(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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 30, 2014
Ecolab, Inc. Ms. Jennifer Willner Senior Director, Regulatory Affairs 370 Wabasha Street North St. Paul, MN 55102
Re: K142173
Trade/Device Name: ORS Scope Pillow Warmer Drape Regulation Number: Unclassified Regulation Name: Equipment Cover Regulatory Class: Unclassified Product Code: LHC Dated: December 3, 2014 Received: December 4, 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.
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Page 2 - Ms. Willner
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance 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.
of Surveillance and Biometrics/Division of Postmarket Surveillance.
Sincerely yours,
Erin I. Keith -S
Erin I. Keith, M.S. 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) K142173
Device Name
ORS Scope Pillow Warmer Drape
Indications for Use (Describe)
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
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) |
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Section 5: 510(k) Summary – K142173
ORS Scope Pillow Warmer Drape
As required by 21 CFR 807.92.
| Date:Administrative Information | August 6, 2014 |
|---|---|
| Submitter: | Ecolab, Inc. |
| EstablishmentRegistration Number: | 1043582 |
| Contact Person: | Jennifer Willner, RAC370 Wabasha Street NorthSt. Paul, MN 55102-1390Sr. Director, Regulatory Affairs - Healthcare651.250.4348 |
| Device Identification | |
| Device Name: | ORS Scope Pillow Warmer Drape |
| 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 Warming Drape cleared on 06/27/2002 viaK021288 and ORS Endoscope Holder cleared on08/30/2005 via K051979 |
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Device Description
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).
Image /page/4/Picture/5 description: In the image, a medical instrument is placed on a table covered with a clear plastic sheet. The instrument has a long, slender metal shaft with a black handle at one end. The table is draped with blue covers, and the background is a light gray wall with horizontal lines.
Figure 5-1 Scope Pillow Warmer Drape
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.
510(k) Discussion
This 510(k) submission requests clearance for the manufacture and distribution of Non-Sterile ORS-400N Scope Pillow Warmer Drape (equipment cover with integrated pillow/endoscope holder). The non-sterile drape will be sold in bulk packaging to
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secondary processors who will then package, label and sterilize the drapes as required under the regulation prior to distribution to end users. The non-sterile drape has the identical polyurethane drape material, and identical drape function as the predicate drape (K021288). The pillow (endoscope holder) provides the same holding function as the predicate Endoscope Holder (K051979). Therefore, the fundamental scientific technology of this equipment drape remains unchanged. The Substantial Equivalence Table (Table 5-1) is provided below.
| Property orCharacteristic | Proposed Device -Non-Sterile ORS-400N Scope Pillow™Warmer Drape | Predicate Device -ORS-1000LDEquipment Cover | Predicate Device -ORS EndoscopeHolder |
|---|---|---|---|
| 510(k) No. | This 510(k)Submission | K021288 | K051979 |
| Device Name | ORS-400N ScopePillow WarmerDrape | ORS-1000LDWarming Drape | ORS Model 6000Endoscope Holder |
| Indications forUse | The ORS pillowdrape is a single-usedisposable deviceintended for use as anaccessory for ORSSolution Warmerswhich is designed tohold the optical endof various endoscopesabove the warmsolution to preventfogging or wetting ofthe scope eyepiece. | The ORS-1000LDLeak Detection Drapeis an equipment coverfor the ORS-2000LDSolution Warmer.This is a single useproduct suppliedsterile. This device isintended for useduring varioussurgeries where warmirrigation solution isrequired. | The ORS 6000Endoscope Holder isa single usedisposable deviceused as an accessoryfor ORS SolutionWarmers. The ORS6000 EndoscopeHolder is designed tohold the optical endof various endoscopesabove the warmsolution to preventfogging or wetting ofthe scope eyepiece. |
| Conditions ofUse | Rx Only, Single Use,Disposable | Identical | Identical |
| Materials | Polyurethane FilmPolyurethane Foam | Identical Film | Thermoplasticpolyester resins |
| Principle ofOperation | Covers surgicalsolution warmers andendoscope holder | Covers surgicalsolution warmers | Endoscope Holder |
| Property orCharacteristic | Proposed Device –Non-Sterile ORS-400N Scope Pillow™Warmer Drape | Predicate Device –ORS-1000LDEquipment Cover | Predicate Device –ORS EndoscopeHolder |
| Packaging | Bulk packaged inpoly bag in quantitiesup to 10 | Individually packagedin poly/Tyvek peelpouches | Individually packagedin poly/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 |
Table 5-1: Substantial Equivalence
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Performance Data Summary
| Table 5-2: Performance Data Summary of the Non-Sterile ORS-400N Scope Pillow | |||
|---|---|---|---|
| Warmer Drape | |||
| Requirement | Specification | Method | Result |
| FunctionalPerformanceRequirements | Dimensional Requirements:ORS-400N (44 in. x 66 in.) | Acceptable results followingvisual inspection during V&Vtesting; VVR-14-0002 V&VSummary Report, Project 8Track | Pass |
| Drape remains intact (freefrom holes or other defectsthat would compromise thesterile barrier) | Acceptable results followingvisual inspection during V&Vtesting; VVR-14-0002 V&VSummary Report, Project 8Track | Pass | |
| Packaging | Packaging Configuration:10 per case, double polybagged | Packaging Configuration per:ORS-400N_DWG;Acceptable results followingvisual inspection during V&Vtesting; VVR-14-0002 V&VSummary Report, Project 8Track | Pass |
| Product must be received bycustomer with folds intact | Acceptable results followingvisual inspection during V&Vtesting; documented in V&Vsummary report VVR-14-0002 | Pass | |
| Simulated Distribution Test | ASTM D4169-09 (DistributionCycle 2, Assurance Level 1)Simulated Distribution Test | Pass |
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| Requirement | Specification | Method | Result |
|---|---|---|---|
| Labeling | Inspection for DrapeDamage | (PKG 001F) documented inPackaging Engineering Report# REPT-18430Acceptable results followingvisual inspection during V&Vtesting; documented in theV&V summary report VVR-14-0002 | Pass |
| Master carton label ispresent and per specification | Master label specifications:ORS-400NMASTERAcceptable results followingvisual inspection during V&Vtesting; documented in theV&V summary report VVR-14-0002. | Pass | |
| Ink (non-smudge/smear) | Acceptable results followingvisual inspection during V&Vtesting; documented in V&Vsummary report VVR-14-0002 | Pass | |
| Insert Sheet/IFU is presentand per specification | Insert Sheet/IFUspecifications:ORS-400N-INSERT SHEET | Pass | |
| Product Identification labelincludes product code andEcolab Logo | Product Identification labelspecification:ORS-400NMISC | Pass |
Statement of Equivalence
The Non-Sterile ORS Scope Pillow Warmer Drape performs as intended using the identical principles of operation as the predicate devices. Specifically, it is designed to protect ORS surgical solution 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. Differences between the Non-Sterile ORS Scope Pillow Warmer Drape and the sterile version (packaging and labeling), as well as the predicate devices (two separate components used together), do not raise any new questions of safety or efficacy when secondary processors sterilize the product as instructed. Based on the risk analysis, review of the product labeling, and successful performance testing (Table 5-2), the ORS Scope Pillow Warmer Drape is substantially equivalent to the legally marketed ORS Warming Drape (K021288) and ORS Endoscope Holder (K051979). The fundamental scientific technology of the device remains unchanged.
§ 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.