The Steri-Cassettes and Steri-Cages are intended to contain dental instruments for cleaning, sterilization, organization, storage and handling. The Steri-Cassettes and Steri-Cages are suitable for pre-vacuum and gravity displacement steam sterilization methods. The cassettes and cages are not intended to maintain sterility; they are intended to be used in conjunction with validated, FDA-cleared sterilization wrap in order to maintain sterility of the enclosed devices.

The validated steam sterilization cycle parameters are as follows:

Steam SterilizationCycle	Minimum ExposureTemperature	MinimumExposure Time	Minimum Dry Time
GravityDisplacement(wrapped)	250°F (121°C)	30 Minutes	15 Minutes
GravityDisplacement(wrapped)	270°F (132°C)	15 Minutes	15 Minutes
GravityDisplacement(wrapped)	275°F (135°C)	10 Minutes	30 Minutes
GravityDisplacement(unwrapped forimmediate use)	132°C (270°F)	3 Minutes	None
Pre-Vacuum(wrapped)	270°F (132°C)	4 Minutes	30 Minutes
Pre-Vacuum(wrapped)	275°F (135°C)	3 Minutes	16 Minutes
Pre-Vacuum(unwrapped forimmediate use)	273°F (134°C)	3 Minutes	None

Device Description

Steri-Cassettes and Steri-Cages are used to hold instruments in a secure way for cleaning, sterilization and presentation at point of use. They keep instrumentation organized in an efficient way. They are available in a variety of sizes to accommodate instruments of various sizes and are offered in an assortment of colors to aid in office organization.

Cassettes and cages are manufactured by Injection Molding process from either high-heat resin or polypropylene with color - materials widely used in the medical field. The colors are already pre-mixed and vary by color in the supplier's proprietary resin mixtures: Steri-Cassettes High-Heat: RoHs-compliant, high-heat resin - Ultem Resin 1000 and Steri-Cassettes Standard Heat and Steri-Cages: polypropylene with color.

The cassettes and cage have a latching lid to contain the products. The proposed devices are designed to fit any standard autoclave and ultrasonic machine, which allows it to be effective for sterilization and be able to withstand the environment of repeated steam sterilization cycles. Since the proposed cassettes and cages have open slots, a legally-marketed and FDA-cleared sterilization wrap must be used for sterilization purposes to maintain the sterility of the contents.

The proposed Steri-Cassettes and Steri-Cages are packaged in non-sterile, plastic shrinkwrap, which is then appropriately labeled and includes a validated Cleaning and Sterilization/ Dry Time Instructions for use.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the Steri-Cassette and Steri-Cage Sterilization Packaging System, based on the provided text:

Important Note: The provided document is a 510(k) summary for a medical device. This type of document focuses on demonstrating substantial equivalence to a predicate device, rather than proving absolute safety and effectiveness through extensive standalone studies typical for novel devices. Therefore, the information regarding "acceptance criteria" and "studies" will primarily relate to demonstrating that the new device performs as well as or in a similar manner to the legally marketed predicate device, especially in terms of sterilization parameters and material compatibility. The document often references standards rather than detailed study protocols and results.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a tabulated format with direct performance metrics in the way one might expect for a novel performance claim (e.g., "X% accuracy"). Instead, the substantial equivalence is demonstrated by aligning the device's capabilities and validated parameters with recognized standards and the predicate device's performance. The key "performance" for this device relates to its ability to withstand and facilitate sterilization effectively.

The closest we get to acceptance criteria are the validated steam sterilization cycle parameters and the general compatibility with cleaning and sterilization processes.

Acceptance Criteria Category (Derived from Standards & Predicate)	Reported Device Performance (Steri-Cassette and Steri-Cage)
Cleaning Parameters (Post-cleaning condition)	"Yes - Per Cleaning Validations conducted." (Implies the device can be effectively cleaned to meet validated standards, though specific residual limits are not provided in this summary).
Steam Sterilization Cycle Parameters (Wrapped)	Gravity Displacement: - 250°F (121°C) for 30 Min Exposure, 15 Min Dry Time - 270°F (132°C) for 15 Min Exposure, 15 Min Dry Time- 275°F (135°C) for 10 Min Exposure, 30 Min Dry Time Pre-Vacuum: - 270°F (132°C) for 4 Min Exposure, 30 Min Dry Time - 275°F (135°C) for 3 Min Exposure, 16 Min Dry Time
Steam Sterilization Cycle Parameters (Unwrapped, immediate use)	Gravity Displacement: - 132°C (270°F) for 3 Min Exposure, None Dry TimePre-Vacuum: - 273°F (134°C) for 3 Min Exposure, None Dry Time
Reusable Life Cycle	"Yes, validated to be reused at least five (5) times." (Implies the device maintains its structural integrity and functionality for at least 5 sterilization cycles).
Material Compatibility with Sterilization Method	"Yes - Materials are compatible with sterilization method" and "Materials of construction are compatible with steam sterilization." (Implies no degradation or adverse effects from sterilization).
Sterilant Penetration	"Yes - Sterilant (steam) penetration through perforations in base and lid - Steam Sterilization Validation testing." (Implies effective sterilant access to contents).
Microbial Barrier (Packaging Integrity)	"To be used with a validated, FDA-cleared sterilization wrap." (The device itself is not a microbial barrier; acceptance is based on its intended use with appropriate external packaging).
Biocompatibility	"Yes - Materials are known to be biocompatible and do not come into direct contact with patient." (Implies non-toxic to patients and users under normal conditions, given the no-patient-contact nature).
Heat Resistance	Standard Heat Steri-Cassettes and Steri-Cages: Withstand 275°F. High Heat Steri-Cassettes: Withstand 320°F. (As per performance and sterilization testing and resin specifications).

2. Sample Sizes Used for the Test Set and Data Provenance

The document is a 510(k) summary, which typically does not provide granular details about sample sizes for each validation test performed. The studies are described in a general manner by referencing standards.

Sample Size for Test Set: Not explicitly stated for any specific test. The phrase "Cleaning Validations conducted," "Sterilization Validation testing," and "validation testing" implies that a sufficient number of units were tested to satisfy the requirements of the referenced standards (e.g., ISO 17665-1, AAMI ST77, etc.).
Data Provenance: The studies were conducted by Sybron Dental Specialties (Kerr Corporation) for their product. It is implied the data is prospective as it's part of the premarket notification process for a new device. The location of the testing is not specified, but the manufacturing involves Mexico (SDS de Mexico S. de R.L. de C.V.) and the applicant is in the USA (Orange, CA).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This type of information is generally not applicable to the evaluation of a sterilization packaging system. "Ground truth" in this context would be established by validated scientific methods and measurements (e.g., temperature probes, biological indicators for sterility, chemical analysis for cleaning residuals, mechanical testing for durability), rather than expert consensus interpretations of medical images or diagnoses.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the "truth" is established by direct measurement and validated scientific methods, not by expert review or consensus.

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

No. An MRMC study is relevant for diagnostic devices that involve human interpretation of medical images or data. This device is a sterilization packaging system and does not involve such an interface.

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

Yes, in essence. The performance evaluations (cleaning, sterilization efficacy, material compatibility, durability) are for the device itself as it functions in the sterilization process defined by its intended use, without human-in-the-loop performance measurement. The device's "performance" is its intrinsic capability to withstand and facilitate sterilization according to established parameters.

7. The Type of Ground Truth Used

The ground truth for the performance of this device is established through:

Validated Sterilization Parameters: Achieving sterility (e.g., a Sterility Assurance Level, SAL of 10^-6) under the specified time, temperature, and pressure conditions using biological indicators (BIs) and physical monitors.
Material Compatibility Testing: Demonstrating that the materials do not degrade, off-gas harmful substances, or otherwise interfere with the sterilization process or the instruments being sterilized. This is often based on adherence to ISO 10993 and ISO 7405 standards.
Cleaning Efficacy Testing: Demonstrating that the device can be effectively cleaned to reduce organic and inorganic residues to predetermined acceptable levels.
Physical Durability/Life Cycle Testing: Showing that the device maintains its structural integrity and functional requirements over a specified number of reprocessing cycles.
Adherence to Recognized Industry Standards: The listed standards (e.g., AAMI ST77, ANSI/AAMI/ISO 17665-1) define the "ground truth" for how such devices should be tested and validated.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm, so there is no "training set."

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

Not applicable, as there is no training set for this device.

Summary

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, layered on top of each other, creating a sense of depth and unity.

Public Health Service

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

April 21, 2017

Sybron Dental Specialties Jennifer Dzidrums Regulatory Affairs Associate Ii 1717 W. Collins Ave. Orange, California 92867

Re: K162063

Trade/Device Name: Steri-Cassette and Steri-Cage Sterilization Packaging System Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: March 15, 2017 Received: March 20, 2017

Dear Jennifer Dzidrums:

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 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.

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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,

Michael J. Ryan -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K162063

Device Name

Steri-Cassette and Steri-Cage Sterilization Packaging Systems

Indications for Use (Describe)

The validated steam sterilization cycle parameters are as follows:

Steam SterilizationCycle	Minimum ExposureTemperature	MinimumExposure Time	Minimum Dry Time
GravityDisplacement(wrapped)	250°F (121°C)	30 Minutes	15 Minutes
GravityDisplacement(wrapped)	270°F (132°C)	15 Minutes	15 Minutes
GravityDisplacement(wrapped)	275°F (135°C)	10 Minutes	30 Minutes
GravityDisplacement(unwrapped forimmediate use)	132°C (270°F)	3 Minutes	None
Pre-Vacuum(wrapped)	270°F (132°C)	4 Minutes	30 Minutes
Pre-Vacuum(wrapped)	275°F (135°C)	3 Minutes	16 Minutes
Pre-Vacuum(unwrapped forimmediate use)	273°F (134°C)	3 Minutes	None

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 shows the logo for Sybron Dental Specialties. The logo consists of the letters "sds" in a bold, sans-serif font, with a curved line above the letters. Below the letters, the words "Sybron Dental Specialties" are written in a smaller, sans-serif font. The logo is blue and white.

510(k) SUMMARY for Steri-Cassette and Steri-Cage

K162063

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:

A. Applicant Information:

Sybron Dental Specialties 1717 W. Collins Ave. Orange CA, 92687 USA Fax: 909-962-5694

Correspondent Contact Information:

Jennifer Dzidrums, MS, RAC Regulatory Affairs Associate II Tel: 909-962-5650 Fax: 909-962-5694

Date Prepared: April 17, 2017

B. Subject Device:

Trade Name	Steri-Cassette and Steri-Cage Sterilization Packaging System
Classification Name	Sterilization wrap containers, trays, cassettes & other accessory
Regulation Number	21 CFR § 880.6850
Common Name	Instrument Cassette, Sterilization Cassette
Device Class	II
Product Code	KCT
Panel	General Hospital

Predicate Device: C.

Trade Name	PolyVac Surgical Instrument Delivery System's InstrumentCassettes
510(k) Holder	Symmetry Medical, Inc. (previously PolyVac, Inc.)
510(k) #	K012105 (FDA-cleared on August 02, 2002)
Classification Name	Sterilization wrap containers, trays, cassettes & other accessory
Regulation Number	21 CFR § 880.6850
Common Name	Instrument Cassette/ Tray, Sterilization Cassette/ Tray
Device Class	II
Product Code	KCT
Panel	General Hospital

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D. Description of Device:

Design

Steri-Cassettes and Steri-Cages have perforations consisting of open-slots on the lid and the base which allows exposure of the device to the sterilant during sterilization. All the five variations of the stackable Steri-Cassettes and Steri-Cages have the same design of open-slot perforations on their lid and base (1) Steri-Cassette AA - Shallow - High Heat, (2) Steri-Cassette AA - Shallow - Standard Heat, (3) Steri-Cassette AB - Medium -High Heat, (4) Steri-Cassette BB - Deep - High Heat and (5) Steri-Cage - Standard Heat. Steri-Cassettes include instrument holder inserts, which are removable and individually hold instruments. Refer to Table 5.1 for the various colors, measurements, construction and heat resistance for these hinged sterilization cassettes and cages. Standard Heat Steri-Cassettes and Steri-Cages and High Heat Steri-Cassettes can withstand 275°F and 320°F per performance and Sterilization testing, and resin specifications).

Since the proposed devices are perforated, an FDA-cleared sterilization wrap must be used to maintain sterility of its contents. The evenly-spaced open slots are sufficient to support sterilant penetration and drying as per ANSI/AAMI ST 77.

Composition and Manufacturing Process

The cassettes and cage have a latching lid to contain the products. The proposed devices are designed to fit any standard autoclave and ultrasonic machine (Table 5.1), which allows it to be effective for sterilization and be able to withstand the environment of repeated steam sterilization cvcles. Since the proposed cassettes and cages have open slots, a legally-marketed and FDA-cleared sterilization wrap must be used for sterilization purposes to maintain the sterility of the contents.

Table 5.2 describes the validated, FDA-cleared sterilization pouch required for the sterilization procedure.

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Table 5.1: Design Description: Subject Device – Size, Color and Heat-Resistance Type

Proposed DeviceName and Heat-Resistance	Part Number	PeelVue+Part Number	Color	Outer Dimensions(when closed)Width x Depth x Height
Steri-Cassette AA –Shallow – HighHeat	31591	31615	Beige
Steri-Cassette AA –Shallow – StandardHeat	32520, 32521,32522, 32523,32524, 32525	31615	French Vanilla,Sand, LightMauve, Seafoam,Lilac, Baby Blue	7.5" x 5.5" x 1.5"
Steri-Cassette AB –Medium – HighHeat	31592	Baby Blue31643 orForest Green31647	Beige	7.5" x 5.5" x 2.25"
Steri-Cassette BB –Deep – High Heat	31593	Baby Blue31643 orForest Green31647	Beige	7.5" x 5.5" x 3.0"
Steri-Cage –Standard Heat	32506, 32507,32508, 32509,32510, 32511,32512, 32513,32514	3164531615	French Vanilla,Sand, LightMauve, Seafoam,Lilac, Baby Blue,White, Gray,Beige	8.00" x 1.75" x 1.75"

Note: Coordinating PeelVue+ size and shape identified by Part Number.

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Description andSpecific Recommendation	FDA Clearance Information	Manufacturer
Validated, FDA-clearedsterilization pouch –PeelVue+ sterilization pouchesrecommended*	• 510(k) #: K894437• Product Code: FRG• Regulation #: 21 CFR §880.6850• Class: II	Kerr Corporation1717 W. Collins Ave.Orange, CA 92867 USAEstablishmentRegistration: 2024312

Table 5.2: Recommended System Components - Used in Conjunctions with Subject 01710000

*Specific brand used in Sterilization Validation testing for the subject devices.

E. Statement of Indications for Use:

The validated steam sterilization cycle parameters are as follows:

SteamSterilization Cycle	Minimum ExposureTemperature	MinimumExposure Time	Minimum Dry Time
GravityDisplacement(wrapped)	250°F (121°C)	30 Minutes	15 Minutes
GravityDisplacement(wrapped)	270°F (132°C)	15 Minutes	15 Minutes
GravityDisplacement(wrapped)	275°F (135°C)	10 Minutes	30 Minutes
GravityDisplacement(unwrapped forimmediate use)	132°C (270°F)	3 Minutes	None
Pre-Vacuum(wrapped)	270°F (132°C)	4 Minutes	30 Minutes
Pre-Vacuum(wrapped)	275°F (135°C)	3 Minutes	16 Minutes
Pre-Vacuum(unwrapped for	273°F (134°C)	3 Minutes	None

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immediate use)

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Element	Subject DeviceSteri-Cassette and Steri-Cage	Predicate Device (K012105)PolyVac Surgical Instrument Delivery System'sInstrument Cassettes	Subject Devicevs.Predicate Device
Trade/ ProprietaryName	Steri-Cassette and Steri-Cage Sterilization PackagingSystem	PolyVac Surgical Instrument Delivery System'sInstrument Cassettes	N/A
FundamentalScientific Technology	Sterilization Cassette	Sterilization Cassette	Same
Product Code.Regulation No. andDevice Class	KCT (21 CFR § 880.6850), Class II	KCT (21 CFR § 880.6850), Class II	Same
Legal Manufacturer	Kerr Corporation1717 W. Collins Ave.Orange, CA 92867 USARegistration Number: 2024312	Symmetry Medical, Inc. (previously PolyVac, Inc.)220 West Market StreetWarsaw, Indiana 46582 USARegistration Number: Not stated in predicate's 510(k)summary	N/A
Contract Manufacturer	SDS de Mexico S. de R.L. de C.V. (subsidiary of Kerr)Circuito Sur Num. 31Parque Ind. NelsonMexicali, B.C. C.P. Baja California, MEXICO 21395Registration Number: 9680845	Not stated in predicate's 510(k) summary	N/A
Intended Use	Perforated trays with lids to hold surgical instruments inplace during transport, steam sterilization, and storage	Perforated trays with lids to hold surgical instruments inplace during transport, steam sterilization, and storage	Same

Table 5.3: Device Comparison Table Demonstrating Substantial Equivalence

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Element	Subject DeviceSteri-Cassette and Steri-Cage	Predicate Device (K012105)PolyVac Surgical Instrument Delivery System'sInstrument Cassettes	Subject Devicevs.Predicate Device
Description	Steri-Cassettes and Steri-Cages are used to hold instrumentsin a secure way for cleaning, sterilization and presentation atpoint of use. They keep instrumentation organized in anefficient way. They are available in a variety of sizes toaccommodate instruments of various sizes and are offered inan assortment of colors to aid in office organization.	PolyVac Delivery Systems consist of different sizes of thesame basic configuration. All systems consist of aminimum of a plastic or metal base and lid. All lids can befastened to the base by means of assembled hardware or bya locking tab, designed as part of the lid. Accessories maybe used with systems to organize or separate contents to beplaced in them for use.The Delivery Systems are designed using plastic and metalmaterials that can be reused with steam sterilizationmethods. Each tray and lid has an evenly distributed holepattern in relation to its size.	Similar
Element	Subject Device	Predicate Device (K012105)PolyVac Surgical Instrument Delivery System'sInstrument Cassettes	Subject Devicevs.Predicate Device
	Steri-Cassette and Steri-Cage
	The Steri-Cassettes and Steri-Cages are intended to contain dental instruments for cleaning, sterilization, organization, storage and handling. The Steri-Cassettes and Steri-Cages are suitable for pre-vacuum and gravity displacement steam sterilization methods. The cassettes and cages are not intended to maintain sterility; they are intended to be used in conjunction with validated, FDA-cleared sterilization wrap in order to maintain sterility of the enclosed devices.The validated steam sterilization cycle parameters are as follows:	PolyVac's delivery systems consist of perforated trays with lids, which are intended to enclose and protect medical device instrumentation, and to facilitate the sterilization process by allowing steam penetration and air removal. When used in conjunction with an approved sterilization wrap, sterility of the enclosed medical device is maintained until used.PolyVac's delivery systems are to be sterilized in one of the following cycles:Prevacuum Steam: 132°C - 4 minutes minimumGravity Steam: 132°C - 30 minutes minimumGravity Steam: 121°C - 55 minutes minimum	Similar
Indications for Use	SteamSterilizationCycle	MinimumExposureTemperature	MinimumExposureTime	MinimumDry Time
	GravityDisplacement(wrapped)	250°F(121°C)	30 Minutes	15 Minutes
	GravityDisplacement(wrapped)	270°F(132°C)	15 Minutes	15 Minutes
	GravityDisplacement(wrapped)	275°F(135°C)	10 Minutes	30 Minutes
	GravityDisplacement(unwrappedfor immediateuse)	132°C(270°F)	3 Minutes	None
	Pre-Vacuum(wrapped)	270°F(132°C)	4 Minutes	30 Minutes
	Pre-Vacuum(wrapped)	275°F(135°C)	3 Minutes	16 Minutes
Element	Subject DeviceSteri-Cassette and Steri-Cage	Predicate Device (K012105)PolyVac Surgical Instrument Delivery System'sInstrument Cassettes	Subject Devicevs.Predicate Device
- DESIGN -
Material Composition	Cassettes – High Heat: High-Resistant Plastic - Ultem Resin1000 (proprietary mixture with pigments) (thermoplastic)Cassettes - Standard Heat: polypropylene with color(proprietary mixture with pigments) (thermoplastic)Cages: polypropylene with color (proprietary mixture withpigments) (thermoplastic)	Trays & Lids: Aluminum, 300 Series stainless steel,biomedical grade silicone; or Radal R PlasticInstrument Cassettes: Radal R Plastic (thermoplastic)	Similar
Design/ Configuration	Cassettes and cages are manufactured from one of twothermoplastic mixtures used in injection molding.Perforated (slotted) base and lid hinge together and aresecured with a latch mechanism (tab on lid).Cassettes have built-in inserts used to stabilize theinstruments. These inserts are removable and composed ofthe same thermoplastic as the body of the cassette.Cassettes and cages are stackable.	Instrument Cassettes:Manufactured from a thermoplastic mixture (Radal R) usedin injection molding.Perforated (slots and holes) base and lid hinge together andare secured with a latch mechanism (tab on lid).Cassettes have built-in slots (Radal R) used to stabilize theinstruments or may use a non-slip, silicone mat to securethe instruments while providing ventilation to facilitatedrying.Cassettes are stackable.	Similar
ManufacturingProcess	Injection Molding	Injection Molding	Same

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Element	Subject DeviceSteri-Cassette and Steri-Cage	Predicate Device (K012105)PolyVac Surgical Instrument Delivery System'sInstrument Cassettes	Subject Devicevs.Predicate Device
Dimensions	Various - refer to Table 5.1 for outer dimensions	Various depending on model of Instrument Cassette:Device Name Part Number Outer Dimensions (when closed)Width x Depth x Height Shallow Cassette w/ Silicone Mat 7-6050 8.0" x 4.5" x 0.61" Deep Cassette w/ Silicone Mat 7-1250 8.0" x 4.5" x 1.2" 6-Position Slots 7-6000 8.0" x 4.5" x 0.61" 12-Position Slots 7-1200 8.0" x 4.5" x 0.61"		Similar
Air Permeance	Yes	Yes	Same
Percent Perforation	Each base and lid contains evenly distributed slot-pattern in relation to its size.	Each base and lid contains evenly distributed slot and hole pattern in relation to its size.	Same
- PERFORMANCE CHARACTERISTICS and VALIDATION TESTING -
Cleaning Instructions for Reusable Devices	Yes - Per Cleaning Validations conducted.	Yes - Per Cleaning Validations conducted.	Same
Sterilization Method	• Pre-Vacuum• Gravity Displacement	• Pre-Vacuum• Gravity Displacement	Same

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Element	Subject DeviceSteri-Cassette and Steri-Cage				Predicate Device (K012105)PolyVac Surgical Instrument Delivery System'sInstrument Cassettes				Subject Devicevs.Predicate Device
SterilizationParameters per USRequirements(wrapped)*	SteamSterilizationCycle	MinimumExposureTemperature	MinimumExposureTime	MinimumDry Time	SteamSterilizationCycle	MinimumExposureTemperature	MinimumExposureTime	Minimum DryTime	Similar
	GravityDisplacement	250°F (121°C)	30Minutes	15Minutes	GravityDisplacement	250°F(121°C)	55Minutes	20-50Minutesas needed
	GravityDisplacement	270°F (132°C)	15Minutes	15Minutes	GravityDisplacement	270°F(132°C)	30Minutes	20-50Minutesas needed
	GravityDisplacement	275°F (135°C)	10Minutes	30Minutes	Pre-Vacuum	270°F(132°C)	4 Minutes	20-40Minutesas needed
	Pre-Vacuum	270°F (132°C)	4 Minutes	30Minutes
Pre-Vacuum	275°F (135°C)	3 Minutes	16Minutes
*Refer to Indications for Use for immediate use sterilizationparameters (unwrapped).
Reusable	Yes, validated to be reused at least five (5) times.				Yes				Similar
Material Compatibilitywith SterilizationMethod	Yes - Materials are compatible with sterilization method				Yes - Materials are compatible with sterilization method				Same
Sterilant PenetrationStudies	Yes - Sterilant (steam) penetration through perforations inbase and lid - Steam Sterilization Validation testing				Yes - Sterilant (steam) penetration through perforations inbase and lid - Steam Sterilization Validation testing				Same

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Element	Subject Device	Predicate Device (K012105)PolyVac Surgical Instrument Delivery System'sInstrument Cassettes	Subject Devicevs.Predicate Device
Microbial BarrierStudies (packagingintegrity to maintainsterility)	To be used with a validated, FDA-cleared sterilization wrap	To be used with a validated, FDA-cleared sterilizationwrap	Same
Material Compatibilitywith RepeatSterilization	Yes - Materials are compatible with repeated sterilizationcycles per validation testing.Materials of construction are compatible with steamsterilization.	Yes - Materials are compatible with repeated sterilizationcycles.	Similar
- SAFETY / BIOCOMPATIBILITY ASSESSMENT -
ToxicologicalProperties	Yes - Materials are known to be biocompatible and do notcome into direct contact with patient.	Yes - Materials are known to be biocompatible and do notcome into direct contact with patient.	Same
Patient Contact	No	No	Same
Blood/Fluid Contact	None	None	Same
- PACKAGING INTEGRITY -
Packaging	Non-Sterile Plastic Wrap	Non-Sterile - Specific packaging not stated in predicate's510(k) summary.	Same
Labeling	Labeled Plastic Wrap Containing Device and Cleaning andSterilization IFU	Labeled Polybag Containing Device and Cleaning andSterilization IFU	Similar
Distribution Process	Shipped Non-Sterile	Shipped Non-Sterile	Same

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F. Non-clinical Performance Testing

Testing was conducting in accordance with the following standards:

ISO 10993-1:2009 (Biological evaluation of medical devices Part 1: Evaluation . and testing within a risk management process)
. ISO 7405:2008 (Dentistry - Evaluation of biocompatibility of medical devices used in dentistry)
. ISO 17664:2004 (Sterilization of medical devices - Information to be provided by the manufacturer for the processing of sterilizable medical devices)
. ANSI/AAMI/ISO 17665-1:2006 (Sterilization of health care products - Moist Heat - Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices)
. ISO14937:2000 (Sterilization of health care products – General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices)
. AAMI TIR12:2010 (Designing, testing, and labeling for reprocessing in health care facilities: A guide for medical device manufacturers)
. AAMI TIR30:2011 (A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices)
. AAMI ST77, Rev. 2013 (Containment devices for reusable medical device sterilization)
. ANSI/AAMI ST79:2010 (Comprehensive guide to steam sterilization and sterility assurance in health care facilities)

H. Conclusion

Based on the intended use, indications for use, technological characteristics, performance data and comparison to the predicate device, the subject Steri-Cassette and Steri-Cage product line has been shown to be substantially equivalent to the legally marketed predicate device PolyVac Surgical Instrument Delivery System's Instrument Cassettes (K012105).

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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).