(29 days)
Upon intravenous administration of SPY AGENT™ GREEN (Indocyanine green for injection, USP) the SPY-PHI System is used with SPY AGENT™ GREEN in capturing and viewing fluorescence images for the visual assessment of blood flow as an adjunctive method for the evaluation of tissue perfusion, and related tissue-transfer circulation in tissue and free flaps used in plastic, micro- and reconstructive surgical procedures.
The SPY-PHI System is used with SPY AGENT™ GREEN to provide fluorescence images for the visual assessment of blood flow in vessels and related tissue perfusion before, during and after gastrointestinal surgical procedures.
The SPY-PHI System is an imaging system used in capturing and viewing fluorescent images for the visual assessment of blood flow, as an adjunctive method for the evaluation of tissue perfusion, and related tissuetransfer circulation in tissue and free flaps used during plastic, micro-, reconstructive, and gastrointestinal surgical procedures.
The SPY-PHI System consists of the following main components: Imaging Head/ Imager (HH9030) with an integrated light guide cable and the Video Processor/Illuminator (VPI) (PC9001).
Indocyanine green (ICG) is injected intravenously into the patient. The Imaging Head may be either handheld or attached to a mechanical arm and provides illumination of the regions of a patient's body to be observed with near infrared laser light to excite ICG fluorescence. Alternatively, the Imaging Head provides white light illumination of the reqions of a patient's body to be observed for color imaging.
A CMOS camera in the Imaging Head captures the fluorescent image under laser illumination or a color image under white light illumination. The VPI receives the video signal from the Imaging Head and processes and outputs the video image to a medical grade video monitor and/or video recorder. Adjustments to the operation of the SPY-PHI System are possible through switches at either the Imaging Head or the VPI.
Here's an analysis of the provided text regarding the acceptance criteria and study proving the device meets them, formatted as requested:
Acceptance Criteria and Device Performance Study for SPY Portable Handheld Imaging (SPY-PHI) System (K190729)
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly state specific numerical acceptance criteria for clinical performance metrics (e.g., sensitivity, specificity, accuracy) for the SPY-PHI System. Instead, it focuses on demonstrating substantial equivalence to a predicate device by comparing technological characteristics, intended use, and confirming adherence to various safety and performance standards.
Therefore, the "acceptance criteria" primarily relate to compliance with regulatory standards and the "reported device performance" is its demonstrated conformance to these standards and its substantial equivalence to the predicate.
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Safety & Essential Performance | Conformance with IEC 60601-1:2006 (General requirements for basic safety and essential performance) | SPY-PHI was tested and determined to be in conformance with IEC 60601-1:2006. |
| Electromagnetic Compatibility (EMC) | Conformance with IEC 60601-1-2 (4th edition) | SPY-PHI was tested and determined to be in conformance with IEC 60601-1-2 (4th edition). |
| Laser Safety | Conformance with IEC 60825:2007 (Safety of laser products -- Part 1: Equipment classification and requirements) | SPY-PHI was tested and determined to be in conformance with IEC 60825:2007. |
| Software Life-Cycle Processes | Conformance with IEC 62304:2006 (Medical device software - Software life-cycle processes) | An assessment of the SPY-PHI system software was conducted, demonstrating that all processes and activities necessary for the safe design and maintenance of SPY-PHI software are performed in accordance with IEC 62304:2006. |
| Drug Compatibility | Compatibility with Stryker ICG - SPY AGENT™ GREEN (Indocyanine green for injection, USP) | Bench testing was performed to demonstrate compatibility of the SPY-PHI System with Stryker ICG - SPY AGENT™ GREEN. |
| Substantial Equivalence | Demonstrated substantial equivalence to the predicate device (SPY PHI Open Field Handheld Fluorescence Imaging System, K162885) based on fundamental scientific technological characteristics, principle of operation, intended use, environment of use, and indications for use. | Based on the information presented, and on the fundamental scientific technological characteristics, principle of operation, intended use, environment of use, and indications for use, the SPY-PHI System has been determined to be substantially equivalent to the predicate device (K162885). Minor technological/design differences and the change in drug labeling do not raise safety or effectiveness concerns. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not include information about a distinct "test set" with a specific sample size, nor does it detail data provenance (e.g., country of origin, retrospective/prospective) for clinical performance evaluation. The submission primarily relies on bench testing, software assessment, and a comparison of technological characteristics to a predicate device to establish substantial equivalence.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Given the lack of a distinct clinical "test set" with performance metrics, the document does not mention the number of experts used or their qualifications to establish ground truth. The study is primarily focused on engineering and regulatory compliance rather than clinical accuracy adjudicated by experts.
4. Adjudication Method for the Test Set
As there is no described clinical "test set" with performance data requiring expert review, no adjudication method is mentioned.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size
The provided text does not mention a Multi Reader Multi Case (MRMC) comparative effectiveness study. The submission focuses on demonstrating substantial equivalence through technical and regulatory compliance, not on comparing human reader performance with and without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done
The SPY-PHI System is an imaging system designed for visual assessment by a human user ("capturing and viewing fluorescence images for the visual assessment of blood flow"). It is not described as an AI-powered diagnostic algorithm that would operate in a standalone mode without human interpretation. Therefore, a standalone (algorithm-only) study is not applicable or mentioned in this context.
7. The Type of Ground Truth Used
For the safety and performance studies mentioned, the "ground truth" was established by regulatory standards and industry requirements, such as:
- Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60825:2007 for physical device performance.
- Compliance with IEC 62304:2006 for software processes.
- Demonstrating physical compatibility through bench testing for the drug-device combination.
- The overall "ground truth" for the 510(k) submission is the demonstration of substantial equivalence to a previously cleared predicate device.
8. The Sample Size for the Training Set
Since the SPY-PHI System is described as an imaging system and not an AI/machine learning algorithm requiring a "training set" for model development, no training set sample size is mentioned.
9. How the Ground Truth for the Training Set Was Established
As no training set is applicable or mentioned, no information on how its ground truth was established is provided.
§ 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.