(28 days)
No
The device description and intended use are for physical sterilization pouches and trays, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
This device is designed to contain and facilitate the sterilization of medical devices, not to provide any therapeutic treatment itself.
No
This device, which includes sterilization pouches/tubing and trays, is intended for containing and facilitating the sterilization of medical devices, not for diagnosing medical conditions.
No
The device description clearly states that the devices are physical sterilization pouches/tubing and sterilization trays made of materials like Tyvek/plastic film and mineral-filled polypropylene. These are hardware components, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the pouches and trays are for sterilizing medical devices used by healthcare providers. This is a process related to preparing medical devices for use on or in a patient, not for performing tests on samples taken from the body.
- Device Description: The description details the physical characteristics of the pouches and trays and their function in containing devices during sterilization. There is no mention of reagents, analyzing biological samples, or providing diagnostic information.
- Performance Studies: The performance studies focus on demonstrating the sterilization efficacy of the pouches and trays in conjunction with specific sterilization systems. This is consistent with a device used in the sterilization process, not an IVD.
IVD devices are specifically designed to perform tests on samples (like blood, urine, tissue) to provide information about a person's health or condition. The devices described here are for preparing medical instruments for use, which is a different category of medical device.
N/A
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*
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.
to be sterilized in the:
- Lumen. Non Lumen. Flexible. Fast Non Lumen and Fast Cvcles 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
- Non-lumened devices 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 4 mm ID and 1 mm ID and 0.7 mm ID and 1 mm ID and 3 mm ID and 1 mm ID and ≤ 1050 mm in length.
Load 2: - 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
- Single, dual or triple channel stainless steel lumens that are > 0.48 mm ID and ≤ 100 mm in length
V-PRO maX 2 Fast Non Lumen Cycle:
Non-lumened devices including non-lumened rigid, semi-rigid and flexible endossopes and non-lumened devices with diffusion-restricted spaces such as the hinged portion of forceps and scissors.
Intended Sterilization Cycles and Intended Tray Load for Tray Models: VP0045, VP0047, VP0048, VP0049, VP0050, VP0051, VP0052
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
§ 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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
September 9, 2022
Steris Anthony Piotrkowski Director Regulatory Affairs 5960 Heisey Road Mentor, Ohio 44060
Re: K222440
Trade/Device Name: Vis-U-All Low Temperature Sterilization Pouches / Tubing, PRO-LITE Sterilization Trays Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: FRG, KCT Dated: August 11, 2022 Received: August 12, 2022
Dear Anthony Piotrkowski:
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.
1
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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-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, III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K222440
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.
to be sterilized in the:
- · Lumen. Non Lumen. Flexible. Fast Non Lumen and Fast Cvcles 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
· Non-lumened devices 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 4 mm ID and 1 mm ID and 0.7 mm ID and 1 mm ID and Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
6
Indications for Use
510(k) Number (if known) K222440
Device Name PRO-LITE Sterilization Tray
- The PRO-LITE Sterilization Trays are used to contain medical devices for sterilization in the following Cycles:
- · 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
• Standard, Flex Scope, Express and DUO Cycles of the STERRAD 100NX with ALLClear Technology Sterilizers
*STERRAD and ALLClear are trademarks of Advanced Sterilization Products
Prior to placing in the Sterilizer, the trays must either be:
· wrapped with a legally marketed sterilization wrap for use in the Sterilizers listed above
Or
· placed inside a legally marketed pouch for enclosing trays in the Sterilizers listed above.
The PRO-LITE Sterilization Trays are not intended to maintain sterility; they are intended to be used in conjunction with a validated, FDA-cleared sterilization wrap or pouch in order to maintain sterility of the enclosed medical instruments.
Intended Sterilization Cycles and Intended Tray Load for Tray Models: VP0045, VP0047, VP0048, VP0048, VP0048, VP0050. VP0051. VP0052
V-PRO 60 and s2 Lumen Cycle:
- · Non-lumened devices 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 channeled devices with stainless steel lumens that are:
≥ 0.77 mm ID and ≤ 410 mm in length
≥ 1.8 mm ID x ≤ 542 mm in length
o Triple channeled devices with stainless steel lumens that are:
≥ 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 and s2 Non Lumen Cycle:
Non-lumened devices including non-lumened rigid, semi-rigid and flexible endossopes and non-lumened devices with diffusion-restricted spaces such as the hinged portion of forceps and scissors.
V-PRO 60 and 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
7
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
- ≥ 1.0 mm ID and 3 mm ID and 1 mm ID and ≤ 1050 mm in length.
Load 2:
• 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
• Single, dual or triple channel stainless steel lumens that are > 0.48 mm ID and ≤ 100 mm in length
V-PRO maX 2 Fast Non Lumen Cycle:
Non-lumened devices including non-lumened rigid, semi-rigid and flexible endossopes and non-lumened devices with diffusion-restricted spaces such as the hinged portion of forceps and scissors.
Intended Sterilization Cycles and Intended Tray Load for Tray Models: VP0045, VP0047, VP0048, VP0049,
8
VP0050, VP0051, VP0052
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 Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
10
Image /page/10/Picture/1 description: The image shows the logo for STERIS. The logo consists of the word "STERIS" in a bold, sans-serif font, with a registered trademark symbol to the right of the word. Below the word is a graphic of several horizontal, wavy lines in blue, resembling water.
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: Anthony Piotrkowski Director, Regulatory Affairs
Telephone: (440) 392-7437 Fax No: (440) 357-9198 e-mail: tony piotrkowski(@steris.com
Submission Date: September 7, 2022
Premarket Notification Number: K222440
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
11
1. Device Name
| Trade Name: | Vis-U-All Low Temperature Sterilization
Pouches/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, K183401
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 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 1.
| Table 1. Sizes and Configurations of Vis-U-All Low Temperature Sterilization Pouches/Tubing | ||||||
|---|---|---|---|---|---|---|
| -- | -- | -- | --------------------------------------------------------------------------------------------- | -- | -- | -- |
| Type | Size * | Type | Size* | Type | Size* |
|---|---|---|---|---|---|
| Heat | |||||
| Seal | |||||
| Pouch | 3 x 7 | 3 x 7 | Tubing | 3" x 100' | |
| 4 x 9 | 4 x 9 | 4" x 100' | |||
| 4 x 12 | Self Seal | ||||
| Pouch | 4 x 12 | 6" x 100' | |||
| 4 x 22 | 4 x 22 | 9" x 100' | |||
| 6 x 10 | 6 x 10 | 14" x 100' | |||
| 8 x 12 | 8 x 12 | ||||
| 10 x 15 | 10 x 15 | ||||
| 12 x 18 | 12 x 18 | ||||
| 8 x 21 | |||||
| 8 x 27 | |||||
| 9 x 27 | |||||
| 11 x 22 | |||||
| 12 x 27 |
*Sizes are in inches unless specified otherwise
The purpose of this submission is to qualify use of the Vis-U-All Low Temperature Sterilization Pouches and Tubing for extended claims in the V-PRO 60, s2, maX and maX 2 Sterilizer Cycles.
12
Intended Use/ Indications for Use 4.
The Vis-U-All Low Temperature Sterilization Pouches/Tubing Intended use remains the same. The indications for use are being modified to expand lumen claims. A detailed comparison of the cleared and proposed indications for use are provided in Table 2.
5. Comparison of the Modified Device to the Predicate
The proposed and predicate devices are single use sterilization pouches for use in V-PRO Sterilizers. Table 2 summarizes the difference between the proposed device and predicate device cleared under K183401.
| Table 2. Technical Comparison to the Predicate. |
|---|
| ------------------------------------------------- |
| Feature | Modified Vis-U-All Low Temperature
Sterilization Pouch (proposed) K222440 | Vis-U-All Low Temperature
Sterilization Pouch (K183401) | Comparison |
|---------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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*
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.
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 | 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.
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 | Identical except
for:
• Clarification
of lumen
claims for V-
PRO lumen
cycles
• Clarification
of endoscope
claims for V-
PRO flexible
cycles
• Removal of
"stainless steel
or titanium"
from V-PRO
Non Lumen
cycles. |
| Feature | Modified Vis-U-All Low Temperature
Sterilization Pouch (proposed) K222440 | Vis-U-All Low Temperature
Sterilization Pouch (K183401) | Comparison |
| | *STERRAD and ALLClear are
trademarks of Advanced Sterilization
Products | *STERRAD and ALLClear are
trademarks of Advanced Sterilization
Products | |
| | The pouches maintain the sterility of the
enclosed devices until used. | 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. | 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 | 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
• Non-lumened devices 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
• $\ge$ 0.77 mm internal diameter
(ID) and $\le$ 410 mm in length
• $\ge$ 1.8 mm ID x $\le$ 542 mm in
length
o 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 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 and semi-
rigid endoscopes, with the following
configurations:
o single or dual lumen devices
• $\ge$ 0.77 mm internal diameter
(ID) and $\le$ 410 mm in length
o 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 | |
| Feature | Modified Vis-U-All Low Temperature
Sterilization Pouch (proposed) K222440 | Vis-U-All Low Temperature
Sterilization Pouch (K183401) | Comparison |
| | 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 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
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 $\ge$ 1 mm ID and $\le$
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 configurations:
• $\ge$ 0.76 mm ID and $\le$ 233 mm in length
• $\ge$ 1.0 mm ID and $\le$ 254 mm in length
• $\ge$ 1.8 mm ID and $\le$ 542 mm in length | V-PRO 60 & s2 Flexible 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:
• single or dual lumen device with
lumens that are $\ge$ 1 mm ID and $\le$ 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:
• $\ge$ 2 mm ID and $\le$ 400 mm in length
• $\ge$ 0.76 mm ID and $\le$ 233 mm in length
• $\ge$ 1.0 mm ID and $\le$ 254 mm in length | |
| | V-PRO s2 Fast Cycle
• Non-lumened devices including non-
lumened rigid and semi-rigid and
flexible endoscopes and non-lumened
devices with diffusion-restricted spaces
such as the hinged portion of forceps
and scissors.
• Medical devices (including single, dual
and triple channeled rigid and semi-
rigid endoscopes) with the following
configurations:
• single or dual lumen devices
$\ge$ 0.77 mm ID and $\le$ 410 mm in
length
$\ge$ 1.8 mm ID x $\le$ 542 mm in
length
• Triple channeled devices with stainless | V-PRO s2 Fast Cycle
• Non-lumened devices including non-
lumened rigid and semi-rigid and
flexible endoscopes and non-lumened
devices with diffusion-restricted spaces
such as the hinged portion of forceps
and 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 $\ge$ 0.77 mm ID and $\le$ 410 mm
in length
• Triple channeled devices with stainless | |
| | steel lumens that are either: | steel lumens that are either: | |
| Feature | Modified Vis-U-All Low Temperature
Sterilization Pouch (proposed) K222440 | Vis-U-All Low Temperature
Sterilization Pouch (K183401) | Comparison |
| | $\geq$ 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, 1 Plus, maX & maX 2 Lumen Cycle Non-lumened devices 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: $\geq$ 0.77 mm ID and $\leq$ 527 mm in length $\geq$ 0.8 mm ID and $\leq$ 542 mm in length $\geq$ 0.48 mm ID and $\leq$ 100 mm in length Medical devices with Dead end lumens that are $\geq$ 1.3 mm ID and $\leq$ 73 mm in length Devices with rigid non-metallic lumens (such as those used in endoscope sheaths, take-apart forceps and trocars) that are: $\geq$ 3 mm ID and $\leq$ 298 mm in length $\geq$ 4 mm ID and $\leq$ 424 mm in length | $\geq$ 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, 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 and semi-rigid endoscopes, with the following configurations: single or dual lumen devices $\geq$ 0.77 mm ID and $\leq$ 410 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, 1 Plus, maX & maX2 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 1, 1 Plus, maX & maX2 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. | |
| Feature | Modified Vis-U-All Low Temperature
Sterilization Pouch (proposed) K222440 | Vis-U-All Low Temperature
Sterilization Pouch (K183401) | Comparison |
| | 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 or dual channel lumen that
is $\geq$ 1 mm ID and $\leq$ 1050 mm in length
Load 2:
• 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
• Single, dual or triple channel stainless
steel lumen that is $\geq$ 0.48 mm ID and
$\leq$ 100 mm in length. | 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 2 Fast 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 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 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 | 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:
• $\geq$ 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 | |
| | 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. | 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 | |
| Feature | PRO-LITE Sterilization Trays
Modified Vis-U-All Low Temperature
Sterilization Pouch (proposed) K222440 | Vis-U-All Low Temperature
Sterilization Pouch (K183401) | Comparison |
| | 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 | 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. | 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 | 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 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 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- | STERRAD 100NX and 100NX with
ALLClear Technology Express Cycle
Metal and nonmetal medical devices
(surfaces sterilization only) and | |
| PRO-LITE Sterilization Trays | | | |
| Feature | Modified Vis-U-All Low Temperature
Sterilization Pouch (proposed) K222440 | Vis-U-All Low Temperature
Sterilization Pouch (K183401) | Comparison |
| | 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
$\geq$ 1 mm ID and $\leq$ 875 mm in length accessory devices that are normally
connected to a flexible endoscope
during use flexible endoscopes without lumens | 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
$\geq$ 1 mm ID and $\leq$ 875 mm in length accessory devices that are normally
connected to a flexible endoscope
during use flexible endoscopes without lumens | |
| Device
Features | Chevron end of pouches for ease of
opening
Chemical process indicator for EO | Chevron end of pouches for ease of
opening
Chemical process indicator for EO | Identical |
| Maintenance
of Sterility | 1 year | 1 year | Identical |
| Materials of
Construction | Tyvek and plastic | Tyvek and plastic | Identical |
| Types | Self Seal, Heat Seal, Tubing | Self Seal, Heat Seal, Tubing | Identical |
13
14
15
16
17
18
6. Summary of Performance Testing
Table 3 summarizes the testing of the Vis-U-All Low Temperature Sterilization Pouches/Tubing to demonstrate that the proposed pouch is qualified for use in V-PRO Low temperature Sterilization Systems.
Table 3. Performance Test Summary
| Test | Result | Conclusion |
|---|---|---|
| ½ Cycle | ||
| Verification of | ||
| Mated Surfaces | Sterile efficacy was demonstrated for mated surfaces under worst case conditions in the V-PRO Sterilizer cycles. | PASS |
| ½ Cycle Efficacy | The standard injection weight resulted in all sterile results within the validation load used to qualify each sterilizer cycle. | PASS |
| Simulated Use | ||
| Test | Simulated use testing verified the ability of the sterilizer cycles to sterilize medical devices under worst-case processing conditions. | PASS |
| In Use Test | The in use investigation demonstrated the ability of the V-PRO Sterilizer cycles to sterilize patient-soiled, clinically-cleaned, medical instruments. | PASS |
19
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 (K183401), Class II (21 CFR 880.6850), product code FRG.
20
510(k) Summary For PRO-LITE™ Sterilization Tray
Sponsor Facility
STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 357-9198
Anthony Piotrkowski Contact: Director, Regulatory Affairs
Telephone: (440) 392-7437 Fax No: (440) 357-9198 e-mail: tony piotrkowski(@steris.com
Submission Date: September 7, 2022
Premarket Notification Number: K222440
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
21
Device Name 7.
| Trade Name: | PRO-LITE Sterilization Tray |
|---|---|
| Common/usual Name: | Sterilization Trays, cassettes and other accessories |
| Classification Name: | Sterilization Wrap |
| Classification | 21 CFR 880.6850 |
| Class | II |
| Product Code | KCT, FRG |
8. Predicate Device
PRO-LITE Sterilization Tray, K183402
9. Description of Device
The PRO-LITE Sterilization Trays contain medical devices for sterilization in the V-PRO Low Temperature Sterilization Systems and STERRAD Sterilizers. The trays are available in various sizes, outlined in Table 4, to accommodate the loads to be processed. The proposed trays are identical in design to the predicate Sterilization Tray (K183402) and are composed of a base and a lid. The lid includes clamping mechanisms designed to secure the lid onto the base. There are numerous holes in the base and lid for sterilant penetration. The tray is categorized as a cassette and requires complete enclosure in a legally-marketed sterilization wrap or pouch to maintain sterility of the enclosed devices. Both the base and the lid for the proposed tray are made of a mineral-filled polypropylene material.
| Model | Description (in) | Model | Description (in) | Model | Description (in) |
|---|---|---|---|---|---|
| VP0045 | 13 x 4.5 x 2.25 | VP0048 | 13 x 7.75 x 2.25 | VP0051 | 12 x 11.75 x 4 |
| VP0046 | 19 x 4.5 x 2.25 | VP0049 | 19 x 7.75 x 2.25 | VP0052 | 25 x 11.75 x 4 |
| VP0047 | 25 x 4.5 x 2.25 | VP0050 | 27 x 7.75 x 4 | VP0053 | 25 x 14 x 5 |
Table 4. External Dimensions of Trav Line
Optional instrument organizers are provided as accessories to the trays and allow stabilization of various cylindrical medical devices during processing. Table 5 lists the organizer sizes. The organizers are either "blank" and are used to partition the tray or have a device holding portion into which the devices are inserted. At the organizer base is a flapped groove that is used to position the organizer within a PRO-LITE Sterilization Tray.
Table 5. Instrument Organizer Model Numbers
| Model | Description | Model | Description |
|---|---|---|---|
| VP0054 | Blank, Tall | VP0055 | Blank, Short |
| VP0063 | 3 mm - 7mm, Tall | VP0067 | 3 mm - 7 mm, Short |
| VP0064 | 7 mm - 11mm, Tall | VP0068 | 7 mm - 11 mm, Short |
| VP0065 | 11 mm - 15 mm, Tall | VP0069 | 11 mm - 15 mm, Short |
| VP0066 | 15 mm - 19mm, Tall | VP0070 | 15 mm - 19 mm, Short |
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
22
Optional sterilization mats are provided as accessories to the trays. The mats, which are used to cushion and stabilize devices placed into the trays, are available in sizes as shown in Table 6 to fit the nine PRO-LITE Sterilization Trays. The mats are a diamond grid design with "fingers" that extend from each corner of the diamond and at the midpoint of each diamond side. The fingers cushion and stabilize instruments, helping to prevent the instruments from freely moving in the tray during packaging, sterilization and storage. The cushioning and stabilization qualities help protect delicate instruments placed into the trays.
| Model | Description (in) | Model | Description (in) | Model | Description (in) |
|---|---|---|---|---|---|
| VP0071 | 13 x 4.5 | VP0074 | 13 x 7.75 | VP0077 | 12 x 11.75 |
| VP0072 | 19 x 4.5 | VP0075 | 19 x 7.75 | VP0078 | 25 x 11.75 |
| VP0073 | 25 x 4.5 | VP0076 | 27 x 7.75 | VP0079 | 25 x 14 |
Tahle 6 Silicone Mat Model Numbers
The purpose of this submission is to expand claims for the use of these tray models in the following sterilizer cycles:
- V-PRO 1, 1 Plus, maX and maX 2 Lumen Cycle ●
- V-PRO 1 Plus, maX and maX 2 Non Lumen Cycle ●
- V-PRO maX and maX 2 Flexible Cycle ●
- V-PRO maX 2 Fast Non Lumen Cycle ●
- V-PRO 60 and s2 Lumen, Non Lumen and Flexible Cycles ●
- V-PRO s2 Fast Cycle
10. Intended Use/ Indications for Use
The tray indications for use are included in Table 7 which compares the proposed device to the predicate.
Instrument organizers are optional accessories intended to stabilize cylindrical medical instruments within the PRO-LITE Sterilization Trays.
| Model | Description | Model | Description |
|---|---|---|---|
| VP0054 | Blank, Tall | VP0055 | Blank, Short |
| VP0063 | 3 mm - 7 mm, Tall | VP0067 | 3 mm - 7 mm, Short |
| VP0064 | 7 mm - 11 mm, Tall | VP0068 | 7 mm - 11 mm, Short |
| VP0065 | 11 mm - 15 mm, Tall | VP0069 | 11 mm - 15 mm, Short |
| VP0066 | 15 mm - 19 mm, Tall | VP0070 | 15 mm - 19 mm, Short |
Sterilization mats are optional accessories intended to cushion and stabilize instruments within the PRO-LITE Sterilization Trays.
| Model | Description (in) | Model | Description (in) | Model | Description (in) |
|---|---|---|---|---|---|
| VP0071 | 13 x 4.5 | VP0074 | 13 x 7.75 | VP0077 | 12 x 11.75 |
| VP0072 | 19 x 4.5 | VP0075 | 19 x 7.75 | VP0078 | 25 x 11.75 |
| VP0073 | 25 x 4.5 | VP0076 | 27 x 7.75 | VP0079 | 25 x 14 |
23
11. Summary of Technical Characteristics
The proposed PRO-LITE sterilization trays, sterilization mats and instrument organizers are identical in composition to the claimed predicate device. The technical characteristics are summarized below in Table 7.
| Table 7. Summary of Tray Physical Description and Technological Properties |
|---|
| ---------------------------------------------------------------------------- |
| Feature | PRO-LITE Sterilization Tray (proposed) K222440 | PRO-LITE Sterilization Tray (K183402) | Comparison |
|---|---|---|---|
| Intended Use / Indications for Use | The PRO-LITE Sterilization Trays are used to contain medical devices for sterilization in the following Cycles: | ||
| • 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 | |||
| • Standard, Flex Scope, Express and DUO Cycles of the STERRAD 100NX and 100NX with ALLClear Technology Sterilizers |
*STERRAD and ALLClear are trademarks of Advanced Sterilization Products
Prior to placing in the Sterilizer, the trays must either be:
• wrapped with a legally marketed sterilization wrap for use in the Sterilizers listed above
or
• placed inside a legally marketed pouch for enclosing trays in the Sterilizers listed above.
The PRO-LITE Sterilization Trays are not intended to maintain sterility; they are intended to be used in conjunction with a validated, FDA-cleared sterilization wrap or pouch in order to maintain sterility of the enclosed | The PRO-LITE Sterilization Trays are used to contain medical devices for sterilization in the following Cycles:
• 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
• Standard, Flex Scope, Express and DUO Cycles of the STERRAD 100NX and 100NX with ALLClear Technology Sterilizers
*STERRAD and ALLClear are trademarks of Advanced Sterilization Products
Prior to placing in the Sterilizer, the trays must either be:
• wrapped with a legally marketed sterilization wrap for use in the Sterilizers listed above
or
• placed inside a legally marketed pouch for enclosing trays in the sterilizers listed above
The PRO-LITE Sterilization Trays are not intended to maintain sterility; they are intended to be used in conjunction with a validated, FDA-cleared sterilization wrap or pouch in order to maintain sterility of the enclosed | Identical except for:
• Clarification of lumen claims for V-PRO lumen cycles
• Clarification of endoscope claims for V-PRO flexible cycles
Removal of “stainless steel or titanium” from V-PRO Non Lumen cycles. |
| Feature | PRO-LITE Sterilization Tray
(proposed) K222440 | PRO-LITE Sterilization Tray
(K183402) | Comparison |
| | Intended Sterilization Cycles and
Intended Tray Load for Tray Models:
VP0045, VP0046, VP0047, VP0048,
VP0049, VP0050, VP0051, VP0052 | Intended Sterilization Cycles and
Intended Tray Load for Tray Models:
VP0045, VP0046, VP0047, VP0048,
VP0049, VP0050, VP0051, VP0052 | |
| | V-PRO 60 and s2 Lumen Cycle:
• Non-lumened devices 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 channeled devices
with stainless steel lumens that are:
■ $\ge$ 0.77 mm ID and $\le$ 410 mm in
length
■ $\ge$ 1.8 mm ID x $\le$ 542 mm in
length
o Triple channeled devices with
stainless steel lumens that are:
■ $\ge$ 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 60 and 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 and
semi-rigid endoscopes with the
following configurations:
o Single or dual lumen devices
■ $\ge$ 0.77 mm ID and $\le$ 410 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 60 and 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 and 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 and s2 Flexible 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: | V-PRO 60 and s2 Flexible 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: | |
| Feature | PRO-LITE Sterilization Tray
(proposed) K222440 | PRO-LITE Sterilization Tray
(K183402) | Comparison |
| | Single or dual lumen device with
lumens that are $\geq$ 1 mm ID and $\leq$ 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 configurations: $\geq$ 0.76 mm ID and $\leq$ 233 mm in length $\geq$ 1.0 mm ID and $\leq$ 254 mm in length $\geq$ 1.8 mm ID and $\leq$ 542 mm in length Intended Sterilization Cycle and Intended Tray Load for Tray Models:
VP0045, VP0046, VP0047, VP0048, VP0049 | Single or dual lumen device with
lumens that are $\geq$ 1 mm ID and $\leq$ 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 configurations: $\geq$ 2.0 mm ID and $\leq$ 400 mm in length $\geq$ 0.76 mm ID and $\leq$ 233 mm in length $\geq$ 1.0 mm ID and $\leq$ 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 and 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 $\geq$ 0.77 mm ID and $\leq$ 410 mm in length $\geq$ 1.8 mm ID and $\leq$ 542 mm in length Triple channeled devices with stainless steel lumens that are either $\geq$ 1.2 mm ID and $\leq$ 275 mm in length $\geq$ 1.8 mm ID and $\leq$ 310 mm in length $\geq$ 2.8 mm ID and $\leq$ 317 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 spaces such as the hinged portion of forceps and 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 $\geq$ 0.77 mm ID and $\leq$ 410 mm in length Triple channeled devices with stainless steel lumens that are either $\geq$ 1.2 mm ID and $\leq$ 275 mm in length $\geq$ 1.8 mm ID and $\leq$ 310 mm in length $\geq$ 2.8 mm ID and $\leq$ 317 mm in length | |
| Feature | PRO-LITE Sterilization Tray
(proposed) K222440 | PRO-LITE Sterilization Tray
(K183402) | Comparison |
| | Intended Sterilization Cycles and
Intended Tray Load for Tray Models:
VP0045, VP0046, VP0047, VP0048,
VP0049, VP0050, VP0051, VP0052,
VP0053 | Intended Sterilization Cycles and
Intended Tray Load for Tray Models:
VP0045, VP0046, VP0047, VP0048,
VP0049, VP0050, VP0050, VP0051,
VP0052, VP0053 | |
| | V-PRO 1, 1 Plus, maX, and maX 2
Lumen Cycle:
• Non-lumened devices with diffusion-
restricted spaces such as the hinged
portion of forceps and scissors
• 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
• Devices with rigid non-metallic
lumens (such as those used in
endoscope sheaths, take-apart forceps
and trocars) that are:
○ ≥ 3 mm ID and ≤ 298 mm in length
○ ≥ 4 mm ID and ≤ 424 mm in length | V-PRO 1, 1 Plus, maX, and maX 2
Lumen Cycle:
• Instruments with diffusion-restricted
spaces such as the hinged portions 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 ID and ≤ 410 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
■ ≥ 2.8 mm ID and ≤ 317 mm in
length | |
| | V-PRO 1 Plus, maX, and maX 2 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 1 Plus, maX, and 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, and 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. | V-PRO maX, and 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. | |
| Feature | PRO-LITE Sterilization Tray
(proposed) K222440 | PRO-LITE Sterilization Tray
(K183402) | Comparison |
| | The flexible endoscopes may contain
either a single or dual lumen that is ≥ 1
mm ID and ≤ 1050 mm in length
Load 2:
• 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
• Single, dual or triple channel stainless
steel lumens that are ≥ 0.48 mm ID
and ≤ 100 mm in length | 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