(677 days)
Not Found
No
The document describes a standard electric surgical drill system with variable speed and direction control. There is no mention of AI, ML, image processing, or data training/testing, which are typical indicators of AI/ML integration in medical devices. The performance studies focus on functional, safety, and software validation aspects of a traditional electromechanical device.
Yes
The device is intended for trepanating, incision, cutting, removal, shaping, sawing of soft and hard tissue, bone, and bone replacement materials in neurosurgery and spinal surgery, which are therapeutic interventions.
No
Explanation: The device is a surgical drill system used for cutting, removing, shaping, and sawing tissues and bones. Its intended use is therapeutic (surgical intervention), not diagnostic (identifying or characterizing a disease or condition).
No
The device description explicitly lists multiple hardware components including an electric motor hand piece, AC-powered control unit, foot control unit, adapters, nosepiece attachments, and an optional irrigation pump. While software is mentioned for the wireless foot control and overall system validation, the core functionality relies on physical hardware.
Based on the provided information, the Velocity Alpha™ Drill System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body.
- Velocity Alpha™ Function: The description clearly states that the Velocity Alpha™ Drill System is a surgical motor drill system used for "trepanating, incision, cutting, removal, shaping, sawing of soft and hard tissue, bone, and bone replacement materials" within the body during neurosurgery and spinal surgery.
- Lack of Specimen Analysis: There is no mention of the device being used to analyze samples or specimens taken from the patient. Its function is purely mechanical manipulation of tissue and bone during surgery.
Therefore, the Velocity Alpha™ Drill System is a surgical device used in vivo (within the living body), not an in vitro diagnostic device.
N/A
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 soft tissue, bone, and bone replacement materials.
Areas of use: Neurosurgery and spinal surgery.
Product codes (comma separated list FDA assigned to the subject device)
HBE
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Neurosurgery and spinal surgery (implying brain, skull, spine)
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Test: Functional (motor speed / torque analysis)
Description: Analyzed motor speed / torque curve
Acceptance criteria: Torque was reached as specified
Results: Pass
Test: Temperature
Description: Analyzed motor temperature during activity
Acceptance criteria: Temperature was in compliance to specifications.
Results: Pass
Test: Lifetime
Description: Analyzed System lifetime during regular duty cycle
Acceptance criteria: The System functioned according to specifications.
Results: Pass
Test: Noise level
Description: Analyzed Noise level during activity
Acceptance criteria: The Noise level did not exceed the limit.
Results: Pass
Test: Electrical Safety
Description: Electric powered instruments evaluated for electrical safety
Acceptance criteria: Be aligned with IEC60601-1:2005 Electrical Safety
Results: Pass
Test: Electromagnetic Compatibility
Description: Electric powered instruments evaluated for electromagnetic compatibility
Acceptance criteria: Be aligned with IEC60601-1-2:2014 Electromagnetic compatibility
Results: Pass
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 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).
0
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the acronym "FDA" followed by "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
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
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 (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
2
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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3
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.
4
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 and
soft 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 Drill
System | 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 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 Elan 4 Electro motor
system is intended for high
speed cutting, sawing and
drilling of bone in the fields of
Spine, ENT, Neuro and
Maxillofacial 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 speed
motor (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 | Substantially
equivalent -
no question to |
| | • Change programs
• Motor control (on/off and variable) | • Foot pad | safety and
effectiveness |
| Power supply: | • Wireless via 3xAA batteries
• cable | Cable | Substantially
equivalent -
no question to
safety and
effectiveness |
| Features | | | |
| Control
mechanism | Foot or touch screen | Foot or touch screen | Identical |
| Ability to connect
different motor
handpieces | no | yes | Identical |
| Motor
connections | 1 | 2 | Identical |
| Footswitch
connections | 1 | 1 | Identical |
| Control unit | Touch screen | Touch screen | Identical |
| Applied
standards | IEC60601-1
IEC60601-1-2
IEC62304 | IEC60601-1
IEC60601-1-2
IEC62304 | Identical |
| Materials | | | |
| Control unit with
housing | 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 to
IPX8, 1 m depth of immersion, 1 hour (water-
tight in accordance with IEC 60529).
Control Unit and foot control (cabled or
Bluetooth): cleaning wiped with moist tissue.
Wiping disinfection.
Attachments: validated manual and
mechanical cleaning and disinfection. For
more details see IFU page 30 to 35).
Cutters/burrs: only sterile packed single-use
cutters/burrs are being used (not part of this
submission, see HiCUT Instruments
K130755). | Similar cleaning procedure.
(see annex IFU ELAN4
Electric System) | Substantially
equivalent -
no question
in safety and
effectiveness |
| Sterilization | Gravity method: 15min, 132°C, drying time:
20min
Pre-vacuum method: 4min, 132°C, drying time:
16min
For more details see IFU page 35. | • Steam Autoclave/Gravity
Air Displacement 132°C/
15 minutes wrapped or
unwrapped 30 minutes dry
time
• Steam autoclave / Pre-
vacuum: 132°C/ 3
minutes wrapped or
unwrapped, 30 minutes
dry time. | Substantially
equivalent -
no question
in safety and
effectiveness |
5
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
6
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 / torque | ||
| curve | Torque was reached as | ||
| specified | Pass | ||
| Temperature | Analyzed motor temperature | ||
| during activity | Temperature was in | ||
| compliance to specifications. | Pass | ||
| Lifetime | Analyzed System lifetime during | ||
| regular duty cycle | The System functioned | ||
| according to specifications. | Pass | ||
| Noise level | Analyzed Noise level during | ||
| activity | The Noise level did not | ||
| exceed the limit. | Pass | ||
| Electrical Safety | Electric powered instruments | ||
| evaluated for electrical safety | Be aligned with IEC60601- | ||
| 1:2005 Electrical Safety | Pass | ||
| Electromagnetic Compatibility | Electric powered instruments | ||
| evaluated for electromagnetic | |||
| compatibility | Be aligned with IEC60601-1- | ||
| 2:2014 Electromagnetic | |||
| compatibility | 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.