Espire Elbow Pro, Espire Elbow Hybrid

K182757 · College Park Industries, Inc. · GXY · Nov 29, 2018 · Neurology

Device Facts

• Record ID: K182757
• Device Name: Espire Elbow Pro, Espire Elbow Hybrid
• Applicant: College Park Industries, Inc.
• Product Code: GXY · Neurology
• Decision Date: Nov 29, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1320
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Espire Elbow is an upper extremity prosthetic component; available in Pro (powered) and Hybrid (auto-forearm balance) configurations. Inputs include cutaneous electrodes (myoelectric signals), linear transducers, touchpads, or switches. Certified prosthetist uses tablet-based setup application via secure Bluetooth to program device parameters. Device provides battery power and control signals to third-party terminal devices (wrists/hands). Pro model provides powered flexion/extension; Hybrid model assists manual positioning. Used in clinic for fitting; patient uses in daily life. Output is physical movement of prosthetic elbow. Benefits include restoration of limb function and assistance with daily activities. Battery must be removed for charging via wall charger.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by non-clinical performance testing, including biocompatibility (ISO 10993), electrical safety (AAMI IEC ES60601-1, IEC 60601-1-11), EMC (IEC 60601-1-2), usability (IEC 60601-1-6, IEC 62366-1), battery safety (IEC 62133-2), software verification/validation (IEC 62304), and mechanical testing (ISO 22523).

Technological Characteristics

Powered elbow joint (Pro) or auto-forearm balance mechanism (Hybrid). Materials: 316L stainless steel contact material. Power: 10.8V, 3000 mAh Li-Ion battery. Connectivity: Bluetooth for setup. Standards: ISO 10993, IEC 60601 series, ISO 22523. Software: Tablet-based setup application.

Indications for Use

Indicated for adult patients with unilateral above elbow upper limb amputations requiring external prosthetic fittings for assistance in daily living and returning to work. Not indicated for driving motorized vehicles, operating heavy machinery, or use in extreme sports or extreme temperatures.

Regulatory Classification

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.

Predicate Devices

• Axon-Bus Prosthetic System (K123795)

Submission Summary (Full Text)

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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.

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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 ([e-mail]) or phone [phone] 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

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### 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)

| <span>☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> |
|-------------------------------------------------------------|
| <span>☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> |

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# 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: [phone]

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)<br>Secondary: IRE (Joint, Elbow, External Limb Component, Powered) |
| Device Class: | Class II |
| Classification Panel: | Neurology |

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#### 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)<br>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.

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The CPI Elbow unit contains the following components:

- Espire Elbow 1.
- 2. Pro Powered Elbow Joint or Hybrid Elbow Joint
- ന് Removeable Battery - 2 included
- 4. Battery Wall Charger
- ഗ് Selected Input Device Cables
- 6. Set-up application on tablet
- 7. 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<br>Product GmbH | Device<br>Comparison |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| Trade Name | Espire Elbow | Axon-Bus Prosthetic System | |
| 510(k) Number | TBD | K123795 | N/A |
| Product Code | Primary: GXY (Electrode,<br>Cutaneous) | Primary: GXY (Electrode,<br>Cutaneous) | Same Primary<br>Product Code |
| Secondary Product<br>Code | Secondary: IRE (Joint, Elbow,<br>External Limb Component,<br>Powered) | Secondary: IQZ (Hand,<br>External Limb Component,<br>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<br>used exclusively for external<br>prosthetic fittings of the<br>upper limbs. The Espire<br>Elbow processes user's input<br>signals to activate and<br>control elbow movement. | The Axon-Bus Prosthetic<br>System is to be used<br>exclusively for exoprosthetic<br>fittings of the upper limbs. | Similar. Subject<br>device has added<br>description of<br>application area<br>and use of inputs. |
| Manufacturer | College Park Industries, Inc. | Otto Bock Health Care<br>Product GmbH | Device<br>Comparison |
| Trade Name | Espire Elbow | Axon-Bus Prosthetic System | |
| Use/Field of<br>Application | The Espire Elbow System is<br>suitable for unilateral or<br>bilateral amputations starting<br>with transhumeral<br>amputation level. | The Axon-Bus Prosthetic<br>System is suitable for<br>unilateral or bilateral<br>amputations starting with the<br>transradial / transhumeral<br>amputation level or, in case of<br>dysmelia, for forearm or<br>upper arm fittings. | Similar |
| Conditions for Use | The Espire Elbow is to be<br>used for normal daily routine<br>type activities, as well as<br>returning to work. The Espire<br>Elbow is not indicated for use<br>while driving any motorized<br>vehicle, operation of heavy<br>machinery, or use in any<br>extreme sport. The device is<br>also not to be used in any<br>extremely warm or cold<br>environments. | The Axon-Bus Prosthetic<br>System was developed for<br>everyday use and must not be<br>used for unusual activities.<br>These activities include, for<br>example, sports with<br>excessive strain and/or shocks<br>to the wrist unit (pushups,<br>downhill, mountain biking) or<br>extreme sports (free climbing,<br>paragliding, etc.) Furthermore,<br>the Axon-Bus Prosthetic<br>System should not be used for<br>the operation of motor<br>vehicles or motor driven<br>equipment. | Similar |
| Mechanism of<br>Action | The components of the<br>Espire Elbow system are<br>assembled by a prosthetist<br>according to the individual<br>needs of the patient. | The components of the Axon-<br>Bus Prosthetic System are<br>assembled by a prosthetist<br>according to the individual<br>needs of the amputee. | Similar |
| Myo Control<br>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<br>Product GmbH | Device<br>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<br>regard to Hybrid<br>model |
| Adjustment | Within Setup Software, | Potentiometer 1-7 | Differs with<br>regard to Hybrid<br>model |
| Testing | ISO-10993 | ISO-10993 | Same |
| Elbow | | | |
| Powered | Pro — yes, Hybrid — no | No | Differs |
| Product Code IRE<br>Applicable | Yes | No - elbow joint is not<br>powered | Differs |
| Automatic<br>Forearm Balance | Pro - no, Hybrid - Yes | No | Differs |
| Lock | Electric | Mechanical, electric | Similar |
| Right and Left<br>Configurations | Yes | No | Differs |
| Wrist size | 45 mm / 50 mm | 45 mm / 50 mm | Same |
| Maximum forearm<br>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<br>Product GmbH | Device<br>Comparison |
| Trade Name | Espire Elbow | Axon-Bus Prosthetic System | |
| Hand | | | |
| Manufactures<br>Hand | No, uses other<br>manufacturers' terminal<br>devices. Only supplies 1<br>degree of freedom. | Yes, multiarticulating hand. | Differs |
| Setup | | | |
| Device<br>Programming | Espire Hub Tablet Application | Axon Bus Computer<br>Application | Similar |

#### Table 5A – Comparison of Characteristics

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#### 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.

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### 11. Statement of Substantial Equivalence

The Espire Elbow, as designed and manufactured, is determined to be substantially equivalent to the referenced predicate device.