Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a sterilization pouch, a passive containment product, and the description focuses on its physical properties and performance in a sterilization system. There is no mention of any computational or analytical functions that would involve AI/ML.

Therapeutic

No.
The device is a sterilization containment pouch used to maintain the sterility of medical devices, not to provide therapy itself.

Diagnostic

No

Explanation: The device description clearly states that the Vis-U-All Low Temperature Sterilization Pouch/Tubing is a "sterilization containment pouch" designed to hold medical devices during sterilization and maintain their sterility. Its function is to facilitate the sterilization process, not to diagnose medical conditions or analyze biological data.

SaMD (Software as a Medical Device)

No

The device description clearly indicates the device is a physical sterilization pouch made of Tyvek/plastic film, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to enclose medical devices for sterilization and maintain their sterility. This is a function related to the preparation and storage of medical devices, not the diagnosis of diseases or conditions.
Device Description: The device is described as a sterilization containment pouch made of Tyvek/plastic film. This is a packaging material, not a diagnostic tool.
Lack of Diagnostic Function: There is no mention of the device being used to analyze samples from the human body (blood, urine, tissue, etc.) or to provide information for the diagnosis, monitoring, or treatment of a disease or condition.
Performance Studies: The performance studies focus on the pouch's ability to withstand sterilization, maintain sterility, and its physical properties (tensile strength, seal strength, etc.). These are relevant to packaging and sterilization, not diagnostic performance.

In summary, the Vis-U-All Low Temperature Sterilization Pouches/Tubing are accessories for the sterilization of medical devices, not devices used for in vitro diagnostic testing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

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 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

Product codes

FRG

Device Description

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,

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

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
Pouch Integrity: Physical and Microbial Barrier Properties - 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

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K090371

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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).

Summary

0

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

.

1

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). 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 .

2

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 of
Construction	Tyvek and plastic	Tyvek and plastic	Same
Types	Self Seal, Heat Seal, Tubing	Self Seal, Heat Seal, Tubing	Same
Chemical
Indicator	Ethylene Oxide Process Chemical
Indicator Printed on both sides of
Tyvek	Ethylene Oxide Process
Chemical Indicator Printed
on both sides of Tyvek	Same
Intended Use	The Vis-U-All Low Temperature
Sterilization Pouch/Tubing is a
sterilization containment pouch for
use by health care providers to
enclose medical devices to be
sterilized and maintains the sterility
of the enclosed devices until used.	The Vis-U-All Low
Temperature Sterilization
Pouch/Tubing is a
sterilization containment
pouch for use by health care
providers to enclose medical
devices to be sterilized and
maintains the sterility of the
enclosed devices until used.	Same
Indications for
Use	The Vis-U-All Low Temperature
Sterilization Pouch/Tubing is a
sterilization containment pouch 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 pouch maintains 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
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	The Vis-U-All Low
Temperature Tyvek
Sterilization Pouches are
sterilization containment
pouches for use by health
care providers to enclose
medical devices to be
sterilized in the AMSCO V-
PRO1 Low Temperature
Sterilization System. The
pouches maintain the sterility
of the enclosed medical
device during normal
handling and storage until the
pouch is opened and the
medical device is removed
for use.	Proposed
Indications for
Use include
new
sterilization
cycles. Data
demonstating
safety and
efficacy of the
pouches in
these cycles are
presented in this
submission.
Device Features	Chevron end of pouches for
ease of opening
Chemical process indicator for
EO	• Chevron end of pouches
for ease of opening
• Chemical process
indicator for EO	Same

Comparison of Technological Characteristics 6.

June 20, 2014

4

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
	Effective Sterilant Penetration	Worst case test article shall be
reproducibly sterilized under worst case
½ cycle conditions.	PASS
Pouch
Integrity:
Physical
and
Microbial
Barrier
Properties	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

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.

5

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

7

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'