(37 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*
to be sterilized in the Lumen, Non Lumen and Fast Cycles of the V-PRO® Low Temperature Sterilization Systems. 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 acceptance criteria and study proving device performance are described below:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Effective Sterilant Penetration into Pouches: | ||
| V-PRO s2 Sterilizer Fast Cycle | Worst case stainless steel lumen test articles shall be reproducibly sterilized under worst case 1x10^-2 cycle conditions for the Fast Cycle. | PASS |
| Diffusion-restricted spaces shall be reproducibly sterilized under worst case 1x10^-2 cycle conditions for Fast Cycle. | PASS | |
| Contact points between medical devices and tray accessories shall be reproducibly sterilized under worst case 1x10^-2 cycle conditions for the Fast Cycle. | PASS | |
| Worst case surface sterilization test articles shall be reproducibly sterilized under worst case 1x10^-2 cycle conditions for the Fast Cycle. | PASS | |
| V-PRO 60 & s2 Sterilizer Non Lumen Cycle, diffusion-restricted spaces claims | Diffusion-restricted spaces shall be reproducibly sterilized under worst case 1x10^-2 cycle conditions for the Non Lumen Cycle. | PASS |
| V-PRO 60 & s2 Sterilizer Flexible Cycle, diffusion-restricted spaces claims | Diffusion-restricted spaces shall be reproducibly sterilized under worst case 1x10^-2 cycle conditions for the Flexible Cycle. | PASS |
| V-PRO 60 & s2 Sterilizer Flexible Cycle extended claims | Stainless steel test articles shall be reproducibly sterilized under worst case 1x10^-2 cycle conditions for the Flexible 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 |
| Whole Package Integrity (Burst) | Pouch burst strength will show no statistical difference between processed and unprocessed pouches. | PASS |
| Seal Strength | Pouch seal strength will show no statistical difference between processed and unprocessed pouches. | PASS |
| 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 for dermal contact in Fast Non Lumen Cycle with 3 minute aeration. | PASS |
Study Proving Device Meets Acceptance Criteria:
The document describes a submission (K183297) to add claims for the Vis-U-All Low Temperature Sterilization Pouches/Tubing, including use with specific lumen configurations and diffusion-restricted spaces in various V-PRO sterilizer cycles (V-PRO 60, V-PRO s2, V-PRO 1, 1 Plus, maX & maX 2). The study is non-clinical performance testing.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the numerical sample sizes used for each specific test (e.g., number of pouches, lumens, or test articles). It refers to "worst case" scenarios for sterilant penetration tests and "samples" for physical property tests.
The data provenance is not explicitly mentioned as retrospective or prospective, nor the country of origin. However, given the context of a 510(k) submission to the U.S. FDA, it is highly likely that the testing was conducted in a controlled laboratory environment to support regulatory approval in the U.S.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This is a performance study for sterilization efficacy and package integrity. The "ground truth" for the test set is established through scientific and engineering principles of sterilization and package testing, rather than human expert interpretation of images or physiological data. Therefore, the concept of "experts" to establish ground truth in the same way as, for example, radiologists for image analysis, does not apply. The tests described (e.g., microbial retention, tensile strength) rely on objective measurements and established standards.
4. Adjudication Method for the Test Set:
Not applicable in the context of this type of performance study. Adjudication methods (like 2+1 or 3+1) are typically used for subjective clinical assessments where multiple human readers interpret data to reach a consensus ground truth. Here, the outcomes are objective measurements of sterilization and physical properties.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No. This is not a study involving human readers or AI assistance. It is a performance study of a medical device (sterilization pouches).
6. Standalone (Algorithm Only Without Human-in-the Loop Performance) Study:
Not applicable. This device is a physical product (sterilization pouches), not an AI algorithm.
7. Type of Ground Truth Used:
The ground truth used for these tests is based on objective, quantifiable measures related to sterilization efficacy and physical properties, typically defined by:
- Microbial Sterilization: Defined by the absence of microbial growth after processing, often using sterility assurance levels (SAL) based on biological indicator (BI) challenge testing. The "worst case 1x10^-2 cycle conditions" refers to a reduced cycle used for BI testing to demonstrate appropriate sterilant penetration and microbial kill.
- Physical and Barrier Properties: Defined by adherence to established engineering standards for tensile strength, burst strength, seal strength, and microbial retention, often with statistical comparisons between processed and unprocessed samples.
- Chemical Residuals: Defined by laboratory analysis to ensure residual levels of hydrogen peroxide are below acceptable safety thresholds.
8. Sample Size for the Training Set:
Not applicable. This is a physical medical device, not an AI model 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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
January 3, 2018
STERIS Corporation Jennifer Nalepka Senior Regulatory Affairs Specialist 5960 Heisley Road Mentor, Ohio 44060
Re: K183297
Trade/Device Name: Vis-U-All Low Temperature Sterilization Pouches/Tubing Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: FRG Dated: November 26, 2018 Received: November 27, 2018
Dear Jennifer Nalepka:
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 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
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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.htm); 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 medical devices and radiation-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.
Elizabeth F. Claverie -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) K183297
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*
to be sterilized in the Lumen, Non Lumen and Fast Cycles of the V-PRO® Low Temperature Sterilization Systems. 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
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, 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
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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 ≤ 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 1, 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 1, 1 Plus, 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-lumened instruments including instruments with diffusion-restricted areas such as the hinged portion of forceps or scissors.
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.
- 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.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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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 30, 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 |
Predicate Device 2.
Vis-U-All Low Temperature Sterilization Pouches/Tubing (K172749)
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 5-1.
Table 5-1. 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 |
| 4 x 9 | |
| 4 x 12 | |
| 4 x 22 | |
| 6 x 10 | |
| 8 x 12 |
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| 10 x 15 | |
|---|---|
| 12 x 18 | |
| 8 x 21* | |
| 8 x 27* | |
| 9 x 27* | |
| 11 x 22* | |
| 12 x 27* | |
| 3" x 100' | |
| 4" x 100' | |
| Tubing | 6" x 100' |
| 9" x 100' | |
| 14" x 100' |
- Additional pouch sizes
The purpose of this submission is to add claims for:
- Use with devices having stainless steel lumens of the following . configurations:
- o > 2.0 mm internal diameter (ID) and ≤ 400 mm in length
- o ≥ 1.0 mm ID and ≤ 254 in length
- o ≥ 0.76 mm ID and ≤ 233 mm in length
in the V-PRO 60 and V-PRO s2 Sterilizer Flexible Cycle
- Use with diffusion restricted spaces in addition to stainless steel and titanium when used in the V-PRO 60 and V-PRO s2 Sterilizer Non Lumen and Flexible Cycles.
- Use in the V-PRO s2 Sterilizer Fast Lumen Cycle ●
- . Addition of the V-PRO s2 Sterilizer to the indications for use in the Lumen Cycle of the V-PRO 60 Sterilizer. The V-PRO s2 Sterilizer Lumen Cycle is performed identically to the previously cleared cycle listed in Table 5-2. The updated claims being sought for the V-PRO 60/s2 Sterilizer Non Lumen and Flexible Cycles as well as the V-PRO s2 Sterilizer Fast Cycle are the subject of a concurrent submission (K182528).
- Notify FDA of an extension of the self seal pouch line to include five additional pouch models whose sizes were optimized to contain the smaller PRO-LITE Sterilization Trays that has recently been implemented.
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| Cycle | Most RecentPremarketNotification Clearance | V-PRO 60 | V-PRO s2 |
|---|---|---|---|
| Lumen Cycle | K172319 | X | X |
| Non Lumen Cycle | K172319 and | X | X |
| Flexible Cycle | Concurrent submission(K182827) | X | X |
| Fast Cycle | Concurrent Submission(K182827) | X |
- Shaded cell indicates that the V-PRO Sterilizer does not include the identified cycle.
NOTE: V-PRO Sterilizer cycles are pre-set and thus the name of the cycle describes the cycle conditions.
4. Intended Use/ 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 tray*
to be sterilized in the Lumen, Non Lumen, Flexible, Fast Non Lumen and Fast Cycles of the V-PRO® Low Temperature Sterilization Systems. 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 &s2 LumenCycle | • Instruments with diffusion-restricted spaces such as the hinged portion offorceps 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 ≥ 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 lengthor ≥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 | |
| V-PRO 60 &s2 Non LumenCycle | Non-lumened devices including non-lumened rigid, semi-rigid and flexibleendoscopes and non-lumened devices with diffusion-restricted spaces such asthe hinged portion of forceps and scissors. | |
| V-PRO 60 &s2 FlexibleCycle | Load 1: One flexible surgical endoscope or bronchoscope with a light cord (ifnot integral to endoscope) and mat without any additional load. The flexibleendoscope may be a:single or dual lumen device with lumens that are ≥ 1 mm ID and ≤ 990 mmin length Load 2: Non-lumened devices including non-lumened rigid, semi-rigid, andflexible endoscopes and non-lumened devices with diffusion-restricted areassuch as the hinged portion of forceps or scissors. Medical devices, includingrigid 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 s2Fast Cycle | Non-lumened devices including non-lumened rigid, semi-rigid and flexibleendoscopes, and non-lumened devices with diffusion-restricted areas such asthe hinged portion of forceps or scissors. Medical devices (including single, dual and triple channeled rigid and semi-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 lengthor > 2.8 mm ID and ≤ 317 mm in length Instruments with diffusion-restricted spaces such as the hinged portion offorceps and scissors | |
| V-PRO 1, 1Plus, maX &maX 2 LumenCycle | 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 ≥ 0.77 mm 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 lengthor ≥ 2.8 mm ID and ≤ 317 mm in length | |
| V-PRO 1Plus, maX &maX 2 NonLumen Cycle | Non-lumened devices including non-lumened rigid, semi-rigid and flexibleendoscopes 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 2Flexible Cycle | Load 1: Single or dual lumen surgical flexible endoscopes (such as those usedin ENT, Urology and Surgical Care) and bronchoscopes with a light cord (if notintegral to endoscope) and mat with no additional load.The flexible endoscopes may contain either: | |
| IntendedSterilizationCycles | Intended Pouch Load when Medical Devices are:• Directly Pouched or• Placed Inside of a Tray* and the Tray* Pouched | |
| • 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 lengthLoad 2: Non-lumened instruments including instruments with diffusion-restricted areas such as the hinged portion of forceps or scissors. | ||
| 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. |
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STERIS Traditional 510(k) PREMARKET NOTIFICATION Vis-U-All Low Temperature Sterilization Pouches/Tubing
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- 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.
Description of Safety and Substantial Equivalence 5.
The proposed and predicate devices are single use sterilization pouches for use in V-PRO Sterilizers. Table 5-3 summarizes the difference between the proposed device and predicate device cleared under K172749.
| Characteristic | Proposed | PredicateK172749 | Comparison |
|---|---|---|---|
| Intended Use | The Vis-U-All LowTemperature SterilizationPouches/Tubing aresterilization containmentpouches for use by health careproviders to enclose:• medical devices in a singleor double pouchconfiguration• trays* containing medicaldevices in a single ordouble pouch configuration• small items requiringsurface sterilization in asingle pouch configurationwithin a tray*to be sterilized in the:• Lumen, Non Lumen,Flexible, Fast Non Lumenand Fast Cycles of the V-PRO® Low TemperatureSterilization Systems | The Vis-U-All LowTemperature SterilizationPouches/Tubing aresterilization containmentpouches for use by healthcare providers to enclose:• medical devices in a singleor double pouchconfiguration• trays* containing medicaldevices in a single ordouble pouch configuration• small items requiringsurface sterilization in asingle pouch configurationwithin a tray*to be sterilized in the Lumen,Non Lumen, Flexible andFast Non Lumen Cycles ofthe V-PRO Low TemperatureSterilization Systems. | SimilarData ispresented inthis submissionto support safeand effectiveuse of thepouches in theadditionalcycles and loadconfigurations.Combined V-PRO 1, 1 Plusand maXSterilizerLumen, NonLumen andFlexible Cycleclaims with theV-PRO maX 2Lumen, NonLumen and |
| The pouches maintain the | The pouches maintain the | Flexible Cycle | |
| sterility of the enclosed | sterility of the enclosed | claims. | |
| devices until used. | devices until used. | ||
| When used to enclosemedical devices, the pouchesare intended to contain thedevices in such a manner asto leave a minimum of oneinch between the devices andseal on all sides. When usedto enclose a tray, the traymust fit loosely within thepouch. | When used to enclose medicaldevices, the pouches areintended to contain thedevices in such a manner as toleave a minimum of one inchbetween the devices and sealon all sides. When used toenclose a tray, the tray mustfit loosely within the pouch. | ||
| V-PRO 60 & s2 Lumen Cycle• Instruments with diffusion-restricted spaces such as thehinged portion of forcepsand scissors• Non-lumened devicesincluding non-lumenedrigid and semi-rigidendoscopes• Medical devices, includingsingle, dual and triplechanneled rigid and semi-rigid endoscopes, with thefollowing configurations:o single or dual lumendevices■ ≥ 0.77 mm internaldiameter (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 Lumen Cycle• Instruments with diffusion-restricted spaces such as thehinged portion of forcepsand scissors• Non-lumened devicesincluding non-lumenedrigid and semi-rigidendoscopes• Medical devices, includingsingle, dual and triplechanneled rigid and semi-rigid endoscopes, with thefollowing configurations:o single or dual lumendevices■ ≥ 0.77 mm 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 & s2 Non LumenCycleNon-lumened devicesincluding non-lumened rigid,semi-rigid and flexibleendoscopes and non-lumeneddevices with diffusion- | V-PRO 60 Non Lumen CycleNon-lumened devicesincluding non-lumened rigid,semi-rigid and flexibleendoscopes and non-lumeneddevices with stainless steel ortitanium diffusion-restricted | ||
| restricted spaces such as thehinged portion of forceps andscissors. | spaces such as the hingedportion of forceps andscissors. | ||
| V-PRO 60 & s2 FlexibleCycleLoad 1: One flexible surgicalendoscope or bronchoscopewith a light cord (if notintegral to endoscope) andmat without any additionalload. The flexible endoscopemay be a:single or dual lumen devicewith lumens that are $\ge$ 1mm ID and $\le$ 990 mm inlength Load 2: Non-lumened devicesincluding non-lumened rigid,semi-rigid, and flexibleendoscopes and non-lumeneddevices with diffusion-restricted areas such as thehinged portion of forceps orscissors. Medical devices,including rigid and semi-rigidendoscopes, with thefollowing dimensions:$\ge$ 2 mm ID and $\le$ 400 mmin length $\ge$ 0.76 mm ID and $\le$ 233mm in length $\ge$ 1.0 mm ID and $\le$ 254 mmin length V-PRO s2 Fast Cycle Non-lumened devicesincluding non-lumenedrigid, semi-rigid andflexible endoscopes, andnon-lumened devices withdiffusion-restricted areassuch as the hinged portionof forceps or scissors. Medical devices (includingsingle, dual and triplechanneled rigid and semi-rigid endoscopes) with thefollowing configurations: | V-PRO 60 Flexible CycleOne flexible surgicalendoscope or bronchoscopewith a light cord (if notintegral to endoscope) andmat without any additionalload. The flexible endoscopemay be a: single or dual lumendevice with lumens thatare $\ge$ 1 mm ID and $\le$ 990mm in length | ||
| • Single or dual channeleddevices with stainlesssteel lumens that are ≥$0.77 mm$ ID and ≤ $410$mm in length• Triple channeled deviceswith stainless steellumens that are either:≥ $1.2 mm$ ID and ≤ $275$mm in length≥ $1.8 mm$ ID and ≤ $310$mm in lengthor• ≥ $2.8 mm$ ID and ≤ $317$mm in lengthV-PRO 1, 1 Plus, maX &maX 2 Lumen Cycle• Instruments with diffusion-restricted spaces such as thehinged portion of forcepsand scissors• Non-lumened devicesincluding non-lumenedrigid and semi-rigidendoscopes• Medical devices, includingsingle, dual and triplechanneled rigid and semi-rigid endoscopes, with thefollowing configurations:o single or dual lumendevices≥ $0.77 mm$ ID and ≤$527 mm$ in length o 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 1, 1 Plus, maX &maX2 Non Lumen CycleNon-lumened devicesincluding non-lumened rigid,semi-rigid and flexibleendoscopes and non-lumened | V-PRO 1, 1 Plus & maXLumen Cycle• Instruments with diffusion-restricted spaces such as thehinged portion of forcepsand scissors• Non-lumened devicesincluding non-lumenedrigid and semi-rigidendoscopes• Medical devices, includingsingle, dual and triplechanneled rigid and semi-rigid endoscopes, with thefollowing configurations:o single or dual lumendevices≥ $0.77 mm$ ID and ≤$527 mm$ in length o 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 1 Plus & maX NonLumen CycleNon-lumened devicesincluding non-lumened rigid,semi-rigid and flexibleendoscopes and non-lumened |
Table 5-3. Technical Comparison to the Predicate.
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| devices with stainless steel ortitanium diffusion-restrictedspaces such as the hingedportion of forceps andscissors. | devices with stainless steeldiffusion-restricted spacessuch as the hinged portion offorceps and scissors. |
|---|---|
| V-PRO maX and maX 2Flexible CycleLoad 1: Single or dual lumensurgical flexible endoscopes(such as those used in ENT,Urology and Surgical Care)and bronchoscopes with alight cord (if not integral toendoscope) and mat with noadditional load.The flexible endoscopes maycontain either:• a single lumen that is ≥ 1mm ID and ≤ 1050 mmin length• or two lumens with:• one lumen that is ≥ 1mm ID and ≤ 990mm in length• and the other lumenthat is ≥ 1 mm ID and≤ 850 mm in lengthLoad 2: Non-lumenedinstruments includinginstruments with diffusion-restricted areas such as thehinged portion of forceps orscissors. | V-PRO maX Flexible CycleLoad 1: Single or dual lumensurgical flexible endoscopes(such as those used in ENT,Urology and Surgical Care)and bronchoscopes with alight cord (if not integral toendoscope) and mat with noadditional load.The flexible endoscopes maycontain either:• a single lumen that is ≥ 1mm ID and ≤ 1050 mmin lengthor two lumens with:• one lumen that is ≥ 1mm ID and ≤ 990mm in length• and the other lumenthat is ≥ 1 mm ID and≤ 850 mm in lengthLoad 2: Non-lumenedinstruments includinginstruments with diffusion-restricted areas such as thehinged portion of forceps orscissors. |
| V-PRO maX 2 Fast NonLumen CycleNon-lumened devicesincluding non-lumened rigid,semi-rigid and flexibleendoscopes and non-lumeneddevices with stainless steel ortitanium diffusion-restrictedspaces such as the hingedportion of forceps andscissors.*Trays must be legallymarketed for use in the V-PRO Low Temperature | V-PRO maX 2 Lumen Cycle• Instruments with diffusion-restricted spaces such as thehinged portion of forcepsand scissors• Non-lumened devicesincluding non-lumenedrigid and semi-rigidendoscopes• Medical devices, includingsingle, dual and triplechanneled rigid and semi-rigid endoscopes, with thefollowing configurations: |
| Sterilization Systems and | |
| contain a vent surface area to tray volume ratio $\ge$ 0.135 in -1 with the maximum number of instrument organizers installed. | single or dual lumen devices $\ge$ 0.77 mm ID and $\le$ 527 mm in length triple lumen devices $\ge$ 1.2 mm ID and $\le$ 275 mm in length $\ge$ 1.8 mm ID and $\le$ 310 mm in length or $\ge$ 2.8 mm ID and $\le$ 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.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 $\ge$ 1 mm ID and $\le$ 1050 mm in length or two lumens with: one lumen that is $\ge$ 1 mm ID and $\le$ 990 mm in length and the other lumen that is $\ge$ 1 mm ID and $\le$ 850 mm in length Load 2: Non-lumened instruments including instruments with diffusion- |
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| restricted areas such as thehinged portion of forceps orscissors.V-PRO maX 2 Fast NonLumen CycleNon-lumened devicesincluding non-lumened rigid,semi-rigid and flexibleendoscopes and non-lumeneddevices with stainless steel ortitanium diffusion-restrictedspaces such as the hingedportion of forceps andscissors.* Trays must be legallymarketed for use in the V-PRO Low TemperatureSterilization Systems andcontain a vent surface area totray volume ratio $≥ 0.135 in⁻¹$with the maximum number ofinstrument organizersinstalled. | |||
|---|---|---|---|
| DeviceFeatures | ■ Chevron end of pouchesfor ease of opening■ Chemical processindicator for EO | ■ Chevron end of pouches forease of opening■ Chemical process indicatorfor EO | Same |
| Maintenance ofSterility | 1 year | 1 year | Same |
| Materials ofConstruction | Tyvek and plastic | Tyvek and plastic | Same |
| Types | Self Seal, Heat Seal,Tubing | Self Seal, Heat Seal, Tubing | Same |
| ChemicalIndicator | Ethylene Oxide ProcessChemical IndicatorPrinted on both sides ofTyvek | Ethylene Oxide ProcessChemical Indicator Printedon both sides of Tyvek | Same |
Table 5-4 summarizes the testing of the Vis-U-All Low Temperature Sterilization Pouches/Tubing to demonstrate that the proposed pouch is qualified for use in the V-PRO s2 Fast Cycle and for extended sterilization claims in the V-PRO 60 and s2 Sterilizers Non Lumen and Flexible Cycles and is as safe, as effective, and performs the same as the predicate device.
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| Table 5-4. Performance Test Summary | |||
|---|---|---|---|
| Test | Acceptance Criteria | Conclusion | |
| EffectiveSterilantPenetrationintoPouches(includingpouchedtrays and,ifapplicable,pouchesplacedwithin atray): | V-PRO s2 SterilizerFast Cycle | Worst case stainless steel lumen testarticles shall be reproducibly sterilizedunder worst case 1 $ 1 2 $ cycle conditions forthe Fast Cycle. | PASS |
| Diffusion-restricted spaces shall bereproducibly sterilized under worst case 1 $ 1 2 $ cycle conditions for Fast Cycle. | PASS | ||
| Contact points between medical devicesand tray accessories shall be reproduciblysterilized under worst case 1 $ 1 2 $ cycleconditions for the Fast Cycle. | PASS | ||
| Worst case surface sterilization testarticles shall be reproducibly sterilizedunder worst case 1 $ 1 2 $ cycle conditions forthe Fast Cycle. | PASS | ||
| V-PRO 60 & s2Sterilizer NonLumen Cycle,diffusion-restrictedspaces claims | Diffusion-restricted spaces shall bereproducibly sterilized under worst case 1 $ 1 2 $ cycle conditions for the Non LumenCycle. | PASS | |
| V-PRO 60 & s2Sterilizer FlexibleCycle, diffusion-restricted spacesclaims | Diffusion-restricted spaces shall bereproducibly sterilized under worst case 1 $ 1 2 $ cycle conditions for the Flexible Cycle | PASS | |
| V-PRO 60 & s2Sterilizer FlexibleCycle extendedclaims | Stainless steel test articles shall bereproducibly sterilized under worst case 1 $ 1 2 $ cycle conditions for the Flexible 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 | |
| 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 fordermal contact in Fast Non Lumen Cyclewith 3 minute aeration. | PASS |
| Table 5-4. Performance Test Summary | |||
|---|---|---|---|
| ------------------------------------- | -- | -- | -- |
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8. Conclusion
Based on the intended use, technological characteristics and non-clinical performance data, the subject device is as safe, as effective and performs at least as well as 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).