(91 days)
No
The description focuses on wireless control of motor speed based on user pressure, with no mention of AI or ML algorithms for data analysis, decision-making, or adaptation. The software development follows standard medical device software processes (IEC 62304), not specifically AI/ML frameworks.
No
This device is an accessory to a surgical system that cuts and shapes bone; it does not directly treat a disease or condition itself, which is the definition of a therapeutic device.
No
The device is described as an accessory for controlling the speed of a high-speed surgical system used for cutting and shaping bone, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly states it consists of two physical articles: a sterile, single-use Wireless Hand Control and a non-sterile reusable Receiver. It also mentions hardware verification and validation, and compliance with hardware standards like IEC 60601-1.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "cutting and shaping bone including spine and cranium." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device is a wireless hand control system for a high-speed surgical system used for bone cutting. It controls the speed of a motor.
- Lack of IVD Characteristics: An IVD device is 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 such specimens.
The device is a surgical accessory used during a procedure, not for in vitro testing of biological samples.
N/A
Intended Use / Indications for Use
The eG1 High Speed System is indicated for cutting and shaping bone including spine and cranium.
Product codes
HBC, ERL
Device Description
The eG1 Wireless Hand Control System is intended to be used as an optional accessory to the eG1 High Speed System (K133604) to provide an alternative method for controlling the eG1 Handpiece motor speed instead of using the existing wired foot control pedal.
The eG1 Wireless Hand Control System consists of two articles:
-
The Wireless Hand Control, EG1A (article # WIRELESS-HC) is a sterile, single-use device that snaps on the eG1 Handpiece.
-
The Receiver for Wireless Hand Control, EG1A (article # RECEIVER-HC) is a non-sterile reusable device that plugs into the eG1 Control Console.
The WIRELESS-HC sends information about the amount of pressure applied by the user on its button to the RECEIVER-HC wirelessly. The RECEIVER-HC uses this information to modulate the speed of the eG1 Handpiece motor.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
spine and cranium
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
A design verification analysis was conducted to verify that the physical characteristics of the eG1 Wireless Hand Control System meet the design inputs related to the interfaces with the user, eG1 Handpiece and Console.
Design verification testing was conducted to verify the functional aspects of the proposed device.
The software of the proposed device was developed applying IEC 62304:2015 Medical device software - Software life cycle processes. Design verification analysis, Design verification testing and Software Validation were conducted on the proposed device firmware.
The proposed device was developed, tested and certified according to IEC 60601-1:2012 / ANSI/AAMI ES60601-1:2012 Medical Electrical Equipment – General Requirements for Basic Safety and Essential Performance.
The proposed device was developed, tested and certified according to IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests. The proposed device was found compliant with applicable US FCC regulations and standards 47 CFR Part 15 Subpart B and 47 CFR § 15.247.
The radio emissions were tested according to IEC 62311:2007 Assessment of electronic and electrical equipment related to human exposure restrictions for electromagnetic fields (0 Hz to 300 GHz).
The WIRELESS-HC is sterilized by Ethylene Oxide. The sterilization cycle was validated according to ISO 11135:2014 Sterilization of health-care products - Ethylene oxide -Requirements for the development, validation and routine control of a sterilization process for medical devices.
All acceptance criteria are met. The differences in technological characteristics do not raise new questions of safety or effectiveness based on results of risk-based verification and validation testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.4360 Electric cranial drill motor.
(a)
Identification. An electric cranial drill motor is an electrically operated power source used with removable rotating surgical cutting tools or drill bits on a patient's skull.(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.
May 19, 2022
The Anspach Effort, Inc. % Marie Ferrier Senior Regulatory Affairs Program Lead Synthes GmbH Eimattstrasse 3 Oberdorf, 4436, Switzerland
Re: K220485
Trade/Device Name: Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A (RECEIVER-HC) Regulation Number: 21 CFR 882.4360 Regulation Name: Electric Cranial Drill Motor Regulatory Class: Class II Product Code: HBC, ERL Dated: April 20, 2022 Received: April 21, 2022
Dear Marie Ferrier:
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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,
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) K220485
Device Name
Wireless Hand Control, EG1A (WIRELESS-HC); Receiver for Wireless Hand Control, EG1A (RECEIVER-HC)
Indications for Use (Describe)
The eG1 High Speed System is indicated for cutting and shaping bone including spine and cranium.
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
The Anspach Effort, Inc. eG1 Wireless Hand Control System: Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A (RECEIVER-HC)
510(k) Summary
A. Device Information:
| Category | Comments |
|---|---|
| Sponsor: | The Anspach Effort, Inc. |
| 4500 Riverside Drive | |
| Palm Beach Gardens FL 33410, United States | |
| Tel: 1-561-627-1080 | |
| Correspondent Contact | |
| Information: | Mrs. Marie Ferrier |
| Synthes GmbH | |
| Eimattstrasse 3 | |
| Oberdorf 4436, Switzerland | |
| Tel: +33(0)675765048 | |
| Device Common Name: | Wireless Hand Control System |
| Device Regulation & Name: | 882.4360 – Electrical cranial drill motor |
| 874.4250 – Ear, nose, and throat electric or pneumatic | |
| surgical drill | |
| Classification & Product Code: | HBC (Class 2) – Motor, Drill, Electric |
| ERL (Class 2) – Drill, Surgical, Ent (Electric or | |
| Pneumatic) Including Handpiece | |
| 510(k) Number: | K220485 |
| Device Proprietary Name: | eG1 Wireless Hand Control System |
Predicate Device Information:
| Predicate Device: | Foot control pedals used with eG1 High
Speed System |
|----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|
| Predicate Device Manufacturer: | The Anspach Effort, Inc. |
| Predicate Device Common Name: | eG1 High Speed System |
| Predicate Device Premarket Notification # | K133604 |
| Predicate Device Regulation & Name: | 882.4360 - Electrical cranial drill motor
874.4250 - Ear, nose, and throat electric or
pneumatic surgical drill |
| Predicate Device Classification
& Product Code: | HBC (Class 2) – Motor, Drill, Electric
ERL (Class 2) – Drill, Surgical, Ent
(Electric or Pneumatic) Including
Handpiece |
4
B. Date Summary Prepared
May 19th, 2022
C. Description of Device
The eG1 Wireless Hand Control System is intended to be used as an optional accessory to the eG1 High Speed System (K133604) to provide an alternative method for controlling the eG1 Handpiece motor speed instead of using the existing wired foot control pedal.
The eG1 Wireless Hand Control System consists of two articles:
-
The Wireless Hand Control, EG1A (article # WIRELESS-HC) is a sterile, single-use device that snaps on the eG1 Handpiece.
-
The Receiver for Wireless Hand Control, EG1A (article # RECEIVER-HC) is a non-sterile reusable device that plugs into the eG1 Control Console.
The WIRELESS-HC sends information about the amount of pressure applied by the user on its button to the RECEIVER-HC wirelessly. The RECEIVER-HC uses this information to modulate the speed of the eG1 Handpiece motor.
D. Indications for Use
The eG1 High Speed System is indicated for cutting and shaping bone including spine and cranium.
5
| Characteristic | Application Device:
eG1 Wireless Hand
Control System
K220485 | Predicate Device:
Foot control pedals used
with eG1 High Speed
System K133604 | Impact on Substantial
Equivalence |
|---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company | The Anspach Effort, Inc. | The Anspach Effort, Inc. | - |
| Regulation
Number | 882.4360 – Electrical
cranial drill motor
874.4250 – Ear, nose, and
throat electric or
pneumatic surgical drill | 882.4360 – Electrical
cranial drill motor
874.4250 – Ear, nose, and
throat electric or
pneumatic surgical drill | Identical |
| FDA Product
Code | HBC (Class 2) – Motor,
Drill, Electric
ERL (Class 2) – Drill,
Surgical, Ent (Electric or
Pneumatic) Including
Handpiece | HBC (Class 2) – Motor,
Drill, Electric
ERL (Class 2) – Drill,
Surgical, Ent (Electric or
Pneumatic) Including
Handpiece | Identical |
| Intended Use
& Indications
for Use | Cutting and shaping bone
including spine and
cranium | Cutting and shaping bone
including spine and
cranium | Identical |
| The device
controls/
function | Speed (increase/
decrease) of the
handpiece motor | Speed (increase/ decrease)
of the handpiece motor
Depending on model:
-rotation
-irrigation pump | Identical (the predicate
has additional functions) |
| Principle of
operation/
Technology | The pressure on the
button is transferred from
the WIRELESS-HC to
RECEIVER-HC
wirelessly (radio signal)
and transformed into an
electric signal | The pressure on the pedal
is transformed into an
electric signal | The predicate device
does not contain any
wireless technology.
The device Wireless
Foot control used with
ELAN 4 Electro Motor
System (K203739) is
used as a reference
device for this
application as it shares
the same indications for
use, function and usage
of the wireless
technology to transmit a
signal in order to
regulate the speed of the
handpiece motor. The
proposed device and the
reference device operate
in the same frequency
band (2.4 GHz).
Software, Wireless and
Electromagnetic
Compatibility testing are |
| | | | provided in this
application to
demonstrate the
Substantial Equivalence. |
| Power tool
compatibility | eG1 High Speed System | eG1 High Speed System | Identical |
| Interface with
the user (user
action) | Increase/ decrease the
pressure on the button to
increase/ decrease the
speed | Increase/ decrease the
pressure on the pedal to
increase/ decrease the
speed
Depending on model:
-Press the dedicated button
to change rotation
-Press the dedicated button
to activate irrigation pump | Identical (the predicate
has additional functions) |
| Interface with
the console | Receiver plugs into the
eG1 consoles (foot pedal
connector port) | Cord plugs into the eG1
consoles (foot pedal
connector port) | Identical |
| Power source | RECEIVER-HC: main
power through the
console
WIRELESS-HC: contains
a lithium coin battery | Main power through the
console | Electrical Safety testing
is provided in this
application to
demonstrate the
Substantial Equivalence. |
| Patient
contact | No direct or indirect
patient contact | No direct or indirect
patient contact | Identical |
| Sterilization/
Reprocessing | RECEIVER-HC: non
sterile, reusable (cleaning
only)
WIRELESS-HC: sterile,
single-use | Non sterile, reusable
(cleaning only) | The predicate device is
non sterile. Sterilization
Validation is provided
in this application to
demonstrate the
Substantial Equivalence. |
E. Comparison of the Technological Characteristics
6
F. Summary of Supporting Data
The proposed device eG1 Wireless Hand Control System has the same intended use, function, interface with the eG1 console and patient contact as the predicate device Foot control pedals used with eG1 High Speed System (K133604). The proposed device shows some differences regarding the power source, the technology (wireless) and sterilization.
A design verification analysis was conducted to verify that the physical characteristics of the eG1 Wireless Hand Control System meet the design inputs related to the interfaces with the user, eG1 Handpiece and Console.
Design verification testing was conducted to verify the functional aspects of the proposed device.
The software of the proposed device was developed applying IEC 62304:2015 Medical device software - Software life cycle processes. Design verification analysis, Design verification testing and Software Validation were conducted on the proposed device firmware.
The proposed device was developed, tested and certified according to IEC 60601-1:2012 / ANSI/AAMI ES60601-1:2012 Medical Electrical Equipment – General Requirements for
7
Basic Safety and Essential Performance.
The proposed device was developed, tested and certified according to IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests. The proposed device was found compliant with applicable US FCC regulations and standards 47 CFR Part 15 Subpart B and 47 CFR § 15.247.
The radio emissions were tested according to IEC 62311:2007 Assessment of electronic and electrical equipment related to human exposure restrictions for electromagnetic fields (0 Hz to 300 GHz).
The WIRELESS-HC is sterilized by Ethylene Oxide. The sterilization cycle was validated according to ISO 11135:2014 Sterilization of health-care products - Ethylene oxide -Requirements for the development, validation and routine control of a sterilization process for medical devices.
G. Discussion of Performance Testing
All acceptance criteria are met. The differences in technological characteristics do not raise new questions of safety or effectiveness based on results of risk-based verification and validation testing.
H. Conclusion
Following the 510(k) Decision-Making Flowchart, it is determined that the eG1 Wireless Hand Control System is substantially equivalent to the predicate Foot control pedals used with eG1 High Speed System (K133604) as there is no difference in the intended use and the differences in technological characteristics do not raise new questions of safety or effectiveness.