Skeletal Dynamics Sterilization Trays are intended to contain Skeletal Dynamics reusable medical devices for convenient organized storage, sterilization and transport between usages. The full Din and half DIN trays include as accessories an insert to hold instruments and a 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 sterilization 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 with a validated sterilization wrap in order to maintain the sterility of the enclosed devices.

Device Description

Skeletal Dynamics Sterilization Trays are designed to contain Skeletal Dynamics reusable medical devices during transport, sterilization and storage and to allow optimal exposure of the tray's contents to sterilization process. The trays are intended ONLY for use with Skeletal Dynamics medical devices. The trays must be used in conjunction with an FDA cleared sterilization wrap in order to maintain the 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 trays and caddies facilitate organization, storage and transport. They also contain perforations to allow optimal exposure of the tray's contents to sterilant during the sterilization process.

AI/ML Overview

The document describes the Skeletal Dynamics Sterilization Trays and their performance testing.

1. Table of Acceptance Criteria and Reported Device Performance:

The primary acceptance criteria for these sterilization trays are their ability to effectively allow sterilization of the contained medical devices according to validated sterilization parameters.

Acceptance Criteria (Validated Sterilization Parameters)	Reported Device Performance (Achieved Sterilization)	Specific Trays/Methods
For Full DIN and Half DIN Trays:	Confirmed for all three device models	Pre-vacuum steam
Method: Pre-vacuum steam
Temperature: 270°F
Exposure Time: 4 minutes
Drying Time: 20 minutes
	Confirmed for full DIN and half DIN models	Gravity steam
Method: High Temperature Gravity Steam
Temperature: 270°F
Exposure Time: 15 minutes
Drying Time: 20 minutes
For Akro-Vu Tray:	Confirmed for all three device models	Pre-vacuum steam
Method: Pre-vacuum steam
Temperature: 270°F
Exposure Time: 4 minutes
Drying Time: 20 minutes

2. Sample Size Used for the Test Set and Data Provenance:

The document states that "Performance testing was conducted which confirmed that sterilization was achieved to the validated sterilization parameters above indicated for all three device models..." This implies that the three distinct device models (TRAY-STT-CBF1, TRAY-STT-CBH1, AKR-CTR-CBC1) were part of the test set. The exact number of units of each model tested is not specified.

The data provenance is retrospective, as the testing was conducted to support a 510(k) submission for a device already developed. The country of origin of the data is not explicitly stated, but it is for a US FDA submission, suggesting the testing was likely conducted in the US or under US regulatory standards.

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 efficacy testing, ground truth is typically established by laboratory methods (e.g., sterility testing of Biological Indicators or Process Challenge Devices) rather than expert consensus on images or observations.

4. Adjudication Method for the Test Set:

This information is not provided in the document. Adjudication methods like "2+1" or "3+1" are relevant for subjective assessments, typically in diagnostic imaging or clinical trials where expert opinions may differ. For objective performance testing of sterilization efficacy, such adjudication is not applicable. The assessment would involve direct measurement of sterility based on established laboratory protocols.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No, an MRMC comparative effectiveness study was not done. This type of study is used to evaluate the impact of a new technology (like an AI algorithm) on human reader performance, often in diagnostic settings. The Skeletal Dynamics Sterilization Trays are physical medical devices for containing instruments during sterilization, not diagnostic tools.

6. If a Standalone (i.e., algorithm-only without human-in-the-loop performance) was Done:

No, a standalone algorithm-only performance study was not done. This concept is not applicable to the Skeletal Dynamics Sterilization Trays, as they are not software algorithms. The performance testing described is for the physical device's ability to facilitate sterilization.

7. The Type of Ground Truth Used:

The ground truth used for this type of performance testing is sterility, as determined by validated laboratory methods (e.g., inoculation of biological indicators and subsequent incubation to check for microbial growth, or other standard sterility assurance level testing). The document states that "sterilization was achieved," implying such objective methods were used to confirm efficacy.

8. The Sample Size for the Training Set:

This information is not applicable/not provided. The Skeletal Dynamics Sterilization Trays are physical medical devices, not an AI or machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable. As these are physical medical devices and not an AI/ML model, there is no training set or associated ground truth establishment for a training set.

Summary

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K102103
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Image /page/0/Picture/1 description: The image shows a logo for "skeletal dynamics". The logo consists of a stylized four-petal flower-like shape to the left of the text. The text "skeletal" is on the first line, and "dynamics" is on the second line, with the "d" in dynamics directly below the "s" in skeletal.

510(k) Summary of Safety and Effectiveness Skeletal Dynamics Sterilization Trays

July 22, 2010

Submitter:

DEC - 7 2010

Skeletal Dynamics, LLC 8905 SW 87 Avenue Suite 102 Miami, FL 33176 Tel: (305) 596-7585 Fax: (305) 596-7591 Contact: Ana Escagedo / Vice President Quality & Requlatory Affairs Email: aescagedo@skeletaldynamics.com

FDA Establishment Registration Number: Pending

Trade Name, Common Name, Classification:

Trade Name: Skeletal Dynamics Sterilization Trays

Classification Name: Sterilization wrap containers, trays, cassettes and other accessories (21 CFR §888.6850)

Common Name: Sterilization Cassettes, Instrument Tray, Sterilization Tray, Instrument Delivery System

Class: Class II (KCT)

Predicate Devices:

Smith & Nephew Instrument Tray - K090562 Riley Medical, Inc. MetaPak Multi-Purpose Instrument Tray - K993535

Description of the Device:

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can be used to organize instruments and hold caddies in which smaller components are stored. The insert trays and caddies facilitate organization, storage and transport. They also contain perforations to allow optimal exposure of the tray's contents to sterilant during the sterilization process.

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Intended Use:

Skeletal Dynamics Sterilization Trays are intended to contain Skeletal Dynamics reusable medical devices for convenient organized storage, sterilization and transport between usages. The full Din and half DIN trays include as accessories an insert to hold instruments and a caddy to hold implants and smaller components. The Akro-Vu trav only contains brackets to hold the Akro-Vu System's reusable components.

validated Sterilization Parameters for full DIN and half DIN trays:
Method	Temperature	Exposure Time	Drying Time
Pre-vacuum steam	270°F	4 minutes	20 minutes
High Temperature	270°F	15 minutes	20 minutes
Gravity Steam

/alidated Sterilization Parameters for full DIN and half DIN travs:

Validated Sterilization Parameters for Akro-Vu tray:

Method	Temperature	Exposure Time	Drying Time
Pre-vacuum steam	270°F	4 minutes	20 minutes

Device models that are the subject of this pre-market notification:

Reference	Description	Dimensions(L x W x H)
TRAY-STT-CBF1	Tray, Sterilization Full Din (Align)	19in x 9.5in x 3.6in
TRAY-STT-CBH1	Tray, Sterilization Half Din (Implate)	9.7in x 9.7in x 3.6in
AKR-CTR-CBC1	Tray, Sterilization Akro-Vu	15in x 12in x 4in

Comparison of Technological Characteristics to Predicate Devices:

The Skeletal Dynamics Sterilization Trays have the same technological characteristics as the predicates. They are all used for storage, transport and sterilization of reusable medical devices between uses. The full DIN and half DIN trays are suitable for use in both pre-vacuum steam and high temperature gravity steam sterilization methods. The Akro-Vu'tray is suitable for use in pre-vacuum steam sterilization method. They are substantially equivalent in material, design and intended use to the predicate devices. The subject trays do not incorporate any new technological characteristics. There are no significant differences between the proposed and predicate devices that raise new questions of safety or effectiveness.

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Performance Testing:

Performance testing was conducted which confirmed that sterilization was achieved to the validated sterilization parameters above indicated for all three device models in prevacuum steam sterilization process, and for the full DIN and half DIN models in gravity steam sterilization process.

Conclusion:

We believe the subject device is substantially equivalent to the predicate device and conclude that the subject device is as safe and effective as the predicate device.

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

JAN 2 5 2011

Ms. Ana M. Escagedo Vice President Skeletal Dynamics, LLC 8905 SW 87th Avenue, Suite 201 Miami, Florida 33176

Re: K102103

Trade/Device Name: Skeletal Dynamics Sterilization Trays Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: KCT Dated: December 1, 2010 Received: December 3, 2010

Dear Ms. Escagedo:

This letter corrects our substantially equivalent letter of December 7, 2010.

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 (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.

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. Escagedo

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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 vours.

Anthony D.m

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number K102103

DEC - 7 2010

Device Name: Skeletal Dynamics Sterilization Trays

Indications For Use:

Validated Sterilization Parameters for full DIN and half DIN trays:

Method	Temperature	Exposure Time	Drying Time
Pre-vacuum steam	270°F	4 minutes	20 minutes
High TemperatureGravity Steam	270°F	15 minutes	20 minutes

Validated Sterilization Parameters for Akro-Vu tray:

Method	Temperature	Exposure Time	Drying Time
Pre-vacuum steam	270°F	4 minutes	20 minutes

Device models that are the subject of this pre-market notification:

Reference	Description	Dimensions(L x W x H)
TRAY-STT-CBF1	Tray, Sterilization Full Din (Align)	19in x 9.5in x 3.6in
TRAY-STT-CBH1	Tray, Sterilization Half Din (Implate)	9.7in x 9.7in x 3.6in
AKR-CTR-CBC1	Tray, Sterilization Akro-Vu	15in x 12in x 4in

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use × (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Stop-Off)' .md

sion Sign-Off Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K102103

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).