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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

*3-D printed items should not be double pouched.

to be sterilized in the:

· Lumen, Non Lumen, Flexible, Fast Non Lumen, Fast and Specialty 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

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.

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.

V-PRO 60 & s2 Lumen Cycle

· Non-lumened instruments and 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:

o single or dual lumen devices

0.77 mm internal diameter (ID) and < 410 mm in length

≥ 1.8 mm ID x ≤ 542 mm in length

o 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

V-PRO 60 & s2 Non Lumen Cycle

•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:

o single or dual lumen device with lumens that are ≥ 1 mm ID and ≤ 990 mm in length

•Load 2: Non-lumened instruments including non-lumened 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 configurations:

○ ≥ 0.76 mm ID and ≤ 233 mm in length

o ≥ 1.0 mm ID and ≤ 254 mm in length

o ≥ 1.8 mm ID and ≤ 542 mm in length

V-PRO s2 Fast Cycle

o 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

o Medical devices (including single, dual and triple channeled rigid endoscopes) with the following configurations:

o Single or dual lumen devices

≥ 0.77 mm ID and ≤ 410 mm in length

≥ 1.8 mm ID and ≤ 542 mm in length

o 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

V-PRO 1, 1 Plus, maX & maX 2 Lumen Cycle

• Non-lumened instruments and 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 or triple channeled stainless steel lumens that are:

≥ 0.77 mm ID and ≤ 527 mm in length

≥ 0.8 mm ID and ≤ 542 mm in length

≥ 0.48 mm ID and ≤ 100 mm in length

• Medical devices with Dead end stainless steel lumens that are ≥ 1.3 mm ID and ≤ 73 mm in length

· Instruments with rigid non-metallic lumens (such as those used in endoscope sheaths, take-apart forceps) that are:

≥ 3 mm ID and ≤ 298 mm in length

≥ 4 mm ID and ≤ 424 mm in length

V-PRO 1, 1 Plus, maX & maX2 Non Lumen Cycle

· Non-lumened instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors

· Non-lumened instruments including non-luments, non-luments, non-lumened rigid, semi-rigid and flexible endoscopes.

V-PRO maX and maX 2 Flexible Cycle

· Non-lumened instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors

· Single or dual lumen surgical flexible endoscopes (such as those used in ENT, Urology and Surgical Care) and bronchoscopes in either of the two load configurations:

o Load 1: Two flexible endoscopes with single or dual channel lumens that are ≥ 1 mm ID and ≤ 1050 mm in length with a light cord (if not integral to endoscope) and mat with no additional load

o Load 2: One flexible endoscope with single or dual channel lumens that are ≥ 1 mm ID and ≤ 1050 mm in length with a light cord (if not integral to endoscope accessories, mat, and additional instruments that may include nonlumened or lumened medical devices with the following configurations:

o Single, dual or triple channel stainless steel lumen that is ≥ 0.48 mm ID and ≤ 100 mm in length.

V-PRO maX 2 Fast Non Lumen Cycle

· Non-lumened instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors

· Non-lumened instruments including non-lumened general medical instruments, non-lumened rigid, semi-rigid and flexible endoscopes.

V-PRO maX 2 Specialty Cycle:

Patient-specific surgical guides (e.g. osteotomy, shoulder, hip, knee, spine) or anatomical models fabricated via additive manufacturing (3D printing) processes and intended for single-use during operative procedures .* or

Non-lumened instruments including non-luments, non-luments, non-lumened rigid, semi-rigid and flexible endoscopes. **

• The validation studies were conducted using a validation load consisting of pouched guide(s) (with or without tray) for a total weight of 5 lbs (2.3 kg) 3D printed material.

** The validation studies were conducted using a validation load consisting of one pouched instrument tray or one pouched instrument tray or one pouch with guide(s) (with or without tray) for a total weight of 11 lbs (5 kg).

STERRAD 100S Default Cycle

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:
• ≥ 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:

≥ 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

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 Scope 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

STERRAD 100NX and 100NX with ALLClear Technology Express Cycle

• Metal and nonmetal medical devices (surfaces sterilization only) 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:

o most flexible endoscopes with a single channel of polyethylene and Teflon (polytetrafluoroethylene) with ≥ 1 mm ID and ≤ 875 mm in length

o accessory devices that are normally connected to a flexible endoscope during use

o flexible endoscopes without lumens

• Trays must be legally marketed for use in the V-PRO Low Temperature Sterilization Systems and contain a vent surface area to tray volume ratio ≥0.135 in-1 with the maximum number of instrument organizers installed.

Ethylene Oxide Sterilization

The Vis-U-All Low Temperature Sterilization Pouch has been qualified by STERIS as suitable for use by health care providers to enclose and seal other medical devices to be sterilized by ethylene oxide (ETO). The Vis-U-All Low Temperature Sterilization Pouch for ethylene oxide is designed to maintain sterility of properly processed medical devices during normal handling and storage until the pouch is opened and the medical device is removed for use.

The following are the validated test conditions:

• · 1 hour exposure, at 130(±5) °F, * >30% RH using 100% ETO (750-790 mg/L)
• · 4.5 hour exposure at 100(±5) °F, * >30% RH using 100% ETO (750-790 mg/L)
• *±5 °F is used during sterilization phase following an equilibrium period of 10% of exposure time.

The ethylene oxide process indicator is intended to be used by health care providers with the Vis- U-All Low Temperature Sterilization Pouches to distinguish between processed and unprocessed units.

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)

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 or STERRAD 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 5-1.

The provided text describes the acceptance criteria and study for the STERIS Vis-U-All Low Temperature Sterilization Pouches/Tubing (K231500).

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific "sample size used for the test set" in terms of the number of individual pouches or sterilization cycles. However, it mentions "worst-case test articles" were used in the testing.

The data provenance is not explicitly stated in terms of country of origin. The study appears to be retrospective as it's a validation study for an existing product to extend its claims (qualify for use in the V-PRO maX 2 Specialty Cycle).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This information is not provided in the document. The study's ground truth for sterilization effectiveness is based on the ability of the worst-case test articles to be reproducibly sterilized under specific cycle conditions, which implies a direct measurement of sterility rather than expert consensus on an image or clinical assessment.

4. Adjudication Method for the Test Set

This information is not applicable as the ground truth is based on physical sterilization validation, not expert review or consensus.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic or AI-assisted interpretation devices to assess human performance with and without AI assistance. The described device is a sterilization pouch, and its performance is evaluated through physical tests of sterilization effectiveness.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone performance evaluation was done. The study assessed the device's ability to achieve sterilization in the specified V-PRO cycles without human intervention in the sterilization process itself, beyond loading and operating the sterilizer. The performance criteria directly relate to the pouch's material and design allowing sterilant penetration.

7. The Type of Ground Truth Used

The ground truth used is based on physical sterilization effectiveness, specifically demonstrating that "Worst case test articles shall be reproducibly sterilized under worst case ½ cycle conditions." This implies microbiological testing to confirm the absence of viable microorganisms after sterilization.

8. The Sample Size for the Training Set

This information is not applicable/not provided. The device is a physical product (a sterilization pouch), not an AI algorithm that requires a training set of data.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable. As mentioned above, the device is a physical product and does not involve an AI algorithm with a training set.

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