NON-STERILE ORS WARNING DRAPES/SLUSH+WARMER DISC-DRAPE/SLUSH+WARMER PALTE-DRAPE /FLUID WARMER DRAPE,SKIRTED

K142080 · Ecolab, Inc. · LHC · Aug 28, 2014 · Physical Medicine

Device Facts

• Record ID: K142080
• Device Name: NON-STERILE ORS WARNING DRAPES/SLUSH+WARMER DISC-DRAPE/SLUSH+WARMER PALTE-DRAPE /FLUID WARMER DRAPE,SKIRTED
• Applicant: Ecolab, Inc.
• Product Code: LHC · Physical Medicine
• Decision Date: Aug 28, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 890.5950
• Device Class: Class 1

Intended Use

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.

Device Story

Non-Sterile ORS Warming and Slush Drapes are single-use polyurethane film covers; designed to protect surgical fluid warmers and slush machines from contamination during surgical procedures. Drapes are supplied in bulk to secondary processors/kit packers who perform final packaging, labeling, and sterilization. Device is used in clinical settings (OR); operated by surgical staff. Output is a physical barrier/drape; ensures equipment remains sterile/protected during use. Benefits include maintenance of sterile field and protection of surgical equipment.

Clinical Evidence

No clinical data. Bench testing only. Verification and validation testing confirmed dimensional requirements, integrity of sterile barrier (no holes/defects), attachment to slush machines, and packaging durability per ASTM D4169-09.

Technological Characteristics

Materials: Polyurethane film (polypropylene skirt on model ORS-188231N). Form factor: Various sizes/shapes to fit specific surgical fluid warmers and slush machines. Connectivity: None. Sterilization: Not sterile (intended for sterilization by secondary processor).

Indications for Use

Indicated for use as a single-use equipment cover during surgeries requiring warm irrigation, slush, or cold solutions. No specific patient population or contraindications described.

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-1000LD (K021288)
• ORS-3000LD (K023282)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Sajjad H. Syed

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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, RAC<br>370 Wabasha Street North<br>St. Paul, MN 55102-1390<br>Director, Regulatory Affairs - Healthcare<br>651.250.4348 |

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,<br>ORS-188231] cleared on 06/27/2002 via K021288 and<br>ORS-3000LD [covers ORS-320, ORS-321, ORS-330]<br>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 or<br>Characteristic | Proposed Device | Predicate Device<br>(Warming Drapes) | Predicate Device<br>(Slush Drapes) |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| 510(k) No. | This 510(k)<br>Submission | K021288 | K023282 |
| Device Name | Non-Sterile ORS<br>Warming and<br>Slush Drapes<br>(includes: ORS-<br>100N, ORS-300N,<br>ORS-301N, ORS-<br>320N, ORS-321N,<br>ORS-330N and<br>ORS-188231N) | ORS-1000LD<br>(includes: ORS-100,<br>ORS-300, ORS-301,<br>and ORS-188231) | ORS-3000LD<br>(includes: ORS-320,<br>ORS-321, and ORS-<br>330) |
| Indications for<br>Use | The ORS drape is<br>a single-use<br>equipment cover<br>intended for use<br>during various<br>surgeries where | The ORS-1000LD<br>Leak Detection<br>Drape is an<br>equipment cover for<br>the ORS-2000LD<br>Solution Warmer. | The ORS-3000LD is<br>an equipment cover<br>for the ORS-<br>1075LD Hush-<br>Slush® machine.<br>This is a single use |

Table 5-1: Substantial Equivalence

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| Property or<br>Characteristic | Proposed Device | Predicate Device<br>(Warming Drapes) | Predicate Device<br>(Slush Drapes) |
|-------------------------------|------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| | warm irrigation,<br>slush and/or cold<br>solution is<br>required. | This is a single use<br>product supplied<br>sterile. This device<br>is intended for use<br>during various<br>surgeries where<br>warm irrigation<br>solution is required. | product supplied<br>sterile. This device<br>is intended for use<br>during various<br>surgeries where<br>slush and/or cold<br>solution is required. |
| Conditions of<br>Use | Rx Only, Single<br>Use, Disposable | Identical | Identical |
| Materials | Polyurethane Film<br>Polypropylene<br>skirt for ORS-<br>188231N only | Identical | Identical |
| Principle of<br>Operation | Covers surgical<br>solution warmers<br>and/or slush<br>machines | Covers surgical<br>solution warmers | Covers surgical<br>solution warmers<br>and/or slush<br>machines |
| Packaging | Bulk packaged in<br>poly bag in<br>quantities up to 24 | Individually<br>packaged in<br>poly/Tyvek peel<br>pouches | Individually<br>packaged in<br>poly/Tyvek peel<br>pouches |
| Sterilized | No; intended to be<br>sterilized before<br>distribution to end<br>user | Yes; provided in<br>sterile condition via<br>EO at SAL 10-6 | Yes; provided in<br>sterile condition via<br>EO 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 |
| Functional<br>Performance<br>Requirements<br>(of selected<br>drape types) | Dimensional Requirements:<br>ORS-301N (66 in. x 52 in.)<br>ORS-321N (66 in x 52 in.)<br>ORS-330N (66 in. x 44 in.)<br>ORS-188231N, Skirted<br>(44 in. x 44 in. x 36 in.) | Representative drapes were chosen to<br>cover all drape types. Drapes selected:<br>ORS-301N (largest size), ORS-<br>188231N (only skirted drape), ORS-<br>321N (largest size Disc drape), ORS-<br>330N (largest Plate drape)<br>Acceptable results following visual<br>inspection during V&V testing; VVR-<br>14-0002 V&V Summary Report,<br>Project 8 Track | Pass |
| | Drape remains intact (free<br>from holes or other defects<br>that would compromise the<br>sterile barrier) | Acceptable results following visual<br>inspection during V&V testing:<br>VVR-14-0002 V&V Summary<br>Report, Project 8 Track | Pass |
| | Disc/Plate must stay attached<br>to drape during use | Acceptable results following V&V<br>testing (based on sterile product<br>testing); VVR-14-0002 V&V<br>Summary Report, Project 8 Track | Pass |
| | Drape/Device must attach to<br>Slush Machine | Acceptable results following V&V<br>testing (based on sterile product<br>testing); VVR-14-0002 V&V<br>Summary Report, Project 8 Track | Pass |
| Packaging | Packaging Configuration: 24<br>per case, double poly bagged | Packaging Configuration per:<br>ORS-301N_DWG<br>ORS-321N_DWG<br>ORS-330N_DWG<br>ORS-188231N_DWG; acceptable<br>results following visual inspection<br>during V&V testing; documented in<br>V&V Summary Report VVR-14-0002 | Pass |
| | Product must be received by<br>customer with folds intact | Acceptable results following visual<br>inspection during V&V testing:<br>documented in V&V Summary Report<br>VVR-14-0002 | Pass |
| | Simulated Distribution Test | ASTM D4169-09 (Distribution Cycle<br>2. Assurance Level 1) Simulated<br>Distribution Test (PKG 001F) | Pass |
| Requirement | Specification | Method | Result |
| Labeling | Inspection for Drape<br>Damage | documented in Packaging Engineering<br>Report # REPT-18430<br>Acceptable results following visual<br>inspection during V&V testing;<br>documented in V&V summary report<br>VVR-14-0002 | Pass |
| | Master carton label is present<br>and per specification | Master label specifications:<br>ORS-301NMASTER<br>ORS-321NMASTER<br>ORS-330NMASTER<br>ORS-188231NMASTER<br>Acceptable results following visual<br>inspection during V&V testing;<br>documented in V&V summary report<br>VVR-14-0002 | Pass |
| | Ink (non-smudge/smear) | Acceptable results following visual<br>inspection during V&V testing;<br>documented in V&V summary report<br>VVR-14-0002 | Pass |
| | Insert Sheet/IFU is present<br>and per specification | Insert Sheet/IFU specifications:<br>1) ORS-WARMER DRAPE_2014-<br>5/NEW INSERT SHEET (ORS-<br>100N, ORS-300N, ORS-301N,<br>ORS-188231N)<br>2) ORS-320N/ORS-321N_2014-<br>5/NEW SLUSH/WARMER<br>DISC-DRAPE INSERT SHEET<br>3) ORS-330N_2014-5/NEW<br>SLUSH/WARMER PLATE<br>DRAPE INSERT SHEET | Pass |
| | Product Identification label<br>includes product code and<br>Ecolab Logo | Product Identification label<br>specification:<br>ORS-301NMISC<br>ORS-188231NMISC<br>ORS-321NMISC<br>ORS-330NMISC | Pass |

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## Non-Sterile ORS Warming and Slush Drapes

Ecolab Inc.