(101 days)
The Stryker 1488 HD Video Camera with Infrared Compatibility is indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery wherever a laparoscope/endoscope/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. The users of the Stryker 1488 HD Video Camera with Infrared Capability are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons and urologists.
The Stryker 1488 HD Video Camera with Infrared Compatibility (hereafter referred to as "proposed device") is used to view endoscopic surgical sites on video monitors. The optical image is transferred from the surgical site to the camera head by a variety of rigid and flexible scopes that are attached to the camera head using an optical coupler or by direct connection. The system is sensitive in the visible and infrared spectrum. The system control unit (CCU) and a camera head with an integral cable that connects to the CCU. The camera will provide a high quality image while remaining lightweight and easy to use. The system is intended to be used in orthopedic, laparoscopic, endoscopic, urological, microscopic, sinuscopic and plastic surgery and in dentistry, cardiology and wherever endoscopic procedures are deemed appropriate.
This document describes the Stryker 1488 HD Video Camera with Infrared Compatibility, a medical device. This type of device is an endoscopic camera system, and as such, the performance criteria and studies required are generally for hardware validation and safety, rather than software algorithm performance.
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Acceptance Criteria and Device Performance Study
The primary "study" proving the device meets acceptance criteria for this type of medical device (an endoscopic camera) involves demonstrating substantial equivalence to a predicate device and adherence to recognized performance standards, rather than clinical efficacy studies with specific image-based performance metrics like sensitivity/specificity or human reader improvement with AI.
1. Table of Acceptance Criteria and Reported Device Performance:
| Criteria Category | Acceptance Criteria (Standards Adhered To) | Reported Device Performance Statement |
|---|---|---|
| Predicate Equivalence | Identical indications for use, same intended use, and same technological characteristics as the predicate device (Stryker Model 888 Video Camera). | The proposed device has the following similarities as compared to its predicate device: |
- Identical indications for use.
- Same Intended Use.
- Same technological characteristics.
In conclusion, the proposed device raises no new questions of safety and effectiveness as compared to its predicate device. Therefore, the proposed device is substantially equivalent to the predicate device Stryker Model 888 Video Camera. |
| Electrical Safety | Conformance to IEC 60601-1:2005 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance). | "Electrical safety and electromagnetic compatibility testing was performed in accordance to IEC 60601-1:2005 and IEC 60601-1-2:2007, respectively. Testing indicates that the proposed device conforms to the aforementioned voluntary standards." |
| EMC | Conformance to IEC 60601-1-2:2007 (Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests). | "Electrical safety and electromagnetic compatibility testing was performed in accordance to IEC 60601-1:2005 and IEC 60601-1-2:2007, respectively. Testing indicates that the proposed device conforms to the aforementioned voluntary standards." |
| Software Validation | Conformance to IEC 62304:2006/AC:2008 (Medical device software – Software life-cycle processes) and FDA Guidance documents, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." | "The software validation activities were performed in accordance with IEC 62304:2006/AC: 2008 as well as the FDA Guidance documents, 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices'." |
| Sterilization Validation | Conformance to ISO 14937:2009 (Sterilization of health care products — General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices). | "The sterilization validation testing activities were performed in accordance with ISO 14937:2009 as described in Section 11, Device Description." |
| Endoscopic Equipment | Conformance to IEC 60601-2-18:2009 (Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment). | "Stryker Endoscopy has chosen to comply with the following voluntary standards, which are recognized consensus standards for the product code GCJ..." (Implies compliance was achieved). |
| Endoscope General Req. | Conformance to ISO 8600-1:2005 (Optics and photonics -- Medical endoscopes and endotherapy devices -- Part 1: General requirements). | "Stryker Endoscopy has chosen to comply with the following voluntary standards..." (Implies compliance was achieved). |
| Endoscope Max Width | Conformance to ISO 8600-4:1997 (Optics and optical instruments -- Medical endoscopes and certain accessories -- Part 4: Determination of maximum width of insertion portion). | "Stryker Endoscopy has chosen to comply with the following voluntary standards..." (Implies compliance was achieved). |
| Endoscope Field/Dir. | Conformance to ISO 8600-3:1997 + Amendment 1 (Optics and optical instruments - Medical endoscopes and endoscopic accessories Part 3: Determination of field of view and direction of view of endoscopes with optics). | "Stryker Endoscopy has chosen to comply with the following voluntary standards..." (Implies compliance was achieved). |
| Endoscope Optical Res.| Conformance to ISO 8600-5:2005 (Optics and photonics - Medical endoscopes and endotherapy devices - Part 5: Determination of optical resolution of rigid endoscopes with optics). | "Stryker Endoscopy has chosen to comply with the following voluntary standards..." (Implies compliance was achieved). |
| Endoscope Vocabulary | Conformance to ISO 8600-6:2005 (Optics and photonics - Medical endoscopes and endotherapy devices - Part 6: Vocabulary). | "Stryker Endoscopy has chosen to comply with the following voluntary standards..." (Implies compliance was achieved). |
| Internal Design Specs | Conformance to internal design specifications and risk analysis outputs. | "The proposed device was tested for performance in accordance with internal design specifications and with the applicable performance standards. Risk analysis was carried out, and subsequently design verification/validation activities and corresponding acceptance criteria were identified and performed in accordance with the risk analysis assessment." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document describes a hardware device, not an AI software. Therefore, there is no "test set" in the context of diagnostic data samples (e.g., medical images for AI performance evaluation).
- The "testing" mentioned refers to engineering verification and validation activities (electrical safety, EMC, software validation, sterilization validation, performance against various ISO/IEC standards). These typically involve testing the physical device and its components, not a dataset of patient information.
- Data provenance for these engineering tests is generally not relevant or specified in the same way as for clinical studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. As this is a hardware device, there is no "ground truth" established by experts for a test set of diagnostic data. The "ground truth" for hardware validation is typically the specified performance criteria, measured by calibrated equipment and verified by engineers (e.g., measuring light output, electrical resistance, software function according to its design).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. There is no "test set" of diagnostic data that would require adjudiciation by experts.
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:
- Not applicable. This device is an endoscopic camera, not an AI diagnostic tool. No MRMC study was performed because there is no AI component involved in image interpretation, nor is its purpose to improve human reader performance in diagnostic tasks. Its purpose is to generate images for human surgeons to view.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is a hardware camera; it does not contain a standalone algorithm for diagnostic performance that would operate without human interaction.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable in the context of diagnostic performance. The "ground truth" in this context refers to the specified engineering standards and internal design requirements. For example, the ground truth for electrical safety is defined by IEC 60601-1; for optical resolution, it's defined by ISO 8600-5. Compliance is measured directly against these technical specifications.
8. The sample size for the training set:
- Not applicable. This device is hardware; it does not utilize a "training set" in the machine learning sense.
9. How the ground truth for the training set was established:
- Not applicable. As there is no training set, there is no ground truth established for one.
§ 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.