(28 days)
Not Found
No
The device description and performance studies focus on the physical properties and functionality of a single-use equipment cover, with no mention of AI or ML technologies.
No
The device is described as an "equipment cover" intended to protect surgical fluid warmers and slush machines from contamination; it does not directly provide therapy to a patient.
No
Explanation: The device is described as an "equipment cover" and "drape" intended to protect surgical fluid warmers and slush machines from contamination. Its purpose is to maintain sterility and protect equipment, not to diagnose medical conditions or provide diagnostic information.
No
The device is described as a physical equipment cover made of polyurethane film, intended to protect surgical fluid warmers and slush machines. It is a tangible hardware product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to cover equipment (fluid warmers and slush machines) during surgery to protect them from contamination. This is a protective function for the equipment, not a diagnostic test performed on a biological sample.
- Device Description: The description clearly states it's an "equipment cover" made of polyurethane film. It's designed to fit and protect machines, not to analyze biological specimens.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
- Reagents, calibrators, or controls used in diagnostic testing
The device's function is purely mechanical and protective for surgical equipment.
N/A
Intended Use / Indications for 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.
The following models are included: ORS-100N, ORS-300N, ORS-301N, ORS-320N, ORS-330N and ORS-188231N.
Product codes (comma separated list FDA assigned to the subject device)
LHC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Functional Performance Requirements (of selected drape types)
Specification: 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.)
Method: 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
Result: Pass
Specification: Drape remains intact (free from holes or other defects that would compromise the sterile barrier)
Method: Acceptable results following visual inspection during V&V testing: VVR-14-0002 V&V Summary Report, Project 8 Track
Result: Pass
Specification: Disc/Plate must stay attached to drape during use
Method: Acceptable results following V&V testing (based on sterile product testing); VVR-14-0002 V&V Summary Report, Project 8 Track
Result: Pass
Specification: Drape/Device must attach to Slush Machine
Method: Acceptable results following V&V testing (based on sterile product testing); VVR-14-0002 V&V Summary Report, Project 8 Track
Result: Pass
Packaging
Specification: Packaging Configuration: 24 per case, double poly bagged
Method: 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
Result: Pass
Specification: Product must be received by customer with folds intact
Method: Acceptable results following visual inspection during V&V testing: documented in V&V Summary Report VVR-14-0002
Result: Pass
Specification: Simulated Distribution Test
Method: ASTM D4169-09 (Distribution Cycle 2. Assurance Level 1) Simulated Distribution Test (PKG 001F)
Result: Pass
Labeling
Specification: Inspection for Drape Damage
Method: 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
Result: Pass
Specification: Master carton label is present and per specification
Method: 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
Result: Pass
Specification: Ink (non-smudge/smear)
Method: Acceptable results following visual inspection during V&V testing; documented in V&V summary report VVR-14-0002
Result: Pass
Specification: Insert Sheet/IFU is present and per specification
Method: 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
Result: Pass
Specification: Product Identification label includes product code and Ecolab Logo
Method: Product Identification label specification: ORS-301NMISC ORS-188231NMISC ORS-321NMISC ORS-330NMISC
Result: Pass
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and features the department's name around the perimeter. In the center of the logo is an abstract symbol of a human figure, represented by three overlapping profiles.
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.
1
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
2
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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3
K140280 – 510(K) SUMMARY
4
Non-Sterile ORS Warming and Slush Drapes
Image /page/4/Picture/1 description: The image shows the logo for Ecolab Inc. The text "Ecolab Inc." is at the top of the image in a small, dark font. Below that is the Ecolab logo in a large, blue font. The logo includes a stylized image of a four-bladed propeller.
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 |
| 370 Wabasha Street North | |
| St. Paul, MN 55102-1390 | |
| Director, Regulatory Affairs - Healthcare | |
| 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, |
| ORS-188231] cleared on 06/27/2002 via K021288 and | |
| ORS-3000LD [covers ORS-320, ORS-321, ORS-330] | |
| cleared 11/13/2002 via K023282 |
5
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
Characteristic | Proposed Device | Predicate Device
(Warming Drapes) | Predicate Device
(Slush Drapes) |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| 510(k) No. | This 510(k)
Submission | K021288 | K023282 |
| Device Name | Non-Sterile ORS
Warming and
Slush Drapes
(includes: ORS-
100N, ORS-300N,
ORS-301N, ORS-
320N, ORS-321N,
ORS-330N and
ORS-188231N) | ORS-1000LD
(includes: ORS-100,
ORS-300, ORS-301,
and ORS-188231) | ORS-3000LD
(includes: ORS-320,
ORS-321, and ORS-
330) |
| Indications for
Use | The ORS drape is
a single-use
equipment cover
intended for use
during various
surgeries where | The ORS-1000LD
Leak Detection
Drape is an
equipment cover for
the ORS-2000LD
Solution Warmer. | The ORS-3000LD is
an equipment cover
for the ORS-
1075LD Hush-
Slush® machine.
This is a single use |
Table 5-1: Substantial Equivalence
6
| Property or
Characteristic | Proposed Device | Predicate Device
(Warming Drapes) | Predicate Device
(Slush Drapes) |
|-------------------------------|------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| | warm irrigation,
slush and/or cold
solution is
required. | This is a single use
product supplied
sterile. This device
is intended for use
during various
surgeries where
warm irrigation
solution is required. | product supplied
sterile. This device
is intended for use
during various
surgeries where
slush and/or cold
solution is required. |
| Conditions of
Use | Rx Only, Single
Use, Disposable | Identical | Identical |
| Materials | Polyurethane Film
Polypropylene
skirt for ORS-
188231N only | Identical | Identical |
| Principle of
Operation | Covers surgical
solution warmers
and/or slush
machines | Covers surgical
solution warmers | Covers surgical
solution warmers
and/or slush
machines |
| Packaging | Bulk packaged in
poly bag in
quantities up to 24 | 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 |
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.
7
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 | |||
| 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 | |||
| 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 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 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 |
- Assurance Level 1) Simulated
Distribution Test (PKG 001F) | Pass |
| Requirement | Specification | Method | Result |
| Labeling | Inspection for Drape
Damage | 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 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) | 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-WARMER DRAPE_2014-
5/NEW INSERT SHEET (ORS-
100N, ORS-300N, ORS-301N,
ORS-188231N) - ORS-320N/ORS-321N_2014-
5/NEW SLUSH/WARMER
DISC-DRAPE INSERT SHEET - ORS-330N_2014-5/NEW
SLUSH/WARMER PLATE
DRAPE INSERT SHEET | Pass |
| | Product Identification label
includes product code and
Ecolab Logo | Product Identification label
specification:
ORS-301NMISC
ORS-188231NMISC
ORS-321NMISC
ORS-330NMISC | Pass |
8
Non-Sterile ORS Warming and Slush Drapes
Ecolab Inc.