(145 days)
The ORS pillow drape is a single-use disposable device intended for use as an accessory for ORS Solution Warmers which is designed to hold the optical end of various endoscopes above the warm solution to prevent fogging or wetting of the scope eyepiece.
The following model(s) are included: ORS-400 and ORS-400N
The ORS-400N Scope Pillow™ Warmer Drape is a single-use disposable device provided non-sterile to secondary processors, who then package, label and sterilize the device. The Scope Pillow Warmer Drape is an accessory/equipment drape for use with the ORS-2057 Irrigation Solution Warming System which is designed to both protect ORS surgical fluid warmers from contamination during various procedures as well as hold the optical end of various endoscopes above the warm solution to prevent fogging or wetting of the scope eyepiece.
The drape material is the identical polyurethane film that is used on all standard ORS Warmer Drapes (K021288). A soft polyurethane foam pillow is integrated within the polyurethane drape and has no direct or indirect patient contact. The pillow (endoscope holder) is designed to provide stable positioning of scope(s) during warming and prevents one or more scopes from rolling or tipping while the scope rests in the fluid warmer during the procedure (Figure 5-1).
The ORS-400 and ORS-400N model drapes are identical with the exception of how they are packaged and labeled. The ORS-400 model consists of drapes individually packaged in labeled peel pouches or header bags which are stacked inside a double poly-lined corrugate case with Instructions for Use (IFU) insert and sterilized by an Ecolab subcontractor before it is released for sale. The ORS-400N model consists of the identical drapes which are individually wrapped in a poly tie secured by a product ID label and stacked inside a double poly-lined corrugate case with IFU insert that does not get sterilized before it is released for sale to kit packer customers. The IFU insert differs between the two models in that the ORS-400N contains sterilization instructions for kit packer customers to evaluate their sterilization process as it applies to placing the product in their commercial procedure kits.
NOTE: Both device models are designed and intended to be used by clinical staff in sterile condition.
The provided text describes the acceptance criteria and study for the ORS Scope Pillow Warmer Drape. This device is an accessory designed to protect surgical fluid warmers and hold endoscope eyepieces above warm solution to prevent fogging or wetting.
Here is the requested information:
1. Table of Acceptance Criteria and the Reported Device Performance
| Requirement | Specification | Method | Reported Device Performance (Result) |
|---|---|---|---|
| Functional Performance | |||
| Dimensional Requirements | ORS-400N (44 in. x 66 in.) | Acceptable results following visual inspection during V&V testing; VVR-14-0002 V&V Summary Report, Project 8 Track | Pass |
| Drape Integrity | Drape remains intact (free from holes or other defects that would compromise the sterile barrier) | Acceptable results following visual inspection during V&V testing; VVR-14-0002 V&V Summary Report, Project 8 Track | Pass |
| Packaging | |||
| Packaging Configuration | 10 per case, double poly bagged | Packaging Configuration per: ORS-400N_DWG; Acceptable results following visual inspection during V&V testing; VVR-14-0002 V&V Summary Report, Project 8 Track | Pass |
| Fold Integrity | Product must be received by customer with folds intact | Acceptable results following visual inspection during V&V testing; documented in V&V summary report VVR-14-0002 | Pass |
| Simulated Distribution Test | N/A (Specification is the test itself) | ASTM D4169-09 (Distribution Cycle 2, Assurance Level 1) Simulated Distribution Test | Pass |
| Labeling | |||
| Inspection for Drape Damage | N/A (Specification is the purpose of the inspection) | (PKG 001F) documented in Packaging Engineering Report # REPT-18430; Acceptable results following visual inspection during V&V testing; documented in the V&V summary report VVR-14-0002 | Pass |
| Master Cartion Label Presence | Master carton label is present and per specification | Master label specifications: ORS-400NMASTER; Acceptable results following visual inspection during V&V testing; documented in the V&V summary report VVR-14-0002. | Pass |
| Ink Quality | Ink (non-smudge/smear) | Acceptable results following visual inspection during V&V testing; documented in V&V summary report VVR-14-0002 | Pass |
| Insert Sheet/IFU Presence | Insert Sheet/IFU is present and per specification | Insert Sheet/IFU specifications: ORS-400N-INSERT SHEET | Pass |
| Product Identification Label Mfg | Product Identification label includes product code and Ecolab Logo | Product Identification label specification: ORS-400NMISC | Pass |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the specific sample sizes for the "test set" for each individual requirement. However, it indicates Validation & Verification (V&V) testing was performed, and the results were documented in VVR-14-0002 V&V Summary Report, Project 8 Track, and Packaging Engineering Report # REPT-18430. The nature of the tests (visual inspections, dimensional checks, simulated distribution) suggests that the testing was prospective, conducted specifically for this regulatory submission. Country of origin of the data is not specified, but the submitter is Ecolab, Inc., located in St. Paul, MN, USA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This device is an equipment cover/accessory, not a diagnostic imaging device. Therefore, the concept of "experts" establishing ground truth for performance metrics (like dimensional requirements, drape integrity, packaging, and labeling) is not applicable in the same way it would be for a medical AI device interpreting images. The assessment appears to be based on engineering specifications and visual inspections rather than expert clinical interpretation. The document does not mention the use of experts in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation of medical data (e.g., radiology reads) where discrepancies need to be resolved. For the performance tests described (visual inspections, dimensional requirements, packaging integrity), this type of adjudication method is not relevant. The document does not suggest any formal adjudication process was used.
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 MRMC comparative effectiveness study was done. This device is a passive accessory and does not involve AI or human readers for interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No standalone algorithm performance study was done. This device is a physical accessory and does not involve any algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the device's performance is based on its engineering specifications and physical characteristics. For functional and packaging requirements, the ground truth is whether the device meets the predefined dimensional requirements, remains intact, has correct packaging counts, maintains fold integrity, and withstands distribution stress as per the specified methods (e.g., visual inspection, ASTM D4169-09). For labeling, the ground truth is adherence to specific label designs and content. These are objective criteria rather than subjective expert consensus, pathology, or outcomes data.
8. The sample size for the training set
This device is a physical product, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established
As there is no training set for an AI/ML algorithm, this question is not applicable.
§ 890.5950 Powered heating unit.
(a)
Identification. A powered heating unit is a device intended for medical purposes that consists of an encased cabinet containing hot water and that is intended to heat and maintain hot packs at an elevated temperature.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9.