(131 days)
The NSO Supplemental Instrument Trays are intended to organize, and transport instruments during steam sterilization and subsequent storage. NSO Supplemental Instrument Trays are not intended to maintain sterility; they are intended to be used in conjunction with a validated FDA cleared sterilization wrap in order to maintain sterility of the enclosed medical instruments. The following sterilization cycle is to be used:
Pre-vacuum Steam Sterilization parameters: 132°C for 4 minutes with 40 minutes dry time
The validated worst case loading configuration (non-stacked) for the Supplemental Instrument Trays included the following worst case lumen dimension and maximum weight for each of the trays:
| Tray | Model | Dimensions(Inner Diameter x Length) | Number ofLumens | Maximum Weight(lbs.) |
|---|---|---|---|---|
| Supplemental Instrument Tray | SIT1-000 | 0.146" x 10.75" | 1 | 10.0 |
| Supplemental Reamer Tray | SRT1-000 | 0.125" x 18.4" | 1 | 13.1 |
| Flexible Reamer Tray | SRT2-000 | 0.096" x 19.314" | 1 | 14.4 |
The NSO Supplemental Instrument Trays are comprised of a Supplemental Instrument Tray, a Supplemental Reamer Tray, and a Flexible 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 Instruments within the trays are composed of Flexible Reamers, Quick Connect Adaptors, an Intraoperative X-Ray Ruler, a Direct AO Depth Gauge, a Diamond Point Awl, a Guide Wire Chuck, a Soft Tissue Protector - Paddle, a Soft Tissue Protector - Tube, a Teardrop Cannulated Driver, a Screw Gauge, and a Guide Wire Pusher. The Supplemental Instrument Tray has the following approximate external dimensions: 510 mm (length) x 250 mm (width) x 45 mm (depth). The Supplemental Reamer and Flexible Reamer Tray have the following external dimensions: 510 mm (length) x 250 mm (width) x 87 mm (depth). An insert tray is used with the Supplemental Reamer and Flexible Reamer Tray. The insert tray for the Supplemental Reamer Tray has the following dimensions: 497 mm (length) x 240 mm (width) x 52 mm (depth). The insert tray for the Flexible Reamer Tray has the following dimensions: 490 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.
The provided text describes information about the NSO Supplemental Instrument Trays and a new Flexible Reamer Tray, which is being evaluated for substantial equivalence to a predicate device. The information focuses on design, materials, and sterilization validation rather than on AI/ML device performance. Therefore, many of the requested points are not applicable.
Here's an analysis of the provided text against the requested criteria:
1. A table of acceptance criteria and the reported device performance
The document does not specify general "acceptance criteria" for the overall device in terms of diagnostic performance metrics like sensitivity, specificity, or AUC, as it's not an AI/ML diagnostic device. Instead, it refers to validation criteria for sterilization and cleaning processes, which are listed in the tables below. The document explicitly states that the acceptance criteria for the drying time validation were met.
| Acceptance Criteria (Dry Time Validation) | Reported Device Performance |
|---|---|
| Autoclave data showing appropriate dwell time at 132°C (+3°C) for each full cycle | Met |
| Confirmation of the absence of moisture on the trays and sterilization wrap | Met |
| No more than 3% difference in weight prior to and after sterilization | Met |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document refers to "testing" and "validation" for sterilization and cleaning. However, it does not specify a numerical sample size for these tests in terms of how many trays were tested or the number of runs. It mentions "100 sterilization cycles" for material compatibility. The document also does not specify the data provenance (e.g., country of origin, retrospective/prospective). Since this is a test for a physical medical device (instrument trays), the "test set" would refer to the physical trays and instruments subjected to the validation processes.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This question is not applicable. The device is a physical instrument tray, not an AI/ML diagnostic product, so there is no "ground truth" to be established by experts in the context of diagnostic interpretation. Ground truth for sterilization efficacy is typically established through biological indicators and physical/chemical indicators, not expert consensus.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This question is not applicable for a physical instrument tray. Adjudication methods like 2+1 or 3+1 are used in studies where multiple human readers assess medical images/data and need to resolve discrepancies, which is not relevant here.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This question is not applicable. An MRMC study is relevant for AI-powered diagnostic devices, which is not the case for these instrument trays.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done
This question is not applicable. This is not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the sterilization validation, the "ground truth" would be established by objective measurements verifying sterility assurance levels (SAL of 10^-6), absence of moisture, and maintenance of weight/integrity after sterilization. For cleaning validation, the ground truth would be based on test results for hemoglobin, Micro BCA protein, and TOC meeting acceptance criteria. These are empirical/scientific ground truths rather than expert consensus on interpretation.
8. The sample size for the training set
This question is not applicable. This is not an AI/ML device that requires a training set. The "training" for such physical devices involves rigorous design, material selection, and engineering validation.
9. How the ground truth for the training set was established
This question is not applicable. There is no AI/ML training set.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, arranged in a stacked formation. The profiles are depicted in a dark color, creating a silhouette effect. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 8, 2017
Nuvasive Specialized Orthopedics, Inc % Ms. Cora Sim Associate Manager, Regulatory Affairs Nuvasive Specialized Orthopedics, Inc: 101 Enterprise Aliso Viejo, California 92656
Re: K170939
Trade/Device Name: Supplemental Instrument Trays Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: July 18, 2017 Received: July 19, 2017
Dear Cora 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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
{1}------------------------------------------------
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,
Tara A. Ryan -S
for
Lori Wiggins, MPT, CLT Acting 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)
K170939
Device Name NSO Supplemental Instrument Trays
Indications for Use (Describe)
The N S O Supplemental Instrument Trays are intended to organize, and transport instruments during steam sterilization and subsequent storage. NSO Supplemental Instrument Trays are not intended to maintain sterility; they are intended to be used in conjunction with a validated FDA cleared sterilization wrap in order to maintain sterility of the enclosed medical instruments. The following sterilization cycle is to be used:
Pre-vacuum Steam Sterilization parameters: 132°C for 4 minutes with 40 minutes dry time
The validated worst case loading configuration (non-stacked) for the Supplemental Instrument Trays included the following worst case lumen dimension and maximum weight for each of the trays:
| Tray | Model | Dimensions(Inner Diameter x Length) | Number ofLumens | Maximum Weight(lbs.) |
|---|---|---|---|---|
| Supplemental Instrument Tray | SIT1-000 | 0.146" x 10.75" | 1 | 10.0 |
| Supplemental Reamer Tray | SRT1-000 | 0.125" x 18.4" | 1 | 13.1 |
| Flexible Reamer Tray | SRT2-000 | 0.096" x 19.314" | 1 | 14.4 |
List of Devices:
| Tray | Model | Dimensions (Length x Width x Depth) | Validated Weight ofTray with Instruments |
|---|---|---|---|
| Supplemental Instrument Tray | SIT1-000 | 510mm x 250mm x 45mm | 10.0 lbs |
| Supplemental Reamer Tray | SRT1-000* | 510mm x 250mm x 87mm | 13.1 lbs* |
| Flexible Reamer Tray | SRT2-000‡ | 510mm x 250mm x 87mm | 14.4 lbs‡ |
*Includes insert tray with dimensions 497mm x 240mm x 52mm. #Includes insert tray with dimensions 490mm 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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Image /page/3/Picture/0 description: The image is a logo for Nuvasive Specialized Orthopedics, Inc. The logo features a stylized, abstract shape in purple and gray on the left side. To the right of the shape is the word "NUVASIVE" in gray, block letters. Below "NUVASIVE" is the phrase "SPECIALIZED ORTHOPEDICS, INC." in a smaller, purple font.
NSO Supplemental Instrument Trays 510(k) Summary - K170939 August 7, 2017
| 1. | Company: | NuVasive Specialized Orthopedics, Inc.101 Enterprise, Suite 100Aliso Viejo, CA 92656 |
|---|---|---|
| Contact: | Cora SimAssociate Manager, Regulatory AffairsPhone: (949) 544-6478Fax: (949) 837-3664 | |
| Date Summary Prepared: | August 7, 2017 | |
| 2. | Proprietary Trade Name: | NSO Supplemental Instrument Trays |
| 3. | Classification Name: | Sterilization Wrap Containers, Trays, Cassettes, & otherAccessories (21 CFR 880.6850) |
| 4. | Product Code: | KCT (Sterilization Tray) |
| 5. | Device Classification: | Class II |
| 6. | Predicate Device: | NSO Supplemental Instrument Trays(K151594) |
-
- Indications for Use: The NSO Supplemental Instrument Trays are intended to organize, protect, and transport instruments during steam sterilization and subsequent storage. NSO Supplemental Instrument Trays are not intended to maintain sterility; they are intended to be used in conjunction with a validated FDA cleared sterilization wrap in order to maintain sterility of the enclosed medical instruments. The following sterilization cycle is to be used:
Pre-vacuum Steam Sterilization parameters: 132°C for 4 minutes with 40 minutes dry time
The validated worst case loading configuration (non-stacked) for the NSO Supplemental Instrument Trays included the following worst case lumen dimension and maximum weight for each of the trays:
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| Tray | Model | Lumen Dimensions(Inner Diameter x Length) | NumberofLumens | MaximumTray Weight(lbs.) |
|---|---|---|---|---|
| Supplemental Instrument Tray | SIT1-000 | 0.146" x 10.75" | 1 | 10.0 |
| Supplemental Reamer Tray | SRT1-000 | 0.125" x 18.4" | 1 | 13.1* |
| Flexible Reamer Tray | SRT2-000 | 0.096" x 19.314" | 1 | 14.4‡ |
List of Devices:
| Tray | Model | Dimensions(Length x Width x Depth) | Validated Weight ofTray with Instruments |
|---|---|---|---|
| Supplemental Instrument Tray | SIT1-000 | 510mm x 250mm x 45mm | 10.0 lbs |
| Supplemental Reamer Tray | SRT1-000* | 510mm x 250mm x 87mm | 13.1 lbs* |
| Flexible Reamer Tray | SRT2-000‡ | 510mm x 250mm x 87mm | 14.4 lbs‡ |
*Includes insert tray with dimensions 497mm x 240mm x 52mm. Includes insert tray with dimensions 490mm x 240mm x 52mm.
-
- Device Description: The NSO Supplemental Instrument Trays are comprised of a Supplemental Instrument Tray, a Supplemental Reamer Tray, and a Flexible 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 Instruments within the trays are composed of Flexible Reamers, Quick Connect Adaptors, an Intraoperative X-Ray Ruler, a Direct AO Depth Gauge, a Diamond Point Awl, a Guide Wire Chuck, a Soft Tissue Protector - Paddle, a Soft Tissue Protector - Tube, a Teardrop Cannulated Driver, a Screw Gauge, and a Guide Wire Pusher. The Supplemental Instrument Tray has the following approximate external dimensions: 510 mm (length) x 250 mm (width) x 45 mm (depth). The Supplemental Reamer and Flexible Reamer Tray have the following external dimensions: 510 mm (length) x 250 mm (width) x 87 mm (depth). An insert tray is used with the Supplemental Reamer and Flexible Reamer Tray. The insert tray for the Supplemental Reamer Tray has the following dimensions: 497 mm (length) x 240 mm (width) x 52 mm (depth). The insert tray for the Flexible Reamer Tray has the following dimensions: 490 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.
The type of instruments and maximum number of instruments for each of the sterilization trays listed above are as follows:
- Device Description: The NSO Supplemental Instrument Trays are comprised of a Supplemental Instrument Tray, a Supplemental Reamer Tray, and a Flexible 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 Instruments within the trays are composed of Flexible Reamers, Quick Connect Adaptors, an Intraoperative X-Ray Ruler, a Direct AO Depth Gauge, a Diamond Point Awl, a Guide Wire Chuck, a Soft Tissue Protector - Paddle, a Soft Tissue Protector - Tube, a Teardrop Cannulated Driver, a Screw Gauge, and a Guide Wire Pusher. The Supplemental Instrument Tray has the following approximate external dimensions: 510 mm (length) x 250 mm (width) x 45 mm (depth). The Supplemental Reamer and Flexible Reamer Tray have the following external dimensions: 510 mm (length) x 250 mm (width) x 87 mm (depth). An insert tray is used with the Supplemental Reamer and Flexible Reamer Tray. The insert tray for the Supplemental Reamer Tray has the following dimensions: 497 mm (length) x 240 mm (width) x 52 mm (depth). The insert tray for the Flexible Reamer Tray has the following dimensions: 490 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.
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Image /page/5/Picture/0 description: The image shows the logo for "Nuvasive Specialized Orthopedics, Inc." The logo features a stylized purple and silver graphic to the left of the company name. The text "NUVASIVE" is in silver, and below that, "SPECIALIZED ORTHOPEDICS, INC." is in a smaller font.
Supplemental Instrument Tray (SIT1-000):
| Model Number | Instrument Description | Quantity |
|---|---|---|
| DPA1-000 | 11mm DIAMOND POINT AWL | 1 |
| DGA1-000 | DIRECT AO DEPTH GAUGE | 1 |
| GWC1-000 | GUIDE WIRE CHUCK | 1 |
| STP1-000 | SOFT TISSUE PROTECTOR - PADDLE | 1 |
| STT1-000 | SOFT TISSUE PROTECTOR - TUBE | 1 |
| XRR1-000 | INTEROPERATIVE X-RAY RULER | 1 |
| TCD1-000 | TEARDROP CANNULATED DRIVER | 1 |
| PSG1-000 | SCREW GAUGE | 1 |
| GWP1-000 | GUIDE WIRE PUSHER | 1 |
| Maximum number of instruments | 9 |
Supplemental Reamer Tray (SRT1-000):
| Model Number | Instrument Description | Quantity |
|---|---|---|
| RMR1-070 | REAMER - 7.0MM | 1 |
| RMR1-075 | REAMER - 7.5MM | 1 |
| RMR1-080 | REAMER - 8.0MM | 1 |
| RMR1-085 | REAMER - 8.5MM | 1 |
| RMR1-090 | REAMER - 9.0MM | 1 |
| RMR1-095 | REAMER - 9.5MM | 1 |
| RMR1-100 | REAMER - 10.0MM | 1 |
| RMR1-105 | REAMER - 10.5MM | 1 |
| RMR1-110 | REAMER - 11.0MM | 1 |
| RMR1-115 | REAMER - 11.5MM | 1 |
| RMR1-120 | REAMER - 12.0MM | 1 |
| RMR1-125 | REAMER - 12.5MM | 1 |
| RMR1-130 | REAMER - 13.0MM | 1 |
| RMR1-135 | REAMER - 13.5MM | 1 |
| RMR1-140 | REAMER - 14.0MM | 1 |
| RMR1-145 | REAMER - 14.5MM | 1 |
| RMR1-150 | REAMER - 15.0MM | 1 |
| LQC1-000 | LARGE AO QUICK CONNECT | 1 |
| Maximum number of instruments | 18 |
Flexible Reamer Tray (SRT2-000):
| Model Number | Instrument Description | Quantity |
|---|---|---|
| T18151 | FLEXIBLE REAMER - 7.0MM | 1 |
| T18152 | FLEXIBLE REAMER - 7.5MM | 1 |
| T18153 | FLEXIBLE REAMER - 8.0MM | 1 |
| T18154 | FLEXIBLE REAMER - 8.5MM | 1 |
| T18155 | FLEXIBLE REAMER - 9.0MM | 1 |
| T12065 | FLEXIBLE REAMER - 9.5MM | 1 |
| T12066 | FLEXIBLE REAMER - 10.0MM | 1 |
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Image /page/6/Picture/0 description: The image shows the logo for Nuvasive Specialized Orthopedics, Inc. The logo consists of a stylized purple and gray leaf-like shape on the left, followed by the word "NUVASIVE" in gray, and the words "SPECIALIZED ORTHOPEDICS, INC." in purple. The leaf-like shape is made up of two curved segments, one purple and one gray, that are connected at the top and bottom. The text is in a sans-serif font and is arranged in two lines.
| T12067 | FLEXIBLE REAMER - 10.5MM | 1 |
|---|---|---|
| T12068 | FLEXIBLE REAMER - 11.0MM | 1 |
| T12069 | FLEXIBLE REAMER - 11.5MM | 1 |
| T12070 | FLEXIBLE REAMER - 12.0MM | 1 |
| T12071 | FLEXIBLE REAMER - 12.5MM | 1 |
| T12072 | FLEXIBLE REAMER - 13.0MM | 1 |
| T18156 | FLEXIBLE REAMER - 13.5MM | 1 |
| T18157 | FLEXIBLE REAMER - 14.0MM | 1 |
| T18158 | FLEXIBLE REAMER - 14.5MM | 1 |
| T18159 | FLEXIBLE REAMER - 15.0MM | 1 |
| LQC2-000 | LARGE AO QUICK CONNECT | 1 |
| Maximum number of instruments | 18 |
After sterilization of NSO Supplemental Instrument Trays, a minimum cooling time of 30 minutes is recommended prior to removing or handling the instrument trays.
-
- Technological Characteristics: Substantial equivalence is based on identical intended use, design, technological characteristics, materials of composition, and principles of operation. The Flexible Reamer Tray subject of this 510(k) submission is identical to the NSO Supplemental Instrument Trays. The additional tray that is subject of this premarket notification and the predicate device have the same intended use. Specifically, both the predicate NSO Supplemental Instrument Trays and the Flexible Reamer Tray that is subject of this submission are intended to store various reusable instruments in order to organize, and transport instruments during steam sterilization and subsequent storage. The additional tray is available in the same dimensions, materials, and configuration as the predicate NSO Supplemental Instrument Trays. No changes are being made to the materials, technological characteristics, or principles of operation as a result of this premarket notification. The trays are composed of a lid and base tray with handles and are perforated for steam penetration. The additional Flexible Reamer Tray subject of this submission is substantially equivalent to the NSO Supplemental Instrument Trays cleared in K151594.
| Feature | Predicate NSO Supplemental InstrumentTrays | Subject NSO SupplementalInstrument Trays |
|---|---|---|
| 510(k) Number | K15194 | K170939 |
| Product Code | KCT | KCT |
| Intended Use | The NSO Supplemental Instrument Traysintended to organize, protect, and transportinstruments during steam sterilization andsubsequent storage. | Same |
| Design | The lid, base tray, and insert tray are composedof anodized aluminum. An internal individualinsert tray is utilized by the SupplementalReamer Tray. Medical grade Class VI Siliconeinstrument holders and with stainless steelmounting hardware are used to secure,separate, and organize the instruments withinthe trays. | Same |
| Dimensions | Supplemental Instrument Tray:Base tray: 510mm (length) x 250mm (width) x45mm (depth)Supplemental Reamer Tray:Base tray: 510mm (length) x 250mm (width) x87mm (depth)Insert Tray:497 mm (length) x 240 mm (width) x 52 mm(depth)* | Flexible Instrument Tray:Base tray: Same asSupplemental Reamer TrayInsert Tray:490 mm (length) x 240 mm(width) x 52 mm (depth)* |
| Material composition | Anodized aluminum, Stainless Steel, Silicone | Same |
| Physical Properties | Evenly distributed perforated hole pattern. | Same |
| Sterilization Method | Steam | Same |
| Sterilant Penetration | Sterilant (steam) penetration throughperforations in tray. | Same |
| Sterilization cycle | Pre-vacuum | Same |
| Exposure Temperature | 132° C | Same |
| Exposure time | 4 minutes | Same |
| Dry Time | 40 minutes | Same |
| Air permeance | Yes | Same |
| Diameter of eachperforation | 0.197 inches | Same |
| Number of perforations | Supplemental Instrument Tray:Tray Lid: 916Base Tray: 871Supplemental Reamer Tray:Tray Lid: 916Base Tray: 956Insert Tray: 948 | Flexible Reamer Tray:Tray Lid: IdenticalBase Tray: Same asSupplemental Reamer TrayInsert Tray: 931 |
| Vent to volume ratios | Supplemental Instrument Tray:0.192 in⁻¹Supplemental Reamer Tray:0.147 in⁻¹ | Flexible Reamer Tray:Same as SupplementalReamer Tray |
| Material compatibility withsterilization process | The materials used in the NSO SupplementalInstrument Trays were exposed to 100sterilization cycles and no material degradationwas observed. All materials maintained theirintegrity and remained fully functional.Performance testing demonstrated that thematerials of construction are compatible withsteam sterilization. | Same |
| Toxicological properties | Extracts of test article (polymeric component)on L-939 mouse fibroblast cells in MEMelution assay did not display a cytotoxicresponse and is considered non-cytotoxic.Testing demonstrated that the materials ofconstruction are biocompatible. | Same |
| Results of transportationstudies | Shipping validation was performed on the NSOSupplemental Instrument Trays. The packageperformance testing results demonstrated allacceptance criteria were met. | Same |
| Summary of cleaningvalidation information | The NSO Supplemental Instrument Trays havebeen validated to be cleaned using both amanual and automated process.Hemoglobin, Micro BCA protein, andTOCtest results met all acceptance criteria. | Same |
| Limitations of reprocessing | The function and physical construction of theNSO Supplemental Instrument Trays and theircomponents are safe and effective afterexposure to 100 sterilization cycles. The end oftray life is determined through the inspection ofeach tray after the required cleaning andsterilization cycles. The life of the trays arelimited only by irreparable physical damagefrom mishandling. | Same |
Device Comparison Table for Substantial Equivalence:
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Image /page/7/Picture/0 description: The image shows the logo for Nuvasive Specialized Orthopedics, Inc. The logo features a stylized purple and silver graphic to the left of the company name. The text "SPECIALIZED ORTHOPEDICS, INC." is in a smaller font below the company name. The logo is clean and modern, with a focus on the company's name and specialization.
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Image /page/8/Picture/0 description: The image is a logo for Nuvasive Specialized Orthopedics, Inc. The logo features a purple and silver abstract shape on the left, followed by the word "NUVASIVE" in silver letters. Below the word "NUVASIVE" is the text "SPECIALIZED ORTHOPEDICS, INC." in a smaller font.
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Image /page/9/Picture/0 description: The image is a logo for "NUVASIVE SPECIALIZED ORTHOPEDICS, INC." The logo features a stylized leaf-like shape on the left, with the top portion in purple and the bottom portion in silver. To the right of the leaf shape is the word "NUVASIVE" in silver, and below that is the phrase "SPECIALIZED ORTHOPEDICS, INC." in a smaller, dark purple font.
| The dry time validation was successful indetermining an effective dry time of 40minutes for the validated pre-vacuum steamsterilization cycle. Acceptance criteria belowwere met during validation of the dry time: | ||
|---|---|---|
| Summary of drying timevalidation | 1) Autoclave data showing appropriate dwelltime at 132°C (+3°C) for each full cycle2) Confirmation of the absence of moisture onthe trays and sterilization wrap3) No more than 3% difference in weight priorto and after sterilization | Same |
*For use with the Reamer Tray
-
- Performance Data: Since the Flexible Reamer Tray contains with a worst case dimension (smaller lumen diameter and longer length) compared to the NSO Supplemental Instrument Trays, non-clinical performance testing was conducted to establish substantial equivalence of the Flexible Reamer Tray to the predicate device. Sterilization testing was conducted to confirm that a sterility assurance level (SAL) of 106 was achieved at the validation sterilization parameter in the pre-vacuum steam sterilization cycle according to ISO 17665-1 and AAMI TIR12. A dry time validation was performed and was successful in determining an effective dry time of 40 minutes for the validated pre-vacuum steam sterilization cycle. The cleaning and sterilization study demonstrated that the previously validated cleaning and sterilization parameters for the predicate NSO Supplemental Instrument Trays were effective and will adequately clean and sterilize the Flexible Reamer Tray. No changes are being made to the design or materials of the NSO Supplement Trays; therefore, testing with regard to biocompatibility and limits of reprocessing was not repeated and the original testing results are still applicable. Results of the testing demonstrated that the device is safe and effective for its intended use.
-
- Conclusion: Based on the intended use, technological characteristics, performance data, and nonclinical tests performed, the subject NSO Supplement Trays are as safe and as effective as, the legally marketed predicate device, Ellipse Supplemental Instrument Trays cleared under K151594 under regulation 21 CFR 880.6850, product code KCT.
§ 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).