V-PRO maX 2 Low Temperature Sterilization System

K233065 · Steris · MLR · Oct 20, 2023 · General Hospital

Device Facts

• Record ID: K233065
• Device Name: V-PRO maX 2 Low Temperature Sterilization System
• Applicant: Steris
• Product Code: MLR · General Hospital
• Decision Date: Oct 20, 2023
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.6860
• Device Class: Class 2

Intended Use

The V-PRO maX 2 Low Temperature Sterilization System using VAPROX HC Sterilant is intended for use in the terminal sterilization of properly prepared (cleaned, rinsed and dried) medical devices in Healthcare Facilities. The preprogrammed sterilization cycles operate at low pressure and temperature, suitable for processing medical devices without leaving toxic residues.

Device Story

V-PRO maX 2 is a vaporized hydrogen peroxide sterilizer for terminal sterilization of medical devices in healthcare facilities. System uses VAPROX HC Sterilant (59% hydrogen peroxide) in pre-programmed cycles: Lumen, Non Lumen, Flexible, Fast Non Lumen, and Specialty. Operation involves conditioning, sterilization, and aeration phases at low pressure/temperature. Devices are ready for use immediately post-cycle. System processes various loads including stainless steel lumens, flexible endoscopes, and 3D-printed surgical guides. Healthcare personnel load cleaned/dried/packaged instruments into the chamber; system automates sterilization process. Output is a sterile, residue-free device ready for clinical use. Benefits include rapid turnaround and material compatibility for heat-sensitive instruments.

Clinical Evidence

Bench testing only. Performance testing included D-value verification, biocompatibility testing per ISO 10993-1, and shelf-life stability testing (package appearance, color, clarity, concentration, pH). All tests met acceptance criteria.

Technological Characteristics

Vaporized hydrogen peroxide sterilizer; 59% hydrogen peroxide active ingredient. Features multiple-use cup delivery system with RFID/data matrix coding. Operates via conditioning, sterilization, and aeration phases. Compatible with stainless steel, various 3D-printed resins (Formlabs, Stratasys), and flexible endoscopes. No physical changes to the sterilization system hardware.

Indications for Use

Indicated for terminal sterilization of cleaned, rinsed, and dried medical devices in healthcare facilities, including non-lumened instruments, rigid/semi-rigid/flexible endoscopes, single/dual lumen surgical flexible endoscopes, bronchoscopes, and patient-specific 3D-printed surgical guides/anatomical models.

Regulatory Classification

Identification

An ethylene gas sterilizer is a nonportable device intended for use by a health care provider that uses ethylene oxide (ETO) to sterilize medical products.

Predicate Devices

• V-PRO maX 2 Low Temperature Sterilization Systems (K223476)

Submission Summary (Full Text)

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October 20, 2023

Steris Jennifer Nalepka Manager, Regulatory Affairs 5960 Heisley Road Mentor, Massachusetts 44060

Re: K233065

Trade/Device Name: V-PRO maX 2 Low Temperature Sterilization System Regulation Number: 21 CFR 880.6860 Regulation Name: Ethylene Oxide Gas Sterilizer Regulatory Class: Class II Product Code: MLR Dated: September 25, 2023 Received: September 26, 2023

Dear Jennifer Nalepka:

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 (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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Christopher K. Dugard -S

Christopher K. Dugard, M.S. Assistant Director DHT4B: Division of Infection Control

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and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K233065

#### Device Name

V-PRO maX 2 Low Temperature Sterilization System

#### Indications for Use (Describe)

The V-PRO maX 2 Low Temperature Sterilization System using VAPROX HC Sterilant is intended for use in the terminal sterilization of properly prepared (cleaned, rinsed and dried) medical devices in Healthcare Facilities. The preprogrammed sterilization cycles operate at low pressure and temperature, suitable for processing medical devices without leaving toxic residues.

Each Cycle can sterilize non-luments with diffusion-restricted spaces such as the hinged portion of forceps and scissors.

The Non Lumen Cycle can sterilize: †

Non-lumened instruments including non-luments, non-luments, non-lumened rigid, sem-rigid and flexible endoscopes.

t The validation studies were conducted using a validation load consisting of two instrument trays for a total weight of 50 lbs (22.7 kg).

The Fast Non Lumen Cycle can sterilize: *

Non-lumened instruments including non-luments. non-luments. non-lumened rigid, semi-rigid and flexible endoscopes.

* The validation studies were conducted using a validation load consisting of one pouched instrument tray for a total weight of 11 lbs (5 kg).

The Flexible Cycle can sterilize:

Single or dual lumen surgical flexible endoscopes (such as those used in ENT, Urology and Surgical Care) and bronchoscopes in either of the two load configurations:

1. Two flexible endoscopes with a light cord (if not integral to endoscope) and mat with no additional load. * The flexible endoscopes may contain single or dual channel lumens that are > 1 mm internal diameter (ID) and ≤ 1050 mm in length. * The validation studies were conducted with two flexible endoscopes, each packaged into a tray with silicone mat and light cord (if not integral to endoscope).

2. One flexible endoscope with a light cord (if not integral to endoscope accessories, mat, and additional instruments. ** The flexible endoscope may contain single or dual channel lumens that are > 1 mm ID and ≤ 1050 mm in length

• Additional instruments may include non-lumened or lumened medical devices with the following configurations:

o Single, dual or triple channel stainless steel lumen that is

· ≥ 0.48 mm ID and ≤ 100 mm in length

** The validation studies were conducted with a flexible endoscope accessories, silicone mat, light cord (if not integral to endoscope) and 5 stainless steel lumens. Also included in the load was a tray with additional instruments, and silicone mat for a total weight of 24 lbs (11 kg).

The Lumen Cycle can sterilize: †

Medical devices with the following configurations:

· Single, dual or triple channeled stainless steel lumen that are:

• ≥ 0.77 mm ID and ≤ 527 mm in length

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• ≥ 0.8 mm ID and ≤ 542 mm in length

- ≥ 0.48 mm ID and ≤ 100 mm in length
- · Dead end lumen that is ≥ 1.3 mm ID and ≤ 73 mm in length
- Rigid non-metallic lumen (such as those used in endoscope sheaths, take-apart forceps and trocars) that are:
- ≥ 3 mm ID and ≤ 298 mm in length
- ≥ 4 mm ID and < 424 mm in length

* Validation testing for all lumen sizes was conducted using a maximum of 20 lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing. The validation studies were performed using a validation load consisting of two instrument trays and two pouches for a total weight of 19.65 lbs (8.9 kg).

The Specialty Cycle can sterilize:

Patient-specific surgical guides (e.g. osteotomy, shoulder, hip, knee, spine) or anatomical models fabricated via additive manufacturing (3D printing) processes and intended for single-use during operative procedures .*

or

Non-lumened instruments including non-luments, non-luments, non-lumened rigid, semi-rigid and flexible endoscopes. **

3D Printed Devices constructed of the following materials, and lumen if present, must be sterilized in the Specialty Cycle identified

| Material | Manufacturer | Specialty Cycle | Lumens |
|--------------------------|--------------|-----------------|---------------------|
| Surgical Guide Resin | Formlabs | F | ≥3 mm ID x ≤30 mm L |
| BioMed Amber Resin | Formlabs | F | ≥3 mm ID x ≤30 mm L |
| Dental LT Clear V2 Resin | Formlabs | D | ≥3 mm ID x ≤30 mm L |
| BioMed Clear Resin | Formlabs | D | ≥3 mm ID x ≤30 mm L |
| MED615RGD | Stratasys | E | ≥3 mm ID x ≤20 mm L |
| MED620 | Stratasys | E | ≥3 mm ID x ≤20 mm L |
| MED610 | Stratasys | E | ≥3 mm ID x ≤20 mm L |

* The validation studies were conducted using a validation load consisting of single-pouched guide(s) (with or without tray) with a total weight of 5 lbs. (2.3 kg) of 3D printed material.

** The validation studies were conducted using a validation load consisting of pouched devices (with or without tray) for a total weight of 11 lbs. (5 kg).

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/5/Picture/0 description: The image shows the STERIS logo. The logo consists of a blue wave-like design on the left and the word "STERIS" in black capital letters on the right. The wave design is made up of five horizontal lines that curve up and down, creating a sense of movement. The word "STERIS" is written in a bold, sans-serif font.

# 510(k) Summary for K233065 V-PRO® maX 2 Low Temperature Sterilization System

STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: [phone]

Contact: Jennifer Nalepka Manager, Regulatory Affairs Phone: [phone] email: jennifer nalepka(@steris.com

Submission Date: October 19, 2023

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#### 1. Device Name

| Trade Name: | |
|------------------------|--|
| Device Class: | |
| Common/usual Name: | |
| Classification Name: | |
| Classification Number: | |
| Product Code: | |

V-PRO maX 2 Low Temperature Sterilization System Class II Vapor Phase Hydrogen Peroxide Sterilizer Sterilizer, Ethylene Oxide Gas 21 CFR 880.6860 MLR

## 2. Predicate Device

The claimed primary predicate device is the V-PRO maX 2 Low Temperature Sterilization Systems, cleared most recently under K223476. VAPROX HC Sterilant is the required sterilant used in the V-PRO Low Temperature Sterilization Systems. The comparison table, Table 1 in Section 5, compares the predicate and proposed VAPROX HC Sterilant. There are no changes to any of the V-PRO Low Temperature Sterilization Systems.

The proposed and predicate device are identical in all ways except the grade of sterilant in the predicate compared to the proposed.

## 3. Description of Device

The V-PRO Low Temperature Sterilization Systems are vaporized hydrogen peroxide sterilizers.

The V-PRO maX 2 sterilizer has the following pre-programmed cycles: the Lumen Cycle, the Non Lumen Cycle, the Flexible Cycle, the Fast Non Lumen Cycle, and the Specialty Cycle. The V-PRO Low Temperature Sterilization Systems are intended for terminal sterilization of cleaned, rinsed, dried, and packaged surgical instruments used in healthcare facilities.

The five pre-programmed cycles all use a conditioning phase, a sterilize phase and an aeration phase. The packaged sterilized devices are ready for use at the completion of the cycle, no cool down or aeration period is required following completion of the cycle.

VAPROX HC Sterilant is a 59% hydrogen peroxide sterilant used only the V-PRO Low Temperature Sterilization Systems (V-PRO). It was originally cleared for use in K062297 and the cup was modified in K112813. It has also been cleared as part of the various V-PRO Sterilizer models. The most recent Premarket Notifications for each model are identified in Table 1. This Premarket Notification is only for a proposed modification to VAPROX HC; there are no modifications to any of the V-PRO Low Temperature Sterilization Systems listed below:

- V-PRO 1
- V-PRO 1 Plus ●
- V-PRO maX ●
- V-PRO maX 2 ●
- V-PRO 60
- V-PRO s2 ●

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## 4. Intended Use/Indications for Use

This modification is related to the VAPROX HC sterilant, which has the following intended use: VAPROX HC Sterilant is intended for use in the V-PRO Low Temperature Sterilization Systems for terminal sterilization of cleaned, rinsed and dried metal and nonmetal medical devices used in healthcare facilities. It has been validated for use in all cycles currently implemented on each of the V-PRO Low Temperature Sterilization Systems.

#### Intended Use/Indications for Use V-PRO maX 2:

The V-PRO maX 2 Low Temperature Sterilization System using VAPROX HC Sterilant is intended for use in the terminal sterilization of properly prepared (cleaned, rinsed and dried) medical devices in Healthcare Facilities. The preprogrammed sterilization cycles operate at low pressure and temperature, suitable for processing medical devices without leaving toxic residues.

Each Cycle can sterilize non-luments with diffusion-restricted spaces such as the hinged portion of forceps and scissors.

#### The Non Lumen Cycle can sterilize: +

Non-lumened instruments including non-lumened general medical instruments, nonlumened rigid, semi-rigid and flexible endoscopes.

* The validation studies were conducted using a validation load consisting of two instrument trays for a total weight of 50 lbs (22.7 kg).

## The Fast Non Lumen Cycle can sterilize: *

Non-lumened instruments including non-lumened general medical instruments, nonlumened rigid, semi-rigid and flexible endoscopes.

" The validation studies were conducted using a validation load consisting of one pouched instrument tray for a total weight of 11 lbs (5 kg).

## The Flexible Cycle can sterilize:

Single or dual lumen surgical flexible endoscopes (such as those used in ENT, Urology and Surgical Care) and bronchoscopes in either of the two load configurations:

1. Two flexible endoscopes with a light cord (if not integral to endoscope) and mat with no additional load. * The flexible endoscopes may contain single or dual channel lumens that are > 1 mm internal diameter (ID) and < 1050 mm in length.

* The validation studies were conducted with two flexible endoscopes, each packaged into a tray with silicone mat and light cord (if not integral to endoscope).

2. One flexible endoscope with a light cord (if not integral to endoscope), endoscope accessories, mat, and additional instruments. th The flexible endoscope may contain single or dual channel lumens that are ≥ 1 mm ID and ≤ 1050 mm in length

- Additional instruments may include non-lumened medical devices with the ● following configurations:
- o Single, dual or triple channel stainless steel lumen that is
- · ≥ 0.48 mm ID and ≤ 100 mm in length

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** The validation studies were conducted with a flexible endoscope in a tray with endoscope accessories, silicone mat, light cord (if not integral to endoscope) and 5 stainless steel lumens. Also included in the load was a tray with additional instruments, and silicone mat for a total weight of 24 lbs (11 kg).

# The Lumen Cycle can sterilize: *

Medical devices with the following configurations:

- · Single, dual or triple channeled stainless steel lumen that are:
- · ≥ 0.77 mm ID and ≤ 527 mm in length
- · ≥ 0.8 mm ID and ≤ 542 mm in length
- · ≥ 0.48 mm ID and ≤ 100 mm in length
- · Dead end lumen that is > 1.3 mm ID and < 73 mm in length
- · Rigid non-metallic lumen (such as those used in endoscope sheaths, take-apart forceps and trocars) that are:
- ≥ 3 mm ID and ≤ 298 mm in length
- · > 4 mm ID and < 424 mm in length

* Validation testing for all lumen sizes was conducted using a maximum of 20 lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing. The validation studies were performed using a validation load consisting of two instrument trays and two pouches for a total weight of 19.65 lbs (8.9 kg).

## The Specialty Cycle can sterilize:

Patient-specific surgical guides (e.g. osteotomy, shoulder, hip, knee, spine) or anatomical models fabricated via additive manufacturing (3D printing) processes and intended for single-use during operative procedures.*

or

Non-lumened instruments including non-lumened general medical instruments, nonlumened rigid, semi-rigid and flexible endoscopes. **

3D Printed Devices constructed of the following materials, and lumen if present, must be sterilized in the Specialty Cycle identified

| Material | Manufacturer | Specialty<br>Cycle | Lumens |
|--------------------------|--------------|--------------------|---------------------|
| Surgical Guide Resin | Formlabs | F | ≥3 mm ID x ≤30 mm L |
| BioMed Amber Resin | Formlabs | F | ≥3 mm ID x ≤30 mm L |
| Dental LT Clear V2 Resin | Formlabs | D | ≥3 mm ID x ≤30 mm L |
| BioMed Clear Resin | Formlabs | D | ≥3 mm ID x ≤30 mm L |
| MED615RGD | Stratasys | E | ≥3 mm ID x ≤20 mm L |
| MED620 | Stratasys | E | ≥3 mm ID x ≤20 mm L |
| MED610 | Stratasys | E | ≥3 mm ID x ≤20 mm L |

* The validation studies were conducted using a validation load consisting of single-pouched guide(s)/model(s) (with or without tray) with a total weight of 5 lbs. (2.3 kg) of 3D printed material. ** The validation studies were conducted using a validation load consisting of pouched devices (with or without tray) for a total weight of 11 lbs. (5 kg).

## 5. Technological Characteristics Comparison

The proposed and predicate device are identical in all technological characteristics including but not limited to: fundamental scientific technology, composition, mechanism

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#### STERIS SPECIAL 510(K) PREMARKET NOTIFICATION Modification to VAPROX HC Sterilant

of action, components and accessories. No physical changes were made to the devices for this modification.

| Feature | VAPROX HC Sterilant<br>Predicate K223476 | VAPROX HC Sterilant<br>Proposed | Comparison |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Intended Use | VAPROX HC Sterilant is intended for use in the V-PRO Low<br>Temperature Sterilization Systems<br>for terminal sterilization of cleaned,<br>rinsed and dried metal and nonmetal<br>medical devices used in healthcare<br>facilities. | VAPROX HC Sterilant is intended for use in the V-PRO Low<br>Temperature Sterilization Systems<br>for terminal sterilization of cleaned,<br>rinsed and dried metal and nonmetal<br>medical devices used in healthcare<br>facilities. | Identical |
| Active<br>Ingredient | 59% Hydrogen Peroxide (nominal) | 59% Hydrogen Peroxide (nominal) | Identical |
| Design of Cup | Multiple use cup | Multiple use cup | Identical |
| Minimum<br>Cycles per<br>Cup | SKUs:<br>PB007 – 15<br>PB011 – 15<br>PB012 – 4<br>PB028 – 4 | SKUs:<br>PB007 – 15<br>PB011 – 15<br>PB012 – 4<br>PB028 – 4 | Identical |
| Form during<br>Use | Vaporized hydrogen peroxide | Vaporized hydrogen peroxide | Identical |
| Sterilant<br>Delivery | External chamber placement | External chamber placement | Identical |
| Sterilant<br>Injection | Fixed dose | Fixed dose | Identical |
| Label Coding | SKUs:<br>PB007 – Data matrix<br>PB011 – RFID<br>PB012 – RFID<br>PB028 – Data matrix | SKUs:<br>PB007 – Data matrix<br>PB011 – RFID<br>PB012 – RFID<br>PB028 – Data matrix | Identical |
| Shelf Life | SKUs:<br>PB007 – 15 months<br>PB011 – 15 months<br>PB012 – 6 months<br> | SKUs:<br>PB007 – 15 months<br>PB011 – 15 months<br>PB012 – 6 months<br>PB028 - 6 months | Identical |

| Table 1. A comparison between the proposed and predicate devices |
|------------------------------------------------------------------|
|------------------------------------------------------------------|

# 6. Summary of Nonclinical Testing

The proposed devices have the same intended use and the same technological characteristics as the predicate devices. Performance testing, based on a risk assessment of the proposed change to the predicate, is summarized below.

| Test | Result | Acceptance Criteria | Conclusion |
|------------------|-------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|------------|
| D-value | The D-value for the proposed meets<br>specifications of the predicate. | D-value of proposed formulation must<br>meet that established for the predicate. | PASS |
| Biocompatibility | Testing in accordance with ISO 10993-1 have<br>demonstrated an equivalent biocompatibility<br>profile between the proposed and predicate. | The biocompatibility profile of the<br>proposed formulation must be<br>equivalent to the predicate<br>formulation. | PASS |

Table 2. Summary of Testing

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## STERIS SPECIAL 510(K) PREMARKET NOTIFICATION Modification to VAPROX HC Sterilant

| Test | Result | Acceptance Criteria | Conclusion |
|------------|-----------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Shelf Life | The proposed meets specifications over the<br>same shelf life as that of the predicate. | The proposed formulation must meet<br>the same specifications as the predicate<br>in shelf life testing:<br>• Package appearance<br>• Sterilant Color<br>• Clarity<br>• Hydrogen peroxide Concentration<br>• Sterilant pH | PASS |

## 7. Conclusions

The conclusion drawn from the nonclinical tests demonstrates that the subject device in this 510(k) submission, V-PRO® maX 2 Low Temperature Sterilization System, is as safe, as effective, and performs as well as or better than the legally marketed predicate and reference devices cleared under K223476, Class II (21 CFR 880.6860), product code MLR.