STERITITE UNIVERSAL CONTAINER SYSTEM AND MEDITRAY PRODUCTS
Device Facts
| Record ID | K090068 |
|---|---|
| Device Name | STERITITE UNIVERSAL CONTAINER SYSTEM AND MEDITRAY PRODUCTS |
| Applicant | Case Medical, Inc. |
| Product Code | FRG · General Hospital |
| Decision Date | Feb 24, 2010 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.6850 |
| Device Class | Class 2 |
Indications for Use
The SteriTite universal container system with MediTray products is a reusable sterilization container system used to enclose other medical devices, which are to be sterilized, transported and stored by a health care provider. The SteriTite container system is intended for use in Steris Amsco V-PRO 1 low temperature Sterilization System Lumen Cycle. SteriTite Sealed Container system is recommended for surface and stainless steel lumens (process up to 20 stainless steel lumened instruments of 3mm diameter or larger and a length up to 400 mm or shorter).
Device Story
Rigid, reusable sterilization container system; anodized aluminum base/lid; passivated stainless steel hardware; silicone gaskets. Houses medical instruments in MediTray baskets/trays/inserts during sterilization in Steris Amsco V-PRO 1 low temperature system. Disposable non-woven polypropylene filter provides bacterial barrier. Latching mechanism secures lid; offset vent holes prevent strike-through. Used by healthcare providers in clinical settings to maintain sterility of instruments during transport and storage. Benefits patient by ensuring sterile delivery of surgical instruments.
Clinical Evidence
Bench testing only. Sterility assurance validated using 'overkill method' with biological indicators placed in most difficult-to-sterilize areas, including lumens (3mm x 400mm), under lids, and within instrument brackets. Validated for worst-case scenarios with representative MediTray inserts.
Technological Characteristics
Anodized aluminum container; passivated stainless steel hardware; silicone gaskets; disposable non-woven polypropylene filter. Rigid form factor; modular inserts (baskets, trays, brackets). Compatible with Steris Amsco V-PRO 1 low temperature sterilization system. Mechanical design features offset vent holes for bacterial barrier protection.
Indications for Use
Indicated for healthcare providers to enclose, sterilize, transport, and store medical devices. Compatible with Steris Amsco V-PRO 1 low temperature sterilization system (Lumen Cycle). Recommended for surface and stainless steel lumens (up to 20 instruments, min 3mm diameter, max 400mm length).
Regulatory Classification
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.
Predicate Devices
- SteriTite universal container system (K080558)
Submission Summary (Full Text)
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K090068
FEB 2 4 2010
## 510(k) Summary of Safety and Effectiveness
SteriTite Universal Container System with MediTray Products for Steris Amsco V-PRO 1 low temperature Sterilization System
Date Prepared: February 22, 2010
Company Name: Case Medical, Inc. 65 Railroad Avenue Ridgefield, NJ 07657
Contact: Tania Lupu Phone: 201-313-1999 ext.229 Fax: 201-313-9090
| Trade Name: | SteriTite® universal container system |
|------------------------------------|-----------------------------------------------------------------------------------------------------------|
| Common Name: | Sterilization container with disposable filter. |
| Establishment registration number: | 2248608 |
| Classification name: | Sterilization Wrap |
| Class of Device: | Class II device, |
| Product Code: | 80FRG |
| Review Panel: | General Hospital |
| Legally Marketed Predicate: | SteriTite universal container system previously cleared for<br>STERRAD 200 and STERRAD NX, 510k # K080558 |
#### Indications for Use:
The SteriTite universal container system with MediTray products is a reusable sterilization The Sterrific universal container of other medical devices, which are to be sterilized, transported container system used to cheriTite container system is intended for use in Steris Amsco V-PRO 1 low temperature Sterilization System Lumen Cycle.
SteriTite Sealed Container system is recommended for surface and stainless steel lumens (process up to 20 stainless steel lumened instruments of 3mm diameter or larger and a length up to 400 mm or shorter).
### Description of the Device:
The SteriTite universal container system consists of a family of rigid reusable containers and inserts that provide an effective sterilization packaging method for operating The SteriTite® container is made out of anodized aluminum with room instruments. passivated stainless steel hardware and silicone gaskets. Stainless steel latching mechanism with handles on both ends secures the lid to the base and provides a method to incorporate with handles on bour chus secures as filter retention plate secures a disposable filter for Various instrument trays as well as stacked baskets and inserts a bacterial barrier filtration. bacterial barrier intration. - Various morement anys as were manager. The
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lids and bases as well as retention plates of the same model and size are compatible and interchangeable throughout its useful life. Vent holes are offset to prevent strike through. All components may be easily disassembled for cleaning.
### Performance Data
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1
Case Medical, Inc. follows the "overkill method" of sterility assurance to show an elimination of a biological challenge. Microbial challenge testing included placement of biological indicators and inoculated products in the most difficult-to-sterilize areas of the container in opposing corners, under the lid, inside of lumens, within insert boxes, and under occlusion within the slot of an instrument bracket securing a surgical instrument. The lumens tested were stainless steel lumens of 3 mm diameter x 400mm length.
All containers were tested with inner baskets or trays representative of the MediTray line of products.
Furthermore, sample containers were validated in worst-case scenarios.
#### Substantial Equivalence:
Case Medical's SteriTite container system is substantially equivalent to the company's previously cleared device for STERRAD 200. All containers are of equivalent sizes, have gasketed lids that latch, and offer tamper evident features.
References:
ANSVAAMI ST 77:2006 - Containment Devices for Reusable Medical Devices Sterilization ANSVAAMI ST 79:2006 - Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities
Division of Dental, Infection Control, and General Hospital Devices
510(k) Number_K090068
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of a bird-like figure, possibly representing an eagle or other national symbol. The figure is composed of three curved lines that suggest movement or flight.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Tania Lupu Quality Assurance Quality Consultant Director Case Medical, Incorporated 65 Railroad Avenue Ridgefied, New Jersey 07657
FEB 2 4 2010
Re: K090068
Trade/Device Name: SteriTite Universal Container System and MediTray Products Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: FRG Dated: February 11, 2010 Received: February 16, 2010
Dear Ms. Lupu:
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.
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## Page 2- Ms. Lupu
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/A.boutlFDA/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Susan Runne
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 (if known): K090068
Device Name: SteriTite Universal Container System and MediTray products
Indications for Use:
The SteriTite universal container system with MediTray products is a reusable sterilization container system used to enclose other medical devices, which are to be sterilized, transported and stored by a health care provider. The SteriTite container system is intended for use in Steris Amsco V-PRO 1 low temperature Sterilization System Lumen Cycle.
SteriTite Sealed Container system is recommended for surface and stainless steel lumens (process up to 20 stainless steel lumened instruments of 3mm diameter or larger and a length up to 400 mm or shorter).
The table below identifies the SteriTite Sealed Containers with disposable filter , which may be sterilized in Steris Amsco V-PRO 1 low temperature Sterilization System:
Over-The-Counter Use_ Prescription Use AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of *2*
Elisut Б.Саши шел
(Division Sign-Off)
Division of Anesthesiology, General Hospital
infection Control, Dental Devices
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| Part<br>Number | Description | Steris Amsco<br>V-PRO 1 w/<br>polypropylene<br>disposable<br>filter | Maximum load<br>(lbs) inclusive<br>of sealed<br>container<br>weight |
|----------------|-------------------------------------------|---------------------------------------------------------------------|---------------------------------------------------------------------|
| SC03MG | 3" high Endo mini-size w/ perforated base | X | 5.63 |
| SC03QG | 3" high Endo mid-size w/ perforated base | X | 8.85 |
| SC04FG | 4" high Full-size w/ perforated base | X | 19.97 |
| SC04HG | 4" high Half-size w/ perforated base | X | 9.90 |
| SC04QG | 4" high Mid-size w/ perforated base | X | 15.70 |
| SC06FG | 6" high Full-size w/ perforated base | X | 19.97 |
| SC06HG | 6" high Half-size w/ perforated base | X | 13.16 |
| SC06QG | 6" high Mid-size w/ perforated base | X | 19.97 |
| SC08FG | 8" high Full-size w/ perforated base | X | 19.97 |
| SC08HG | 8" high Half-size w/ perforated base | X | 15.92 |
| SC08QG | 8" high Mid-size w/ perforated base | X | 19.97 |
| SC05WG | 5" high Extra Wide w/ perforated base | X | 19.97 |
Note: All containers for Steris Amsco V-PRO 1 low temperature Sterilization System Note. An containers for Steners, which must be used with single-use non-woven Polypro filter.
## MediTray Products Compatibility Table
| MEDITRAY PRODUCT | Steris Amsco V-PRO 1 |
|-------------------|----------------------|
| Baskets | X |
| Trays | X |
| Insert Boxes | X |
| Metal Brackets | X |
| Metal Partitions | X |
| Posts | X |
| Silicone Brackets | X |
| Racks | X |
| Stringers | X |
Over-The-Counter Use X Prescription Use AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Conalityence (Mish Rightighting of Device Evaluation (ODE) Division of Anesthesiology, General Hospital - Page 2 of _2 _________ Paral Hospital ్రగా Infection Control, Dental Devices Infection Control, Demai Devices
K090068 510(k) Number: _KO 510(k) Number: _______________________________________________________________________________________________________________________________________________________________
