(62 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description of the device's control methods (cutaneous electrodes, linear transducers, touchpads, switches) and setup process (prosthetist programming custom criteria) do not suggest the use of AI/ML for signal processing or control.
No.
The device is an external prosthetic component designed to assist with daily living activities for upper limb amputees, not to treat or diagnose a medical condition.
No
Explanation: The device is an advanced upper extremity prosthetic component designed to provide external prosthetic fittings and control elbow movement, not to diagnose medical conditions.
No
The device description explicitly states it is an "advanced upper extremity prosthetic component" and details hardware aspects like a powered elbow joint, auto-forearm balance mechanism, battery, electronics, and various control means (electrodes, transducers, touchpads, switches). It also mentions mechanical testing and battery safety testing, which are related to hardware components. While it includes a setup application (software), the core device is a physical prosthetic component.
Based on the provided information, the Espire Elbow is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for "external prosthetic fittings of the upper limbs" to "activate and control elbow movement." This describes a device used on the body to restore function, not a device used in vitro (outside the body) to examine specimens for diagnostic purposes.
- Device Description: The description details a prosthetic component that processes user input signals (electrodes, transducers, etc.) to control physical movement. This aligns with a prosthetic device, not an IVD.
- Lack of IVD Characteristics: The description does not mention analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information about a patient's health condition.
Therefore, the Espire Elbow falls under the category of a prosthetic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Espire Elbow is to be used exclusively for external prosthetic fittings of the upper limbs. The Espire Elbow processes user's input signals to activate and control elbow movement.
Product codes (comma separated list FDA assigned to the subject device)
GXY, IRE
Device Description
The Espire Elbow is an advanced upper extremity prosthetic component that when paired with other manufacturers' devices can create a complete upper extremity prosthetic system. Control means of the Espire Elbow include cutaneous electrodes, linear transducers, touchpads and/or switches. The manual control methods (linear transducer, touchpads, and switches) only require that the patient can press/touch the buttons as well as provide a pull type activation. The cutaneous electrodes offer an advanced method of control that uses the patient's muscle signals to govern the movement of the upper extremity prosthetic system. Depending on patient preferences the Espire Elbow comes in two configurations, Pro and Hybrid. The Espire Elbow (Pro) is designed to provide natural flexion and extension through a powered elbow joint which is activated by the input signals from the user. The Espire Elbow (Hybrid) contains an auto-forearm balance mechanism that assists the user with manually moving the elbow into different positions. use the same battery, electronics, inputs, and outputs.
At the time of the fitting a certified prosthetist uses the set-up application to program the device with custom criteria specific for each patient's needs. The setup is completed over a secure Bluetooth connection, no patient information is kept within the application. The Espire Elbow is designed to work seamlessly with most major manufacturers' wrist and hand devices. The Espire Elbow provides the control signals and battery power to these terminal devices.
The Espire Elbow is suitable for adult patients that are unilateral above elbow upper limb amputees. The device can be administered via prescription by a licensed and certified prosthetist only. For the prosthetist fitting the arm, CPI does not require any specific training related to the technology. The prosthetist will determine the combination of control means to be used with the Espire Elbow. The Espire Elbow is to be used for assistance in daily living; this includes normal daily routine type activities, as well as returning to work. The Espire Elbow is not indicated for use while driving any motorized vehicle or operation of heavy machinery. The device is also not to be used in any extremely warm or cold environments; this is primarily determined by the battery pack requirements. The battery pack must be removed in order to charge the device, using the supplied wall charger. Use in very wet environments, showering or swimming with the device is also outside the system capabilities.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper limbs
Indicated Patient Age Range
adult patients
Intended User / Care Setting
licensed and certified prosthetist
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)
Non-Clinical Performance Data:
The Espire Elbow passed all the testing in accordance with internal requirements, national standards, and international standards, including those shown below to support substantial equivalence of the subject device:
- Biocompatibility testing per ISO 10993-1, ISO 10993-5 and ISO 10993-10
- Electrical safety (including home healthcare) testing per AAMI IEC ES60601-1 and IEC 60601-1-11
- Electromagnetic Compatibility (EMC) testing per IEC 60601-1-2
- Usability testing per IEC 60601-1-6 and IEC 62366-1
- Battery safety testing per IEC 62133-2
- Software verification and validation testing per IEC 62304/FDA Guidance
- Mechanical Testing per ISO 22523
Clinical Performance Data:
There was no human clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. These types of devices, including the predicate devices, have been on the market for many years with proven safety and efficacy for the device. The non-clinical testing detailed in this submission supports the substantial equivalence of the device.
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
§ 882.1320 Cutaneous electrode.
(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
November 29, 2018
College Park Industries, Inc. % Ken Pilgrim Senior RA/QA Consultant Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, Texas 78746
Re: K182757
Trade/Device Name: Espire Elbow Pro, Espire Elbow Hybrid Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY, IRE Dated: September 21, 2018 Received: September 28, 2018
Dear Ken Pilgrim:
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 avare 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.
1
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 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Vivek J. Pinto -S
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K182757
Device Name ESPIRE ELBOW
Indications for Use (Describe)
The Espire Elbow is to be used exclusively for external prosthetic fittings of the upper limbs. The Espire Elbow processes user's input signals to activate and control elbow movement.
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) Summary
ESPIRE DIGITAL ELBOW
K182757
1. Submission Sponsor
College Park Industries, Inc.
27955 College Park Dr.
Warren, MI 48088 USA
Contact: Deborah Mackmin, Regulatory Specialist
2. Submission Correspondent
Emergo Global Consulting, LLC
2500 Bee Cave Road
Building 1, Suite 300
Austin, TX 78746 USA
Office Phone: (512) 327.9997
Contact: Ken Pilgrim, Senior Consultant, RA&QA
3. Date Prepared
21 September 2018
4. Device Identification
| Trade/Proprietary Name: | Espire Elbow |
|---|---|
| Classification Name: | Cutaneous Electrode |
| Regulation Number: | 882.1320 |
| Product Code: | Primary: GXY (Electrode, Cutaneous) |
| Secondary: IRE (Joint, Elbow, External Limb Component, Powered) | |
| Device Class: | Class II |
| Classification Panel: | Neurology |
4
5. Legally Marketed Predicate Device
| 510[k] Number: | K123795 |
|---|---|
| Device Name: | Axon-Bus Prosthetic System |
| Manufacturer: | Otto Bock Healthcare Product GmbH |
| Product Code: | Primary: GXY (Electrode, Cutaneous) |
| Secondary: IQZ (Hand, External Limb Component, Powered) |
6. Indications for Use Statement
The Espire Elbow is to be used exclusively for external prosthetic fittings of the upper limbs. The Espire Elbow processes user's input signals to activate and control elbow movement.
7. Device Description
The Espire Elbow is an advanced upper extremity prosthetic component that when paired with other manufacturers' devices can create a complete upper extremity prosthetic system. Control means of the Espire Elbow include cutaneous electrodes, linear transducers, touchpads and/or switches. The manual control methods (linear transducer, touchpads, and switches) only require that the patient can press/touch the buttons as well as provide a pull type activation. The cutaneous electrodes offer an advanced method of control that uses the patient's muscle signals to govern the movement of the upper extremity prosthetic system. Depending on patient preferences the Espire Elbow comes in two configurations, Pro and Hybrid. The Espire Elbow (Pro) is designed to provide natural flexion and extension through a powered elbow joint which is activated by the input signals from the user. The Espire Elbow (Hybrid) contains an auto-forearm balance mechanism that assists the user with manually moving the elbow into different positions. use the same battery, electronics, inputs, and outputs.
At the time of the fitting a certified prosthetist uses the set-up application to program the device with custom criteria specific for each patient's needs. The setup is completed over a secure Bluetooth connection, no patient information is kept within the application. The Espire Elbow is designed to work seamlessly with most major manufacturers' wrist and hand devices. The Espire Elbow provides the control signals and battery power to these terminal devices.
The Espire Elbow is suitable for adult patients that are unilateral above elbow upper limb amputees. The device can be administered via prescription by a licensed and certified prosthetist only. For the prosthetist fitting the arm, CPI does not require any specific training related to the technology. The prosthetist will determine the combination of control means to be used with the Espire Elbow. The Espire Elbow is to be used for assistance in daily living; this includes normal daily routine type activities, as well as returning to work. The Espire Elbow is not indicated for use while driving any motorized vehicle or operation of heavy machinery. The device is also not to be used in any extremely warm or cold environments; this is primarily determined by the battery pack requirements. The battery pack must be removed in order to charge the device, using the supplied wall charger. Use in very wet environments, showering or swimming with the device is also outside the system capabilities.
5
The CPI Elbow unit contains the following components:
- Espire Elbow 1.
-
- Pro Powered Elbow Joint or Hybrid Elbow Joint
- ന് Removeable Battery - 2 included
-
- Battery Wall Charger
- ഗ് Selected Input Device Cables
-
- Set-up application on tablet
-
- Dome electrodes (provided separately)
8. Substantial Equivalence Discussion
The following table compares the Espire Elbow to the predicate device with respect to indications for use, principles of operation, technological characteristics, and performance testing. The comparison of the devices provides more detailed information regarding the basis for the determination of substantial equivalence. The subject device does not raise any new issues of safety or effectiveness based on the similarities to the predicate device.
| Manufacturer | College Park Industries, Inc. | Otto Bock Health Care
Product GmbH | Device
Comparison |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| Trade Name | Espire Elbow | Axon-Bus Prosthetic System | |
| 510(k) Number | TBD | K123795 | N/A |
| Product Code | Primary: GXY (Electrode,
Cutaneous) | Primary: GXY (Electrode,
Cutaneous) | Same Primary
Product Code |
| Secondary Product
Code | Secondary: IRE (Joint, Elbow,
External Limb Component,
Powered) | Secondary: IQZ (Hand,
External Limb Component,
Powered) | Differs |
| Regulation No. | 21 CFR 890.3450 | 21 CFR 890.3450 | Same |
| Regulation Name | Cutaneous electrode | Cutaneous electrode | Same |
| Indications for Use | The Espire Elbow is to be
used exclusively for external
prosthetic fittings of the
upper limbs. The Espire
Elbow processes user's input
signals to activate and
control elbow movement. | The Axon-Bus Prosthetic
System is to be used
exclusively for exoprosthetic
fittings of the upper limbs. | Similar. Subject
device has added
description of
application area
and use of inputs. |
| Manufacturer | College Park Industries, Inc. | Otto Bock Health Care
Product GmbH | Device
Comparison |
| Trade Name | Espire Elbow | Axon-Bus Prosthetic System | |
| Use/Field of
Application | The Espire Elbow System is
suitable for unilateral or
bilateral amputations starting
with transhumeral
amputation level. | The Axon-Bus Prosthetic
System is suitable for
unilateral or bilateral
amputations starting with the
transradial / transhumeral
amputation level or, in case of
dysmelia, for forearm or
upper arm fittings. | Similar |
| Conditions for Use | The Espire Elbow is to be
used for normal daily routine
type activities, as well as
returning to work. The Espire
Elbow is not indicated for use
while driving any motorized
vehicle, operation of heavy
machinery, or use in any
extreme sport. The device is
also not to be used in any
extremely warm or cold
environments. | The Axon-Bus Prosthetic
System was developed for
everyday use and must not be
used for unusual activities.
These activities include, for
example, sports with
excessive strain and/or shocks
to the wrist unit (pushups,
downhill, mountain biking) or
extreme sports (free climbing,
paragliding, etc.) Furthermore,
the Axon-Bus Prosthetic
System should not be used for
the operation of motor
vehicles or motor driven
equipment. | Similar |
| Mechanism of
Action | The components of the
Espire Elbow system are
assembled by a prosthetist
according to the individual
needs of the patient. | The components of the Axon-
Bus Prosthetic System are
assembled by a prosthetist
according to the individual
needs of the amputee. | Similar |
| Myo Control
Options | 5 | 4 | Similar |
| Power Source | | | |
| Battery Pack | Li-Ion, 3 cell | Li-Ion, 3 cell | Same |
| Battery Capacity | 3000 mAh | 1150/1500 mAh | Differs |
| Nominal Voltage | 10.8 V | 11.1 V | Similar |
| Manufacturer | College Park Industries, Inc. | Otto Bock Health Care
Product GmbH | Device
Comparison |
| Trade Name | Espire Elbow | Axon-Bus Prosthetic System | |
| Charge Time | 3.5 hours | 3.5 hours | Same |
| Weight | 174 g | 142 g | Differs |
| Rechargeable | Yes | Yes | Same |
| Electrode | | | |
| Contact Material | 316L Stainless Steel | Titanium | Differs with
regard to Hybrid
model |
| Adjustment | Within Setup Software, | Potentiometer 1-7 | Differs with
regard to Hybrid
model |
| Testing | ISO-10993 | ISO-10993 | Same |
| Elbow | | | |
| Powered | Pro — yes, Hybrid — no | No | Differs |
| Product Code IRE
Applicable | Yes | No - elbow joint is not
powered | Differs |
| Automatic
Forearm Balance | Pro - no, Hybrid - Yes | No | Differs |
| Lock | Electric | Mechanical, electric | Similar |
| Right and Left
Configurations | Yes | No | Differs |
| Wrist size | 45 mm / 50 mm | 45 mm / 50 mm | Same |
| Maximum forearm
length | 12 in | 12 in | Same |
| Flexion Angle | -5-135° | 15-145° | Differs |
| Maximum Lifting | 10 lbs | 10 lbs | Same |
| Maximum Holding | 25 lbs | 50 lbs | Differs |
| Manufacturer | College Park Industries, Inc. | Otto Bock Health Care
Product GmbH | Device
Comparison |
| Trade Name | Espire Elbow | Axon-Bus Prosthetic System | |
| Hand | | | |
| Manufactures
Hand | No, uses other
manufacturers' terminal
devices. Only supplies 1
degree of freedom. | Yes, multiarticulating hand. | Differs |
| Setup | | | |
| Device
Programming | Espire Hub Tablet Application | Axon Bus Computer
Application | Similar |
Table 5A – Comparison of Characteristics
6
7
8
9. Non-Clinical Performance Data
As part of demonstrating safety and effectiveness of the Espire Elbow and in showing substantial equivalence to the predicate device that is subject to this 510(k) submission, College Park Industries, Inc. completed a number of non-clinical performance tests. The Espire Elbow meets all the requirements for overall design, biocompatibility and electrical safety results confirming that the design output meets the design inputs and specifications for the device.
The Espire Elbow passed all the testing in accordance with internal requirements, national standards, and international standards, including those shown below to support substantial equivalence of the subject device:
- . Biocompatibility testing per ISO 10993-1, ISO 10993-5 and ISO 10993-10
- Electrical safety (including home healthcare) testing per AAMI IEC ES60601-1 and IEC 60601-1-11
- . Electromagnetic Compatibility (EMC) testing per IEC 60601-1-2
- Usability testing per IEC 60601-1-6 and IEC 62366-1
- Battery safety testing per IEC 62133-2
- Software verification and validation testing per IEC 62304/FDA Guidance
- Mechanical Testing per ISO 22523
10. Clinical Performance Data
There was no human clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. These types of devices, including the predicate devices, have been on the market for many years with proven safety and efficacy for the device. The non-clinical testing detailed in this submission supports the substantial equivalence of the device.
9
11. Statement of Substantial Equivalence
The Espire Elbow, as designed and manufactured, is determined to be substantially equivalent to the referenced predicate device.