(338 days)
C040069
No
The document describes a control system for operating room equipment and communication, focusing on routing and interfacing. There is no mention of AI, ML, or related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices.
No
The device is described as a control system and an interface for managing equipment and communication in the operating room, not for treating conditions or diseases.
No.
The device description indicates its purpose is to control room and surgical equipment, and act as a communication interface, not to diagnose medical conditions.
No
The device description explicitly states it is an "integrated voice, video, and data router and teleconferencing interface," which implies the presence of hardware components beyond just software. It also controls "room equipment, and audio/video equipment" and acts as a "center point for controlling all equipment and communication in surgery," further suggesting a hardware-based system.
Based on the provided text, the Switchpoint Infinity™ Control System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Switchpoint Infinity™ Function: The description clearly states the device's purpose is to control equipment (room, audio/video, surgical) and act as a communication interface (voice, video, data routing, teleconferencing) within the operating room. It does not mention any interaction with biological specimens or providing diagnostic information based on such specimens.
Therefore, the Switchpoint Infinity™ Control System falls under the category of a surgical control and communication system, not an IVD.
N/A
Intended Use / Indications for Use
The Switchpoint Infinity™ Control System is a medical device that is designed to allow direct control of the state, selection, and settings of room equipment, and audio/video equipment and indirect control through the Stryker Endoscopy Sidne™ System of the state, selection, and settings of surgical equipment in the operating room. The Switchpoint Infinity™ Control System is also an integrated voice, video, and data router and teleconferencing interface for the operating room. The intent of the Switchpoint Infinity™ Control System is to allow operating room personnel a center point for controlling all equipment and communication in surgery.
The Stryker Switchpoint Infinity™ Control System is indicated for use with the Stryker Endoscopy Sidne™ System [510(k) # K022393] and Sidne™ compatible endoscopic and general surgery devices.
Product codes
GCJ
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The users of Switchpoint Infinity™ Control System are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons, urologists, and any other surgeon whom requires the use of voice, video, or control in the operating room or a teleconferencing interface.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
C040069
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
SEP - 2 2004
12140 Community Road Poway, CA 92064 t: 619 401 8400 f: 619 401-8484 www.stryker.com
stryke
Communications
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
Device Name
| Common and Usual Name: | Stryker Switchpoint Infinity™ Control System |
|---|---|
| Proprietary Name: | Switchpoint Infinity™ Control System |
| Classification Name: | 876.1500 - Accessory to Laparoscope, General and Plastic Surgery |
This 510(k) summary and effectiveness is being submitted in accordance with requirements of SMDA 1990.
The Switchpoint Infinity™ Control System is substantially equivalent in safety and efficacy as the currently marketed Sidne™ System and Nurse's Assistant OR Control System. The Sidne™ System was cleared under 510(k)# K022393. The Nurse's Assistant OR Control System was cleared under 510(k)# K010754. The Switchpoint Infinity™ Control System is also substantially equivalent in reference to the teleconferencing feature to the Stryker Switchpoint™ III, a Class I device as determined by 513(g) #C040069, and the KSEA Storz Communication Bus (SCB) Media Control™ already cleared in 510(k) #K020640.
Indications for Use: The Switchpoint Infinity™ Control System is a medical device that is designed to allow direct control of the state, selection, and settings of room equipment, and audio/video equipment and indirect control through the Stryker Endoscopy Sidne™ System of the state, selection, and settings of surgical equipment in the operating room. The Switchpoint Infinity™ Control System is also an integrated voice, video, and data router and teleconferencing interface for the operating room. The intent of the Switchpoint Infinity™ Control System is to allow operating room personnel a center point for controlling all equipment and communication in surgery.
The Stryker Switchpoint Infinity™ Control System is indicated for use with the Stryker Endoscopy Sidne™ System [510(k) # K022393] and Sidne™ compatible endoscopic and general surgery devices. The users of Switchpoint Infinity™ Control System are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons, urologists, and any other surgeon whom requires the use of voice, video, or control in the operating room or a teleconferencing interface.
The Switchpoint Infinity™ Control System conforms to the following voluntary standards: UL 60601-1, 18 Edition (April 25, 2003) Medical Electrical Equipment, Part 1: General Requirements for Safety: EN 60601-1-2 Medical Electrical Equipment Part 1: General Requirements for Safety 2: Collateral Standard: Electromagnetic Compatibility - Requirements and Tests.
The technological differences between the Stryker Switchpoint Infinity™ Control System and the predicate devices (Sidne™ System, Nurse's Assistant OR Control System, Switchpoint™ III, and KSEA Storz Communication Bus (SCB) Media Control™) do not raise new issues of safety and efficacy. Therefore, the Stryker Switchpoint Infinity™ Control System is substantially equivalent to the currently marketed Sidne™ System, Nurse's Assistant OR Control System, Switchpoint™ III, and KSEA Storz Communication Bus (SCB) Media Control™.
Laura Murphy Quality Assurance/Regulatory Affairs Representative Stryker Communications
Date:
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 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" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 2 2004
Ms. Laura Murphy Quality Assurance/Regulatory Affairs Representative Stryker Communications Corporation 12140 Community Road Poway, California 92064
Re: K033132
Trade/Device Name: Stryker Switchpoint Infinity™ Control System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: August 19, 2004 Received: August 19, 2004
Dear Ms. Murphy:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your be dever is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for aboven on 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). and Cosmeter Ace (110) the device, subject to the general controls provisions of the Act. The r ou may, ateres, and on the Act include requirements for annual registration, listing of general oonarols profiseturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your de reach 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 or any I vith all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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.
2
Page 2 - Ms. Laura Murphy
This letter will allow you to begin marketing your device as described in your Section 510(k) rms let notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you attire of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrb/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): K033132
Device Name: Stryker Switchpoint Infinity™ Control System
Indications For Use:
The Switchpoint Infinity™ Control System is a medical device that is designed to allow direct control of the state, selection, and settings of room equipment, and audio/video equipment and indirect control through the Stryker Endoscopy Sidne™ System of the state, selection, and settings of surgical equipment in the operating room. The Switchpoint Infinity™ Control System is also an integrated voice, video, and data router and teleconferencing interface for the operating room. The intent of the Switchpoint Infinity™ Control System is to allow operating room personnel a center point for controlling all equipment and communication in surgery.
The Stryker Switchpoint Infinity™ Control System is indicated for use with the Stryker Endoscopy Sidne™ System [510(k) # K022393] and Sidne™ compatible endoscopic and general surgery devices. The users of Switchpoint Infinity™ Control System are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons, urologists, and any other surgeon whom requires the use of voice, video, or control in the operating room or a teleconferencing interface.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(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)
Miriam C. Provost
(Division Sign Off)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
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510(k) Number K033132