(262 days)
PMS Steripack Tyvek Sterilization Pouches (TP) with Chemical Indicator; are intended to provide healthcare workers with an effective method to enclose medical devices intended for sterilization in vaporized hydrogen peroxide (VHP) sterilization method.
PMS Steripack Tyvek Sterilization Pouches (TP) with Chemical Indicator is a device intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed medical devices and also maintain sterility of the enclosed devices until used.
The recommended (and validated) sterilization cycle parameters are:
The Steris V-PRO 1 PLUS LUMEN CYCLE is a single preprogramed standard sterilization cycle with NO cycle parameter variables allowed by the end user.
Chemical process indicator on the exterior of the Tyvek pouches and rolls indicates that the pouch has been exposed to V-PRO 1 Plus, Lumen Cycle sterilization process by changing color from red to blue or (lighter).
Devices with stainless steel lumens with the following internal diameter (ID) and maximum length can be processed in V-PRO 1 Plus, Lumen Cycle.
| Pouch Size | Max. lumen length | Min. internal diameter | Max # Lumens |
|---|---|---|---|
| 50 x | |||
| 200mm | 50 mm | 1.5 mm | 1 |
| 150 x | |||
| 300mm | 3 mm | 200 mm | 1 |
| 350 x | |||
| 600mm | 3 mm | 400 mm | 1 |
PMSSteriback Tvvek Sterilization Pouches (TP) and Rolls (TY) with Chemical Indicator; are manufactured from tyvek material/laminated PET/PE film that are heat sealed on sides. Triple band seal provides three independent barriers to contamination, while reducing the risk of fibre tear.
PMSSteripack Tyvek Sterilization Pouches (TP) and Rolls (TY) with Chemical Indicator; are divided into 2 main configuration groups as below.
Sterilization Pouches, Flat:
These pouches are manufactured from twek material/ laminated PET/PE plastic film that are heat sealed on 3 sides, the remaining open side is heat sealed by the end user.
Sterilization Rolls, Flat:
These rolls are manufactured from tyvek material and laminated PET/PE plastic film that are heat sealed on opposite two sides. The required size is cut from the roll and the remaining open sides are heat sealed by the end user.
This document is a 510(k) summary for the PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical Indicator. It compares the submission device to a predicate device (STERIS Vis-U-All Low Temperature Sterilization Pouch/Tubing) to demonstrate substantial equivalence.
Here's an analysis of the acceptance criteria and study information provided, focusing on the requested categories:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Design and Construction & Material Composition | "Tyvek material and heat sealed laminated PET/PE plastic film. Externally printed H2O2 chemical process indicator ink. Pouches are manufactured from tyvek material/plastic film that are heat sealed on 3 sides. The remaining side is left opened and heat sealed by the end user. Rolls are manufactured from tyvek material/plastic film that are heat sealed on opposite two sides. The required size is cut from the roll and the remaining open two sides are heat sealed by the end user." |
| Indications for Use | "PMS Steripack Tyvek Sterilization Pouches (TP) and Rolls (TY) with Chemical Indicator; are intended to provide healthcare workers with an effective method to enclose medical devices intended for sterilization in vaporized hydrogen peroxide (VHP) sterilization method. PMS Steripack Tyvek Sterilization Pouches (TP) and Rolls (TY) with Chemical Indicator is a device intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed medical devices and also maintain sterility of the enclosed devices until used." "The recommended (and validated) sterilization cycle parameters are: The Steris V-PRO 1 PLUS LUMEN CYCLE is a single preprogramed standard sterilization cycle with NO cycle parameter variables allowed by the end user. Chemical process indicator on the exterior of the Tyvek pouches and rolls indicates that the pouch has been exposed to V-PRO 1 Plus, Lumen Cycle sterilization process by changing color from red to blue or (lighter). Devices with stainless steel lumens with the following internal diameter (ID) and maximum length can be processed in V-PRO 1 Plus, Lumen Cycle." (Specific lumen claims are listed in the document's Table 1.) "Worst Case Load: The worst case load for the 50 mm x 200 mm pouch is 0.058 lbs. of instruments. The worst case load for the 150 mm x 300 mm pouch is 0.630 lbs. of instruments. The worst case load for the 350 mm x 600 mm pouch is 3.054 lbs. of instruments." |
| Sterilization Properties | "V-PRO 1 Plus, Lumen Cycle" |
| Principle of Operations | "Medical device to be sterilized is put into pouch or roll and the open parts of the packages are closed by the end user with heat sealing. Sterilization Pouches then are subjected to sterilization operation in recommended (validated) VHP (Vaporized Hydrogen Peroxide) sterilization devices and the cycle as V-PRO 1 PLUS, Lumen Cycle. Sterilant penetration occurs through the tyvek material into the packages and microorganisms on the surfaces of the enclosed medical devices are destroyed via the sterilant." |
| Principles of Operation for Chemical Indicators | "The Process Indicators Ink printed on the tyvek material will exhibit a color change after the pouch is exposed to Hydrogen Peroxide (H2O2) gas. Hydrogen Peroxide (H2O2) sterilization printed indicator bar changes from red to blue (or lighter) when exposed to hydrogen peroxide vapor." The indicators are classified as Class 1 type process indicator according to ISO 11140-1 standard. |
| Shelf Life (Prior to Sterilization) | 3 years (Note: Predicate device is 2 years, but this is reported as "YES" for substantial equivalence) |
| Shelf Life (Post Sterilization) | "Sterility was maintained for at least 30 days after processing in V-PRO 1 Plus, Lumen Cycle" (Note: Predicate device is 1 year, but this is reported as "YES" for substantial equivalence and meets the specified 30-day maintenance claim). |
| Configurations & Dimensions | "Various sizes (width and height/length)" |
| Sterilant Penetration | "The sterilization (VHP) was validated to a sterility assurance level (SAL) of 10-6" |
| Microbial Barrier Properties | "Sterility was maintained for at least 30 days after processing in V-PRO 1 Plus, Lumen Cycle" |
| Material Compatibility | "Suitability for use in V-PRO 1 Plus, Lumen Cycle sterilization process and cycle parameters." |
| Biocompatibility | "Not direct patient-contacting devices; Materials are non-toxic and meet ISO 10993-1 requirements." |
| Package Integrity | "Porous material providing a microbial barrier." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a separate "test set" sample size for evaluating the device's performance against the acceptance criteria. Instead, it refers to "non-clinical performance tests summaries" and mentions validation of sterilization to a "sterility assurance level (SAL) of 10-6".
- Sample Size for Test Set: Not explicitly stated as a single "test set" sample size in the provided text. The validation to SAL 10-6 typically involves a statistically significant number of biological indicator tests across multiple cycles and loads, but the exact number isn't quantified here. Individual tests, such as those for microbial barrier, material compatibility, and package integrity, would have their own sample sizes, but these are not precisely detailed.
- Data Provenance: Not specified. The document states that PMS TIBBI CIHAZLAR TEKNOLOJISI SANA YI VE TICARET ANONIM ŞIRKETI is based in Turkey, suggesting the studies could have been conducted there or by a contracted lab. It doesn't specify if the data is retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This type of device (sterilization pouch with chemical indicator) does not typically involve human expert interpretation for "ground truth" in the same way clinical diagnostic imaging might. The "ground truth" for its performance is established through objective laboratory testing (e.g., microbiology for sterility, physical testing for barrier properties, chemical reaction for indicators). Therefore, information about experts for ground truth is not applicable in this context.
4. Adjudication Method for the Test Set
Not applicable for this type of device and testing. Performance is assessed through objective measurements against technical standards (e.g., ISO 11140-1, ISO 11607-1).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This device is a sterilization pouch and not an AI or diagnostic imaging system that would be evaluated for human reader improvement.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This is a physical medical device (sterilization packaging), not an AI algorithm. Its performance is inherent to its physical and chemical properties.
7. Type of Ground Truth Used
The "ground truth" for this device's performance is established through:
- Sterility Assurance Level (SAL) of 10-6: Achieved through microbiological validation studies, which would involve biological indicators.
- Microbial Barrier Properties: Determined through physical challenge tests (e.g., bacterial challenge tests, dye penetration tests).
- Material Compatibility: Assessed through chemical and physical interaction studies with the sterilant and within the sterilization cycle.
- Biocompatibility: Evaluated against ISO 10993-1 standards for materials that indirectly contact patients, typically through testing of extracts from the materials.
- Chemical Indicator Efficacy: Verified by observing color change response to exposure/non-exposure to the sterilant, often against standards like ISO 11140-1.
- Package Integrity: Assessed through tests like seal strength, visual inspection, and aging studies.
- Outcomes data: While "patient outcomes" are not directly measured for the pouch itself, the ultimate outcome is the sterilization of medical devices, which is fundamental to patient safety.
8. Sample Size for the Training Set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
§ 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).