(37 days)
No
The device is a physical sterilization tray and does not involve any software or data processing that would utilize AI/ML.
No
The device is a sterilization tray used to contain medical devices during sterilization, not to provide therapy itself.
No
The PRO-LITE Sterilization Trays are used to contain medical devices during the sterilization process, not to diagnose medical conditions.
No
The device description clearly states that the device is a physical tray made of mineral-filled polypropylene material, designed to contain medical devices for sterilization. It also mentions optional physical accessories like instrument organizers and sterilization mats. This is a hardware device, 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 PRO-LITE Sterilization Trays are used to "contain medical devices for sterilization." This is a function related to the processing and handling of medical devices, not for performing diagnostic tests on biological samples.
- Device Description: The description details the physical characteristics of the trays, their materials, and how they are used to hold instruments during sterilization. There is no mention of any components or functions related to analyzing biological samples or providing diagnostic information.
- Performance Studies: The performance studies focus on the effectiveness of sterilization, material compatibility, drying, cleaning, and biocompatibility of the trays themselves. These are all relevant to a device used in the sterilization process, not for diagnostic purposes.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease. The PRO-LITE Sterilization Trays do not perform this function. They are accessories used in the sterilization of other medical devices.
N/A
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
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, VP0049, VP0050, VP0050, VP0051, VP0052
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 2 mm ID and 1.2 mm ID and ID > 1050
- · single or dual lumen devices
-
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.
Instrument organizers are optional accessories intended to stabilize cylindrical instruments within the Sterilization Trays.
Sterilization mats are optional accessories intended to cushion and stabilize instruments within the Sterilization Trays.
Product codes
KCT
Device Description
The PRO-LITE Sterilization Trays contain medical devices for sterilization in the V-PRO Low Temperature Sterilization Systems: V-PRO 1, V-PRO 1 Plus, V-PRO maX, V-PRO maX 2, V-PRO 60 and V-PRO s2 Low Temperature Sterilization Systems. The trays are available in various sizes, outlined in Table 5-1, to accommodate the loads to be processed. The proposed trays are identical in design to the predicate Sterilization Trav (K172755) 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.
Optional instrument organizers are provided as accessories to the trays and allow stabilization of various cylindrical medical devices during processing. 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.
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 5-3 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Summary of Non-clinical Tests
Demonstration of Effective Sterilant Penetration:
-
Test: V-PRO s2 Sterilizer Fast Cycle
-
Acceptance Criteria: Worst case stainless steel lumen test articles shall be reproducibly sterilized under worst case 1/2 cycle conditions for the Fast Cycle; Diffusion-restricted spaces shall be reproducibly sterilized under worst case 1/2 cycle conditions for the Fast Cycle; Contact points between medical devices and tray accessories shall be reproducibly sterilized under worst case 1/2 cycle conditions for the Fast Cycle; Worst case surface sterilization test articles shall be reproducibly sterilized under worst case 1/2 cycle conditions for the Fast cycle
-
Conclusion: PASS
-
Test: V-PRO 60 & s2 Sterilizer Non Lumen Cycle, diffusion-restricted spaces claims
-
Acceptance Criteria: Diffusion-restricted spaces shall be reproducibly sterilized under worst case 1/2 cycle conditions for the Non Lumen Cycle
-
Conclusion: PASS
-
Test: V-PRO 60 & s2 Sterilizer Flexible Cycle, diffusion-restricted spaces claims
-
Acceptance Criteria: Diffusion-restricted spaces shall be reproducibly sterilized under worst case 1/2 cycle conditions for the Flexible Cycle
-
Conclusion: PASS
-
Test: V-PRO 60 & s2 Sterilizer Flexible Cycle Extended Claims
-
Acceptance Criteria: Stainless steel test articles shall be reproducibly sterilized under worst case 1/2 cycle conditions for the Flexible Cycle
-
Conclusion: PASS
Package Integrity: Not applicable. The Sterilization Tray meets the definition of a "tray" in ANSI/AAMI ST77:2013, Containment devices for reusable medical device sterilization, therefore package integrity and maintenance of package integrity testing are not applicable.
Demonstration of Effective Drying and Aeration:
- Acceptance Criteria: Residual hydrogen peroxide levels shall be below acceptable levels after exposure to worst case Sterilizer Cycle conditions
- Conclusion: PASS
Demonstration of Material Compatibility:
- Acceptance Criteria: After processing through multiple worst case sterilization cycles, the trays and accessories shall retain functionality
- Conclusion: PASS
Demonstration of Biocompatibility:
- Acceptance Criteria: Component materials shall be non-cytotoxic after exposure to worst case Sterilizer Conditions
- Conclusion: PASS
Demonstration of Effective Cleaning:
- Acceptance Criteria: Sterilization Trays and accessories must be clean following automated and manual cleaning
- Conclusion: PASS
Key Metrics
Not Found
Predicate Device(s)
PRO-LITE Sterilization Tray, K172755
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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 shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.
January 3, 2019
STERIS Corporation Jennifer Nalepka Senior Regulatory Affairs Specialist 5960 Heisley Road Mentor, Ohio 44060
Re: K183301
Trade/Device Name: PRO-LITE Sterilization Tray Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT 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
1
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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
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
2
Indications for Use
510(k) Number (if known) K183301
Device Name PRO-LITE Sterilization Trays
Indications for Use (Describe)
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
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, VP0049, VP0050, VP0050, VP0051, VP0052
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 2 mm ID and 1.2 mm ID and ID > 1050
- · single or dual lumen devices
-
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 2.0 mm ID and ≤ 400 mm in length
- o ≥1.0 mm ID and ≤ 254 mm in length
- o > 0.76 mm ID and ≤ 233 mm in length
in the V-PRO 60 and V-PRO s2 Sterilizer Flexible Cycle
- Qualification of 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 Cycle and Flexible Cycle.
- Oualification of use in the V-PRO s2 Sterilizer Fast Cycle
- Addition of the V-PRO s2 Sterilizer to the indications for use in the Lumen ● Cycle
8
| Cycle | Most Recent
Premarket
Notification
Clearance | V-PRO 60 | V-PRO s2 |
|-----------------|-------------------------------------------------------|----------|----------|
| Lumen Cycle | | X | X |
| Non Lumen Cycle | K172319 | X | X |
| Flexible Cycle | | X | X |
| Fast Cycle | Concurrent
Submission
(K182528) | | X |
| Table 5-4: V-PRO Cycles Provided V-PRO 60 and s2 Sterilizers | |
|---|---|
| -------------------------------------------------------------- | -- |
- 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. 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
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.
| Tray
Models | Intended
Sterilization
Cycles | Intended Tray Load |
|----------------------------------------------------------------------------------------|----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| VP0045
VP0046
VP0047
VP0048
VP0049
VP0050
VP0051
VP0052 | 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
• ≥ 0.77 mm internal diameter (ID) and ≤ 410 mm in length
o triple lumen devices |
| Tray
Models | Intended
Sterilization
Cycles | Intended Tray Load |
| | | ≥1.2 mm ID and ≤ 275 mm in length ≥1.8 mm ID and ≤ 310 mm in length or
≥2.8 mm ID and ≤ 317 mm in length |
| | V-PRO 60 &
s2 Non
Lumen Cycle | Non-lumened devices including non-lumened rigid, semi-rigid and
flexible endoscopes and non-lumened devices with diffusion-
restricted spaces such as the hinged portion of forceps and
scissors. |
| | V-PRO 60 &
s2 Flexible
Cycle | Load 1: One flexible surgical endoscope or bronchoscope with a
light cord (if not integral to endoscope) and mat without any
additional load. The flexible endoscope may be a:
○ single or dual lumen device with lumens that are ≥ 1 mm ID
and ≤ 990 mm in length
Load 2: Non-lumened devices including non-lumened rigid, semi-
rigid, and flexible endoscopes and non-lumened devices with
diffusion-restricted areas such as the hinged portion of forceps or
scissors. Medical devices, including rigid and semi-rigid
endoscopes, with the following configurations:
○ ≥ 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 |
| VP0045
VP0046
VP0047
VP0048
VP0049 | V-PRO s2
Fast Cycle | Non-lumened devices including non-lumened rigid, semi-rigid
and flexible endoscope, 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 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 length or
≥2.8 mm ID and ≤ 317 mm in length |
| Tray
Models | Intended
Sterilization
Cycles | Intended Tray Load |
| VP0045
VP0046
VP0047
VP0048
VP0049
VP0050
VP0051
VP0052
VP0053 | 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
■ $\ge$ 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 1
Plus, maX &
maX 2 Non
Lumen Cycle | Non-lumened devices including non-lumened rigid, semi-rigid and flexible endoscopes and non-lumened devices with stainless steel or titanium diffusion-restricted spaces such as the hinged portion of forceps and scissors. |
| | V-PRO maX
& maX 2
Flexible
Cycle | Load 1: Single or dual lumen surgical flexible endoscopes (such as those used in ENT, Urology and Surgical Care) and bronchoscopes with a light cord (if not integral to endoscope) and mat with no additional load.
The flexible endoscopes may contain either:
• a single lumen that is $\ge$ 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-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. |
9
10
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 |
11
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 |
ട. Technological Characteristic Comparison Table
The proposed PRO-LITE sterilization trays, sterilization mats and instrument organizers are identical in composition to the claimed predicate devices. The technical characteristics are summarized below in Table 5-5.
| Feature | PRO-LITE Sterilization
Tray (proposed) | PRO-LITE Sterilization
Tray (K172755) | Comparison |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
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 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, | The PRO-LITE Sterilization
Trays are used to contain
medical devices for
sterilization in the Lumen, Non
Lumen, Flexible and Fast Non
Lumen Cycles of the V-PRO
Low Temperature Sterilization
Systems. Prior to placing in the
Sterilizer, the trays must either
be:
wrapped with a legally
marketed sterilization wrap
for use in the V-PRO Low
Temperature Sterilization
Systems or placed inside a legally
marketed pouch for
enclosing trays in the V-PRO
Low Temperature
Sterilization Systems. The PRO-LITE Sterilization
Trays are not intended to
maintain sterility; they are
intended to be used in
conjunction with a validated, | Identical except
for:
The addition
of the Fast
Cycle of the
V-PRO s2
Sterilizer.
The Fast
Cycle is a
new cycle in
the V-PRO s2
Low
Temperature
Sterilizer,
subject of a
concurrent
submission
(K182568). The extension
of claims in
the V-PRO
60 & s2
Sterilizers
Flexible
Cycle. |
| Feature | PRO-LITE Sterilization
Tray (proposed) | PRO-LITE Sterilization
Tray (K172755) | Comparison |
| | wrap or pouch in order to
maintain sterility of the
enclosed medical
instruments. | or pouch in order to maintain
sterility of the enclosed
medical instruments. | |
| | Intended Sterilization Cycles
and Intended Tray Loads for
Tray models: VP0045,
VP0046, VP0047, VP0048,
VP0049, VP0050, VP0051,
VP0052 | Intended Sterilization Cycles
and Intended Tray Loads for
Tray models: VP0045,
VP0046, VP0047, VP0048,
VP0049, VP0050, VP0051,
VP0052 | |
| | 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
■ ≥ 0.77 mm internal
diameter (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
or
■ ≥ 2.8 mm ID and ≤
317 mm in length | V-PRO 60 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
≥ 0.77 mm ID and less
than or equal to 410 mm in
length
► triple lumen devices
≥1.2 mm ID and less than
or equal to 275 mm in
length
≥1.8 mm ID and less than
or equal to 310 mm in
length
or
≥2.8 mm ID and less than
or equal to 317 mm in
length | |
| Feature | PRO-LITE Sterilization
Tray (proposed) | PRO-LITE Sterilization
Tray (K172755) | 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 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 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 ≥ 1 mm ID and ≤
990 mm in length
Load 2: Non-lumened
devices including non-
lumened rigid, semi-rigid,
and flexible endoscopes and
non-lumened devices with
diffusion-restricted areas
such as the hinged portion of
forceps or scissors. Medical
devices, including rigid and
semi-rigid endoscopes, with
the following configurations:
• ≥ 2 mm ID and ≤ 400
mm in length
• ≥ 0.76 mm ID and ≤ 233
mm in length
• ≥ 1.0 mm ID and ≤ 254
mm in length | V-PRO 60 Flexible Cycle - One flexible surgical
endoscope or bronchoscope
with a light cord (if not
integral to endoscope) and
mat without any additional
load. The flexible endoscope
may be a single or dual lumen
device with lumens that are ≥
1 mm ID and less than or
equal 990 mm in length | |
| Feature | PRO-LITE Sterilization
Tray (proposed) | PRO-LITE Sterilization
Tray (K172755) | Comparison |
| | Intended Sterilization Cycles
and Intended Tray Loads for
Tray models: VP0045,
VP0046, VP0047, VP0048,
VP0049 | | |
| | V-PRO s2 Fast Cycle:
• Non-lumened devices
including non-lumened
rigid, semi-rigid and
flexible endoscope, 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 and
semi-rigid endoscopes,
with the following
configurations:
o single or dual lumen
devices
■ ≥ 0.77 mm internal
diameter (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
or | | |
| | ■ ≥2.8 mm ID and ≤ 317
mm in length | | |
| | Intended Sterilization Cycles
and Intended Tray Loads for
Tray models: VP0045,
VP0046, VP0047, VP0048,
VP0049, VP0050, VP0051,
VP0052, VP0053 | Intended Sterilization Cycles
and Intended Tray Loads for
Tray models: VP0045,
VP0046, VP0047, VP0048,
VP0049, VP0050, VP0051,
VP0052, VP0053 | |
| | V-PRO 1, 1 Plus, maX &
maX 2 Lumen Cycle:
• Instruments with diffusion-
restricted spaces such as
the hinged portion of
forceps and scissors | V-PRO 1, 1 Plus, maX, &
maX 2 Lumen Cycle
• Instruments with diffusion-
restricted spaces such as the
the hinged portion of forceps
and scissors | |
| Feature | PRO-LITE Sterilization | PRO-LITE Sterilization | Comparison |
| | Tray (proposed) | Tray (K172755) | |
| | • 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 ≤
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 length
or
■ ≥2.8 mm ID and ≤ 317
mm in length | • 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 less
than or equal to 527 mm in
length
triple lumen devices
≥1.2 mm ID and less than
or equal to 275 mm in
length
≥1.8 mm ID and less than
or equal to 310 mm in
length
or
≥2.8 mm ID and less than
or equal to 317 mm in
length | |
| | 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 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. | V-PRO maX & maX 2
Flexible Cycle
Load 1: Single or dual lumen
surgical flexible endoscopes
(such as those used in ENT.
Urology and Surgical Care)
and
bronchoscopes with a light
cord (if not integral to
endoscope) and mat with no
additional load. | |
| Feature | PRO-LITE Sterilization
Tray (proposed) | PRO-LITE Sterilization
Tray (K172755) | Comparison |
| | 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. | The flexible endoscopes may
contain either:
a single lumen that is ≥ 1 mm
ID and less than or equal 1050
mm in length
or two lumens with:
one lumen that is ≥ 1 mm ID
and less than or equal 990 mm
in length
and the other lumen that is ≥ 1
mm ID and less than or equal
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. | V-PRO maX 2 Fast Non
Lumen
Non-lumened devices
including non-lumened rigids,
semi-rigids and flexible
endoscopes and non-lumened
devices with stainless steel or
titanium diffusion-restricted
spaces such as the hinged
portion of forceps and scissors. | |
| | Instrument organizers are
optional accessories
intended to stabilize
cylindrical medical
instruments with in the
Sterilization Trays. | Instrument organizers are
optional accessories intended
to stabilize cylindrical medical
instruments within the PRO-
LITE Sterilization Trays. | |
| | Sterilization mats are
optional accessories
intended to cushion and
stabilize instruments within
the Sterilization Trays. | Sterilization mats are optional
accessories intended to cushion
and stabilize instruments within
the PRO-LITE Sterilization
Trays. | |
| Vent to
Volume
Ratio | All trays are the same:
$0.135 \text{ in}^{-1}$ | All trays are the same:
$0.135 \text{ in}^{-1}$ | Identical. |
| Tray
Composition | Mineral-filled
polypropylene, stainless
steel | Mineral-filled polypropylene,
stainless steel | Identical. |
| Feature | PRO-LITE Sterilization
Tray (proposed) | PRO-LITE Sterilization
Tray (K172755) | Comparison |
| Instrument
Organizer
Composition | Medical Grade Silicone,
USP grade VI | Medical Grade Silicone, USP
grade VI | Identical. |
| Mat
Composition | Medical Grade Silicone,
USP grade VI | Medical Grade Silicone, USP
grade VI | Identical. |
Table 5-5. Summary of Tray Physical Description and Technological Properties
12
13
14
15
16
17
6. Summary of Non-clinical Tests
Performance testing to demonstrate substantial equivalence to the predicate has been completed and is summarized in Table 5-5 below.
| Test | Acceptance Criteria | Conclusion | |
|---|---|---|---|
| Demonstration | |||
| of Effective | |||
| Sterilant | |||
| Penetration | V-PRO s2 | ||
| Sterilizer Fast | |||
| Cycle | Worst case stainless steel lumen test | ||
| articles shall be reproducibly | |||
| sterilized under worst case 1/2 cycle | |||
| conditions for the Fast Cycle | |||
| Diffusion-restricted spaces shall be | |||
| reproducibly sterilized under worst | |||
| case 1/2 cycle conditions for the Fast | |||
| Cycle | |||
| Contact points between medical | |||
| devices and tray accessories shall be | |||
| reproducibly sterilized under worst | |||
| case 1/2 cycle conditions for the Fast | |||
| Cycle | |||
| Worst case surface sterilization test | |||
| articles shall be reproducibly | |||
| sterilized under worst case 1/2 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 1/2 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 1/2 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 1/2 cycle conditions for the | |||
| Flexible Cycle | PASS |
Table 5-5. Summary of Non-clinical Testing
18
| Package Integrity | Not applicable. The Sterilization Tray meets the definition of a “tray” in ANSI/AAMI ST77:2013, Containment devices for reusable medical device sterilization, therefore package integrity and maintenance of package integrity testing are not applicable | |
|---|---|---|
| Maintenance of Package Integrity | ||
| Demonstration of Effective Drying and Aeration | Residual hydrogen peroxide levels shall be below acceptable levels after exposure to worst case Sterilizer Cycle conditions | PASS |
| Demonstration of Material Compatibility | After processing through multiple worst case sterilization cycles, the trays and accessories shall retain functionality | PASS |
| Demonstration of Biocompatibility | Component materials shall be non-cytotoxic after exposure to worst case Sterilizer Conditions | PASS |
| Demonstration of Effective Cleaning | Sterilization Trays and accessories must be clean following automated and manual cleaning | PASS |
7. Conclusion
Based on the intended use, technological characteristics and non-clinical performance data, the subject device is as safe, as effective and performs as well as or better than the legally marketed predicate device (K172755), Class II (21 CFR 880.6850), product code KCT.