(90 days)
No
The device description and performance studies focus on the mechanical aspects and structural integrity of a headholder system, with no mention of AI or ML capabilities.
No.
The device is a mechanical support system used for rigid skeletal fixation and cranial stabilization during surgery; it does not directly treat a disease or condition.
No
Explanation: The device is described as a mechanical support system used for cranial stabilization and positioning during surgery and intra-operative imaging. Its function is to hold the head, not to diagnose a condition or disease.
No
The device description explicitly lists multiple hardware components (Skull Clamp, Skull Pins, Base Unit, Torque Screw Driver, U-Belt) and the performance studies focus on mechanical testing of these physical components.
Based on the provided information, the DORO® QR3 XTom Headholder System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's a "mechanical support system" used for "cranial stabilization" during surgery and intra-operative imaging. This describes a physical device used to position and stabilize a patient's head.
- Device Description: The description details the mechanical components of the system (Skull Clamp, Skull Pins, Base Unit, etc.) and their function in positioning and supporting the head.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze biological specimens.
- Performance Studies: The performance studies focus on the mechanical integrity and functionality of the device (static load, torque, creep test, force delivery accuracy, dynamic load). These are typical tests for a mechanical medical device, not an IVD.
In summary, the DORO® QR3 XTom Headholder System is a surgical support device, not a diagnostic device that analyzes biological samples.
N/A
Intended Use / Indications for Use
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.
Product codes
HBL
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT-Scanner
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. 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.
DORO® QR3 XTom Headholder System:
- System Test: Verifies the ability of the system to sustain a certain load. Result: Pass. The System supports the static load without mechanical failure.
- Usability: Verifies if the usability of the System is given. Result: Pass. The 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 a certain load with an additional safety factor. Result: 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. Result: Pass. The Rocker Arm must withstand the torque without damaging, opening or malfunction of the Open-Lock mechanism.
- Creep Test: Verifies the mechanical integrity of the skull clamp and its ability to withstand loading over time without a significant loss of clamping force. Result: 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.
- Force delivery accuracy Verification: Verifies the force delivery component of the skull clamp. This verification is intended to ensure the force readings are accurate and depict the actual force applied to the patient's skull. Result: 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: Verifies the ability of the Belt to sustain a certain dynamic load. Result: Pass. The Belt must withstand the dynamic load without breakage or opening of the Belt.
Testing confirmed that the performance of the DORO® QR3 XTom Headholder System meets the product specification of the device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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 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
1
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
2
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 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.: +49761384 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 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.
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 | 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 | 882.4460 | 2 |
3 Predicate Device
| Device | Predicate Device | 510(k)
Number | 510(k) Holder |
|-------------------------------------|----------------------------------------------------|------------------|--------------------------|
| DORO® QR3 XTom
Headholder System | DORO RADIOLUCENT HEADREST
SYSTEM AND COMPONENTS | K032331 | pro med instruments GmbH |
Reference Device 4
| Device | Reference Device | 510(k)
Number | 510(k) Holder |
|-------------------------------------|-----------------------|------------------|--------------------------|
| DORO® QR3 XTom
Headholder 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.
5
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 Headholder
System (New Device) | pro med instruments GmbH
DORO® Radiolucent Headrest System
and Horseshoe Headrest
(Predicate Device) |
|-------------------|-------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| Device Name | DORO® QR3 XTom Headholder
System | DORO® Radiolucent Headrest System
and 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 between
uses | Manual cleaning and disinfection between
uses |
7.1 Device Characteristics Table
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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 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'.
| Company | pro med instruments GmbH
DORO® QR3 XTom Headholder
System (New Device) | pro med instruments GmbH
DORO® Radiolucent Headrest System
and Horseshoe Headrest |
|-----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| | | (Predicate Device) |
| Type of head fixation | 3 point fixation | 3 point fixation |
| Shape/ general
design | U-shape with extension arms | 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 |
| Imaging modality | radiolucent | radiolucent |
| Patient contact
components/
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 between
uses | Manual cleaning and disinfection between
uses |
| 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 for
height adjustment | Transitional members can be moved up or
down for height |
| Adjustable Parts:
height and lateral
position | height and lateral position can be adjusted
by moving the base handle assembly up
or down | height and lateral position can be adjusted
by moving the transitional members up or
down |
| Adjustable Parts:
Angulation | Angulation can be adjusted by moving the
base Handle Assembly forward or
backward
Or by moving the spindle device sideways | Angulation can be adjusted by moving the
swivel adaptor forward or backward
Or by moving it sideways |
| Patient contact
components/
materials | None | None |
| Materials: | Aluminum, stainless steel, synthetic
material | Aluminum, stainless steel, synthetic
material |
| Imaging | Base Unit is underneath the OR-table and
therefore not in the imaging area | Base Unit is underneath the OR-table and
therefore 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 Test | |
| Verifies the ability of the system to sustain a | |
| certain load. | Pass |
| The System supports the static load without | |
| mechanical failure. | |
| Usability | |
| Verifies if the usability of the System is given. | Pass |
| The 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 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. | |
| Creep Test | |
| Verifies the mechanical integrity of the skull | |
| clamp and its ability to withstand loading over | |
| time without a significant loss of clamping force. | 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. | |
| Force delivery accuracy Verification | |
| Verifies the force delivery component of the skull | |
| clamp. This verification is intended to ensure the | |
| force readings are accurate and depict the actual | |
| force applied to the patient's skull. | 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 | |
| Verifies the ability of the Belt to sustain a certain | |
| dynamic load. | Pass |
| The Belt must withstand the dynamic load without | |
| breakage 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.