(253 days)
The NuVasive Sterilization Trays are intended to contain NuVasive implants and surgical instruments for sterilization, storage and handling. The NuVasive Sterilization Trays are suitable for dynamic air removal (pre-vacuum) steam sterilization methods. The 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 devices.
The NuVasive Sterilization Trays are designed to contain NuVasive implants and instruments for sterilization, storage, and handling, and to allow optimal exposure of the tray's content to steam during the sterilization process. The trays are intended only for use with NuVasive medical devices. The trays must be used in conjunction with an FDA cleared sterilization wrap in order to maintain sterility of the contents.
The trays are different sizes of the same basic configuration and consist of a rectangular base with a lid that fastens to the base with latches. The trays have perforations on the lid, base bottom and sides. Insert trays with custom made brackets can be used to organize instruments and hold caddies in which smaller components are stored. The insert travs and caddies also contain perforations to allow optimal exposure of the tray's contents to sterilant during the sterilization process.
The provided text describes a medical device, the NuVasive® Sterilization Trays, and its 510(k) premarket notification to the FDA. The document focuses on establishing substantial equivalence to a predicate device (Skeletal Dynamics Sterilization Trays - K102103) through comparison of technological characteristics and performance testing related to sterilization efficacy.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Typically for Sterilization) | Reported Device Performance |
|---|---|
| Sterilization Efficacy: Sterility Assurance Level (SAL) of 10⁻⁶ achieved. (Implicitly a primary criterion for sterilization devices) | Performance testing was conducted "to confirm that SAL (10⁻⁶) sterility level was achieved at the validated sterilization parameters in prevacuum steam sterilization cycle per ISO 17665-1 and AAMI TIR 12." |
| Sterilization Cycle Parameters: Validated for specific steam sterilization method (Pre-Vacuum), temperature, exposure time, and dry time. | Method: SteamCycle: Pre-VacuumTemperature: 270°F (132°C)Exposure Time: 4 minutesMinimum Dry Time: 30 minutesMinimum Cool Down Time: 40 minutes |
| Loading Configurations: Efficacy proven for different types and weights of contents. | Sterilization validations included three different loading configurations for a worst-case tray (20.5" x 10" x 7.375"): - Implant only content (26.4 lbs.) - Instrument only content (39.95 lbs.) - Mixed instruments and implant content (30.45 lbs.) Note: Maximum load specified as 25 lbs, which contradicts the validated loading configurations. This inconsistency would typically require clarification or further justification in a regulatory submission. |
| Instrument Types (especially lumens): Efficacy proven for instruments with challenging geometries like lumens. | Validated worst-case loading configurations included 23 instruments with lumens, with specific dimensions: - 1.6 mm x 306.8 mm - 1.1 mm x 166.4 mm - 7.2 mm x 331.9 mm - 5.5 mm x 356.9 mm |
| Functionality: Ability to contain and organize instruments, allow sterilant exposure, and maintain integrity during sterilization, storage, and handling. | Device description states: "designed to contain NuVasive implants and instruments for sterilization, storage, and handling, and to allow optimal exposure of the tray's content to steam during the sterilization process." "The trays have perforations on the lid, base bottom and sides." |
| Material Compatibility: Materials must withstand sterilization process without degradation or adverse effects. | Material composition listed: Aluminum, Nylon, Silicone, Stainless Steel, Polypropylene, Polyphenylsulfone. (Implicitly, these materials were assessed for compatibility with the sterilization method). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the quantitative "sample size" of trays or sterilization cycles tested. It mentions "sterilization validations for three level worst case tray" and "validated worst case loading configurations included 23 instruments with lumens." This suggests that the testing focused on representative "worst-case" scenarios rather than a large statistical sample of every tray model or load.
The data provenance is not specified in terms of country of origin. The study appears to be prospective as it involves performance testing and validation specifically conducted for this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. For sterilization validation, "ground truth" would typically be established through standardized microbiological testing (e.g., using biological indicators to confirm sterility) rather than expert consensus on images or interpretations. The document states validation was done "per ISO 17665-1 and AAMI TIR 12," which are standards for sterilization of health care products, implying a reliance on established scientific methods and accredited labs.
4. Adjudication Method for the Test Set
This concept is not applicable to this type of device and study. Adjudication methods (like 2+1, 3+1) are typically used in studies involving human interpretation of data (e.g., medical images) where multiple experts assess the same case, and a method is needed to resolve discrepancies. For sterilization validation, the outcome is determined by objective physical and biological tests.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not done. This type of study is relevant for AI systems that aid human readers in diagnostic tasks, such as radiology or pathology. The NuVasive Sterilization Trays are a physical medical device for sterilization, not an AI system.
6. Standalone Performance Study
A standalone performance study was done. The sterilization validation tests the performance of the device (tray) itself under defined sterilization parameters to achieve sterility. The "algorithm" here is the physical design of the tray and the defined sterilization process, which operates independently without human intervention during the sterilization cycle. The performance is assessed directly on the device and its contents.
7. Type of Ground Truth Used
The ground truth used is sterility assurance level (SAL) of 10⁻⁶ confirmed through biological indicator testing and adherence to recognized sterilization standards (ISO 17665-1 and AAMI TIR 12). This is a form of objective, quantitative outcomes data related to microbial inactivation.
8. Sample Size for the Training Set
There is no training set in the context of this device. This is not an AI/machine learning device. The "training" here would be the design and development efforts of the trays, informed by engineering principles and existing sterilization knowledge.
9. How the Ground Truth for the Training Set Was Established
Since there is no training set as understood in AI/machine learning, this question is not applicable. The "ground truth" for the device's development and design would be based on established engineering principles for medical device design, material science, fluid dynamics (for sterilant penetration), and regulatory requirements for sterilization efficacy.
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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 depiction of a human face in profile, composed of three overlapping profiles. The profiles are black and are oriented to the right. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 28, 2015
NuVasive, Inc. Ms. Olga Lewis Regulatory Affairs Lead Specialist 7475 Lusk Blvd. San Diego, CA 92121
Re: K143579
Trade/Device Name: NuVasive® Sterilization Trays Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: KCT Dated: July 23, 2015 Received: July 24, 2015
Dear Ms. Lewis:
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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Page 2 - Ms. Lewis
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 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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| 510(k) Number (if known) | K143579 |
|---|---|
| Device Name | NuVasive Sterilization Trays |
| Indications for Use (Describe) | The NuVasive Sterilization Trays are intended to contain NuVasive implants and surgical instruments for sterilization, storage and handling. The NuVasive Sterilization Trays are suitable for dynamic air removal (pre-vacuum) steam sterilization methods. The 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 devices.Sterilization validations for three level worst case tray (20.5" x 10" x 7.375") included three different loading configurations: implant only content (26.4 lbs.), instrument only content (39.95 lbs.) and mixed instruments and implant content (30.45 lbs.)Validated worst case loading configurations included 23 instruments with lumens including the following worst case lumen dimensions:- 1.6 mm x 306.8 mm- 1.1 mm x 166.4 mm- 7.2 mm x 331.9 mm- 5.5 mm x 356.9 mm |
| Do not exceed a maximum load of 25 lbs in the sterilization tray. | |
| Validated sterilization parameters for NuVasive Sterilization Trays: | |
| Method: SteamCycle: Pre-VacuumTemperature: 270°F (132°C)Exposure Time: 4 minutesMinimum Dry Time: 30 minutesMinimum Cool Down Time: 40 minutes |
11
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| FOOTPRINT | MODEL | DIMENSIONS(L x W x H) |
|---|---|---|
| Footprint 3 | 3-38 | 20.5" x 9.8" x 3.0" |
| 3-39 | 20.5" x 9.8" x 3.1" | |
| 3-40 | 20.5" x 9.8" x 3.3" | |
| 3-41 | 20.5" x 9.8" x 3.5" | |
| 3-42 | 20.5" x 9.8" x 3.6" | |
| 3-43 | 20.5" x 9.8" x 3.7" | |
| 3-44 | 20.5" x 9.8" x 3.8" | |
| 3-45 | 20.5" x 9.8" x 3.9" | |
| 3-46 | 20.5" x 9.8" x 4.0" | |
| 3-47 | 20.5" x 9.8" x 4.1" | |
| 3-48 | 20.5" x 9.8" x 4.3" | |
| 3-49 | 20.5" x 9.8" x 4.4" | |
| 3-50 | 20.5" x 9.8" x 4.5" | |
| 3-51 | 20.5" x 9.8" x 4.6" | |
| 3-52 | 20.5" x 9.8" x 4.7" | |
| 3-53 | 20.5" x 9.8" x 4.8" | |
| 3-54 | 20.5" x 9.8" x 5.0" | |
| 3-55 | 20.5" x 9.8" x 5.3" | |
| 3-56 | 20.5" x 9.8" x 5.5" | |
| 3-57 | 20.5" x 9.8" x 5.7" | |
| 3-58 | 20.5" x 9.8" x 6.0" | |
| 3-59 | 20.5" x 9.8" x 6.1" | |
| 3-60 | 20.5" x 9.8" x 6.3" | |
| 3-61 | 20.5" x 9.8" x 6.6" | |
| 3-62 | 20.5" x 9.8" x 7.1" | |
| 3-63 | 20.5" x 9.8" x 7.2" | |
| 3-64 | 20.6" x 9.7" x 3.4" | |
| 3-65 | 20.6" x 9.7" x 3.6" | |
| 3-66 | 20.6" x 9.7" x 4.4" | |
| 3-67 | 20.6" x 9.7" x 4.7" | |
| 3-68 | 20.8" x 9.8" x 2.8" | |
| 3-69 | 20.8" x 9.8" x 5.2" | |
| 3-70 | 20.9" x 10.0" x 2.3" | |
| 3-71 | 20.9" x 9.8" x 6.6" | |
| 3-72 | 21.0" x 10.0" x 4.0" | |
| 3-73 | 21.0" x 10.0" x 4.2" | |
| 3-74 | 21.0" x 10.0" x 4.3" | |
| 3-75 | 21.0" x 10.0" x 6.0" | |
| 3-76 | 21.0" x 10.1" x 3.1" | |
| 3-77 | 21.0" x 9.7" x 3.0" | |
| 3-78 | 21.0" x 9.7" x 3.7" |
| FOOTPRINT | MODEL | DIMENSIONS (L x W x H) |
|---|---|---|
| Footprint 1 | 1-1 | 6.0" x 3.3" x 2.2" |
| 1-2 | 6.5" x 3.5" x 2.0" | |
| Footprint 2 | 2-1 | 8.0" x 4.3" x 1.6" |
| 2-2 | 8.0" x 6.0" x 3.5" | |
| Footprint 3 | 3-1 | 19.8" x 9.4" x 2.0" |
| 3-2 | 20.0" x 10.0" x 2.0" | |
| 3-3 | 20.0" x 10.0" x 6.5" | |
| 3-4 | 20.0" x 9.5" x 1.8" | |
| 3-5 | 20.0" x 9.5" x 2.0" | |
| 3-6 | 20.0" x 9.5" x 2.5" | |
| 3-7 | 20.0" x 9.5" x 3.0" | |
| 3-8 | 20.0" x 9.5" x 3.5" | |
| 3-9 | 20.0" x 9.5" x 4.0" | |
| 3-10 | 20.0" x 9.5" x 4.5" | |
| 3-11 | 20.0" x 9.5" x 5.5" | |
| 3-12 | 20.0" x 9.5" x 6.8" | |
| 3-13 | 20.0" x 9.6" x 2.0" | |
| 3-14 | 20.0" x 9.8" x 6.3" | |
| 3-15 | 20.1" x 9.4" x 2.5" | |
| 3-16 | 20.4" x 9.6" x 3.0" | |
| 3-17 | 20.5" x 10.0" x 2.0" | |
| 3-18 | 20.5" x 10.0" x 3.0" | |
| 3-19 | 20.5" x 10.0" x 4.0" | |
| 3-20 | 20.5" x 10.0" x 5.0" | |
| 3-21 | 20.5" x 10.0" x 6.0" | |
| 3-22 | 20.5" x 9.5" x 5.0" | |
| 3-23 | 20.5" x 9.5" x 5.1" | |
| 3-24 | 20.5" x 9.5" x 5.6" | |
| 3-25 | 20.5" x 9.5" x 6.1" | |
| 3-26 | 20.5" x 9.5" x 6.3" | |
| 3-27 | 20.5" x 9.5" x 6.4" | |
| 3-28 | 20.5" x 9.5" x 6.6" | |
| 3-29 | 20.5" x 9.5" x 7.0" | |
| 3-30 | 20.5" x 9.7" x 2.0" | |
| 3-31 | 20.5" x 9.7" x 3.8" | |
| 3-32 | 20.5" x 9.7" x 5.2" | |
| 3-33 | 20.5" x 9.8" x 2.0" | |
| 3-34 | 20.5" x 9.8" x 2.1" | |
| 3-35 | 20.5" x 9.8" x 2.2" | |
| 3-36 | 20.5" x 9.8" x 2.3" | |
| 3-37 | 20.5" x 9.8" x 2.5" |
| C-C4 |
|---|
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| FOOTPRINT | MODEL | DIMENSIONS (L x W x H) |
|---|---|---|
| Footprint 3 | 3-120 | 21.5" x 10.0" x 3.0" |
| 3-121 | 21.5" x 10.0" x 3.8" | |
| 3-122 | 21.5" x 10.0" x 4.6" | |
| 3-123 | 21.6" x 9.8" x 4.2" | |
| 3-124 | 21.6" x 9.9" x 3.0" | |
| 3-125 | 21.7" x 10.0" x 3.1" | |
| 3-126 | 21.7" x 9.9" x 4.1" | |
| 3-127 | 21.7" x 9.9" x 5.0" | |
| 3-128 | 21.7" x 9.9" x 6.3" | |
| 3-129 | 21.8" x 10.4" x 4.1" | |
| 3-130 | 21.8" x 10.5" x 4.7" | |
| 3-131 | 21.9" x 10.0" x 3.2" | |
| 3-132 | 21.9" x 10.0" x 3.5" | |
| 3-133 | 21.9" x 10.0" x 6.0" | |
| 3-134 | 22.0" x 9.7" x 6.2" | |
| 3-135 | 22.0" x 10.0" x 6.6" | |
| Footprint 4 | 4-1 | 9.0" x 6.5" x 2.5" |
| 4-2 | 9.8" x 6.3" x 3.6" | |
| 4-3 | 9.8" x 8.3" x 2.1" | |
| 4-4 | 9.8" x 9.0" x 3.5" | |
| 4-6 | 9.9" x 7.8" x 2.0" | |
| Footprint 5 | 5-1 | 10.0" x 10.0" x 2.0" |
| 5-2 | 10.0" x 10.0" x 2.3" | |
| 5-3 | 10.4" x 9.8" x 2.1" | |
| 5-4 | 10.4" x 9.8" x 2.3" | |
| 5-5 | 10.4" x 9.8" x 2.5" | |
| 5-6 | 10.4" x 9.8" x 3.0" | |
| 5-7 | 10.6" x 10.0" x 3.5" | |
| 5-8 | 10.6" x 9.7" x 2.9" | |
| 5-9 | 10.6" x 9.7" x 3.6" | |
| Footprint 6 | 6-1 | 12.3" x 8.3" x 2.1" |
| 6-2 | 13.3" x 9.3" x 2.1" | |
| 6-3 | 14.5" x 9.8" x 2.3" | |
| Footprint 7 | 7-1 | 15.0" x 10.0" x 2.5" |
| 7-2 | 15.8" x 9.8" x 5.2" | |
| 7-3 | 16.8" x 9.8" x 3.2" | |
| Footprint 8 | 8-1 | 15.7" x 4.7" x 2.7" |
| 8-2 | 15.8" x 4.5" x 2.5" |
| FOOTPRINT | MODEL | DIMENSIONS (L x W x H) |
|---|---|---|
| Footprint 3 | 3-79 | 21.0" x 9.7" x 4.2" |
| 3-80 | 21.0" x 9.7" x 4.3" | |
| 3-81 | 21.0" x 9.7" x 4.8" | |
| 3-82 | 21.0" x 9.7" x 6.2" | |
| 3-83 | 21.0" x 9.7" x 6.8" | |
| 3-84 | 21.0" x 9.8" x 2.2" | |
| 3-85 | 21.0" x 9.8" x 3.5" | |
| 3-86 | 21.0" x 9.8" x 3.8" | |
| 3-87 | 21.0" x 9.8" x 4.0" | |
| 3-88 | 21.0" x 9.8" x 5.6" | |
| 3-89 | 21.1" x 9.7" x 3.7" | |
| 3-90 | 21.1" x 9.7" x 6.2" | |
| 3-91 | 21.1" x 9.7" x 6.4" | |
| 3-92 | 21.1" x 9.8" x 4.6" | |
| 3-93 | 21.1" x 9.8" x 6.0" | |
| 3-94 | 21.2" x 10.0" x 4.5" | |
| 3-95 | 21.2" x 10" x 5.2" | |
| 3-96 | 21.2" x 9.7" x 4.8" | |
| 3-97 | 21.2" x 9.7" x 4.9" | |
| 3-98 | 21.2" x 9.7" x 5.4" | |
| 3-99 | 21.3" x 10.0" x 4.9" | |
| 3-100 | 21.3" x 10.0" x 6.0" | |
| 3-101 | 21.3" x 10.1" x 5.8" | |
| 3-102 | 21.3" x 8.5" x 5.3" | |
| 3-103 | 21.4" x 10.0" x 4.5" | |
| 3-104 | 21.4" x 10.0" x 5.0" | |
| 3-105 | 21.4" x 10.0" x 6.0" | |
| 3-106 | 21.4" x 10.1" x 2.9" | |
| 3-107 | 21.4" x 10.1" x 3.0" | |
| 3-108 | 21.4" x 10.1" x 3.5" | |
| 3-109 | 21.4" x 10.1" x 3.7" | |
| 3-110 | 21.4" x 10.1" x 3.8" | |
| 3-111 | 21.4" x 10.1" x 4.6" | |
| 3-112 | 21.4" x 10.1" x 4.7" | |
| 3-113 | 21.4" x 10.1" x 5.3" | |
| 3-114 | 21.4" x 10.1" x 6.4" | |
| 3-115 | 21.4" x 10.1" x 6.8" | |
| 3-116 | 21.4" x 10.1" x 7.0" | |
| 3-117 | 21.4" x 9.6" x 5.0" | |
| 3-118 | 21.4" x 9.6" x 6.0" | |
| 3-119 | 21.4" x 9.6" x 6.4" |
AND AND A CANAL AND A
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Image /page/6/Picture/0 description: The image shows the Nuvasive logo. The logo consists of a purple and gray abstract shape on the left, followed by the word "NUVASIVE" in gray. Below the word "NUVASIVE" is the phrase "Speed of Innovation" in a smaller font.
510(k) Summary
In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular 21 CFR §807.92, the following summary of information is provided:
Submitted by: A.
Olga Lewis Regulatory Affairs Lead Specialist NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: (858) 909-1800
Date Prepared: August 25, 2015
B. Device Name
| Trade or Proprietary Name: | NuVasive® Sterilization Trays |
|---|---|
| Common or Usual Name: | Sterilization Trays, Instrument Tray |
| Classification Name: | Sterilization wrap containers, trays, cassettes & other accessories |
| Classification: | Class II; 21 CFR § 880.6850 |
| Product Code: | KCT |
C. Predicate Devices
The subject NuVasive Sterilization Trays are substantially equivalent to the primary predicate device, Skeletal Dynamics Sterilization Trays (K102103).
D. Device Description
The NuVasive Sterilization Trays are designed to contain NuVasive implants and instruments for sterilization, storage, and handling, and to allow optimal exposure of the tray's content to steam during the sterilization process. The trays are intended only for use with NuVasive medical devices. The trays must be used in conjunction with an FDA cleared sterilization wrap in order to maintain sterility of the contents.
The trays are different sizes of the same basic configuration and consist of a rectangular base with a lid that fastens to the base with latches. The trays have perforations on the lid, base bottom and sides. Insert trays with custom made brackets can be used to organize instruments and hold caddies in which smaller components are stored. The insert travs and caddies also contain perforations to allow optimal exposure of the tray's contents to sterilant during the sterilization process.
E. Indications for Use
The NuVasive Sterilization Trays are intended to contain NuVasive implants and surgical instruments for sterilization, storage and handling. The NuVasive Sterilization Trays are suitable for dynamic air removal (pre-vacuum) steam sterilization methods. The 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 devices.
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Image /page/7/Picture/1 description: The image shows the logo for Nuvasive. The logo consists of a stylized purple and gray leaf-like shape on the left, followed by the word "NUVASIVE" in gray, and the tagline "Speed of Innovation" in a smaller font below the company name. The logo is clean and modern, with a focus on the company's name and tagline.
Sterilization validations for three level worst case tray (20.5" x 10" x 7.375") included three different loading configurations: implant only content (26.4 lbs.), instrument only content (39.95 lbs.) and mixed instruments and implants content (30.45 lbs.)
Validated worst case loading configurations included 23 instruments with lumens including the following worst case lumen dimensions:
-
1.6 mm x 306.8 mm
-
1.1 mm x 166.4 mm
-
7.2 mm x 331.9 mm
-
5.5 mm x 356.9 mm
Do not exceed a maximum load of 25 lbs in the sterilization tray.
Validated sterilization parameters for NuVasive Sterilization Trays:
Method: Steam Cycle: Pre-Vacuum Temperature: 270°F (132°C)
Exposure Time: 4 minutes
Minimum Dry Time: 30 minutes
Minimum Cool Down Time: 40 minutes
List of Devices:
| FOOTPRINT | MODEL | DIMENSIONS (L x W x H) | FOOTPRINT | MODEL | DIMENSIONS (L x W x H) |
|---|---|---|---|---|---|
| Footprint 1 | 1-1 | 6.0" x 3.3" x 2.2" | Footprint 3 | 3-20 | 20.5" x 10.0" x 5.0" |
| 1-2 | 6.5" x 3.5" x 2.0" | 3-21 | 20.5" x 10.0" x 6.0" | ||
| Footprint 2 | 2-1 | 8.0" x 4.3" x 1.6" | 3-22 | 20.5" x 9.5" x 5.0" | |
| 2-2 | 8.0" x 6.0" x 3.5" | 3-23 | 20.5" x 9.5" x 5.1" | ||
| Footprint 3 | 3-1 | 19.8" x 9.4" x 2.0" | 3-24 | 20.5" x 9.5" x 5.6" | |
| 3-2 | 20.0" x 10.0" x 2.0" | 3-25 | 20.5" x 9.5" x 6.1" | ||
| 3-3 | 20.0" x 10.0" x 6.5" | 3-26 | 20.5" x 9.5" x 6.3" | ||
| 3-4 | 20.0" x 9.5" x 1.8" | 3-27 | 20.5" x 9.5" x 6.4" | ||
| 3-5 | 20.0" x 9.5" x 2.0" | 3-28 | 20.5" x 9.5" x 6.6" | ||
| 3-6 | 20.0" x 9.5" x 2.5" | 3-29 | 20.5" x 9.5" x 7.0" | ||
| 3-7 | 20.0" x 9.5" x 3.0" | 3-30 | 20.5" x 9.7" x 2.0" | ||
| 3-8 | 20.0" x 9.5" x 3.5" | 3-31 | 20.5" x 9.7" x 3.8" | ||
| 3-9 | 20.0" x 9.5" x 4.0" | 3-32 | 20.5" x 9.7" x 5.2" | ||
| 3-10 | 20.0" x 9.5" x 4.5" | 3-33 | 20.5" x 9.8" x 2.0" | ||
| 3-11 | 20.0" x 9.5" x 5.5" | 3-34 | 20.5" x 9.8" x 2.1" | ||
| 3-12 | 20.0" x 9.5" x 6.8" | 3-35 | 20.5" x 9.8" x 2.2" | ||
| 3-13 | 20.0" x 9.6" x 2.0" | 3-36 | 20.5" x 9.8" x 2.3" | ||
| 3-14 | 20.0" x 9.8" x 6.3" | 3-37 | 20.5" x 9.8" x 2.5" | ||
| 3-15 | 20.1" x 9.4" x 2.5" | 3-38 | 20.5" x 9.8" x 3.0" | ||
| 3-16 | 20.4" x 9.6" x 3.0" | 3-39 | 20.5" x 9.8" x 3.1" | ||
| 3-17 | 20.5" x 10.0" x 2.0" | 3-40 | 20.5" x 9.8" x 3.3" | ||
| 3-18 | 20.5" x 10.0" x 3.0" | 3-41 | 20.5" x 9.8" x 3.5" | ||
| 3-19 | 20.5" x 10.0" x 4.0" | 3-42 | 20.5" x 9.8" x 3.6" |
CONFIDENTIAL
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Image /page/8/Picture/0 description: The image shows the Nuvasive logo. The logo consists of a purple and gray abstract shape on the left, followed by the word "NUVASIVE" in gray. Below the word "NUVASIVE" is the phrase "Speed of Innovation" in a smaller, blurred font. The logo is simple and modern, with a focus on the company name and tagline.
FOOT
| FOOTPRINT | MODEL | DIMENSIONS (L x W x H) |
|---|---|---|
| Footprint 3 | 3-43 | 20.5" x 9.8" x 3.7" |
| 3-44 | 20.5" x 9.8" x 3.8" | |
| 3-45 | 20.5" x 9.8" x 3.9" | |
| 3-46 | 20.5" x 9.8" x 4.0" | |
| 3-47 | 20.5" x 9.8" x 4.1" | |
| 3-48 | 20.5" x 9.8" x 4.3" | |
| 3-49 | 20.5" x 9.8" x 4.4" | |
| 3-50 | 20.5" x 9.8" x 4.5" | |
| 3-51 | 20.5" x 9.8" x 4.6" | |
| 3-52 | 20.5" x 9.8" x 4.7" | |
| 3-53 | 20.5" x 9.8" x 4.8" | |
| 3-54 | 20.5" x 9.8" x 5.0" | |
| 3-55 | 20.5" x 9.8" x 5.3" | |
| 3-56 | 20.5" x 9.8" x 5.5" | |
| 3-57 | 20.5" x 9.8" x 5.7" | |
| 3-58 | 20.5" x 9.8" x 6.0" | |
| 3-59 | 20.5" x 9.8" x 6.1" | |
| 3-60 | 20.5" x 9.8" x 6.3" | |
| 3-61 | 20.5" x 9.8" x 6.6" | |
| 3-62 | 20.5" x 9.8" x 7.1" | |
| 3-63 | 20.5" x 9.8" x 7.2" | |
| 3-64 | 20.6" x 9.7" x 3.4" | |
| 3-65 | 20.6" x 9.7" x 3.6" | |
| 3-66 | 20.6" x 9.7" x 4.4" | |
| 3-67 | 20.6" x 9.7" x 4.7" | |
| 3-68 | 20.8" x 9.8" x 2.8" | |
| 3-69 | 20.8" x 9.8" x 5.2" | |
| 3-70 | 20.9" X 10.0" X 2.3" | |
| 3-71 | 20.9" x 9.8" x 6.6" | |
| 3-72 | 21.0" x 10.0" x 4.0" | |
| 3-73 | 21.0" x 10.0" x 4.2" | |
| 3-74 | 21.0" x 10.0" x 4.3" | |
| 3-75 | 21.0" x 10.0" x 6.0" | |
| 3-76 | 21.0" x 10.1" x 3.1" | |
| 3-77 | 21.0" x 9.7" x 3.0" | |
| 3-78 | 21.0" x 9.7" x 3.7" | |
| 3-79 | 21.0" x 9.7" x 4.2" | |
| 3-80 | 21.0" x 9.7" x 4.3" | |
| 3-81 | 21.0" x 9.7" x 4.8" | |
| 3-82 | 21.0" x 9.7" x 6.2" | |
| FOOTPRINT | MODEL | DIMENSIONS(L x W x H) |
| Footprint 3 | 3-83 | 21.0" x 9.7" x 6.8" |
| 3-84 | 21.0" x 9.8" x 2.2" | |
| 3-85 | 21.0" x 9.8" x 3.5" | |
| 3-86 | 21.0" x 9.8" x 3.8" | |
| 3-87 | 21.0" x 9.8" x 4.0" | |
| 3-88 | 21.0" x 9.8" x 5.6" | |
| 3-89 | 21.1" x 9.7" x 3.7" | |
| 3-90 | 21.1" x 9.7" x 6.2" | |
| 3-91 | 21.1" x 9.7" x 6.4" | |
| 3-92 | 21.1" x 9.8" x 4.6" | |
| 3-93 | 21.1" x 9.8" x 6.0" | |
| 3-94 | 21.2" x 10.0" x 4.5" | |
| 3-95 | 21.2" x 10" x 5.2" | |
| 3-96 | 21.2" x 9.7" x 4.8" | |
| 3-97 | 21.2" x 9.7" x 4.9" | |
| 3-98 | 21.2" x 9.7" x 5.4" | |
| 3-99 | 21.3" x 10.0" x 4.9" | |
| 21.3" x 10.0" x 6.0 | ||
| 3-100 | "" | |
| 3-101 | 21.3" x 10.1" x 5.8" | |
| 3-102 | 21.3" x 8.5" x 5.3" | |
| 3-103 | 21.4" x 10.0" x 4.5" | |
| 3-104 | 21.4" x 10.0" x 5.0" | |
| 3-105 | 21.4" x 10.0" x 6.0" | |
| 3-106 | 21.4" x 10.1" x 2.9" | |
| 3-107 | 21.4" x 10.1" x 3.0" | |
| 3-108 | 21.4" x 10.1" x 3.5" | |
| 3-109 | 21.4" x 10.1" x 3.7" | |
| 3-110 | 21.4" x 10.1" x 3.8" | |
| 3-111 | 21.4" x 10.1" x 4.6" | |
| 3-112 | 21.4" x 10.1" x 4.7" | |
| 3-113 | 21.4" x 10.1" x 5.3" | |
| 3-114 | 21.4" x 10.1" x 6.4" | |
| 3-115 | 21.4" x 10.1" x 6.8" | |
| 3-116 | 21.4" x 10.1" x 7.0" | |
| 3-117 | 21.4" x 9.6" x 5.0" | |
| 3-118 | 21.4" x 9.6" x 6.0" | |
| 3-119 | 21.4" x 9.6" x 6.4" | |
| 3-120 | 21.5" x 10.0" x 3.0" | |
| 3-121 | 21.5" x 10.0" x 3.8" | |
| 3-122 | 21.5" x 10.0" x 4.6" |
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Image /page/9/Picture/0 description: The image shows the logo for Nuvasive. The logo features a stylized purple and gray leaf-like shape on the left, followed by the company name "NUVASIVE" in gray, sans-serif font. Below the company name, in a smaller font, is the tagline "Speed of Innovation".
| FOOTPRINT | MODEL | DIMENSIONS (L x W x H) |
|---|---|---|
| Footprint 3 | 3-123 | 21.6" x 9.8" x 4.2" |
| 3-124 | 21.6" x 9.9" x 3.0" | |
| 3-125 | 21.7" x 10.0" x 3.1" | |
| 3-126 | 21.7" x 9.9" x 4.1" | |
| 3-127 | 21.7" x 9.9" x 5.0" | |
| 3-128 | 21.7" x 9.9" x 6.3" | |
| 3-129 | 21.8" x 10.4" x 4.1" | |
| 3-130 | 21.8" x 10.5" x 4.7" | |
| 3-131 | 21.9" x 10.0" x 3.2" | |
| 3-132 | 21.9" x 10.0" x 3.5" | |
| 3-133 | 21.9" x 10.0" x 6.0" | |
| 3-134 | 22.0" x 9.7" x 6.2" | |
| 3-135 | 22.0" x 10.0" x 6.6" | |
| Footprint 4 | 4-1 | 9.0" x 6.5" x 2.5" |
| 4-2 | 9.8" x 6.3" x 3.6" | |
| 4-3 | 9.8" x 8.3" x 2.1" | |
| 4-4 | 9.8" x 9.0" x 3.5" | |
| 4-6 | 9.9" x 7.8" x 2.0" | |
| FOOTPRINT | MODEL | DIMENSIONS (L x W x H) |
| Footprint 5 | 5-1 | 10.0" x 10.0" x 2.0" |
| 5-2 | 10.0" x 10.0" x 2.3" | |
| 5-3 | 10.4" x 9.8" x 2.1" | |
| 5-4 | 10.4" x 9.8" x 2.3" | |
| 5-5 | 10.4" x 9.8" x 2.5" | |
| 5-6 | 10.4" x 9.8" x 3.0" | |
| 5-7 | 10.6" x 10.0" x 3.5" | |
| 5-8 | 10.6" X 9.7" X 2.9" | |
| 5-9 | 10.6" X 9.7" X 3.6" | |
| Footprint 6 | 6-1 | 12.3" x 8.3" x 2.1" |
| 6-2 | 13.3" x 9.3" x 2.1" | |
| 6-3 | 14.5" x 9.8" x 2.3" | |
| Footprint 7 | 7-1 | 15.0" x 10.0" x 2.5" |
| 7-2 | 15.8" x 9.8" x 5.2" | |
| 7-3 | 16.8" x 9.8" x 3.2" | |
| Footprint 8 | 8-1 | 15.7" x 4.7" x 2.7" |
| 8-2 | 15.8" x 4.5" x 2.5" |
F. Technological Characteristics
As was established in this submission, the subject NuVasive Sterilization Trays are substantially equivalent to other predicate devices cleared by the FDA for commercial distribution in the United States. The subject device was shown to be substantially equivalent and have equivalent technological characteristics to its predicate device through comparison in areas including design, labeling/intended use, material composition, sterilization method, and function.
Performance Testing G.
To establish substantial equivalence with a predicate device, the performance testing was conducted to confirm that SAL (106) sterility level was achieved at the validated sterilization parameters in prevacuum steam sterilization cycle per ISO 17665-1 and AAMI TIR 12. Upon completion of the SAL (10-6) validations, dry time validation was executed.
H. Conclusions
Based on the indications for use, technological characteristics, performance data, and comparison to predicate device, the subject NuVasive Sterilization Trays has been shown to be substantially equivalent to legally marketed predicate device.
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Image /page/10/Picture/1 description: The image shows the Nuvasive logo. The logo consists of a purple and gray abstract shape on the left, followed by the word "NUVASIVE" in gray. Below the word "NUVASIVE" is the phrase "Speed of Innovation" in a smaller, lighter font.
| Characteristics | Predicate DeviceK102103 | Subject Device NuVasiveSterilization Trays | |
|---|---|---|---|
| Product Code | KCT | KCT | |
| 21 CFR | 888.6850 | 888.6850 | |
| SystemComponents | Base, lid, insert trays, brackets, caddies | Base, lid, insert trays, brackets, caddies | |
| MaterialComposition | Aluminum, Nylon, Silicone, StainlessSteel, Polypropylene,Polyphenylsulfone | Aluminum, Nylon, Silicone, StainlessSteel, Polypropylene,Polyphenylsulfone | |
| PhysicalProperties | Evenly distributed perforated holepattern | Evenly distributed perforated holepattern | |
| Configurations/Dimensions | Rectangle base with lid, inserts,brackets and caddies; Multipledimensions to accommodate differentproduct configurations | Rectangle base with lid, inserts, bracketsand caddies; Multiple dimensions toaccommodate different productconfigurations | |
| SterilantPenetration | Sterilant (steam) penetration throughperforations in tray | Sterilant (steam) penetration throughperforations in tray | |
| Sterilizationmethod | Steam | Steam | |
| Sterilization cycle | Pre-vacuum and Gravity | Pre-vacuum | |
| Exposuretemperature | 270°F (132°C) | 270°F (132°C) | |
| Exposure time | 4 minutes | 4 minutes | |
| Drv time | 20 minutes | 30 minutes | |
| Reusable | Yes | Yes |
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Image /page/11/Picture/1 description: The image shows the Nuvasive logo. The logo consists of a purple and gray abstract shape on the left, followed by the word "NUVASIVE" in gray. Below the word "NUVASIVE" is the phrase "Speed of Innovation" in a smaller, lighter gray font.
| Characteristics | Predicate Device K102103 | Subject Device NuVasive Sterilization Trays | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Indications for Use | Skeletal Dynamics Sterilization Trays are intended to contain Skeletal Dynamics reusable surgical instruments for convenient organized storage, sterilization and transport between usages. The full DIN and half DIN tray include as accessories an insert to hold instruments and caddy to hold implants and smaller components. The Akro-Vu tray only contains brackets to hold the Akro-Vu System's reusable components.The full DIN and half DIN trays are suitable for use in both pre-vacuum steam and high temperature gravity steam serialization methods. The Akro-Vu tray is suitable for use in pre- vacuum steam sterilization method. The trays are not intended to maintain sterility; they are intended to be used in conjunction with a validated sterilization wrap in order to maintain sterility of the enclosed devices.Validated sterilization parameters for full DIN and half DIN trays and Akro-Vu tray: Method Steam Pre-Vacuum High Temp. Gravity Steam Temperature 270°F 270°F Exposure Time 4 min 15 min Min Dry Time 20 min 20 minValidated sterilization parameters for full DIN and half DIN trays: Method: Steam Cycle: High Temperature Gravity Steam Temperature: 270°F (132°C) Exposure Time: 15 minutes Minimum Dry Time: 20 minutes | The NuVasive Sterilization Trays are intended to contain NuVasive implants and surgical instruments for sterilization, storage and handling. The NuVasive Sterilization Trays are suitable for dynamic air removal (pre-vacuum) steam sterilization methods. The 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 devices.Sterilization validations for three level worst case tray (20.5" x 10" x 7.375") included three different loading configurations: implant only content (26.4 lbs.), instrument only content (39.95 lbs.) and mixed instruments and implants content (30.45 lbs.)Validated worst case loading configurations included 23 instruments with lumens including the following worst case lumen dimensions:- 0.16 cm x 30.68 cm- 0.11 cm x 16.64 cm- 0.72 cm x 33.19 cm- 0.55 cm x 35.69 cmDo not exceed a maximum load of 25 lbs in the sterilization tray.Validated sterilization parameters for NuVasive Sterilization Trays: Method: Steam Cycle: Pre-Vacuum Temperature: 270°F (132°C) Exposure Time: 4 minutes Minimum Dry Time: 30 minutes Minimum Cool Down Time: 40 minutes |
§ 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).