Who is the manufacturer of NON-STERILE ORS-400N SCOPE PILLOW WARMER DRAPE?

Ecolab, Inc. filed the 510(k) submission for NON-STERILE ORS-400N SCOPE PILLOW WARMER DRAPE (K142173).

What is the FDA product code for NON-STERILE ORS-400N SCOPE PILLOW WARMER DRAPE?

LHC. It is classified under 21 CFR 890.5950 as a Class 1 device in the Physical Medicine panel.

What is the regulatory pathway for NON-STERILE ORS-400N SCOPE PILLOW WARMER DRAPE?

510(k) clearance (submission type: Traditional).

What are the predicate devices for NON-STERILE ORS-400N SCOPE PILLOW WARMER DRAPE?

ORS Warming Drape (K021288); ORS Endoscope Holder (K051979).

Who can help prepare an FDA 510(k) submission like NON-STERILE ORS-400N SCOPE PILLOW WARMER DRAPE?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

NON-STERILE ORS-400N SCOPE PILLOW WARMER DRAPE

K142173 · Ecolab, Inc. · LHC · Dec 30, 2014 · Physical Medicine

Device Facts

Record ID	K142173
Device Name	NON-STERILE ORS-400N SCOPE PILLOW WARMER DRAPE
Applicant	Ecolab, Inc.
Product Code	LHC · Physical Medicine
Decision Date	Dec 30, 2014
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 890.5950
Device Class	Class 1

Intended Use

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.

Device Story

The ORS Scope Pillow Warmer Drape is a single-use, disposable equipment cover and endoscope holder accessory for ORS surgical fluid warmers. It consists of a polyurethane film drape with an integrated polyurethane foam pillow. The device is used in clinical settings by surgical staff to protect fluid warmers from contamination and to provide stable positioning for endoscopes, preventing them from rolling or tipping while resting in the warm solution. The non-sterile version (ORS-400N) is supplied to secondary processors who package, label, and sterilize the device before clinical use. By keeping the scope eyepiece above the fluid, the device prevents fogging and wetting, ensuring clear visualization for the surgeon during procedures.

Clinical Evidence

Bench testing only. Performance testing included dimensional verification, drape integrity (sterile barrier maintenance), and simulated distribution testing per ASTM D4169-09. All tests passed.

Technological Characteristics

Materials: Polyurethane film and polyurethane foam. Form factor: 44 in. x 66 in. drape with integrated foam pillow. Connectivity: None. Sterilization: Provided non-sterile; intended for sterilization by secondary processors. Energy source: None (passive).

Indications for Use

Indicated for use as an accessory for ORS Solution Warmers to hold endoscope optical ends above warm solutions to prevent fogging/wetting during surgical procedures.

Regulatory Classification

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.

Predicate Devices

ORS Warming Drape (K021288)
ORS Endoscope Holder (K051979)

Related Devices

K051979 — ORS MODEL 6000 ENDOSCOPE HOLDER · O.R. Solutions, Inc. · Aug 30, 2005
K021288 — ORS-1000LD · O.R. Solutions, Inc. · Jun 27, 2002
K142080 — NON-STERILE ORS WARNING DRAPES/SLUSH+WARMER DISC-DRAPE/SLUSH+WARMER PALTE-DRAPE /FLUID WARMER DRAPE,SKIRTED · Ecolab, Inc. · Aug 28, 2014
K053311 — STRYKER SCOPE WARMER · Stryker Endoscopy · Jan 27, 2006

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of a human figure, with three profiles overlapping to create a sense of depth and connection. The logo is black and white. 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. {1}------------------------------------------------ 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 {2}------------------------------------------------ ## 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) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the text "Ecolab Inc." The text is in a simple, sans-serif font and is horizontally aligned. The background of the image is plain white, which makes the text stand out clearly. a u #### 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. | | Establishment Registration Number: | 1043582 | | Contact Person: | Jennifer Willner, RAC 370 Wabasha Street North St. Paul, MN 55102-1390 Sr. Director, Regulatory Affairs - Healthcare 651.250.4348 | | 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 via K021288 and ORS Endoscope Holder cleared on 08/30/2005 via K051979 | {4}------------------------------------------------ #### 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 {5}------------------------------------------------ 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 or Characteristic | Proposed Device - Non-Sterile ORS- 400N Scope Pillow™ Warmer Drape | Predicate Device - ORS-1000LD Equipment Cover | Predicate Device - ORS Endoscope Holder | |-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) No. | This 510(k) Submission | K021288 | K051979 | | Device Name | ORS-400N Scope Pillow Warmer Drape | ORS-1000LD Warming Drape | ORS Model 6000 Endoscope Holder | | Indications for Use | 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 ORS-1000LD Leak Detection Drape is an equipment cover for the ORS-2000LD Solution Warmer. This is a single use product supplied sterile. This device is intended for use during various surgeries where warm irrigation solution is required. | The ORS 6000 Endoscope Holder is a single use disposable device used as an accessory for ORS Solution Warmers. The ORS 6000 Endoscope Holder is designed to hold the optical end of various endoscopes above the warm solution to prevent fogging or wetting of the scope eyepiece. | | Conditions of Use | Rx Only, Single Use, Disposable | Identical | Identical | | Materials | Polyurethane Film Polyurethane Foam | Identical Film | Thermoplastic polyester resins | | Principle of Operation | Covers surgical solution warmers and endoscope holder | Covers surgical solution warmers | Endoscope Holder | | Property or Characteristic | Proposed Device – Non-Sterile ORS- 400N Scope Pillow™ Warmer Drape | Predicate Device – ORS-1000LD Equipment Cover | Predicate Device – ORS Endoscope Holder | | Packaging | Bulk packaged in poly bag in quantities up to 10 | Individually packaged in poly/Tyvek peel pouches | Individually packaged in poly/Tyvek peel pouches | | Sterilized | No; intended to be sterilized before distribution to end user | Yes; provided in sterile condition via EO at SAL 10-6 | Yes; provided in sterile condition via EO at SAL 10-6 | #### Table 5-1: Substantial Equivalence {6}------------------------------------------------ # Performance Data Summary | | Table 5-2: Performance Data Summary of the Non-Sterile ORS-400N Scope Pillow | | | |-------------------------------------------|------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------| | Warmer Drape | | | | | | | | | | Requirement | Specification | Method | Result | | Functional Performance Requirements | 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 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 | | | 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 | ASTM D4169-09 (Distribution Cycle 2, Assurance Level 1) Simulated Distribution Test | Pass | {7}------------------------------------------------ | Requirement | Specification | Method | Result | |-------------|--------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------| | Labeling | Inspection for Drape Damage | (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 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 (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 specifications: ORS-400N-INSERT SHEET | Pass | | | Product Identification label includes product code and Ecolab Logo | Product Identification label specification: 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.