(90 days)
The DORO® QR3 XTom Headholder System is 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 with a CT-Scanner is used.
The DORO® QR3 XTom Headholder System ensures an adequate positioning of a patient's head for neurosurgery. Due to the utilized material the device can be used for intraoperative CT imaging procedures. The DORO® QR3 XTom Headholder System consists of the following: Skull Clamp, Skull Pins, Base Unit, Torque Screw Driver and U-Belt. The Base Unit is used to connect the Skull Clamp (including Skull Pins) to the OR-Table. Additional components like the Torque Screw Driver and U-Belt supports the performance of the Headholder System.
Here's an analysis of the provided text regarding the acceptance criteria and study for the DORO® QR3 XTom Headholder System.
It's important to note that the provided text is an FDA 510(k) summary for a mechanical support system (Neurosurgical Head Holder/Skull Clamp) and not an AI/ML medical device. Therefore, the questions related to AI/ML specific aspects like training data, expert consensus for ground truth, MRMC studies, and various performance metrics like sensitivity, specificity, AUC are not applicable to this type of device. The acceptance criteria and performance are based on mechanical and usability testing.
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Implied by "Pass" Result) | Reported Device Performance |
|---|---|---|
| DORO® QR3 XTom Headholder System (System Test) | Ability of the system to sustain a certain load without mechanical failure. | Pass: The System supports the static load without mechanical failure. |
| DORO® QR3 XTom Headholder System (Usability) | Usability of the System is given. | Pass: The usability of the System is given. |
| DORO® QR3 XTom Skull Clamp (Static Load - Latching teeth mechanism) | The interface must withstand the static load over the defined duration without damage or malfunction. | Pass: The interface must withstand the static load over the defined duration without damage or malfunction. |
| DORO® QR3 XTom Skull Clamp (Torque - Rocker Arm) | The Rocker Arm must withstand the torque without damaging, opening, or malfunction of the Open-Lock mechanism. | Pass: The Rocker Arm must withstand the torque without damaging, opening or malfunction of the Open-Lock mechanism. |
| DORO® QR3 XTom Skull Clamp (Creep Test) | The skull clamp must maintain the applied maximum force for a defined time without a force deviation from the initially applied load by a defined value. | Pass: The skull clamp must maintain the applied maximum force for a defined time without a force deviation from the initially applied load by a defined value. |
| DORO® QR3 XTom Skull Clamp (Force Delivery Accuracy Verification) | The skull clamp force delivery component must be verified at each major graduation throughout its range for a defined time to deliver the stated force within a defined range of the actual setting. | Pass: The skull clamp force delivery component must be verified at each major graduation throughout its range for a defined time to deliver the stated force within a defined range of the actual setting. |
| DORO® XTom U-Belt (Dynamic Load) | The Belt must withstand the dynamic load without breakage or opening of the Belt. | Pass: The Belt must withstand the dynamic load without breakage or opening of the Belt. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact number of units tested. It states "The devices have been tested as a system and single device," implying that at least one of each (system, skull clamp, U-Belt) was subjected to testing. For mechanical tests, the sample size might be small, typically 1 to 3 units, as per engineering testing standards, unless statistical significance for variability is a concern.
- Data Provenance: The manufacturer is "pro med instruments GmbH" located in "Freiburg im Breisgau, Germany." This suggests the testing and data likely originated from Germany. The document indicates these were direct performance tests on the physical device, not retrospective or prospective patient data studies.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not Applicable (N/A). As this is a mechanical device, ground truth for its performance is established through objective physical measurements and engineering standards, not through expert human interpretation or consensus like in AI/ML image analysis.
4. Adjudication Method for the Test Set
- N/A. Adjudication methods (e.g., 2+1, 3+1) are typically used in studies involving human interpretation (like radiology reads) to resolve disagreements or establish consensus. For mechanical performance tests, the results are quantitative and objective, not subject to human interpretation disagreement in the same way.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC study was done. This type of study is relevant for diagnostic imaging AI/ML devices to assess the impact on human reader performance. This device is a mechanical support system, not an imaging interpretation aid.
- Effect Size: N/A, as no MRMC study was conducted.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)
- N/A. This is a mechanical device, not an algorithm or software. Its performance is inherent to its physical design, materials, and manufacturing, not dictated by an algorithm.
7. The Type of Ground Truth Used
- Objective Mechanical Measurements and Engineering Standards: The "ground truth" for this device's performance is derived from its ability to meet predefined physical requirements (e.g., load bearing, torque resistance, force accuracy, maintaining clamping force over time) as measured by calibrated testing equipment and adherence to established engineering principles and safety margins. The "Pass" results confirm it met these criteria.
8. The Sample Size for the Training Set
- N/A. This device does not involve machine learning; therefore, there is no "training set."
9. How the Ground Truth for the Training Set was Established
- N/A. Since there is no training set, this question is not applicable.
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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which 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, Germany 79111
Re: K191979
Trade/Device Name: DORO QR3 XTom Headholder System Regulation Number: 21 CFR 882.4460 Regulation Name: Neurosurgical Head Holder (Skull Clamp) Regulatory Class: Class II Product Code: HBL Dated: July 24, 2019 Received: July 24, 2019
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 probibitions 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
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801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for 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) K191979
Device Name
DORO® QR3 XTom Headholder System
Indications for Use (Describe)
The DORO® QR3 XTom Headholder System is 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 with a CT-Scanner is used.
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 primarily blue and features a stylized lowercase 'm' and 'i' connected together. To the right of the 'm' and 'i' is the text 'pro med instruments' in a smaller font size.
| DATE OF APPLICATION: | 19.07.2019 |
|---|---|
| APPLICANT: | pro med instruments GmbHBötzinger Straße 3879111 Freiburg im BreisgauGermanyTel: +49 (0) 761 384 222 10Fax: +49 (0) 761 384 222 81E-Mail: pmi@pmisurgical.com |
CONTACT PERSON:
Name: Sandra Untenberger Position: Regulatory Affairs Tel.: +49761384 222 45 E-Mail: ra@pmisurgical.com
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1 Device Name
| Trade Name: | DORO® QR3 XTom Headholder System |
|---|---|
| Common Name: | Neurosurgical Head Holder (Skull Clamp) |
| Device Classification Name: | Holder, head, neurosurgical (skull clamp) |
Classification / Product Code 2
DORO® QR3 XTomHeadholder Systemcan 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 | 882.4460 | 2 |
3 Predicate Device
| Device | Predicate Device | 510(k)Number | 510(k) Holder |
|---|---|---|---|
| DORO® QR3 XTomHeadholder System | DORO RADIOLUCENT HEADRESTSYSTEM AND COMPONENTS | K032331 | pro med instruments GmbH |
Reference Device 4
| Device | Reference Device | 510(k)Number | 510(k) Holder |
|---|---|---|---|
| DORO® QR3 XTomHeadholder System | DORO® Headrest System | K001808 | pro med instruments GmbH |
Device Description ട
The DORO® QR3 XTom Headholder Systemensures an adequate positioning of a patient's head for neurosurgery. Due to the utilized material the device can be used for intraoperative CT imaging procedures.
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Image /page/5/Picture/2 description: The image shows the logo for Pro Med Instruments. The logo is primarily blue and features a stylized "pmi" with the "pro med instruments" text to the right of the letters. The "pmi" is designed with rounded shapes, and the dot over the "i" is a large circle.
The DORO® QR3 XTom Headholder Systemconsists of the following: Skull Clamp, Skull Pins, Base Unit, Torque Screw Driver and U-Belt. The Base Unit is used to connect the Skull Clamp (including Skull Pins) to the OR-Table. A Headholder Systemis shown in Figure 1.
Image /page/5/Picture/4 description: The image shows a Mayfield skull clamp, a medical device used to stabilize a patient's head during neurosurgical procedures. The clamp consists of a horseshoe-shaped headrest that supports the patient's forehead and occiput, and two adjustable pins that are inserted into the skull to provide rigid fixation. The device is made of metal and has a gray finish. The image is taken against a white background.
Figure 1: DORO® QR3 XTom Headholder System
Additional components like the Torque Screw Driver and U-Belt supports the performance of the Headholder System.
Intended Use 6
The DORO® QR3 XTom Headholder Systemis 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 with a CT - Scanner is used.
7 Technological Characteristics
The technological characteristics of DORO® QR3 XTomHeadholder System are the same as the technological characteristics of the predicate device.
| Company | pro med instruments GmbH---DORO® QR3 XTom HeadholderSystem (New Device) | pro med instruments GmbH---DORO® Radiolucent Headrest Systemand Horseshoe Headrest(Predicate Device) |
|---|---|---|
| Device Name | DORO® QR3 XTom HeadholderSystem | DORO® Radiolucent Headrest Systemand Horseshoe Headrest |
| Regulation Number | 882.4460 | 882.4460 |
| Class | 2 | 2 |
| Code | HBL | HBL |
| 510(k) number | --- | K032331 |
| Set Packaging | Case | Case |
| Item name | DORO® QR3 XTom Skull Clamp | DORO® Skull Clamp Radiolucent |
| Item number | 4002.001 | 3034-00 |
| Sterility | Nonsterile | Nonsterile |
| Reprocessing | Manual cleaning and disinfection betweenuses | Manual cleaning and disinfection betweenuses |
7.1 Device Characteristics Table
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| Company | pro med instruments GmbHDORO® QR3 XTom HeadholderSystem (New Device) | pro med instruments GmbHDORO® Radiolucent Headrest Systemand Horseshoe Headrest |
|---|---|---|
| (Predicate Device) | ||
| Type of head fixation | 3 point fixation | 3 point fixation |
| Shape/ generaldesign | U-shape with extension arms | U-shape |
| Adjustment forvarious 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 |
| Imaging modality | radiolucent | radiolucent |
| Patient contactcomponents/materials | None | None |
| Item name | DORO® XTom Base Unit Parkbench | DORO® Skull Clamp Radiolucent |
| Item number | 4002-10 | 3031-00 |
| Sterility | Nonsterile | Nonsterile |
| Reprocessing | Manual cleaning and disinfection betweenuses | Manual cleaning and disinfection betweenuses |
| Interface OR-table | OR table brackets with locking levers | OR table brackets with locking levers |
| Interface Skull Clamp | Starburst with thread | Starburst with screw |
| Adjustable Parts:height | Spindle can be moved up or down forheight adjustment | Transitional members can be moved up ordown for height |
| Adjustable Parts:height and lateralposition | height and lateral position can be adjustedby moving the base handle assembly upor down | height and lateral position can be adjustedby moving the transitional members up ordown |
| Adjustable Parts:Angulation | Angulation can be adjusted by moving thebase Handle Assembly forward orbackwardOr by moving the spindle device sideways | Angulation can be adjusted by moving theswivel adaptor forward or backwardOr by moving it sideways |
| Patient contactcomponents/materials | None | None |
| Materials: | Aluminum, stainless steel, syntheticmaterial | Aluminum, stainless steel, syntheticmaterial |
| Imaging | Base Unit is underneath the OR-table andtherefore not in the imaging area | Base Unit is underneath the OR-table andtherefore not in the imaging area |
The DORO® QR3 XTom Headholder Systemuses the same DORO® Sterile Disposable Skull Pins, Stainless Steel, Adult (Itemnumber 3006-00) as the reference device DORO® Headrest System (K001808).
7.2 Summary of Technological Characteristics
The above listed Technological Characteristics show that the DORO® QR3 XTom Headholder System, and the DORO Radiolucent Headrest Systemare substantially equivalent. Therefore safety and effectiveness can be ensured for these items.
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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 gray. The letters "pmi" are shown in blue, with the "p" being a stylized shape. The words "pro med instruments" are in gray and are to the right of the "pmi" letters.
Performance Data 8
The devices have been tested as a systemand single device. Testing was performed using Skull Pins that were determined to be mechanically equivalent to the 3006-00 pins. Tests were performed and the results are shown in the table below.
| Test | Result |
|---|---|
| DORO® QR3 XTom Headholder System | |
| System TestVerifies the ability of the system to sustain acertain load. | PassThe System supports the static load withoutmechanical failure. |
| UsabilityVerifies if the usability of the System is given. | PassThe usability of the System is given. |
| DORO® QR3 XTom 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. |
| Creep TestVerifies the mechanical integrity of the skullclamp and its ability to withstand loading overtime without a significant loss of clamping force. | PassThe skull clamp must maintain the appliedmaximum force for a defined time without a forcedeviation from the initially applied load by adefined value. |
| Force delivery accuracy VerificationVerifies the force delivery component of the skullclamp. This verification is intended to ensure theforce readings are accurate and depict the actualforce applied to the patient's skull. | PassThe skull clamp force delivery component must beverified at each major graduation throughout itsrange for a defined time to deliver the statedforce within a defined range of the actual setting. |
| DORO® XTom U-Belt | |
| Dynamic loadVerifies the ability of the Belt to sustain a certaindynamic load. | PassThe Belt must withstand the dynamic load withoutbreakage or opening of the Belt. |
Testing confirmed that the performance of the DORO® QR3 XTom Headholder System meets the product specification of the device.
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Image /page/8/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.
Substantial Equivalence Summary / Conclusion 0
The DORO® QR3 XTom Headholder System components are used as 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 devices.
Based on available 510(k) information herein provided, DORO® QR3 XTom Headholder System.components are considered substantially equivalent to the predicate device in t erms 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).