The Stryker SDC3 HD Information Management System (SDC3) is intended 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 & 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, and urologists.

Device Description

The Stryker SDC3 HD Information Management System (referred to as "SDC3 system" in the following sections) is a medical device that allows the surgeon to control the state, selection, and settings of any compatible device attached to it. It also has operating room documentation functionalities (Class I device function) to electronically capture, transfer, store and display medical device data independently of the functions or parameters of any connected medical device.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Stryker SDC3 HD Information Management System:

Summary of Acceptance Criteria and Device Performance (Limited Information Provided)

The document provides very high-level information about "performance testing" but does not detail specific acceptance criteria values or specific device performance results in a quantitative manner. The acceptance criteria are broadly described as being in accordance with "internal design specifications" and "applicable performance standards." The reported performance is generally stated as "conforms" or "successfully passed."

Acceptance Criteria Category	Reported Device Performance	Comments
Risk Analysis	Carried out in accordance with ISO 14971:2007; design verification activities and acceptance criteria identified and performed.	General statement of compliance with a standard. No specific risk acceptance levels or outcomes are provided.
Voice Recognition	Verification/validation testing for voice recognition performance conducted.	No specific metrics (e.g., accuracy rate, response time) or target criteria are given.
Device Control	Verification/validation testing for device control performance conducted.	No specific metrics (e.g., latency, reliability) or target criteria are given.
Digital Documentation	Verification/validation testing for digital documentation performance conducted.	No specific metrics (e.g., data integrity, transfer speed, display accuracy) or target criteria are given.
Environmental Performance	Verification/validation testing for environmental performance evaluation conducted.	No specific environmental conditions or performance thresholds are given.
Electrical Safety	Conforms to IEC 60601-1:1988/A1:1991/A2:1995.	General statement of compliance to a standard.
Electromagnetic Compatibility	Conforms to IEC 60601-1-2: 2001 + A1: 2004.	General statement of compliance to a standard.
Software Validation	Performed in accordance with IEC 62304:2006 and FDA Guidance documents. Unit, integration, system-level, and simulated use testing conducted.	General statement of compliance and testing levels. No specific bug rates, reliability metrics, or test coverage criteria are mentioned.

Detailed Study Information:

The document describes various performance tests conducted, but it does not present a typical clinical study or a study specifically designed to establish acceptance criteria with quantitative outcomes. Instead, it refers to internal verification and validation activities.

Sample Size used for the test set and the data provenance:
- Test Set Sample Size: Not specified. The document mentions "verification/validation testing" and "simulated use testing," but does not provide any sample sizes in terms of number of users, cases, or data points used for these tests.
- Data Provenance: Not specified. Given that these are internal verification and validation tests, the data would likely originate from Stryker's internal testing environments. It's not a retrospective or prospective clinical study on patient data.
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):
- Not applicable/Not specified. The document does not describe a process of establishing ground truth by external experts for a clinical test set. The ground truth for internal performance testing would be defined by engineering specifications and expected behavior.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not specified. This type of adjudication method is used in studies involving human reviewers and ambiguous cases, which is not described here.
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:
- No MRMC comparative effectiveness study was done or reported in this document. The SDC3 system is an information management and control system, not an AI-assisted diagnostic tool for "human readers." Its purpose is to control other surgical devices and manage documentation.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- The document describes "system level testing and simulated use testing" which implies testing the algorithm's performance in isolation or in simulated environments. However, the term "standalone" performance usually refers to diagnostic algorithms operating without human intervention for decision-making. In the context of a control and information management system, the "standalone" performance would be its ability to accurately execute commands, capture data, and maintain system integrity, which is implicitly covered by the various verification/validation tests mentioned (voice recognition, device control, digital documentation). No specific "standalone" study is detailed with quantitative results.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The term "ground truth" as typically used in medical AI studies (e.g., for disease detection) is not directly applicable here. For the types of tests described (voice recognition, device control, digital documentation), the "ground truth" would be established by:
  - Voice Recognition: Correct interpretation of spoken commands based on predefined linguistic models.
  - Device Control: Accurate and timely execution of commands to connected devices as per specifications.
  - Digital Documentation: Correct capture, storage, transfer, and display of data as per functional requirements and data integrity standards.
  - Electrical Safety/EMC: Compliance with the pass/fail criteria of the relevant IEC standards.
  - Software Validation: Adherence to software requirements specifications and absence of bugs, verified by unit, integration, and system-level tests.
The sample size for the training set:
- Not applicable/Not specified. The document does not describe the use of machine learning that would require a distinct "training set." While voice recognition technology does involve training, the details of such a training set are not provided in this 510(k) summary, which focuses on validation of the final product.
How the ground truth for the training set was established:
- Not applicable/Not specified. As no training set is described for the device's functionality, the method for establishing its ground truth is also not provided.

Conclusion based on the provided text:

The provided document, a 510(k) summary, primarily seeks to establish substantial equivalence to a predicate device (Stryker SIDNE™ System). It details various engineering verification and validation activities rather than a clinical study with quantitative acceptance criteria and performance metrics. The focus is on demonstrating that the device conforms to internal specifications and relevant industry standards (e.g., ISO, IEC), and that any differences from the predicate device do not raise new questions of safety or effectiveness. Specific numerical acceptance criteria, clinical study designs, expert ground truth establishment, or sample sizes for testing beyond general statements of "verification/validation testing" are not included in this summary.

Summary

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.

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

JUL 2 7 2015

Stryker Endoscopy % Underwriters Laboratories, Incorporated Mr. Ned Divine Senior Staff Engineer 333 Pfingsten Road Northbrook, IL 60062

Re: K121893

Trade/Device Name: Stryker SDC3 HD Information Management System (SDC3) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ, HRX Dated (Date on orig SE ltr): August 17, 2012 Received (Date on orig SE ltr): August 21, 2012

Dear Mr. Divine,

This letter corrects our substantially equivalent letter of September 5, 2012.

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

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

Page 2 -

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-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 Small Manufacturers, International and Consumer Assistance 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Benjamin R. Fisher -S

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

SECTION 4

Traditional 510(k) Premarket Notification SDC3 HD Information Management System

INDICATIONS FOR USE STATEMENT

Device Name: Stryker SDC3 HD Information Management System (SDC3)

KIS 1893 510{k} Number (if known): _

Indications for Use:

Prescription Use __ X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - COUNTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (OD

Nil R.P. Ogden firmen

cal, Orthopedic.

510(k) Number K121893

Section 4, Page 1

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

k 12 1893 ps I of 3

stryker

SECTION 5

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

General Information 1.

Traditional 510(k) Premarket Notification:

SDC3 HD Information Management System

510(k) Sponsor:	Stryker Endoscopy
Address:	5900 Optical CourtSan Jose, CA 95138
FDA Registration Number:	2936485
Correspondence person:	Lifei Liu, RACSenior Regulatory Affairs AnalystStryker EndoscopyEmail: lifei.liu@stryker.comPhone: (408) 754-2315

2. Device Identification

Proposed Device:

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

Predicate Device:

Proprietary Name:	Stryker SIDNE™ System
Premarket Notification	K022393
Classification Name:	Laparoscope, General and Plastic Surgery
Regulation Number:	21 CFR 876.1500
Product Code:	GCJ
Subsequent Product Codes:	HRX, KOG
Regulatory Class:	II

3. Device Description

4. Indications for Use

The SDC3 system is intended 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

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

Image /page/4/Picture/18 description: The image shows the word "stryker" in a bold, sans-serif font. The letters are all lowercase and connected, giving the word a dynamic and modern appearance. The color of the text is black, contrasting with the white background.

Traditional 510(k) Premarket Notification: SDC3 HD Information Management System

SECTION 5

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

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 hysterectorny. laparoscopic & 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.

The Indications for Use for the SDC3 system is identical to the Indications for Use previously cleared for the Stryker SIDNE™ System (K022393).

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.

The only difference between the Intended Use of the SDC3 system and the Stryker SIDNE™ System is the addition of digital documentation functionality (Class I device function) to the SDC3 system. Addition of such functionality does not render SDC3 system exceeding the limitations set forth in 21 CFR 876.1500, nor does it impact the safety and effectiveness for the intended use of device control. As a result, the Intended Use of the SDC3 system and the Stryker SIDNE™ System is deemed to be the same based on FDA guidance "510/k) 'Substantial Equivalence' Decision Making Process".+

thttp://www.fda.goy/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/Pre marketSubmissions/PremarketNotification510k/ucm134783.htm

6. Technological Comparison

The SDC3 system has similar hardware as the predicate device, uses the same communication protocols as the predicate device, employs the same voice recognition technology and controls the same types of connected devices as the predicate device. Therefore, the SDC3 has the same technological characteristics as the predicate device in the following areas:

Operating principle
Software architecture
Electrical characteristics ●
. Mechanical characteristics
. Communication characteristics

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

K121893
pg 3 of 3

Image /page/5/Picture/1 description: The image contains the Stryker logo. The logo is in black and consists of the word "stryker" in a bold, sans-serif font. Below the main logo, the words "Stryker Endoscopy" are written in a smaller, sans-serif font.

SECTION 5

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

Performance characteristics ●
Compatibility with controllable devices as listed in the product labeling ●
Energy source

Traditional 510(k) Premarket Notification:

SDC3 HD Information Management System

Material (no patient contacting material) ●

7. Performance Testing

The SDC3 System was tested for performance in accordance with internal design specifications and with the applicable performance standards. Risk analysis was carried out in accordance with ISO 14971:2007; subsequently design verification activities and corresponding acceptance criteria were identified and performed in accordance to the risk analysis assessment. The performance testing for design verification and validation is as follows:

Verification/validation testing for voice recognition performance ●
. Verification/validation testing for device control performance
Verification/validation testing for digital documentation performance ●
Verification/validation testing for environmental performance evaluation ●

Electrical safety and electromagnetic compatibility testing was performed in accordance to IEC 60601-1:1988/A1:1991/A2:1995 and IEC 60601-1-2: 2001 + A1: 2004, respectively. Testing indicates that the SDC3 System conforms to the aforementioned voluntary standards.

The software validation activities were performed in accordance with IEC 62304:2006 as well as the FDA Guidance documents, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", "Off-The-Shelf Software Use in Medical Devices", and "Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Softwore". The testing for the software verification and validation activities is as follows:

Unit level testing .
Integration level testing ●
System level testing and simulated use testing .
1. Conclusion

The SDC3 system has the following similarities as compared to its predicated device:

Identical indications for use, .
. Same Intended Use
Same technological characteristics ●

In conclusion, the Stryker SDC3 system raises no new questions of safety and effectiveness as compared to its predicate device. Therefore, the SDC3 system is substantially equivalent to the predicate device the Stryker SIDNE™ system.

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.