(84 days)
The Vis-U-All Low Temperature Sterilization Pouches/Tubing are sterilization containment pouches for use by health care providers to enclose:
- medical devices in a single or double pouch configuration
- trays containing medical devices in a single or double pouch configuration
- small items requiring surface sterilization in a single pouch configuration within a tray
NOTE: Trays must be legally marketed for use in the V-PRO Low Temperature or STERRAD Sterilization Systems and contain a vent surface area to tray volume ratio ≥ 0.135 in-1 with the maximum number of instrument organizers installed.
and to be sterilized in the:
- Lumen, Non Lumen, Flexible, Fast Non Lumen and Fast Cycles of the V-PRO® Low Temperature Sterilization Systems
- Default Cycle of the STERRAD 100S Sterilizer
- Standard and Advanced Cycles of the STERRAD NX and NX with ALLClear Technology Sterilizers
- Express, Standard, Flex Scope, and DUO Cycles of the STERRAD 100NX with ALLClear Technology Sterilizers
The pouches maintain the sterility of the enclosed devices until used.
When used to enclose medical devices, the pouches are intended to contain the devices in such a manner as to leave a minimum of one inch between the devices and seal on all sides. When used to enclose a tray, the tray must fit loosely within the pouch.
The proposed Vis-U-All Low Temperature Sterilization Pouches/Tubing is identical to the predicate and is a Tyvek/plastic film sterilization containment pouch designed for devices to be sterilized by the health care provider in V-PRO Low Temperature Sterilization Systems. As is the predicate device, the proposed device is available as a self seal pouch, a heat seal pouch, or heat seal tubing.
The provided text describes the acceptance criteria and the results of non-clinical testing for the Vis-U-All Low Temperature Sterilization Pouches/Tubing. However, it does not contain information about a study involving AI, human readers, or ground truth established by experts/pathology/outcomes data, nor does it specify sample sizes for test or training sets in the context of an AI/algorithm device.
This document is a 510(k) summary for a medical device (sterilization pouches) and the testing described is related to the physical and microbial barrier properties, as well as the effectiveness of sterilization and residual levels of sterilant, for the pouch itself. It is not an AI/algorithm-based device and therefore does not have the types of criteria or studies you've requested.
Based on the provided text, here is the information that is available concerning the acceptance criteria and study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance (Conclusion) |
|---|---|---|
| Effective Sterilant Penetration into Pouches (including pouched trays and, if applicable, pouches placed within a tray) | Worst case test articles shall be reproducibly sterilized under worst case ½ cycle conditions for the: • STERRAD 100S Default Cycle • STERRAD NX Standard Cycle • STERRAD NX Advanced Cycle • STERRAD 100NX Standard Cycle • STERRAD 100NX Flex Scope Cycle • STERRAD 100NX Express Cycle • STERRAD 100NX Duo Cycle | PASS |
| Pouch Integrity: Physical and Microbial Barrier Properties (Tensile Strength) | Pouch material tensile strength will show no statistical difference between processed and unprocessed samples. | PASS |
| Pouch Integrity: Physical and Microbial Barrier Properties (Whole Package Integrity - Burst) | Pouch burst strength will show no statistical difference between processed and unprocessed pouches. | PASS |
| Pouch Integrity: Physical and Microbial Barrier Properties (Seal Strength) | Pouch seal strength will show no statistical difference between processed and unprocessed pouches. | PASS |
| Pouch Integrity: Physical and Microbial Barrier Properties (Microbial Retention) | Tyvek microbial retention will show no statistical difference between processed and unprocessed pouches. | PASS |
| Maintenance of Package Integrity | Packaged instruments shall remain sterile through event-related and real-time studies. | PASS |
| Aeration: Hydrogen Peroxide Residuals | Hydrogen peroxide residuals on the pouch will be reduced to acceptable levels. | PASS |
Information Not Applicable/Not Provided in the Document:
The product mentioned in the document (Vis-U-All Low Temperature Sterilization Pouches/Tubing) is a physical medical device (sterilization pouches/tubing), not an AI/algorithm or diagnostic imaging device. Therefore, the following requested information points are not applicable to the context of this document:
- Sample sizes used for the test set and the data provenance: Not applicable. This refers to test sets for algorithmic performance, not physical product testing.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/algorithm.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.
March 25, 2019
STERIS Corporation Jennifer Nalepka Senior Regulatory Affairs Specialist 5960 Heisley Rd Mentor, Ohio 44060
Re: K183401
Trade/Device Name: Vis-U-All Low Temperature Sterilization Pouch/Tubing Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization wrap Regulatory Class: Class II Product Code: FRG Dated: December 6, 2018 Received: December 7, 2018
Dear Jennifer Nalepka:
This letter corrects our substantially equivalent letter of March 1, 2019.
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Clarence W. Murray lii III -S
For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, 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) K183401
Device Name
Vis-U-All Low Temperature Sterilization Pouches/Tubing
Indications for Use (Describe)
The Vis-U-All Low Temperature Sterilization Pouches/Tubing are sterilization containment pouches for use by health care providers to enclose:
- · medical devices in a single or double pouch configuration
- · trays containing medical devices in a single or double pouch configuration
- · small items requiring surface sterilization in a single pouch configuration within a tray
- NOTE: Trays must be legally marketed for use in the V PRO Low Temperature or STERRAD Sterilization Systems and contain a vent surface area to tray volume ratio ≥ 0.135 in-1 with the maximum number of instrument organizers installed.
and to be sterilized in the:
- · Lumen, Non Lumen, Flexible, Fast Non Lumen and Fast Cycles of the V-PRO® Low Temperature Sterilization Systems
- · Default Cycle of the STERRAD 100S Sterilizer
- Standard and Advanced Cycles of the STERRAD NX and NX with ALLClear Technology Sterilizers
- · Express, Standard, Flex Scope, and DUO Cycles of the STERRAD 100NX with ALLClear Technology Sterilizers
*STERRAD and ALLClear are trademarks of Advanced Sterilization Products
The pouches maintain the sterility of the enclosed devices until used.
When used to enclose medical devices, the pouches are intended to contain the devices in such a manner as to leave a minimum of one inch between the devices and seal on all sides. When used to enclose a tray, the tray must fit loosely within the pouch.
Intended Sterilization Cycles and Intended Pouch Loads when Medical Devices are:
- · Directly pouched
- · Placed inside of a tray and the tray pouched
V-PRO 60 & s2 Lumen Cycle
- · Instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors
- · Non-lumened devices including non-lumened rigid and semi-rigid endoscopes
- · Medical devices, including single, dual and triple channeled rigid endoscopes, with the following configurations:
- single or dual lumen devices
-
0.77 mm internal diameter (ID) and ≤ 410 mm in length
-
- · triple lumen devices
- ≥ 1.2 mm ID and ≤ 275 mm in length
- ≥ 1.8 mm ID and < 310 mm in length
- or
- ≥ 2.8 mm ID and ≤ 317 mm in length
- single or dual lumen devices
V-PRO 60 & s2 Non Lumen Cycle
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Non-lumened devices including non-lumened rigid, semi-rigid and flexible endoscopes and non-lumened devices with diffusion-restricted spaces such as the hinged portion of forceps and scissors.
V-PRO 60 & s2 Flexible Cycle
Load 1: One flexible surgical endoscope with a light cord (if not integral to endoscope) and mat without any additional load. The flexible endoscope may be a:
· single or dual lumen device with lumens that are ≥ 1 mm ID and ≤ 990 mm in length
Load 2: Non-lumened devices including non-lumened rigid, semi-rigid, and flexible endoscopes and non-lumened devices with diffusion-restricted areas such as the hinged portion of forceps or scissors. Medical devices, including rigid and semi-rigid endoscopes, with the following dimensions:
- ≥ 2 mm ID and ≤ 400 mm in length
- ≥ 0.76 mm ID and ≤ 233 mm in length
- ≥ 1.0 mm ID and ≤ 254 mm in length
V-PRO s2 Fast Cycle
- Non-lumened devices including non-lumened rigid, semi-rigid and flexible endoscopes, and non-lumened devices with diffusion-restricted areas such as the hinged portion of forceps or scissors.
- · Medical devices (including single, dual and triple channeled rigid endoscopes) with the following configurations:
- Single or dual channeled devices with stainless steel lumens that are ≥ 0.77 mm ID and ≤ 410 mm in length
- · Triple channeled devices with stainless steel lumens that are either:
- · ≥ 1.2 mm ID and ≤ 275 mm in length
- · ≥ 1.8 mm ID and ≤ 310 mm in length
- or
- · ≥ 2.8 mm ID and ≤ 317 mm in length
V-PRO 1, 1 Plus, maX & maX 2 Lumen Cycle
- · Instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors
- · Non-lumened devices including non-lumened rigid and semi-rigid endoscopes
- · Medical devices, including single, dual and triple channeled rigid endoscopes, with the following configurations:
- · single or dual lumen devices:
-
0.77 mm internal diameter (ID) and ≤ 527 mm in length
-
- · triple lumen devices:
- · ≥ 1.2 mm ID and ≤ 275 mm in length
- · ≥ 1.8 mm ID and ≤ 310 mm in length
- or
- · ≥ 2.8 mm ID and ≤ 317 mm in length
- · single or dual lumen devices:
V-PRO 1 Plus, maX & maX 2 Non Lumen Cycle
Non-lumened devices including non-lumened rigid, semi-rigid and flexible endoscopes and non-lumened devices with stainless steel or titanium diffusion-restricted spaces such as the hinged portion of forceps and scissors
V-PRO maX & maX 2 Flexible Cycle
Load 1: Single or dual lumen surgical flexible endoscopes (such as those used in ENT, Urology and Surgical Care) and bronchoscopes with a light cord (if not integral to endoscope) and mat with no additional load.
The flexible endoscopes may contain either:
- · a single lumen that is ≥ 1 mm ID and ≤ 1050 mm in length
- · or two lumens with:
- one lumen that is ≥ 1 mm ID and < 990 mm in length
- · and the other lumen that is ≥ 1 mm ID and ≤ 850 mm in length
Load 2: Non-luments including instruments with diffusion-restricted areas such as the hinged portion of forceps or scissors.
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V-PRO maX 2 Fast Non Lumen Cycle
Non-lumened devices including non-lumened rigid, semi-rigid and flexible endoscopes and non-lumened devices with stainless steel or titanium diffusion-restricted spaces such as the hinged portion of forceps and scissors.
STERRAD 100S Default Cycle
- · Metal and non-metal medical devices including instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors.
- · Metal and non metal lumened instruments with:
- · ≥ 6 mm ID and ≤ 310 mm in length
- · Medical devices with a single stainless steel lumen with:
- ≥ 1 mm ID and ≤ 125 mm in length
- ≥ 2 mm ID and ≤ 250 mm in length
- · ≥ 3 mm ID and ≤ 400 mm in length
STERRAD NX and NX with ALLClear Technology Standard Cycle
- · Metal and nonmetal medical devices including instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors.
- · Medical devices with a single stainless steel lumen with:
- ≥ 1 mm ID and < 150 mm in length
- ≥ 2 mm ID and ≤ 400 mm in length
STERRAD NX and NX with ALLClear Technology Advanced Cycle
- · Metal and nonmetal medical devices including instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors.
- · Medical Devices, including most flexible endoscopes, with:
- a single stainless steel lumen with:
- ≥ 1 mm ID and ≤ 500 mm in length
- · single channel polyethylene and Teflon (polytetrafluoroethylene):
- · ≥ 1 mm ID and < 850 mm in length
- a single stainless steel lumen with:
STERRAD 100NX and 100NX with ALLClear Technology Standard Cycle
- · Metal and nonmetal medical devices including instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors.
- · Medical devices with a single stainless steel lumen with:
- · ≥ 0.7 mm ID and ≤ 500 mm in length
STERRAD 100NX and 100NX with ALLClear Technology Flex Cycle
- · Metal and nonmetal medical devices including instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors.
- · Medical Devices, including most flexible endoscopes, with:
- · Single channel polyethylene and Teflon (polytetrafluoroethylene)
- ≥ 1 mm ID and ≤ 850 mm in length
- · Single channel polyethylene and Teflon (polytetrafluoroethylene)
STERRAD 100NX and 100NX with ALLClear Technology Express Cycle
Metal and nonmetal medical devices surfaces and instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors.
STERRAD 100NX and 100NX with ALLClear Technology Duo Cycle
- · Medical devices including:
- · most flexible endoscopes with a single channel of polyethylene and Teflon (polytetrafluoroethylene) with ≥ 1 mm ID and ≤ 875 mm in length
- · accessory devices that are normally connected to a flexible endoscope during use
- · flexible endoscopes without lumens
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Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/6/Picture/1 description: The image shows the STERIS logo. The logo consists of the word "STERIS" in a bold, sans-serif font, with a registered trademark symbol to the right of the "S". Below the word "STERIS" is an image of several horizontal, wavy lines in blue.
K183401 510(k) Summary for Vis-U-All Low Temperature Sterilization Pouches/Tubing
Sponsor Facility
STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 357-9198
Contact: Jennifer Nalepka Senior Regulatory Affairs Specialist
Telephone: (440) 392-7458 Fax No: (440) 357-9198 e-mail: jennifer_nalepka@steris.com
Submission Date: December 6, 2018
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
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1. Device Name
| Trade Name: | Vis-U-All Low Temperature SterilizationPouches/Tubing |
|---|---|
| Device Classification: | Class II |
| Common/Usual Name: | Sterilization pouch |
| Classification Name: | Sterilization wrap |
| Classification Number: | 21 CFR 880.6850 |
| Product Code: | FRG |
2. Predicate Device
Vis-U-All Low Temperature Sterilization Pouches/Tubing, K172749
Reference Device: Vis-U-All Low Temperature Sterilization Pouch/Tubing K183297
Reference Device: Vis-U-All Low Temperature Sterilization Pouch/Tubing K092745
3. Description of Device
The proposed Vis-U-All Low Temperature Sterilization Pouches/Tubing is identical to the predicate and is a Tyvek/plastic film sterilization containment pouch designed for devices to be sterilized by the health care provider in V-PRO Low Temperature Sterilization Systems. As is the predicate device, the proposed device is available as a self seal pouch, a heat seal pouch, or heat seal tubing. Available sizes and configurations are shown in Table 1.
Table 1. Sizes and Configurations of Vis-U-All Low Temperature Sterilization Pouches/Tubing
| Type | Size(inches unless specified) |
|---|---|
| Heat Seal Pouch | 3 x 7 |
| 4 x 9 | |
| 4 x 12 | |
| 4 x 22 | |
| 6 x 10 | |
| 8 x 12 | |
| 10 x 15 | |
| 12 x 18 | |
| Self Seal Pouch | 3 x 7 |
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| 4 x 9 | |
|---|---|
| 4 x 12 | |
| 4 x 22 | |
| 6 x 10 | |
| 8 x 12 | |
| 10 x 15 | |
| 12 x 18 | |
| 8 x 21 | |
| 8 x 27 | |
| 9 x 27 | |
| 11 x 22 | |
| 12 x 27 | |
| Tubing | 3" x 100' |
| 4" x 100' | |
| 6" x 100' | |
| 9" x 100' | |
| 14" x 100' |
The purpose of this submission is to allow for use of the products in the following sterilizer cycles:
- STERRAD® 100S Sterilizer Default Cycle ●
- STERRAD NX® with and without ALLClear™ Technology Sterilizer ● Standard and Advanced Cycles
- STERRAD 100NX® with and without ALLClear Technology Sterilizer ● Standard, Flex Scope, Express and Duo Cycles
4. Indications for Use
The Vis-U-All Low Temperature Sterilization Pouches/Tubing are sterilization containment pouches for use by health care providers to enclose:
- medical devices in a single or double pouch configuration ●
- trays containing medical devices in a single or double pouch configuration ●
- small items requiring surface sterilization in a single pouch configuration within ● a trav
NOTE: Trays must be legally marketed for use in the V-PRO Low Temperature or STERRAD Sterilization Systems and contain a vent surface area to tray volume ratio ≥ 0.135 in - with the maximum number of instrument organizers installed.
and to be sterilized in the:
- Lumen, Non Lumen, Flexible, Fast Non Lumen and Fast Cycles of the V-● PRO® Low Temperature Sterilization Systems
- Default Cycle of the STERRAD® 100S Sterilizer
- Standard and Advanced Cycles of the STERRAD NX and NX with . ALLClear™ Technology Sterilizers
- Express, Standard, Flex Scope, and DUO Cycles of the STERRAD 100NX . and 100NX with ALLClear Technology Sterilizers
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*STERRAD and ALLClear are trademarks of Advanced Sterilization Products
The pouches maintain the sterility of the enclosed devices until used.
When used to enclose medical devices, the pouches are intended to contain the devices in such a manner as to leave a minimum of one inch between the devices and seal on all sides. When used to enclose a tray, the tray must fit loosely within the pouch.
| IntendedSterilizationCycles | Intended Pouch Load when Medical Devices are:• Directly Pouched or• Placed Inside of a Tray and the Tray Pouched |
|---|---|
| V-PRO 60 & s2Lumen Cycle | • Instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors• Non-lumened devices including non-lumened rigid and semi-rigid endoscopes• Medical devices, including single, dual and triple channeled rigid and semi-rigid endoscopes, with the following configurations:o single or dual lumen devices≥ 0.77 mm internal diameter (ID) and ≤ 410 mm in lengtho triple lumen devices≥1.2 mm ID and ≤ 275 mm in length≥1.8 mm ID and ≤ 310 mm in lengthor≥2.8 mm ID and ≤ 317 mm in length |
| V-PRO 60 & s2Non LumenCycle | Non-lumened devices including non-lumened rigid, semi-rigid and flexible endoscopes and non-lumened devices with diffusion-restricted spaces such as the hinged portion of forceps and scissors. |
| V-PRO 60 & s2Flexible Cycle | Load 1: One flexible surgical endoscope or bronchoscope with a light cord (if not integral to endoscope) and mat without any additional load. The flexible endoscope may be a:o single or dual lumen device with lumens that are ≥ 1 mm ID and < 990 mm in lengthLoad 2: Non-lumened devices including non-lumened rigid, semi-rigid, and flexible endoscopes and non-lumened devices with diffusion-restricted areas such as the hinged portion of forceps or scissors. Medical devices, including rigid and semi-rigid endoscopes, with the following dimensions:o ≥ 2.0 mm ID and ≤ 400 mm in lengtho ≥ 1.0 mm ID and ≤ 254 mm in lengtho ≥0.76 mm ID and ≤ 233 mm in length |
| V-PRO s2 FastCycle | • Instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors• Non-lumened devices including non-lumened rigid and semi-rigid endoscopes• Medical devices (including single, dual and triple channeled rigid and semi-rigid endoscopes) with the following configurations:• single or dual channeled devices:o ≥ 0.77 mm ID and ≤ 410 mm in length• triple channeled devices:o ≥ 1.2 mm ID and ≤ 275 mm in lengtho ≥ 1.8 mm ID and ≤ 310 mm in lengthoro ≥ 2.8 mm ID and ≤ 317 mm in length |
| IntendedSterilizationCycles | Intended Pouch Load when Medical Devices are:Directly Pouched or Placed Inside of a Tray and the Tray Pouched |
| Instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors Non-lumened devices including non-lumened rigid and semi-rigid endoscopes | |
| Medical devices, including single, dual and triple channeled rigid and semi-rigid endoscopes, with the following configurations: single or dual lumen devices $\geq$ 0.77 mm ID and $\leq$ 527 mm in length triple lumen devices $\geq$ 1.2 mm ID and $\leq$ 275 mm in length $\geq$ 1.8 mm ID and $\leq$ 310 mm in length or $\geq$ 2.8 mm ID and $\leq$ 317 mm in length | |
| V-PRO 1, 1Plus, maX &maX 2 LumenCycle | |
| V-PRO 1 Plus,max & maX 2Non LumenCycle | Non-lumened devices including non-lumened rigid, semi-rigid and flexible endoscopes and non-lumened devices with stainless steel or titanium diffusion-restricted spaces such as the hinged portion of forceps and scissors. |
| Load 1: Single or dual lumen surgical flexible endoscopes (such as those used in ENT, Urology and Surgical Care) and bronchoscopes with a light cord (if not integral to endoscope) and mat with no additional load. The flexible endoscopes may contain either: a single lumen that is $\geq$ 1 mm ID and $\leq$ 1050 mm in length or two lumens with: one lumen that is $\geq$ 1 mm ID and $\leq$ 990 mm in length and the other lumen that is $\geq$ 1 mm ID and $\leq$ 850 mm in length | |
| Load 2: Non-lumened instruments including instruments with diffusion-restricted areas such as the hinged portion of forceps or scissors. | |
| V-PRO maX &maX 2 FlexibleCycle | |
| V-PRO maX 2Fast NonLumen Cycle | Non-lumened devices including non-lumened rigid, semi-rigid and flexible endoscopes and non-lumened devices with stainless steel or titanium diffusion-restricted spaces such as the hinged portion of forceps and scissors. |
| Metal and nonmetal medical devices including instruments which have diffusion- restricted spaces, such as the hinged portion of forceps and scissors. Metal and nonmetal lumened instruments with: $\geq$ 6 mm ID and $\leq$ 310 mm in length Medical devices with a single stainless steel lumen with: $\geq$ 1 mm ID and $\leq$ 125 mm in length $\geq$ 2 mm ID and $\leq$ 250 mm in length $\geq$ 3 mm ID and $\leq$ 400 mm in length | |
| STERRAD100S (DefaultCycle) | |
| STERRAD NXand NX withALLClearTechnologyStandard Cycle | Metal and nonmetal medical devices including instruments which have diffusion- restricted spaces, such as the hinged portion of forceps and scissors. Medical devices with a single stainless steel lumen with: $\geq$ 1 mm ID and $\leq$ 150 mm in length $\geq$ 2 mm ID and $\leq$ 400 mm in length |
| STERRAD NXand NX withALLClearTechnologyAdvancedCycle | Metal and nonmetal medical devices including instruments which have diffusion- restricted spaces, such as the hinged portion of forceps and scissors. Medical Devices, including most flexible endoscopes, with: a single stainless steel lumen with: $\geq$ 1 mm ID and $\leq$ 500 mm in length Single channel polyethylene and Teflon (polytetrafluoroethylene) $\geq$ 1 mm ID and $\leq$ 850 mm in length |
| STERRAD100NX and | Metal and nonmetal medical devices including instruments which have diffusion- restricted spaces, such as the hinged portion of forceps and scissors. |
| IntendedSterilizationCycles | Intended Pouch Load when Medical Devices are:• Directly Pouched or• Placed Inside of a Tray and the Tray Pouched |
| 100NX withALLClearTechnologyStandard Cycle | Medical devices with a single stainless steel lumen with:• $\ge$ 0.7 mm ID and $\le$ 500 mm in length |
| STERRAD100NX and100NX withALLClearTechnologyFlex ScopeCycle | Metal and nonmetal medical devices including instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors.Medical Devices, including most flexible endoscopes, with:• Single channel polyethylene and Teflon (polytetrafluoroethylene)o $\ge$ 1 mm ID and $\le$ 850 mm in length |
| STERRAD100NX and100NX withALLClearTechnologyExpress Cycle | Metal and nonmetal medical devices (surfaces sterilization only) and instruments whichhave diffusion-restricted spaces, such as the hinged portion of forceps and scissors. |
| STERRAD100NX and100NX withALLClearTechnologyDuo Cycle | Medical devices including:• most flexible endoscopes with a single channel of polyethylene and Teflon(polytetrafluoroethylene) with $\ge$ 1 mm ID and $\le$ 875 mm in length• accessory devices that are normally connected to a flexible endoscope duringuse• flexible endoscopes without lumens |
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STERIS Traditional 510(k) PREMARKET NOTIFICATION Vis-U-All Low Temperature Sterilization Pouches/Tubing
5. Technological Characteristics
The proposed and predicate devices are single use sterilization pouches for use in V-PRO Sterilizers. Table 3 summarizes the difference between the proposed device and predicate device cleared under K172749.
| Characteristic | K183401 | Predicate |
|---|---|---|
| K172749 | ||
| Indications for Use | The Vis-U-All Low TemperatureSterilization Pouches/Tubing aresterilization containment pouches foruse by health care providers toenclose:• medical devices in a single ordouble pouch configuration• trays containing medical devices ina single or double pouchconfiguration• small items requiring surfacesterilization in a single pouchconfiguration within a trayNOTE: Trays must be legally | The Vis-U-All Low TemperatureSterilization Pouches/Tubing aresterilization containment pouches foruse by health care providers toenclose:• medical devices in a single ordouble pouch configuration• trays* containing medical devicesin a single or double pouchconfiguration• small items requiring surfacesterilization in a single pouchconfiguration within a tray*to be sterilized in the Lumen, NonLumen, Flexible and Fast Non |
| marketed for use in the V-PRO LowTemperature or STERRADSterilization Systems and contain avent surface area to tray volume ratio$\geq$ 0.135 in-1 with the maximumnumber of instrument organizersinstalled.and to be sterilized in the:Lumen, Non Lumen, Flexible,Fast Non Lumen and Fast Cyclesof the V-PRO® Low TemperatureSterilization Systems Default Cycle of the STERRAD®100S Sterilizer Standard and Advanced Cycles ofthe STERRAD NX and NX withALLClearTM TechnologySterilizers Express, Standard, Flex Scope,and DUO Cycles of theSTERRAD 100NX and 100NXwith ALLClear TechnologySterilizers *STERRAD and ALLClear aretrademarks of Advanced SterilizationProducts | Lumen Cycles of the V-PRO LowTemperature Sterilization Systems.The pouches maintain the sterility ofthe enclosed devices until used.When used to enclose medicaldevices, the pouches are intended tocontain the devices in such a manneras to leave a minimum of one inchbetween the devices and seal on allsides. When used to enclose a tray,the tray must fit loosely within thepouch. | |
| The pouches maintain the sterility ofthe enclosed devices until used.When used to enclose medicaldevices, the pouches are intended tocontain the devices in such a manneras to leave a minimum of one inchbetween the devices and seal on allsides. When used to enclose a tray,the tray must fit loosely within thepouch. | ||
| V-PRO 60 & s2 Lumen Cycle Instruments with diffusion-restricted spaces such as the hingedportion of forceps and scissors Non-lumened devices includingnon-lumened rigid and semi-rigidendoscopes Medical devices, including single,dual and triple channeled rigid and | V-PRO 60 Lumen Cycle Instruments with diffusion-restricted spaces such as the hingedportion of forceps and scissors Non-lumened devices includingnon-lumened rigid and semi-rigidendoscopes Medical devices, including single,dual and triple channeled rigid and | |
| semi-rigid endoscopes, with thefollowing configurations: | semi-rigid endoscopes, with thefollowing configurations: | |
| ○ single or dual lumen devices ≥ 0.77 mm internal diameter(ID) and ≤ 410 mm in length ○ triple lumen devices ≥1.2 mm ID and ≤ 275 mmin length ≥1.8 mm ID and ≤ 310 mmin lengthor ≥ 2.8 mm ID and ≤ 317 mmin length | ○ single or dual lumen devices ≥ 0.77 mm ID and ≤ 410 mmin length ○ triple lumen devices ≥1.2 mm ID and ≤ 275 mmin length ≥1.8 mm ID and ≤ 310 mmin lengthor ≥2.8 mm ID and ≤ 317 mmin length | |
| V-PRO 60 & s2 Non Lumen CycleNon-lumened devices including non-lumened rigid, semi-rigid and flexible endoscopes and non-lumened devices with diffusion-restricted spaces such as the hinged portion of forceps and scissors. | V-PRO 60 Non Lumen CycleNon-lumened devices including non-lumened rigid, semi-rigid and flexible endoscopes and non-lumened devices with stainless steel or titanium diffusion-restricted spaces such as the hinged portion of forceps and scissors. | |
| V-PRO 60 & s2 Flexible CycleLoad 1: One flexible surgical endoscope or bronchoscope with a light cord (if not integral to endoscope) and mat without any additional load. The flexible endoscope may be a: single or dual lumen device with lumens that are ≥ 1 mm ID and ≤ 990 mm in length Load 2: Non-lumened devices including non-lumened rigid, semi-rigid, and flexible endoscopes and non-lumened devices with diffusion-restricted areas such as the hinged portion of forceps or scissors.Medical devices, including rigid and semi-rigid endoscopes, with the following dimensions: ≥ 2 mm ID and ≤ 400 mm in length ≥ 0.76 mm ID and ≤ 233 mm in length ≥1.0 mm ID and ≤ 254 mm in length | V-PRO 60 Flexible CycleOne flexible surgical endoscope or bronchoscope with a light cord (if not integral to endoscope) and mat without any additional load. The flexible endoscope may be a: single or dual lumen device with lumens that are ≥ 1 mm ID and ≤ 990 mm in length |
Table 3. Technical Characteristic Comparison Table
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STERIS Traditional 510(k) PREMARKET NOTIFICATION Vis-U-All Low Temperature Sterilization Pouches/Tubing
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| V-PRO s2 Fast Cycle | V-PRO 1, 1 Plus & maX Lumen Cycle |
|---|---|
| • Non-lumened devices includingnon-lumened rigid, semi-rigid andflexible endoscopes, and non-lumened devices with diffusion-restricted areas such as the hingedportion of forceps or scissors.• Medical devices (including single,dual and triple channeled rigid andsemi-rigid endoscopes) with thefollowing configurations:• Single or dual channeled deviceswith stainless steel lumens thatare $\ge$ 0.77 mm ID and $\le$ 410 mmin length• Triple channeled devices withstainless steel lumens that areeither:$\ge$ 1.2 mm ID and $\le$ 275 mm inlength$\ge$ 1.8 mm ID and $\le$ 310 mm inlengthor• $\ge$ 2.8 mm ID and $\le$ 317 mm inlength | • Instruments with diffusion-restricted spaces such as the hingedportion of forceps and scissors• Non-lumened devices includingnon-lumened rigid and semi-rigidendoscopes• Medical devices, including single,dual and triple channeled rigid andsemi-rigid endoscopes, with thefollowing configurations:○ single or dual lumen devices$\ge$ 0.77 mm ID and $\le$ 527 mmin length• triple lumen devices$\ge$ 1.2 mm ID and $\le$ 275 mmin length$\ge$ 1.8 mm ID and $\le$ 310 mmin lengthor• $\ge$ 2.8 mm ID and $\le$ 317 mmin length |
| V-PRO 1, 1 Plus, maX & maX2 NonLumen CycleNon-lumened devices including non-lumened rigid, semi-rigid andflexible endoscopes and non-lumened devices with stainless steelor titanium diffusion-restrictedspaces such as the hinged portion offorceps and scissors. | V-PRO 1 Plus & maX Non LumenCycleNon-lumened devices including non-lumened rigid, semi-rigid andflexible endoscopes and non-lumened devices with stainless steeldiffusion-restricted spaces such asthe hinged portion of forceps andscissors. |
| V-PRO maX and maX 2 FlexibleCycleLoad 1: Single or dual lumensurgical flexible endoscopes (such asthose used in ENT, Urology andSurgical Care) and bronchoscopeswith a light cord (if not integral toendoscope) and mat with noadditional load.The flexible endoscopes maycontain either:• a single lumen that is ≥ 1 mmID and ≤ 1050 mm in length• or two lumens with:• one lumen that is ≥ 1 mm IDand ≤ 990 mm in length• and the other lumen that is >1 mm ID and ≤ 850 mm inlengthLoad 2: Non-lumened instrumentsincluding instruments with diffusion-restricted areas such as the hingedportion of forceps or scissors. | V-PRO maX Flexible CycleLoad 1: Single or dual lumensurgical flexible endoscopes (such asthose used in ENT, Urology andSurgical Care) and bronchoscopeswith a light cord (if not integral toendoscope) and mat with noadditional load.The flexible endoscopes maycontain either:• a single lumen that is ≥ 1 mmID and ≤ 1050 mm in length• or two lumens with:• one lumen that is ≥ 1 mm IDand ≤ 990 mm in length• and the other lumen that is >1 mm ID and ≤ 850 mm inlengthLoad 2: Non-lumened instrumentsincluding instruments with diffusion-restricted areas such as the hingedportion of forceps or scissors. |
| V-PRO maX 2 Fast Non LumenCycleNon-lumened devices including non-lumened rigid, semi-rigid andflexible endoscopes and non-lumened devices with stainless steelor titanium diffusion-restrictedspaces such as the hinged portion offorceps and scissors. | V-PRO maX 2 Lumen Cycle• Instruments with diffusion-restricted spaces such as the hingedportion of forceps and scissors• Non-lumened devices includingnon-lumened rigid and semi-rigidendoscopes• Medical devices, including single,dual and triple channeled rigid andsemi-rigid endoscopes, with thefollowing configurations:○ single or dual lumen devices■ ≥ 0.77 mm ID and ≤ 527 mmin length○ triple lumen devices |
| STERRAD 100S Default CycleMetal and nonmetal medical devicesincluding instruments which havediffusion-restricted spaces, such asthe hinged portion of forceps andscissors. | |
| Metal and nonmetal lumened instruments with: ≥ 6 mm ID and ≤ 310 mm in length Medical devices with a single stainless steel lumen with: ≥ 1 mm ID and ≤ 125 mm in length ≥ 2 mm ID and ≤ 250 mm in length ≥ 3 mm ID and ≤ 400 mm in length | ≥ 1.2 mm ID and ≤ 275 mm in length ≥ 1.8 mm ID and ≤ 310 mm in length or ≥ 2.8 mm ID and ≤ 317 mm in length V-PRO maX 2 Non Lumen CycleNon-lumened devices including non-lumened rigid, semi-rigid and flexible endoscopes and non-lumened devices with stainless steel or titanium diffusion-restricted spaces such as the hinged portion of forceps and scissors. |
| STERRAD NX and NX with ALLClear Technology Standard CycleMetal and nonmetal medical devices including instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors.Medical devices with a single stainless steel lumen with: ≥ 1 mm ID and ≤ 150 mm in length ≥ 2 mm ID and ≤ 400 mm in length | V-PRO maX 2 Flexible CycleLoad 1: Single or dual lumen surgical flexible endoscopes (such as those used in ENT, Urology and Surgical Care) and bronchoscopes with a light cord (if not integral to endoscope) and mat with no additional load.The flexible endoscopes may contain either: a single lumen that is ≥ 1 mm ID and ≤ 1050 mm in length or two lumens with: one lumen that is ≥ 1 mm ID and < 990 mm in length and the other lumen that is ≥ 1 mm ID and < 850 mm in length Load 2: Non-lumened instruments including instruments with diffusion-restricted areas such as the hinged portion of forceps or scissors. |
| STERRAD NX and NX with ALLClear Technology Advanced CycleMetal and nonmetal medical devices including instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors.Medical Devices, including most flexible endoscopes, with: a single stainless steel lumen with: ≥ 1 mm ID and ≤ 500 mm in length Single channel polyethylene and Teflon (polytetrafluoroethylene) ≥1 mm ID and ≤ 850 mm in length | V-PRO maX 2 Fast Non Lumen CycleNon-lumened devices including non-lumened rigid, semi-rigid and flexible endoscopes and non-lumened devices with stainless steel or titanium diffusion-restricted spaces such as the hinged portion of forceps and scissors. |
| STERRAD 100NX and 100NX withALLClear Technology StandardCycleMetal and nonmetal medical devicesincluding instruments which havediffusion-restricted spaces, such asthe hinged portion of forceps andscissors.Medical devices with a singlestainless steel lumen with:• ≥ 0.7 mm ID and ≤ 500 mm inlength | * Trays must be legally marketed foruse in the V-PRO Low TemperatureSterilization Systems and contain avent surface area to tray volume ratio≥ 0.135 in⁻¹ with the maximumnumber of instrument organizersinstalled. |
| STERRAD 100NX and 100NX withALLClear Technology Flex ScopeCycleMetal and nonmetal medical devicesincluding instruments which havediffusion-restricted spaces, such asthe hinged portion of forceps andscissors.Medical Devices, including mostflexible endoscopes, with:• Single channel polyethyleneand Teflon(polytetrafluoroethylene)o ≥ 1 mm ID and ≤ 850 mm inlength | |
| STERRAD 100NX and 100NX withALLClear Technology ExpressCycleMetal and nonmetal medical devices(surfaces sterilization only) andinstruments which have diffusion-restricted spaces, such as the hingedportion of forceps and scissors. | |
| STERRAD 100NX and 100NX withALLClear Technology Duo CycleMedical devices including:• most flexible endoscopes with asingle channel of polyethyleneand Teflon(polytetrafluoroethylene) with ≥1 mm ID and ≤ 875 mm inlength• accessory devices that arenormally connected to a flexibleendoscope during use |
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STERIS Traditional 510(k) PREMARKET NOTIFICATION Vis-U-All Low Temperature Sterilization Pouches/Tubing
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STERIS Traditional 510(k) PREMARKET NOTIFICATION Vis-U-All Low Temperature Sterilization Pouches/Tubing
| • flexible endoscopes withoutlumens | ||
|---|---|---|
| DeviceFeatures | ■ Chevron end of pouches for easeof opening■ Chemical process indicator forEO | ■ Chevron end of pouches for ease ofopening■ Chemical process indicator forEO |
| Maintenance ofSterility | 1 year | 1 year |
| Materials ofConstruction | Tyvek and plastic | Tyvek and plastic |
| Types | Self Seal, Heat Seal, Tubing | Self Seal, Heat Seal, Tubing |
| ChemicalIndicator | Ethylene Oxide ProcessChemical Indicator Printed onboth sides of Tyvek | Ethylene Oxide Process ChemicalIndicator Printed on both sides ofTyvek |
6. Summary of Non-Clinical Testing
Table 4 summarizes the testing of the Vis-U-All Low Temperature Sterilization Pouches/Tubing to demonstrate that the proposed pouch is qualified for use in STERRAD 100S Sterilizer Default Cycle, STERRAD NX and NX with ALLClear Technology Sterilizer Standard and Advanced Cycles, and the STERRAD 100NX with and without ALLClear Technology Sterilizer Standard, Flex Scope, Express and Duo Cycles.
Table 4. Performance Test Summary
| Test | Acceptance Criteria | Conclusion | |
|---|---|---|---|
| Effective Sterilant Penetration intoPouches (including pouched traysand, if applicable, pouches placedwithin a tray): | Worst case test articles shall bereproducibly sterilized under worst case ½cycle conditions for the:• STERRAD 100S Default Cycle• STERRAD NX Standard Cycle• STERRAD NX Advanced Cycle• STERRAD 100NX Standard Cycle• STERRAD 100NX Flex ScopeCycle• STERRAD 100NX Express Cycle• STERRAD 100NX Duo Cycle | PASS | |
| PouchIntegrity:PhysicalandMicrobialBarrierProperties | Tensile Strength | Pouch material tensile strength will showno statistical difference betweenprocessed and unprocessed samples. | PASS |
| Whole PackageIntegrity (Burst) | Pouch burst strength will show nostatistical difference between processedand unprocessed pouches. | PASS | |
| Seal Strength | Pouch seal strength will show nostatistical difference between processedand unprocessed pouches. | PASS | |
| Microbial Retention | Tyvek microbial retention will show nostatistical difference between processedand unprocessed pouches. | PASS |
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| Test | Acceptance Criteria | Conclusion |
|---|---|---|
| Maintenance of Package Integrity | Packaged instruments shall remain sterilethrough event related and real timestudies. | PASS |
| Aeration: Hydrogen PeroxideResiduals | Hydrogen peroxide residuals on the pouchwill be reduced to acceptable levels | PASS |
7. Conclusion
Based on the intended use, technological characteristics and non-clinical performance data, the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device (K172749), Class II (21 CFR 880.6850), product code FRG.
§ 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).