(75 days)
Not Found
No
The device description and intended use clearly define the product as a physical tray for containing medical devices during sterilization. There is no mention of any software, algorithms, or data processing capabilities that would indicate the presence of AI or ML. The "Mentions AI, DNN, or ML" section also explicitly states "Not Found".
No.
The device is a sterilization tray used to contain medical devices during the sterilization process, not to provide therapy itself.
No
The device description and intended use clearly state that the PRO-LITE Sterilization Trays are used to contain medical devices for sterilization. They do not diagnose conditions or diseases.
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 is a hardware component.
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 trays are used to contain medical devices for sterilization. This is a process related to preparing medical devices for use, not for performing diagnostic tests on biological samples.
- Device Description: The description focuses on the physical characteristics of the tray and its function in the sterilization process. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Indicators: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The device is a sterilization accessory, designed to facilitate 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, Fast, and Specialty Cycles of the V-PRO Low Temperature Sterilization Systems
- Default Cycle of the STERRAD®* 100S Sterilizer
- Standard and Advanced Cycles of the STERRAD NX and NX with ALLClear Technology Sterilizers
- 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.
Product codes (comma separated list FDA assigned to the subject device)
KCT
Device Description
The PRO-LITE Sterilization Trays contain medical devices for sterilization in the V-PRO Low Temperature Sterilization Systems:
- V-PRO 1 Low Temperature Sterilization System,
- V-PRO 1 Plus Low Temperature Sterilization System,
- V-PRO maX Low Temperature Sterilization System,
- V-PRO maX 2 Low Temperature Sterilization System
- V-PRO 60 Low Temperature Sterilization System and
- V-PRO s2 Low Temperature Sterilization System
and the following STERRAD Sterilizers and cycles:
- STERRAD 100S Sterilizer Default Cycle
- STERRAD NX with and without ALLClear Technology Sterilizer Standard and Advanced Cycles
- STERRAD 100NX with and without ALLClear Technology Sterilizer Standard, Flex Scope, Express and Duo Cycles
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 Tray (K222440) 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. Table 5-2 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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing to demonstrate substantial equivalence to the predicate has been completed and is summarized in Table 5-5 below.
| Test | Result | Conclusion |
|---|---|---|
| Demonstration of Effective Sterilant Penetration | Cycle specific test articles shall be reproducibly sterilized under ½ cycle conditions for the V-PRO maX 2 Specialty Cycle | PASS |
Based on the intended use, technological characteristics and non-clinical performance data, the subject device is as safe, as effective and performs at least as well as the legally marketed predicate device (K222440), Class II (21 CFR 880.6850), product code KCT.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
August 7, 2023
STERIS Corporation Jennifer Nalepka Manager, Regulatory Affairs 5960 Heisley Road Mentor, Ohio 44060
Re: K231501
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: May 22, 2023 Received: May 24, 2023
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/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 medical devices and radiation-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).
Sincerelv.
Christopher K. Dugard -S
for Clarence W. Murray, III, Ph.D. 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) K231501
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, Fast, and Specialty Cycles of the V-PRO Low Temperature Sterilization Systems
- · Default Cycle of the STERRAD®* 100S Sterilizer
- · Standard and Advanced Cycles of the STERRAD NX and NX with ALLClear Technology Sterilizers
- · 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 Loads for Tray Models: VP0045, 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 endoscopes with the following configurations:
- · Single or dual channeled devices with stainless steel lumens that are:
- · ≥ 0.77 mm ID and 1.0 mm ID and ≤ 254 mm in length
- · Single or dual channeled devices with stainless steel lumens that are:
- · ≥ 1.8 mm ID and ≤ 542 mm in length
Intended Sterilization Cycles and Intended Tray Loads for Tray Models: VP0045, VP0047, VP0049, VP0049
V-PRO s2 Fast Cycle:
• Nor-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 endoscopes, with the following configurations:
- · Single or dual channeled devices with stainless steel lumens
- · > 0.77 mm ID and ≤ 410 mm in length
- ≥ 1.8 mm ID and ≤ 542 mm in length
- · Triple channeled devices with stainless steel lumens
- · > 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, VP0047, VP0048, VP0049, VP0050, VP0051, VP0052, VP0053
V-PRO 1, 1 Plus, maX, and maX 2 Lumen Cycle:
-
Non-lumened instruments 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 4 mm ID and 6 mm ID and ≤ 310 mm in length
Medical devices with a single stainless steel lumen with:
- ≥ 1 mm ID and ≤ 125 mm in length
- · ≥ 2 mm ID and ≤ 250 mm in length
· ≥ 3 mm ID and ≤ 400 mm in length
Intended Sterilization Cycles and Intended Tray Loads for Tray Models: VP0045, VP0048, VP0049
STERRAD NX and NX with ALLClear Technology Standard Cycle:
Metal and nonmetal medical devices including instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors.
Medical devices with a single stainless steel lumen with:
· ≥ 1 mm ID and ≤ 150 mm in length
· > 2 mm ID and 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)
- · > 1mm ID and ≤ 850 mm in length
STERRAD 100NX and 100NX with ALLClear Technology Express Cycle:
D I LIGHTS and roometal devices and instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors.
STERRAD 100NX and 100NX with ALLClear Technology Duo Cycle:
Medical devices including:
- · most flexible endoscopes with a single channel of polyethylene and Teflon (polytetrafluoroethylene) with ≥ 1 mm ID and 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."
7
STERIS®
510(k) Summary For K231501 PRO-LITE™ Sterilization Tray
Sponsor Facility
STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 357-9198
Jennifer Nalepka Contact: Manager, Regulatory Affairs
Telephone: (440) 392-7458 e-mail: jennifer nalepka(@steris.com
August 3, 2023 Submission Date:
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
8
1. Device Name
| 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 |
2. Predicate Device
PRO-LITE Sterilization Tray, K222440
3. Description of Device
The PRO-LITE Sterilization Trays contain medical devices for sterilization in the V-PRO Low Temperature Sterilization Systems:
- V-PRO 1 Low Temperature Sterilization System,
- V-PRO 1 Plus Low Temperature Sterilization System, ●
- V-PRO maX Low Temperature Sterilization System, ●
- V-PRO maX 2 Low Temperature Sterilization System ●
- V-PRO 60 Low Temperature Sterilization System and ●
- V-PRO s2 Low Temperature Sterilization System ●
and the following STERRAD Sterilizers and cycles:
- STERRAD 100S Sterilizer Default Cycle ●
- STERRAD NX with and without ALLClear Technology Sterilizer Standard ● and Advanced Cycles
- STERRAD 100NX with and without ALLClear Technology Sterilizer ● Standard, Flex Scope, Express and Duo Cycles
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 Tray (K222440) 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.
9
| Model | Description (in) | Model | Description (in) |
|---|---|---|---|
| VP0045 | 13 x 4.5 x 2.25 | VP0050 | 27 x 7.75 x 4 |
| VP0046 | 19 x 4.5 x 2.25 | VP0051 | 12 x 11.75 x 4 |
| VP0047 | 25 x 4.5 x 2.25 | VP0052 | 25 x 11.75 x 4 |
| VP0048 | 13 x 7.75 x 2.25 | VP0053 | 25 x 14 x 5 |
| VP0049 | 19 x 7.75 x 2.25 |
| Table 5-1. External Dimensions of Tray Line |
|---|
| --------------------------------------------- |
Optional instrument organizers are provided as accessories to the trays and allow stabilization of various cylindrical medical devices during processing. Table 5-2 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 5.2. 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 |
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.
| Model | Description (in) | Model | Description (in) |
|---|---|---|---|
| VP0071 | 13 x 4.5 | VP0076 | 27 x 7.75 |
| VP0072 | 19 x 4.5 | VP0077 | 12 x 11.75 |
| VP0073 | 25 x 4.5 | VP0078 | 25 x 11.75 |
| VP0074 | 13 x 7.75 | VP0079 | 25 x 14 |
| VP0075 | 19 x 7.75 |
Table 5-3. Silicone Mat Model Numbers
The purpose of this submission is to add or expand claims for the use of these tray models in the following sterilizer cycles V-PRO maX 2 Specialty Cycle. No changes have been made to the device for this claim other than labeling.
10
4. 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, Fast and Specialty Cycles ● of the V-PRO® Low Temperature Sterilization Systems
- Default Cycle of the STERRAD®* 100S Sterilizer ●
- Standard and Advanced Cycles of the STERRAD NX and NX with ALLClear Technology Sterilizers
- . Express, Standard, Flex Scope, and DUO Cycles of the STERRAD 100NX and 100 NX 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.
| Tray
Models | Intended
Sterilization
Cycles | Intended Tray Load | |
|----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|
| 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: Single or dual lumen devices with stainless steel lumens that are: $\geq$ 0.77 mm ID and $\leq$ 410 mm in length $\geq$ 1.8 mm ID and $\leq$ 542 mm in length Triple lumen devices with stainless steel lumens $\geq$ 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 60 and
s2 Non Lumen
Cycle | Non-lumened devices including non-lumened rigid, semi-rigid and flexible endoscopes and non-lumened devices with | |
| Tray
Models | Intended
Sterilization
Cycles | Intended Tray Load | |
| | V-PRO 60 and
s2 Flexible
Cycle | diffusion-restricted spaces such as the hinged portion of forceps
and scissors.
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:
≥ 0.76 mm ID and ≤ 233 mm in length ≥ 1.0 mm ID and ≤ 254 mm in length ≥ 1.8 mm ID and ≤ 542 mm in length | |
| VP0045
VP0046
VP0047
VP0048
VP0049 | V-PRO s2 Fast
Cycle | Non-lumened devices including non-lumened rigid, semi-rigid and flexible endoscopes, and non-lumened devices with diffusion restricted areas such as the hinged portion of forceps or scissors. Medical devices, including single, dual and triple channeled rigid and semi-rigid endoscopes, with the following configurations: Single or dual lumen channeled devices with stainless steel lumens ≥ 0.77 mm ID and ≤ 410 mm in length ≥ 1.8 mm ID and ≤ 542 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 | |
| VP0045
VP0046
VP0047
VP0048
VP0049
VP0050
VP0051
VP0052
VP0053 | V-PRO 1, 1
Plus, maX, and
maX 2 Lumen
Cycle | Non-lumened instruments 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 Instruments 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 Plus,
maX, and maX | Non-lumened devices including non-lumened rigid, semi-rigid and flexible endoscopes and non-lumened devices with | |
| Tray
Models | Intended
Sterilization
Cycles | Intended Tray Load | |
| | 2 Non Lumen
Cycle | 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. The flexible endoscopes may
contain either a single or dual lumen that is $\ge$ 1 mm ID and $\le$
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 stainless steel lumens that are $\ge$ 0.48
mm ID and $\le$ 100 mm in length | |
| | 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. | |
| VP0045
VP0046
VP0047
VP0048
VP0049
VP0050 | V-PRO maX 2
Specialty Cycle | Patient-specific surgical guides (e.g. osteotomy, shoulder, hip,
knee, spine) or anatomical models fabricated via additive
manufacturing (3D printing) processes and intended for single-
use during operative procedures.*
or
Non-lumened instruments including non-lumened general
medical instruments, non-lumened rigid, semi-rigid and flexible
endoscopes.**
- The validation studies were conducted using a validation load
consisting of pouched guide(s)/model(s) (with or without tray)
for a total weight of 5 lbs (2.3kg) 3D printed material.
**The validation studies were conducted using a validation
load consisting of one pouched instrument tray or one pouch
with guide(s)/model(s) (with or without tray) for a total weight
of 11 lbs (5kg). | |
| | | | |
| | | | |
| | | | |
| | | | |
| Material | Manufacturer | Specialty
Cycle | Lumens |
| Surgical Guide
Resin | Formlabs | F | $\ge$ 3 mm ID x $\le$ 30
mm L |
| BioMed
Amber Resin | Formlabs | F | $\ge$ 3 mm ID x $\le$ 30
mm L |
| Dental LT
Clear V2
Resin | Formlabs | D | $\ge$ 3 mm ID x $\le$ 30
mm L |
| BioMed Clear
Resin | Formlabs | D | $\ge$ 3 mm ID x $\le$ 30
mm L |
| Tray
Models | Intended
Sterilization
Cycles | Intended Tray Load | |
| | | Biocompatible
Clear
MED610
Stratasys E ≥3 mm ID x ≤20 mm L | |
| | | Biocompatible
Opaque
MED615RGD
Stratasys E ≥3 mm ID x ≤20 mm L | |
| | | VeroGlaze™
MED620
Stratasys E ≥3 mm ID x ≤20 mm L | |
| VP0045
VP0046
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 ≤ 250 mm in length
• ≥ 3 mm ID and ≤ 400 mm in length | |
| VP0045
VP0046
VP0048
VP0049 | STERRAD NX
and NX with
ALLClear
Technology
Standard Cycle | Metal and non-metal medical devices including instruments
which have diffusion-restricted spaces, such as the hinged
portion of forceps and scissors.
Medical devices with a single stainless steel lumen with:
• ≥ 1 mm ID and ≤ 150 mm in length
• > 2 mm ID and ≤ 400 mm in length | |
| VP0045
VP0046
VP0048
VP0049 | STERRAND
NX and NX
with ALLClear
Technology
Advanced Cycle | Metal and non-metal 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:
o a single stainless steel lumen with:
o ≥ 1 mm ID and ≤ 500 mm in length
o single channel polyethylene and Teflon
(polytetrafluoroethylene)
o > 1mm ID and ≤ 850 mm in length | |
| VP0045
VP0046
VP0047
VP0048
VP0049
VP0051
VP0052
VP0053 | STERRAD
100NX and
100NX with
ALLClear
Technology
Standard Cycle | Metal and nonmetal medical devices including instruments with
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 | |
| VP0045
VP0046
VP0047
VP0048
VP0049
VP0051
VP0052
VP0053 | 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)
o ≥ 1mm ID and ≤ 850 mm in length | |
| VP0045
VP0046
VP0047
VP0048
VP0049
VP0051
VP0052
VP0053 | STERRAD
100NX and
100NX with | Metal and nonmetal devices surfaces and instruments which
have diffusion-restricted spaces, such as the hinged portion of
forceps and scissors | |
| Tray
Models | Intended
Sterilization
Cycles | Intended Tray Load | |
| | ALLClear
Technology
Express Cycle | | |
| | STERRAD
100NX and
100NX with
ALLClear
Technology Duo
Cycle | Medical devices including:
most flexible endoscopes with a single channel of
polyethylene and Teflon (polytetrafluoroethylene) with
≥ 1 mm ID and ≤ 875 mm in length accessory devices that are normally connected to a
flexible endoscope during use flexible endoscopes without lumens | |
11
12
13
14
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 |
5. Summary of Technical Characteristics
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.
15
| Feature | PRO-LITE Sterilization Tray
(proposed / K231501) | PRO-LITE Sterilization Tray
(predicate / K222440) | Comparison |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| | The PRO-LITE Sterilization Trays are used
to contain medical devices for sterilization in
the following Cycles:
• Lumen, Non Lumen, Flexible, Fast Non
Lumen, Fast and Specialty Cycles of the V-
PRO Low Temperature Sterilization
Systems
• Default Cycle of the STERRAD®* 100S
Sterilizer
• Standard and Advanced Cycles of the
STERRAD NX and NX with ALLClear
Technology Sterilizers
• Standard, Flex Scope, Express and DUO
Cycles of the STERRAD 100NX and
100NX with ALLClear Technology
Sterilizers | 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 | Additional
claims have
been added
for the V-
PRO maX 2
Specialty
Cycle - all
other
indications for
use are the
same |
| Intended
Use /
Indications
for Use | *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 Loads for Tray Models: VP0045,
VP0046, VP0047, VP0048, VP0049,
VP0050, VP0051, VP0052 | *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,
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 | V-PRO 60 and s2 Lumen Cycle:
• Non-lumened devices with diffusion-
restricted spaces such as the hinged portion
of forceps and scissors | |
| Feature | PRO-LITE Sterilization Tray
(proposed / K231501) | PRO-LITE Sterilization Tray
(predicate / K222440) | Comparison |
| | • 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:
■ $\geq$ 0.77 mm ID and $\leq$ 410 mm in length
■ $\geq$ 1.8 mm ID x $\leq$ 542 mm in length
o 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
or
■ $\geq$ 2.8 mm ID and $\leq$ 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:
o Single or dual channeled devices with
stainless steel lumens that are:
■ $\geq$ 0.77 mm ID and $\leq$ 410 mm in length
■ $\geq$ 1.8 mm ID x $\leq$ 542 mm in length
o Triple channeled devices with stainless
steel lumens that are:
■ $\geq$ 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 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:
• 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 | 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:
• 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 Cycles and Intended
Tray Loads for Tray Models: VP0045,
VP0046, VP0047, VP0048, VP0049 | Intended Sterilization Cycle and Intended
Tray Load for Tray Models: VP0045,
VP0046, VP0047, VP0048, VP0049 | |
| Feature | PRO-LITE Sterilization Tray
(proposed / K231501) | PRO-LITE Sterilization Tray
(predicate / K222440) | Comparison |
| | V-PRO s2 Fast Cycle: | 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. | • 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: | • 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 | o Single or dual channeled devices with
stainless steel lumens | |
| | ■ ≥ 0.77 mm ID and ≤ 410 mm in length | ■ ≥ 0.77 mm ID and ≤ 410 mm in length | |
| | ■ ≥ 1.8 mm ID and ≤ 542 mm in length | ■ ≥ 1.8 mm ID and ≤ 542 mm in length | |
| | o Triple channeled devices with stainless
steel lumens | o Triple channeled devices with stainless
steel lumens that are either | |
| | ■ ≥ 1.2 mm ID and ≤ 275 mm in length | ■ ≥ 1.2 mm ID and ≤ 275 mm in length | |
| | ■ ≥ 1.8 mm ID and ≤ 310 mm in length | ■ ≥ 1.8 mm ID and ≤ 310 mm in length | |
| | ■ ≥ 2.8 mm ID and ≤ 317 mm in length | ■ ≥ 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 Load for Tray Models: VP0045,
VP0046, VP0047, VP0048, VP0049,
VP0050, VP0051, VP0052, VP0053 | |
| | | | |
| | V-PRO 1, 1 Plus, maX, and maX 2 Lumen
Cycle: | V-PRO 1, 1 Plus, maX, and maX 2 Lumen
Cycle: | |
| | • Non-lumened instruments with diffusion-
restricted spaces such as the hinged portion
of forceps and scissors | • 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: | • Medical devices, including single, dual or
triple channeled stainless steel lumens that
are: | |
| | o ≥ 0.77 mm ID and ≤ 527 mm in length | o ≥ 0.77 mm ID and ≤ 527 mm in length | |
| | o ≥ 0.8 mm ID and ≤ 542 mm in length | o ≥ 0.8 mm ID and ≤ 542 mm in length | |
| | o ≥ 0.48 mm ID and ≤ 100 mm in length | o ≥ 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 | • Medical devices with dead end stainless
steel lumens that are ≥ 1.3 mm ID and ≤ 73
mm in length | |
| | • Instruments with rigid non-metallic lumens
(such as those used in endoscope sheaths,
take-apart forceps and trocars) that are: | • Devices with rigid non-metallic lumens
(such as those used in endoscope sheaths,
take-apart forceps and trocars) that are: | |
| | o ≥ 3 mm ID and ≤ 298 mm in length | o ≥ 3 mm ID and ≤ 298 mm in length | |
| | o ≥ 4 mm ID and ≤ 424 mm in length | o ≥ 4 mm ID and ≤ 424 mm in length | |
| | V-PRO 1 Plus, maX, and maX 2 Non Lumen
Cycle: | V-PRO 1 Plus, maX, and maX 2 Non Lumen
Cycle: | |
| | | | |
| Feature | PRO-LITE Sterilization Tray
(proposed / K231501) | PRO-LITE Sterilization Tray
(predicate / K222440) | Comparison |
| | 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 | 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, 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.
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
Intended Sterilization Cycles and Intended | 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.
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 | |
| | Tray Loads for Tray Models:
VP0045, VP0046, VP0047, VP0048,
VP0049, VP0050 | | |
| | 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
diffusion-restricted spaces such as the hinged
portion of forceps and scissors. | |
| | V-PRO maX 2 Specialty Cycle:
Patient-specific surgical guides (e.g.
osteotomy, shoulder, hip, knee, spine) or
anatomical models fabricated via additive
manufacturing (3D printing) processes and
intended for single-use during operative
procedures. *
or
Non-lumened instruments including non-
lumened general medical instruments, non- | | |
| Feature | PRO-LITE Sterilization Tray
(proposed / K231501) | PRO-LITE Sterilization Tray
(predicate / K222440) | Comparison |
| | lumened rigid, semi-rigid and flexible
endoscopes.** | | |
| | * The validation studies were conducted
using a validation load consisting of pouched
guide(s)/model(s) (with or without tray) for a
total weight of 5 lbs (2.3kg) 3D printed
material. | | |
| | **The validation studies were conducted
using a validation load consisting of one
pouched instrument tray or one pouch with
guide(s)/model(s) (with or without tray) for a
total weight of 11 lbs (5kg). | | |
| | • Formlabs Surgical Guide Resin, Specialty
Cycle F, Lumens $\ge$ 3 mm ID x $\le$ 30 mm L
• Formlabs BioMed Amber Resin, Specialty
Cycle F, Lumens $\ge$ 3 mm ID x $\le$ 30 mm L
• Formlabs Dental LT Clear V2 Resin,
Specialty Cycle D, Lumens $\ge$ 3 mm ID x $\le$
30 mm L
• Formlabs BioMed Clear Resin, Specialty
Cycle D, Lumens $\ge$ 3 mm ID x $\le$ 30 mm L
• Stratasys Biocompatible Clear MED610,
Specialty Cycle E, Lumens $\ge$ 3 mm ID x $\le$
20 mm L
• Stratasys Biocompatible Clear MED610,
Specialty Cycle E, Lumens $\ge$ 3 mm ID x $\le$
20 mm L
• Stratasys Biocompatible Opaque MED615
RGD, Specialty Cycle E, Lumens $\ge$ 3 mm
ID x $\le$ 20 mm L Stratasys VeroGlaze
MED620, Specialty Cycle E, Lumens $\ge$ 3
mm ID x $\le$ 20 mm L | | |
| | Intended Sterilization Cycles and Intended
Tray Loads 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 | |
| | 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
• $\ge$ 6 mm ID and $\le$ 310 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
• $\ge$ 6 mm ID and $\le$ 310 mm in length | |
| Feature | PRO-LITE Sterilization Tray
(proposed / K231501) | PRO-LITE Sterilization Tray
(predicate / K222440) | Comparison |
| | Medical devices with a single stainless steel
lumen with:
• ≥ 1 mm ID and ≤ 125 mm in length
• ≥ 2 mm ID and ≤ 250 mm in length
• ≥ 3 mm ID and ≤ 400 mm in length | Medical devices with a single stainless steel
lumen with:
• ≥ 1 mm ID and ≤ 125 mm in length
• ≥ 2 mm ID and ≤ 250 mm in length
• ≥ 3 mm ID and ≤ 400 mm in length | |
| | Intended Sterilization Cycles and Intended
Tray Loads for Tray Models:
VP0045, VP0046, VP0048, VP0049 | Intended Sterilization Cycles and Intended
Tray Load for Tray Models: VP0045,
VP0046, VP0048, VP0049 | |
| | STERRAD NX and NX with ALLClear
Technology Standard Cycle:
Metal and non-metal medical devices
including instruments which have diffusion-
restricted spaces, such as the hinged portion
of forceps and scissors.
Medical devices with a single stainless steel
lumen with:
• ≥ 1 mm ID and ≤ 150 mm in length
• ≥ 2 mm ID and ≤ 400 mm in length | STERRAD NX and NX with ALLClear
Technology Standard Cycle:
Metal and non-metal medical devices
including instruments which have diffusion-
restricted spaces, such as the hinged portion
of forceps and scissors.
Medical devices with a single stainless steel
lumen with:
• ≥ 1 mm ID and ≤ 150 mm in length
• ≥ 2 mm ID and ≤ 400 mm in length | |
| | STERRAND NX and NX with ALLClear
Technology Advanced Cycle:
Metal and non-metal 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:
o a single stainless steel lumen with:
○ ≥ 1 mm ID and ≤ 500 mm in length
o single channel polyethylene and Teflon
(polytetrafluoroethylene)
○ ≥ 1mm ID and ≤ 850 mm in length | STERRAND NX and NX with ALLClear
Technology Advanced Cycle:
Metal and non-metal 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:
o a single stainless steel lumen with:
○≥ 1 mm ID and ≤ 500 mm in length
o single channel polyethylene and Teflon
(polytetrafluoroethylene)
○ ≥ 1mm ID and ≤ 850 mm in length | |
| | Intended Sterilization Cycles and Intended
Tray Loads for Tray Models:
VP0045, VP0046, VP0047, VP0048,
VP0049, VP0051, VP0052, VP0053 | Intended Sterilization Cycles and Intended
Tray Load for Tray Models: VP0045,
VP0046, VP0048, VP0049, VP0051,
VP0052, VP0053 | |
| | STERRAD 100NX and 100NX with
ALLClear Technology Standard Cycle:
Metal and nonmetal medical devices
including instruments with have diffusion-
restricted spaces, such as the hinged portion
of forceps and scissors
Medical devices with a single stainless steel
lumen with: | STERRAD 100NX and 100NX with
ALLClear Technology Standard Cycle:
Metal and nonmetal medical devices
including instruments with have diffusion-
restricted spaces, such as the hinged portion
of forceps and scissors
Medical devices with a single stainless steel
lumen with: | |
| | | | |
| Feature | PRO-LITE Sterilization Tray
(proposed / K231501) | PRO-LITE Sterilization Tray
(predicate / K222440) | Comparison |
| | • ≥ 0.7 mm ID and ≤ 500 mm in length | • ≥ 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)
○ ≥ 1mm 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)
○ ≥ 1mm ID and ≤ 850 mm in length | |
| | STERRAD 100NX and 100NX with
ALLClear Technology Express Cycle:
Metal and nonmetal devices surfaces and
instruments which have diffusion-restricted
spaces, such as the hinged portion of forceps
and scissors. | STERRAD 100NX and 100NX with
ALLClear Technology Express Cycle:
Metal and nonmetal devices surfaces and
instruments which have diffusion-restricted
spaces, such as the hinged portion of forceps
and scissors. | |
| | STERRAD 100NX and 100NX with
ALLClear Technology Duo Cycle:
Medical devices including:
• most flexible endoscopes with a single
channel of polyethylene and Teflon
(polytetrafluoroethylene) with ≥ 1 mm ID
and ≤ 875 mm in length
• accessory devices that are normally
connected to a flexible endoscope during
use
• flexible endoscopes without lumens | STERRAD 100NX and 100NX with
ALLClear Technology Duo Cycle:
Medical devices including:
• most flexible endoscopes with a single
channel of polyethylene and Teflon
(polytetrafluoroethylene) with ≥ 1 mm ID
and ≤ 875 mm in length
• accessory devices that are normally
connected to a flexible endoscope during
use
• flexible endoscopes without lumens | |
| Vent to
Volume
Ratio | All trays are the same:
0.135 in-1 | All trays are the same:
0.135 in-1 | Same |
| Tray
Composition | Mineral-filled polypropylene, stainless steel | Mineral-filled polypropylene, stainless steel | Same |
| Instrument
Organizer
Composition | Medical Grade Silicone, USP grade VI | Medical Grade Silicone, USP grade VI | Same |
| Mat
Composition | Medical Grade Silicone, USP grade VI | Medical Grade Silicone, USP grade VI | Same |
Table 5-5. Summary of Tray Physical Description and Technological Properties
16
17
18
19
20
21
6. Summary of Non-clinical Tests
22
Performance testing to demonstrate substantial equivalence to the predicate has been completed and is summarized in Table 5-5 below.
| Test | Result | Conclusion |
|---|---|---|
| Demonstration | ||
| of Effective | ||
| Sterilant | ||
| Penetration | Cycle specific test articles shall be reproducibly | |
| sterilized under ½ cycle conditions for the V-PRO | ||
| maX 2 Specialty Cycle | PASS |
Table 5-5. Summary of Non-clinical Testing
7. Conclusion
Based on the intended use, technological characteristics and non-clinical performance data, the subject device is as safe, as effective and performs at least as well as the legally marketed predicate device (K222440), Class II (21 CFR 880.6850), product code KCT.