(112 days)
No
The device is a sterilization pouch, a passive containment product, and the summary contains no mention of AI or ML.
No
The device is a sterilization containment pouch, not a device used for treating medical conditions.
No
The device is a sterilization containment pouch used to maintain the sterility of enclosed medical devices until use, not to diagnose a condition or disease.
No
The device is a physical sterilization pouch/tubing made of Tyvek/plastic film, not software.
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 pouches are for "sterilization containment" of medical devices and trays. This is a physical containment function for sterilization processes, not a diagnostic test performed on biological samples.
- Device Description: The description reinforces that it's a "sterilization containment pouch."
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information about a patient's health status.
Therefore, the Vis-U-All Low Temperature Sterilization Pouches/Tubing are classified as a medical device used in the sterilization process, not an in vitro diagnostic device.
N/A
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 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.
Product codes (comma separated list FDA assigned to the subject device)
FRG
Device Description
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.
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
health care providers
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)
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 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 |
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.
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
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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
| Intended
Sterilization
| Cycles | Intended Pouch Load when Medical Devices are: | |
|---|---|---|
| • Directly Pouched or | ||
| • Placed Inside of a Tray* and the Tray* Pouched | ||
| 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. | ||
| 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 | ||
| 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 | |
3
| 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. |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 $\geq$ 1 mm ID and $\leq$ 1050 mm in length |
| | • or two lumens with: |
| | • one lumen that is $\geq$ 1 mm ID and $ 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
5
1. Device Name
| Trade Name: | Vis-U-All Low Temperature Sterilization
Pouch/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.
6
| Intended
Sterilization
| Cycles | Intended Pouch Load when Medical Devices are: |
|---|---|
| V-PRO 60 | |
| Lumen 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 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 $\geq$ 1 mm ID and $ |