Relign System

K162770 · Relign Corporation · GEI · Jan 4, 2017 · General, Plastic Surgery

Device Facts

• Record ID: K162770
• Device Name: Relign System
• Applicant: Relign Corporation
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jan 4, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Relign Arthroscopic System is indicated for use in orthopedic and arthroscopic procedures. The Fluid Management System of the Relign Arthroscopic System provides fluid distension of the knee, shoulder, ankle, elbow, wrist and hip, and fluid suction during diagnostic and operative arthroscopic procedures. The Shaver Blade/RF Probe of the Relign Arthroscopic System provides abrasion, resection, debridement, and removal of bone through its shaver blade; removal, ablation, and coagulation of soft tissue; as well as hemostasis of blood vessels through its shaver blade and probe. Examples of uses of the product include resection of torn knee cartilage, subacromial decompression, and resection of synovial tissue in other joints.

Device Story

Integrated system for orthopedic/arthroscopic surgery; combines radiofrequency (RF) controller, shaver system, and fluid management. Inputs: user settings via touch screen, handpiece buttons, or footswitch. Operation: peristaltic pumps manage fluid inflow/outflow; handpiece motor drives shaver blades for bone/tissue resection; RF energy delivered via bipolar contacts for ablation/coagulation. Outputs: visual feedback on controller/handpiece LCDs; mechanical resection; RF-induced tissue ablation/hemostasis. Used in OR by surgeons. System automates suction levels based on shaver/RF activation and performs automatic window/electrode positioning upon activation release. Benefits: integrated control of fluid, resection, and ablation in one unit; improved visualization via automated field clearing; precise tissue management.

Clinical Evidence

Bench testing only. Included flow rate, pressure control, electrode temperature/coagulation depth, mechanical/durability, simulated use, cadaver, distribution, and shelf-life testing. Software verified per IEC 62304. Electrical safety/EMC per IEC 60601-1, 60601-2-2, 60601-1-2. Biocompatibility per ISO 10993. Sterilization validated per ISO 11137-2 (Gamma) and ISO 14937 (STERRAD). Human factors (formative/summative) confirmed user ability to set up and operate.

Technological Characteristics

Integrated controller with touch screen; peristaltic inflow/outflow pumps; handpiece with LCD and hand switches. Materials: Zirconia (burr/cutter), 304 Stainless Steel (electrode), Ceramic (insulation). Energy: Bipolar RF (400W max, 225kHz). Connectivity: Standalone system. Sterilization: Gamma (disposables), STERRAD (reusable handpiece). Software: IEC 62304 compliant.

Indications for Use

Indicated for orthopedic and arthroscopic procedures in knee, shoulder, ankle, elbow, wrist, and hip joints. Contraindicated for procedures using nonconductive irrigants or in patients with cardiac pacemakers or other electronic implants.

Regulatory Classification

Identification

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

Predicate Devices

• Stryker Crossfire Integrated Arthroscopy System (K071859)
• Stryker CrossFlow Integrated Arthroscopy Pump (K123441)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 4, 2017

ReLIGN Corporation Mr. Nathan Nguyen Sr. Director, Quality Assurance & Regulatory Affairs 1601 South De Anza Boulevard. Suite 200 Cupertino, California 95014

Re: K162770

Trade/Device Name: ReLIGN Arthroscopic System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI, HRX Dated: December 2, 2016 Received: December 5, 2016

Dear Mr. Nguyen:

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. 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 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

# Jennifer R. Stevenson -A

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known) K162770

Device Name

Relign Arthroscopic System

### Indications for Use (Describe)

The Relign Arthroscopic System is indicated for use in orthopedic and arthroscopic procedures. The Fluid Management System of the Relign Arthroscopic System provides fluid distension of the knee, shoulder, ankle, elbow, wrist and hip, and fluid suction during diagnostic and operative arthroscopic procedures. The Shaver Blade/RF Probe of the Relign Arthroscopic System provides abrasion, resection, debridement, and removal of bone through its shaver blade; removal, ablation, and coagulation of soft tissue; as well as hemostasis of blood vessels through its shaver blade and probe. Examples of uses of the product include resection of torn knee cartilage, subacromial decompression, and resection of synovial tissue in other joints.

Contraindications: The electrosurgical probe should not be used in procedures where a nonconductive irrigant is used or with patients having cardiac pacemakers or other electronic implants.

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------|-------------------------------------------------------------------------------|
| <div> <span>☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span>☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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Image /page/3/Picture/0 description: The image shows the logo for ReLIGN Corporation. The word "ReLIGN" is written in a bold, sans-serif font, with "Re" in blue and "LIGN" in black. Below the word "ReLIGN" is the word "CORPORATION" written in a smaller, thinner, sans-serif font. The letters in "CORPORATION" are gray.

## 510(k) Summary

#### 1. Date Prepared: December 22, 2016

#### 2. Submitter Name and Address:

ReLIGN Corporation 1601 South De Anza Boulevard, Suite 200 Cupertino, CA 95014 Phone: [phone] Ext. 320 Fax: [phone]

Contact: Nathan Nguyen, Sr. Director, Quality Assurance & Regulatory Affairs

#### 3. Device Name:

| Trade Name: | Relign Arthroscopic System |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name(s): | Arthroscope and Electrosurgical Cutting & Coagulation<br>Device and Accessories; Arthroscopic Pump, Tubing<br>Sets and Accessories |
| Classification Name(s): | Electrosurgical Cutting and Coagulation Device and<br>Accessories (21 CFR 878.4400); and Arthroscope and<br>Accessories (21 CFR 888.1100) |
| Product Code: | GEI, HRX |

#### Predicate Devices: 4.

| K071859 | Stryker Crossfire Integrated Arthroscopy System |
|---------|-------------------------------------------------|
| K123441 | Stryker CrossFlow Integrated Arthroscopy Pump |

#### 5. Device Description:

The Relign Arthroscopic System is a combination radiofrequency controller, shaver system, and fluid management system. The integrated system simultaneously controls a reusable shaver handpiece with disposable shaver blades and probes that include electrosurgical energy, as well as fluid management through inflow and outflow pumps that operate on the peristaltic principle. The system is comprised of five (5) major system components: The Relign Controller that includes a Footswitch, a reusable Shaver Handpiece, a disposable sterile single-use Combination Shaver Blade, a disposable sterile single-use Reciprocating RF Probe, and a disposable sterile single-use Fluid Management Accessories.

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Image /page/4/Picture/0 description: The image shows the logo for ReLIGN Corporation. The first two letters, "Re", are in blue, while the rest of the letters are in black. Below the word ReLIGN is the word "CORPORATION" in a smaller, light gray font. The logo is simple and modern.

#### Indications for Use: 6.

The Relign Arthroscopic System is indicated for use in orthopedic and arthroscopic procedures. The Fluid Management System of the Relign Arthroscopic System provides fluid distension and irrigation of the knee, shoulder, ankle, elbow, wrist and hip, and fluid suction during diagnostic and operative arthroscopic procedures. The Shaver Blade/RF Probe of the Relign Arthroscopic System provides abrasion, resection, debridement, and removal of bone through its shaver blade; removal, ablation, and coaqulation of soft tissue; as well as hemostasis of blood vessels through its shaver blade and probe. Examples of uses of the product include resection of torn knee cartilage, subacromial decompression, and resection of synovial tissue in other ioints.

Contraindications: The electrosurgical probe should not be used in procedures where a nonconductive irrigant is used or with patients having cardiac pacemakers or other electronic implants.

#### 7. Technological Characteristics

The Relign Arthroscopic System is substantially equivalent to the predicate devices. The Relian Controller provides control to the Fluid Management Accessories to deliver fluid under pressure control to the joint, control to the Shaver Handpiece for arthroscopic shaving and bone burring, and RF power through the shaver handpiece into the RF shaver blades/probes. The Shaver Handpiece is an electrically powered, hand-held surgical instrument that uses interchangeable shaver blades/probes to abrade and remove bone and debride soft tissue. The Shaver Handbiece has RF contacts which connect to the shaver blades/probes to deliver RF to the tissue sufficient for the resection, ablation, and coagulation of soft tissue within the joint. The Shaver Handpiece features hand switches for controlling shaver parameters, a screen providing visual indication of shaver parameters, and a suction irrigation port for removing fluid and tissue from the operating site. The shaver blade/probe is an arthroscopic shaver blade that provides abrasion, resection, debridement, and removal of bone; removal, ablation, and coagulation of soft tissue; as well as hemostasis of blood vessels. The Fluid Management Accessories provides control of the infusion and outflow of fluids within the joint space. Fundamentally, the Relign Arthroscopic System simply combines well-known and understood device types into one integrated system to abrade, resect, debride, and remove bone; remove, ablate and coagulate soft tissues; as well as provide hemostasis of blood vessels.

#### 8. Bench Performance Data

The Relign Arthroscopic System performance was tested in accordance with design specifications and with voluntary external standards. Performance testing to design specifications included: flow rate testing, pressure control testing, electrode temperature and coaqulation depth testing, mechanical testing, durability testing, simulated use testing, cadaver testing, distribution testing, and shelf life testing. The bench testing performed on the Relign Arthroscopic System verifies that the device satisfies design specifications and acceptance criteria. Software was developed, tested, and verified per FDA guidance

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Image /page/5/Picture/1 description: The image shows the logo for ReLIGN Corporation. The word "ReLIGN" is written in a stylized font, with the "Re" in blue and the "LIGN" in black. Below the word "ReLIGN" is the word "CORPORATION" in a smaller, gray font. The logo is simple and modern, and the use of color helps to make it stand out.

documents and IEC 62304:2006. Electrical safety and electromagnetic compatibility testing were verified per IEC 60601-1:2005, IEC 60601-2-2:2009, and IEC 60601-1-2:2014. The biocompatibility of the patient contacting materials of the Relign Arthroscopic System, specifically the Shaver Handpiece, Combination Shaver Blade. Reciprocating RF probe and Fluid Management Accessories component devices, was assessed in accordance with ISO 10993:2009 and FDA's "Guidance for Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process, 16 June 2016." Biocompatibility was demonstrated based on the results of biological assessment and testing performed on the materials. The sterile disposable devices were validated for use with Gamma Irradiation in accordance with VDmax method as outlined in ANSI/AAMI/ISO 11137-2:2013. The results were found to be acceptable, thus substantiating that the minimum sterilization dose evaluated provides a SAL of 10°. The Relign Shaver Handpiece was validated for use with STERRAD sterilization. The low temperature plasma sterilization process was validated in accordance with the "Overkill Sterilization Method" per AAMI TIR12:2010 and ISO 14937:2009. The results were found to be acceptable, thus substantiating that each sterilization cycle evaluated provides a SAL of 10°. Pursuant to FDA's Guidance, "Draft Guidance for Industry and Food and Drug Administration Staff - Applying Human Factors and Usability Engineering to Optimize Medical Device Design", Human Factors testing was performed on the Relign Arthroscopic System. Both Formative and Summative Testing were conducted to determine whether users trained per the IFU were able to set-up and operate the Relign Arthroscopic System. User testing demonstrated that the users were able to successfully execute the test scenarios without failures. The minor differences in the design between the Relign Arthroscopic System and the predicate devices do not raise any new types of safety or effectiveness questions as confirmed by design verification testing.

#### 9. Substantial Equivalence

Based on the results of the Bench Performance, Biocompatibility, Cadaver Studies and Usability Testing, the Relign Arthroscopic System with integrated functionality is substantially equivalent to the currently cleared Stryker Crossfire RF and Shaver System (K071859) and Stryker CrossFlow Integrated Arthroscopy Pump (K123441) with respect to intended use/indication for use, technological characteristics, and principles of operation. The minor differences in the design between the Relign Arthroscopic System and the predicate devices do not raise any new types of safety or effectiveness questions as confirmed by design verification testing. Therefore, the Relign Arthroscopic System is substantially equivalent to the previously-cleared predicate devices.

The following comparison tables show the similarities and differences regarding the technological characteristics of the subject and the predicate devices:

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Image /page/6/Picture/0 description: The image shows the logo for ReLIGN Corporation. The first two letters, "Re", are in blue, while the rest of the word, "LIGN", is in black. Below the word "ReLIGN" is the word "CORPORATION" in a smaller, light gray font.

| Table 9-1: Radiofrequency Comparison | | |
|--------------------------------------|----------------------------|-------------------|
| Feature | Subject Device | Predicate Device |
| | Relign Arthroscopic System | Stryker Crossfire |
| Bipolar Ablation Radiofrequency | Yes | Same |
| RF Max Power (W) | 400W | Same |
| RF peak Voltage (V) | 500V | 400V |
| RF Frequency(kHz) | 225kHz | 200kHz |
| Waveform | Square Wave | Same |
| Crest Factor | <1.6 @175 ohms | <1.5 @ 200 ohms |
| Bipolar Coagulation | Yes | Same |
| | | Coag 1: 20w, |
| RF Coagulation Max Power (W) | 50w | Coag 2: 30w, |
| | | Coag 3: 50w |
| RF Coagulation Peak Voltage (V) | 180V | 150V |
| RF Coagulation Frequency (kHz) | 225kHz | 200kHz |

| Feature | Subject Device<br>Relign Arthroscopic System | Predicate Device<br>Stryker Crossfire |
|-----------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Table 9-2: Shaver Control and Shaver Handpiece Comparison | | |
| Maximum RPM | 15,000 | 12,000 |
| Oscillate maximum RPM | 5,000 | 3,000 |
| RF Shaver Mode | Simultaneous RF activation and motor activation | Same |
| Shaver Handpiece Motor peak torque | $1.5in*lbs.$ | $1.4in*lbs.$ |
| Graphical display of settings | Yes<br>The Relign Controller contains a graphical display which displays the shaver settings: mode of operation, rotational speed, ablation power, and suction levels can be controlled from the touch screen graphical display<br><br>Yes<br>The Relign Shaver Handpiece contains an integrated LCD screen which displays rotational speed, ablation power levels, and suction levels | Yes<br>Controller screen displays the RF power levels and the rotational speed. (The suction levels are displayed on the Stryker Crossflow graphical display) |

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Image /page/7/Picture/0 description: The image shows the logo for ReLIGN Corporation. The word "ReLIGN" is written in a stylized font, with "Re" in blue and "LIGN" in black. Below the word "ReLIGN" is the word "CORPORATION" in a smaller, light gray font. The logo is simple and modern, and the use of color helps to draw the eye.

| Table 9-2: Shaver Control and Shaver Handpiece Comparison | | |
|-----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature | Subject Device | Predicate Device |
| Control of Handpiece settings (rpm, oscillate, etc.) | Relign Arthroscopic System<br>Control of the Shaver Handpiece settings on the graphical display on the Controller touch screen, using the buttons and graphical display on the Handpiece, or using the foot pedal | Stryker Crossfire<br>Control of Handpiece settings on the graphical display on the Controller touch screen, using the buttons on the Shaver Handpiece, or using foot pedal |
| Functions activated by the Shaver Handpiece | Shaver Handpiece motor activation on Handpiece RF ablation activation on Shaver Handpiece Coagulation activation on Shaver Handpiece | Shaver Handpiece motor activation on Handpiece |
| Suction lever | Electronic Suction lever:<br>Suction is controlled through the software communication with joystick on the Handpiece | Physical Suction lever which controls the opening and closing of a valve in the suction channel |
| RF | Bipolar radiofrequency contacts within the Handpiece | No RF contacts within the Handpiece |
| Biocompatibility | Yes. Fluid Contacting | Same |
| Cleaning Validation of Reusable Handpiece | User manual instructs end-user manually clean Shaver Handpiece prior to sterilization cleaning steps validation & verification per FDA Guidance for Reprocessing Medical Devices in Health Care Settings – Validation Methods and Labeling, March 17, 2015 | Same |
| Sterilization Validation of Reusable Handpiece | Sterrad 100s<br>Sterrad 100NX<br>Sterrad NX | Steam sterilization (Flash, PreVac, Gravity)<br>Sterrad 100s<br>100% EO<br>ETO/Oxyfume 2002 |

| Table 9-3: Fluid Management Comparison | | | |
|----------------------------------------|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Function | Feature | Subject Device<br>Relign Arthroscopic<br>System | Predicate Device<br>Stryker CrossFlow |
| Fluid<br>Management: | Fluid Management<br>Inflow Pump Type | Peristaltic Pump | Same |
| Table 9-3: Fluid Management Comparison | | | |
| Function | Feature | Subject Device<br>Relign Arthroscopic<br>System | Predicate Device<br>Stryker CrossFlow |
| Inflow | Maximum Average Flow<br>Rate (ml/min) | 1150 | 1200 |
| | Pressure Sensing (1) | In-line pressure sensing<br>measuring the pressure<br>within the inflow tubing<br>and subsequently the<br> | Same |
| | Pressure Sensing (2) | Direct in-joint pressure<br>sensing | N/A |
| | Joint Pressure setting<br>range | 15-150mmHg | Same |
| | Default joint pressure<br>settings | Knee: 45mmHg<br>Shoulder: 50mmHg<br>Hip: 50mmHg<br>Small Joint: 35mmHg | Same |
| | Cannula Sheath<br>calibration | Yes | Same |
| | Stored Cannula sheath<br>combinations | No | Yes |
| | Tube set presence<br>detection | Yes | Same |
| Fluid<br>Management:<br>Aspiration | Fluid Management<br>Outflow Pump Type | Peristaltic Pump | Same |
| | Maximum Average Flow<br>Rate (ml/min) | 950 | 850 |
| | Suction | Outflow Peristaltic<br>Pump | Same |
| | Suction pinch valves | No pinch valves.<br><br>The Relign Arthroscopic<br>System combines RF<br>and Shaver into a single<br>unit as such switching<br>the suction is not<br>necessary. | Suction pinch vales<br>direct the suction<br>between different<br>suction tubes. Ex.<br>Pinch valve will switch<br>between RF probe<br>suction or shaver<br>suction depending<br>which is activated |
| | Clear/Wash Mode | Increased flow activated<br>to clear field of view | Increased flow activated<br>to clear field of view,<br>Increased flow and<br>increased pressure |
| Table 9-3: Fluid Management Comparison | | | |
| Function | Feature | Subject Device<br>Relign Arthroscopic System | Predicate Device<br>Stryker CrossFlow |
| | Single use | Disposable Tubing set | Same |
| | Shaver Activation Detection | Yes. The Relign Controller integrates fluid management, shaver and RF control into a single unit. Upon activation of the Shaver Handpiece for either RF or motor activation the Controller will activate the appropriate suction level. | Yes. The Stryker Crossflow and the Stryker Crossfire are connected with an independent cable. When the Shaver Handpiece or a Serfas Energy RF probe from the Stryker Crossfire is activated a signal is sent to the Stryker Crossflow to initiate suction from the Stryker Crossflow. In this manner, the independent Stryker Crossflow and Stryker Crossfire controllers work together as a single unit. |
| | Tubing Cassette | Yes<br>Tubing supplied in dual inflow and outflow tubing cassette | Yes<br>Tubing supplied as individual inflow and outflow tubing cassettes |
| | Tubing Biocompatibility | Yes | Same |
| | Tubing Sterilization validation | Gamma Irradiation | Ethylene Oxide |

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Image /page/8/Picture/0 description: The image shows the logo for ReLIGN Corporation. The word "ReLIGN" is written in a stylized font, with the "Re" in blue and the "LIGN" in black. Below the word "ReLIGN" is the word "CORPORATION" in a smaller, light gray font.

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Image /page/9/Picture/0 description: The image shows the logo for ReLIGN Corporation. The word "ReLIGN" is written in a stylized font, with the "Re" in blue and the "LIGN" in black. Below the word "ReLIGN" is the word "CORPORATION" in a smaller, light gray font.

| Table 9-4: Combination Shaver Blade Comparison | | | |
|-----------------------------------------------------------------------------------------|----------------|-------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Function | Feature | Subject Device | Predicate Device |
| Universal<br>product<br>features<br>These features<br>are universal to<br>the three (3) | Shaft Diameter | Relign Arthroscopic<br>System | Stryker Crossfire |
| | | 6.35mm | Stryker 5.5 Barrel Bur:<br>7.18mm<br>Stryker 5.5 Aggressive<br>Plus: 5.5mm<br>Stryker Serfas Energy<br>90-S 3.5+: 4.0mm |
| | Working Length | 5" | Same |

| C<br>Page<br>7<br>of | 9 |
|----------------------|---|
|----------------------|---|

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Image /page/10/Picture/0 description: The image shows the logo for ReLIGN Corporation. The word "ReLIGN" is written in a modern sans-serif font, with "Re" in blue and "LIGN" in black. Below the word is the word "CORPORATION" in a smaller, light gray font.

| Table 9-4: Combination Shaver Blade Comparison | | | |
|------------------------------------------------|--------------------------|-------------------------------------------------------------------------------------------------------------------|------------------------------------------|
| Function | Feature | Subject Device<br>Relign Arthroscopic<br>System | Predicate Device<br>Stryker Crossfire |
| predicate<br>devices | Window positioning | The software positions<br>the window position<br>automatically after<br>release of the activation<br>button/pedal | No window positioning<br>feature |
| | Aspiration | Aspiration channel for<br>chip removal | Same |
| | Biocompatibility | Biocompatibility per ISO<br>10993-1 | Same |
| | Sterilization | Gamma radiation | Ethylene oxide |
| | Use | Single Use | Same |
| | Disposable Device | Relign Combination<br>Shaver Blade | Stryker 5.5 Barrel Bur |
| Bone Burr | Burr diameter | 6.35mm | 5.5mm |
| | Number of flutes | 3 | 12 |
| | Burr material | Zirconia | Stainless Steel |
| | Disposable device | Relign Combination<br>Shaver Blade | Stryker 5.5 Aggressor<br>Plus |
| Soft Tissue<br>Resection | Cutter diameter | 5.5mm | 4.5mm |
| | Number of teeth | 5 | 6 |
| | Cutter material | Zirconia | Stainless Steel |
| | Disposable device | Relign Combination<br>Shaver Blade | Stryker Serfas Energy<br>Super 90-S 3.5+ |
| RF Ablation<br>and<br>Coagulation | Energy delivered | Bi-Polar<br>Radiofrequency | Same |
| | Controller compatibility | Relign Controller | Stryker Crossfire |
| | Shaft diameter | 6.35mm | 4.0mm |
| | Working Length | 5" | Same |
| | Electrode material | 304 Stainless steel | Tungsten |
| | Electrode Insulation | Ceramic | Same |
| | Electrode size | 3mm x 1.5mm (oval<br>shape) | 2.6mm (round shape) |

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Image /page/11/Picture/0 description: The image shows the logo for ReLIGN Corporation. The word "ReLIGN" is written in a stylized font, with "Re" in blue and "LIGN" in black. Below the word "ReLIGN" is the word "CORPORATION" in a smaller, gray font. The logo is simple and modern, and the use of color helps to make it stand out.

| Table 9-5: Reciprocating RF Probe Comparison | | | |
|----------------------------------------------|--------------------------|-------------------------------------------------------------------------------------------------------------|---------------------------------------|
| Function | Feature | Subject Device<br>Relign Arthroscopic<br>System | Predicate Device<br>Stryker Crossfire |
| | Disposable Device | Reciprocating RF probe | Stryker Serfas Energy<br>90-S 3.5mm |
| RF Ablation<br>and<br>Coagulation | Shaft Diameter | 4.2mm | 4.0mm |
| | Working Length | 5" | Same |
| | Electrode Positioning | The software positions<br>the electrode<br>automatically after<br>release of the activation<br>button/pedal | No window positioning<br>feature |
| | Aspiration | Aspiration channel | Same |
| | Biocompatibility | Biocompatibility per<br>ISO 10993-1 | Same |
| | Sterilization | Gamma radiation | Ethylene oxide |
| | Use | Single Use | Same |
| | Energy delivered | Bi-Polar<br>Radiofrequency | Bi-Polar<br>Radiofrequency |
| | Controller compatibility | Relign Controller | Stryker Crossfire |
| | Electrode material | 304 Stainless steel | Tungsten |
| | Electrode Insulation | Ceramic | Same |
| | Electrode size | 0.5mm x 2.67mm | 2.62mm (round shape) |
| | Electrode motion | 2.75mm of electrode<br>reciprocation in plasma<br>shaver mode | Stationary electrode |

#### Conclusions 10.

Relign concludes that based on the results of the Bench Performance, Biocompatibility, Cadaver Studies and Usability Testing, the Relign Arthroscopic System is substantially equivalent to the FDA-cleared predicate devices currently legally marketed in the United States.