(29 days)
The E-Z-EM PROTOCO2L COLON Insufflator administers and regulates carbon dioxide (CO2) as a distention media to the colon during CT Colonography (CTC or Virtual Colonoscopy) and conventional Colonoscopy.
The EZEM PROTOCO>L with performance improvements, as with the predicate device is an insufflation system that is used in conjunction with a consumable and is intended to displace and regulate carbon dioxide (CO2) as a distention media to a patient's colon for purposes of CT Colonography and conventional colonoscopy. As with the predicate, the PROTOCO2L system with performance improvements consists of 3 components. These are the insufflator, consumable and accessory cart.
The provided document describes a 510(k) submission for the PROTOCOL™ Insufflator with Performance Improvements. This submission focuses on comparing the improved device to its predicate device to demonstrate substantial equivalence, rather than a standalone study proving novel acceptance criteria.
Therefore, many of the requested elements (like sample size for test/training sets, data provenance, number/qualification of experts, adjudication methods, MRMC studies, specific ground truth types) are NOT applicable or NOT explicitly stated in this type of regulatory submission. The document primarily highlights modifications to existing performance specifications and confirms that the indications for use remain the same.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document presents a comparison of the proposed device's performance specifications against the predicate device's specifications. The improvements themselves serve as the "acceptance criteria" for the new design, aiming to meet or exceed previous performance in specific areas while maintaining core functionalities.
| Specification Category | Acceptance Criteria (Proposed Device) | Reported Device Performance (Implied by submission) |
|---|---|---|
| Start-Up Ramp (Flow Rate) | At the onset of the procedure, flow of CO2 to the patient to be ramped to the patient in accordance with the following increments: | |
| 1.0 Liters/Minute for 0 to 0.5 Liter of Delivered Volume | ||
| 2.0 Liters/Minute for greater than 0.5 to 1.0 Liter Delivered Volume | ||
| 3.0 Liters/Minute for Delivered Volumes Greater than 1.0 Liter | The proposed device is designed to implement these ramped flow rates, indicating its performance meets these criteria. (The 510(k) submission implicitly states the device performs according to its proposed specifications to demonstrate substantial equivalence). | |
| Electronic Pressure Relief | 50 mm Hg for 5 seconds (absolute) | The proposed device's electronic relief valve opens when colon pressure goes above 50 mmHg for a sustained 5 seconds. This is the intended performance. |
| Independent Redundant Mechanical Relief | 75 mm Hg | The proposed device's independent redundant mechanical relief valve opens when colon pressure is at 75 mmHg. This is the intended performance. |
| Volume Delivery Logic | Upon Pressing the RUN/STOP Button at the start of the procedure, the unit will remain in run mode until 4 Liters of CO2 have been delivered. Once 4 Liters has been delivered, the unit automatically returns to stop mode. | |
| Thereafter pressing the RUN/STOP button a 2nd time will resume the delivery of CO2 for an additional 2 Liters of CO2. Once an additional 2 Liters has been delivered, the unit automatically returns to stop mode. | ||
| Subsequent presses of the RUN/STOP button will deliver additional 2 Liter boluses of CO2 as required by the user. | ||
| The user can always depress the RUN/STOP button during any of these volume increments to STOP delivery of CO2. | The proposed device is designed to operate according to these sequential, volumentrically controlled delivery modes. (Implied performance based on design changes for 510(k)). | |
| Flow Rate Accuracy | Not to exceed ± 20% @ 3 Liters/minute | The proposed device maintains this accuracy, similar to the predicate device. |
| Delivery Pressure (Range & Accuracy) | 0 to 25 mm Hg in increments of 1 mm Hg | |
| Accuracy: +/- 10% | The proposed device maintains this range and accuracy, similar to the predicate device. | |
| Delivery Volume Accuracy | +/- 20 % | The proposed device maintains this accuracy, similar to the predicate device. |
| Environmental Requirements (Safety Standards) | Meets Requirements set forth in IEC/EN60601-1, Medical Electrical Equipment Part 1: General Requirements for Safety. | The proposed device is stated to meet these requirements. |
| EMC Requirements | Meets Requirements set forth in IEC/EN 60601-1-2, CISPR 11, IEC 801-2, 801-3, 801-4, 801-5. | The proposed device is stated to meet these requirements. |
| UL/CSA Compliance | Medical Device Listing to UL 2601-1 / CSA C22.2 No. 601.1, Electrical Class I, Type B Isolation rating. | The proposed device is stated to meet these requirements. |
2. Sample size used for the test set and the data provenance
- Not explicitly stated. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device based on design, material, and performance specifications. It does not typically include detailed study results with sample sizes for specific tests conducted on the modified device, unless a new clinical trial was deemed necessary (which appears not to be the case here, as it's a "special 510(k)"). The performance improvements are described as design changes substantiated by technical data, likely bench testing or engineering verification rather than a clinical human subject study testing the acceptance criteria.
- Data provenance: Not specified, but likely from in-house engineering and bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not stated. This type of information would be relevant for studies evaluating a device's diagnostic accuracy or clinical effectiveness against a gold standard, often involving expert review of images or clinical outcomes. For modifications to an insufflator that primarily affect flow, pressure, and volume delivery mechanisms, the "ground truth" is established through physical measurements and engineering standards rather than expert consensus on diagnostic images.
4. Adjudication method for the test set
- Not applicable/Not stated. Adjudication methods like 2+1 or 3+1 are used in studies where multiple experts evaluate cases and a consensus is needed to establish ground truth or resolve discrepancies in interpretations (e.g., in diagnostic AI studies). This is not relevant for the type of engineering verification demonstrated in this 510(k) submission.
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. This device is an insufflator, not an AI-powered diagnostic tool. MRMC studies are used to evaluate changes in human reader performance (e.g., radiologists) when assisted by AI. This is entirely outside the scope of this device and submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This question pertains to AI algorithms. The PROTOCOL™ Insufflator is a medical device for physical CO2 delivery, not an algorithm.
7. The type of ground truth used
- For the performance specifications (flow rate, pressure relief, volume delivery logic, accuracy figures), the "ground truth" would be established through engineering measurements and calibration standards. This involves using validated equipment to measure CO2 flow, pressure, and volume output from the device under specified conditions and comparing these measurements against the defined performance specifications. Compliance with international safety and EMC standards (IEC/EN60601-1, IEC/EN 60601-1-2) would also be verified through standardized testing procedures.
8. The sample size for the training set
- Not applicable. There is no "training set" in the context of this device. Training sets are relevant for machine learning algorithms, which is not what this device is.
9. How the ground truth for the training set was established
- Not applicable. As stated above, this device does not involve machine learning or training sets.
§ 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.