(41 days)
Stryker SwitchPoint Infinity® 3 Control Systern is intended to be a central point of control and integration of ancillary compatible equipment, audio, video, and data routing, as well as teleconferencing for medical personnel.
This submission describes the Stryker SwitchPoint Infinity® 3 Control System intended for use as a central point of control and integration of ancillary compatible equipment, audio, video, and data routing, as well as and teleconferencing for medical personnel. The system provides a user interface through which to centrally control and provide visual status of various compatible devices including surgical devices, such as through the Stryker SIDNE™ system, as well as other devices, such as audio/video equipment used by medical personnel. It also functions as a matrix router capable of dynamically routing an array of audio, video, or other data sources to an array of audio, video or other data destinations. The routing capability is used to integrate local audio/video sources and destinations within a room. The SPI3 system provides an interface to facilitate audio/video communications to other rooms within the hospital campus, as well as off-site.
The provided document is a 510(k) premarket notification for the Stryker SwitchPoint Infinity® 3 Control System. This device is described as a "central point of control and integration of ancillary compatible equipment, audio, video, and data routing, as well as teleconferencing for medical personnel."
It's important to understand that a 510(k) submission generally focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and standalone AI performance as typically found in submissions for AI/ML-driven diagnostic devices.
Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes for test sets, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance of an algorithm, and training set details are not applicable to this type of regulatory submission for this specific device.
Based on the provided text, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance:
This information is not provided in the document. The submission focuses on demonstrating substantial equivalence to predicate devices rather than meeting specific performance criteria.
2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
This information is not provided. The submission details engineering and design comparisons, not a clinical performance study with a test set of data.
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 as there is no mention of a clinical test set requiring expert ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not provided as there is no mention of a clinical test set.
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 provided. This device is an integration and control system, not an AI-driven diagnostic or assistive tool, so an MRMC study is not relevant to its stated purpose.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not provided. The device is an integration system and not an algorithm with standalone performance metrics.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not provided as there is no mention of a clinical test set requiring ground truth.
8. The sample size for the training set:
This information is not provided as the device is not described as an AI/ML system that undergoes a training phase with a dataset.
9. How the ground truth for the training set was established:
This information is not provided as there is no mention of a training set.
Summary of Device and Regulatory Approach as per the Document:
- Device Name: Stryker SwitchPoint Infinity® 3 Control System (SPI3)
- Intended Use: "A central point of control and integration of ancillary compatible equipment, audio, video, and data routing, as well as teleconferencing for medical personnel." It provides a user interface to centrally control compatible devices, acts as a matrix router for audio/video/data, and facilitates audio/video communications within and outside the hospital.
- Regulatory Basis: 510(k) Premarket Notification based on demonstrating substantial equivalence to legally marketed predicate devices.
- Predicate Devices:
- Claim of Equivalence: The submission states that "The minor differences between the Stryker SwitchPoint Infinity® 3 Control System and the predicate device raise no new issues of safety and effectiveness, as these differences have no effect on the performance, function or general intended use of the device." The conclusion is that it "does not raise any new safety or efficacy issues" based on "applicable testing and the equivalence information presented." (The details of this "applicable testing" are not provided in the excerpt, but typically include device verification and validation activities showing it meets its own design specifications and functions as intended, not a comparative clinical study).
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. 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 an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
JUL 2 7 2015
Stryker Communications % TUV Rheinland of North America, Inc. Mr. Tamas Borsai Program Manager 12 Commerce Road Newton, CT 06470
Re: K100852
Trade/Device Name: Stryker SwitchPoint Infinity® 3 Control System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: OCS Dated (Date on orig SE ltr): April 20, 2010 Received (Date on orig SE 1tr): April 22, 2010
Dear Mr. Borsai,
This letter corrects our substantially equivalent letter of May 6, 2010.
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/Safetv/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/ResourcesforYou/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: Indications for Use Statement
ommunications
510(k) Number (if known): K100852
Device Name: Stryker SwitchPoint Infinity® 3 Control System
Stryker SwitchPoint Infinity® 3 Control Systern is intended to be a central point of control and integration of ancillary compatible equipment, audio, video, and data routing, as well as teleconferencing for medical personnel.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use_ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dild RP Anden for mkin
(Division Sign bm
Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K100852
Stryker Communications March 9, 2010
7
{3}------------------------------------------------
C100852
510(k) Premarket Application
Section 5: 510(k) Summary
MAY - 6 2010
The following information is provided as required by 21 CFR § 807.87 for Stryker SwitchPoint Infinity® 3 Control System 510(k) premarket notification. In response to the Safe Medical Devices Act of 1990, the following is a summary of the safety and effectiveness information upon which the substantial equivalence determination is based.
| Device Proprietary Name: | Stryker SwitchPoint Infinity® 3 Control System |
|---|---|
| Device Common Name: | Stryker SwitchPoint Infinity® 3 or SPI3 |
| Classification Name: | GCJ |
| Classification Number: | 21CFR § 876.1500 - Accessory to Laparoscope,General and Plastic Surgery |
| Sponsor: | Stryker Communications1410 Lakeside Parkway # 100Flower Mound, Texas 75028Phone: 972-410-7279Fax: 408-754-8356 |
| Contact Person: | Alma Relja, RAC |
| Date Prepared: | March 9, 2010 |
This submission describes the Stryker SwitchPoint Infinity® 3 Control System intended for use as a central point of control and integration of ancillary compatible equipment, audio, video, and data routing, as well as and teleconferencing for medical personnel. The system provides a user interface through which to centrally control and provide visual status of various compatible devices including surgical devices, such as through the Stryker SIDNE™ system, as well as other devices, such as audio/video equipment used by medical personnel. It also functions as a matrix router capable of dynamically routing an array of audio, video, or other data sources to an array of audio, video or other data destinations. The routing capability is used to integrate local audio/video sources and destinations within a room. The SPI3 system provides an interface to facilitate audio/video communications to other rooms within the hospital campus, as well as off-site.
{4}------------------------------------------------
Equivalence for this device is based on similarities in intended uses, design and operational principles to the following substantially equivalent devices: Stryker SwitchPoint Infinity Control System (K033132), Olympus EndoALPHA Integrated Endosurgery System (K051613), and KSEA Storz Communication Bus (SCB) Media Control (K020640). The minor differences between the Stryker SwitchPoint Infinity® 3 Control System and the predicate device raise no new issues of safety and effectiveness, as these differences have no effect on the performance, function or general intended use of the device. Therefore, based on the applicable testing and the equivalence information presented in this submission, Stryker Communications believes that the Stryker SwitchPoint Infinity® 3 Control System does not raise any new safety or efficacv issues.
Stryker Communications March 9, 2010
§ 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.