(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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 28, 2014
Ecolab. Incorporated Jennifer Willner Director, Regulatory Affairs - Healthcare 370 Wabasha Street North St. Paul, Minnesota 55102
Re: K142080
Trade/Device Name: Non-Sterile ORS Warming and Slush Drapes Regulatory Class: Unclassified Product Code: LHC Dated: July 30, 2014 Received: July 31, 2014
Dear Ms. Willner:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Erin I. Keith -S
Erin Keith, M.S. Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K142080
Device Name
Non-Sterile ORS Warming and Slush Drapes.
Indications for Use (Describe)
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 following models are included: ORS-100N, ORS-300N, ORS-301N, ORS-320N, ORS-330N and ORS-188231N.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Sajjad H. Syed
Digitally signed by Saiiad H. Sved -S DN: c=US. o=U.S. Government. ou=HHS. ou=FDA. ou=People. cn=Saijad H. Syed -S. 0.9.2342.19200300.100.1.1=2000601742 Date: 2014.08.26 17:00:38 -04'00'
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K140280 – 510(K) SUMMARY
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Non-Sterile ORS Warming and Slush Drapes
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Section 5: 510(k) Summary
Non-Sterile ORS Warming and Slush Drapes
As required by 21 CFR 807.92. Date: July 30, 2014 Administrative Information Submitter: Ecolab, Inc. Establishment
Registration Number:
| Registration Number: | 1043582 |
|---|---|
| Contact Person: | Jennifer Willner, RAC370 Wabasha Street NorthSt. Paul, MN 55102-1390Director, Regulatory Affairs - Healthcare651.250.4348 |
Device Identification
| Device Name: | Non-Sterile ORS Warming and Slush Drapes |
|---|---|
| Common Name: | Equipment Cover |
| Device Classification Name: | Warmer, Irrigation Solution |
| Device Classification: | Unclassified |
| Classification Product Code: | LHC |
| Panel: | General and Plastic Surgery |
| Classification Regulation: | Pre-amendment |
| Performance Standards: | No Recognized Consensus Standards |
| Predicate Device: | ORS-1000LD [covers ORS-100, ORS-300, ORS-301,ORS-188231] cleared on 06/27/2002 via K021288 andORS-3000LD [covers ORS-320, ORS-321, ORS-330]cleared 11/13/2002 via K023282 |
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Non-Sterile ORS Warming and Slush Drapes
Ecolab Inc.
Device Description
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.
Special 510(k) Discussion
This Special 510(k) submission requests clearance for the manufacture and distribution of non-sterile ORS drapes from an identical subset of cleared sterile ORS devices. The nonsterile drapes will be sold in bulk packaging to other secondary processors, including kit packers, who will then package, label and sterilize the drapes prior to distribution to end users. The fundamental scientific technology of these equipment drapes remains unchanged. The Substantial Equivalence Table (Table 5-1) is provided below.
| Property orCharacteristic | Proposed Device | Predicate Device(Warming Drapes) | Predicate Device(Slush Drapes) |
|---|---|---|---|
| 510(k) No. | This 510(k)Submission | K021288 | K023282 |
| Device Name | Non-Sterile ORSWarming andSlush Drapes(includes: ORS-100N, ORS-300N,ORS-301N, ORS-320N, ORS-321N,ORS-330N andORS-188231N) | ORS-1000LD(includes: ORS-100,ORS-300, ORS-301,and ORS-188231) | ORS-3000LD(includes: ORS-320,ORS-321, and ORS-330) |
| Indications forUse | The ORS drape isa single-useequipment coverintended for useduring varioussurgeries where | The ORS-1000LDLeak DetectionDrape is anequipment cover forthe ORS-2000LDSolution Warmer. | The ORS-3000LD isan equipment coverfor the ORS-1075LD Hush-Slush® machine.This is a single use |
Table 5-1: Substantial Equivalence
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| Property orCharacteristic | Proposed Device | Predicate Device(Warming Drapes) | Predicate Device(Slush Drapes) |
|---|---|---|---|
| warm irrigation,slush and/or coldsolution isrequired. | This is a single useproduct suppliedsterile. This deviceis intended for useduring varioussurgeries wherewarm irrigationsolution is required. | product suppliedsterile. This deviceis intended for useduring varioussurgeries whereslush and/or coldsolution is required. | |
| Conditions ofUse | Rx Only, SingleUse, Disposable | Identical | Identical |
| Materials | Polyurethane FilmPolypropyleneskirt for ORS-188231N only | Identical | Identical |
| Principle ofOperation | Covers surgicalsolution warmersand/or slushmachines | Covers surgicalsolution warmers | Covers surgicalsolution warmersand/or slushmachines |
| Packaging | Bulk packaged inpoly bag inquantities up to 24 | Individuallypackaged inpoly/Tyvek peelpouches | Individuallypackaged inpoly/Tyvek peelpouches |
| Sterilized | No; intended to besterilized beforedistribution to enduser | Yes; provided insterile condition viaEO at SAL 10-6 | Yes; provided insterile condition viaEO at SAL 10-6 |
Statement of Equivalence
The Non-Sterile ORS Warming and Slush Drapes perform as intended using the identical principles of operation as the predicate device(s). Differences between the Non-Sterile ORS Warming and Slush Drapes and the sterile versions do not raise any new questions of safety or efficacy when secondary processors finish the product as instructed. Based on the risk analysis, review of the product labeling, and successful performance and safety testing, the Non-Sterile ORS Warming and Slush Drapes are substantially equivalent to the legally marketed Sterile ORS Warming and Slush Drapes (K021288 and K023282). The fundamental scientific technology of the device remains unchanged.
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Ecolab Inc.
| Performance Data Summary | |||
|---|---|---|---|
| Table 5-2: Performance Data Summary of the Non-Sterile ORS Warming and Slush Drapes | |||
| Requirement | Specification | Method | Result |
| FunctionalPerformanceRequirements(of selecteddrape 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 tocover 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 visualinspection during V&V testing; VVR-14-0002 V&V Summary Report,Project 8 Track | Pass |
| Drape remains intact (freefrom holes or other defectsthat would compromise thesterile barrier) | Acceptable results following visualinspection during V&V testing:VVR-14-0002 V&V SummaryReport, Project 8 Track | Pass | |
| Disc/Plate must stay attachedto drape during use | Acceptable results following V&Vtesting (based on sterile producttesting); VVR-14-0002 V&VSummary Report, Project 8 Track | Pass | |
| Drape/Device must attach toSlush Machine | Acceptable results following V&Vtesting (based on sterile producttesting); VVR-14-0002 V&VSummary Report, Project 8 Track | Pass | |
| Packaging | Packaging Configuration: 24per case, double poly bagged | Packaging Configuration per:ORS-301N_DWGORS-321N_DWGORS-330N_DWGORS-188231N_DWG; acceptableresults following visual inspectionduring V&V testing; documented inV&V Summary Report VVR-14-0002 | Pass |
| Product must be received bycustomer with folds intact | Acceptable results following visualinspection during V&V testing:documented in V&V Summary ReportVVR-14-0002 | Pass | |
| Simulated Distribution Test | ASTM D4169-09 (Distribution Cycle2. Assurance Level 1) SimulatedDistribution Test (PKG 001F) | Pass | |
| Requirement | Specification | Method | Result |
| Labeling | Inspection for DrapeDamage | documented in Packaging EngineeringReport # REPT-18430Acceptable results following visualinspection during V&V testing;documented in V&V summary reportVVR-14-0002 | Pass |
| Master carton label is presentand per specification | Master label specifications:ORS-301NMASTERORS-321NMASTERORS-330NMASTERORS-188231NMASTERAcceptable results following visualinspection during V&V testing;documented in V&V summary reportVVR-14-0002 | Pass | |
| Ink (non-smudge/smear) | Acceptable results following visualinspection during V&V testing;documented in V&V summary reportVVR-14-0002 | Pass | |
| Insert Sheet/IFU is presentand 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/WARMERDISC-DRAPE INSERT SHEET3) ORS-330N_2014-5/NEWSLUSH/WARMER PLATEDRAPE INSERT SHEET | Pass | |
| Product Identification labelincludes product code andEcolab Logo | Product Identification labelspecification:ORS-301NMISCORS-188231NMISCORS-321NMISCORS-330NMISC | Pass |
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Non-Sterile ORS Warming and Slush Drapes
Ecolab Inc.
§ 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.