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 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.

AI/ML Overview

Here's an analysis of the provided text regarding the ReLIGN Arthroscopic System's acceptance criteria and studies, organized by your requested information:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of "acceptance criteria" alongside specific reported performance metrics in the way one might expect for a diagnostic AI device (e.g., sensitivity, specificity, AUC). Instead, it describes performance testing conducted to ensure the device meets its design specifications and complies with various standards. The "reported device performance" is essentially that the device "satisfies design specifications and acceptance criteria" and that various tests were "found to be acceptable."

Here's a summary of the performance claims based on the text:

Acceptance Criteria Category	Reported Device Performance
General Performance (Bench Testing)	Tested in accordance with design specifications and voluntary external standards.
Flow Rate	Testing performed; results satisfy design specifications and acceptance criteria.
Pressure Control	Testing performed; results satisfy design specifications and acceptance criteria.
Electrode Temperature	Testing performed; results satisfy design specifications and acceptance criteria.
Coagulation Depth	Testing performed; results satisfy design specifications and acceptance criteria.
Mechanical Testing	Testing performed; results satisfy design specifications and acceptance criteria.
Durability Testing	Testing performed; results satisfy design specifications and acceptance criteria.
Simulated Use Testing	Testing performed; results satisfy design specifications and acceptance criteria.
Distribution Testing	Testing performed; results satisfy design specifications and acceptance criteria.
Shelf Life Testing	Testing performed; results satisfy design specifications and acceptance criteria.
Software	Developed, tested, and verified per FDA guidance documents and IEC 62304:2006.
Electrical Safety & EMC	Verified per IEC 60601-1:2005, IEC 60601-2-2:2009, and IEC 60601-1-2:2014.
Biocompatibility	Assessed in accordance with ISO 10993:2009 and FDA guidance. Demonstrated based on biological assessment and testing. (Specific to Shaver Handpiece, Combination Shaver Blade, Reciprocating RF probe, and Fluid Management Accessories).
Sterilization (Disposable Devices)	Validated for use with Gamma Irradiation in accordance with VDmax method (ANSI/AAMI/ISO 11137-2:2013). Results acceptable, substantiating a SAL of 10⁻⁶.
Sterilization (Reusable Handpiece)	Validated for use with STERRAD sterilization (Sterrad 100s, 100NX, NX) in accordance with "Overkill Sterilization Method" per AAMI TIR12:2010 and ISO 14937:2009. Results acceptable, substantiating a SAL of 10⁻⁶. Cleansed manually.
Human Factors/Usability	Formative and Summative Testing conducted per FDA guidance. User testing demonstrated users successfully executed test scenarios without failures.
Cadaver Testing	Results contributed to the conclusion of substantial equivalence. (No specific performance metrics are provided in the summary, just that the study was done).
Substantial Equivalence to Predicates	The "minor differences" in the design do not raise new safety or effectiveness questions, as confirmed by design verification testing. The device is substantially equivalent to 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.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document provides very limited detail on specific sample sizes for most tests, particularly for the " cadaver testing" or "simulated use" that would involve a "test set" in the context of evaluation of AI/diagnostic devices.

Human Factors/Usability Testing: "User testing" was performed, but no number of users is specified.
Other Performance Tests (Flow rate, pressure, mechanical, durability, etc.): No specific sample sizes (e.g., number of devices, number of repetitions) are provided in this summary.
Data Provenance: Not mentioned. It's a medical device submission, typically implying company internal testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. The ReLIGN Arthroscopic System is a surgical tool, not a diagnostic AI device that would typically involve "ground truth" established by experts in the context of a diagnostic dataset. The "cadaver testing" and "human factors testing" would involve users (surgeons, nurses, technicians) but their role would be as operators or participants, not necessarily "experts establishing ground truth" in the diagnostic sense.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable/provided. As above, the device is a surgical tool, not a diagnostic system requiring adjudication of diagnostic outcomes.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable/provided. This is a surgical device, not an AI-assisted diagnostic tool for "human readers." MRMC studies are specific to diagnostic performance evaluation.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This information is not applicable/provided. The ReLIGN Arthroscopic System is a physical device operated by a human, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not applicable/provided in the context of diagnostic "ground truth." For a surgical device, "ground truth" would relate to the successful execution of surgical tasks, device functionality (e.g., actual flow rates matching set flow rates, tissue ablation matching expectations), and safety. The document indicates that "cadaver testing" was performed, which would serve as a form of "ground truth" for surgical performance in a simulated environment, but no specifics on how success was measured or by whom are given in this summary.

8. The sample size for the training set

This information is not applicable/provided. Since the device is a physical surgical tool and not an AI/ML algorithm that requires a "training set" in the conventional sense, this concept does not apply.

9. How the ground truth for the training set was established

This information is not applicable/provided as the device is not an AI/ML algorithm with a training set requiring ground truth establishment.

Summary of Device Type and Document Limitations:

It's important to note that the provided document is a 510(k) summary for a surgical device (arthroscopic system), not an AI/ML-driven diagnostic device. Therefore, many of the requested points, particularly those related to "test sets," "ground truth," "experts," "adjudication," and "MRMC studies," are not directly applicable or are described using different terminology. The evaluation of this device focuses on its functional performance, safety, sterility, biocompatibility, and substantial equivalence to legally marketed predicate devices, rather than the diagnostic accuracy or impact on human reader performance that would be pertinent for AI/ML diagnostic tools.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing to the right, layered on top of each other. The profiles are black, and the text is also in black.

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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)

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)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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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: (408) 996-2517 Ext. 320 Fax: (408) 642-1455

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

3. Device Name:

Trade Name:	Relign Arthroscopic System
Common Name(s):	Arthroscope and Electrosurgical Cutting & CoagulationDevice and Accessories; Arthroscopic Pump, TubingSets and Accessories
Classification Name(s):	Electrosurgical Cutting and Coagulation Device andAccessories (21 CFR 878.4400); and Arthroscope andAccessories (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:

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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 DeviceRelign Arthroscopic System	Predicate DeviceStryker 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	YesThe 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 displayYesThe Relign Shaver Handpiece contains an integrated LCD screen which displays rotational speed, ablation power levels, and suction levels	YesController 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 SystemControl 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 CrossfireControl 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: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 100sSterrad 100NXSterrad NX	Steam sterilization (Flash, PreVac, Gravity)Sterrad 100s100% EOETO/Oxyfume 2002

Table 9-3: Fluid Management Comparison
Function	Feature	Subject DeviceRelign ArthroscopicSystem	Predicate DeviceStryker CrossFlow
FluidManagement:	Fluid ManagementInflow Pump Type	Peristaltic Pump	Same
Table 9-3: Fluid Management Comparison
Function	Feature	Subject DeviceRelign ArthroscopicSystem	Predicate DeviceStryker CrossFlow
Inflow	Maximum Average FlowRate (ml/min)	1150	1200
	Pressure Sensing (1)	In-line pressure sensingmeasuring the pressurewithin the inflow tubingand subsequently the	Same
	Pressure Sensing (2)	Direct in-joint pressuresensing	N/A
	Joint Pressure settingrange	15-150mmHg	Same
	Default joint pressuresettings	Knee: 45mmHgShoulder: 50mmHgHip: 50mmHgSmall Joint: 35mmHg	Same
	Cannula Sheathcalibration	Yes	Same
	Stored Cannula sheathcombinations	No	Yes
	Tube set presencedetection	Yes	Same
FluidManagement:Aspiration	Fluid ManagementOutflow Pump Type	Peristaltic Pump	Same
	Maximum Average FlowRate (ml/min)	950	850
	Suction	Outflow PeristalticPump	Same
	Suction pinch valves	No pinch valves.The Relign ArthroscopicSystem combines RFand Shaver into a singleunit as such switchingthe suction is notnecessary.	Suction pinch valesdirect the suctionbetween differentsuction tubes. Ex.Pinch valve will switchbetween RF probesuction or shaversuction dependingwhich is activated
	Clear/Wash Mode	Increased flow activatedto clear field of view	Increased flow activatedto clear field of view,Increased flow andincreased pressure
Table 9-3: Fluid Management Comparison
Function	Feature	Subject DeviceRelign Arthroscopic System	Predicate DeviceStryker 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	YesTubing supplied in dual inflow and outflow tubing cassette	YesTubing 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
UniversalproductfeaturesThese featuresare universal tothe three (3)	Shaft Diameter	Relign ArthroscopicSystem	Stryker Crossfire
		6.35mm	Stryker 5.5 Barrel Bur:7.18mmStryker 5.5 AggressivePlus: 5.5mmStryker Serfas Energy90-S 3.5+: 4.0mm
	Working Length	5"	Same

CPage7of	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 DeviceRelign ArthroscopicSystem	Predicate DeviceStryker Crossfire
predicatedevices	Window positioning	The software positionsthe window positionautomatically afterrelease of the activationbutton/pedal	No window positioningfeature
	Aspiration	Aspiration channel forchip removal	Same
	Biocompatibility	Biocompatibility per ISO10993-1	Same
	Sterilization	Gamma radiation	Ethylene oxide
	Use	Single Use	Same
	Disposable Device	Relign CombinationShaver 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 CombinationShaver Blade	Stryker 5.5 AggressorPlus
Soft TissueResection	Cutter diameter	5.5mm	4.5mm
	Number of teeth	5	6
	Cutter material	Zirconia	Stainless Steel
	Disposable device	Relign CombinationShaver Blade	Stryker Serfas EnergySuper 90-S 3.5+
RF AblationandCoagulation	Energy delivered	Bi-PolarRadiofrequency	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 (ovalshape)	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 DeviceRelign ArthroscopicSystem	Predicate DeviceStryker Crossfire
	Disposable Device	Reciprocating RF probe	Stryker Serfas Energy90-S 3.5mm
RF AblationandCoagulation	Shaft Diameter	4.2mm	4.0mm
	Working Length	5"	Same
	Electrode Positioning	The software positionsthe electrodeautomatically afterrelease of the activationbutton/pedal	No window positioningfeature
	Aspiration	Aspiration channel	Same
	Biocompatibility	Biocompatibility perISO 10993-1	Same
	Sterilization	Gamma radiation	Ethylene oxide
	Use	Single Use	Same
	Energy delivered	Bi-PolarRadiofrequency	Bi-PolarRadiofrequency
	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 electrodereciprocation in plasmashaver 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.

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
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.(b)
Classification. Class II.