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510(k) Data Aggregation
(64 days)
Steriking® LT-Blueline Pouches with Tyvek® are intended to provide health care workers with an effective method to enclose devices intended for sterilization in the STERIS® V-Pro® Sterilizer Systems.
The device is intended to allow sterilization of enclosed devices and to maintain sterility of the enclosed devices until used up to 1 year post sterilization. The products are for single use only.
Steriking® LT-Blueline Pouches with Tyvek are intended for use in the following STERIS® V-Pro® Sterilization Cycles: Lumen Cycle Non Lumen Cycle Flexible Cycle
Device lumen dimensions:
Flexible Cycle: 1 lumen max and 1 mm min ID x 1050 mm max length for all pouch sizes.
Lumen Cycle: 1 lumen max for all pouch sizes.
1 mm min ID for pouch sizes: 130 x 380 mm, 130 x 270 mm, 90 x 250 mm, 90 x 200 mm 2 mm min ID for pouch sizes: 300 x 450 mm, 250 x 400 mm, 190 x 330 mm 125 mm max length for pouch sizes: 130 x 380 mm, 130 x 250 mm, 90 x 250 mm, 90 x 200 mm 250 mm max length for pouch sizes: 300 x 450 mm, 250 x 400 mm, 190 x 330 mm
Max Weights: 1.234 pounds for pouch sizes below (Flexible, Lumen, and Non-Lumen Cycles) 300 x 450 mm 250 x 400 mm 190 x 330 mm
.122 pounds for pouch sizes below (Flexible and Lumen Cycles) 130 x 380 mm 130 x 270 mm 90 x 250 mm 90 x 200 mm
.204 pounds for pouch sizes below (Non-Lumen Cycle) 130 x 380 mm 130 x 270 mm 90 x 250 mm 90 x 200 mm
Pouch Sizes: 300 x 450 mm 250 x 400 mm
Steriking® LT-Blueline Pouches with Tyvek® are intended to provide health care workers with an effective method to enclose devices intended for sterilization in the STERIS® V-Pro® Sterilizer Systems.
The device is intended to allow sterilization of enclosed devices and to maintain sterility of the enclosed devices until used up to 1 year post sterilization. The products are for single use only.
Steriking® LT-Blueline Pouches with Tyvek are intended for use in the following STERIS® V-Pro® Sterilization Cycles: Lumen Cycle Non Lumen Cycle Flexible Cycle
Device lumen dimensions:
Flexible Cycle: 1 lumen max and 1 mm min ID x 1050 mm max length for all pouch sizes.
Lumen Cycle: 1 lumen max for all pouch sizes.
1 mm min ID for pouch sizes: 130 x 380 mm, 130 x 270 mm, 90 x 250 mm, 90 x 200 mm 2 mm min ID for pouch sizes: 300 x 450 mm, 250 x 400 mm, 190 x 330 mm 125 mm max length for pouch sizes: 130 x 380 mm, 130 x 250 mm, 90 x 250 mm, 90 x 200 mm 250 mm max length for pouch sizes: 300 x 450 mm, 250 x 400 mm, 190 x 330 mm
Max Weights: 1.234 pounds for pouch sizes below (Flexible, Lumen, and Non-Lumen Cycles) 300 x 450 mm 250 x 400 mm 190 x 330 mm
.122 pounds for pouch sizes below (Flexible and Lumen Cycles) 130 x 380 mm 130 x 270 mm 90 x 250 mm 90 x 200 mm
.204 pounds for pouch sizes below (Non-Lumen Cycle) 130 x 380 mm 130 x 270 mm 90 x 250 mm 90 x 200 mm
Pouch Sizes: 300 x 450 mm 250 x 400 mm
This document is an FDA 510(k) clearance letter for a medical device: "Steriking® LT-Blueline Pouches with Tyvek®". It confirms that the device is substantially equivalent to legally marketed predicate devices.
However, the provided text does not contain any information about acceptance criteria or a study proving that an AI/ML device meets those criteria. The document is a regulatory approval for a physical medical device (sterilization pouches), not an AI/ML diagnostic or therapeutic device.
Therefore, I cannot answer your specific questions regarding acceptance criteria and performance studies for an AI/ML device based on the input provided. The requested information (e.g., sample size for test set, number of experts for ground truth, MRMC studies, standalone performance, training set details) is relevant for AI/ML device submissions, but this document pertains to a physical sterilization product.
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(64 days)
Steriking® LT-Blueline Pouches with Tyvek® are intended to provide health care workers with an effective method to enclose devices intended for sterilization in the STERRAD® Sterilizer Systems. The device is intended to allow sterilization of enclosed devices and to maintain sterility of the enclosed devices until used up to 1 years post sterilization. The products are for single use only. The Steriking® LT-Blueline Pouches with Tyvek are intended for use in the following STERRAD® Sterilization Cycles:
NX Standard
NX Advanced
100NX Duo
100NX Flex
100NX Standard
Max weights:
NX Standard Cycle:
For pouch sizes 90 x 200 mm, 90 x 250 mm, 130 x 270 mm, 130 x 380 mm, .094 lbs. For pouch sizes 190 x 330 mm, 250 x 400 mm, 300 x 450 mm, 1.194 pounds.
NX Advanced Cycle:
For pouch sizes 90 x 200 mm, 90 x 250 mm, 130 x 270 mm, 130 x 380 mm, .096 lbs. For pouch sizes 190 x 330 mm, 250 x 400 mm, 300 x 450 mm, 1.224 pounds.
100NX Duo Cycle:
For pouch sizes 90 x 200 mm, 90 x 250 mm, 130 x 270 mm, 130 x 380 mm, .116 lbs. For pouch sizes 190 x 330 mm, 250 x 400 mm, 300 x 450 mm, 1.222 pounds.
100NX Flex Cycle:
For pouch sizes 90 x 200 mm, 90 x 250 mm, 130 x 270 mm, 130 x 380 mm, .202 lbs. For pouch sizes 190 x 330 mm, 250 x 400 mm, 300 x 450 mm, 1.220 pounds.
100NX Standard Cycle:
For pouch sizes 90 x 200 mm, 90 x 250 mm, 130 x 270 mm, 130 x 380 mm, .202 lbs. For pouch sizes 190 x 330 mm, 250 x 400 mm, 300 x 450 mm, 4.478 pounds.
Max Count of lumens:
1 lumen max for All cycles
Max ID of lumens:
NX Standard Cycle:
1 mm ID for all pouch sizes
NX Advanced Cycle:
2 mm ID for all pouch sizes
100NX Cycle:
1 mm ID for all pouch sizes
100NX Flex Cycle:
1 mm ID for all pouch sizes
100NX Standard Cycle:
2 mm ID for all pouch sizes
Max lumen lengths:
NX Standard Cycle:
For pouch sizes 90 x 200 mm, 90 x 250 mm, 130 x 270 mm, 130 x 380 mm, 125 mm. For pouch sizes 190 x 330 mm, 250 x 400 mm, 300 x 450 mm, 250 mm.
NX Advanced Cycle:
For pouch sizes 90 x 200 mm, 90 x 250 mm, 130 x 270 mm, 130 x 380 mm, 125 mm. For pouch sizes 190 x 330 mm, 250 x 400 mm, 300 x 450 mm, 250 mm.
100NX Duo Cycle:
850 mm for all pouch sizes
100NX Flex Cycle:
850 mm for all pouch sizes
100NX Standard Cycle:
For pouch sizes 90 x 200 mm, 90 x 250 mm, 130 x 270 mm, 130 x 380 mm, 125 mm. For pouch sizes 190 x 330 mm, 250 x 400 mm, 300 x 450 mm, 250 mm.
Pouch Sizes:
300 x 450 mm
250 x 400 mm
190 x 330 mm
130 x 380 mm
130 x 270 mm
90 x 250 mm
90 x 200 mm
Steriking® LT-Blueline Pouches with Tyvek® are intended to be used to contain medical devices to be terminally sterilized in the STERRAD® Sterilization System. The medical devices are inserted into the Pouch, sealed, and then sterilized in the STERRAD ® Sterilization System. Sterilization Cycles are noted below. After completion of the sterilization process, the Pouch maintains sterility of the enclosed medical devices until the seal is opened. These pouches are made from a plastic film and Tyvek that is heat-sealed on three sides. The fourth side is left opened and will be self-sealed when used.
Steriking® LT-Blueline Pouches with Tyvek® are intended to allow sterilization of enclosed devices and to maintain sterility of the enclosed devices until used up to 1 year post sterilization. The products are for single use only.
The pouches are constructed from Tyvek®/plastic films. The self-sealed pouches are self sealed prior to processing in the STERRAD® Sterilization Systems.
Sterilization Systems:
STERRAD® Cycles:
NX Standard
NX Advanced
100NX Duo
100NX Flex
100NX Standard
The document provided describes the Steriking® LT-Blueline Pouches with Tyvek®, which are intended to enclose devices for sterilization in STERRAD® Sterilizer Systems and maintain their sterility for up to one year. This device is a sterilization wrap, regulated as Class II.
The study presented is a non-clinical performance study to demonstrate that the proposed device, a self-seal pouch, is as safe and effective as its predicate device, a heat-seal pouch, with an added adhesive strip for sealing.
Here's an analysis of the acceptance criteria and the study results based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Category | Test | Acceptance Criteria | Reported Device Performance | Conclusion |
|---|---|---|---|---|
| Package Integrity, Pre-Sterilization Shelf Life | Dye Migration | No leaks detected after dye migration | All self-seal pouches passed the dye penetration at time zero | Pass |
| Package Integrity, Pre-Sterilization Shelf Life | Tensile | All samples are > 1.5N/15mm per ASTM F88 | All samples are > 1.5N/15mm per ASTM F88 | Pass |
| Package Integrity, Post-Sterilization | Tensile | All samples are > 1.5N/15mm per ASTM F88 | All samples are > 1.5N/15mm per ASTM F88 | Pass |
| Biocompatibility | Cytotoxicity | Not greater than Grade 2 reactivity (mildly reactive) | No reduction of cell growth and cell lysis | Pass |
| Package Integrity, Post-Sterilization | Microbial Aerosol Challenge | A sample which demonstrates that all items remain sterile following exposure | Each pouch met the sterility maintenance requirement as there was no growth in any of the culture tubes containing the stainless-steel coupons at the end if the incubation period. | Pass |
| Sterilization Penetration | Sterilization Penetration | Demonstrating that a minimum of $1.0\times10^6$ Geobacillus stearothermophilus spores were killed in a half-cycle (6-log reduction) using a worst-case, end of shelf-life injection volume | Negative for growth following the minimum incubation period (for all STERRAD cycles: 100NX Standard, NX Standard, NX Advanced, 100NX Flex, 100NX Duo) | Pass |
| Post Sterilization Shelf Life | Maintenance of Sterility | No growth after exposure | Pass. No growth following exposure (for 100NX Standard cycle, aged 365 days) | Pass |
| Package Integrity, Post-Sterilization | Accelerated Aging | Seal maintains integrity | Pass. No suspect seals were observed, and the test samples remained intact. (for 100NX Standard cycle, aged 3 years accelerated aging) | Pass |
| Package Integrity, Post-Sterilization | Tensile (after accelerated aging) | All samples are > $1.5N/15mm$ per ASTM F88 | All samples are > $1.5N/15mm$ per ASTM F88 (for 100NX Standard cycle, aged 3 years accelerated aging) | Pass |
2. Sample Sizes Used for the Test Set and Data Provenance
The document does not explicitly state the specific numerical sample sizes ("N") for each test. Instead, it refers to "All self-seal pouches," "All samples," and "Each pouch." This implies that the tests were conducted on a sufficient number of samples according to the referenced standards (e.g., ASTM, AAMI, ISO), which typically specify minimum sample sizes.
The data provenance is not specified regarding country of origin. The study appears to be prospective as it's a performance study for a new iteration of a device (the addition of a self-sealing adhesive strip) on the market. The phrase "Studies on the self-seal pouch were performed concurrently to the heat-seal pouch studies" suggests newly generated data for the proposed device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The tests performed are primarily laboratory-based physical, chemical, and microbiological evaluations against established standards, rather than expert-based assessments of images or patient data. Therefore, the concept of "ground truth" derived from human experts in the context of diagnostic interpretation is not applicable here.
4. Adjudication Method for the Test Set
This is not applicable as the tests are analytical and objective measurements against defined standards, not subjective assessments requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. The device is a sterilization pouch and not a diagnostic imaging or AI-driven decision support tool that would typically involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
No, a standalone study in the context of an algorithm or AI is not applicable. The device is a physical product (sterilization pouch), and the performance assessments are for the device's physical and functional properties.
7. The Type of Ground Truth Used
The ground truth used for these performance tests is based on established industry standards and scientific principles as outlined in various ASTM, AAMI, and ISO documents (e.g., ASTM F1929 for dye migration, ASTM F88 for tensile strength, ISO 10993-5 for cytotoxicity, AAMI TIR12 for microbial aerosol challenge and sterilization penetration). For biological tests like sterility, the "ground truth" is determined by the absence or presence of microbial growth under specified conditions (e.g., kill of $1.0\times10^6$ Geobacillus stearothermophilus spores, no growth after exposure).
8. The Sample Size for the Training Set
This is not applicable as there is no "training set" in the context of an AI/ML algorithm. The device is a physical product.
9. How the Ground Truth for the Training Set was Established
This is not applicable as there is no "training set" for this type of device.
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