(134 days)
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.
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 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.
Here's a breakdown of the acceptance criteria and the study that proves the device meets the acceptance criteria, based on the provided text.
Important Note: The provided document is a 510(k) Pre-market Notification for a medical device (ORS Fluid Warming and Slush Drapes). It focuses on demonstrating substantial equivalence to predicate devices, particularly regarding a change in packaging. This means the study described is primarily focused on validating the packaging change and its impact on the device's performance, rather than a de novo validation of device performance itself. It does not contain information typically found in studies for AI/algorithm-based medical devices (e.g., MRMC studies, ground truth establishment by experts for AI, training set details). Therefore, many of the requested points related to AI/algorithm performance (e.g., effect size for human readers with AI assistance, independent algorithm performance, expert qualifications for ground truth) are not applicable to this document.
1. Table of Acceptance Criteria and Reported Device Performance
This table summarizes the design verification testing results presented in Table 5-2 of the document.
| Test | Acceptance Criteria (Requirement) | Reported Performance (Results) | Pass (Y/N) |
|---|---|---|---|
| EO Residuals | EO not exceed 4 mg; ECH not exceed 9 mg; Cycle 48 Processing Group, 24 hours aeration | EO: 2.9 mg; ECH: None recovered; Cycle 48 Processing Group, 24 hours aeration | Yes |
| Seal Strength (Pre Seal Current) | Minimum load of 4.4 N (1 lbf) for a 1" wide sample (LAB-ALPH-025) | 15 of 15 pass | Yes |
| Seal Strength (Post Seal Current) | Minimum load of 4.4 N (1 lbf) for a 1" wide sample (LAB-ALPH-025) | 15 of 15 pass | Yes |
| Seal Strength (Pre Seal New) | Minimum load of 4.4 N (1 lbf) for a 1" wide sample (LAB-ALPH-025) | 15 of 15 pass | Yes |
| Seal Strength (Post Seal New) | Minimum load of 4.4 N (1 lbf) for a 1" wide sample (LAB-ALPH-025) | 15 of 15 pass | Yes |
| Sterilization Cycle Temp (Pre-Conditioning) | Current Pouch (080700900094) and POU708 header bag meet 100-125°F (37.8-51.6°C) by the end of preconditioning | Temp = 94.7- 110.2 °F | No* |
| Sterilization Cycle RH (Pre-Conditioning) | Current Pouch (080700900094) and POU708 header bag meet 45-80% RH by the end of preconditioning | RH= 46.8- 54.0% | Yes |
| Sterilization Cycle Temp (Gas Dwell) | 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* |
| Sterilization Cycle RH (Gas Dwell) | Current Pouch (080700900094) and POU708 header bag meet 45-80% RH by the end of preconditioning | RH =47.2 - 47.5% | Yes |
| Sterilization Adoption | Approved FORM 0424 /JX-092 | Approved FORM 0424/JX-092 and supporting documents attached to the report | Yes |
| ISO 11607-1 Transport Challenge Package Integrity Testing (ORS-301) | 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 Dye Penetration (ORS-301 - ASTM F3039-13) | No evidence of dye completely penetrating through a seal creating an open path through the entire seal width via a channel of dye. | 22 of 22 Pass | Yes |
| ISO 11607-1 Transport Challenge Dye Penetration (ORS-301 - ASTM F1929-12) | No evidence of dye completely penetrating through a seal creating an open path through the entire seal width via a channel of dye. | 22 of 22 Pass | Yes |
| ISO 11607-1 Transport Challenge Bubble Emission (ORS-301 - ASTM F2096-11) | No evidence of a constant stream of bubbles penetrating through the seal or material creating a path through package seal or material. | 22 of 22 Pass | Yes |
| ISO 11607-1 Transport Challenge Seal Strength (ORS-301 - ASTM F88-09) | Mean peak load equal to or greater than 1.0 lbf. | Seal A, B, C, D: 22 of 22 Pass | Yes |
| ISO 11607-1 Transport Challenge Package Integrity Testing (ORS-321) | 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 Dye Penetration (ORS-321 - ASTM F3039-13) | No evidence of dye completely penetrating through a seal creating an open path through the entire seal width via a channel of dye. | 22 of 22 Pass | Yes |
| ISO 11607-1 Transport Challenge Dye Penetration (ORS-321 - ASTM F1929-12) | No evidence of dye completely penetrating through a seal creating an open path through the entire seal width via a channel of dye. | 22 of 22 Pass | Yes |
| ISO 11607-1 Transport Challenge Bubble Emission (ORS-321 - ASTM F2096-11) | No evidence of a constant stream of bubbles penetrating through the seal or material creating a path through package seal or material. | 22 of 22 Pass | Yes |
| ISO 11607-1 Transport Challenge Seal Strength (ORS-321 - ASTM F88-09) | Mean peak load equal to or greater than 1.0 lbf. | Seal A, B, C, D: 22 of 22 Pass | Yes |
| Packaging Shelf Life Assessment | Assessment of new packaging materials (POU708 & POU709) against ISO 11607-1 guidelines | Equivalent to RBA229 KYPHOPLASTY/VERTERBOPLASY DRAPE WITH RADIATION SHIELD as a representative product packaging. 4 years accelerated. | Assessment allows for 4 years accelerated. No additional testing required |
| Biocompatibility Assessment (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 (assessment assures biocompatibility) |
Note on Temperature Failures: The document explains that although the temperature results for pre-conditioning and gas dwell did not strictly meet the protocol's acceptance criteria, it was determined the criteria were inappropriate for the assessment. The performance was deemed acceptable because temperature penetration into the new packaging was comparable to the incumbent packaging, avoiding an adverse impact on sterility assurance.
2. Sample Size Used for the Test Set and Data Provenance
-
Sample Size for Test Set:
- EO Residuals: ORS-321 (flat pack; 24/case) - Implies testing on a representative sample from this lot size.
- Seal Strength (various tests): 15 samples for each of the "Pre Seal Current," "Post Seal Current," "Pre Seal New," and "Post Seal New" tests.
- Sterilization Cycle Comparison: ORS-321 (file pack; 24/case) - Implies representative samples.
- ISO 11607-1 Transport Challenge & Package Integrity Testing (ORS-301): 3 samples for the initial transport challenge, and 22 samples for each of the dye penetration, bubble emission, and seal strength tests.
- ISO 11607-1 Transport Challenge & Package Integrity Testing (ORS-321): 3 samples for the initial transport challenge, and 22 samples for each of the dye penetration, bubble emission, and seal strength tests.
- Packaging Shelf Life Assessment: POU708 & POU709 Header Bags (assessment, not direct testing on specific number of samples for results).
- Biocompatibility Assessment: POU708 Header Bag (assessment, not direct testing on specific number of samples for results).
-
Data Provenance: The document does not specify the country of origin for the data. The testing appears to be internal verification and validation testing performed by Ecolab, Inc., for a 510(k) submission to the FDA (USA). The studies are inherently prospective in nature, as they involve testing conducted specifically to validate a manufacturing or design change (changing the packaging configuration).
3. Number of Experts Used to Establish Ground Truth and Qualifications
This document describes design verification and validation testing for a physical medical device (equipment covers) and a change in its packaging. It does not involve an AI/algorithm where "ground truth" related to expert interpretations (e.g., radiology reads) would be established. Therefore, this section is Not Applicable.
4. Adjudication Method for the Test Set
This document describes physical and chemical testing (tensile strength, dye penetration, sterilization cycle parameters, etc.). "Adjudication methods" like 2+1 or 3+1 are typically used in clinical studies involving multiple human readers for diagnostic interpretation. Therefore, this section is Not Applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was Not Applicable and therefore not done. This type of study is relevant for AI-powered diagnostic devices where human readers' performance with and without AI assistance is evaluated. This document pertains to sterile equipment covers.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This document does not involve an algorithm. Therefore, this section is Not Applicable.
7. The Type of Ground Truth Used
For this device and the tests performed, the "ground truth" is established by:
- Engineering specifications and standards: e.g., minimum seal strength, maximum EO residuals, temperature/RH requirements for sterilization, and compliance with ASTM and ISO standards (e.g., ISO 14971, ISO 10993-7, ISO 11607-1, ASTM D4169-14, ASTM F3039-13, ASTM F1929-12, ASTM F2096-11, ASTM F88-09).
- Laboratory measurements and observations: The quantitative results from the tests (e.g., 2.9 mg EO, 15 of 15 passes for seal strength, observed lack of dye penetration).
- Prior predicate device performance: The basis for demonstrating substantial equivalence is that the new packaging performs comparably to the previously cleared packaging, without raising new questions of safety or effectiveness.
This is not a clinical "ground truth" derived from expert consensus, pathology, or outcomes data in the sense used for diagnostic algorithms.
8. The Sample Size for the Training Set
This document does not describe the development or testing of an AI/algorithm, and thus there is no "training set" in this context. Therefore, this section is Not Applicable.
9. How the Ground Truth for the Training Set was Established
As explained above, there is no AI/algorithm and no training set involved. Therefore, this section is Not Applicable.
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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 (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
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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)
| ☑ 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)
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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, RAC370 Wabasha Street NorthSt. Paul, MN 55102-1390Sr. Director, Regulatory Affairs - Healthcare651.250.4348 |
Device Identification
| Device Name: | ORS-3000LD Slush DrapesORS-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-1000LDCovers 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 orCharacteristic | Proposed Device | Predicate Device(WarmingDrapes) | Predicate Device(Slush Drapes) |
|---|---|---|---|
| 510(k) No. | This 510(k)Submission | K021288 | K023282 |
| Device Name | ORS-1000LD FluidWarming Drapesand ORS-3000LDSlush 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, andORS-301) | ORS-3000LD(includes: ORS-130,ORS-320, ORS-321,ORS-325, ORS-330,and ORS-331) |
| Indications forUse | The ORS-1000LDLeak DetectionDrape is anequipment coverfor the ORS-2000LD SolutionWarmer. This is asingle use productsupplied sterile.This device isintended for useduring varioussurgeries wherewarm irrigationsolution is required.The ORS-1000LDLeak DetectionDrape is anequipment coverfor the ORS-2000LD SolutionWarmer. | The ORS-1000LDLeak DetectionDrape is anequipment coverfor the ORS-2000LD SolutionWarmer. This is asingle use productsupplied sterile.This device isintended for useduring varioussurgeries wherewarm irrigationsolution is required. | The ORS-3000LD isan equipment coverfor the ORS-1075LD Hush-Slush® machine.This is a single useproduct suppliedsterile. This deviceis intended for useduring varioussurgeries whereslush and/or coldsolution is required. |
| Property orCharacteristic | Proposed Device | Predicate Device(WarmingDrapes) | Predicate Device(Slush Drapes) |
| Warmer. This is asingle use productsupplied sterile.This device isintended for useduring varioussurgeries wherewarm irrigationsolution is required | |||
| Conditions ofUse | Rx Only, Sterile,Single Use,Disposable | Identical | Identical |
| Materials | Polyurethane Filmand Polycarbonatedisc/plate for Slushdrapes only | Polyurethane Film | Polyurethane Filmand Polycarbonatedisc/plate |
| Principle ofOperation | Covers surgicalsolution warmersand/or slushmachines | Covers surgicalsolution warmers | Covers surgicalsolution warmersand/or slushmachines |
| Packaging | Individuallypackaged in polyheader bags | Individuallypackaged inpoly/Tyvek peelpouches | Individuallypackaged inpoly/Tyvek peelpouches |
| Sterilized | Yes; provided insterile condition viaEO at SAL 10⁻⁶ | Yes; provided insterile condition viaEO at SAL 10⁻⁶ | Yes; provided insterile condition viaEO 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.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 CycleTemp/RHcomparison tocurrent pouch | ORS-321(file pack;24/case) | Seal strength must meet a minimumload 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 of15 pass | Yes | |||
| Post Seal New (POU708)= 15 of15 pass | Yes | |||
| Current Pouch (080700900094) andPOU708 header bag meet 100-125°F(37.8-51.6°C) and 45-80% RH by theend of preconditioning | Temp = 94.7- 110.2 °F | No* | ||
| RH= 46.8- 54.0% | Yes | |||
| Current Pouch (080700900094) andPOU708 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 | |||
| SterilizationAdoption | ORS-301(flat pack;24/case)ORS-321(flat pack;24/case) | Approved FORM 0424 /JX-092 | Approved FORM 0424/JX-092and supporting documentsattached to the report | Yes |
| All samples must complete the entiredistribution sample w/ no damage ordegradation to the product thatimpacts product functionality orcompromises sterility. Labels must beattached and legible. ASTM D4169-14 | 3 of 3 Pass | Yes | ||
| ISO 11607-1transport challengepackage integritytesting | ORS-301(flat pack;24/case) | There shall be no evidence of dyecompletely penetrating through a sealcreating an open path through theentire seal width via a channel of dye.ASTM F3039-13 | 22 of 22 Pass | Yes |
| There shall be no evidence of dyecompletely penetrating through a sealcreating an open path through theentire seal width via a channel of dyeASTM F1929 – 12 | 22 of 22 Pass | Yes | ||
| There shall be no evidence of aconstant stream of bubblespenetrating through the seal ormaterial creating a path throughpackage seal or material ASTM F2096-11 | 22 of 22 Pass | Yes | ||
| Mean peak load equal to or greaterthan 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 entiredistribution sample w/ no damage ordegradation to the product that impactsproduct functionality or compromisessterility. Labels must be attached andlegible. ASTM D4169-14 | 3 of 3 Pass | Yes | |
| There shall be no evidence of dyecompletely penetrating through a sealcreating an open path through theentire seal width via a channel of dye.ASTM F3039-13 | 22 of 22 Pass | Yes | ||
| There shall be no evidence of dyecompletely penetrating through a sealcreating an open path through theentire seal width via achannel of dye ASTM F1929 – 12 | 22 of 22 Pass | Yes | ||
| There shall be no evidence of aconstant stream of bubbles penetratingthrough the seal or material creating apath through package seal or materialASTM F2096-11 | 22 of 22 Pass | Yes | ||
| Mean peak load equal to or greaterthan 1.0 lbf. ASTM F88-09 | Seal A = 22 of 22 PassSeal B= 22 of 22 PassSeal C= 22 of 22 PassSeal D= 22 of 22 Pass | Yes | ||
| Packaging Shelf LifeAssessment | POU708&POU709HeaderBags | Assessment of new packagingmaterials (POU708 & POU709) againstISO 11607-1 guidelines | Equivalent to RBA229KYPHOPLASTY/VERTERBOPLASY DRAPE WITH RADIATIONSHIELD as a representativeproduct packaging. 4 yearsaccelerated. | Assessmentallows for 4yearsaccelerated.Noadditionaltestingrequired |
| BiocompatibilityAssessment,ISO-11607-1 | POU708HeaderBag | Assessment of Biocompatibility ofORS-321 Header Bag POU708 | POU708 will not adverselyimpact the biocompatibility ofthe drape (Ref ORS-400Testing) | N/Ahoweverassessmentassuresbiocompatibility |
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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.
§ 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.