(145 days)
No
The device is a simple disposable drape and foam pillow accessory for a solution warmer, with no mention of any computational or analytical capabilities.
No.
The device is an accessory that holds the optical end of endoscopes and protects warming systems, not directly providing therapy.
No
Explanation: The device is described as an accessory for ORS Solution Warmers, designed to protect warmers and hold endoscopes to prevent fogging or wetting of the eyepiece. It solely serves as a protective and positioning accessory, without any function in diagnosing diseases or conditions.
No
The device description clearly states it is a physical, single-use disposable device made of polyurethane film and foam, intended for use as an accessory to a warming system. It does not mention any software components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to hold the optical end of endoscopes above warm solution to prevent fogging or wetting. This is a physical function related to surgical equipment, not a diagnostic test performed on biological samples.
- Device Description: The description details a physical drape and foam pillow designed to protect a warmer and position an endoscope. It does not mention any components or processes related to analyzing biological specimens.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological samples (blood, urine, tissue, etc.)
- Detection or measurement of analytes
- Providing diagnostic information about a patient's health status
- Reagents or test kits
The device is clearly described as an accessory for a solution warmer used in a clinical setting, focused on the physical handling of an endoscope.
N/A
Intended Use / 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 following model(s) are included: ORS-400 and ORS-400N
Product codes
LHC
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).
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.
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
clinical staff
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: Dimensional Requirements for ORS-400N (44 in. x 66 in.) were found acceptable following visual inspection during V&V testing, as documented in VVR-14-0002 V&V Summary Report, Project 8 Track. Result: 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, as documented in VVR-14-0002 V&V Summary Report, Project 8 Track. Result: Pass.
Packaging Configuration: 10 per case, double poly bagged. Acceptable results following visual inspection during V&V testing, as documented in VVR-14-0002 V&V Summary Report, Project 8 Track. Result: 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. Result: Pass.
Simulated Distribution Test: ASTM D4169-09 (Distribution Cycle 2, Assurance Level 1) Simulated Distribution Test was performed. Result: Pass.
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. Result: 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. Result: Pass.
Ink (non-smudge/smear): Acceptable results following visual inspection during V&V testing; documented in V&V summary report VVR-14-0002. Result: Pass.
Insert Sheet/IFU is present and per specification: Insert Sheet/IFU specifications: ORS-400N-INSERT SHEET. Result: Pass.
Product Identification label includes product code and Ecolab Logo: Product Identification label specification: ORS-400NMISC. Result: Pass.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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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.
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) |
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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. |
| 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 |
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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
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 |
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| 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.