(189 days)
Not Found
No
The device description and performance studies focus on the physical design, material compatibility, and sterilization efficacy of the trays and accessories, with no mention of AI or ML technology.
No
The device is a sterilization tray used to contain medical devices during the sterilization process, which is a supportive function for sterilization, not a therapeutic action itself.
No
The device is a sterilization tray used to contain medical devices for sterilization, not to diagnose a condition or disease.
No
The device description clearly outlines physical components (trays, lids, organizers, mats) made of materials, and the performance studies focus on physical properties and sterilization efficacy, not software functionality.
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 trays and their accessories, designed to hold and stabilize instruments during sterilization. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring analytes
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The device is a sterilization accessory, designed to facilitate the sterilization process of other medical devices.
N/A
Intended Use / Indications for Use
The Sterilization Trays are used to contain medical devices for sterilization in the Lumen, Non Lumen and Flexible 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 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 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 and V-PRO 60 Low Temperature Sterilization Systems. The trays are available in various sizes, outlined in Table 10-1, to accommodate the loads to be processed. The proposed trays are similar in design to the predicate V-PRO Sterilization Tray (K140494) 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.
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 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 10-3 to fit the nine 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.
The tests performed include:
- Demonstration of Effective Sterilant Penetration: Worst case test article packaged in the trays shall be reproducibly sterilized under worst case ½ cycle conditions. (PASS)
- Package Integrity Maintenance of Package Integrity: Not applicable, Trays to be used with legally marketed sterilization wrap or pouch.
- 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 Effective Cleaning: Clean following automated and manual cleaning. (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 Cycle conditions. (PASS)
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a series of human profiles.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 7, 2016
STERIS Corporation Mr. Tony Piotrkowski Senior Manager, Regulatory Affairs 5960 Heisley Road Mentor, OH 44060
Re: K160912
Trade/Device Name: Sterilization Tray Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: September 9, 2016 Received: September 12, 2016
Dear Mr. Tony Piotrkowski :
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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 801 and Part 809); medical device reporting (reporting of
1
medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and Part 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael J. Ryan -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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Sterilization Trays
Indications for Use (Describe)
The Sterilization Trays are used to contain medical devices for sterilization in the Lumen, Non Lumen and Flexible 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 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.
| Model Number (size
LxWxH in inches) | Intended
Sterilization
Cycles | Intended Tray Load |
|----------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| VP0045 (13x4.5x2.25)
VP0046 (19x4.5x2.25)
VP0047 (25x4.5x2.25)
VP0048 (13x7.75x2.25)
VP0049 (19x7.75x2.25)
VP0050 (27x7.75x4) | 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:
o single or dual lumen devices
▪ ≥ 0.77 mm ID and ≤ 410 mm in length
o triple lumen devices
▪ ≥1.2 mm ID and ≤ 275 mm in length
▪ ≥1.8 mm ID and ≤ 310 mm in length
or
▪ ≥2.8 mm ID and ≤ 317 mm in length |
| | 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. |
| VP0045 (13x4.5x2.25)
VP0046 (19x4.5x2.25)
VP0047 (25x4.5x2.25)
VP0048 (13x7.75x2.25)
VP0049 (19x7.75x2.25)
VP0050 (27x7.75x4) | 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 ≤ 990 mm in length |
| VP0051 (12x11.75x4)
VP0052 (25x11,75x4.5)
VP0053 (25x14x5) | V-PRO 1, 1
Plus & maX
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 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 |
| | V-PRO 1
Plus & maX
Non Lumen
Cycle | Non-lumened devices including non-lumened rigid, semi-rigid and flexible endoscopes and non-lumened devices with stainless steel diffusion-restricted spaces such as the hinged portion of forceps and scissors. |
3
| Model Number (size
LxWxH in inches) | Intended
Sterilization
Cycles | Intended Tray Load |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| VP0045 (13x4.5x2.25)
VP0046 (19x4.5x2.25)
VP0047 (25x4.5x2.25)
VP0048 (13x7.75x2.25)
VP0049 (19x7.75x2.25)
VP0050 (27x7.75x4)
VP0051 (12x11.75x4)
VP0052 (25x11.75x4.5)
VP0053 (25x14x5) | V-PRO maX
Flexible
Cycle | Load 1: Single or dual lumen surgical flexible endoscopes (such as those used in
ENT, Urology and Surgical Care) and bronchoscopes with a light cord (if not
integral to endoscope) and mat with no additional load.
The flexible endoscopes may contain either:
• a single lumen that is ≥ 1 mm ID and ≤ 1050 mm in length
• or two lumens with:
• one lumen that is ≥ 1 mm ID and ≤ 990 mm in length
• and the other lumen that is ≥ 1 mm ID and ≤ 850 mm in length
Load 2: Non-lumened instruments including instruments with diffusion-restricted
areas such as the hinged portion of forceps or scissors. |
Instrument organizers are optional accessories intended to stabilize cylindrical instruments within the Sterilization Trays.
| Model | Description | Model | Description |
|---|---|---|---|
| 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 Sterilization Trays.
| Model | Description | Model | Description | Model | Description |
|---|---|---|---|---|---|
| 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 |
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
| X Over-The-Counter Use (21 CFR 801 Subpart C)
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FORM FDA 3881 (8/14)
EF
4
STERIS®
510(k) Summary For Sterilization Trays
Sponsor Facility
STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 357-9198
Repackager/Relabeler Facility
STERIS Corporation 9325 Pinecone Drive Mentor, OH 44060 Phone: (440) 392-7800 Fax No: (440) 392-7896
Contact: Tony Piotrkowski Senior Manager, Regulatory Affairs
Telephone: (440) 392-7437 Fax No: (440) 357-9198 e-mail: tpiotrko@steris.com
Submission Date: September 9, 2016
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
5
K160912/S001 STERIS Response to 5/31/16 Request for Additional Information Sterilization Travs
Device Name 1.
| Trade Name: | Sterilization Trays |
|---|---|
| Common/usual Name: | Sterilization Trays, cassettes and other accessories |
| Classification Name: | Sterilization Wrap |
| 21 CFR 880.6850 | |
| Class II | |
| Product Code KCT |
Predicate Device 2.
V-PRO Sterilization Tray K140494
3. Description of Device
The 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 and V-PRO 60 Low Temperature Sterilization Systems. The trays are available in various sizes, outlined in Table 10-1, to accommodate the loads to be processed. The proposed trays are similar in design to the predicate V-PRO Sterilization Tray (K140494) 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.
| Model | Description | Model | Description |
|---|---|---|---|
| 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 4.5 |
| VP0048 | 13 x 7.75 x 2.25 | VP0053 | 25 x 14 x 5 |
| VP0049 | 19 x 7.75 x 2.25 |
Table 10-1. 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 10-2 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 Sterilization Tray.
6
| Model | Description | Model | Description |
|---|---|---|---|
| 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 |
K160912/S001 STERIS Response to 5/31/16 Request for Additional Information Sterilization Travs
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 10-3 to fit the nine 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.
Table 10-3. Sterilization Tray Model Numbers
| Model | Description | Model | Description |
|---|---|---|---|
| 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 |
4. Intended Use/ Indications for Use
The Sterilization Trays are used to contain medical devices for sterilization in the Lumen, Non Lumen and Flexible 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 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.
7
K160912/S001 STERIS Response to 5/31/16 Request for Additional Information Sterilization Trays
| Model Number (size
LxWxH in inches) | Intended
Sterilization
Cycles | Intended Tray Load |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 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:
o single or dual lumen devices
• ≥ 0.77 mm ID and ≤ 410 mm in length
o triple lumen devices
• ≥1.2 mm ID and ≤ 275 mm in length
• ≥1.8 mm ID and ≤ 310 mm in length
or
• ≥2.8 mm ID and ≤ 317 mm in length |
| VP0045 (13x4.5x2.25)
VP0046 (19x4.5x2.25)
VP0047 (25x4.5x2.25)
VP0048 (13x7.75x2.25)
VP0049 (19x7.75x2.25)
VP0050 (27x7.75x4)
VP0051 (12x11.75x4)
VP0052 (25x11,75x4.5)
VP0053 (25x14x5) | 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
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