(677 days)
The Velocity Alpha™ Drill System is indicated for trepanating, incision, cutting, removal, shaping, sawing of soft and hard tissue, bone, and bone replacement materials.
Applications: Cutting, removing, shaping and sawing hard and soft tissue, bone, and bone replacement materials.
Areas of use: Neurosurgery and spinal surgery.
The Velocity Alpha™ Highspeed Surgical Drill System is an electric AC powered surgical motor drill system for rapid cutting, sawing, drilling and manipulation of soft tissue and bone.
The Subject Device has several components, such as an electric motor hand piece connected to and driven by an AC-powered control unit, a foot control unit (wired or wireless (Bluetooth)) and several adapters and nosepiece attachments, e.g. straight & angled nosepiece attachments, craniotome attachments, speed reducer attachments and sawing attachments.
The device has an optional irrigation pump that can supply irrigation through sterile tubing. Speed is variable from 1.000 RPM up to 80.000 RPM in order to adjust the speed to the surgeon's requirements. The direction of rotation can be pre-selected to the left and to the right.
The provided text describes the "Velocity Alpha Highspeed Surgical Drill System" and presents a summary of its substantial equivalence to a predicate device, including performance data. However, it does not contain a typical study design with acceptance criteria and results in the format implied by your request for "device performance" in relation to specific clinical outcomes or diagnostic accuracy.
The document primarily focuses on demonstrating substantial equivalence to a predicate device for regulatory clearance (510(k)). The "Performance data testing" section refers to engineering and functional tests rather than clinical studies or those involving expert review of diagnostic output.
Here's an analysis of the provided information based on your requested headings:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Functional (motor speed / torque analysis) | Torque was reached as specified | Pass |
| Temperature | Temperature was in compliance to specifications | Pass |
| Lifetime | The System functioned according to specifications | Pass |
| Noise level | The Noise level did not exceed the limit | Pass |
| Electrical Safety | Be aligned with IEC60601-1:2005 Electrical Safety | Pass |
| Electromagnetic Compatibility | Be aligned with IEC60601-1-2:2014 Electromagnetic compatibility | Pass |
2. Sample Size Used for the Test Set and Data Provenance
This document does not specify a "test set" in the context of clinical data, diagnostic images, or patient-specific results. The performance data presented are for the device itself (e.g., motor speed, temperature, electrical safety). Therefore, there is no information on sample size or data provenance in that regard.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. The "ground truth" for the engineering performance tests (motor speed, temperature, etc.) would be established by technical specifications and validated measurement equipment, not by clinical experts.
4. Adjudication Method for the Test Set
Not applicable. There is no mention of adjudication, as the tests performed are technical and do not involve subjective interpretation.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The document does not describe any studies comparing human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a surgical drill system, not an AI algorithm or diagnostic tool. The performance tests are for the physical device's operation.
7. The Type of Ground Truth Used
The ground truth for the performance data testing was based on technical specifications and established international standards (e.g., IEC 60601-1, IEC 60601-1-2) which define acceptable limits for motor speed, torque, temperature, noise, electrical safety, and electromagnetic compatibility.
8. The Sample Size for the Training Set
Not applicable. This device is a mechanical/electrical surgical system and does not utilize a "training set" in the AI/machine learning sense.
9. How the Ground Truth for the Training Set was Established
Not applicable for the same reason as above.
Summary of the Study that Proves the Device Meets the Acceptance Criteria:
The document describes a series of engineering and functional performance tests conducted on the Velocity Alpha Highspeed Surgical Drill System. These tests evaluated various technical aspects of the device, including:
- Motor speed and torque analysis: To confirm the motor performs within its specified range.
- Temperature analysis: To ensure the motor temperature remains within safe and specified limits during activity.
- Lifetime testing: To verify the system's durability and functionality over its expected operational lifespan.
- Noise level analysis: To confirm the noise generated by the device does not exceed specified limits.
- Electrical Safety testing: Conducted to ensure compliance with IEC 60601-1:2005, a standard for medical electrical equipment safety.
- Electromagnetic Compatibility (EMC) testing: Conducted to ensure compliance with IEC 60601-1-2:2014, a standard for EMC of medical electrical equipment.
- Wireless Foot Control testing: Included software verification/validation (IEC 62304:2006), EMC (IEC 60601-1-2:2007), and Electrical Safety (IEC 60601-1-1:2005) tests.
- Software Validation: Met requirements according to IEC 62304:2006.
- Biocompatibility testing: Performed on patient-contacting components (attachments/nosepieces) to meet ISO 10993 and EN ISO 10993-1 requirements.
Conclusion of the study: All tests "Passed," indicating that the device met its specified technical and safety acceptance criteria, demonstrating its substantial equivalence to the predicate device (Aesculap ELAN 4 Electro Motor System) based on technological characteristics, functionality, and intended use, without negative effects on safety or effectiveness. The document explicitly states "No clinical data is required for this device classification submission."
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April 11, 2021
adeor medical AG Ulrike Winkler Vice President QM/RA/R&D Martinshof 5 Valley, Bavaria 83626 Germany
Re: K191479
Trade/Device Name: Velocity Alpha Highspeed Surgical Drill System Regulation Number: 21 CFR 882.4310 Regulation Name: Powered Simple Cranial Drills, Burrs, Trephines, and Their Accessories Regulatory Class: Class II Product Code: HBE Dated: March 8, 2021 Received: March 10, 2021
Dear Ulrike Winkler:
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/cdrl/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 (OS) 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 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.
Xiaolin Zheng -S
Xiaolin Zheng, Ph.D. 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) K191479
Device Name
Velocity Alpha Highspeed Surgical Drill System
Indications for Use (Describe)
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X 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/0 description: The image shows the logo for Adeor Medical. The logo consists of a stylized blue brain on the left, followed by the word "adeor" in black, with the word "MEDICAL" in smaller black letters below it. The brain graphic is a simplified representation of a human brain, with geometric lines forming its structure.
510(k) Summary
-
- Company: adeor medical AG Martinshof 5 83626 Valley Germany
- II. Contact: Ulrike Winkler Vice President QM / RA / R&D (QMR)
- III. Preparation Date: 04th March, 2020
- IV. Proprietary Trade Name: Velocity Alpha™ Highspeed Surgical Drill System
- V. Common Name: Powered Drill System
- VI. Classification Name: Drills, Burrs, Trephines & Accessories (21 CFR 882.4310)
- VII. Classification: Class II
- VIII. Product Code: HBE
IX. Market device claiming equivalence to: The electric drill system is substantially equivalent to the Aesculap ELAN 4 Electro Motor System cleared via K152960.
X. Device Description:
The Velocity Alpha™ Highspeed Surgical Drill System is an electric AC powered surgical motor drill system for rapid cutting, sawing, drilling and manipulation of soft tissue and bone.
The Subject Device has several components, such as an electric motor hand piece connected to and driven by an AC-powered control unit, a foot control unit (wired or wireless (Bluetooth)) and several adapters and nosepiece attachments, e.g. straight & angled nosepiece attachments, craniotome attachments, speed reducer attachments and sawing attachments.
The device has an optional irrigation pump that can supply irrigation through sterile tubing. Speed is variable from 1.000 RPM up to 80.000 RPM in order to adjust the speed to the surgeon's requirements. The direction of rotation can be pre-selected to the left and to the right.
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Image /page/4/Picture/0 description: The image shows the logo for Adeor Medical. On the left side of the logo is a blue image of a brain. To the right of the brain is the word "adeor" in black, with the word "MEDICAL" in smaller black letters underneath.
XI. Intended Use / Indications for Use:
The Velocity Alpha™ Drill System is indicated for trepanating, incision, cutting, removal, shaping, sawing of soft and hard tissue, bone, and bone replacement materials.
| Applications: | Cutting, removing, shaping and sawing hard andsoft tissue, bone, and bone replacement materials. |
|---|---|
| Areas of use: | Neurosurgery and spinal surgery. |
- XII. Comparison of the Technological Characteristics and Substantial Equivalence: The technological characteristics of subject device are based on the same highspeed motor drill technology as the predicate devices.
| Item | New device | Predicate device | Equiva-lence |
|---|---|---|---|
| Trade Name | Velocity Alpha™ Highspeed Surgical DrillSystem | Aesculap ELAN 4 Electro | - |
| Picture | Image: Velocity Alpha Highspeed Surgical Drill System | Image: Aesculap ELAN 4 Electro | - |
| Intended Use | The Velocity Alpha™ Drill System is indicatedfor trepanating, incision, cutting, removal,shaping, sawing of soft and hard tissue,bone, and bone replacement materials.Applications: Cutting, removing, shaping andsawing hard and soft tissue, bone, and bonereplacement materials.Areas of use: Neurosurgery and spinalsurgery. | The Elan 4 Electro motorsystem is intended for highspeed cutting, sawing anddrilling of bone in the fields ofSpine, ENT, Neuro andMaxillofacial surgery. | Similar |
| Control Unit | |||
| Maximum speed | 80,000 rpm | 80,000 rpm | Identical |
| Voltage | 100-240 V | 110-240 V | Identical |
| Frequency | 50-60 Hz | 50-60 Hz | Identical |
| Irrigation Pump | Yes | Yes | Identical |
| Motor | |||
| High speedmotor (min /max) | 1.000 / 80.000 rpm | 10.000 / 80.000 rpm | Identical |
| Motor rotation | Right and left speed rotation | Right and left speed rotation | Identical |
| Materials | Stainless Steel | Stainless Steel | Identical |
| Foot Control | |||
| Control buttons | 4 buttons for• pump on/off• Forward/reverse | 3 buttons:• Pump on/off• Forward/reverse | Substantiallyequivalent -no question to |
| • Change programs• Motor control (on/off and variable) | • Foot pad | safety andeffectiveness | |
| Power supply: | • Wireless via 3xAA batteries• cable | Cable | Substantiallyequivalent -no question tosafety andeffectiveness |
| Features | |||
| Controlmechanism | Foot or touch screen | Foot or touch screen | Identical |
| Ability to connectdifferent motorhandpieces | no | yes | Identical |
| Motorconnections | 1 | 2 | Identical |
| Footswitchconnections | 1 | 1 | Identical |
| Control unit | Touch screen | Touch screen | Identical |
| Appliedstandards | IEC60601-1IEC60601-1-2IEC62304 | IEC60601-1IEC60601-1-2IEC62304 | Identical |
| Materials | |||
| Control unit withhousing | Plastic material | Plastic material | Identical |
| Motor with cable | Stainless steel | Stainless steel | Identical |
| attachments /nosepieces | Stainless steel | Stainless steel | Identical |
| Hygiene / Maintenance | |||
| Cleaning | The foot control is water-tight according toIPX8, 1 m depth of immersion, 1 hour (water-tight in accordance with IEC 60529).Control Unit and foot control (cabled orBluetooth): cleaning wiped with moist tissue.Wiping disinfection.Attachments: validated manual andmechanical cleaning and disinfection. Formore details see IFU page 30 to 35).Cutters/burrs: only sterile packed single-usecutters/burrs are being used (not part of thissubmission, see HiCUT InstrumentsK130755). | Similar cleaning procedure.(see annex IFU ELAN4Electric System) | Substantiallyequivalent -no questionin safety andeffectiveness |
| Sterilization | Gravity method: 15min, 132°C, drying time:20minPre-vacuum method: 4min, 132°C, drying time:16minFor more details see IFU page 35. | • Steam Autoclave/GravityAir Displacement 132°C/15 minutes wrapped orunwrapped 30 minutes drytime• Steam autoclave / Pre-vacuum: 132°C/ 3minutes wrapped orunwrapped, 30 minutesdry time. | Substantiallyequivalent -no questionin safety andeffectiveness |
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Image /page/5/Picture/0 description: The image shows the logo for Adeor Medical. On the left is a blue graphic of a brain. To the right of the brain is the word "adeor" in black, with the word "MEDICAL" in smaller black letters underneath.
XIII. Substantial Equivalence Discussion:
The technologic characteristics of the subject device are based on the same electric motor drill technology as the predicate devices. The adeor® Velocity Alpha™ Highspeed Surgical
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Image /page/6/Picture/0 description: The image shows the logo for Adeor Medical. The logo consists of a stylized blue brain on the left and the word "adeor" in black on the right. Below the word "adeor" is the word "MEDICAL" in smaller black letters.
Drill System is substantially equivalent to the predicate devices based upon the comparison of the technological characteristics.
Any difference that exists between the Velocity Alpha™ Highspeed Surgical Drill System and the predicate devices has no negative effects on safety or effectiveness of the subject device when used as labelled.
XIV. Performance data testing:
| Test | Description | Acceptance criteria | Results |
|---|---|---|---|
| Functional (motor speed /torque analysis) | Analyzed motor speed / torquecurve | Torque was reached asspecified | Pass |
| Temperature | Analyzed motor temperatureduring activity | Temperature was incompliance to specifications. | Pass |
| Lifetime | Analyzed System lifetime duringregular duty cycle | The System functionedaccording to specifications. | Pass |
| Noise level | Analyzed Noise level duringactivity | The Noise level did notexceed the limit. | Pass |
| Electrical Safety | Electric powered instrumentsevaluated for electrical safety | Be aligned with IEC60601-1:2005 Electrical Safety | Pass |
| Electromagnetic Compatibility | Electric powered instrumentsevaluated for electromagneticcompatibility | Be aligned with IEC60601-1-2:2014 Electromagneticcompatibility | Pass |
XV. Wireless Foot control:
For the wireless foot switch (VAFCBT) software verification/validation of the functions of the foot switch was conducted according to IEC 62304:2006. Additionally, EMC testing was performed to evaluate the risk of communication loss according to IEC 60601-1-2:2007 and Electrical Safety Tests have been done according to IEC 60601-1-1:2005.
XVI. Software:
Software validation meets the requirements according to IEC 62304:2006: Medical device software - Part 1: Guidance on the application of ISO 14972 to medical device software.
XVII. Biocompatibility:
Biocompatibility was evaluated on attachments/nosepieces which have patient contact and meets the requirements of ISO10993. In addition, Biocompatibility testing per EN ISO 10993-1 was performed.
XVIII. Animal and Clinical Performance Data:
No clinical data is required for this device classification submission.
XIX. Conclusion:
Substantial equivalence of the adeor® Velocity Alpha™ Highspeed Surgical Drill System can be assumed based on the similarity of the devices' technological characteristics, functionality and indications of use.
§ 882.4310 Powered simple cranial drills, burrs, trephines, and their accessories.
(a)
Identification. Powered simple cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments are used with a power source but do not have a clutch mechanism to disengage the tip after penetrating the skull.(b)
Classification. Class II (performance standards).