ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming Drapes

K152522 · Ecolab, Inc. · LHC · Jan 15, 2016 · Physical Medicine

Device Facts

• Record ID: K152522
• Device Name: ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming Drapes
• Applicant: Ecolab, Inc.
• Product Code: LHC · Physical Medicine
• Decision Date: Jan 15, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 890.5950
• Device Class: Class 1

Intended Use

The ORS-3000LD is an equipment cover for the ORS-1075LD Hush-Slush®machine. This is a single use product supplied sterile. This device is intended to be used during various surgeries where slush and/or is required. Models: ORS-130/0RS-130-16, ORS-320/ORS-320-16, ORS-321-16, ORS-325/0RS-325-16, 330/0RS-330-16, ORS-331/0RS-331-16 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. Models: ORS-100, ORS-110, ORS-300, ORS-301

Device Story

ORS Fluid Warming and Slush Drapes are sterile, single-use equipment covers; constructed from polyurethane film; slush drapes include a polycarbonate disc/plate. Devices function as protective barriers for surgical fluid warming consoles and slush machines in clinical settings. Drapes prevent contamination of equipment during surgeries requiring warm irrigation, slush, or cold solutions. Healthcare providers (surgeons, nurses, OR staff) install the drapes over the equipment prior to use. The device does not transform inputs or provide clinical data; it serves a purely mechanical protective function. The current submission introduces an alternative packaging configuration (header bag) to replace the previous poly-Tyvek pouch. The fundamental scientific technology and intended use remain unchanged from the predicate devices.

Clinical Evidence

Bench testing only. No clinical data provided. Verification testing included EO residual analysis (ISO 10993-7), seal strength testing (LAB-ALPH-025, ASTM F88-09), distribution simulation (ASTM D4169-14), and package integrity testing (ASTM F3039-13, ASTM F1929-12, ASTM F2096-11). Biocompatibility and shelf-life assessments were performed per ISO 11607-1.

Technological Characteristics

Materials: Polyurethane film, polycarbonate disc/plate. Principle: Mechanical equipment cover. Energy: None. Form factor: Various sizes/shapes for specific consoles. Connectivity: None. Sterilization: Ethylene Oxide (EO) to SAL 10^-6. Packaging: Poly header bags.

Indications for Use

Indicated for use as sterile, single-use equipment covers for surgical fluid warming consoles and slush machines during various surgical procedures requiring warm irrigation, slush, or cold solutions.

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

January 15, 2016

Ecolab, Inc. Ms. Jennifer Willner Sr. Director Regulatory Affairs 370 Wabasha Street North Saint Paul, Minnesota 55102

Re: K152522

Trade/Device Name: ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming Drapes Regulation Number: Unclassified Regulation Name: N/A Regulatory Class: Unclassified Product Code: LHC Dated: December 7, 2015 Received: December 8, 2015

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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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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 yours,

Tina Kiang -

for 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) K152522

Device Name ORS-3000LD Slush Drapes ORS-1000LD Fluid Warming Drapes

Indications for Use (Describe)

The ORS-3000LD is an equipment cover for the ORS-1075LD Hush-Slush@machine. This is a single use product supplied sterile. This device is intended to be used during various surgeries where slush and/or is required.

Models: ORS-130/0RS-130-16, ORS-320/ORS-320-16, ORS-321-16, ORS-325/0RS-325-16, 330/0RS-330-16, ORS-331/0RS-331-16

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.

Models: ORS-100, ORS-110, ORS-300, ORS-301

Type of Use (Select one or both, as applicable)

| <span style="font-family: DejaVu Sans, sans-serif">☑</span> Prescription Use (Part 21 CFR 201 Subpart D) | <span style="font-family: DejaVu Sans, sans-serif">☐</span> Over-The-Counter Use (21 CFR 201 Subpart C) |
|----------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
|----------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|

| X | 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 | K152522 |
|------------|----------------|---------|
|------------|----------------|---------|

ORS Fluid Warming and Slush Drapes

As required by 21 CFR 807.92.

| Date: | December 7, 2015 |
|-------|------------------|
|-------|------------------|

Administrative Information

| Submitter: | Ecolab, Inc. |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment Registration Number: | 1043582 |
| Contact Person: | Jennifer Willner, RAC<br>370 Wabasha Street North<br>St. Paul, MN 55102-1390<br>Sr. Director, Regulatory Affairs - Healthcare<br>651.250.4348 |

Device Identification

| Device Name: | ORS-3000LD Slush Drapes<br>ORS-1000LD Warming Drapes |
|------------------------------|----------------------------------------------------------------------|
| Common Name: | Equipment Cover |
| Device Classification Name: | Warmer, Irrigation Solution |
| Device Classification: | Unclassified |
| Classification Product Code: | LHC |
| Panel: | General Hospital |
| Classification Regulation: | Pre-amendment |
| Performance Standards: | No Recognized Consensus Standards |
| Predicate Device: | K021288: ORS-1000LD<br>Covers ORS-100, ORS-110, ORS-300, and ORS-301 |

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K023282: ORS-3000LD Covers ORS-130, ORS-320, ORS-321, ORS-325, ORS-330, and ORS-331

### Intended Use

The ORS-3000LD is an equipment cover for the ORS-1075LD Hush-Slush®machine. This is a single use product supplied sterile. This device is intended to be used during various surgeries where slush and/or cold solution is required.

Models: ORS-130/0RS-130-16, ORS-320/ORS-320-16, ORS-321/0RS-321-16, ORS-325/0RS-325-16, 330/0RS-330-16, ORS-331/0RS-331-16

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.

Models: ORS-100, ORS-110, ORS-300, ORS-301

### Device Description

The ORS Fluid Warming and Slush Drapes are sterile, single-use equipment covers intended for use during various surgeries where warm irrigation, slush and/or cold solution is required. The ORS Fluid Warming drapes consist of a polyurethane film base material manufactured to protect ORS surgical fluid warming consoles. The ORS Surgical Slush drapes consist of a polyurethane film base secured to a polycarbonate disc or plate manufactured to protect ORS surgical slush machines from contamination during various procedures throughout the clinical setting.

The ORS Fluid Warming and Slush Drapes come in a variety of sizes and shapes specifically designed for safe use and proper fit on ORS Fluid Warming Consoles and Slush Machines.

### Special 510(k) Discussion

This Special 510(k) submission requests FDA clearance for the manufacture and distribution of ORS Fluid Warming and Slush Drapes in an alternative packaging configuration. Specifically, Ecolab has identified an improvement opportunity in changing from the current poly-Tyvek pouch to a header bag as the primary sterile barrier package for the ORS Fluid Warming and Slush Drapes. The fundamental scientific technology of the drapes remains unchanged.

The Substantial Equivalence Table 5-1 is provided below.

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| Property or<br>Characteristic | Proposed Device | Predicate Device<br>(Warming<br>Drapes) | Predicate Device<br>(Slush Drapes) |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) No. | This 510(k)<br>Submission | K021288 | K023282 |
| Device Name | ORS-1000LD Fluid<br>Warming Drapes<br>and ORS-3000LD<br>Slush Drapes<br>(includes: ORS-<br>100, ORS-110,<br>ORS-130/ORS-<br>130-16, ORS-300,<br>ORS-301, ORS-<br>320/ORS-320-16,<br>ORS-321/ORS-<br>321-16, ORS-325/<br>ORS-325-16, ORS-<br>330/ORS-330-16,<br>and ORS-331/ORS-<br>331-16) | ORS-1000LD<br>(includes: ORS-<br>100, ORS-110,<br>ORS-300, and<br>ORS-301) | ORS-3000LD<br>(includes: ORS-130,<br>ORS-320, ORS-321,<br>ORS-325, ORS-330,<br>and ORS-331) |
| Indications for<br>Use | The ORS-1000LD<br>Leak Detection<br>Drape is an<br>equipment cover<br>for the ORS-<br>2000LD Solution<br>Warmer. This is a<br>single use product<br>supplied sterile.<br>This device is<br>intended for use<br>during various<br>surgeries where<br>warm irrigation<br>solution is required.<br>The ORS-1000LD<br>Leak Detection<br>Drape is an<br>equipment cover<br>for the ORS-<br>2000LD Solution<br>Warmer. | The ORS-1000LD<br>Leak Detection<br>Drape is an<br>equipment cover<br>for the ORS-<br>2000LD Solution<br>Warmer. This is a<br>single use product<br>supplied sterile.<br>This device is<br>intended for use<br>during various<br>surgeries where<br>warm irrigation<br>solution is required. | The ORS-3000LD is<br>an equipment cover<br>for the ORS-<br>1075LD Hush-<br>Slush® machine.<br>This is a single use<br>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. |
| Property or<br>Characteristic | Proposed Device | Predicate Device<br>(Warming<br>Drapes) | Predicate Device<br>(Slush Drapes) |
| | Warmer. This is a<br>single use product<br>supplied sterile.<br>This device is<br>intended for use<br>during various<br>surgeries where<br>warm irrigation<br>solution is required | | |
| Conditions of<br>Use | Rx Only, Sterile,<br>Single Use,<br>Disposable | Identical | Identical |
| Materials | Polyurethane Film<br>and Polycarbonate<br>disc/plate for Slush<br>drapes only | Polyurethane Film | Polyurethane Film<br>and Polycarbonate<br>disc/plate |
| 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 | Individually<br>packaged in poly<br>header bags | Individually<br>packaged in<br>poly/Tyvek peel<br>pouches | Individually<br>packaged in<br>poly/Tyvek peel<br>pouches |
| Sterilized | 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 | Yes; provided in<br>sterile condition via<br>EO at SAL 10⁻⁶ |

Table 5-1: Substantial Equivalence Summary

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## Performance Data Summary

A risk assessment was performed per ISO 14971 and the following tests were determined to be needed to verify and validate the changes made to the packaging.

| | Table 5-2: Summary of Design Verification Testing and Other Supporting Evidence |
|--|---------------------------------------------------------------------------------|
|--|---------------------------------------------------------------------------------|

| Test | Rep.<br>Part(s) | Requirement | Results | Pass<br>(Y/N) |
|--------------------------------------------------------------------|--------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| EO Residuals | ORS-321 | EO shall not exceed 4 mg | 2.9 mg | Yes |
| Test | Rep.<br>Part(s) | Requirement | Results | Pass<br>(Y/N) |
| (ISO 10993-7) | (flat pack;<br>24/case) | ECH shall not exceed 9 mg | None recovered | Yes |
| | | Cycle 48 Processing Group | 24 hours aeration | Yes |
| Sterilization Cycle<br>Temp/RH<br>comparison to<br>current pouch | ORS-321<br>(file pack;<br>24/case) | Seal strength must meet a minimum<br>load of 4.4 N<br>(1 lbf) for a 1" wide sample (LAB-<br>ALPH-025) | Pre Seal Current (0800700094)<br>=15 of 15 pass | Yes |
| | | | Post Seal Current (0800700094<br>= 15 of 15 pass | Yes |
| | | | Pre Seal New (POU708)= 15 of<br>15 pass | Yes |
| | | | Post Seal New (POU708)= 15 of<br>15 pass | Yes |
| | | Current Pouch (080700900094) and<br>POU708 header bag meet 100-125°F<br>(37.8-51.6°C) and 45-80% RH by the<br>end of preconditioning | Temp = 94.7- 110.2 °F | No* |
| | | | RH= 46.8- 54.0% | Yes |
| | | Current Pouch (080700900094) and<br>POU708 header bag meet 120-140°F<br>(48.9-60°C) during EO gas dwell within<br>± 2 minutes of each other. | Temp =96.4- 110.1°F | No* |
| | | | RH =47.2 - 47.5% | Yes |
| Sterilization<br>Adoption | ORS-301<br>(flat pack;<br>24/case)<br>ORS-321<br>(flat pack;<br>24/case) | Approved FORM 0424 /JX-092 | Approved FORM 0424/JX-092<br>and supporting documents<br>attached to the report | Yes |
| | | All samples must complete the entire<br>distribution sample w/ no damage or<br>degradation to the product that<br>impacts product functionality or<br>compromises sterility. Labels must be<br>attached and legible. ASTM D4169-14 | 3 of 3 Pass | Yes |
| ISO 11607-1<br>transport challenge<br>package integrity<br>testing | ORS-301<br>(flat pack;<br>24/case) | There shall be no evidence of dye<br>completely penetrating through a seal<br>creating an open path through the<br>entire seal width via a channel of dye.<br>ASTM F3039-13 | 22 of 22 Pass | Yes |
| | | There shall be no evidence of dye<br>completely penetrating through a seal<br>creating an open path through the<br>entire seal width via a channel of dye<br>ASTM F1929 – 12 | 22 of 22 Pass | Yes |
| | | There shall be no evidence of a<br>constant stream of bubbles<br>penetrating through the seal or<br>material creating a path through<br>package seal or material ASTM F2096-<br>11 | 22 of 22 Pass | Yes |
| | | Mean peak load equal to or greater<br>than 1.0 lbf. ASTM F88-09 | Seal A = 22 of 22 Pass | Yes |
| | | | Seal B= 22 of 22 Pass | Yes |
| | | | Seal C= 22 of 22 Pass | Yes |
| Test | Rep.<br>Part(s) | Requirement | Results | Pass<br>(Y/N) |
| | | | Seal D= 22 of 22 Pass | Yes |
| | ORS-321<br>(flat pack;<br>16/case) | All samples must complete the entire<br>distribution sample w/ no damage or<br>degradation to the product that impacts<br>product functionality or compromises<br>sterility. Labels must be attached and<br>legible. ASTM D4169-14 | 3 of 3 Pass | Yes |
| | | There shall be no evidence of dye<br>completely penetrating through a seal<br>creating an open path through the<br>entire seal width via a channel of dye.<br>ASTM F3039-13 | 22 of 22 Pass | Yes |
| | | There shall be no evidence of dye<br>completely penetrating through a seal<br>creating an open path through the<br>entire seal width via a<br>channel of dye ASTM F1929 – 12 | 22 of 22 Pass | Yes |
| | | There shall be no evidence of a<br>constant stream of bubbles penetrating<br>through the seal or material creating a<br>path through package seal or material<br>ASTM F2096-11 | 22 of 22 Pass | Yes |
| | | Mean peak load equal to or greater<br>than 1.0 lbf. ASTM F88-09 | Seal A = 22 of 22 Pass<br>Seal B= 22 of 22 Pass<br>Seal C= 22 of 22 Pass<br>Seal D= 22 of 22 Pass | Yes |
| Packaging Shelf Life<br>Assessment | POU708<br>&<br>POU709<br>Header<br>Bags | Assessment of new packaging<br>materials (POU708 & POU709) against<br>ISO 11607-1 guidelines | Equivalent to RBA229<br>KYPHOPLASTY/VERTERBOPLAS<br>Y DRAPE WITH RADIATION<br>SHIELD as a representative<br>product packaging. 4 years<br>accelerated. | Assessment<br>allows for 4<br>years<br>accelerated.<br>No<br>additional<br>testing<br>required |
| Biocompatibility<br>Assessment,<br>ISO-11607-1 | POU708<br>Header<br>Bag | Assessment of Biocompatibility of<br>ORS-321 Header Bag POU708 | POU708 will not adversely<br>impact the biocompatibility of<br>the drape (Ref ORS-400<br>Testing) | N/A<br>however<br>assessment<br>assures<br>biocompatibility |

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*The temperature results, pre-conditioning, for both current pouch and the POU708, did not meet the acceptance criteria of the protocol. However, it was determined that the pre-conditioning temperature acriteria were inappropriate for this assessment. The temperature penetration into the POU708 met or exceeded the temperature penetration into the incumbent 080700094 pouch. The performance of the POU708 during gas dwell met the acceptance criteria indicating that the steam penetrated the candidate header bag comparable to the incumbent 080700094, thus not having an adverse impact on sterility assurance

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## Conclusion

The ORS Fluid Warming and Slush Drapes perform as intended using the identical principles of operation as the predicate device(s). Differences between the packaging configurations do not raise different questions of safety and effectiveness. Based on the risk analysis and successful packaging performance testing, the ORS Fluid Warming and Slush Drapes are substantially equivalent to the legally marketed ORS Fluid Warming and Slush Drapes (K021288 and K023282). The fundamental scientific technology of the devices remain unchanged.