Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and intended use are solely focused on physical trays for sterilization and storage, with no mention of software, algorithms, or data processing.

Therapeutic

No
The device is a sterilization tray used to contain medical implants and instruments for sterilization, storage, and handling. It is not intended for any direct therapeutic application to a patient.

Diagnostic

No
The device is a sterilization tray used to contain implants and instruments during the sterilization process, not to diagnose medical conditions.

SaMD (Software as a Medical Device)

No

The device is a physical sterilization tray, not software. The description details hardware components like a base, lid, latches, and perforations.

IVD (In Vitro Diagnostic)

Based on the provided information, the NuVasive Sterilization Trays are not an IVD (In Vitro Diagnostic) device.

Here's why:

Intended Use: The intended use is to contain medical devices (implants and surgical instruments) for sterilization, storage, and handling. This is a function related to the preparation and management of medical devices, not the diagnosis of a disease or condition using samples from the human body.
Device Description: The description focuses on the physical characteristics of the trays and their function in the sterilization process. There is no mention of analyzing biological samples or providing diagnostic information.
Performance Studies: The performance studies described are related to achieving a specific sterility level (SAL) and dry time, which are relevant to the sterilization process of medical devices, not diagnostic accuracy.

IVD devices are specifically designed to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The NuVasive Sterilization Trays do not perform this function.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.
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: Steam
Cycle: Pre-Vacuum
Temperature: 270°F (132°C)
Exposure Time: 4 minutes
Minimum Dry Time: 30 minutes
Minimum Cool Down Time: 40 minutes

Product codes (comma separated list FDA assigned to the subject device)

KCT

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.

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)

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. Upon completion of the SAL (10-6) validations, dry time validation was executed.

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.

K102103

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

Regulation Number and Section

§ 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).

Summary

0

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.

1

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

2

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: Steam
Cycle: Pre-Vacuum
Temperature: 270°F (132°C)
Exposure Time: 4 minutes
Minimum Dry Time: 30 minutes
Minimum Cool Down Time: 40 minutes |

11

3

(Arit) 1888 Ada MAOT

| 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-C

4

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ຂອງເບອົາ ປີ 10 ປະເທດໄປ

4

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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

5

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:

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Office of Chief Information Officer
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."

FORM FDA 3881 (1/14)
Page 4 of 4

6

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.

7

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

8

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"

9

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.

10

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 Device
K102103 | Subject Device NuVasive
Sterilization Trays | |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|--|
| Product Code | KCT | KCT | |
| 21 CFR | 888.6850 | 888.6850 | |
| System
Components | Base, lid, insert trays, brackets, caddies | Base, lid, insert trays, brackets, caddies | |
| Material
Composition | Aluminum, Nylon, Silicone, Stainless
Steel, Polypropylene,
Polyphenylsulfone | Aluminum, Nylon, Silicone, Stainless
Steel, Polypropylene,
Polyphenylsulfone | |
| Physical
Properties | Evenly distributed perforated hole
pattern | Evenly distributed perforated hole
pattern | |
| Configurations/
Dimensions | Rectangle base with lid, inserts,
brackets and caddies; Multiple
dimensions to accommodate different
product configurations | Rectangle base with lid, inserts, brackets
and caddies; Multiple dimensions to
accommodate different product
configurations | |
| Sterilant
Penetration | Sterilant (steam) penetration through
perforations in tray | Sterilant (steam) penetration through
perforations in tray | |
| Sterilization
method | Steam | Steam | |
| Sterilization cycle | Pre-vacuum and Gravity | Pre-vacuum | |
| Exposure
temperature | 270°F (132°C) | 270°F (132°C) | |
| Exposure time | 4 minutes | 4 minutes | |
| Drv time | 20 minutes | 30 minutes | |
| Reusable | Yes | Yes | |

11

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
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 min
Validated 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 cm
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 | | | | | | |