(12 days)
This product is a balloon pump apparatus intended to inflate or deflate a balloon to assist with endoscope and over tube insertion. This product is not intended for use for any neonates, infants or children.
The Fujifilm Balloon Controller PB-30 is a modified version of the legally marketed Fujifilm Balloon Controller PB-20 in K143556. Just like K143556, the proposed PB-30 is a balloon pump apparatus intended to inflate or deflate a balloon to assist with endoscope and over tube insertion. This product is not intended for use for any neonates, infants or children.
PB-30 is connected to the over-tube and double balloon endoscope via a tube kit. PB-30 feeds /evacuates air to the balloon of over-tube and to the balloon at the tip of the endoscope. All of the PB-30's accessories are legally marketed in the US.
This document is a 510(k) premarket notification for the Fujifilm Balloon Controller PB-30. It states that the PB-30 is a modification of the legally marketed Fujifilm Balloon Controller PB-20. As such, the purpose of the submission is to demonstrate that the modified device performs equivalently to the predicate.
Here's an analysis of the provided information concerning acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| EMC and Electrical Safety: Based on consensus standards: ANSI/AAMI ES60601-1:2005 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance)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)IEC 60601-1-6:2010 (Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability)IEC 60601-2-18:2009 (Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment) | "In all cases, the device met the pre-defined acceptance criteria for the test." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a separate "test set" in the context of clinical data for performance evaluation. The performance testing described relates to EMC and electrical safety, likely involving single units or a small sample of the device, rather than a large patient-based test set.
- Sample Size: Not explicitly stated, but typically involves a limited number of devices (e.g., 1-3) for electrical and EMC testing.
- Data Provenance: Not specified, but likely from laboratory testing conducted by Fujifilm or a certified testing facility. It is not clinical data, so country of origin or retrospective/prospective does not apply in the usual sense.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not applicable. The performance testing for this device (EMC and electrical safety) does not involve human expert interpretation or ground truth establishment in the way a diagnostic imaging device might. The "ground truth" for these tests would be the established international standards themselves.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are used for reconciling discordant expert interpretations in clinical studies. The testing performed here (EMC and electrical safety) does not involve such a process.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence through technical performance testing (EMC and electrical safety) and functional equivalence to the predicate device (PB-20), not on human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, this question is not applicable to the device described. The Balloon Controller PB-30 is a hardware device (a balloon pump apparatus) and does not involve an AI algorithm or human-in-the-loop performance testing.
7. The Type of Ground Truth Used
The "ground truth" for the performance testing described (EMC and electrical safety) is defined by established international consensus standards (e.g., ANSI/AAMI ES60601-1, IEC 60601-1-2). Compliance with these standards serves as the ground truth for safety and performance in these specific areas.
8. The Sample Size for the Training Set
This information is not applicable. The device is a hardware product, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no training set for this hardware device.
§ 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.