(119 days)
Not Found
No
The device description and performance studies focus on mechanical properties and usability, with no mention of AI or ML.
No
The device is a cranial stabilization system designed for rigid skeletal fixation during surgery, not for treating a disease or condition itself.
No
The device is a cranial stabilization system designed to hold the patient's head and neck securely during surgical procedures, not to diagnose a condition.
No
The device description clearly outlines physical components (Skull clamp, Swivel Adapter, Adjustable Base Unit) and the performance studies focus on mechanical and physical properties, not software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to physically hold a patient's head and neck in a specific position during surgery (craniotomies and spinal surgery). This is a mechanical function performed directly on the patient's body.
- Device Description: The description details a system of components (skull clamp, swivel adapter, adjustable base unit) designed for rigid skeletal fixation. This is a physical support and positioning device.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens from the human body (like blood, tissue, urine, etc.) to provide information for diagnosis, monitoring, or treatment.
- Performance Studies: The performance studies focus on the mechanical integrity and usability of the device, not on diagnostic accuracy or analytical performance.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (on the body) for surgical positioning.
N/A
Intended Use / Indications for Use
The DORO QR3 Headrest System is placed on the patient's skull to hold their head and neck securely in a particular position when rigid fixation is desired. The clamp is indicated for use in open and percutaneous craniotomies as well as spinal surgery when rigid skeletal fixation is necessary.
Product codes (comma separated list FDA assigned to the subject device)
HBL
Device Description
DORO® QR3 Headrest System consists of 3 components.
- Skull clamp
- Swivel Adapter
- Adjustable Base Unit
DORO® QR3 Headrest System (Aluminum) is a cranial stabilization device, designed to provide rigid skeletal fixation. The DORO Headrest System is placed on the patient's skull to hold their head and neck securely in a particular position when rigid fixation is desired. The clamp is indicated for use in open and percutaneous craniotomies as well as spinal surgery when rigid skeletal fixation is necessary.
The Swivel Adaptor connects the Base Unit (by means of the Transitional Member) with the Skull Clamp. The Swivel Adaptor provides 360 degrees rotation. This allows a fully flexible adjustment of the DORO® Headrest System to the patient's position.
The Base Unit is designed for patient positioning in prone or supine, lateral and sitting positions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Patient's skull, head and neck
Indicated Patient Age Range
Not recommended for children under 5 years of age
Intended User / Care Setting
Used in the operating room of the hospital.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The DORO® QR3 Headrest System have been tested as a system and single device.
- System Test - Test is performed in accordance with ASTM F3395 / F3395M-19. Result: Pass
- Torque Load Resistance Test - Test is performed in accordance with ASTM F3395 / F3395M-19. Result: Pass
- Force Delivery Verification - Test is performed in accordance with ASTM F3395 / F3395M-19. Result: Pass
- Creep Test - Test is performed in accordance with ASTM F3395 / F3395M-19. Result: Pass
- Static Load - Test is performed in accordance with ASTM F3395 / F3395M-19. Result: Pass
- Fourfold Load- Skull Clamp - Test is performed in accordance with DIN EN 60601-2-46. Result: Pass
- Fourfold Load- Interface Skull Clamp to Swivel Adaptor - Test is performed in accordance with DIN EN 60601-2-46. Result: Pass
- Usability Test - Test is performed in accordance with EC 62366 as well as FDA-2011-D-0469. Result: Pass
- Automated cleaning including disinfection - The test is performed in accordance with: EN ISO 15883-1:2014 – 10, RKI Guideline: 2012 Hygiene Requirements for the Reprocessing of Medical Devices, RKI Guideline: 2012 Hygiene Requirements for the Reprocessing of Medical Devices, AAMI TIR 30: 2011 as well as Guideline DGKH, DGSV, AKI: 2014 Leitlinie von DGKH, DGSV und AKI für die Validierung und Routineüberwachung maschineller Reinigungs- und thermischer Desinfektionsprozesse für Medizinprodukte. Result: Pass
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 29, 2021
Pro Med Instruments GmbH Muhammad Zubair Regulatory Affairs Manager Boetziger Str. 38 Freiburg, Bad Wuerttemberg 79111 Germany
Re: K203505
Trade/Device Name: DORO QR3 Headrest System (Aluminum) Regulation Number: 21 CFR 882.4460 Regulation Name: Neurosurgical Head Holder (Skull Clamp) Regulatory Class: Class II Product Code: HBL Dated: February 15, 2021 Received: February 23, 2021
Dear Muhammad Zubair:
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
1
801); medical device 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 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,
Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K203505
Device Name DORO QR3 Headrest System (Aluminum)
Indications for Use (Describe)
The DORO QR3 Headrest System is placed on the patient's skull to hold their head and neck securely in a particular position when rigid fixation is desired. The clamp is indicated for use in open and percutaneous craniotomies as well as spinal surgery when rigid skeletal fixation is necessary.
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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3
510(k) SUBMISSION NUMBER: K203505
| DATE: | March 29, 2021 |
|---|---|
| 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: regulatoryaffairs@blackforestmedical.com | |
| CONTACT PERSON: | Muhammad Zubair |
| Regulatory Affairs Manager | |
| E-Mail: regulatoryaffairs@blackforestmedical.com |
4
1 Device Name
| Trade Name: | DORO® QR3 Headrest System |
|---|---|
| Common Name: | DORO® QR3 Headrest System (Aluminum) |
| Device Classification Name: | Holder, head, neurosurgical (skull clamp) |
2 Classification / Product Code
DORO QR3 Headrest System can be classified according to following device name and product code:
| Device | Regulation
Description | Regulation
Medical
Specialty | Review
Panel | Product
Code | Regulation
Number | Device
Classification |
|-------------------------------------------------|-----------------------------------------------|------------------------------------|-----------------|-----------------|----------------------|--------------------------|
| Holder, head,
neurosurgical
(skull clamp) | Neurosurgical
head holder
(skull clamp) | Neurology | Neurology | HBL | 882.4460 | 2 |
Predicate Device / Reference Device 3
Subject Device: DORO QR3 Headrest System (Aluminum)
| Subject Device | Predicate Device | 510(k)
Number | 510(k) Holder |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|------------------|--------------------------|
| DORO® QR3 Headrest
System (Aluminum) | DORO RADIOLUCENT HEADREST SYSTEM
AND HORSESHOE HEADRESTS, AND NON-
RADIOLUCENT J-ARM RETRACTOR
SYSTEM (ALUMINUM ALLOY) | K032331 | Pro med instruments GmbH |
Device Description ব
DORO® QR3 Headrest System consists of 3 components.
-
- Skull clamp
-
- Swivel Adapter
-
- Adjustable Base Unit
4.1 DORO® QR3 Headrest System (Aluminum)
DORO® QR3 Headrest System (Aluminum) is a cranial stabilization device, designed to provide rigid skeletal fixation. The DORO Headrest System is placed on the patient's skull to hold their head and neck securely in a particular position when rigid fixation is desired. The clamp is indicated for use in open and percutaneous craniotomies as well as spinal surgery when rigid skeletal fixation is necessary.
The Swivel Adaptor connects the Base Unit (by means of the Transitional Member) with the Skull Clamp. The Swivel Adaptor provides 360 degrees rotation. This allows a fully flexible adjustment of the DORO® Headrest System to the patient's position.
The Base Unit is designed for patient positioning in prone or supine, lateral and sitting positions.
Intended Use 5
The DORO® QR3 Headrest System (Aluminum) is a mechanical support system which is used in head and neck surgery. This system allows the patient's head to be positioned and
5
secured for the operation. It can be used for cranial fixation of the patient in prone, supine, lateral and sitting positions.
Technological Characteristics e
The technological characteristics of DORO® QR3 Headrest System (Aluminum) are the same as the technological characteristics of the predicate device(s).
6.1 DORO QR3 Aluminum Headrest System
| Device Name and
510k Submission
number for
Predicate or
Subject Device | DORO® QR3 Aluminum Headrest System
K203505 | DORO Radiolucent Headrest System and
Horseshoe Headrest and non-radiolucent J-
Arm Retractors System
K032331 |
|------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company name | pro med instruments GmbH | pro med instruments GmbH |
| Regulation Number | 882.4460 | 882.4460 |
| Class | 2 | 2 |
| Code | HBL | HBL |
| Intended use | The DORO® QR3 Headrest System (Aluminum) is a
mechanical support system which is used in head
and neck surgery. This system allows the patient's
head to be positioned and secured for the operation.
It can be used for cranial fixation of the patient in
prone, supine, lateral and sitting positions. | The DORO® Radiolucent Headrest System is
used as a support mechanism for head and
neck surgery.
The DORO Non-Radiolucent J-Arm Retractor
System is used as a component of the head
and neck support during neurosurgical
procedures to facilitate retraction of tissue is
also required. |
| Indication for Use | The DORO® QR3 Headrest System is placed on
the patient's skull to hold their head and neck
securely in a particular position when rigid fixation is
desired. The clamp is indicated for use in open and
percutaneous craniotomies as well as spinal surgery
when rigid skeletal fixation is necessary. | Stabilization of head and neck during
neurosurgical surgery through invasive or
noninvasive fixation
Support head and neck retraction of brain
tissue and provide hand rest during
neurosurgical surgery. |
| Material | Aluminum
Stainless steel
POM
PTFE
EPDM70 | Novotex
POM
PEEK
Polyurethan |
| Shape | Curved Uprights | Curved Uprights |
| Adjustment for
various Head Sizes | Ratchet arm is adjustable | Ratchet arm is adjustable |
| Load Range | 0-80 Ibs | 0-80 Ibs |
| 80lb force
applicator | Yes | Yes |
| Three point fixation | Yes | Yes |
| 2 pin | Yes | Yes |
| Chile Rocker Arm | No | No |
| Removable | No | No |
| Secured using the
swivel lock knob | No | No |
| MR | Unsafe | Unsafe |
| Sterility | Non Sterile | Non Sterile |
| Swivel Adaptor | | |
| Type of Head
Fixation | Non Invasive | Non Invasive |
| Swivel Adapter
Function | Connects Skull Clamp with Base Unit | Connects Skull Clamp with Base Unit |
| Sterility | Non Sterile | Non Sterile |
| Device Name and
510k Submission
number for
Predicate or
Subject Device | DORO® QR3 Aluminum Headrest System
K203505 | DORO Radiolucent Headrest System and
Horseshoe Headrest and non-radiolucent J-
Arm Retractors System
K032331 |
| Company name | pro med instruments GmbH | pro med instruments GmbH |
| 360° rotation under
full impingement
force | Yes | Yes |
| MR | Unsafe | Unsafe |
| Base Unit | | |
| Type of Head
Fixation | Non Invasive | Non Invasive |
| Base Unit Design | Connects the Headrest System to OP table | Connects the Headrest System to OP Table |
| Interface for
accessories | Side Rail | Side Rail |
| Sterlity | Non Sterile | Non Sterile |
| MR | Unsafe | Unsafe |
| Target Patient
Population | Not recommended for children under 5 years of age | Not recommended for children under 5
years of age |
| Cleaning
/Decontamination | Intended to be used non-sterile.
Intended to be cleaned by user between uses with
manual pre -cleaning and washer disinfector
according the process stated in the IFU. | Manual cleaning as stated in the IFU. |
| Operating
environment | Used in the operating room of the hospital. | Used in the operating room of the hospital. |
| Compatibility with
other DORO
Products | DORO Skull Pins(Not part of this 510(k) Submission) | DORO Skull Pins |
6
6.2 Summary of Technological Characteristics
DORO QR3 Headrest System is substantially equivalent in intended use, indication for use, dimensions and design to the predicate device(s).
7
Performance Data 7
The DORO® QR3 Headrest System have been tested as a system and single device. Tests were performed and the status of the results are shown in the table below.
| Test | Result | |
|---|---|---|
| DORO® QR3 Headrest System (Aluminum) | ||
| 1. | System Test | |
| Test is performed in accordance with ASTM F3395 / F3395M-19. | Pass | |
| 2. | Torque Load Resistance Test | |
| Test is performed in accordance with ASTM F3395 / F3395M-19. | Pass | |
| 3. | Force Delivery Verification | |
| Test is performed in accordance with ASTM F3395 / F3395M-19 | Pass | |
| 4. | Creep Test | |
| Test is performed in accordance with ASTM F3395 / F3395M-19 | Pass | |
| 5. | Static Load | |
| Test is performed in accordance with ASTM F3395 / F3395M-19 | Pass | |
| 6. | Fourfold Load- Skull Clamp | |
| Test is performed in accordance with DIN EN 60601-2-46 | Pass | |
| 7. | Fourfold Load- Interface Skull Clamp to Swivel Adaptor | |
| Test is performed in accordance with DIN EN 60601-2-46 | Pass | |
| 9. | Usability Test | |
| Test is performed in accordance with EC 62366 as well as FDA- | ||
| 2011-D-0469 | Pass | |
| 10. | Automated cleaning including disinfection | |
| The test is performed in accordance with: | ||
| EN ISO 15883-1:2014 – 10, RKI Guideline: 2012 Hygiene | ||
| Requirements for the Reprocessing of Medical Devices, RKI | ||
| Guideline: 2012 Hygiene Requirements for the Reprocessing of | ||
| Medical Devices, | ||
| AAMI TIR 30: 2011 as well as Guideline DGKH, DGSV, AKI: 2014 | ||
| Leitlinie von DGKH, DGSV und AKI für die Validierung und | ||
| Routineüberwachung maschineller Reinigungs- und thermischer | ||
| Desinfektionsprozesse für Medizinprodukte | Pass |
8
Substantial Equivalence Summary / Conclusion တ
DORO® QR3 Headrest System (Aluminum) is used together with the DORO® Skull Pins, intended as a neck and head support to stabilize the patient's head during neurosurgical procedures.
These devices are comparable in design, construction, intended use and performance characteristics to the predicate devices.
Based on available 510(k) information herein provided, DORO® QR3 Headrest System (Aluminum) is considered substantially equivalent to the predicate device(s) 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.