Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical properties, sterilization efficacy, and material composition of instrument trays, with no mention of AI or ML.

Therapeutic

No
The device is described as trays intended to organize, protect, and transport instruments during sterilization and storage, not to treat or diagnose a disease.

Diagnostic

No

The device is described as trays intended to organize, protect, and transport instruments during steam sterilization and subsequent storage. Its purpose is related to instrument management and sterilization, not to diagnosing a medical condition.

SaMD (Software as a Medical Device)

No

The device description clearly states that the device is comprised of physical components (trays, lids, bases, handles, instrument holders, mounting hardware) made of materials like anodized aluminum and silicone. It also describes physical dimensions and weight limits. There is no mention of software as a component or function of the device.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is clearly stated as organizing, transporting, and facilitating the steam sterilization and storage of medical instruments. This is a function related to the handling and preparation of medical devices, not the diagnosis of diseases or conditions using in vitro methods.
Device Description: The description details the physical components of the trays and the types of surgical instruments they hold. There is no mention of reagents, samples (like blood, urine, or tissue), or any process related to analyzing biological specimens.
Performance Studies: The performance studies focus on sterilization efficacy, dry time validation, and cleaning. These are all related to the reprocessing and preparation of medical instruments for use, not diagnostic performance.

IVD devices are specifically designed to examine specimens taken from the human body to provide information for the diagnosis, treatment, or prevention of disease. The NSO Supplemental Instrument Trays do not perform this function.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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 of Lumens	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

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

KCT

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:

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
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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-clinical performance testing was conducted to establish substantial equivalence of the Flexible Reamer Tray to the predicate device, given it has a worst-case dimension (smaller lumen diameter and longer length) compared to the NSO Supplemental Instrument Trays. Sterilization testing was performed 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 successful, 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 adequately clean and sterilize the Flexible Reamer Tray. No changes were made to the design or materials of the NSO Supplement Trays, so biocompatibility and limits of reprocessing testing were not repeated, and original testing results remain applicable. Testing results demonstrated that the device is safe and effective for its intended use.

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.

K151594

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 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

2

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 of
Lumens | 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 of
Tray 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 100
Aliso Viejo, CA 92656 |
|----|-------------------------|---------------------------------------------------------------------------------------------------|
| | Contact: | Cora Sim
Associate Manager, Regulatory Affairs
Phone: (949) 544-6478
Fax: (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, & other
Accessories (21 CFR 880.6850) |
| 4. | Product Code: | KCT (Sterilization Tray) |
| 5. | Device Classification: | Class II |
| 6. | Predicate Device: | NSO Supplemental Instrument Trays
(K151594) |

1. 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:

4

| Tray | Model | Lumen Dimensions
(Inner Diameter x Length) | Number
of
Lumens | Maximum
Tray 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 of
Tray 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.

1. 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:

5

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.

1. 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 Instrument
Trays | Subject NSO Supplemental
Instrument Trays |
|------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K15194 | K170939 |
| Product Code | KCT | KCT |
| Intended Use | The NSO Supplemental Instrument Trays
intended to organize, protect, and transport
instruments during steam sterilization and
subsequent storage. | Same |
| | | |
| Design | The lid, base tray, and insert tray are composed
of anodized aluminum. An internal individual
insert tray is utilized by the Supplemental
Reamer Tray. Medical grade Class VI Silicone
instrument holders and with stainless steel
mounting hardware are used to secure,
separate, and organize the instruments within
the trays. | Same |
| Dimensions | Supplemental Instrument Tray:
Base tray: 510mm (length) x 250mm (width) x
45mm (depth)

Supplemental Reamer Tray:
Base tray: 510mm (length) x 250mm (width) x
87mm (depth)

Insert Tray:
497 mm (length) x 240 mm (width) x 52 mm
(depth)* | Flexible Instrument Tray:

Base tray: Same as
Supplemental Reamer Tray

Supplemental Reamer Tray:
Tray Lid: 916
Base Tray: 956
Insert Tray: 948 | Flexible Reamer Tray:
Tray Lid: Identical
Base Tray: Same as
Supplemental Reamer Tray
Insert Tray: 931 |
| Vent to volume ratios | Supplemental Instrument Tray:
0.192 in⁻¹

Supplemental Reamer Tray:
0.147 in⁻¹ | Flexible Reamer Tray:
Same as Supplemental
Reamer Tray |
| Material compatibility with
sterilization process | The materials used in the NSO Supplemental
Instrument Trays were exposed to 100
sterilization cycles and no material degradation
was observed. All materials maintained their
integrity and remained fully functional.
Performance testing demonstrated that the
materials of construction are compatible with
steam sterilization. | Same |
| Toxicological properties | Extracts of test article (polymeric component)
on L-939 mouse fibroblast cells in MEM
elution assay did not display a cytotoxic
response and is considered non-cytotoxic.
Testing demonstrated that the materials of
construction are biocompatible. | Same |
| Results of transportation
studies | Shipping validation was performed on the NSO
Supplemental Instrument Trays. The package
performance testing results demonstrated all
acceptance criteria were met. | Same |
| Summary of cleaning
validation information | The NSO Supplemental Instrument Trays have
been validated to be cleaned using both a
manual and automated process.
Hemoglobin, Micro BCA protein, and
TOC
test results met all acceptance criteria. | Same |
| Limitations of reprocessing | The function and physical construction of the
NSO Supplemental Instrument Trays and their
components are safe and effective after
exposure to 100 sterilization cycles. The end of
tray life is determined through the inspection of
each tray after the required cleaning and
sterilization cycles. The life of the trays are
limited only by irreparable physical damage
from mishandling. | 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 in
determining an effective dry time of 40
minutes for the validated pre-vacuum steam
sterilization cycle. Acceptance criteria below
were met during validation of the dry time: | |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Summary of drying time
validation | 1) Autoclave data showing appropriate dwell
time at 132°C (+3°C) for each full cycle

Confirmation of the absence of moisture on
the trays and sterilization wrap
No more than 3% difference in weight prior
to and after sterilization | Same |

*For use with the Reamer Tray

1. 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.
1. 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.