(143 days)
The Bracco Diagnostics, Inc. (BDI) CO2MPACT ENDOSCOPIC INSUFFLATOR™ is designed to use CO2 as a distention media in the gastrointestinal tract when used in conjunction with a gastrointestinal endoscope.
The BDI CO2MPACT ENDOSCOPIC INSUFFLATOR™ allows the physician to modulate and control the CO2 to the patient in an identical manner to that being done currently with room air which is supplied by an air pump in the light source of the endoscopic equipment.
The Bracco Diagnostics, Inc. (BDI), CO2MPACT ENDOSCOPIC INSUFFLATOR™ (CO2MPACT) is designed to use CO2 as a distention media in the gastrointestinal tract when used in conjunction with a gastrointestinal endoscope. The BDI CO2MPACT regulates CO2 flow rate and pressure during the insufflation process.
The BDI CO2MPACT allows the physician to modulate and control the CO2 to the patient in an identical manner to that being done currently with room air which is supplied by an air pump in the light source of the endoscopic equipment.
Consistent with the predicate devices, the BDI CO2MPACT is used to administer CO2 to the patient for distention purposes. For this application, the actual displacement of CO2 to the patient through the endoscope is controlled by the clinician modulating an "air-water" valve on the endoscope. The BDI CO2MPACT only provides source pressure and flow to the endoscope in a similar manner to the predicates BDI CO2Efficient Endoscopic Insufflator (K053008) and Olympus UCR Endoscopic CO2 Regulation Unit (K081173), or the internal air pump included within the endoscope light source.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Bracco Diagnostics, Inc. CO2MPACT ENDOSCOPIC INSUFFLATOR™:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicitly based on stated tests and standards) | Reported Device Performance |
|---|---|---|
| Performance Testing | Compliance with internal requirements and applicable standards for controlling CO2 flow rate and pressure for gastrointestinal distention. | The BDI CO2MPACT complies with its predetermined specification and with the applicable Standards. |
| Biocompatibility | Patient contact materials (within device and tubing set) perform according to ISO 10993-1: 2009. | Verification results indicated that the materials comply with predetermined specifications. |
| Software Testing | Software modifications designed/developed according to robust software development process, verified, and validated (following FDA guidance: "Content of premarket submissions for software contained in medical devices," "Off-the-shelf software use in medical devices," "General principles of software validation;" and IEC 60601-1-4: 2000). | Test results indicate that the BDI CO2MPACT complies with its predetermined specification. |
| Electrical Safety | Patient safety complies with IEC 60601-1: 1988 (Am1: 1991, Am2: 1995) and UL 60601-1: 2006. | Test results indicated that the BDI CO2MPACT complies with applicable Standards. |
| Electromagnetic Compatibility (EMC) | EMC complies with IEC 60601-1-2: 2007. | Test results indicated that the BDI CO2MPACT complies with applicable Standards. |
| Conclusion of Equivalence | Device demonstrated to be safe and effective for its intended use and substantially equivalent to predicate device. | Verification and validation activities... demonstrate that the BDI CO2MPACT is safe and effective when used in accordance with its intended use and labeling. Therefore, the BDI CO2MPACT is considered substantially equivalent to the predicate device. |
2. Sample Size Used for the Test Set and the Data Provenance
The provided text does not specify a sample size for a test set in the context of clinical data or patient studies. The testing described is primarily bench testing, software verification/validation, and compliance with recognized standards (electrical safety, EMC, biocompatibility).
The data provenance is internal testing by Bracco Diagnostics, Inc. on the device itself and its components. There is no mention of external data or patient data, nor is there any indication of retrospective or prospective data collection from human subjects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable or not provided in the submission. The "ground truth" for the tests described relates to compliance with engineering standards and internal specifications, which would be established by the engineering and quality control teams at Bracco Diagnostics, Inc., rather than clinical experts establishing ground truth for diagnostic accuracy.
4. Adjudication Method for the Test Set
This information is not applicable or not provided. Since the testing is primarily objective measurements against specifications and standards, a clinical adjudication method (like 2+1, 3+1 concensus) is not relevant to the studies described.
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
No, an MRMC comparative effectiveness study was not done. This device is a CO2 insufflator, a physical medical device, not an AI or imaging diagnostic tool. Therefore, questions regarding human reader improvement with or without AI assistance are not relevant to this submission.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm study was not done. As mentioned, this is a physical medical device, not a software algorithm or AI.
7. The Type of Ground Truth Used
The "ground truth" used for evaluating the device's performance was predetermined specifications and applicable engineering/medical device standards (e.g., ISO, IEC, UL, FDA guidances for software). This is not a clinical ground truth like pathology, expert consensus on images, or patient outcomes data.
8. The Sample Size for the Training Set
This information is not applicable or not provided. There is no mention of a "training set" as this device does not involve machine learning or AI that would require such a set. Any "development" or "design" process for the device refers to engineering and software development, not model training.
9. How the Ground Truth for the Training Set was Established
This information is not applicable or not provided for the reasons stated in point 8.
§ 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.