The Smith & Nephew DYONICS 25 Fluid Management System is indicated for use during arthroscopic joint surgery to regulate flow of irrigation fluids in the knee, shoulder, hip, and small joints to maintain intra-articular pressure for uniform distension and clear visualization of the surgical site.

Device Description

The Smith & Nephew DYONICS 25 Fluid Management System is a centrifugal fluid management pump used in arthroscopic surgery to regulate the flow of irrigation fluids through the joint to maintain intra-articular pressure for distension and visualization of the surgical site. This is accomplished using an electronic pressure control feedback loop between the control unit and the tube set cassettes.

The Smith & Nephew DYONICS 25 Fluid Management System includes -

. control unit
. inflow tube set
. inflow /outflow tube set
inflow/outflow tube set with forked suction lines
. day-tube set
. patient tube set
. wired/wireless (IR) remote control (optional)
. Luer to colder Connector (optional)

Additionally, the Smith & Nephew LEVELERT II Fluid Level Sensors (K060123) as well as a shaver system interface cable, U.S. and international power cords can be used with the Smith & Nephew DYONICS 25 Fluid Management System (DYONICS 25).

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Smith & Nephew DYONICS 25 Fluid Management System:

This document is a 510(k) Summary of Safety and Effectiveness Information for a medical device. It's important to understand that a 510(k) submission generally aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving absolute safety and effectiveness through extensive clinical trials as might be required for a novel device. The "acceptance criteria" here refer to meeting performance specifications and relevant standards to demonstrate equivalence, not necessarily clinical outcome measures.

Description of Acceptance Criteria and Study to Prove Device Meets Them

The Smith & Nephew DYONICS 25 Fluid Management System is a centrifugal fluid management pump used in arthroscopic surgery. The current submission (K171794) is for a modified version of a previously cleared device (K051326). The "acceptance criteria" for this submission are primarily that the modified device performs comparably to the predicate device and meets relevant performance specifications and recognized consensus standards, without raising new questions of safety or effectiveness due to the design changes.

The study proving the device meets these criteria is a series of bench and engineering tests and software verification and validation.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Description of Criteria (Implied from the document)	Reported Device Performance
Functional Performance	Maintain intra-articular pressure for uniform distension and clear visualization of the surgical site during arthroscopic joint surgery. (This is the core intended use and functional expectation).	Testing demonstrated that the system "has met the performance specifications." (Specific metrics are not detailed in this summary).
Package/Performance Testing	Ensure integrity and functionality after packaging and during typical use/handling.	Conducted.
Environmental Testing	Demonstrate performance over expected environmental conditions (temperature, humidity, etc.).	Conducted.
Fluids Testing	Verify proper interaction and handling of irrigation fluids.	Conducted.
EMC Testing	Compliance with electromagnetic compatibility standards to ensure proper operation without interference and without causing interference to other devices. Specifically, IEC 60601-1-2:2015.	Meets IEC 60601-1-2:2015.
Safety Testing	Compliance with general requirements for basic safety and essential performance. Specifically, IEC 60601-1.	Meets IEC 60601-1.
Software Verification & Validation	Ensure the updated operating system, drivers, and software function correctly and safely according to specifications, and that changes to printed circuit boards (PCBs) and the new touch-screen LCD display operate as intended. Compliance with IEC 62304 for medical device software lifecycle.	Conducted, and meets IEC 62304:2006.
Substantial Equivalence	Demonstrated that the device has the same indications for use, utilizes the same principle of operation and fundamental scientific technology, incorporates the same basic design, and incorporates the same materials as the predicate device (K051326), despite updated PCBs, new touch-screen LCD display, and software updates.	No major differences from the predicate device that would raise new safety/effectiveness questions. Found substantially equivalent.

2. Sample Size Used for the Test Set and Data Provenance

This document does not specify a "sample size" in the context of patient data or a test set of clinical images. The testing described (Package/Performance, Environmental, Fluids, EMC, Safety, Software V&V) are bench and engineering tests, performed on the device itself or its components. Therefore, terms like "test set," "data provenance," or "country of origin for data" are not applicable in the typical sense of a clinical study or AI model evaluation.

Sample size: Not applicable as it's not a clinical or image-based study. The "sample" would be the device units or components tested.
Data provenance: Not applicable. The data is from internal engineering and bench testing.
Retrospective/Prospective: Not applicable.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Not applicable. This is not a study requiring expert readers or consensus to establish ground truth. The "ground truth" for the engineering and performance tests is defined by the technical specifications, international standards (e.g., IEC), and the functional requirements of the device.

4. Adjudication Method for the Test Set

Not applicable. There is no expert adjudication process for bench and engineering tests. The results are typically pass/fail based on predefined technical criteria and standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is common for evaluating diagnostic imaging devices or AI systems, especially when comparing human performance with and without AI assistance. This device is a fluid management pump, not a diagnostic or AI-powered imaging device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device does not feature an "algorithm only" component in the sense of an AI/ML system that would operate autonomously. While it has software and a feedback loop for pressure control, its operation is an integral part of an arthroscopic surgical procedure that always involves a human surgeon. The "software verification & validation" conducted is the closest equivalent to testing the "standalone" performance of its control logic.

7. Type of Ground Truth Used

The "ground truth" for this submission is based on:

Technical specifications derived from the intended function of the device (e.g., maintaining pressure, regulating flow).
International consensus standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 62304) which define safety and performance requirements.
Comparison to the predicate device's established performance.

8. Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a "training set" of data in the common sense. The software development process involves coding, verification, and validation, but not training on a dataset to learn patterns.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As noted in point 8, there is no "training set" for this device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.

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

June 27, 2017

Smith & Nephew, Inc. Ms. Kathleen Solomon Senior Regulatory Affairs Specialist 150 Minuteman Road Andover, Massachusetts 01810

Re: K171794

Trade/Device Name: Smith & Nephew DYONICS 25 Fluid Management System Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX Dated: June 14, 2017 Received: June 16, 2017

Dear Ms. Solomon:

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 Actinclude 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 (reporting of medical device

{1}------------------------------------------------

related 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.

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 -S3

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

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K171794

Device Name Smith & Nephew DYONICS 25 Fluid Management System

Indications for Use (Describe)

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)
-------------------------------------------------------------------------------------------------	------------------------------------------------------------------------------------------------

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services

Food and Drug Administration

Office of Chief Information Officer

Paperwork Reduction Act (PRA) Staff

PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below. -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

{3}------------------------------------------------

K171794 p 1/3

Endoscopy
Smith & Nephew, Inc.
150 Minuteman Road
Andover, MA 01810
USA

nith-nenhew com

We are smith&nephew

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

as required by the Safe Medical Devices Act of 1990 and codified in 21 CFR 807.92 upon which the substantial equivalence is based.

Smith & Nephew DYONICS 25 Fluid Management System Date Prepared: June 26, 2017

Submitter's Name:

Smith & Nephew, Inc., Endoscopy Division 150 Minuteman Road, Andover MA. 01810

Company Contact:

Kathleen Solomon Sr. Regulatory Affairs Specialist T 978-749-1605 F 978-749-1443

Device Name

Trade Name:	Smith & Nephew DYONICS 25 Fluid Management System
Common Name:	Arthroscopic Fluid Management System
Classification Name:	Arthroscope
Regulatory class:	II
Product Code:	HRX

Predicate Devices

The Smith & Nephew DYONICS 25 Fluid Management System is substantially equivalent in Intended Use and Fundamental Scientific Technology to the following legally marketed device in commercial distribution: Smith & Nephew DYONICS 25 Fluid Management System-K051326.

{4}------------------------------------------------

Description of Device

The Smith & Nephew DYONICS 25 Fluid Management System includes -

. control unit
. inflow tube set
. inflow /outflow tube set
inflow/outflow tube set with forked suction lines
. day-tube set
. patient tube set
. wired/wireless (IR) remote control (optional)
. Luer to colder Connector (optional)

Intended Use

The Smith & Nephew DYONICS 25 Fluid Management System is intended for use during arthroscopic joint surgery to regulate flow of irrigation fluids to maintain intra-articular pressure for uniform distension and clear visualization of the surgical site.

Comparison of Technological Characteristics

The design changes to the modified Smith & Nephew DYONICS 25 Fluid Management System include updated printed circuit boards (PCBs), new touch-screen LCD display, updated operating system, drivers and software updates. The modified Smith & Nephew DYONICS 25 Fluid Management System has the following similarities as the predicate device cleared in K151326. In that:

The same indications for use/intended use.
Utilizes the same principle of operation and fundamental scientific technology
Incorporates the same basic design
Incorporates the same material

There are no major differences between the modified Smith & Nephew DYONICS 25 Fluid Management System and the currently cleared predicate.

{5}------------------------------------------------

K171794 p 3/3

Endoscopy
Smith & Nephew, Inc.
150 Minuteman Road
Andover, MA 01810
USA

T 978-749-1000
F 978-749-1443
www.smith-nephew.com

We are smith&nephew

Performance Data

Testing demonstrated that the Smith & Nephew DYONICS 25 Fluid Management System has met the performance specifications and therefore, is substantially equivalent to the predicate device cleared in K051326.

The following performance data and validations were conducted:

Package/Performance Testing
. Environmental Testing
Fluids Testing
EMC Testing
Safety Testing
Software Verification & Validation ●

The Smith & Nephew DYONICS 25 Fluid Management System meets the following FDA recognized consensus standards:

IEC 60601-1-2:2015 Part 1-2: General requirements for basic safety and essential ● performance -Collateral Standard: Electromagnetic disturbances - Requirements and tests
IEC 60601-1 Medical Electrical Equipment Part 1: General Requirements for Safety ●
IEC 62304 Medical Device Software - Lifecycle:2006

Conclusion:

The Smith & Nephew DYONICS 25 Fluid Management System met all specified criteria and did not raise new safety or effectiveness questions. The substantial equivalence of the modified device is based on same indications for use, fundamental technology including design, and operational principles. Based on the similarities to the predicates and the performance data, the Smith & Nephew DYONICS 25 Fluid Management System is substantially equivalent to its predicate (K051326).

Regulation Number and Section

§ 888.1100 Arthroscope.

(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.