(28 days)
The ORS drape is a single-use equipment cover intended for use during various surgeries where warm irrigation, slush and/or cold solution is required.
The Non-Sterile ORS Warming and Slush Drapes are single-use equipment covers intended for use during various surgeries where warm irrigation, slush and/or cold solution is required. These equipment drapes consist of a polyurethane film base material manufactured to protect ORS surgical fluid warmers and slush machines from contamination during various procedures throughout the clinical setting.
These equipment drapes come in a variety of sizes and shapes to allow the device to properly fit ORS surgical fluid warmers and slush machines.
The provided text describes a 510(k) summary for "Non-Sterile ORS Warming and Slush Drapes." This submission is for a medical device (equipment cover) and not an AI/ML-driven device. Therefore, many of the requested elements pertaining to AI model performance, expert review, training sets, and statistical studies are not applicable.
However, I can extract the acceptance criteria and performance data as presented for this medical device from the "Performance Data Summary" table (Table 5-2).
1. Table of Acceptance Criteria and Reported Device Performance
| Requirement | Specification | Method | Result |
|---|---|---|---|
| Functional Performance Requirements (of selected drape types) | |||
| Dimensional Requirements | ORS-301N (66 in. x 52 in.) ORS-321N (66 in x 52 in.) ORS-330N (66 in. x 44 in.) ORS-188231N, Skirted (44 in. x 44 in. x 36 in.) | Representative drapes were chosen to cover all drape types. Drapes selected: ORS-301N (largest size), ORS-188231N (only skirted drape), ORS-321N (largest size Disc drape), ORS-330N (largest Plate drape). Acceptable results following visual inspection during V&V testing; VVR-14-0002 V&V Summary Report, Project 8 Track. | Pass |
| 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 |
| Disc/Plate must stay attached | Disc/Plate must stay attached to drape during use. | Acceptable results following V&V testing (based on sterile product testing); VVR-14-0002 V&V Summary Report, Project 8 Track. | Pass |
| Drape/Device must attach | Drape/Device must attach to Slush Machine. | Acceptable results following V&V testing (based on sterile product testing); VVR-14-0002 V&V Summary Report, Project 8 Track. | Pass |
| Packaging | |||
| Packaging Configuration | 24 per case, double poly bagged. | Packaging Configuration per: ORS-301N_DWG, ORS-321N_DWG, ORS-330N_DWG, ORS-188231N_DWG; acceptable results following visual inspection during V&V testing; documented in V&V Summary Report VVR-14-0002. | Pass |
| Product must be received with folds intact | 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 (implied by method: ASTM D4169-09 Distribution Cycle 2. Assurance Level 1) | ASTM D4169-09 (Distribution Cycle 2. Assurance Level 1) Simulated Distribution Test (PKG 001F). | Pass |
| Labeling | |||
| Inspection for Drape Damage | N/A (implied by method: consistent with documentation). | Documented in Packaging Engineering Report # REPT-18430. Acceptable results following visual inspection during V&V testing; documented in V&V summary report VVR-14-0002. | Pass |
| Master carton label is present and per specification | Master carton label is present and per specification. | Master label specifications: ORS-301NMASTER, ORS-321NMASTER, ORS-330NMASTER, ORS-188231NMASTER. Acceptable results following visual inspection during V&V testing; documented in V&V summary report VVR-14-0002. | Pass |
| Ink (non-smudge/smear) | Ink is 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 is present and per specification | Insert Sheet/IFU is present and per specification. | Insert Sheet/IFU specifications: 1) ORS-WARMER DRAPE_2014-5/NEW INSERT SHEET (ORS-100N, ORS-300N, ORS-301N, ORS-188231N), 2) ORS-320N/ORS-321N_2014-5/NEW SLUSH/WARMER DISC-DRAPE INSERT SHEET, 3) ORS-330N_2014-5/NEW SLUSH/WARMER PLATE DRAPE INSERT SHEET. | Pass |
| Product Identification label includes product code and Ecolab Logo | Product Identification label includes product code and Ecolab Logo. | Product Identification label specification: ORS-301NMISC, ORS-188231NMISC, ORS-321NMISC, ORS-330NMISC. | Pass |
Regarding the other requested information, they are not applicable as this is a traditional medical device, not an AI/ML product:
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 mentions "Representative drapes were chosen to cover all drape types" for functional testing. It also refers to "VVR-14-0002 V&V Summary Report, Project 8 Track" and "PKG 001F" and "REPT-18430" which suggests internal validation and verification testing. Specific sample sizes for each test are not provided in this summary. Data provenance (country of origin, retrospective/prospective) is not mentioned, but is likely internal testing by the manufacturer.
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)
- Not applicable. The "ground truth" for this device is based on physical specifications, visual inspection according to engineering drawings and internal reports, and adherence to ASTM standards for packaging. There is no indication of expert interpretation, as would be required for diagnostic AI devices.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. The tests involve objective measurements, visual inspections, and adherence to specifications, not subjective expert reviews requiring adjudication.
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
- Not applicable. This device is an equipment cover, not a diagnostic AI tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The ground truth for this device's performance relies on adherence to engineering drawings, visual inspection criteria, and industry-standard physical testing methods (e.g., ASTM D4169-09 for distribution testing).
8. The sample size for the training set
- Not applicable. This is not an AI/ML device where a training set is used.
9. How the ground truth for the training set was established
- Not applicable. There is no training set for this device.
§ 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.