(119 days)
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.
DORO® QR3 Headrest System consists of 3 components: 1. Skull clamp, 2. Swivel Adapter, 3. 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.
The provided document is a 510(k) premarket notification for a medical device called the DORO QR3 Headrest System (Aluminum). This document primarily focuses on establishing substantial equivalence to a predicate device and outlines performance testing for safety and effectiveness, rather than detailing clinical study results for an AI/algorithm-based device.
Therefore, many of the requested categories related to AI/algorithm performance (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this submission.
Here's the information that can be extracted relevant to acceptance criteria and device performance based on the provided text:
Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the "Pass" results of the performance tests, indicating that the device met the established benchmarks for each test. The study performed is a series of engineering and usability tests.
| Acceptance Criteria (Test) | Reported Device Performance (Result) |
|---|---|
| System Test (in accordance with ASTM F3395 / F3395M-19) | Pass |
| Torque Load Resistance Test (in accordance with ASTM F3395 / F3395M-19) | Pass |
| Force Delivery Verification (in accordance with ASTM F3395 / F3395M-19) | Pass |
| Creep Test (in accordance with ASTM F3395 / F3395M-19) | Pass |
| Static Load Test (in accordance with ASTM F3395 / F3395M-19) | Pass |
| Fourfold Load - Skull Clamp (in accordance with DIN EN 60601-2-46) | Pass |
| Fourfold Load - Interface Skull Clamp to Swivel Adaptor (in accordance with DIN EN 60601-2-46) | Pass |
| Usability Test (in accordance with IEC 62366 as well as FDA-2011-D-0469) | Pass |
| Automated cleaning including disinfection (in accordance with EN ISO 15883-1:2014 – 10, RKI Guideline: 2012, AAMI TIR 30: 2011, Guideline DGKH, DGSV, AKI: 2014) | Pass |
Additional Information:
- Sample size used for the test set and the data provenance: Not applicable. These were engineering performance tests of the physical device, not a test set of medical data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for engineering tests is typically based on established physical standards and measurements, not expert human interpretation.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This document is for a physical medical device, not an AI/algorithm.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used:
- For engineering tests (Load, Torque, Creep, System Tests): The ground truth is the performance specified by the referenced ASTM and DIN EN standards. The "Pass" results indicate the device met these engineering specifications.
- For Usability Test: The ground truth would be adherence to the usability requirements outlined in IEC 62366 and FDA-2011-D-0469.
- For Cleaning and Disinfection Test: The ground truth is compliance with the referenced ISO, RKI, AAMI, and DGKH/DGSV/AKI guidelines for reprocessing medical devices.
- The sample size for the training set: Not applicable. This is for a physical device, not an AI/algorithm.
- How the ground truth for the training set was established: Not applicable.
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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
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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
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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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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 |
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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 | RegulationDescription | RegulationMedicalSpecialty | ReviewPanel | ProductCode | RegulationNumber | DeviceClassification |
|---|---|---|---|---|---|---|
| Holder, head,neurosurgical(skull clamp) | Neurosurgicalhead 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 HeadrestSystem (Aluminum) | DORO RADIOLUCENT HEADREST SYSTEMAND HORSESHOE HEADRESTS, AND NON-RADIOLUCENT J-ARM RETRACTORSYSTEM (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
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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 and510k Submissionnumber forPredicate orSubject Device | DORO® QR3 Aluminum Headrest SystemK203505 | DORO Radiolucent Headrest System andHorseshoe Headrest and non-radiolucent J-Arm Retractors SystemK032331 |
|---|---|---|
| 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 amechanical support system which is used in headand neck surgery. This system allows the patient'shead to be positioned and secured for the operation.It can be used for cranial fixation of the patient inprone, supine, lateral and sitting positions. | The DORO® Radiolucent Headrest System isused as a support mechanism for head andneck surgery.The DORO Non-Radiolucent J-Arm RetractorSystem is used as a component of the headand neck support during neurosurgicalprocedures to facilitate retraction of tissue isalso required. |
| Indication for Use | The DORO® QR3 Headrest System is placed onthe patient's skull to hold their head and necksecurely in a particular position when rigid fixation isdesired. The clamp is indicated for use in open andpercutaneous craniotomies as well as spinal surgerywhen rigid skeletal fixation is necessary. | Stabilization of head and neck duringneurosurgical surgery through invasive ornoninvasive fixationSupport head and neck retraction of braintissue and provide hand rest duringneurosurgical surgery. |
| Material | AluminumStainless steelPOMPTFEEPDM70 | NovotexPOMPEEKPolyurethan |
| Shape | Curved Uprights | Curved Uprights |
| Adjustment forvarious Head Sizes | Ratchet arm is adjustable | Ratchet arm is adjustable |
| Load Range | 0-80 Ibs | 0-80 Ibs |
| 80lb forceapplicator | Yes | Yes |
| Three point fixation | Yes | Yes |
| 2 pin | Yes | Yes |
| Chile Rocker Arm | No | No |
| Removable | No | No |
| Secured using theswivel lock knob | No | No |
| MR | Unsafe | Unsafe |
| Sterility | Non Sterile | Non Sterile |
| Swivel Adaptor | ||
| Type of HeadFixation | Non Invasive | Non Invasive |
| Swivel AdapterFunction | Connects Skull Clamp with Base Unit | Connects Skull Clamp with Base Unit |
| Sterility | Non Sterile | Non Sterile |
| Device Name and510k Submissionnumber forPredicate orSubject Device | DORO® QR3 Aluminum Headrest SystemK203505 | DORO Radiolucent Headrest System andHorseshoe Headrest and non-radiolucent J-Arm Retractors SystemK032331 |
| Company name | pro med instruments GmbH | pro med instruments GmbH |
| 360° rotation underfull impingementforce | Yes | Yes |
| MR | Unsafe | Unsafe |
| Base Unit | ||
| Type of HeadFixation | Non Invasive | Non Invasive |
| Base Unit Design | Connects the Headrest System to OP table | Connects the Headrest System to OP Table |
| Interface foraccessories | Side Rail | Side Rail |
| Sterlity | Non Sterile | Non Sterile |
| MR | Unsafe | Unsafe |
| Target PatientPopulation | Not recommended for children under 5 years of age | Not recommended for children under 5years of age |
| Cleaning/Decontamination | Intended to be used non-sterile.Intended to be cleaned by user between uses withmanual pre -cleaning and washer disinfectoraccording the process stated in the IFU. | Manual cleaning as stated in the IFU. |
| Operatingenvironment | Used in the operating room of the hospital. | Used in the operating room of the hospital. |
| Compatibility withother DOROProducts | DORO Skull Pins(Not part of this 510(k) Submission) | DORO Skull Pins |
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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).
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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 TestTest is performed in accordance with ASTM F3395 / F3395M-19. | Pass |
| 2. | Torque Load Resistance TestTest is performed in accordance with ASTM F3395 / F3395M-19. | Pass |
| 3. | Force Delivery VerificationTest is performed in accordance with ASTM F3395 / F3395M-19 | Pass |
| 4. | Creep TestTest is performed in accordance with ASTM F3395 / F3395M-19 | Pass |
| 5. | Static LoadTest is performed in accordance with ASTM F3395 / F3395M-19 | Pass |
| 6. | Fourfold Load- Skull ClampTest is performed in accordance with DIN EN 60601-2-46 | Pass |
| 7. | Fourfold Load- Interface Skull Clamp to Swivel AdaptorTest is performed in accordance with DIN EN 60601-2-46 | Pass |
| 9. | Usability TestTest is performed in accordance with EC 62366 as well as FDA-2011-D-0469 | Pass |
| 10. | Automated cleaning including disinfectionThe test is performed in accordance with:EN ISO 15883-1:2014 – 10, RKI Guideline: 2012 HygieneRequirements for the Reprocessing of Medical Devices, RKIGuideline: 2012 Hygiene Requirements for the Reprocessing ofMedical Devices,AAMI TIR 30: 2011 as well as Guideline DGKH, DGSV, AKI: 2014Leitlinie von DGKH, DGSV und AKI für die Validierung undRoutineüberwachung maschineller Reinigungs- und thermischerDesinfektionsprozesse für Medizinprodukte | Pass |
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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.
§ 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).