The SDC3 is indicated for use with compatible endoscopic and general surgery devices. SDC3 can be used in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery wherever a laparoscope, endoscope, or an arthroscope is indicated for use. A few examples of the more common endoscopic surgeries are laparoscopic cholecystectomy, laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic pelvic lymph node dissection, laparoscopically assisted hysterectomy, laparoscopic and thorascopic anterior spinal fusion, anterior cruciate ligament reconstruction, knee arthroscopy, shoulder arthroscopy, small joint arthroscopy, decompression fixation, wedge resection, lung biopsy, pleural biopsy, dorsal sympathectomy, pleurodesis, internal mammary artery dissection for coronary artery bypass, coronary artery bypass grafting where endoscopic visualization is indicated and examination of the evacuated cardiac chamber during performance of valve replacement. SDC3 users are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons, and urologists.

Device Description

The Stryker SDC3 HD Information Management System with wireless device control capability (herein referred to as 'proposed device') consists of the following:

Stryker SDC3 HD Information Management System (SDC3) that consists of:
a. A stand-alone console containing SDC3 software version 1.5 and above
b. A device control package (contains optional software upgrade and a handheld Infrared (IR) remote control)
c. A voice control package (contains optional software upgrade and a microphone/headset).
The Universal Gateway System (Gateway) (acts as a medium for transferring medical device and non-medical device data).

The proposed device is a modification of the Stryker SDC3 HD Information Management System (hereafter referred to as "predicate device", cleared under K121893) to add wired and wireless device control functionality via the Gateway. The wired device control feature (cleared under K121893) and the operating room documentation functionalities of electronically capturing, transferring, storing and displaying of medical device data (Class I device function) provided by the SDC3 remains the same compared to the predicate device. It should be noted that the device control functionality (both wired and wireless) of the proposed device only provides users with convenient, centralized control of connected (wired and wireless), compatible medical devices. The SDC3 accesses existing controls within each device and is secondary to the built-in control interface that is already on each device.

AI/ML Overview

The provided text describes the Stryker SDC3 HD Information Management System with Wireless Device Control Capability (K160332), a modification of a predicate device (K121893) to add wired and wireless device control functionality via a Universal Gateway System. The document focuses on regulatory compliance and the safety and effectiveness of the new wireless functionality.

However, the document does not contain the level of detail requested for a typical study proving a device meets acceptance criteria, particularly for an AI/ML-based diagnostic device where performance metrics like sensitivity, specificity, or AUC are expected. This submission is for a device providing enhanced control and information management in a surgical setting, not a diagnostic or AI-driven decision-making tool. Therefore, the "acceptance criteria" and "device performance" are related to its functionality, reliability, and safety in controlling other medical devices and handling data, rather than diagnostic accuracy.

Here's an attempt to extract and interpret the information based on the provided text, acknowledging its limitations for the requested format:

Acceptance Criteria and Reported Device Performance

Given the nature of the device (a control and information management system with new wireless capabilities), the "acceptance criteria" are implied by the verification and validation activities described, focusing on functionality, safety, and reliability of the wireless communication and device control. No specific numerical thresholds (e.g., >90% accuracy) for clinical performance are applicable or provided.

Acceptance Criteria Category (Implied)	Specific Tests / Performance Reported
Device Control Functionality	SDC3 and Gateway Software Device Control Verification: Verified device/voice control of compatible devices via Gateway through SDC3's GUI, IR Remote, and supported Camera Head when devices are connected to Gateway.
Wireless Connectivity & Security	SDC3 and Gateway Connectivity Software Verification: Verified the compatibility of SDC3 with Universal Gateway System and the connection security between the SDC3 and the Universal Gateway System.Software Network Security Verification: Verified network security features of the SDC3.Security Recommendation: User advised to use WPA2-Enterprise with AES encryption for Wi-Fi security.
Wireless Co-existence & Latency	Wireless Co-existence Verification Test: Verified SDC3's ability to upload case data to an external server wirelessly under co-existence environment.Benchmarking Test: Verified latency of wireless device control data transmission under co-existence environment, as compared to an identical wired system. Also verified the data accuracy in a non-coexistence environment.SDC3 and Gateway Accuracy and Reliability Coexistence Report: Verified accuracy and reliability of wireless device control data transmission under co-existence environment.QoS (Quality of Service): Wireless QoS needed for wireless device control is stated to be the same quality of service currently offered by wired device control; metrics considered included latency, data rate, accuracy, and communication reliability to achieve equivalent performance.
Timing & Connection Reliability	Timing Test: Verified that the connection and disconnection times between the SDC3 and the Gateway meet the specification.
Design Validation	Validated expanded functionality of wireless device control to ensure defined user needs and intended use are met under simulated use conditions.
Electrical Safety & EMC	Conforms to ANSI/AAMI ES60601-1:2005 and IEC60601-1-2:2007.
Software Life Cycle Processes	Complies with IEC 62304:2006.

Study Details (based on interpretation of provided text)

Sample size used for the test set and the data provenance:
- The document does not specify a "test set" in terms of patient data or clinical images, as this is neither an AI/diagnostic device nor a device that processes such data for clinical output.
- The testing described is focused on engineering verification and validation of the device's functionality, connectivity, security, and performance in various operational environments (e.g., co-existence with other wireless devices).
- No information on data provenance (e.g., country of origin, retrospective/prospective) is applicable or provided, as no clinical data set is referenced for performance evaluation.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable. There is no "ground truth" to be established by clinical experts for the type of device tested. The "ground truth" for the tests performed would be the engineering specifications and expected functional behavior (e.g., "does the device turn on/off the connected medical device as commanded?", "is the wireless connection stable?").
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No clinical test set requiring adjudication by multiple readers is mentioned.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers interpret medical images or data, and their performance with and without AI assistance is compared. The Stryker SDC3 is a control and information management system, not a diagnostic tool.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This concept is largely not applicable in the context of this device. The core functionality is human-in-the-loop (surgeon/personnel controlling devices via SDC3). However, the "Benchmarking Test" did verify latency and data accuracy for wireless device control data transmission (algorithm/system performance) compared to a wired system, which could be considered a form of standalone performance evaluation for its wireless data transfer capabilities. The "SDC3 and Gateway Accuracy and Reliability Coexistence Report" also evaluated the system's performance in a standalone manner regarding its data transmission.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable in the clinical sense. The "ground truth" for the engineering performance tests performed would be defined by the device's design specifications and expected functional outcomes, verified through controlled experiments and measurements. For example, for the "Timing Test," the ground truth would be the specified connection/disconnection times.
The sample size for the training set:
- Not applicable. This device is not an AI/ML model that would typically have a "training set" of clinical data to learn from for diagnostic or predictive purposes. The software development follows a standard life cycle process (IEC 62304), which includes verification and validation but not machine learning training.
How the ground truth for the training set was established:
- Not applicable, as no training set (in the AI/ML sense) is mentioned or implied for this device.

Summary

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and features the department's name around the perimeter. In the center is an abstract symbol that resembles a stylized caduceus or a series of human profiles. The symbol is composed of three curved lines that converge to form a shape suggestive of a bird or a human figure.

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

May 18, 2016

Stryker Endoscopy Ms. Angela Wong Staff Regulatory Affairs Analyst 5900 Optical Court San Jose, California 95138

Re: K160332

Trade/Device Name: Stryker SDC3 HD Information Management System with Wireless Device Control Capability

Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ, HRX Dated: April 15, 2016 Received: April 18, 2016

Dear Ms. Wong:

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

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

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 yours,

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

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K160332

Device Name

Stryker SDC3 HD Information Management System with Wireless Device Control Capability

Indications for Use (Describe)

The SDC3 is indicated for use with compatible endoscopic and general surgery devices. SDC3 can be used in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery wherever a laparoscope, or an arthroscope is indicated for use. A few examples of the more common endoscopic surgeries are laparoscopic cholecystectomy, laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic pelvic lymph node dissection, laparoscopically assisted hysterectomy, laparoscopic anterior spinal fusion, anterior cruciate ligament reconstruction, knee arthroscopy, small joint arthroscopy, decompression fixation, wedge resection, lung biopsy, pleural biopsy, dorsal sympathectomy, pleurodesis, internal mammary artery artery bypass, coronary artery bypass grafting where endoscopic visualization is indicated and examination of the evacuated cardiac chamber during performance of valve replacement. SDC3 users are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, and urologists.

X 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."

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

Image /page/3/Picture/1 description: The image shows the Stryker logo in black. The logo is a stylized wordmark with a distinctive design. The letters are bold and connected, giving the logo a modern and recognizable appearance.

Endoscopy

510(k) SUMMARY

1) General Information

510(k) Sponsor	Stryker Endoscopy
Address	5900 Optical CourtSan Jose, CA 95138
FDA Registration Number	2936485
Correspondence Person	Angela WongStaff Regulatory Affairs AnalystStryker Endoscopy
Contact Information	Email: angela.wong @ stryker.comPhone: (408) 754-2737
Date Prepared	4 February 2016

2) Device Identification

Proposed Device:

Proprietary Name	Stryker SDC3 HD Information ManagementSystem with Wireless Device Control Capability
Common Name	SDC3 HD Information Management System
Classification Name	Laparoscope, General and Plastic Surgery
Regulation Number	21 CFR 876.1500
Product Code	GCJ
Subsequent Product Code	HRX
Regulatory Class	II

Predicate Device:

Proprietary Name	Stryker SDC3 HD Information Management System
Common Name	SDC3 HD Information Management System
Premarket Notification	K121893
Classification Name	Laparoscope, General and Plastic Surgery
Regulation Number	21 CFR 876.1500
Product Code	GCJ
Subsequent Product Code	HRX
Regulatory Class	II

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

3) Device Description

The Stryker SDC3 HD Information Management System with wireless device control capability (herein referred to as 'proposed device') consists of the following:

1. Stryker SDC3 HD Information Management System (SDC3) that consists of:
- a. A stand-alone console containing SDC3 software version 1.5 and above
- b. A device control package (contains optional software upgrade and a handheld Infrared (IR) remote control)
- c. A voice control package (contains optional software upgrade and a microphone/headset).
1. The Universal Gateway System (Gateway) (acts as a medium for transferring medical device and non-medical device data).

Wirelesstechnology andfunctions	Universal Gateway System Wireless Module: Wireless Technology : 2.4GHz 802.11n (Wi-Fi) wireless radio.
RF Frequenciesand Maximumoutput powers	Universal Gateway System Wireless Module: RF Frequencies 802.11n (ISM band): 2.412 - 2.484 GHz Maximum Output Power 802.11n: 14.5 dBm +/- 1.5 dB Range at Maximum Output Power 100+ feet depending on a number of factors
Wireless Quality ofService	The wireless quality of service needed for wireless device control is the same quality of service that is currently offered by wired device control. Therefore, the Quality of Service

The table below summarizes the wireless technology of the proposed device.

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

		(QoS) metrics considered for the proposed device accountedfor the latency, data rate, accuracy, and communicationreliability required to achieve equivalent performance ascompared to the wired device control.
Security		It is recommended that the user use WPA2-Enterprise withAES encryption for Wi-Fi security.
Alarm Signals		No alarm signals are transmitted wirelessly in the proposeddevice. The SDC3 monitors its connection to each Gateway.If a connection to a given Gateway is dropped, an audiblealert will be issued by the SDC3 for each compatible devicethat is connected to that Gateway.
Connection toother wirelessdevices		No other wireless products or devices are able to establish awireless device control connection. This is enforced by theproposed device security measures.

4) Indication for Use

5) Intended Use

The intended use of the SDC3 system is to allow for voice control and remote control of medical device settings by the surgeons or operating room personnel, thereby eliminating the need of manual operation of those devices compatible with SDC3, or relying upon verbal communications between the surgeon and other personnel in the operating room in order to adjust the surgical equipment. It also has an additional digital documentation functionality to electronically capture, transfer, store and display medical device data (Class I device function), which is independent of the functions or parameters of any attached device.

{6}------------------------------------------------

6) Comparison of Technological Characteristics with the Predicate Device

The Stryker SDC3 HD Information Management System (SDC3) with wireless device control capability (herein referred to as the proposed device) has the same technological characteristics and design as the predicate device except for the addition of wired and wireless device control functionality via the Gateway. The addition of wired and wireless device control functionality is achieved via a software update to allow the predicate device to be compatible with Universal Gateway System (Gateway), which act as a medium for the SDC3 to transfer device control data wired and wirelessly.

All other technological characteristics of the proposed device are identical to the predicate device. The proposed device uses the same hardware and communication protocols, employs the same voice recognition technology, and is compatible with the same types of controllable devices as listed in the predicate device's product labeling.

In accordance with 21 CFR807.92 (a) (6), a summary of the differences between the proposed and predicate device is provided in Table 5.1. A complete comparison of technological characteristics between the proposed and predicate devices is provided in Section 12 - Substantial Equivalence Discussion.

Feature/Functions	Proposed Devices	Predicate Devices(K121893)
WirelessDeviceControl	Wireless Technology:2.4GHz 802.11n (Wi-Fi) wireless radio. RF Frequencies:802.11 n (ISM band): 2.412 - 2.484 GHz Maximum Output Power802.11 n: 14.5 dBm +/- 1.5 dB Range at Maximum Output Power100+ feet depending on a number of factors	Not available
ConnectiontoCompatibleControllableDevices	Wired connection to SDC3's device control ports via device control cable. Wired connection to Gateway device control ports via device control cable.	Wired connection to SDC3's device control ports via device control cable.
ControllableDevices	Same type of currently marketed devices aspredicate device.A complete compatible devices list is providedunder Section 12 – Substantial EquivalenceDiscussion.	Compatible controllabledevices include legacy andcurrently marketed devices.A complete compatibledevices list is provided underSection 12 – SubstantialEquivalence Discussion.

Table 5.1: Differences between the Proposed and Predicate Devices

{7}------------------------------------------------

7) Performance Testing

The Stryker SDC3 HD Information Management System with wireless device control capability was tested for performance in accordance with internal design specifications, applicable performance standards and FDA guidance documents. Risk analysis was carried out in accordance with ISO 14971:2007 - Medical Devices - Application of Risk Management to Medical Devices; subsequently design verification/validation activities and corresponding acceptance criteria were identified and performed in accordance to the risk analysis assessment.

Electrical safety and electromagnetic compatibility testing was performed in accordance with the standards listed below. Testing indicates that the proposed device conforms to these standards.

ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009(R)2012 and ● A2:2010/(R)2012 (Consolidated Text) - Medical Electrical Equipment - Part 1 : General Requirements for Basic Safety and Essential Performance
. IEC60601-1-2:2007 - Medical Electrical Equipment – Part 1-2: General Requirements for Basic Safety and Essential Performance – Collateral Standard: Electromagnetic Compatibility – Requirements and Tests

Software was developed, tested, and verified per IEC 62304:2006 - Medical Device Software - Software Life Cycle Processes as well as FDA guidance documents:

Guidance for the Content of Premarket Submissions for Software Contained ● in Medical Devices
Content of Premarket Submissions for Management of Cybersecurity in . Medical Devices
Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf . Software Use in Medical Devices

The software for this device was classified as "moderate" level of concern, since a failure or latent flaw in the software could result in minor injury to the patient or operator.

Performance testing was conducted to ensure that the device functioned as intended and met design specifications, acceptance criteria and the content of the FDA guidance document "Radio Frequency Wireless Technology in Medical Devices." Table 5.2 summarized performance verification and validation data provided within this submission.

{8}------------------------------------------------

Test	Test Description
SDC3 and Gateway Software DeviceControl Verification	Verified device/voice control ofcompatible devices via Gateway throughSDC3's GUI, IR Remote, and supportedCamera Head when the devices areconnected to Gateway.
SDC3 and Gateway ConnectivitySoftware Verification	Verified the compatibility of SDC3 withUniversal Gateway System and theconnection security between the SDC3and the Universal Gateway System.
Software Network SecurityVerification	Verified network security features of theSDC3.
Wireless Co-existence VerificationTest	Verified SDC3's ability to upload casedata to an external server wirelessly underco-existence environment.
Benchmarking Test	Verified latency of wireless device controldata transmission under co-existenceenvironment, as compared to an identicalwired system. Also verified the dataaccuracy in a non-coexistenceenvironment.
SDC3 and Gateway Accuracy andReliability Coexistence Report.	Verified accuracy and reliability ofwireless device control data transmissionunder co-existence environment.
Timing Test	Verified that the connection anddisconnection times between the SDC3and the Gateway meet the specification.
Design Validation	Validated expanded functionality ofwireless device control to ensure defineduser needs and intended use are met undersimulated use conditions

Table 5.2: Performance Verification and Validation Summary

8) Conclusion

Based on the indications for use, intended use, technological characteristics, performance testing and comparison to the predicate device, the Stryker SDC3 HD Information Management System with wireless device control capability raises no new questions of safety and effectiveness as compared to the predicate device.

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.