(281 days)
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No
The document describes a reusable sterilization container system and its components, focusing on materials, design, and sterilization compatibility. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is a sterilization container system, which is used to sterilize other medical devices. It does not directly treat or diagnose a medical condition in a patient.
No
The device is a reusable sterilization container system used to enclose other medical devices for sterilization, transport, and storage, not for diagnosing medical conditions.
No
The device description clearly outlines physical components made of anodized aluminum, stainless steel, and silicone, indicating it is a hardware device. There is no mention of software as the primary or sole component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "reusable sterilization container system intended to be used to enclose other medical devices (blades and lumens), which are to be sterilized, transported and stored by a health care provider." This describes a device used for the sterilization and handling of other medical instruments, not for performing tests on biological samples to diagnose conditions.
- Device Description: The description details the physical components of the container system (aluminum, stainless steel, filters, trays, etc.) and its function in holding and protecting instruments during sterilization. This aligns with a sterilization container, not an IVD.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The device's function is to facilitate the sterilization of other medical devices, which is a crucial step in preventing the spread of infection in a healthcare setting. This falls under the category of a medical device used for sterilization and handling, not an in vitro diagnostic device.
N/A
Intended Use / 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 STERRAD 200, STERRAD NX and Ozone 125L sterilizers, as well as the sealed containers are intended for prevacuum steam flash sterilization (270°F for 4 minutes). The container may be used for sterilization of medical devices including full instrument sets and mixed loads.
SteriTite Sealed Container system is recommended for surface and lumens:
-In STERRAD® 200 Sterilization, process only stainless steel lumened instruments of 3mm diameter or larger and a length up to 400 mm.
-In STERRAD NX standard cycle, process stainless steel lumened instruments of 2mm diameter or larger and up to 400 mm in length.
-In STERRAD NX advanced cycle, process stainless steel lumened instruments of 1mm diameter or larger and up to 500 mm in length and porous lumens (flexible endoscope) of 1mm diameter or larger and up to 850 mm in length.
-In Pre-vacuum Steam Flash Sterilization, process stainless steel lumened instruments of 2mm diameter or larger and a length of up to 400 mm as well as porous lumens of 3mm diameter or larger and a length up to 400 mm.
-In Ozone 125L Sterilization, process stainless steel lumened instruments of 3mm diameter or larger and a length up to 470 mm.
The attached tables identify which products with disposable filter may be sterilized in the respective sterilization cycles.
Product codes (comma separated list FDA assigned to the subject device)
80FRG
Device Description
The SteriTite universal container system consists of a family of rigid reusable containers and inserts that provide an effective sterilization packaging method for operating room instruments. The SteriTite® container has both solid and perforated base containers. The container is made out of anodized aluminum with passivated stainless steel hardware and silicone gaskets. A stainless steel latching mechanism with handles on both ends secures the lid to the base and provide a method to incorporate tamper proof disposable locks. Each filter retention plate secures a disposable filter for bacterial barrier filtration. Various instrument trays as well as stacked baskets and inserts provide instrument protection and secure devices for sterilization within the container. The 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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
Health care provider
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 are as follows:
- STERRAD 200 Sterilization: Max Diameter Lumen 3 mm, Max Length Lumen 400 mm, Material Stainless Steel Blades, Lumens and Mixed Loads
- STERRAD NX Standard cycle: Max Diameter Lumen 2 mm, Max Length Lumen 400 mm, Material Stainless Steel Blades, Lumens and Mixed Loads
- STERRAD NX Advance cycle: Max Diameter Lumen 1 mm, Max Length Lumen 500 mm, Material Stainless Steel Blades, Lumens and Mixed Loads; Max Diameter Lumen 1 mm, Max Length Lumen 850 mm, Material Porous Lumens (Flexible endoscope)
- Pre-Vacuum Flash with paper filter Sterilization: Max Diameter Lumen 2 mm, Max Length Lumen 400 mm, Material Stainless Steel Blades, Lumens and Mixed Loads; Max Diameter Lumen 3 mm, Max Length Lumen 400 mm, Material Porous Lumens
- Ozone 125L Sterilization: Max Diameter Lumen 3 mm, Max Length Lumen 470 mm, Material Stainless Steel Blades, Lumens and Mixed Loads
All containers were tested with inner baskets or trays representative of the MediTrav line of products.
Furthermore, sample containers were validated in worst-case scenarios. In STERRAD NX and STERRAD 200 Sterilization the maximum load was 22lbs. (STU 10 kg) including the container. In Pre-Vacuum Steam Sterilization and Ozone 125L Sterilization, the maximum load was 35lbs. (15.8 kg.) total weight. The test samples represented a worst-case scenario in the SteriTite line of product based on number of holcs (vents) per contamer volume. Internal stacking of trays and utilization of components was also validated under fractional and half cycle conditions. Validation testing utilizing replicate cycles was conducted in independent laboratories in accordance with available AAMI standards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
The SteriTite container system is the same container previously cleared.
Aesculap's Sterilcontainer
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
DEC 05 2008
510(k) Summary of Safety and Effectiveness 5.
SteriTite Universal Container System with MediTray Products for STERRAD 200, STERRAD NX, Ozone 125L Sterilization, and Prevacuum Steam Flash Sterilization
Date Prepared: October, 14 2008
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 |
Indications for Use:
The SteriTite universal container system with MediTray products is a reusable sterilization container system intended to be used to enclose other medical devices (blades and lumens), which are to be sterilized, transported and stored by a health care provider.
The SteriTite container system is intended for use in STERRAD 200. STERRAD NX and Ozone 125L sterilizers, as well as the sealed containers are intended for pre-vacuum steam flash sterilization (270°F for 4 minutes).
The SteriTite perforated bottom container with disposable polypropylene filters (Polypro) must be used for STERRAD Sterilization. The paper filter is recommended for prevacuum steam flash sterilization. For ozone sterilization, either disposable naper or polypropylene filters can be used.
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 room instruments. The SteriTite® container has both solid and perforated base containers. The container is made out of anodized aluminum with passivated stainless steel hardware and
1
silicone gaskets. A stainless steel latching mechanism with handles on both ends secures the lid to the base and provide a method to incorporate tamper proof disposable locks. Each filter retention plate secures a disposable filter for bacterial barrier filtration. Various instrument trays as well as stacked baskets and inserts provide instrument protection and secure devices for sterilization within the container. The 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
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 are as follows:
| Sterilization Method | Max Diameter Lumen | Max Length Lumen | Material |
|---|---|---|---|
| STERRAD 200 Sterilization | 3 mm | 400 mm | Stainless Steel Blades, Lumens and Mixed Loads |
| STERRAD NX Standard cycle | 2 mm | 400 mm | Stainless Steel Blades, Lumens and Mixed Loads |
| STERRAD NX Advance cycle | 1 mm | 500 mm | Stainless Steel Blades, Lumens and Mixed Loads |
| 1 mm | 850 mm | Porous Lumens (Flexible endoscope) | |
| Pre-Vacuum Flash with paper filter Sterilization | 2 mm | 400 mm | Stainless Steel Blades, Lumens and Mixed Loads |
| 3 mm | 400 mm | Porous Lumens | |
| Ozone 125L Sterilization | 3 mm | 470 mm | Stainless Steel Blades, Lumens and Mixed Loads |
All containers were tested with inner baskets or trays representative of the MediTrav line of products.
Furthermore, sample containers were validated in worst-case scenarios. In STERRAD NX and STERRAD 200 Sterilization the maximum load was 22lbs. (STU 10 kg) including the container. In Pre-Vacuum Steam Sterilization and Ozone 125L Sterilization, the maximum load was 35lbs. (15.8 kg.) total weight. The test samples represented a worst-case scenario in the SteriTite line of product based on number of holcs (vents) per contamer volume. Internal stacking of trays and utilization of components was also validated under fractional and half
2
cycle conditions. Validation testing utilizing replicate cycles was conducted in independent laboratories in accordance with available AAMI standards.
Substantial Equivalence:
Case Medical's SteriTite container system is substantially equivalent to the company's previously device as well as Aesculap's Sterilcontainer in STERRAD 100s and Ozone 125L, as well as Aesculap's Sterilcontainer and One Tray for prevacuum steam sterilization. The SteriTite container system is the same container previously cleared. However, the STERRAD compatible Aesculap Sterilcontainer is made out of non-anodized aluminum and is thus a different Aesculap Sterilcontainer than that used for steam sterilization. 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
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and service. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", indicating the department's name and national affiliation.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Tania Lupu Quality Assurance - Quality Control Director Case Medical, Incorporated 65 Railroad Avenue Ridgefield, New Jersey 07657-0402
DEC 0 5 2008
Re: K080558
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: November 13, 2008 Received: November 28, 2008
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
4
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): good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
line, Chiu S. Lin. Ph. D
Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
5
Indications for Use
510(k) Number (if known):
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 STERRAD 200, STERRAD NX and Ozone 125L sterilizers, as well as the sealed containers are intended for prevacuum steam flash sterilization (270°F for 4 minutes). The container may be used for sterilization of medical devices including full instrument sets and mixed loads.
SteriTite Sealed Container system is recommended for surface and lumens:
-In STERRAD® 200 Sterilization, process only stainless steel lumened instruments of 3mm diameter or larger and a length up to 400 mm.
-In STERRAD NX standard cycle, process stainless steel lumened instruments of 2mm diameter or larger and up to 400 mm in length.
-In STERRAD NX advanced cycle, process stainless steel lumened instruments of 1mm diameter or larger and up to 500 mm in length and porous lumens (flexible endoscope) of 1mm diameter or larger and up to 850 mm in length.
-In Pre-vacuum Steam Flash Sterilization, process stainless steel lumened instruments of 2mm diameter or larger and a length of up to 400 mm as well as porous lumens of 3mm diameter or larger and a length up to 400 mm.
-In Ozone 125L Sterilization, process stainless steel lumened instruments of 3mm diameter or larger and a length up to 470 mm.
The attached tables identify which products with disposable filter may be sterilized in the respective sterilization cycles.
Over-The-Counter Use Prescription Use V AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of O of Device Evaluation (ODE)
Shulie Murphy, MD
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Page 1 of
510(k) Number: K080558
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SteriTite Universal Container System Compatibility Table in Prevacuum flash w/ paper filter
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| Part
Number | Description | Pre-vacuum flash w/ paper
filter |
|----------------|----------------------------------------------|-------------------------------------|
| SC03M | 3" high Endo mini-size w/ solid base | X |
| SC03MG | 3" high Endo mini-size w/
perforated base | X |
| SC03Q | 3" high Endo mid-size w/ solid base | X |
| SC03QG | 3" high Endo mid-size w/ perforated
base | X |
| SC04F | 4" high Full-size w/ solid base | X |
| SC04FG | 4" high Full-size w/ perforated base | X |
| SC04H | 4" high Half -size w/ solid base | X |
| SC04HG | 4" high Half -size w/ perforated
base | X |
| SC04Q | 4" high Mid-size w/ solid base | X |
| SC04QG | 4" high Mid-size w/ perforated base | X |
| SC06F | 6" high Full-size w/ solid base | X |
| SC06FG | 6" high Full-size w/ perforated base | X |
| SC06H | 6" high Half -size w/ solid base | X |
| SC06HG | 6" high Half -size w/ perforated
base | X |
| SC06Q | 6" high Mid-size w/ solid base | X |
| SC06QG | 6" high Mid-size w/ perforated base | X |
| SC08F | 8" high Full-size w/ solid base | X |
| SC08FG | 8" high Full-size w/ perforated base | X |
| SC08H | 8" high Half -size w/ solid base | X |
| SC08HG | 8" high Half -size w/ perforated
base | X |
| SC08Q | 8" high Mid-size w/ solid base | X |
| SC08QG | 8" high Mid-size w/ perforated base | X |
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| Part | Description | Ozone 125L w/ paper or
polypropylene disposable filter |
|--------|-------------------------------------------|-----------------------------------------------------------|
| Number | | |
| SC03M | 3" high Endo mini-size w/ solid base | X |
| SC03MG | 3" high Endo mini-size w/ perforated base | X |
| SC03Q | 3" high Endo mid-size w/ solid base | X |
| SC03QG | 3" high Endo mid-size w/ perforated base | X |
| SC04F | 4" high Full-size w/ solid base | X |
| SC04FG | 4" high Full-size w/ perforated base | X |
| SC04H | 4" high Half -size w/ solid base | X |
| SC04HG | 4" high Half -size w/ perforated base | X |
| SC04Q | 4" high Mid-size w/ solid base | X |
| SC04QG | 4" high Mid-size w/ perforated base | X |
| SC06F | 6" high Full-size w/ solid base | X |
| SC06FG | 6" high Full-size w/ perforated base | X |
| SC06H | 6" high Half -size w/ solid base | X |
| SC06HG | 6" high Half -size w/ perforated base | X |
| SC06Q | 6" high Mid-size w/ solid base | X |
| SC06QG | 6" high Mid-size w/ perforated base | X |
| SC08F | 8" high Full-size w/ solid base | X |
| SC08FG | 8" high Full-size w/ perforated base | X |
| SC08H | 8" high Half -size w/ solid base | X |
| SC08HG | 8" high Half -size w/ perforated base | X |
| SC08Q | 8" high Mid-size w/ solid base | X |
| SC08QG | 8" high Mid-size w/ perforated base | X |
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SteriTite Universal Container System Compatibility Table Ozone 125L w/ paper & polypropylene disposable filter
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| SteriTite Universal Container System Compatibility in STERRAD 200 w/ | ||
|---|---|---|
| polypropylene disposable filter |
| Part | Description | STERRAD 200 w/
polypropylene
disposable filter |
|--------|-------------------------------------------|------------------------------------------------------|
| Number | | |
| SC03MG | 3" high Endo mini-size w/ perforated base | X |
| SC03QG | 3" high Endo mid-size w/ perforated base | X |
| SC04FG | 4" high Full-size w/ perforated base | X |
| SC04HG | 4" high Half-size w/ perforated base | X |
| SC04QG | 4" high Mid-size w/ perforated base | X |
| SC06FG | 6" high Full-size w/ perforated base | X |
| SC06HG | 6" high Half-size w/ perforated base | X |
| SC06QG | 6" high Mid-size w/ perforated base | X |
| SC08FG | 8" high Full-size w/ perforated base | X |
| SC08HG | 8" high Half-size w/ perforated base | X |
| SC08QG | 8" high Mid-size w/ perforated base | X |
Note: Part number with suffix "G" signifies perforated bottom container, which must be used with non-woven Polypro filter for STERRAD Sterilization.
SteriTite Universal Container System Compatibility in STERRAD NX w/ polypropylene disposable filter 1. 1
| Part
Number | Description | STERRAD NX w/
polypropylene
disposable filter |
|----------------|-------------------------------------------|-----------------------------------------------------|
| SC03MG | 3" high Endo mini-size w/ perforated base | X |
| SC03QG | 3" high Endo mid-size w/ perforated base | X |
| SC04FG | 4" high Full-size w/ perforated base | X |
| SC04HG | 4" high Half-size w/ perforated base | X |
| SC04QG | 4" high Mid-size w/ perforated base | X |
Note: For STERRAD NX Sterilization only the 3" high and 4" high containers can be used due to STERRAD NX chamber size
·
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| MEDITRAY
PRODUCT | STERRAD 200 | STERRAD NX | Ozone 125L | Pre-vacuu
flash |
|---------------------|-------------|------------|------------|--------------------|
| Baskets | X | X | X | X |
| Trays | X | X | X | X |
| Insert Boxes | X | X | X | X |
| Metal Brackets | X | X | X | X |
| Metal Partitions | X | X | X | X |
| Posts | X | X | X | X |
| Silicone Brackets | X | X | X | X |
| Racks | X | X | X | X |
| Stringers | X | X | X | X |
MediTray Products Compatibility Table
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