(226 days)
Consure 120 SMS is indicated for fecal management by diverting and collecting liquid or semi-formed stool to minimize skin contact in bedridden patients.
The Consure 120 Stool Management System is a non-sterile device packaged in individual SteriClin (medical grade paper with peel-away PE lamination) pouches. Ten such individual pouches are packed in corrugated boxes for shipping. Each Consure 120 SMS pouch contains: -- I soft and hygienic applicator that houses a soft in-dwelling diverter and -- 3 collection bags. The primary component of the device is the fecal diverter. It consists of an indwelling, pliable, self-expanding lattice structure that remains apposed to the rectal wall and the transit sheath. The indwelling diverter is sufficiently compliant to collapse and expand with the adjacent anatomy during peristaltic contractions of the rectum. This pliancy within the rectum can reduce abrasion and subsequent clinical complications originating from the mucosal damage. The transit sheath is a thin, biocompatible conduit that facilitates the transfer fecal material from the indwelling diverter to the collection bag. The use of thin sheath reduces the foreign body sensation and risk of anal sphincter dysfunction. The applicator is used to hygienically insert and deploy the indwelling diverter at the intended location inside the rectum. Whereas the bag connection interface allows the prevention of accidental soiling of bed sheets, garments, etc. during exchange of collection bag or other regular maneuvers during patient handling.
The Consure 120 SMS™ device underwent several tests to confirm functional performance and structural integrity, as well as a comparative analysis against predicate devices.
1. Acceptance Criteria and Reported Device Performance
| Product Components/Feature | Acceptance Criteria | Reported Device Performance (No specific separate performance data provided, implies compliance with criteria) |
|---|---|---|
| Assembled Crown OD | 50 – 56 mm | - |
| Applicator OD | 15 ± 0.5 mm | - |
| Visual inspection | N/A (Method provided) | - |
| Radial force | 8 ± 3 N | - |
| Fatigue Testing | 50 cycles | - |
| Bonding Strength - Crown foil to sheath | 35 N minimum | - |
| Bonding Strength - Sheath to connector | 35 N minimum | - |
| Bonding Strength - Y-adapter to extrusion | 35 N minimum | - |
| Bonding Strength - Bag to connector | 35 N minimum | - |
| Withdrawal force | 45 N maximum | - |
2. Sample Size and Data Provenance
The document states that "100% receiving and in-process inspection" is performed, and the listed tests are conducted "on each lot prior to release." This suggests a continuous sampling or full inspection approach for manufacturing quality control, rather than a single large-scale test set.
The "Comparative analysis of Consure 120 SMS vs predicate devices" was performed "in-house." The document does not specify the sample size for this comparative analysis.
The data provenance is internal ("in-house") and appears to be from manufacturing and bench-top testing. There is no information regarding country of origin of data or whether it's retrospective or prospective in the context of clinical studies.
3. Number of Experts and Qualifications for Ground Truth
The provided document does not mention any ground truth established by experts for a test set. The testing described is primarily focused on engineering specifications, functional performance, and comparative bench-top analysis against predicate devices, not clinical performance or expert-adjudicated outcomes.
4. Adjudication Method for the Test Set
Not applicable, as no expert-adjudicated test set is described in the provided text.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned in the provided text. The comparative analysis described is a bench-top comparison of device features and specifications, not a study involving human readers or clinical outcomes.
6. Standalone (Algorithm Only) Performance Study
Not applicable, as the Consure 120 SMS is a physical medical device (rectal catheter) and not an algorithm or AI system.
7. Type of Ground Truth Used
The "ground truth" for the device testing appears to be based on:
- Engineering Specifications: Defined dimensional and force thresholds for manufacturing and functional performance.
- Predicate Device Specifications: Published functional parameters and characteristics of the Bard® DigniShield™ Stool Management System, used for bench-top comparison.
8. Sample Size for the Training Set
Not applicable, as the Consure 120 SMS is a physical medical device and not an AI or algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
§ 876.5980 Gastrointestinal tube and accessories.
(a)
Identification. A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).(b)
Classification. (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory 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 (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.