(112 days)
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No
The document describes a physical sterilization container system and its compatibility with specific sterilization cycles. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
No
This device is a sterilization container system used to enclose other medical devices for sterilization, transport, and storage. It does not directly treat or diagnose a disease or condition.
No
This device is described as a reusable sterilization container system used to enclose other medical devices for sterilization, transport, and storage. It is not involved in assessing or identifying a medical condition.
No
The device description clearly states it is a system of rigid reusable containers and inserts made of materials like anodized aluminum and stainless steel, which are physical hardware components.
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 SteriTite Universal Container System is used to "enclose other medical devices, which are to be sterilized, transported and stored by a health care provider." This describes a device used in the process of preparing other medical devices for use, not a device used to perform diagnostic tests on biological samples.
- Device Description: The description focuses on the physical components of the container system (perforated base and lid, filters, materials, trays, inserts) and its function in holding and protecting instruments during sterilization. There is no mention of reagents, assays, or any components related to analyzing biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or treatment decisions based on biological analysis
- Use of reagents or calibrators
The SteriTite Universal Container System is a device used in the sterilization process of other medical devices, which falls under a different regulatory category than IVDs.
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 container consists of a perforated base and lid, with filter retention plates, and disposable polypropylene filters. The SteriTite container system is compatible for use with AMSCO V-PRO 1 Plus low temperature Sterilization System, Lumen and Non-lumen Cycle, and AMSCO V-PRO maX low temperature Sterilization System Lumen, Non-lumen and Flexible Cycle. The SteriTite container has been validated with stainless steel and porous lumens, inoculated product, insert boxes, multilevel tray systems and various inserts, including brackets, posts and partitions. The SteriTite container may be used for sterilization of medical devices, including full instrument sets and mixed loads.
- 30 days of real time shelf-life testing with handling events has been conducted for SteriTite containers after sterilization in Amsco V-PRO sterilization lumen cycle.
- Reuse testing: Material Compatibility was assessed after 100 cycles of AMSCO V-PRO 1 lumen cycles.
SteriTite Universal Container System is recommended for use in:
V-PRO 1 Plus sterilizer in: 1.
- Non-lumen cycles to sterilize non-luments, including non-lumened rigid endoscopes and non-lumened hinged instruments, such as forceps or scissors.
- Lumen cycles to sterilize instruments with diffusion restricted areas, such as the hinged portion of forceps and scissors, and medical devices, including rigid endoscopes, with a single stainless steel lumen, with an inside diameter of 3mm or larger and a length of 400mm or shorter for a maximum of 20 lumens per load.
- V-PRO maX sterilizer in:
- Non-lumen cycles to sterilize non-luments including non-lumened rigid endoscopes and non-lumened hinged instruments, such as forceps or scissors.
- Lumen cycles to sterilize instruments with diffusion restricted areas, such as the hinged portion of forceps and scissors, and medical devices, including rigid endoscopes with a single stainless steel lumen with an inside diameter of 3mm or larger, and a length of 400mm or shorter for a maximum of 20 lumens per load.
- Flexible cvcles to sterilize single or dual lumen surgical flexible endoscopes in either of two load configurations (per sterilizer manufacturer instruction):
- a. Two flexible endoscopes and no additional load, each having either:
- a single lumen with an inside diameter of 1mm or larger, and a length of 1050mm or shorter, or
- two lumens, with one having an inside diameter of 1mm or larger and a length of 998mm or shorter, and the second one an inside diameter of 1 mm or larger and a length of 850mm or shorter.
- b. One flexible endoscope and load, each having either:
- a single lumen with an inside diameter of 1mm or larger and a length of 1050mm or shorter, or
- two lumens with one having an inside diameter of 1 mm or larger and a length of 998mm or shorter and the second one an inside diameter of 1 mm or larger and a length of 850mm or shorter.
- a. Two flexible endoscopes and no additional load, each having either:
The SteriTite Universal Container System is recommended to be used for the sterilization of surfaces and rigid or flexible lumens:
Table 1: SteriTite Universal Container System in AMSCO V-PRO sterilization.
| Sterilizer | Cycle | Rigid lumens 3mm dia. or larger and 400 mm long or shorter | Flexible lumens 1 mm dia. or larger and 1050mm long or shorter | Surfaces |
|---|---|---|---|---|
| Amsco V-PRO 1 Plus | Lumen cycle | X | ||
| Non-lumen cycle | X | |||
| Amsco V-PRO Max | Lumen cycle | X | ||
| Non-lumen cycle | X | |||
| Flexible cycle | X |
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 for use in Amsco V-PRO 1 Plus and V-PRO 1 Max non-lumen and flexible cycle has a perforated base. The container is made out of anodized aluminum with passivated stainless steel hardware and silicone gaskets. Each filter retention plate secures a disposable filter for bacterial barrier filtration. Various instrument trays as well as stacked baskets and inserts including insert boxes, brackets, posts, partitions and racks provide instrument protection and secure devices for sterilization within the container.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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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)
All required testing per "Draft Guidance for the Preparation of Premarket Notifications 510(k)'s" was completed. The SteriTite universal container system with MediTray products were fully validated for Amsco V-PRO 1Plus in Lumen and Non Lumen and V-PRO Max, in Lumen, Non-Lumen and Flexible Cycle. The validation testing was conducted at qualified independent laboratories in accordance with FDA guidance and 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.
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).
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§ 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
JAN 2 4 2012
5. 510(K) Summary of Safety and Effectiveness
SteriTite Universal Container System with MediTray Products for Amsco V-PRO 1 Plus and AMSCO V-PRO Max, in Non-lumen and Flexible Cycle
| Date Prepared: | 9/25/11 |
|---|---|
| Company Name: | Case Medical, Inc. |
| 19 Empire Blvd | |
| South Hackensack, NJ 07606 |
| Contact: | Tania Lupu
Phone: 201-313-1999 ext.229
Fax: 201-373-9090
Email: tlupu@casemed.com |
| ---------- | -------------------------------------------------------------------------------------------- |
|---|
| Trade Name: | SteriTite® Universal Container System & MediTray Products |
|---|---|
| Common Name: | Sterilization container with disposable filter. |
| Regulation number: | 880.6850 |
| Classification name: | Sterilization Wrap |
| Class of Device: | Class II device |
| Product Code: | 80FRG |
| Review Panel: | General Hospital |
| Establishment Registration Number: | 2248608 |
5.1 Substantial Equivalence:
Case Medical believes that the SteriTite universal container system with MediTray Products for Amsco V-PRO 1 Plus and V-PRO Max, in Non-lumen and Flexible Cycle is substantially equivalent to:
- SteriTite® universal container system -anodized- previously cleared for Amsco V-PRO 1 . Lumen cycle, 510(K) #K090068.
5.2 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 for use in Amsco V-PRO 1 Plus and V-PRO 1 Max non-lumen and flexible cycle has a perforated base. The container is made out of anodized aluminum with
1
passivated stainless steel hardware and silicone gaskets. Each filter retention plate secures a disposable filter for bacterial barrier filtration. Various instrument trays as well as stacked baskets and inserts including insert boxes, brackets, posts, partitions and racks provide instrument protection and secure devices for sterilization within the container.
5.3 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 and instrumentation to be sterilized, transported and stored by health care providers. The container consists of a perforated base and lid with filter retention plates, and disposable polypropylene filters. The SteriTite universal container system is compatible for use with Amsco V-PRO 1 Plus and V-PRO 1 Max non-lumen and flexible cycle and the lumen cycle previously cleared. The SteriTite container has been validated with inoculated product, insert boxes, multilevel tray systems and various inserts including brackets, posts and partitions and inoculated flexible lumens. The container may be used for sterilization of medical devices including full instrument sets and mixed loads.
SteriTite container system is recommended to be used for sterilization of surfaces and lumens:
- 30 days of real time Shelf life testing with handling events has been conducted for SteriTite . containers after sterilization in Amsco V-PRO sterilization lumen cycle.
- Reuse testing / Material Compatibility was performed after 100 of AMSCO V-PRO 1 lumen . cycles.
SteriTite universal container system is recommended to be used for sterilization of surfaces and rigid or flexible lumens:
| Sterilizer | Cycle | Rigid lumens 3mm
diameter or > and
400 mm long or and
1050mm long or