(112 days)
The Vis-U-All Low Temperature Sterilization Pouches/Tubing are sterilization containment pouches for use by health care providers to enclose:
- medical devices in a single or double pouch configuration ●
- trays* containing medical devices in a single or double pouch configuration
- . small items requiring surface sterilization in a single pouch configuration within a tray*
to be sterilized in the Lumen. Non Lumen and Flexible Cycles of the V-PRO Low Temperature Sterilization Systems. The pouches maintain the sterility of the enclosed devices until used.
When used to enclose medical devices, the pouches are intended to contain the devices in such a manner as to leave a minimum of one inch between the devices and seal on all sides. When used to enclose a tray, the tray must fit loosely within the pouch.
The proposed Vis-U-All Low Temperature Sterilization Pouch/Tubing is identical to the predicate and is a Tyvek/plastic film sterilization containment pouch designed for devices to be sterilized by the health care provider in V-PRO Low Temperature Sterilization Systems. As is the predicate, 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 add claims for: use in the V-PRO maX Flexible cycle; pouching of sterilization trays and for sterilization of pouched items within a sterilization tray.
While the document provided details about the device's intended use and the tests performed, it does not contain the kind of detailed information about acceptance criteria and study design typically associated with a medical AI/ML device as outlined in the prompt. The device, "Vis-U-All Low Temperature Sterilization Pouch/Tubing," is a physical sterilization containment pouch, not an AI/ML device.
Therefore, the following information cannot be extracted from the provided text as it pertains to AI/ML device evaluation, which is not applicable here:
- Sample size used for the test set and data provenance
- Number of experts used and their qualifications
- Adjudication method
- Multi-reader multi-case (MRMC) comparative effectiveness study
- Standalone (algorithm only) performance
- Type of ground truth used (expert consensus, pathology, outcomes data)
- Sample size for the training set
- How the ground truth for the training set was established
However, I can provide the available information regarding the device's acceptance criteria and reported performance from the document.
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 |
| Package Integrity: Event Related Package Integrity Pouching a Qualified Tray | No visual damage to pouch material (no holes or tears). Seals remain intact. | PASS |
2-9. Information not applicable to this device type.
The provided document describes a 510(k) submission for a sterilization pouch, which is a physical medical device. The evaluation criteria are therefore focused on physical performance, sterility maintenance, and material integrity, rather than AI/ML performance metrics like sensitivity, specificity, reader studies, or training/test set provenance common in the context of AI/ML medical devices.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center -WO66-G609 Silver Spring, MD 20993-000
July 22, 2016
STERIS Corporation Mr. Anthony Piotrkowski Sr. Manager, Regulatory Affairs 5960 Heisley Road Mentor, OH 44060
Re: K160908
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 22, 2016 Received: June 23, 2016
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.
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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/ResourcesforYou/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,
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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 (if known) K160908 Device Name
Vis-U-All Low Temperature Sterilization Pouches/Tubing
Indications for Use (Describe)
The Vis-U-All Low Temperature Sterilization Pouches Tubing are sterilization containment pouches for use by health care providers to enclose:
- medical devices in a single or double pouch configuration .
- . trays* containing medical devices in a single or double pouch configuration
- . small items requiring surface sterilization in a single pouch configuration within a tray*
to be sterilized in the Lumen Non Lumen and Flexible Cycles of the V-PRO Low Temperature Sterilization Systems. The pouches maintain the sterility of the enclosed devices until used.
When used to enclose medical devices, the ntended to contain the devices in such a manner as to leave a minimum of one inch between the devices and seal on all sides. When used to enclose a tray, the tray must fit loosely within the pouch.
Vis-U-All Pouch/Tubing Claims with V-PRO Sterilization Systems
| IntendedSterilizationCycles | Intended Pouch Load when Medical Devices are: | |
|---|---|---|
| • Directly Pouched or | ||
| • Placed Inside of a Tray* and the Tray* Pouched | ||
| V-PRO 60Lumen Cycle | • Instruments with diffusion-restricted spaces such as the hinged portion of forcepsand scissors• Non-lumened devices including non-lumened rigid and semi-rigid endoscopes• Medical devices, including single, dual and triple channeled rigid and semi-rigidendoscopes, with the following configurations: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 60 NonLumen Cycle | Non-lumened devices including non-lumened rigid, semi-rigid and flexibleendoscopes and non-lumened devices with stainless steel or titanium diffusion-restricted spaces such as the hinged portion of forceps and scissors. | |
| V-PRO 60Flexible Cycle | One flexible surgical endoscope or bronchoscope with a light cord (if not integral toendoscope) and mat without any additional load. The flexible endoscope may be asingle or dual lumen device with lumens that are ≥ 1 mm ID and ≤ 990 mm in length | |
| V-PRO 1, 1Plus & maXLumen Cycle | • Instruments with diffusion-restricted spaces such as the hinged portion of forcepsand scissors• Non-lumened devices including non-lumened rigid and semi-rigid endoscopes• Medical devices, including single, dual and triple channeled rigid and semi-rigidendoscopes, with the following configurations: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 |
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| V-PRO 1 Plus& maX NonLumen Cycle | Non-lumened devices including non-lumened rigid, semi-rigid and flexibleendoscopes and non-lumened devices with stainless steel diffusion-restricted spacessuch as the hinged portion of forceps and scissors. |
|---|---|
| V-PRO maXFlexible Cycle | Load 1: Single or dual lumen surgical flexible endoscopes (such as those used inENT, Urology and Surgical Care) and bronchoscopes with a light cord (if not integralto endoscope) and mat with no additional load. |
| The flexible endoscopes may contain either: | |
| • a single lumen that is $\geq$ 1 mm ID and $\leq$ 1050 mm in length | |
| • or two lumens with: | |
| • one lumen that is $\geq$ 1 mm ID and $<$ 990 mm in length | |
| • and the other lumen that is $\geq$ 1 mm ID and $\leq$ 850 mm in length | |
| Load 2: Non-lumened instruments including instruments with diffusion-restrictedareas such as the hinged portion of forceps or scissors. |
area to tray volume ratio ≥ 0.135 in" with the maximum number of instrument organizers installed.
Type of Use (Select one or both, as applicable)
_ Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary for Vis-U-All Low Temperature Sterilization Pouch/Tubing
STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (216) 354-2600 Fax No: (216) 639-4459
Contact: Anthony Piotrkowski Sr. Manager, Regulatory Affairs Telephone: (440) 392-7437 Fax No: (440) 357-9198 E-mail: tpiotrko@steris.com
Submission Date: July 22, 2016
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 Code FRG). |
2. Predicate Device
Vis-U-All Low Temperature Sterilization Pouch/Tubing (K140487)
Reference Device - Vis-U-All Low Temperature Sterilization Pouch/Tubing (K092745)
3. Description of Device
The proposed Vis-U-All Low Temperature Sterilization Pouch/Tubing is identical to the predicate and is a Tyvek/plastic film sterilization containment pouch designed for devices to be sterilized by the health care provider in V-PRO Low Temperature Sterilization Systems. As is the predicate, 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 add claims for: use in the V-PRO maX Flexible cycle; pouching of sterilization trays and for sterilization of pouched items within a sterilization tray.
4. Intended Use/ 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 in a single or double pouch configuration ●
- trays* containing medical devices in a single or double pouch configuration
- . small items requiring surface sterilization in a single pouch configuration within a tray*
to be sterilized in the Lumen. Non Lumen and Flexible Cycles of the V-PRO Low Temperature Sterilization Systems. The pouches maintain the sterility of the enclosed devices until used.
When used to enclose medical devices, the pouches are intended to contain the devices in such a manner as to leave a minimum of one inch between the devices and seal on all sides. When used to enclose a tray, the tray must fit loosely within the pouch.
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| IntendedSterilizationCycles | Intended Pouch Load when Medical Devices are: |
|---|---|
| V-PRO 60Lumen Cycle | Directly Pouched or Placed Inside of a Tray* and the Tray* Pouched Instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors Non-lumened devices including non-lumened rigid and semi-rigid endoscopes Medical devices, including single, dual and triple channeled rigid and semi-rigid endoscopes, with the following configurations: single or dual lumen devices $\geq$ 0.77 mm ID and $\leq$ 410 mm in length triple lumen devices $\geq$ 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 NonLumen 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 60Flexible 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 $\geq$ 1 mm ID and $<$ 990 mm in length |
| V-PRO 1, 1Plus & maXLumen Cycle | Instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors Non-lumened devices including non-lumened rigid and semi-rigid endoscopes Medical devices, including single, dual and triple channeled rigid and semi-rigid endoscopes, with the following configurations: single or dual lumen devices $\geq$ 0.77 mm ID and $\leq$ 527 mm in length triple lumen devices $\geq$ 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 1 Plus& maX NonLumen 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. |
| V-PRO maXFlexible 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 $\geq$ 1 mm ID and $\leq$ 1050 mm in length or two lumens with: one lumen that is $\geq$ 1 mm ID and $<$ 990 mm in length and the other lumen that is $\geq$ 1 mm ID and $\leq$ 850 mm in length Load 2: Non-lumened instruments including instruments with diffusion-restricted areas such as the hinged portion of forceps or scissors. |
Vis-U-All Pouch/Tubing Claims with V-PRO Sterilization Systems
*Trays must be legally marketed for use in the V-PRO Low Temperature Sterilization Systems and contain a vent surface area to tray volume ratio ≥ 0.135 in-1 with the maximum number of instrument organizers installed.
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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 |
Description of Safety and Substantial Equivalence 6.
The device models are identical to the cleared predicate K140487.
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 SterilantPenetration | Worst case test article shall bereproducibly sterilized under worstcase ½ cycle conditions. | PASS |
| Package Integrity: EventRelated Package IntegrityPouching a Qualified Tray | No visual damage to pouchmaterial (no holes or tears).Seals remain intact. | PASS |
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| 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 Printed onboth sides of Tyvek | Same |
| Intended Use | The Vis-U-All Low TemperatureSterilization Pouches/Tubing aresterilization containment pouchesfor use by health care providers toenclose:medical devices in a singleor double pouchconfigurationtrays* containing medicaldevices in a single or doublepouch configurationsmall items requiringsurface sterilization in asingle pouch configurationwithin a tray*to be sterilized in the Lumen,Non Lumen and Flexible Cyclesof the V-PRO LowTemperature SterilizationSystems. The pouches maintainthe sterility of the encloseddevices until used. | The Vis-U-All LowTemperature SterilizationPouches/Tubing aresterilization containmentpouches for use by health careproviders to enclose medicaldevices to be sterilized inLumen and Non LumenCycles in the V-PRO 60 LowTemperature SterilizationSystem. The pouchesmaintain the sterility of theenclosed devices until used. | Similar (boldedtext illustratesdifferences).Data is presentedin thissubmission tosupportsubstantialequivalent use ofthe pouches inthe additionalcycles and loadconfigurations. |
| Device Features | Chevron end of pouches forease of openingChemical process indicatorfor EO | ■ Chevron end of pouches forease of opening■ Chemical process indicatorfor EO | Same |
| Maintenance ofSterility | 1 year | 1 year | Same |
7. Comparison of Technological Characteristics
8. Conclusion
In conclusion, the subject device the Vis-U-All Low Temperature Sterilization Pouches/Tubing is substantially equivalent to predicate device K140487 the Vis-U-All Low Temperature Sterilization Pouches/Tubing. Based on the intended use, technological characteristics, and performance data, the subject The Vis-U-All Low Temperature Sterilization Pouches/Tubing is substantially equivalent and is as safe and as effective as the legally marketed predicate device.
§ 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).