HALYARD SMART-FOLD* Sterilization Wrap (H450, H650)

K181959 · Owens & Minor Halyard, Inc. · FRG · Mar 22, 2019 · General Hospital

Device Facts

• Record ID: K181959
• Device Name: HALYARD SMART-FOLD* Sterilization Wrap (H450, H650)
• Applicant: Owens & Minor Halyard, Inc.
• Product Code: FRG · General Hospital
• Decision Date: Mar 22, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended Use

HALYARD SMART-FOLD* Sterilization Wrap (H450, H650) is intended to enclose that is to be sterlized by a healthcare provider using Steris V-PRO Low Temperature Sterilization system. The following pre-programmed cycles: - STERIS V-PRO 1 low temperature sterilization system (lumen cycle), . - STERIS V-PRO 1 Plus low temperature sterilization system (Lumen and Non-lumen cycle), ● - STERIS V-PRO maX low temperature sterilization system (Lumen cycle, flexible cycle), ● - STERIS V-PRO 60 low temperature sterilization system (Lumen cycle, flexible cycle) ● - STERIS V-PRO maX 2 low temperature sterilization system (Lumen cycle, flexible cycle) ● HALYARD SMART-FOLD* Sterilization Wrap (H450, H650) is intended to allow terminal sterilization of medical devices using vaporized hydrogen peroxide (VHP) and to maintain sterility of the enclosed device(s) until used within the period of time for which performance data demonstrating maintenance of sterility has been provided.

Device Story

Sterilization wrap for medical devices; consists of two pre-shaped sheets of three-layer SMS (spunbond-meltblown-spunbond) polypropylene fabric with antistatic treatment; features reinforcement zones, reference lines, and side-tabs for aseptic presentation. Used by healthcare providers to wrap instruments/trays prior to sterilization in Steris V-PRO Low Temperature Sterilization systems (VHP). Wrap allows sterilant penetration while maintaining sterile barrier post-processing. Benefits include protection of sterilized contents during storage and handling; validated for 365-day shelf life.

Clinical Evidence

Bench testing only. Performance validated via sterilant penetration/efficacy testing (10^-6 SAL in worst-case half-cycle), 365-day maintenance of package integrity study, biocompatibility (ISO 10993-5 cytotoxicity, ISO 10993-10 irritation/sensitization), and physical property testing (bursting strength, air permeability, abrasion resistance, flammability, water resistance, linting, tearing strength, grab tensile strength, and bacterial filtration efficiency).

Technological Characteristics

Three-layer SMS (spunbond-meltblown-spunbond) polypropylene fabric with antistatic treatment. Single-use, non-sterile (bulk). Physical properties tested per ISO 13828-2, ISO 9237, ASTM D4966, ASTM D3776, CPSC 16 CFR 1610, AATCC-127, ISO 9073-10, ASTM D5733, ASTM D5034, ASTM D1683, and ASTM F2101.

Indications for Use

Indicated for healthcare providers to enclose medical devices for terminal sterilization using Steris V-PRO Low Temperature Sterilization systems (V-PRO 1, 1 Plus, maX, maX 2, 60) and to maintain sterility of the enclosed devices until use.

Regulatory Classification

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.

Predicate Devices

• KIMGUARD ONE-STEP* Sterilization Wrap (Models: H100, H200, H300, H400, H500, H600) (K142782)

Reference Devices

• KIMGUARD* SMART-FOLD* sterilization wrap (Models: KC450, KC650) (K140963)
• KIMGUARD* One-Step sterilization (K092167)
• KIMGUARD* One-Step sterilization (K112805)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 22, 2019

Owens & Minor Halyard, Inc Angela L. Bunn, RAC Director, Regulatory Affairs, Products Division 5405 Windward Parkway Alpharetta, GA 30004

Re: K181959

Trade/Device Name: HALYARD SMART-FOLD* Sterilization Wrap (Models: H450, H650) Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: FRG Dated: February 19, 2019 Received: February 21, 2019

Dear Angela L. Bunn:

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.

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

# Clarence W. Murray lii III -S

For Tina Kiang, Ph.D. Acting 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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## DEPARTMENT OF HEALTH AND HUMANSERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

K181959 Device Name

HALYARD SMART-FOLD* Sterilization Wrap (Models: H450, H650)

Indications for Use (Describe)

HALYARD SMART-FOLD* Sterlization Wap (H450, H650) is intended to enclose and is to be sterlized by a healthare provider using Steris V-PRO Low Temperature Sterilization system. The wrap was validated in the following pre-programmed cycles:

- STERIS V-PRO 1 low temperature sterilization system (lumen cycle), ●
- STERIS V-PRO 1 Plus low temperature sterilization system (Lumen and Non-lumen cycle), ●
- STERIS V-PRO maX low temperature sterilization system (Lumen cycle, flexible cycle), .
- STERIS V-PRO 60 sterilizer (Lumen, Non-Lumen cycle, flexible cycle) ●
- STERIS V-PRO maX 2 low temperature sterilization system (Lumen cycle, flexible cycle) ●

HALYARD SMART-FOLD* Sterlization Wrap (H450, H650) is intended to allow terminal sterlization of medical devices using vaporized hydrogen peroxide (VHP) and to maintain sterilly of the enclosed within the period of time for which performance data demonstrating maintenance of sterility has been provided.

| Table 1 Summary of V-PRO Low Temperature Sterilizer System Cycles | | | | | |
|-------------------------------------------------------------------|------------------|--------------|-----------|----------|-------------|
| Sterilization<br>Cycle | Sterilizer Model | | | | |
| | V-PRO 1 | V-PRO 1 Plus | V-PRO maX | V-PRO 60 | V-PRO maX 2 |
| Lumen | Yes | Yes | Yes | Yes | Yes |
| Non-Lumen | N/A | Yes | Yes | Yes | Yes |
| Flexible | N/A | N/A | Yes | Yes | Yes |

Test results validated that HALYARD SMART-FOLD \$160, H650 allowed sterlization of the enclosed devices using Steris V-PRO Love Temperature Sterlization system.All models of the HALYARD Sterilization Wrap (H60, H550) have been valided for use with the STERIS V-PRO Lov Temperature Sterilization System cycles (Table 2, Table 3, and Table 4).

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| TABLE 2: Validated Low Temperature Sterilization Products STERIS V-PRO 1, STERIS V-PRO 1 Plus, STERIS V-PRO maX, STERIS V-PRO maX 2,<br>and STERIS V-PRO 60, Lumen¹ Cycles. | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Note: Refer to the Manufacturer's User's Guide for complete instructions on load and cycle for each STERIS V-PRO System. The instructions<br>provided below are not intended to replace the detailed Instructions for Use provided with the STERIS – VPRO | |
| STERIS V-PRO System<br>Lumen Cycle | Intended Load |
| STERIS V-PRO 1<br>STERIS V-PRO 1 Plus<br>STERIS V-PRO maX<br>STERIS V-PRO maX 2 | STERIS V-PRO maX,<br>Lumened and non-lumened instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors. Medical devices, including single, dual and triple channeled rigid and semi-rigid endoscopes, with the following configurations: Single channeled devices with a stainless lumen that is $\ge$ 0.77mm internal diameter (ID) and $\le$ 500mm in length Dual channeled devices with stainless steel lumens that are $\ge$ 0.77mm ID and $\le$ 527mm in length Triple channeled devices with stainless steel lumens that are $\ge$ 1.2 mm ID and $\le$ 275 mm in length $\ge$ 1.8 mm ID and $\le$ 310 mm in length or $\ge$ 2.8 mm ID and $\le$ 317 mm in length STERIS V-PRO maX 2 Medical devices, including single, dual and triple channeled rigid and semi-rigid endoscopes, with the following configurations: Single channeled devices with a stainless lumen that is $\ge$ 0.77mm internal diameter (ID) and $\le$ 500mm in length Dual channeled devices with stainless steel lumens that are $\ge$ 0.77mm ID and $\le$ 527mm in length Triple channeled devices with stainless steel lumens that are $\ge$ 1.2 mm ID and $\le$ 275 mm in length $\ge$ 1.8 mm ID and $\le$ 310 mm in length or $\ge$ 2.8 mm ID and $\le$ 317 mm in length STERIS V-PRO 1 STERIS V-PRO 1 Plus The V-PRO 1 Cycle and the V-PRO 1 Plus Lumen Cycle can sterilize* instruments/devices with the following features: Instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors. Medical devices with a single lumen with: an inside diameter of 3 mm or larger and a length of 400 mm or shorter an inside diameter of 2 mm or larger and a length of 250 mm or shorter an inside diameter of 1 mm or larger and a length of 125 mm or shorter |
| STERIS V-PRO 60 | The V-PRO 60 sterilizer's Lumen cycle can sterilize: 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: $\Upsilon$ Single or dual lumen devices with stainless steel lumens that are $\ge$ 0.77 mm (~1/32") internal diameter (ID) and $\le$ 410 mm (16-9/64") in length $\Upsilon$ Triple lumen devices with stainless steel lumens that are $\ge$ 1.2 mm (~3/64") ID and $\le$ 275 mm (~10 – 55/64") in length $\ge$ 1.8 mm (~5/64") ID and $\le$ 310 mm (~12 – 13/64") in length or $\ge$ 2.8 mm (~7/64") ID and $\le$ 317 mm (~12 – 31/64") in length |
| TABLE 3: Validated Low Temperature Sterilization Products STERIS V-PRO 1 Plus, STERIS V-PRO maX, STERIS V-PRO maX 2, andSTERIS V-PRO 60, Non-<br>Lumen Cycles<br>Note: Refer to the User's Guide for complete instructions on load and cycle for each STERIS V-PRO System. The instructions provided below are not<br>intended to replace the detailed Instructions for Use provided with the STERIS – VPRO | |
| STERIS V-PRO System Non-Lumen<br>Cycle | Intended Load |
| STERIS V-PRO 1 Plus<br>STERIS V-PRO maX<br>STERIS V-PRO maX 2 | STERIS V-PRO maX 2<br>Non-lumened instruments including non-lumened general medical instruments, non-lumened rigid, semi-rigid and flexible endoscopes.<br>STERIS V-PRO maX<br>The Non-Lumen Cycle can sterilize instruments/devices with the following features:<br>Non-lumened instruments including non-lumened rigid, semi-rigid and flexible endoscopes and non-lumened instruments with stainless steel diffusion-restricted areas such as the hinged portion of forceps or scissors. STERIS V-PRO 1 Plus<br>The V-PRO 1 Plus Non-Lumen Cycle can sterilize instruments/devices with the following features:<br>Non-Lumen instruments including non-lumened instruments with stainless steel diffusion-restricted areas such as the hinged portion of forceps or scissors. |
| STERIS V-PRO 60 | The V-PRO 60 Non-Lumen Cycle can sterilize instruments/devices with the following features:<br>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. |
| | TABLE 4: Validated Low Temperature Sterilization Products STERIS V-PRO maX. STERIS V-PRO maX 2, and STERIS V-PRO 60, Flexible Cycles<br>Note: Refer to the User's Guide for complete instructions on load and cycle for each STERIS V-PRO System. The instructions provided below are not<br>intended to replace the detailed Instructions for Use provided with the STERIS – VPRO |
| STERIS V-PRO System Flexible<br>Cycle | Intended Load |
| STERIS V-PRO maX<br>STERIS V-PRO maX 2 | STERIS V-PRO maX 2<br>The Flexible Cycle can sterilize single or dual lumen surgical flexible endoscopes (such as those used in ENT, Urology and Surgical<br>Care) or bronchoscopes in either of two load configurations:<br>1. Two flexible endoscopes with a light cord (if not integral to the endoscope) and mat with no additional load. The flexible endoscopes may<br>contain either:<br>• A single lumen that is ≥ 1 mm ID and ≤ 1050 mm in length<br>• Or two lumens with:<br>- One lumen that is ≥ 1 mm ID and ≤ 998 mm in length<br>- And the other lumen that is ≥ 1 mm ID and ≤ 850 mm in length<br>2. One flexible endoscope with a light cord (if not integral to endoscope) and mat and additional non-lumened instruments. The flexible<br>endoscopes may contain either:<br>• A single lumen that is ≥ 1 mm ID and ≤ 1050 mm in length<br>• Or two lumens with:<br>- One lumen that is ≥ 1 mm ID and ≤ 990 mm in length<br>- And the other lumen that is ≥ 1 mm ID and ≤ 850 mm in length<br>STERIS V-PRO maX<br>The Flexible Cycle can sterilize single or dual lumen surgical flexible endoscopes (such as those used in ENT, Urology and Surgical Care) or bronchoscopes<br>in either of two load configurations:<br>1. Two flexible endoscopes with a light cord (if not integral to the endoscope) and mat with no additional load3. The flexible endoscopes my contain<br>either:<br>• A single lumen that is ≥ 1 mm ID and ≤ 1050 mm in length<br>• Or two lumens with:<br>- One lumen that is ≥ 1 mm ID and ≤ 998 mm in length<br>- And the other lumen that is ≥ 1 mm ID and ≤ 850 mm in length<br>2. One flexible endoscope with a light cord (if not integral to endoscope) and mat and additional non-lumened instruments including instruments with<br>diffusion-restricted areas such as the hinged portion of forceps or scissors4. The flexible endoscopes my contain either:<br>• A single lumen that is ≥ 1 mm ID and ≤ 1050 mm in length<br>• Or two lumens with:<br>- One lumen that is ≥ 1 mm ID and ≤ 998 mm in length<br>- And the other lumen that is ≥ 1 mm ID and ≤ 850 mm in length |
| STERIS V-PRO 60 | The V-PRO 60 sterilizer's 60 flexible cycle can sterilize:<br>One flexible surgical endoscope or bronchoscope with a light cord (if not integral to endoscope) and mat without any additional load. The flexible endoscope<br>may be a:<br>• Single or dual lumen device with lumens that are $≥ 1 mm (~3/64") ID and ≤990 mm (38-63/64")$ in length |

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# HALYARD SMART-FOLD* Sterlization Wraps (H450, H650) Recommendations for Use with STERS V-PRO Lov Temperature Sterlization (Table 5).

| TABLE 5: Halyard Smart-Fold* Sterilization Wrap Recommendations2 for Use with Steris V-PRO Sterilizer | | | | | | | | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|--------------------------------------------------------|------------------------------|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|
| SMART-<br>FOLD*<br>Sterilization<br>Wrap Model | Intended<br>Loads3 | Maximum Wrapped Package Content Weights 4 | | | | | | |
| | | STERIS<br>V-PRO® 1,<br>V-PRO® 1<br>Plus<br>V-PRO®<br>maX<br>V-PRO®<br>maX 2<br>Lumen | STERIS<br>V-PRO® 1<br>Plus V-<br>PRO®<br>maX<br>V-PRO®<br>maX 2<br>Non-<br>Lumen | STERIS<br>V-PRO®<br>maX<br>V-PRO®<br>maX 2<br>Flexible | STERIS<br>V-PRO®<br>60 Lumen | STERIS<br>V-PRO®<br>60 Non-<br>Lumen | STERIS<br>V-PRO® 60 Flexible | STERIS<br>V-PRO®<br>maX 2<br>Fast Non-Lumen |
| H450 | Moderate to<br>Heavyweight<br>Package (for<br>example:<br>general use<br>medical<br>instruments) | 13 lbs | 13 lbs. | 13 lbs. | 11 lbs. | 12 lbs. | The validation studies were conducted with one flexible<br>endoscope packaged into a tray with silicone wrap, and<br>instrument organizers and light cord ( if not integral to<br>scope) and no additional load. | N/A |
| H650 | Moderate to<br>Heavyweight<br>Package (for<br>example:<br>general use<br>medical<br>instruments) | 19.65 lbs. | 25 lbs.-<br>max2,<br>19.65 - max,<br>1 and 1 plus | 24 lbs. | 11 lbs. | 12 lbs. | The validation studies were conducted with one flexible<br>endoscope packaged into a tray with silicone wrap, and<br>instrument organizers and light cord (if not integral to<br>scope) and no additional load. | N/A |
| 2Individual results may differ due to factors such as variations in handling practices, wrapping techniques, and folding methods. Results may also differ due to the use of irregularly shaped<br>contents, which may put added stress on the wrap. Each healthcare facility should determine for itself which wrap model is most appropriate for each intended use. | | | | | | | | |
| 3Intended loads include: Medical Instruments with and without lumens that include telescopes, endoscopes, cameras, light cords and general use medical instruments. | | | | | | | | |
| 4It is recommended to not exceed the maximum wrapped package content weights indicated for each wrap model. Furthermore, it is recommended to not exceed the number, weight, and<br>size of individual content types that were validated for HALYARD SMART-FOLD* Sterilization Wraps. | | | | | | | | |
| 5The Fast-Non-Lumen cycle is intended to sterilize pouched instruments trays only and is therefore not intended to be used for sterilization of HALYARD SMART-FOLD* Sterilization<br>wraps. | | | | | | | | |

*Registered Trademark or Trademark of O&M Halyard or its affiliates. ©2018. All rights reserved.

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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 HALYARD SMART-FOLD* Sterilization Wrap (H450, H650)

#### Applicant's Name, Address, Telephone, FAX, Contact Person

Owens & Minor Halyard, Inc 5405 Windward Parkway Alpharetta, GA 30004

Contact Name: Angela L. Bunn, RAC

Director, Regulatory Affairs Products Division Tel: [phone] Fax: [phone] Email: [e-mail]

510(k) Number: K181959

Establishment Registration Number: 3014421917

Date: March 22, 2019

## CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME

Classification: Class II per 21 CFR 880.6850 Classification Name: Sterilization Wrap Common/Usual Name: Sterilization Wrap Product Code: FRG Proprietary Name: HALYARD SMART-FOLD* Sterilization Wrap (Models: H450, H650)

#### PREDICATE DEVICE:

K142782- KIMGUARD ONE-STEP* Sterilization Wrap (Models: H100, H200, H300, H400, H500, H600)

#### REFERENCE DEVICE:

K140963 – KIMGUARD* SMART-FOLD* sterilization wrap (Models: KC450, KC650)

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#### INDICATIONS FOR USE

HALYARD SMART-FOLD* Sterilization Wrap (H450, H650) is intended to enclose that is to be sterlized by a healthcare provider using Steris V-PRO Low Temperature Sterilization system. The following pre-programmed cycles:

- STERIS V-PRO 1 low temperature sterilization system (lumen cycle), .
- STERIS V-PRO 1 Plus low temperature sterilization system (Lumen and Non-lumen cycle), ●
- STERIS V-PRO maX low temperature sterilization system (Lumen cycle, flexible cycle), ●
- STERIS V-PRO 60 low temperature sterilization system (Lumen cycle, flexible cycle) ●
- STERIS V-PRO maX 2 low temperature sterilization system (Lumen cycle, flexible cycle) ●

HALYARD SMART-FOLD* Sterilization Wrap (H450, H650) is intended to allow terminal sterilization of medical devices using vaporized hydrogen peroxide (VHP) and to maintain sterility of the enclosed device(s) until used within the period of time for which performance data demonstrating maintenance of sterility has been provided.

| Table 1 Summary of V-PRO Low Temperature Sterilizer System Cycles | | | | | |
|-------------------------------------------------------------------|------------------|--------------|-----------|----------|-------------|
| Sterilization Cycle | Sterilizer Model | | | | |
| | V-PRO 1 | V-PRO 1 Plus | V-PRO maX | V-PRO 60 | V-PRO maX 2 |
| Lumen | Yes | Yes | Yes | Yes | Yes |
| Non-Lumen | N/A | Yes | Yes | Yes | Yes |
| Flexible | N/A | N/A | Yes | Yes | Yes |

Test results validated that HALYARD SMART-FOLD* Sterilization Wrap (H450) allowed sterilization of the enclosed devices using Steris V-PRO Low Temperature Sterilization system. All models of the HAL YARD Smart Fold Sterilization Wrap (H450, H650) have been validated for use with the Steris V-PRO Low Temperature Sterilization System cycles (Table 1.2, Table 1.3).

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| TABLE 2: Validated Low Temperature Sterilization Products STERIS V-PRO 1, STERIS V-PRO 1 Plus, STERIS V-PRO maX, STERIS V-PRO maX 2, and<br>STERIS V-PRO 60, Lumen1 Cycles. | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Note: Refer to the Manufacturer's User's Guide for complete instructions on load and cycle for each STERIS V-PRO System. The instructions<br>provided below are not intended to replace the detailed Instructions for Use provided with the STERIS – VPRO | |
| STERIS V-PRO System Lumen<br>Cycle | Intended Load |
| STERIS V-PRO 1<br>STERIS V-PRO 1 Plus<br>STERIS V-PRO maX<br>STERIS V-PRO maX 2 | STERIS V-PRO maX,<br>Lumened and non-lumened instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors. Medical devices, including single, dual and triple channeled rigid and semi-rigid endoscopes, with the following configurations: Single channeled devices with a stainless lumen that is ≥ 0.77mm internal diameter (ID) and ≤500mm in length Dual channeled devices with stainless steel lumens that are ≥ 0.77mm ID and ≤ 527mm in length Triple channeled devices with stainless steel lumens that are ≥ 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 STERIS V-PRO maX 2 Medical devices, including single, dual and triple channeled rigid and semi-rigid endoscopes, with the following configurations: Single channeled devices with a stainless lumen that is ≥ 0.77mm internal diameter (ID) and ≤500mm in length Dual channeled devices with stainless steel lumens that are ≥ 0.77mm ID and ≤ 527mm in length Triple channeled devices with stainless steel lumens that are ≥ 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 STERIS V-PRO 1 STERIS V-PRO 1 Plus The V-PRO 1 Cycle and the V-PRO 1 Plus Lumen Cycle can sterilize* instruments/devices with the following features: Instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors. Medical devices with a single lumen with: an inside diameter of 3 mm or larger and a length of 400 mm or shorter an inside diameter of 2 mm or larger and a length of 250 mm or shorter an inside diameter of 1 mm or larger and a length of 125 mm or shorter |
| TABLE 2: Validated Low Temperature Sterilization Products STERIS V-PRO 1, STERIS V-PRO 1 Plus, STERIS V-PRO maX, STERIS V-PRO maX 2, and<br>STERIS V-PRO 60, Lumen¹ Cycles. | |
| Note: Refer to the Manufacturer's User's Guide for complete instructions on load and cycle for each STERIS V-PRO System. The instructions<br>provided below are not intended to replace the detailed Instructions for Use provided with the STERIS – VPRO | |
| STERIS V-PRO System Lumen Cycle | Intended Load |
| STERIS V-PRO 60 | The V-PRO 60 sterilizer's Lumen cycle can sterilize :<br>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: Y Single or dual lumen devices with stainless steel lumens that are Ο ≥ 0.77 mm (~1/32") internal diameter (ID) and ≤ 410 mm (16-9/64") in length Y Triple lumen devices with stainless steel lumens that are Ο ≥ 1.2 mm (~ 3/64") ID and ≤ 275 mm (~ 10-55/64") in length Ο ≥ 1.8 mm (~ 5/64") ID and ≤ 310 mm (~ 12-13/64") in length Ο or<br>Ο ≥ 2.8 mm (~ 7/64") ID and ≤ 317 mm (~12-31/64") in length |
| 1 The Non-Lumen articles can be processed in the Lumen cycle as it takes mixed loads | |

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| TABLE 3: Validated Low Temperature Sterilization Products STERIS V-PRO 1 Plus, STERIS V-PRO maX, STERIS V-PRO maX 2, and STERIS V-PRO<br>60, Non-Lumen Cycles<br>Note: Refer to the User's Guide for complete instructions on load and cycle for each STERIS V-PRO System. The instructions provided below are not<br>intended to replace the detailed Instructions for Use provided with the STERIS – VPRO | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------…