(148 days)
The V-PRO Sterilization Tray is used to contain medical devices for sterilization in the Lumen, Non Lumen and Flexible Cycles of the V-PRO Low Temperature Sterilization Systems. The trays must be wrapped with a legally marketed sterilization wrap for use in the V-PRO Low Temperature Sterilization Systems prior to placing in the Sterilizer. The V-PRO Sterilization Tray is not intended to maintain sterility; it is intended to be used in conjunction with a validated, FDA-cleared sterilization wrap in order to maintain sterility of the enclosed medical instruments.
Optional instrument organizers are accessories to the trays and are intended to allow stabilization of various cylindrical medical devices during processing. The instrument organizers attach to the V-PRO Sterilization Tray base and stabilize cylindrical medical instruments.
Optional sterilization mats are accessories to the trays and are intended to be used in conjunction with the V-PRO Sterilization Trays to cushion and stabilize instruments within the trays.
The V-PRO Sterilization Tray is available in various sizes, 10"x 10" x 27" to accommodate the loads to be processed. The tray contains two handles that remain internalized during wrapping/processing and a lid with clamping mechanisms for securing to the trav. There are numerous holes in the tray and larger holes in the lids for sterilant penetration. The purpose of this premarket submission is to modify the trays by adding a longer tray to the existing product line (10' x 27"), to increase the vent area of the tray lid, and to extend indications for use of the tray to include the V-PRO 60 Low Temperature Sterilization System.
Optional instrument organizers are provided as accessories to the tray and are intended to allow stabilization of various cylindrical medical devices during processing. Each organizer consists of a device holding element and lock base that attaches to the V-PRO Sterilization Trav. The sizes for the device holding element range from a 5 mm diameter and 6 mm stem height to a 19 mm diameter and 25 mm stem height. For attachment to the tray, each device holding element is positioned over one of the numerous holes at the inner tray surface and pushed into a lock base located at the respective tray hole on the outer tray surface. A minimum of two, aligned organizers should be used for each device that requires stabilization. Once the device is placed into the organizers, it is secured by each organizer's twist lock. The organizers are identical to those previously cleared under K070769.
Sterilization mats are provided as optional accessories to the trav and are identical to those previously cleared under K103226 for use in V-PRO Low Temperature Sterilizers' Lumen, Non Lumen and Flexible Cycles. A larger mat sized to fit into the new 10" x 27" tray has been added to the existing product line. The sterilization mats are intended to cushion and stabilize devices placed into the V-PRO. 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 V-PRO Sterilization Trays.
Here's a breakdown of the acceptance criteria and study information for the STERIS V-PRO Sterilization Tray, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Demonstration of Effective Sterilant Penetration | Worst case test article packaged in the trays shall be reproducibly sterilized under worst case ½ cycle conditions. | PASS |
| Demonstration of Biocompatibility | Component materials shall be non cytotoxic after exposure to worst case V-PRO 60 Sterilizer Cycle conditions. Residual hydrogen peroxide levels shall be below acceptable levels after exposure to worst case V-PRO 60 Sterilizer Cycle conditions. | PASS |
| Demonstration of Sterilant Compatibility | After processing through multiple worst case sterilization cycles, the trays and accessories shall retain functionality. | PASS |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample size for the test set used in the performance studies. It refers to "worst case test article" and "multiple worst case sterilization cycles" but doesn't provide numerical details.
The data provenance is not explicitly stated in terms of country of origin. The document is a 510(k) summary submitted to the FDA in the USA, implying testing was conducted to meet US regulatory requirements. The studies appear to be prospective, specifically designed to demonstrate the device's performance for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The studies are performance tests related to sterilization efficacy and material compatibility, not studies involving expert interpretation of medical images or diagnoses.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
This information is not applicable and therefore not provided. The studies are laboratory-based performance tests, not clinical evaluations requiring adjudication of expert opinions.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
This information is not applicable and therefore not provided. This is a medical device for sterilization, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable and therefore not provided. This is a physical medical device, not an algorithm. The "standalone" performance here would refer to the device's ability to sterilize effectively by itself, which is what the "Demonstration of Effective Sterilant Penetration" test addresses. The study confirms that the device, in conjunction with the sterilizer, achieves sterilization.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The ground truth for the performance studies would be based on sterility assurance levels and material integrity measurements.
- For "Demonstration of Effective Sterilant Penetration": The ground truth is the absence of viable microorganisms after sterilization, typically confirmed using biological indicators (BIs) or other microbiological assays. The "reproducibly sterilized" criterion implies a defined sterility assurance level (SAL).
- For "Demonstration of Biocompatibility": The ground truth is confirmed absence of cytotoxicity (e.g., cell viability assays) and acceptable levels of chemical residues (e.g., hydrogen peroxide concentration measurements).
- For "Demonstration of Sterilant Compatibility": The ground truth is the continued functionality of the trays and accessories (e.g., visual inspection, mechanical performance tests) after exposure to sterilization cycles.
8. The Sample Size for the Training Set
This information is not applicable and therefore not provided. This is a physical medical device, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and therefore not provided, as there is no training set for this type of device.
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Image /page/0/Picture/0 description: The image shows the STERIS logo. The logo consists of the word "STERIS" in a bold, sans-serif font, with the trademark symbol to the upper right of the word. Below the word is a graphic of several horizontal lines that are slightly curved, resembling waves.
JUL 2 5 2014
510(k) Summary For V-PRO Sterilization Tray
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
Tony Piotrkowski Contact: Manager, Regulatory Affairs
Telephone: (440) 392-7437 Fax No: (440) 357-9198 e-mail: tpiotrko@steris.com
Summary Date: July 25, 2014
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600 T
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Device Name 1.
| Trade Name: | V-PRO Sterilization Trays |
|---|---|
| Common/usual Name: | Sterilization Trays, cassettes and other accessories |
| Classification Name: | Sterilization Wrap21 CFR 880.6850Class IIProduct Code KCT |
2. Predicate Device
VHP® 136 Tray (renamed V-PRO Sterilization Tray) K070769 Sterilization Mat K103226
3. Description of Device
The V-PRO Sterilization Tray is available in various sizes, 10"x 10" x 27" to accommodate the loads to be processed. The tray contains two handles that remain internalized during wrapping/processing and a lid with clamping mechanisms for securing to the trav. There are numerous holes in the tray and larger holes in the lids for sterilant penetration. The purpose of this premarket submission is to modify the trays by adding a longer tray to the existing product line (10' x 27"), to increase the vent area of the tray lid, and to extend indications for use of the tray to include the V-PRO 60 Low Temperature Sterilization System.
Optional instrument organizers are provided as accessories to the tray and are intended to allow stabilization of various cylindrical medical devices during processing. Each organizer consists of a device holding element and lock base that attaches to the V-PRO Sterilization Trav. The sizes for the device holding element range from a 5 mm diameter and 6 mm stem height to a 19 mm diameter and 25 mm stem height. For attachment to the tray, each device holding element is positioned over one of the numerous holes at the inner tray surface and pushed into a lock base located at the respective tray hole on the outer tray surface. A minimum of two, aligned organizers should be used for each device that requires stabilization. Once the device is placed into the organizers, it is secured by each organizer's twist lock. The organizers are identical to those previously cleared under K070769.
Sterilization mats are provided as optional accessories to the trav and are identical to those previously cleared under K103226 for use in V-PRO Low Temperature Sterilizers' Lumen, Non Lumen and Flexible Cycles. A larger mat sized to fit into the new 10" x 27" tray has been added to the existing product line. The sterilization mats are intended to cushion and stabilize devices placed into the V-PRO.
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Sterilization Trays. The mats are available in sizes to fit the five V-PRO 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 V-PRO Sterilization Trays.
4. Intended Use
The V-PRO Sterilization Tray is used to contain medical devices for sterilization in the Lumen, Non Lumen and Flexible Cycles of the V-PRO Low Temperature Sterilization Systems. The trays must be wrapped with a legally marketed sterilization wrap for use in the V-PRO Low Temperature Sterilization Systems prior to placing in the Sterilizer. The V-PRO sterilization Tray is not intended to maintain sterility; it is intended to be used in conjunction with a validated, FDAcleared sterilization wrap in order to maintain sterility of the enclosed medical instruments.
| ProposedTrayModel | IntendedSterilizationCycles | Intended Tray Load |
|---|---|---|
| VP0040VP0041VP0042VP0043VP0044 | V-PRO 60Lumen Cycle | • Instruments with diffusion-restricted spaces such as the hingedportion of forceps and scissors• Non-lumened devices including non-lumened rigid and semi-rigid endoscopes• Medical devices, including single, dual and triple channeledrigid and semi-rigid endoscopes, with the followingconfigurations:o single or dual lumen devices■ 0.77 mm ID and 410 mm in lengtho triple lumen devices■ 1.2 mm ID and 275 mm in length■ 1.8 mm ID and 310 mm in lengthor■ 2.8 mm ID and 317 mm in length |
| V-PRO 60Non LumenCycle | Non-lumened devices including non-lumened rigid, semi-rigid andflexible endoscopes and non-lumened devices with stainless steelor titanium diffusion-restricted spaces such as the hinged portionof forceps and scissors. | |
| V-PRO 60FlexibleCycle | • One flexible surgical endoscope or bronchoscope with a lightcord (if not integral to endoscope) and mat without anyadditional load. The flexible endoscope may be a:o single or dual lumen device with lumens that are ≥ 1 mm IDand < 990 mm in length |
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| ProposedTrayModel | IntendedSterilizationCycles | Intended Tray Load |
|---|---|---|
| V-PRO 1, 1Plus & maxLumen Cycle | • Instruments with diffusion-restricted spaces such as the hingedportion of forceps and scissors• Non-lumened devices including non-lumened rigid and semi-rigid endoscopes• Medical devices, including single, dual and triple channeledrigid and semi-rigid endoscopes, with the followingconfigurations: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 | |
| VP0040VP0041VP0042VP0043VP0044 | V-PRO 1Plus & maxNon LumenCycle | Non-lumened devices including non-lumened rigid, semi-rigid andflexible endoscopes and non-lumened devices with stainless steeldiffusion-restricted spaces such as the hinged portion of forcepsand scissors. |
| V-PRO maxFlexibleCycle | Load 1: Single or dual lumen surgical flexible endoscopes (suchas those used in ENT, Urology and Surgical Care) andbronchoscopes with a light cord (if not integral to endoscope) andmat 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 withdiffusion-restricted areas such as the hinged portion of forceps orscissors. |
Optional instrument organizers are accessories to the trays and are intended to allow stabilization of various cylindrical medical devices during processing. The instrument organizers attach to the V-PRO Sterilization Tray base and stabilize cylindrical medical instruments.
Optional sterilization mats are accessories to the trays and are intended to be used in conjunction with the V-PRO Sterilization Trays to cushion and stabilize instruments within the trays..
ડાં Summary of Technical Characteristics
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34
The sterilization trays, sterilization mats and instrument organizers are identical in composition to the claimed predicate devices. The technical characteristics are summarized in Tables 5-1 and 5-2 below.
| Feature | V-PRO SterilizationTray (proposed) | V-PRO SterilizationTray (K070769) | Comparison |
|---|---|---|---|
| Intended Use | The V-PRO SterilizationTray is used to containmedical devices forsterilization in the Lumen,Non Lumen and FlexibleCycles of the V-PRO LowTemperature SterilizationSystems and to maintainsterility of properlyprocessed medical devicesduring normal handlingand storage until they areremoved for use. The traysmust be wrapped with alegally marketedsterilization wrap for usein the V-PRO LowTemperature SterilizationSystems prior to placing inthe Sterilizer.Optional instrumentorganizers are accessoriesto the tray and areintended to allowstabilization of variouscylindrical medicaldevices during processing.The instrument organizersattach to the V-PROSterilization Tray base andstabilize cylindricalmedical instruments. | The V-PRO SterilizationTray is used to containdevices for sterilization inthe Amsco V-PRO 1 LowTemperature Sterilizer andto maintain sterility ofproperly processedmedical devices duringnormal handling andstorage until they areremoved for use. The traysmust be wrapped with alegally marketed, FDAcleared sterilization wrapfor use in the V-PRO 1Low TemperatureSterilizer prior toplacement in the Sterilizer.The V-PRO SterilizationTray can be used with V-PRO InstrumentOrganizers to allowstabilization of variouscylindrical medicaldevices during processing.The Instrument Organizersattach to the V-PROSterilization Tray bottomand stabilize cylindricalmedical instruments. | Data is presented in thissubmission to demonstratesafety and effectiveness inthe V-PRO 60 LowTemperature SterilizationSystem. |
| MaterialCompatibility | Compatible with VHPSterilization. | Compatible with VHPSterilization. | Same materials ofcomposition |
Table 5-1 Summary of Tray Physical Description and Technological Properties
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| Feature | V-PRO SterilizationTray (proposed) | V-PRO SterilizationTray (K070769) | Comparison |
|---|---|---|---|
| SterilantPenetration | Effective penetration ofthe VAPROX HCSterilant into doublewrapped trays under worstcase conditions during theV-PRO 60 Sterilizer'sprocessing cycles wasdemonstrated.Verification of effectivepenetration to sterilizelongest /narroweststainless steel lumen forthe V-PRO 1/1 Plus/maXLumen Cycle is alsoprovided. | Effective penetration ofthe VAPROX HCSterilant into doublewrapped trays under worstcase conditions during theV-PRO 1 Sterilizer'sprocessing cycle wasdemonstrated. | Data is presented in thissubmission to demonstrateeffective sterilantpenetration in the V-PRO 60Low TemperatureSterilization System. |
| ToxicologicalProperties | Materials of constructionretain biocompatibility. | Materials of constructionretain biocompatibility | Same |
| MicrobialBarrierProperties | To be used with legallymarketed sterilizationwrap. | To be used with legallymarketed sterilizationwrap. | Same |
| Vent toVolume Ratio | All trays are the same:0.137 in-1 | Minimum: 0.049 in-1Maximum: 0.054 in-1 | Proposed device has ahigher vent to volume ratiodue to a modification of thelid vent area, allowing easiersterilant penetration than thepredicate. |
| TrayComposition | Polypropylene, Noryl andstainless steel | Polypropylene, Noryl andstainless steel | Same |
| OrganizerComposition | Polypropylene | Polypropylene | Same |
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Table 5-2 Summary of Mat Physical Description and Technological Properties
| Feature | Sterilization Mat(proposed) | Sterilization Mat(K103226) | Comparison |
|---|---|---|---|
| Intended Use | The sterilization mats areoptional accessoriesintended to be usedexclusively in V-PROSterilization Trays tocushion and stabilizeinstruments duringsterilization in the AmscoV-PRO Low TemperatureSterilization Systems. | The sterilization mats areintended to be used inconjunction with theV-PROTM SterilizationTrays (K070769) tocushion and stabilizeinstruments duringsterilization in the Amsco®V-PRO Low TemperatureSterilization Systems. | New intended use point outthat the mats are optionalaccessories to the V-PROSterilization Tray |
| Composition | USP grade VI Silicone | USP grade VI Silicone | Same |
| ToxicologicalProperties | Materials of constructionretain biocompatibility. | Materials of constructionretain biocompatibility | Same |
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| Feature | Sterilization Mat(proposed) | Sterilization Mat(K103226) | Comparison |
|---|---|---|---|
| SterilantPenetration | Effective penetration ofthe VAPROX HCSterilant into doublewrapped trays under worstcase conditions during theV-PRO 60 Sterilizer'sprocessing cycles wasdemonstrated. | Effective penetration ofthe VAPROX HCSterilant into doublewrapped trays under worstcase conditions during theV-PRO 1 Sterilizer'sprocessing cycle wasdemonstrated. | Data is presented in thissubmission to demonstrateeffective sterilantpenetration in the V-PROSterilization Tray with thesterilization mat in the V-PRO 60 Low TemperatureSterilization System. |
| MaterialCompatibility | Compatible with VHPSterilization. | Compatible with VHPSterilization. | Same materials ofcomposition |
Models and sizes of V-PRO Sterilization Trays, Sterilization Mats and Instrument Organizers are included in Table 5-3. The 10" x 27" sizes of trays and mats are new for this submission. All other sizes are identical to the predicates VHP® 136 Tray (K070769) and Sterilization Mat (K103226).
| Tray ProductCode | Tray BaseSize (inches)* | Mat Size(inches)* | Mat ProductCode |
|---|---|---|---|
| VP0040 | 10 x 10 | 10 x 10 | VP0030 |
| VP0041 | 10 x 14 | 10 x 14 | VP0031 |
| VP0042 | 10 x 17 | 10 x 17 | VP0032 |
| VP0043 | 10 x 21 | 10 x 21 | VP0033 |
| **VP0044 | 10 x 27 | 10 x 27 | VP0034 ** |
Table 5-3. V-PRO Sterilization Tray and Mat Sizes
*Sizes are approximated for ease of reference.
** The 10" x 27" size is being added in this submission
Models and sizes of V-PRO Sterilization Tray Instrument Organizers are included in Table 5-4. The sizes and model numbers are identical to the predicate VHP® 136 Tray (K070769).
Table 5-4. Instrument Organizers Available Sizes
| Stem Length(mm) | Diameter*(mm) | PartNumber | Stem Length(mm) | Diameter*(mm) | PartNumber |
|---|---|---|---|---|---|
| 6 | 5 | 99101 | 6 | 14 | 99110 |
| 13 | 5 | 99102 | 13 | 14 | 99111 |
| 25 | 5 | 99103 | 25 | 14 | 99112 |
| 6 | 9 | 99104 | 6 | 17 | 99113 |
| 13 | 9 | 99105 | 13 | 17 | 99114 |
| 25 | 9 | 99106 | 25 | 17 | 99115 |
| 6 | 11 | 99107 | 6 | 19 | 99116 |
| 13 | 11 | 99108 | 13 | 19 | 99117 |
| 25 | 11 | 99109 | 25 | 19 | 99118 |
| Lock Base | 99120 |
*Sizes are approximated for ease of reference.
{7}------------------------------------------------
ર. Summary of Nonclinical Tests
The sterilization trays, sterilization mats and instrument organizers are identical in composition and have the same or similar intended use as compared to the predicate device. The only substantial difference is the claim of using the subject device with the V-PRO 60 Low Temperature Sterilization System (subject of a separate, concurrent submission). Therefore, 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 ofEffective SterilantPenetration | Worst case test article packaged in the trays shallbe reproducibly sterilized under worst case ½ cycleconditions. | PASS |
| Demonstration ofBiocompatibility | Component materials shall be non cytotoxic afterexposure to worst case V-PRO 60 Sterilizer Cycleconditions.Residual hydrogen peroxide levels shall be belowacceptable levels after exposure to worst caseV-PRO 60 Sterilizer Cycle conditions. | PASS |
| Demonstration ofSterilantCompatibility | After processing through multiple worst casesterilization cycles, the trays and accessories shallretain functionality. | PASS |
Table 5-5. Instrument Organizers Available Sizes
7. Conclusion
The V-PRO Sterilization Trays have been validated to meet the established performance criteria. The results of the verification studies demonstrate that the sterilization trays and accessories perform as intended and based on the nonclinical tests performed the subject device is as safe, as effective and performs at least as safely and effectively as the legally marketed predicate devices, Class II (21 CFR 880.6850, Product code KCT.
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Image /page/8/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 a stylized symbol resembling an eagle or bird in flight, with three curved lines representing its wings or feathers.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 25, 2014
STERIS Corporation Mr. Tony Piotrkowski Manager, Regulatory Affairs 5960 Heisley Road Mentor, OH 44060
Re: K140494
Trade/Device Name: V-PRO Sterilization Tray Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Containers, Trays, Cassettes and other accessories Regulatory Class: II Product Code: KCT Dated: June 20, 2014 Received: June 23, 2014
Dear Mr. 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.
{9}------------------------------------------------
Page 2 - Mr. Tony Piotrkowski
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of 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), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit
Clinical Deputy Director
DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Sincerely yours.
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Indications for Use
510(k) Number (if known): K140494
Device Name:
V-PRO Sterilization Tray
Indications For Use:
The V-PRO Sterilization Tray is used to contain medical devices for sterilization in the Lumen, Non Lumen and Flexible Cycles of the V-PRO Low Temperature Sterilization Systems. The trays must be wrapped with a legally marketed sterilization wrap for use in the V-PRO Low Temperature Sterilization Systems prior to placing in the Sterilizer. The V-PRO Sterilization Tray is not intended to maintain sterility; it is intended to be used in conjunction with a validated, FDA-cleared sterilization wrap in order to maintain sterility of the enclosed medical instruments.
| ProposedTrayModel | IntendedSterilizationCycles | Intended Tray Load |
|---|---|---|
| VP0040VP0041VP0042VP0043VP0044 | V-PRO 60Lumen Cycle | • Instruments with diffusion-restricted spaces such as the hingedportion of forceps and scissors• Non-lumened devices including non-lumened rigid and semi-rigid endoscopes• Medical devices, including single, dual and triple channeledrigid and semi-rigid endoscopes, with the followingconfigurations:o single or dual lumen devices• 0.77 mm ID and 410 mm in lengtho triple lumen devices• 1.2 mm ID and 275 mm in length• 1.8 mm ID and 310 mm in lengthor• 2.8 mm ID and 317 mm in length |
| V-PRO 60Non LumenCycle | Non-lumened devices including non-lumened rigid, semi-rigid andflexible endoscopes and non-lumened devices with stainless steelor titanium diffusion-restricted spaces such as the hinged portionof forceps and scissors. | |
| V-PRO 60FlexibleCycle | 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:o single or dual lumen device with lumens that are ≥ 1 mm IDand < 990 mm in length |
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| ProposedTrayModel | IntendedSterilizationCycles | Intended Tray Load |
|---|---|---|
| V-PRO 1, 1Plus & maXLumen Cycle | • Instruments with diffusion-restricted spaces such as the hingedportion of forceps and scissors• Non-lumened devices including non-lumened rigid and semi-rigid endoscopes• Medical devices, including single, dual and triple channeledrigid and semi-rigid endoscopes, with the followingconfigurations:o single or dual lumen devices• 0.77 mm ID and 527 mm in lengtho triple lumen devices• 1.2 mm ID and 275 mm in length• 1.8 mm ID and 310 mm in lengthor• 2.8 mm ID and 317 mm in length | |
| VP0040VP0041VP0042VP0043VP0044 | V-PRO 1Plus & maXNon LumenCycle | Non-lumened devices including non-lumened rigid, semi-rigid andflexible endoscopes and non-lumened devices with stainless steeldiffusion-restricted spaces such as the hinged portion of forcepsand scissors. |
| V-PRO maXFlexibleCycle | Load 1: Single or dual lumen surgical flexible endoscopes (suchas those used in ENT, Urology and Surgical Care) andbronchoscopes with a light cord (if not integral to endoscope) andmat 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 inlengthLoad 2: Non-lumened instruments including instruments withdiffusion-restricted areas such as the hinged portion of forceps orscissors. |
Optional instrument organizers are accessories to the trays and are intended to allow stabilization of various cylindrical medical devices during processing. The instrument organizers attach to the V-PRO Sterilization Tray base and stabilize cylindrical medical instruments.
Optional sterilization mats are accessories to the trays and are intended to be used in conjunction with the V-PRO Sterilization Trays to cushion and stabilize instruments within the trays.
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Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Image /page/12/Picture/5 description: The image shows a document with the title "Concurrence of CDRH, Office of Device Evaluation (ODE)". The document includes a digital signature from Elizabeth F. Claverie -S. The signature details include the date 2014.07.25 at 09:52:20 -04'00', and other information such as DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, and a numerical identifier 0.9.2342.19200300.100.1.1=1300055864.
§ 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).