defined in the test report. |
{10}------------------------------------------------
| Reprocessing | Pass |
|---|---|
| The reprocessing is done according to specifications that are defined in the instruction for use (IFU) of the product. The accumulation of residue evaluation, Cleaning effectiveness validation and Disinfection effectiveness validation is done according to:• ANSI / AAMI ST98:2022 - Cleaning validation of health care products - Requirements for development and validation of cleaning process for medical devices• DIN EN ISO 17664-1:2021 - Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices• DIN EN ISO 17664-2:2021 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices.• AAMI TIR 12: 2020, Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers | The tests data shows the reprocessing of DORO LUCENT® Skull Clamp is validated and test report in support to the statement is provided. |
Testing confirmed that the performance of the DORO LUCENT® Skull Clamp meets the product specification of the device.
9 Conclusion
The DORO LUCENT® Skull Clamp is used as a head and neck support to stabilize a patient's head during neurosurgical operative procedures.
This device is comparable in design, construction, intended use and performance characteristics to the predicate device and reference devices.
Based on available 510(k) information herein provided, DORO LUCENT® Skull Clamp is considered substantially equivalent to the predicate device in terms of intended use, technology and performance specifications, additional characteristic such as four-pin fixation is comparable to the reference device K001808.
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).