(134 days)
No
The device is a sterile, single-use equipment cover for existing fluid warming and slush machines. The description focuses on material and fit, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No.
The device is an equipment cover for other medical machines (slush machine, solution warmer) and does not directly provide therapy to a patient.
No
The device description clearly states that these are "equipment covers" intended to "protect" other machines during surgery. There is no mention of diagnostic capabilities, data analysis, or medical insights generated by this device.
No
The device is described as physical equipment covers made of polyurethane film and polycarbonate, intended to protect surgical machines. There is no mention of 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 be an "equipment cover" for surgical machines (slush and solution warmers) used during surgery. This is a physical barrier to protect the equipment.
- Device Description: The description reinforces that these are "sterile, single-use equipment covers" made of materials like polyurethane and polycarbonate. Their purpose is to "protect ORS surgical fluid warming consoles and Slush Machines from contamination."
- No mention of biological samples: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with biological samples in this way.
- No mention of diagnostic information: The device does not provide any diagnostic information about a patient's health status.
The device is clearly intended for use in a surgical setting as a protective cover for equipment, not for performing in vitro diagnostic tests.
N/A
Intended Use / Indications for 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
Product codes
LHC
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.
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)
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.
Test: EO Residuals (ISO 10993-7)
Rep. Part(s): ORS-321 (flat pack; 24/case)
Requirement: EO shall not exceed 4 mg; ECH shall not exceed 9 mg.
Results: EO = 2.9 mg; ECH = None recovered.
Pass (Y/N): Yes for both.
Cycle 48 Processing Group: 24 hours aeration. Pass (Y/N): Yes.
Test: Sterilization Cycle Temp/RH comparison to current pouch
Rep. Part(s): ORS-321 (file pack; 24/case)
Requirement: Seal strength must meet a minimum load of 4.4 N (1 lbf) for a 1" wide sample (LAB-ALPH-025).
Results: Pre Seal Current (0800700094) = 15 of 15 pass; Post Seal Current (0800700094) = 15 of 15 pass; Pre Seal New (POU708) = 15 of 15 pass; Post Seal New (POU708) = 15 of 15 pass.
Pass (Y/N): Yes for all.
Requirement: Current Pouch (080700900094) and POU708 header bag meet 100-125°F (37.8-51.6°C) and 45-80% RH by the end of preconditioning.
Results: Temp = 94.7- 110.2 °F (No*); RH= 46.8- 54.0% (Yes).
Requirement: Current Pouch (080700900094) and POU708 header bag meet 120-140°F (48.9-60°C) during EO gas dwell within ± 2 minutes of each other.
Results: Temp =96.4- 110.1°F (No*); RH =47.2 - 47.5% (Yes).
*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 criteria 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.
Test: Sterilization Adoption
Rep. Part(s): ORS-301 (flat pack; 24/case), ORS-321 (flat pack; 24/case)
Requirement: Approved FORM 0424 /JX-092.
Results: Approved FORM 0424/JX-092 and supporting documents attached to the report.
Pass (Y/N): Yes.
Test: ISO 11607-1 transport challenge package integrity testing
Rep. Part(s): ORS-301 (flat pack; 24/case)
Requirement: All samples must complete the entire distribution sample w/ no damage or degradation to the product that impacts product functionality or compromises sterility. Labels must be attached and legible. ASTM D4169-14.
Results: 3 of 3 Pass.
Pass (Y/N): Yes.
Requirement: There shall be no evidence of dye completely penetrating through a seal creating an open path through the entire seal width via a channel of dye. ASTM F3039-13.
Results: 22 of 22 Pass.
Pass (Y/N): Yes.
Requirement: There shall be no evidence of dye completely penetrating through a seal creating an open path through the entire seal width via a channel of dye ASTM F1929 – 12.
Results: 22 of 22 Pass.
Pass (Y/N): Yes.
Requirement: There shall be no evidence of a constant stream of bubbles penetrating through the seal or material creating a path through package seal or material ASTM F2096-11.
Results: 22 of 22 Pass.
Pass (Y/N): Yes.
Requirement: Mean peak load equal to or greater than 1.0 lbf. ASTM F88-09.
Results: Seal A = 22 of 22 Pass; Seal B= 22 of 22 Pass; Seal C= 22 of 22 Pass; Seal D= 22 of 22 Pass.
Pass (Y/N): Yes for all.
Rep. Part(s): ORS-321 (flat pack; 16/case)
Requirement: All samples must complete the entire distribution sample w/ no damage or degradation to the product that impacts product functionality or compromises sterility. Labels must be attached and legible. ASTM D4169-14.
Results: 3 of 3 Pass.
Pass (Y/N): Yes.
Requirement: There shall be no evidence of dye completely penetrating through a seal creating an open path through the entire seal width via a channel of dye. ASTM F3039-13.
Results: 22 of 22 Pass.
Pass (Y/N): Yes.
Requirement: There shall be no evidence of dye completely penetrating through a seal creating an open path through the entire seal width via a channel of dye ASTM F1929 – 12.
Results: 22 of 22 Pass.
Pass (Y/N): Yes.
Requirement: There shall be no evidence of a constant stream of bubbles penetrating through the seal or material creating a path through package seal or material ASTM F2096-11.
Results: 22 of 22 Pass.
Pass (Y/N): Yes.
Requirement: Mean peak load equal to or greater than 1.0 lbf. ASTM F88-09.
Results: Seal A = 22 of 22 Pass; Seal B= 22 of 22 Pass; Seal C= 22 of 22 Pass; Seal D= 22 of 22 Pass.
Pass (Y/N): Yes for all.
Test: Packaging Shelf Life Assessment
Rep. Part(s): POU708 & POU709 Header Bags
Requirement: Assessment of new packaging materials (POU708 & POU709) against ISO 11607-1 guidelines.
Results: Equivalent to RBA229 KYPHOPLASTY/VERTERBOPLASY DRAPE WITH RADIATION SHIELD as a representative product packaging. 4 years accelerated.
Pass (Y/N): Assessment allows for 4 years accelerated. No additional testing required.
Test: Biocompatibility Assessment, ISO-11607-1
Rep. Part(s): POU708 Header Bag
Requirement: Assessment of Biocompatibility of ORS-321 Header Bag POU708.
Results: POU708 will not adversely impact the biocompatibility of the drape (Ref ORS-400 Testing).
Pass (Y/N): N/A however assessment assures biocompatibility.
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.
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing to the right, with the profiles overlapping each other. The profiles are positioned above a set of three wavy lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the top of the logo.
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.
1
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
2
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)
| ☑ Prescription Use (Part 21 CFR 201 Subpart D) | ☐ 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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3
Image /page/3/Picture/1 description: The image shows the logo for Ecolab Inc. The logo is in blue and features the company name in a stylized font. The logo also includes a symbol that looks like a star or asterisk.
| 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 |
| 370 Wabasha Street North | |
| St. Paul, MN 55102-1390 | |
| Sr. Director, Regulatory Affairs - Healthcare | |
| 651.250.4348 |
Device Identification
| Device Name: | ORS-3000LD Slush Drapes
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
Covers ORS-100, ORS-110, ORS-300, and ORS-301 |
4
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.
5
| Property or
Characteristic | Proposed Device | Predicate Device
(Warming
Drapes) | Predicate Device
(Slush Drapes) |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) No. | This 510(k)
Submission | K021288 | K023282 |
| Device Name | ORS-1000LD Fluid
Warming Drapes
and ORS-3000LD
Slush Drapes
(includes: ORS-
100, ORS-110,
ORS-130/ORS-
130-16, ORS-300,
ORS-301, ORS-
320/ORS-320-16,
ORS-321/ORS-
321-16, ORS-325/
ORS-325-16, ORS-
330/ORS-330-16,
and ORS-331/ORS-
331-16) | ORS-1000LD
(includes: ORS-
100, ORS-110,
ORS-300, and
ORS-301) | ORS-3000LD
(includes: ORS-130,
ORS-320, ORS-321,
ORS-325, ORS-330,
and ORS-331) |
| Indications for
Use | 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-1000LD
Leak Detection
Drape is an
equipment cover
for the ORS-
2000LD Solution
Warmer. | 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-3000LD is
an equipment cover
for the ORS-
1075LD Hush-
Slush® machine.
This is a single use
product supplied
sterile. This device
is intended for use
during various
surgeries where
slush and/or cold
solution is required. |
| Property or
Characteristic | Proposed Device | Predicate Device
(Warming
Drapes) | Predicate Device
(Slush Drapes) |
| | Warmer. This is a
single use product
supplied sterile.
This device is
intended for use
during various
surgeries where
warm irrigation
solution is required | | |
| Conditions of
Use | Rx Only, Sterile,
Single Use,
Disposable | Identical | Identical |
| Materials | Polyurethane Film
and Polycarbonate
disc/plate for Slush
drapes only | Polyurethane Film | Polyurethane Film
and Polycarbonate
disc/plate |
| Principle of
Operation | Covers surgical
solution warmers
and/or slush
machines | Covers surgical
solution warmers | Covers surgical
solution warmers
and/or slush
machines |
| Packaging | Individually
packaged in poly
header bags | Individually
packaged in
poly/Tyvek peel
pouches | Individually
packaged in
poly/Tyvek peel
pouches |
| Sterilized | Yes; provided in
sterile condition via
EO at SAL 10⁻⁶ | 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 Summary
6
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.
Part(s) | Requirement | Results | Pass
(Y/N) |
|--------------------------------------------------------------------|--------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| EO Residuals | ORS-321 | EO shall not exceed 4 mg | 2.9 mg | Yes |
| Test | Rep.
Part(s) | Requirement | Results | Pass
(Y/N) |
| (ISO 10993-7) | (flat pack;
24/case) | ECH shall not exceed 9 mg | None recovered | Yes |
| | | Cycle 48 Processing Group | 24 hours aeration | Yes |
| Sterilization Cycle
Temp/RH
comparison to
current pouch | ORS-321
(file pack;
24/case) | Seal strength must meet a minimum
load of 4.4 N
(1 lbf) for a 1" wide sample (LAB-
ALPH-025) | Pre Seal Current (0800700094)
=15 of 15 pass | Yes |
| | | | Post Seal Current (0800700094
= 15 of 15 pass | Yes |
| | | | Pre Seal New (POU708)= 15 of
15 pass | Yes |
| | | | Post Seal New (POU708)= 15 of
15 pass | Yes |
| | | Current Pouch (080700900094) and
POU708 header bag meet 100-125°F
(37.8-51.6°C) and 45-80% RH by the
end of preconditioning | Temp = 94.7- 110.2 °F | No* |
| | | | RH= 46.8- 54.0% | Yes |
| | | Current Pouch (080700900094) and
POU708 header bag meet 120-140°F
(48.9-60°C) during EO gas dwell within
± 2 minutes of each other. | Temp =96.4- 110.1°F | No* |
| | | | RH =47.2 - 47.5% | Yes |
| Sterilization
Adoption | ORS-301
(flat pack;
24/case)
ORS-321
(flat pack;
24/case) | Approved FORM 0424 /JX-092 | Approved FORM 0424/JX-092
and supporting documents
attached to the report | Yes |
| | | All samples must complete the entire
distribution sample w/ no damage or
degradation to the product that
impacts product functionality or
compromises sterility. Labels must be
attached and legible. ASTM D4169-14 | 3 of 3 Pass | Yes |
| ISO 11607-1
transport challenge
package integrity
testing | ORS-301
(flat pack;
24/case) | There shall be no evidence of dye
completely penetrating through a seal
creating an open path through the
entire seal width via a channel of dye.
ASTM F3039-13 | 22 of 22 Pass | Yes |
| | | There shall be no evidence of dye
completely penetrating through a seal
creating an open path through the
entire seal width via a channel of dye
ASTM F1929 – 12 | 22 of 22 Pass | Yes |
| | | There shall be no evidence of a
constant stream of bubbles
penetrating through the seal or
material creating a path through
package seal or material ASTM F2096-
11 | 22 of 22 Pass | Yes |
| | | Mean peak load equal to or greater
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.
Part(s) | Requirement | Results | Pass
(Y/N) |
| | | | Seal D= 22 of 22 Pass | Yes |
| | ORS-321
(flat pack;
16/case) | All samples must complete the entire
distribution sample w/ no damage or
degradation to the product that impacts
product functionality or compromises
sterility. Labels must be attached and
legible. ASTM D4169-14 | 3 of 3 Pass | Yes |
| | | There shall be no evidence of dye
completely penetrating through a seal
creating an open path through the
entire seal width via a channel of dye.
ASTM F3039-13 | 22 of 22 Pass | Yes |
| | | There shall be no evidence of dye
completely penetrating through a seal
creating an open path through the
entire seal width via a
channel of dye ASTM F1929 – 12 | 22 of 22 Pass | Yes |
| | | There shall be no evidence of a
constant stream of bubbles penetrating
through the seal or material creating a
path through package seal or material
ASTM F2096-11 | 22 of 22 Pass | Yes |
| | | Mean peak load equal to or greater
than 1.0 lbf. ASTM F88-09 | Seal A = 22 of 22 Pass
Seal B= 22 of 22 Pass
Seal C= 22 of 22 Pass
Seal D= 22 of 22 Pass | Yes |
| Packaging Shelf Life
Assessment | POU708
&
POU709
Header
Bags | Assessment of new packaging
materials (POU708 & POU709) against
ISO 11607-1 guidelines | Equivalent to RBA229
KYPHOPLASTY/VERTERBOPLAS
Y DRAPE WITH RADIATION
SHIELD as a representative
product packaging. 4 years
accelerated. | Assessment
allows for 4
years
accelerated.
No
additional
testing
required |
| Biocompatibility
Assessment,
ISO-11607-1 | POU708
Header
Bag | Assessment of Biocompatibility of
ORS-321 Header Bag POU708 | POU708 will not adversely
impact the biocompatibility of
the drape (Ref ORS-400
Testing) | N/A
however
assessment
assures
biocompatibility |
7
8
*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
9
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.