(227 days)
Not Found
No
The device description and intended use clearly define the product as instrument trays for sterilization and storage, with no mention of AI or ML capabilities. The performance studies focus on sterilization validation and durability, not algorithmic performance.
No.
The device is described as trays intended to organize, protect, and transport instruments for sterilization and storage, not for therapeutic purposes.
No
This device is not a diagnostic device. It is an instrument tray intended for organizing, protecting, and transporting surgical instruments during sterilization and storage. Its function is limited to holding and facilitating the sterilization of other instruments, not to diagnose medical conditions.
No
The device description clearly details physical components made of anodized aluminum, silicone, and stainless steel, designed to organize, protect, and transport instruments. There is no mention of software as a component or function of the device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as organizing, protecting, and transporting instruments during steam sterilization and storage. This is a function related to the preparation and handling of surgical instruments, not the diagnosis of disease or other conditions through the examination of specimens derived from the human body.
- Device Description: The description details the physical characteristics of trays designed to hold instruments for sterilization. It does not mention any components or functions related to analyzing biological samples.
- Performance Studies: The performance studies focus on sterilization validation and the durability of the trays after sterilization cycles. These are relevant to the function of a sterilization tray, not an IVD.
- Lack of IVD Indicators: There is no mention of analyzing samples, reagents, calibrators, controls, or any other elements typically associated with in vitro diagnostics.
The device is a medical device used in the process of preparing surgical instruments for use, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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 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.
List of Devices:
| Model | Dimensions (Length x Width x Depth) | Number of Instruments: | Validated Weight of tray with instruments: |
|---|---|---|---|
| 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
Product codes
KCT
Device 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 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 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.
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three human profiles facing right, stacked on top of each other. The profiles are rendered in a dark color, creating a sense of depth and unity. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
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
1
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
2
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.
3
| List of Devices:
Model | Dimensions
(Length x Width x Depth) | Number of Instruments: | Validated Weight of tray with
instruments: |
|---------------------------|----------------------------------------|------------------------|-----------------------------------------------|
| 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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4
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, Incorporated
101 Enterprise, Suite 100
Aliso Viejo, CA 92656
USA |
|----|-------------------------|----------------------------------------------------------------------------------------------------|
| | Contact: | Cora Sim
Regulatory Affairs Specialist
Phone: (949) 837-3600 ext. 221
Fax: (949) 837-3664 |
| 2. | Proprietary Trade Name: | Ellipse Supplemental Instrument Trays |
| 3. | Classification Name: | Sterilization Wrap Containers, Trays, Cassettes & Other
Accessories (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
5
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:
| Instrument
Model | Description | Dimensions
(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 |
Supplemental Instrument Tray (Model SIT1-000)
6
The worst case loading configurations included the 18 instruments supplied with the Supplemental Reamer Tray with the following worst case lumen dimensions:
| Instrument
Model | Description | Dimensions
(Inner Diameter x Length) | Number
of
Lumens |
|---------------------|-------------------------|-----------------------------------------|------------------------|
| 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 of
Instruments | Validated Weight of
tray with
instruments |
|----------|-------------------------------------|--------------------------|-------------------------------------------------|
| 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
7
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 | ||
| composition | ||
| Physical Properties | Evenly distributed perforated hole pattern. | Evenly distributed perforated hole pattern. |
| Sterilization | ||
| Method | Steam | Steam |
| Sterilant | ||
| Penetration | Sterilant (steam) penetration through perforations in tray | Sterilant (steam) penetration through perforations in tray. |
| Sterilization cycle | Pre-vacuum | Pre-vacuum |
| Exposure | ||
| Temperature | 132° C | 132° C |
| Exposure time | 4 minutes | 4 minutes |
| Dry Time | 45 minutes | 40 minutes |
| Air permeance | ||
| Diameter of each | ||
| perforation | Yes | |
| 0.197 inches | Yes | |
| 0.197 inches | ||
| Number of | ||
| perforations | Tray Lid: 916 | |
| Base Tray: 1,044 | ||
| Insert Tray: 1,044 | The Supplemental Instrument Tray: | |
| Tray Lid: 916 | ||
| Base Tray: 871 | ||
| The Supplemental Reamer Tray: | ||
| Tray Lid: 916 | ||
| Base Tray: 956 | ||
| Insert Tray: 948 | ||
| Vent to volume | ||
| ratios | 0.045 in -1 | Supplemental Instrument Tray: |
| 0.192 in-1 | ||
| Supplemental Reamer Tray: | ||
| 0.147 in-1 | ||
| Material | ||
| compatibility with | ||
| sterilization process | Materials of construction are | |
| compatible with steam sterilization. | 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. | ||
| Performance testing demonstrated that | ||
| the materials of construction are | ||
| compatible with steam sterilization. | ||
| Toxicological | ||
| properties | Materials of construction are | |
| biocompatible. | 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. | ||
| Results of | ||
| transportation | ||
| studies | Not available. | Shipping validation was performed on |
| the Ellipse Supplemental Instrument | ||
| Trays. The package performance testing | ||
| results demonstrated all acceptance | ||
| criteria were met. | ||
| Summary of | ||
| cleaning validation | ||
| information | Manual cleaning with use of neutral | |
| pH (pH 6.0-8.0) enzymatic detergent | ||
| recommended. | 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. | ||
| Limitations of | ||
| reprocessing | The materials used in the | |
| ContainMed VersaPod™ Instrument | ||
| Trays may be sterilized for an | ||
| indefinite number of cycles. The life | ||
| of the system is limited only by | ||
| irreparable physical damage from | ||
| mishandling. 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 drying | ||
| time validation | Dry time of 45 minutes was validated | |
| for use in the pre-vacuum steam | ||
| cycle of 132°C for 4 minutes. | 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: |
-
Autoclave data showing appropriate
dwell time at 132°C (+3°C) for each full
cycle -
Confirmation of the absence of
moisture on the trays and sterilization
wrap -
No more than 3% difference in
weight prior to and after sterilization |
Device Comparison Table for Substantial Equivalence:
8
9
*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.