(269 days)
Not Found
No
The device description and intended use focus on physical containment and sterilization properties, with no mention of AI or ML capabilities.
No
The device is described as a container for dental instruments during cleaning and sterilization, not a device that directly provides therapy or treatment.
No
Explanation: The device is intended to contain dental instruments for cleaning, sterilization, organization, storage, and handling. It does not perform any diagnostic function.
No
The device described is a physical medical device (cassettes and cages) used for holding instruments during sterilization. It is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Steri-Cassettes and Steri-Cages are for containing dental instruments for cleaning, sterilization, organization, storage, and handling. This is a physical function related to the processing and storage of medical devices, not for performing tests on biological samples to diagnose or monitor a medical condition.
- Device Description: The description focuses on the physical characteristics of the cassettes and cages, such as materials, design, and how they hold instruments. There is no mention of reagents, assays, or any components used for in vitro testing.
- Performance Studies: The performance studies listed are related to sterilization, biocompatibility, and reprocessing of medical devices, which are relevant to devices used in healthcare settings but not specifically to IVDs.
- Predicate Device: The predicate device is also an instrument cassette, further supporting that this device falls under the category of medical device accessories for sterilization and handling, not IVDs.
IVDs are devices intended for use in vitro for the examination of specimens, including blood, tissues, and urine, from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. The Steri-Cassettes and Steri-Cages do not perform this function.
N/A
Intended Use / Indications for Use
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 Sterilization Cycle: Gravity Displacement (wrapped); Minimum Exposure Temperature: 250°F (121°C); Minimum Exposure Time: 30 Minutes; Minimum Dry Time: 15 Minutes
Steam Sterilization Cycle: Gravity Displacement (wrapped); Minimum Exposure Temperature: 270°F (132°C); Minimum Exposure Time: 15 Minutes; Minimum Dry Time: 15 Minutes
Steam Sterilization Cycle: Gravity Displacement (wrapped); Minimum Exposure Temperature: 275°F (135°C); Minimum Exposure Time: 10 Minutes; Minimum Dry Time: 30 Minutes
Steam Sterilization Cycle: Gravity Displacement (unwrapped for immediate use); Minimum Exposure Temperature: 132°C (270°F); Minimum Exposure Time: 3 Minutes; Minimum Dry Time: None
Steam Sterilization Cycle: Pre-Vacuum (wrapped); Minimum Exposure Temperature: 270°F (132°C); Minimum Exposure Time: 4 Minutes; Minimum Dry Time: 30 Minutes
Steam Sterilization Cycle: Pre-Vacuum (wrapped); Minimum Exposure Temperature: 275°F (135°C); Minimum Exposure Time: 3 Minutes; Minimum Dry Time: 16 Minutes
Steam Sterilization Cycle: Pre-Vacuum (unwrapped for immediate use); Minimum Exposure Temperature: 273°F (134°C); Minimum Exposure Time: 3 Minutes; Minimum Dry Time: None
Product codes (comma separated list FDA assigned to the subject device)
KCT
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.
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. 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.
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 manufacturer name and UDI direct part marking will be added to the mold during the Injection Molding 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, 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.
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 according to 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)
Key results:
- Cleaning Instructions for Reusable Devices: Yes - Per Cleaning Validations conducted.
- Sterilization Method: Pre-Vacuum, Gravity Displacement.
- Reusable: Yes, validated to be reused at least five (5) times.
- Material Compatibility with Sterilization Method: Yes - Materials are compatible with sterilization method.
- Sterilant Penetration Studies: Yes - Sterilant (steam) penetration through perforations in base and lid - Steam Sterilization Validation testing.
- Microbial Barrier Studies (packaging integrity to maintain sterility): To be used with a validated, FDA-cleared sterilization wrap.
- Material Compatibility with Repeat Sterilization: Yes - Materials are compatible with repeated sterilization cycles per validation testing. Materials of construction are compatible with steam sterilization.
- Toxicological Properties: Yes - Materials are known to be biocompatible and do not come into direct contact with patient.
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.
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
§ 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).
0
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.
1
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
2
Indications for Use
510(k) Number (if known) K162063
Device Name
Steri-Cassette and Steri-Cage Sterilization Packaging Systems
Indications for Use (Describe)
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 Sterilization
Cycle | Minimum Exposure
Temperature | Minimum
Exposure Time | Minimum Dry Time |
|-------------------------------------------------------------|---------------------------------|--------------------------|------------------|
| Gravity
Displacement
(wrapped) | 250°F (121°C) | 30 Minutes | 15 Minutes |
| Gravity
Displacement
(wrapped) | 270°F (132°C) | 15 Minutes | 15 Minutes |
| Gravity
Displacement
(wrapped) | 275°F (135°C) | 10 Minutes | 30 Minutes |
| Gravity
Displacement
(unwrapped for
immediate 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
immediate 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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3
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 Instrument
Cassettes |
|---------------------|-----------------------------------------------------------------------|
| 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 |
4
D. Description of Device:
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.
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
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 manufacturer name and UDI direct part marking will be added to the mold during the Injection Molding 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.
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.
Table 5.2 describes the validated, FDA-cleared sterilization pouch required for the sterilization procedure.
5
Table 5.1: Design Description: Subject Device – Size, Color and Heat-Resistance Type
| Proposed Device
Name and Heat-
Resistance | Part Number | PeelVue+
Part Number | Color | Outer Dimensions
(when closed)
Width x Depth x Height |
|---------------------------------------------------|---------------------------------------------------------------------------|------------------------------------------------|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------|
| Steri-Cassette AA –
Shallow – High
Heat | 31591 | 31615 | Beige | |
| Steri-Cassette AA –
Shallow – Standard
Heat | 32520, 32521,
32522, 32523,
32524, 32525 | 31615 | French Vanilla,
Sand, Light
Mauve, Seafoam,
Lilac, Baby Blue | 7.5" x 5.5" x 1.5" |
| Steri-Cassette AB –
Medium – High
Heat | 31592 | Baby Blue
31643 or
Forest Green
31647 | Beige | 7.5" x 5.5" x 2.25" |
| Steri-Cassette BB –
Deep – High Heat | 31593 | Baby Blue
31643 or
Forest Green
31647 | Beige | 7.5" x 5.5" x 3.0" |
| Steri-Cage –
Standard Heat | 32506, 32507,
32508, 32509,
32510, 32511,
32512, 32513,
32514 | 31645
31615 | French Vanilla,
Sand, Light
Mauve, 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.
6
| Description and
| Specific Recommendation | FDA Clearance Information | Manufacturer |
|---|---|---|
| Validated, FDA-cleared | ||
| sterilization pouch – | ||
| PeelVue+ sterilization pouches | ||
| recommended* | • 510(k) #: K894437 | |
| • Product Code: FRG | ||
| • Regulation #: 21 CFR § | ||
| 880.6850 | ||
| • Class: II | Kerr Corporation | |
| 1717 W. Collins Ave. | ||
| Orange, CA 92867 USA | ||
| Establishment | ||
| Registration: 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 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
Sterilization Cycle | Minimum Exposure
Temperature | Minimum
Exposure Time | Minimum Dry Time |
|-------------------------------------------------------------|---------------------------------|--------------------------|------------------|
| Gravity
Displacement
(wrapped) | 250°F (121°C) | 30 Minutes | 15 Minutes |
| Gravity
Displacement
(wrapped) | 270°F (132°C) | 15 Minutes | 15 Minutes |
| Gravity
Displacement
(wrapped) | 275°F (135°C) | 10 Minutes | 30 Minutes |
| Gravity
Displacement
(unwrapped for
immediate 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 |
7
| immediate use) | |||
|---|---|---|---|
8
| Element | Subject Device
Steri-Cassette and Steri-Cage | Predicate Device (K012105)
PolyVac Surgical Instrument Delivery System's
Instrument Cassettes | Subject Device
vs.
Predicate Device |
|-----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|
| Trade/ Proprietary
Name | Steri-Cassette and Steri-Cage Sterilization Packaging
System | PolyVac Surgical Instrument Delivery System's
Instrument Cassettes | N/A |
| Fundamental
Scientific Technology | Sterilization Cassette | Sterilization Cassette | Same |
| Product Code.
Regulation No. and
Device Class | KCT (21 CFR § 880.6850), Class II | KCT (21 CFR § 880.6850), Class II | Same |
| Legal Manufacturer | Kerr Corporation
1717 W. Collins Ave.
Orange, CA 92867 USA
Registration Number: 2024312 | Symmetry Medical, Inc. (previously PolyVac, Inc.)
220 West Market Street
Warsaw, Indiana 46582 USA
Registration 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. 31
Parque Ind. Nelson
Mexicali, B.C. C.P. Baja California, MEXICO 21395
Registration Number: 9680845 | Not stated in predicate's 510(k) summary | N/A |
| Intended Use | Perforated trays with lids to hold surgical instruments in
place during transport, steam sterilization, and storage | Perforated trays with lids to hold surgical instruments in
place during transport, steam sterilization, and storage | Same |
Table 5.3: Device Comparison Table Demonstrating Substantial Equivalence
9
| Element | Subject Device
Steri-Cassette and Steri-Cage | Predicate Device (K012105)
PolyVac Surgical Instrument Delivery System's
Instrument Cassettes | Subject Device
vs.
Predicate 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. | PolyVac Delivery Systems consist of different sizes of the
same basic configuration. All systems consist of a
minimum of a plastic or metal base and lid. All lids can be
fastened to the base by means of assembled hardware or by
a locking tab, designed as part of the lid. Accessories may
be used with systems to organize or separate contents to be
placed in them for use.
The Delivery Systems are designed using plastic and metal
materials that can be reused with steam sterilization
methods. Each tray and lid has an evenly distributed hole
pattern in relation to its size. | Similar | |
| Element | Subject Device | Predicate Device (K012105)
PolyVac Surgical Instrument Delivery System's
Instrument Cassettes | Subject Device
vs.
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 minimum
Gravity Steam: 132°C - 30 minutes minimum
Gravity Steam: 121°C - 55 minutes minimum | Similar | |
| Indications for Use | Steam
Sterilization
Cycle | Minimum
Exposure
Temperature | Minimum
Exposure
Time | Minimum
Dry Time |
| | Gravity
Displacement
(wrapped) | 250°F
(121°C) | 30 Minutes | 15 Minutes |
| | Gravity
Displacement
(wrapped) | 270°F
(132°C) | 15 Minutes | 15 Minutes |
| | Gravity
Displacement
(wrapped) | 275°F
(135°C) | 10 Minutes | 30 Minutes |
| | Gravity
Displacement
(unwrapped
for immediate
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 |
| Element | Subject Device
Steri-Cassette and Steri-Cage | Predicate Device (K012105)
PolyVac Surgical Instrument Delivery System's
Instrument Cassettes | Subject Device
vs.
Predicate Device | |
| - DESIGN - | | | | |
| Material Composition | Cassettes – High Heat: High-Resistant Plastic - Ultem Resin
1000 (proprietary mixture with pigments) (thermoplastic)
Cassettes - Standard Heat: polypropylene with color
(proprietary mixture with pigments) (thermoplastic)
Cages: polypropylene with color (proprietary mixture with
pigments) (thermoplastic) | Trays & Lids: Aluminum, 300 Series stainless steel,
biomedical grade silicone; or Radal R Plastic
Instrument Cassettes: Radal R Plastic (thermoplastic) | Similar | |
| Design/ Configuration | Cassettes and cages are manufactured from one of two
thermoplastic mixtures used in injection molding.
Perforated (slotted) base and lid hinge together and are
secured with a latch mechanism (tab on lid).
Cassettes have built-in inserts used to stabilize the
instruments. These inserts are removable and composed of
the same thermoplastic as the body of the cassette.
Cassettes and cages are stackable. | Instrument Cassettes:
Manufactured from a thermoplastic mixture (Radal R) used
in injection molding.
Perforated (slots and holes) base and lid hinge together and
are secured with a latch mechanism (tab on lid).
Cassettes have built-in slots (Radal R) used to stabilize the
instruments or may use a non-slip, silicone mat to secure
the instruments while providing ventilation to facilitate
drying.
Cassettes are stackable. | Similar | |
| Manufacturing
Process | Injection Molding | Injection Molding | Same | |
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| Element | Subject Device
Steri-Cassette and Steri-Cage | Predicate Device (K012105)
PolyVac Surgical Instrument Delivery System's
Instrument Cassettes | Subject Device
vs.
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 Device
Steri-Cassette and Steri-Cage | | | | Predicate Device (K012105)
PolyVac Surgical Instrument Delivery System's
Instrument Cassettes | | | | Subject Device
vs.
Predicate Device |
|------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|------------------------------------|-----------------------------|---------------------|----------------------------------------------------------------------------------------------------------------------|------------------------------------|-----------------------------|-------------------------------|-------------------------------------------|
| Sterilization
Parameters per US
Requirements
(wrapped)* | Steam
Sterilization
Cycle | Minimum
Exposure
Temperature | Minimum
Exposure
Time | Minimum
Dry Time | Steam
Sterilization
Cycle | Minimum
Exposure
Temperature | Minimum
Exposure
Time | Minimu
m Dry
Time | Similar |
| | Gravity
Displacement | 250°F (121°C) | 30
Minutes | 15
Minutes | Gravity
Displacement | 250°F
(121°C) | 55
Minutes | 20-50
Minutes
as needed | |
| | Gravity
Displacement | 270°F (132°C) | 15
Minutes | 15
Minutes | Gravity
Displacement | 270°F
(132°C) | 30
Minutes | 20-50
Minutes
as needed | |
| | Gravity
Displacement | 275°F (135°C) | 10
Minutes | 30
Minutes | Pre-Vacuum | 270°F
(132°C) | 4 Minutes | 20-40
Minutes
as needed | |
| | Pre-Vacuum | 270°F (132°C) | 4 Minutes | 30
Minutes | | | | | |
| Pre-Vacuum | 275°F (135°C) | 3 Minutes | 16
Minutes | | | | | | |
| *Refer to Indications for Use for immediate use sterilization
parameters (unwrapped). | | | | | | | | | |
| Reusable | Yes, validated to be reused at least five (5) times. | | | | Yes | | | | Similar |
| Material Compatibility
with Sterilization
Method | Yes - Materials are compatible with sterilization method | | | | Yes - Materials are compatible with sterilization method | | | | Same |
| Sterilant Penetration
Studies | Yes - Sterilant (steam) penetration through perforations in
base and lid - Steam Sterilization Validation testing | | | | Yes - Sterilant (steam) penetration through perforations in
base and lid - Steam Sterilization Validation testing | | | | Same |
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| Element | Subject Device | Predicate Device (K012105)
PolyVac Surgical Instrument Delivery System's
Instrument Cassettes | Subject Device
vs.
Predicate Device |
|--------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|-------------------------------------------|
| Microbial Barrier
Studies (packaging
integrity to maintain
sterility) | To be used with a validated, FDA-cleared sterilization wrap | To be used with a validated, FDA-cleared sterilization
wrap | Same |
| Material Compatibility
with Repeat
Sterilization | Yes - Materials are compatible with repeated sterilization
cycles per validation testing.
Materials of construction are compatible with steam
sterilization. | Yes - Materials are compatible with repeated sterilization
cycles. | Similar |
| - SAFETY / BIOCOMPATIBILITY ASSESSMENT - | | | |
| Toxicological
Properties | Yes - Materials are known to be biocompatible and do not
come into direct contact with patient. | Yes - Materials are known to be biocompatible and do not
come 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's
510(k) summary. | Same |
| Labeling | Labeled Plastic Wrap Containing Device and Cleaning and
Sterilization IFU | Labeled Polybag Containing Device and Cleaning and
Sterilization 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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