(227 days)
The Ellipse Supplemental Instrument Trays are intended to organize, protect, and transport instruments during steam sterilization and subsequent storage. Sterility of the enclosed instruments is not maintained unless used in conjunction with an FDA-cleared sterilization wrap using the following cycle:
Pre-vacuum Steam Sterilization parameters: 132°C for 4 minutes with 40 minutes dry time
The the worst case validated sterilization load is:
-One (1) Supplemental Instruments (total weight: 10.0 Ibs.) and one (1) Supplemental Reamer Tray with instruments (total weight: 13.1 lbs.); in a non-stacked configuration.
The worst case loading configuration included the 12 instruments supplied with the Supplemental Instrument Tray with the following worst case lumen dimensions:
Supplemental Instrument Tray (Model SIT1-000)
| Instrument Model | Description | Dimension (Inner Diameter x Length) | Number of Lumens |
|---|---|---|---|
| TCD1-000 | Teardrop Cannulated Driver | 0.210" x 4.58" | 1 |
| CED1-011 | 11mm Cannulated Entry Drill | 0.146" x 10.75" | 1 |
| GWC1-000 | Guide Wire Chuck | 0.250" x 5.0" | 1 |
| LQC1-000 | Large AO Quick Connect | 0.175" x 2.91" | 1 |
| DGA1-000 | Direct AO Depth Gauge | 0.394" x 10.43" | 1 |
The worst case loading configuration included the 18 instruments supplied with the Supplemental Reamer Tray with the following worst case lumen dimensions:
Supplemental Reamer Tray (Model SRT1-000):
| Instrument Model | Description | Dimension (Inner Diameter x Length) | Number of Lumen |
|---|---|---|---|
| RMR1-110 | Flexible Reamer, 10.0mm | 0.125" x 18.4" | 1 |
| RMR1-135 | Flexible Reamer, 13.5mm | 0.125" x 18.4" | 1 |
| RMR1-140 | Flexible Reamer, 14.0mm | 0.125" x 18.4" | 1 |
| RMR1-145 | Flexible Reamer, 14.5mm | 0.125" x 18.4" | 1 |
| RMR1-150 | Flexible Reamer, 15.0mm | 0.125" x 18.4" | 1 |
Do not exceed a maximum load of 12 instruments (10.0 lbs.) in the Supplemental Instrument Tray. Do not exceed a maximum load of 18 instruments (13.1 lbs.) in the Supplemental Reamer Tray.
The Ellipse Supplemental Instrument Trays are comprised of a Supplemental Instrument Tray and a Supplemental Reamer Tray. These trays are designed to organize, protect, and transport instruments during steam sterilization and subsequent storage. The trays are composed of a lid and base tray with handles and are perforated for steam penetration. The Supplemental Instrument Tray has the following approximate external dimensions: 510 mm (length) x 250 mm (width) x 45 mm (depth), and is designed to hold 12 instruments. The Supplemental Reamer Tray has the following external dimensions: 510 mm (length) x 250 mm (width) x 87 mm (depth), and is designed to hold 18 flexible reamer instruments. An insert tray with the following dimensions is used with the Supplemental Reamer Tray: 497 mm (length) x 240 mm (width) x 52 mm (depth). The Ellipse Supplemental Instrument Trays are reusable and are used to store instruments prior to, during, and after the sterilization process. The trays are made of anodized aluminum and have medical grade, Class VI Silicone instrument holders with stainless steel mounting hardware which are used to secure, separate, and organize the instruments within the trays. The tray handles are also encased in medical grade, Class VI Silicone.
The document provided describes the Ellipse Supplemental Instrument Trays and their intended use for organizing, protecting, and transporting instruments during steam sterilization. It also details the performance testing conducted to demonstrate their substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't present a single consolidated table of all acceptance criteria with corresponding performance results in a formal way. Instead, it discusses various validation tests and their outcomes. I've extracted the relevant information and organized it into the following table, synthesizing acceptance criteria from the descriptions of the tests performed.
| Acceptance Criteria Category | Specific Criteria (Implicitly Derived) | Reported Device Performance |
|---|---|---|
| Sterilization Efficacy | Achieves a Sterility Assurance Level (SAL) of 10⁻⁶ using the specified Pre-vacuum Steam Sterilization cycle (132°C for 4 minutes with 40 minutes dry time). | Met: "Sterilization validation testing was conducted to confirm that a sterility assurance level (SAL) of 10⁻⁶ was achieved at the validated sterilization parameter in the pre-vacuum steam sterilization cycle according to ISO 17665-1 and AAMI TIR 12." |
| Dry Time Validation | 1. Autoclave data showing appropriate dwell time at 132°C (+3°C) for each full cycle. 2. Confirmation of the absence of moisture on the trays and sterilization wrap. 3. No more than 3% difference in weight prior to and after sterilization. (for 40 minutes dry time) | Met: "The dry time validation was successful in determining an effective dry time of 40 minutes for the validated pre-vacuum steam sterilization cycle. Acceptance criteria below were met during validation of the dry time: 1) Autoclave data showing appropriate dwell time at 132°C (+3°C) for each full cycle; 2) Confirmation of the absence of moisture on the trays and sterilization wrap; 3) No more than 3% difference in weight prior to and after sterilization." |
| Material Durability | Function and physical construction of trays and components maintained after 100 sterilization cycles. | Met: "Performance testing was conducted to demonstrate that the function and physical construction of the Ellipse Supplement Trays and its components are maintained after exposure to 100 sterilization cycles." "The materials used in the Ellipse Supplemental Instrument Trays were exposed to 100 sterilization cycles and no material degradation was observed. All materials maintained their integrity and remained fully functional." |
| Material Compatibility | Materials of construction are compatible with steam sterilization. | Met: "Performance testing demonstrated that the materials of construction are compatible with steam sterilization." |
| Biocompatibility | Materials of construction are biocompatible (non-cytotoxic). | Met: "Extracts of test article (polymeric component) on L-939 mouse fibroblast cells in MEM elution assay did not display a cytotoxic response and is considered non-cytotoxic. Testing demonstrated that the materials of construction are biocompatible." |
| Shipping Validation | All acceptance criteria for package performance testing were met. | Met: "Shipping validation was performed on the Ellipse Supplemental Instrument Trays. The package performance testing results demonstrated all acceptance criteria were met." |
| Cleaning Validation | Hemoglobin, Micro BCA protein, and TOC test results meet all acceptance criteria for both manual and automated cleaning processes. | Met: "The Ellipse Supplemental Instrument Trays have been validated to be cleaned using both a manual and automated process. Hemoglobin, Micro BCA protein, and TOC test results met all acceptance criteria." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a "test set" in the context of an AI/algorithm. This device is a physical medical instrument tray, not a software algorithm. Therefore, the concept of a "test set" for data provenance, country of origin, or retrospective/prospective data as typically used for AI/ML models does not apply here.
For the physical device, the "samples" would be the trays and instruments themselves. The performance testing mentions:
- 100 sterilization cycles for material durability. This implies that the trays were subjected to at least 100 cycles to assess their physical integrity and functionality.
- Worst-case validated sterilization load: This involved one (1) Supplemental Instrument Tray (10.0 lbs) and one (1) Supplemental Reamer Tray (13.1 lbs) in a non-stacked configuration, loaded with specific instruments (12 in the Instrument Tray, 18 in the Reamer Tray), including those with worst-case lumen dimensions.
The provenance of the data would be from laboratory testing performed on the physical trays and associated instruments.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This question is not applicable as the device is a physical instrument tray, not an AI/ML model for which "ground truth" would be established by experts. Performance is determined by objective physical and biological tests (e.g., SAL, material integrity, dryness, cleaning efficacy).
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for evaluating human-expert disagreement for ground truth in AI/ML studies. For a physical device, performance is measured against predefined objective standards and test results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
Not applicable. This is a physical medical device, not an AI system. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
As this is a physical device, the "ground truth" for its performance is established by objective laboratory and scientific testing against established standards and protocols. For example:
- Sterilization Efficacy: Measured by indicator organisms and testing to achieve a specific SAL (10⁻⁶). This is a microbiology-based ground truth.
- Dryness: Measured by the absence of visible moisture or weight difference, which are empirically verifiable physical properties.
- Material Integrity/Durability: Measured by physical inspection for degradation and functional testing after repeated cycles.
- Biocompatibility: Determined by in vitro cytotoxicity assays (e.g., L-939 mouse fibroblast cells).
- Cleaning Efficacy: Measured by chemical assays for residual contaminants (Hemoglobin, Micro BCA protein, TOC).
These are all objective, quantifiable measures rather than human expert consensus, pathology, or outcomes data in the sense of a diagnostic medical device.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This device is not an AI/ML model.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 25, 2016
Ellipse Technologies, Incorporated Ms. Cora Sim Regulatory Affairs Specialist 101 Enterprise, Suite 100 Aliso Vieio. CA 92656
Re: K151594
Trade/Device Name: Ellipse Supplemental Instrument Trays Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization wrap Regulatory Class: II Product Code: KCT Dated: December 28, 2015 Received: December 29, 2015
Dear Ms. Sim:
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 and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements
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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 vou desire specific advice for your device on our labeling regulation (21 CFR Part 801 and Part 809), 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,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin 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) K151594
Device Name Ellipse Supplemental Instrument Trays
Indications for Use (Describe)
The Ellipse Supplemental Instrument Trays are intended to organize, protect, and transport instruments during steam sterilization and subsequent storage. Sterility of the enclosed instruments is not maintained unless used in conjunction with an FDA-cleared sterilization wrap using the following cycle:
Pre-vacuum Steam Sterilization parameters: 132°C for 4 minutes with 40 minutes dry time
The the worst case validated sterilization load is:
-One (1) Supplemental Instruments (total weight: 10.0 Ibs.) and one (1) Supplemental Reamer Tray with instruments (total weight: 13.1 lbs.); in a non-stacked configuration.
The worst case loading configuration included the 12 instruments supplied with the Supplemental Instrument Tray with the following worst case lumen dimensions:
Supplemental Instrument Tray (Model SIT1-000)
| Instrument Model | Description | Dimension (Inner Diameter x Length) | Number of Lumens |
|---|---|---|---|
| TCD1-000 | Teardrop Cannulated Driver | 0.210" x 4.58" | 1 |
| CED1-011 | 11mm Cannulated Entry Drill | 0.146" x 10.75" | 1 |
| GWC1-000 | Guide Wire Chuck | 0.250" x 5.0" | 1 |
| LQC1-000 | Large AO Quick Connect | 0.175" x 2.91" | 1 |
| DGA1-000 | Direct AO Depth Gauge | 0.394" x 10.43" | 1 |
The worst case loading configuration included the 18 instruments supplied with the Supplemental Reamer Tray with the following worst case lumen dimensions:
Supplemental Reamer Tray (Model SRT1-000):
| Instrument Model | Description | Dimension (Inner Diameter x Length) | Number of Lumen |
|---|---|---|---|
| RMR1-110 | Flexible Reamer, 10.0mm | 0.125" x 18.4" | 1 |
| RMR1-135 | Flexible Reamer, 13.5mm | 0.125" x 18.4" | 1 |
| RMR1-140 | Flexible Reamer, 14.0mm | 0.125" x 18.4" | 1 |
| RMR1-145 | Flexible Reamer, 14.5mm | 0.125" x 18.4" | 1 |
| RMR1-150 | Flexible Reamer, 15.0mm | 0.125" x 18.4" | 1 |
Do not exceed a maximum load of 12 instruments (10.0 lbs.) in the Supplemental Instrument Tray. Do not exceed a maximum load of 18 instruments (13.1 lbs.) in the Supplemental Reamer Tray.
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| List of Devices:Model | Dimensions(Length x Width x Depth) | Number of Instruments: | Validated Weight of tray withinstruments: |
|---|---|---|---|
| SIT1-000 | 510mm x 250mm x 45mm | 12 | 10.0 lbs. |
| SRT1-000 | 510mm x 250mm x 87mm | 18 | 13.1 lbs.* |
*Includes insert tray with dimensions 497mm x 240mm x 52mm
Type of Use (Select one or both, as applicable)
_ Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary (pursuant to 21 CFR 807.92 (a)(1))
Ellipse Supplemental Instrument Trays Premarket Notification Number: K151594 January 22, 2016
| 1. | Company: | Ellipse Technologies, Incorporated101 Enterprise, Suite 100Aliso Viejo, CA 92656USA |
|---|---|---|
| Contact: | Cora SimRegulatory Affairs SpecialistPhone: (949) 837-3600 ext. 221Fax: (949) 837-3664 | |
| 2. | Proprietary Trade Name: | Ellipse Supplemental Instrument Trays |
| 3. | Classification Name: | Sterilization Wrap Containers, Trays, Cassettes & OtherAccessories (21 CFR 880.6850) |
| 4. | Product Code: | KCT (Sterilization wrap) |
| 5. | Device Classification: | Class II |
- Predicate Device: The Ellipse Supplemental Instrument Trays are substantially equivalent to the following 510(k) cleared device:
- ContainMed, Inc. VersaPod™ Instrument Trays (K071783)
- Product Description: The Ellipse Supplemental Instrument Trays are comprised of a Supplemental Instrument Tray and a Supplemental Reamer Tray. These trays are designed to organize, protect, and transport instruments during steam sterilization and subsequent storage. The trays are composed of a lid and base tray with handles and are perforated for steam The Supplemental Instrument Tray has the following approximate external penetration. dimensions: 510 mm (length) x 250 mm (width) x 45 mm (depth), and is designed to hold 12 instruments. The Supplemental Reamer Tray has the following external dimensions: 510 mm (length) x 250 mm (width) x 87 mm (depth), and is designed to hold 18 flexible reamer
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instruments. An insert tray with the following dimensions is used with the Supplemental Reamer Tray: 497 mm (length) x 240 mm (width) x 52 mm (depth). The Supplemental Instrument Trays are reusable and are used to store instruments prior to, during, and after the sterilization process. The trays are made of anodized aluminum and have medical grade, Class VI Silicone instrument holders with stainless steel mounting hardware which are used to secure, separate, and organize the instruments within the trays. The tray handles are also encased in medical grade, Class VI Silicone.
- Indications for Use: The Ellipse Supplemental Instrument Trays are intended to organize, protect, and transport instruments during steam sterilization and subsequent storage. Sterility of the enclosed instruments is not maintained unless used in conjunction with an FDAcleared sterilization wrap using the following cycle:
Pre-vacuum Steam Sterilization parameters: 132℃ for 4 minutes with 40 minutes dry time
The worst case validated sterilization load is:
- -One (1) Supplemental Instrument Tray (total weight: 10.0 lbs.) and one (1) Supplemental Reamer Tray (total weight: 13.1 lbs.); in a non-stacked configuration
The worst case loading configuration included the 12 instruments supplied with the Supplemental Instrument Tray with the following worst case lumen dimensions:
| InstrumentModel | Description | Dimensions(Inner Diameter x Length) | NumberofLumens |
|---|---|---|---|
| TCD1-000 | Teardrop Cannulated Driver | 0.210" x 4.58" | 1 |
| CED1-011 | 11mm Cannulated Entry Drill | 0.146" x 10.75" | 1 |
| GWC1-000 | Guide Wire Chuck | 0.250" x 5.0" | 1 |
| LQC1-000 | Large AO Quick Connect | 0.175" x 2.91" | 1 |
| DGA1-000 | Direct AO Depth Gauge | 0.394" x 10.43" | 1 |
Supplemental Instrument Tray (Model SIT1-000)
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The worst case loading configurations included the 18 instruments supplied with the Supplemental Reamer Tray with the following worst case lumen dimensions:
| InstrumentModel | Description | Dimensions(Inner Diameter x Length) | NumberofLumens |
|---|---|---|---|
| RMR1-110 | Flexible Reamer, 10.0mm | 0.125" x 18.4" | 1 |
| RMR1-135 | Flexible Reamer, 13.5mm | 0.125" x 18.4" | 1 |
| RMR1-140 | Flexible Reamer, 14.0mm | 0.125" x 18.4" | 1 |
| RMR1-145 | Flexible Reamer, 14.5mm | 0.125" x 18.4" | 1 |
| RMR1-150 | Flexible Reamer, 15.0mm | 0.125" x 18.4" | 1 |
Supplemental Reamer Tray (Model SRT1-000):
Do not exceed a maximum load of 12 instruments (10.0 lbs.) in the Supplemental Instrument Tray.
Do not exceed a maximum load of 18 instruments (13.1 lbs.) in the Supplemental Reamer Tray.
List of Devices:
| Model | Dimensions (Length x Width x Depth) | Number ofInstruments | Validated Weight oftray withinstruments |
|---|---|---|---|
| SIT1-000 | 510mm x 250mm x 45mm | 12 | 10.0 lbs. |
| SRT1-000 | 510mm x 250mm x 87mm | 18 | 13.1 lbs.* |
*Includes insert tray with dimensions 497mm x 240mm x 52mm.
- Technological Characteristics: Substantial equivalence of the Ellipse Supplemental Instrument Trays to the predicate is based on similar intended use, design, principles of operation, and materials of composition. The Ellipse Supplement Trays and the predicate device have a similar intended use, the same design, and the same principles of operation. Specifically, the Ellipse Supplemental Instrument Trays and the predicate device are both intended to organize, protect, and transport instruments during steam sterilization and subsequent storage. The Ellipse Supplemental Instrument Trays have the same design features as that of the predicate. Both the Ellipse Supplemental Instrument Trays and the predicate are reusable, rigid
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sterilization containers. Both the Ellipse Supplemental Instrument Trays and predicate device have similar dimensions and are made of the same materials.
| Manufacturer | Predicate ContainMed | Ellipse Technologies, Inc. |
|---|---|---|
| 510(k) Number | K071783 | K151594 |
| Product Code | KCT | KCT |
| Intended Use | Perforated instrument trays to organize, protect, and transport medical instruments during pre-vacuum steam sterilization and subsequent storage. | The Ellipse Supplemental Instrument trays are designed to store various reusable instruments in order to organize, protect, and transport instruments during steam sterilization and subsequent storage. |
| Design | Anodized aluminum tray with securing lid and base tray with handles. An optional anodized aluminum insert tray is available for use with the 82mm deep base only. Anodized aluminum placard, and silicone rubber mat and instrument holding accessories (with stainless steel mounting hardware), are available to identify, organize, and protect the contents during use. | The lid, base tray, and insert tray are composed of anodized aluminum. An internal individual insert tray is utilized by the Supplemental Reamer Tray. Medical grade Class VI Silicone instrument holders and with stainless steel mounting hardware are used to secure, separate, and organize the instruments within the trays. |
| Dimensions | Base tray: 510mm (length) x 250mm (width) x 40mm, 60mm, or 82mm (depth) | Supplemental Instrument Tray:Base tray: 510mm (length) x 250mm (width) x 45mm (depth)Supplemental Reamer Tray:Base tray: 510mm (length) x 250mm (width) x 87mm (depth)Insert Tray:497 mm (length) x 240 mm (width) x 52 mm (depth).* |
| Material | Anodized aluminum, Stainless Steel,Silicone | Anodized aluminum, Stainless Steel,Silicone |
| compositionPhysical Properties | Evenly distributed perforated hole pattern. | Evenly distributed perforated hole pattern. |
| SterilizationMethod | Steam | Steam |
| SterilantPenetration | Sterilant (steam) penetration through perforations in tray | Sterilant (steam) penetration through perforations in tray. |
| Sterilization cycle | Pre-vacuum | Pre-vacuum |
| ExposureTemperature | 132° C | 132° C |
| Exposure time | 4 minutes | 4 minutes |
| Dry Time | 45 minutes | 40 minutes |
| Air permeanceDiameter of eachperforation | Yes0.197 inches | Yes0.197 inches |
| Number ofperforations | Tray Lid: 916Base Tray: 1,044Insert Tray: 1,044 | The Supplemental Instrument Tray:Tray Lid: 916Base Tray: 871The Supplemental Reamer Tray:Tray Lid: 916Base Tray: 956Insert Tray: 948 |
| Vent to volumeratios | 0.045 in -1 | Supplemental Instrument Tray:0.192 in-1Supplemental Reamer Tray:0.147 in-1 |
| Materialcompatibility withsterilization process | Materials of construction arecompatible with steam sterilization. | The materials used in the EllipseSupplemental Instrument Trays wereexposed to 100 sterilization cycles andno material degradation was observed.All materials maintained their integrityand remained fully functional.Performance testing demonstrated thatthe materials of construction arecompatible with steam sterilization. |
| Toxicologicalproperties | Materials of construction arebiocompatible. | Extracts of test article (polymericcomponent) on L-939 mouse fibroblastcells in MEM elution assay did notdisplay a cytotoxic response and isconsidered non-cytotoxic.Testing demonstrated that the materialsof construction are biocompatible. |
| Results oftransportationstudies | Not available. | Shipping validation was performed onthe Ellipse Supplemental InstrumentTrays. The package performance testingresults demonstrated all acceptancecriteria were met. |
| Summary ofcleaning validationinformation | Manual cleaning with use of neutralpH (pH 6.0-8.0) enzymatic detergentrecommended. | The Ellipse Supplemental InstrumentTrays have been validated to be cleanedusing both a manual and automatedprocess.Hemoglobin, Micro BCA protein, andTOC test results met all acceptancecriteria. |
| Limitations ofreprocessing | The materials used in theContainMed VersaPod™ InstrumentTrays may be sterilized for anindefinite number of cycles. The lifeof the system is limited only byirreparable physical damage frommishandling. The function and physical construction of the Supplemental Instrument Trays and their components are safe and effective after exposure to 100 sterilization cycles. The end of tray life is determined through the inspection of each tray after the required cleaning and sterilization cycles. The life of the trays are limited only by irreparable physical damage from mishandling. | |
| Summary of dryingtime validation | Dry time of 45 minutes was validatedfor use in the pre-vacuum steamcycle of 132°C for 4 minutes. | The dry time validation was successfulin determining an effective dry time of40 minutes for the validated pre-vacuumsteam sterilization cycle. Acceptancecriteria below were met duringvalidation of the dry time:1) Autoclave data showing appropriatedwell time at 132°C (+3°C) for each fullcycle2) Confirmation of the absence ofmoisture on the trays and sterilizationwrap3) No more than 3% difference inweight prior to and after sterilization |
Device Comparison Table for Substantial Equivalence:
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*For use with the Supplemental Reamer Tray
- Performance Testing: Non-clinical performance testing was conducted to establish substantial equivalence of the Ellipse Supplemental Instrument Trays to the predicate device. Sterilization validation testing was conducted to confirm that a sterility assurance level (SAL) of 10° was achieved at the validated sterilization parameter in the pre-vacuum steam sterilization cycle according to ISO 17665-1 and AAMI TIR 12. Dry time validation was performed following full cycles. Performance testing was conducted to demonstrate that the function and physical construction of the Ellipse Supplement Trays and its components are maintained after exposure to 100 sterilization cycles.
Conclusion: Based on the indications for use, technological characteristics, non-clinical 11. performance data, and a comparison to the predicate device, the Ellipse Supplemental Instrument Trays have been shown to be substantially equivalent to the legally marketed predicate device.
§ 880.6850 Sterilization wrap.
(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).