(145 days)
The Vis-U-All Low Temperature Sterilization Pouches/Tubing are sterilization containment pouches for use by health care providers to enclose medical devices to be sterilized in Lumen and Non Lumen Cycles in the V-PRO 60 Low Temperature Sterilization System. The pouches are intend to maintain the sterility of the enclosed devices until used.
Pouches are intended to contain devices in such a manner as to leave a minimum of one inch between the devices and seal on all sides. Devices with stainless steel lumens and the following minimum internal diameter (ID) and maximum length can be processed in Vis-U-All Low Temperature Sterilization Pouch/Tubing using the Lumen Cycle.
- o single or dual lumen devices
- 0.77 mm ID and 410 mm in length I
- o triple lumen devices
- 1.2 mm ID and 275 mm in length D
- . 1.8 mm ID and 310 mm in length
or
- 트 2.8 mm ID and 317 mm in length
The proposed Vis-U-All Low Temperature Sterilization Pouch/Tubing is a Tyvek/plastic film sterilization containment pouch designed for devices to be sterilized by the health care provider in the V-PRO 60 Low Temperature Sterilization System. The proposed device is available as a self seal pouch, a heat seal pouch, or heat seal tubing.
The STERIS® Vis-U-All Low Temperature Sterilization Pouch/Tubing underwent several tests to demonstrate its safety and substantial equivalence to a predicate device. The information provided outlines the acceptance criteria and a summary of the test results for each.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Effective Sterilant Penetration | Worst case test article shall be reproducibly sterilized under worst case ½ cycle conditions. | PASS |
| Tensile Strength | Pouch material tensile strength will show no statistical difference between processed and unprocessed samples. | PASS |
| Whole Package Integrity (Burst) | Pouch burst strength will show no statistical difference between processed and unprocessed pouches. | PASS |
| Seal Strength | Pouch seal strength will show no statistical difference between processed and unprocessed pouches. | PASS |
| Microbial Retention | Tyvek microbial retention will show no statistical difference between processed and unprocessed pouches. | PASS |
| Maintenance of Package Integrity | Packaged instruments shall remain sterile through event related and real time studies. | PASS |
| Aeration: Hydrogen Peroxide Residuals | Hydrogen peroxide residuals on the pouch will be reduced to acceptable levels for dermal contact. | PASS |
| Cytotoxicity | Pouch materials shall be non-cytotoxic following worst case exposure in a V-PRO 60 Sterilizer. | PASS |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the sample sizes for each specific test or the data provenance (e.g., country of origin, retrospective or prospective) for the test set. It broadly mentions "Testing of the Vis-U-All Low Temperature Sterilization Pouch/Tubing" and provides summarized conclusions.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The tests appear to be laboratory-based performance evaluations with objective, measurable criteria, rather than those requiring expert human interpretation for ground truth establishment.
4. Adjudication method for the test set:
This information is not provided in the document. Given the nature of the tests (physical and microbial barrier properties, chemical residuals), it's unlikely that an adjudication method typically used for subjective assessments (like 2+1 or 3+1 for expert consensus) would be relevant.
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:
A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of AI-assisted diagnostic tools with human readers, which is not applicable to a sterilization pouch.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
The device is a physical sterilization pouch, not an algorithm. Therefore, "standalone" algorithm performance is not applicable. The tests performed are inherent to the physical and chemical properties of the pouch itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth for these tests is based on objective, quantifiable measurements and established scientific/engineering principles for material performance, microbial viability, and chemical safety. For example:
- Effective Sterilant Penetration: Ground truth is achieving sterilization, likely verified by biological indicators or sterility testing methods.
- Tensile Strength, Burst Strength, Seal Strength, Microbial Retention: Ground truth is determined by comparing measured values against statistical equivalence to unprocessed samples or defined material specifications.
- Maintenance of Package Integrity: Ground truth is confirmed by maintaining sterility through various stress tests and real-time aging, likely using microbial challenge tests.
- Hydrogen Peroxide Residuals: Ground truth is the reduction of residuals to acceptable, predefined safety levels.
- Cytotoxicity: Ground truth is the absence of cytotoxic effects, determined by established biological evaluation methods (e.g., ISO 10993).
8. The sample size for the training set:
A "training set" is not applicable as this is a physical medical device (sterilization pouch) undergoing performance validation, not a machine learning algorithm.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for a machine learning algorithm in this context.
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STERIS®
JUL 2 2 2014
K140487
510(k) Summary For
Vis-U-All Low Temperature Sterilization Pouch/Tubing
STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 639-4459
Contact:
Anthony (Tony) Piotrkowski Manager, Regulatory Affairs Telephone: (440) 392-7437 (440) 357-9198 Fax No: e-mail: tpiotrko@steris.com
Summary Date:
June 20, 2014
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
.
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1. Device Name
| Trade Name: | Vis-U-All Low Temperature SterilizationPouch/Tubing |
|---|---|
| Common/usual Name: | Sterilization pouch |
| Classification Name: | Sterilization wrap (21 CFR 880.6850 Product CodeFRG). Class II |
2. Predicate Devices
K090371 - Vis-U-All Low Temperature Tyvek Sterilization Pouch for V-PRO 1 Sterilization System
3. Description of Device
The proposed Vis-U-All Low Temperature Sterilization Pouch/Tubing is a Tyvek/plastic film sterilization containment pouch designed for devices to be sterilized by the health care provider in the V-PRO 60 Low Temperature Sterilization System. The proposed device is available as a self seal pouch, a heat seal pouch, or heat seal tubing,
The purpose of this submission is to demonstrate the Vis-U-All Low Temperature Sterilization Pouch/Tubing is substantially equivalent to the predicate device in terms of safety and effectiveness
4. Intended Use
0
The Vis-U-All Low Temperature Sterilization Pouches/Tubing are sterilization containment pouches for use by health care providers to enclose medical devices to be sterilized in Lumen and Non Lumen Cycles in the V-PRO 60 Low Temperature Sterilization System. The pouches are intended to maintain the sterility of the enclosed devices until used.
Pouches are intended to contain devices in such a manner as to leave a minimum of one inch between the devices and seal on all sides. Devices with stainless steel lumens and the following minimum internal diameter (ID) and maximum length can be processed in Vis-U-All Low Temperature Sterilization Pouch/Tubing using the Lumen Cycle.
- single or dual lumen devices o
- 0.77 mm ID and 410 mm in length
- triple lumen devices
- 1.2 mm ID and 275 mm in length .
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K140487/S001 STERIS Response to 4/28/14 Request for Additional Information Vis-U-All Low Temperature Sterilization Pouch/Tubing
- 1.8 mm ID and 310 mm in length 미
- or
- . 2.8 mm ID and 317 mm in length
5. Available Sizes / Configurations
| Type | Size(inches unless specified) | Part Number |
|---|---|---|
| Heat Seal Pouch | 3 x 7 | 875037 |
| 4 x 9 | 875049 | |
| 4 x 12 | 875412 | |
| 4 x 22 | 875422 | |
| 6 x 10 | 875610 | |
| 8 x 12 | 875812 | |
| 10 x 15 | 875115 | |
| 12 x 18 | 875118 | |
| Self Seal Pouch | 3 x 7 | 876037 |
| 4 x 9 | 876049 | |
| 4 x 12 | 876412 | |
| 4 x 22 | 876422 | |
| 6 x 10 | 876610 | |
| 8 x 12 | 876812 | |
| 10 x 15 | 876115 | |
| 12 x 18 | 876118 | |
| Tubing | 3" x 100' | 872031 |
| 4" x 100' | 872041 | |
| 6" x 100' | 872061 | |
| 9" x 100' | 872091 | |
| 14" x 100' | 872141 |
{3}------------------------------------------------
| Characteristic | Proposed | Predicate | Comparison |
|---|---|---|---|
| Materials ofConstruction | Tyvek and plastic | Tyvek and plastic | Same |
| Types | Self Seal, Heat Seal, Tubing | Self Seal, Heat Seal, Tubing | Same |
| ChemicalIndicator | Ethylene Oxide Process ChemicalIndicator Printed on both sides ofTyvek | Ethylene Oxide ProcessChemical Indicator Printedon both sides of Tyvek | Same |
| Intended Use | The Vis-U-All Low TemperatureSterilization Pouch/Tubing is asterilization containment pouch foruse by health care providers toenclose medical devices to besterilized and maintains the sterilityof the enclosed devices until used. | The Vis-U-All LowTemperature SterilizationPouch/Tubing is asterilization containmentpouch for use by health careproviders to enclose medicaldevices to be sterilized andmaintains the sterility of theenclosed devices until used. | Same |
| Indications forUse | The Vis-U-All Low TemperatureSterilization Pouch/Tubing is asterilization containment pouch foruse by health care providers toenclose medical devices to besterilized in Lumen and Non LumenCycles in the V-PRO 60 LowTemperature Sterilization System.The pouch maintains the sterility ofthe enclosed devices until used.Pouches are intended to containdevices in such a manner as to leavea minimum of one inch between thedevices and seal on all sides.Devices with stainless steel lumensand the following minimum internaldiameter (ID) and maximum lengthcan be processed in Vis-U-All LowTemperature SterilizationPouch/Tubing using the Lumencycle.o single or dual lumen devices• 0.77 mm ID and 410 mm inlengtho triple lumen devices•1.2 mm ID and 275 mm inlength• 1.8 mm ID and 310 mm inlengthor• 2.8 mm ID and 317 mm inlength | The Vis-U-All LowTemperature TyvekSterilization Pouches aresterilization containmentpouches for use by healthcare providers to enclosemedical devices to besterilized in the AMSCO V-PRO1 Low TemperatureSterilization System. Thepouches maintain the sterilityof the enclosed medicaldevice during normalhandling and storage until thepouch is opened and themedical device is removedfor use. | ProposedIndications forUse includenewsterilizationcycles. Datademonstatingsafety andefficacy of thepouches inthese cycles arepresented in thissubmission. |
| Device Features | Chevron end of pouches forease of openingChemical process indicator forEO | • Chevron end of pouchesfor ease of opening• Chemical processindicator for EO | Same |
Comparison of Technological Characteristics 6.
June 20, 2014
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7. Description of Safety and Substantial Equivalence
The device models are identical to the cleared predicate K090371.
Testing of the Vis-U-All Low Temperature Sterilization Pouch/Tubing as summarized in the table below demonstrated that the proposed pouch is qualified for use in the V-PRO 60 Sterilizer and is as safe, as effective, and performs the same as the predicate device.
| Test | Acceptance Criteria | Conclusion | |
|---|---|---|---|
| Effective Sterilant Penetration | Worst case test article shall bereproducibly sterilized under worst case½ cycle conditions. | PASS | |
| PouchIntegrity:PhysicalandMicrobialBarrierProperties | Tensile Strength | Pouch material tensile strength willshow no statistical difference betweenprocessed and unprocessed samples. | PASS |
| Whole PackageIntegrity (Burst) | Pouch burst strength will show nostatistical difference between processedand unprocessed pouches. | PASS | |
| Seal Strength | Pouch seal strength will show nostatistical difference between processedand unprocessed pouches. | PASS | |
| Microbial Retention | Tyvek microbial retention will show nostatistical difference between processedand unprocessed pouches. | PASS | |
| Maintenance of PackageIntegrity | Packaged instruments shall remainsterile through event related and realtime studies. | PASS | |
| Aeration: Hydrogen PeroxideResiduals | Hydrogen peroxide residuals on thepouch will be reduced to acceptablelevels for dermal contact. | PASS | |
| Cytotoxicity | Pouch materials shall be non-cytotoxicfollowing worst case exposure in aV-PRO 60 Sterilizer. | PASS |
8. Conclusion
The Vis-U-All Low Temperature Sterilization Pouches/Tubing have been validated to meet the established performance criteria. The results of the verification studies demonstrate that the Vis-U-All Low Temperature Sterilization Pouch/Tubing performs as intended and the proposed device is substantially equivalent to the predicate.
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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three curved lines representing its wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-000)2
July 22, 2014
Steris Corporation Mr. Anthony Piotrkowski Manager, Regulatory Affairs 5960 Heisley Rd Mentor, OH 44060
Re: K140487
Trade/Device Name: Vis-U-All Low Temperature Sterilization Pouch/Tubing Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: FRG Dated: June 20, 2014 Received: June 23, 2014
Dear Mr. Piotrkowski:
We have reviewed vour 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.
{6}------------------------------------------------
Page 2 - Mr. 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tejashri Purohit-Sheth, M.D. Tejashri Profitt-Sheth, M.D. 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
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Indications for Use
510(k) Number: K140487
Device Name: Vis-U-All Low Temperature Sterilization Pouch/Tubing
Indications For Use:
The Vis-U-All Low Temperature Sterilization Pouches/Tubing are sterilization containment pouches for use by health care providers to enclose medical devices to be sterilized in Lumen and Non Lumen Cycles in the V-PRO 60 Low Temperature Sterilization System. The pouches are intend to maintain the sterility of the enclosed devices until used.
Pouches are intended to contain devices in such a manner as to leave a minimum of one inch between the devices and seal on all sides. Devices with stainless steel lumens and the following minimum internal diameter (ID) and maximum length can be processed in Vis-U-All Low Temperature Sterilization Pouch/Tubing using the Lumen Cycle.
- o single or dual lumen devices
- 0.77 mm ID and 410 mm in length I
- o triple lumen devices
- 1.2 mm ID and 275 mm in length D
- . 1.8 mm ID and 310 mm in length
or
- 트 2.8 mm ID and 317 mm in length
{8}------------------------------------------------
K140487/S001 STERIS Response to 4/28/14 Request for Additional Information Vis-U-All Low Temperature Sterilization Pouch/Tubing
| Type | Size(inches unless specified) | Part Number |
|---|---|---|
| Heat Seal Pouch | 3 x 7 | 875037 |
| 4 x 9 | 875049 | |
| 4 x 12 | 875412 | |
| 4 x 22 | 875422 | |
| 6 x 10 | 875610 | |
| 8 x 12 | 875812 | |
| 10 x 15 | 875115 | |
| 12 x 18 | 875118 | |
| Self Seal Pouch | 3 x 7 | 876037 |
| 4 x 9 | 876049 | |
| 4 x 12 | 876412 | |
| 4 x 22 | 876422 | |
| 6 x 10 | 876610 | |
| 8 x 12 | 876812 | |
| 10 x 15 | 876115 | |
| 12 x 18 | 876118 | |
| Tubing | 3" x 100' | 872031 |
| 4" x 100' | 872041 | |
| 6" x 100' | 872061 | |
| 9" x 100' | 872091 | |
| 14" x 100' | 872141 |
Table 4-1 Vis-U-All Low Temperature Pouch/Tubing Models and Sizes
Prescription Use (Part 21 EFR 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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sreekanth Signally signally signed by Sreekanth
Sreekanth DN: ==US, o=U.S. Government, Gutala -
Digitally signed by Sreekanth ou=HHS, ou=FDA, ou=People, 0.9.2342.19200300.100.1.1=2000 540490, cn=Sreekanth Gutala -S Date: 2014.07.19 22:58:40 -04/00'
§ 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).