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.

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 configurations:

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).
One flexible endoscope with a light cord (if not integral to endoscope) and mat and additional non-lumened 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: 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 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:

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 or one pouch with guide(s)/model(s) (with or without tray) for a total weight of 11 lbs (5 kg).

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. **

** The validation studies were conducted using a validation load consisting of pouched guide(s) (with or without tray) for a total weight of 5 lbs (2.3 kg) 3D printed material. Devices used in validation studies were prepared in accordance with printer manufacturers' instructions for use, to include printing, curing, removal of support material and cleaning.

Device Description

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 V-PRO Sterilizers use VAPROX® HC Sterilant to sterilize the intended devices through exposure to vaporized hydrogen peroxide (VHP). The five preprogrammed 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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the STERIS V-PRO maX 2 Low Temperature Sterilization System. It focuses on the substantial equivalence of the proposed device to a predicate device, specifically regarding the addition of a "Specialty Cycle."

Based on the provided information, the device is a sterilizer, and the "acceptance criteria" and "study proving the device meets the acceptance criteria" refer to the sterilization efficacy and the validation studies conducted to demonstrate that the new Specialty Cycle effectively sterilizes the specified materials/devices.

Here's the breakdown of the information requested, based on the provided document:

Acceptance Criteria and Reported Device Performance

The core acceptance criterion for a sterilizer is to demonstrate the elimination of viable microorganisms. This is typically shown through achieving sterility with a certain Sterility Assurance Level (SAL), often by processing inoculated Biological Indicators (BIs). The effectiveness is demonstrated through "½ Cycle (Sterilization) Efficacy" and "Final Process Qualification."

Table of Acceptance Criteria and Reported Device Performance (Inferred from the document's validation summary):

Acceptance Criterion (Implicit)	Reported Device Performance (Result)
Sterilization Efficacy (½ Cycle): Achieve sterilization (kill all inoculated Biological Indicators) under challenging conditions.	The standard injection weight of 2.1 g resulted in all sterile results within the validation load used to qualify each sterilizer cycle. (PASS)
Material Compatibility: Demonstrate that the sterilization process does not adversely affect the materials intended for processing.	Material evaluations verified the compatibility of tested materials in the V-PRO maX 2 Sterilizer's Specialty Cycle. (PASS)
Biocompatibility: Ensure that processed devices remain biocompatible (absence of toxic residues or material degradation leading to toxicity).	Testing in accordance with ISO 10993-1 have demonstrated biocompatibility of identified materials after processing in three (3) consecutive cycles of the V-PRO maX 2 Sterilizer's Specialty Cycle. (PASS)
Final Process Qualification: Overall validation of the new sterilization cycle to ensure it meets performance requirements.	The V-PRO maX 2 Sterilizer final process qualification was successful for the Specialty Cycle. (PASS)

Additional Requested Information:

1. Sample sizes used for the test set and the data provenance:

Test Set Sample Sizes:
- Non Lumen Cycle: Validation load consisting of two instrument trays for a total weight of 50 lbs (22.7 kg).
- Fast Non Lumen Cycle: Validation load consisting of one pouched instrument tray for a total weight of 11 lbs (5 kg).
- Flexible Cycle (Config 1): Two flexible endoscopes with a light cord and mat (no additional load).
- Flexible Cycle (Config 2): One flexible endoscope with a light cord and mat, plus a tray with additional instruments and silicone mat for a total weight of 24 lbs (11 kg). This configuration also included 5 stainless steel lumens.
- Lumen Cycle: Validation load consisting of two instrument trays and two pouches for a total weight of 19.65 lbs (8.9 kg), with a maximum of 20 lumens per load.
- Specialty Cycle (Non-lumened instruments): Validation load consisting of one pouched instrument tray or one pouch with guide(s)/model(s) (with or without tray) for a total weight of 11 lbs (5 kg).
- Specialty Cycle (3D Printed Materials): Validation load consisting of pouched guide(s)/model(s) (with or without tray) for a total weight of 5 lbs (2.3 kg) 3D printed material.
Data Provenance: The document implies these are prospective validation studies conducted by STERIS Corporation for regulatory submission. The country of origin is not explicitly stated but can be inferred as the United States given the FDA submission.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This is a sterilization device, not an AI diagnostic tool. Ground truth for sterilizers is established through microbiological assays (e.g., biological indicators) and physical/chemical measurements (temperature, pressure, time, hydrogen peroxide concentration, etc.), not expert reader consensus like in imaging. Therefore, the concept of "experts establishing ground truth for the test set" in the context of human readers does not apply here. The expertise lies in microbiology, engineering, and quality assurance to design and execute the validation studies.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable for a sterilization device validation study. Sterility is typically determined by the absence of growth in biological indicators, which is an objective measurement rather than a subjective human interpretation requiring adjudication.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a sterilizer, not an AI or diagnostic imaging system. There are no "human readers" involved in performing or interpreting the sterilization process in a way that would warrant an MRMC study.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a physical device, a sterilizer, not an algorithm. The "performance" is the physical process of sterilization.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The ground truth for sterilization efficacy is established through microbiological assays, specifically the 6-log reduction or complete kill of highly resistant bacterial spores (Geobacillus stearothermophilus) contained within biological indicators (BIs). This is an objective, quantitative measure of sterilization. Additional ground truth includes adherence to engineering specifications for process parameters and chemical validation.

7. The sample size for the training set:

Not applicable. This is a medical device (sterilizer) and its validation, not an AI/machine learning model that requires a "training set." The performance data comes from experimental validations and engineering studies.

8. How the ground truth for the training set was established:

Not applicable, as there is no "training set" in the context of an AI model. The validation studies demonstrate the device's capability to sterilize.

Summary

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August 7, 2023

STERIS Corporation Anthony Piotrkowski Director, Regulatory Affairs 5960 Heisley Rd Mentor, Ohio 44060

Re: K223476

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: July 12, 2023 Received: July 12, 2023

Dear Anthony 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. 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 located 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.

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Christopher K. Dugard -S

for Clarence W. Murray, III, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic 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) K223476

Device Name

V-PRO maX 2 Low Temperature Sterilization System

Indications for Use (Describe)

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.

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 configurations:

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

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

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· 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

The Specialty 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 or one pouch with guide(s)/model(s) (with or without tray) for a total weight of 11 lbs (5 kg).

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
Biocompatible Clear MED610	Stratasys	E	≥3 mm ID x ≤20 mm L
Biocompatible Opaque MED615RGD	Stratasys	E	≥3 mm ID x ≤20 mm L
VeroGlaze™ MED620	Stratasys	E	≥3 mm ID x ≤20 mm L

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/4/Picture/0 description: The image shows the STERIS logo. To the left of the word STERIS is a blue graphic of several horizontal wavy lines stacked on top of each other. The word STERIS is in a bold, sans-serif font.

510(k) Summary For K223476

V-PRO® maX 2 Low Temperature Sterilization System

STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 357-9198

Contact:	Anthony Piotrkowski
	Director, Regulatory Affairs
	Tel: 440-392-7437
	Fax: 440-357-9198
	Email: tony_piotrkowski@steris.com

Submission Date: August 1, 2023

STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600

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1. Device Name

Trade Name:	V-PRO® maX 2 Low Temperature SterilizationSystem
Device Class:	Class II
Common/usual Name:	Vapor Phase Hydrogen Peroxide Sterilizer
Classification Name:	Sterilizer, Ethylene Oxide Gas
Classification Number:	21 CFR 880.6860
Product Code:	MLR

Predicate Device 2.

The claimed primary predicate device is the V-PRO maX 2 Low Temperature Sterilization Systems, cleared most recently under K222093.

Table 5-1. A comparison between the proposed V-PRO maX 2 Low Temperature Sterilization System to the predicate device

Feature	V-PRO maX 2 Low Temperature SterlizationSystem (Predicate Device/K222093)	V-PRO maX 2 Low Temperature SterlizationSystem (Proposed Device/ K223476)
	The V-PRO maX 2 Low Temperature SterilizationSystem using VAPROX HC Sterilant are intended foruse in the terminal sterilization of properly prepared(cleaned, rinsed and dried) medical devices inHealthcare Facilities. The preprogrammed sterilizationcycles operate at low pressure and temperature,suitable for processing medical devices without leavingtoxic residues.	The V-PRO maX 2 Low Temperature SterilizationSystem using VAPROX HC Sterilant is intended foruse in the terminal sterilization of properly prepared(cleaned, rinsed and dried) medical devices inHealthcare Facilities. The preprogrammed sterilizationcycles operate at low pressure and temperature,suitable for processing medical devices without leavingtoxic residues.
	Each Cycle can sterilize non-lumened instrumentswith diffusion-restricted spaces such as the hingedportion of forceps and scissors.	Each Cycle can sterilize non-lumened instrumentswith diffusion-restricted spaces such as the hingedportion of forceps and scissors.
Indicationsfor Use	The Non Lumen Cycle can sterilize: ‡Non-lumened instruments including non-lumenedgeneral medical instruments, non-lumened rigid, semi-rigid and flexible endoscopes.‡ The validation studies were conducted using avalidation load consisting of two instrument trays for atotal weight of 50 lbs (22.7 kg).	The Non Lumen Cycle can sterilize: ‡Non-lumened instruments including non-lumenedgeneral medical instruments, non-lumened rigid, semi-rigid and flexible endoscopes.‡ The validation studies were conducted using avalidation load consisting of two instrument trays for atotal weight of 50 lbs (22.7 kg).
	The Fast Non Lumen Cycle can sterilize:Non-lumened instruments including non-lumenedgeneral medical instruments, non-lumened rigid, semi-rigid and flexible endoscopes. The validation studies were conducted using avalidation load consisting of one pouched instrumenttray for a total weight of 11 lbs (5 kg).	The Fast Non Lumen Cycle can sterilize:Non-lumened instruments including non-lumenedgeneral medical instruments, non-lumened rigid, semi-rigid and flexible endoscopes. The validation studies were conducted using avalidation load consisting of one pouched instrumenttray for a total weight of 11 lbs (5 kg).
Feature	V-PRO maX 2 Low Temperature SterlizationSystem (Predicate Device/K222093)	V-PRO maX 2 Low Temperature SterlizationSystem (Proposed Device/ K223476)
	The Flexible Cycle can sterilize:	The Flexible Cycle can sterilize:
	Single or dual lumen surgical flexible endoscopes(such as those used in ENT, Urology and SurgicalCare) and bronchoscopes in either of the twoconfigurations:	Single or dual lumen surgical flexible endoscopes(such as those used in ENT, Urology and SurgicalCare) and bronchoscopes in either of the twoconfigurations:
	1. Two flexible endoscopes with a light cord (if notintegral to endoscope) and mat with no additionalload.† The flexible endoscopes may contain single ordual channel lumens that are ≥ 1 mm internal diameter(ID) and ≤ 1050 mm in length.† The validation studies were conducted with twoflexible endoscopes, each packaged into a tray withsilicone mat and light cord (if not integral toendoscope).	1. Two flexible endoscopes with a light cord (if notintegral to endoscope) and mat with no additionalload.† The flexible endoscopes may contain single ordual channel lumens that are ≥ 1 mm internal diameter(ID) and ≤ 1050 mm in length.† The validation studies were conducted with twoflexible endoscopes, each packaged into a tray withsilicone mat and light cord (if not integral toendoscope).
	2. One flexible endoscope with a light cord (if notintegral to endoscope) and mat and additional non-lumened instruments. ‡‡ The flexible endoscope maycontain single or dual channel lumens that are ≥ 1 mmID and ≤ 1050 mm in length■ Additional instruments may include non-lumenedor lumened medical devices with the followingconfigurations:■ Single, dual or triple channel stainless steellumen that is■ ≥ 0.48 mm ID and ≤ 100 mm in length‡‡ The validation studies were conducted with a flexibleendoscope in a tray with endoscope accessories,silicone mat, light cord (if not integral to endoscope)and 5 stainless steel lumens. Also included in the loadwas a tray with additional instruments, and silicone matfor a total weight of 24 lbs (11 kg).	2. One flexible endoscope with a light cord (if notintegral to endoscope) and mat and additional non-lumened instruments. ‡‡ The flexible endoscope maycontain single or dual channel lumens that are ≥ 1 mmID and ≤ 1050 mm in length■ Additional instruments may include non-lumenedor lumened medical devices with the followingconfigurations:■ Single, dual or triple channel stainless steellumen that is■ ≥ 0.48 mm ID and ≤ 100 mm in length‡‡ The validation studies were conducted with a flexibleendoscope in a tray with endoscope accessories,silicone mat, light cord (if not integral to endoscope)and 5 stainless steel lumens. Also included in the loadwas a tray with additional instruments, and silicone mafor a total weight of 24 lbs (11 kg).
	The Lumen Cycle can sterilize: †	The Lumen Cycle can sterilize: †
	Medical devices with the following configurations:• Single, dual or triple channeled stainless steel lumenthat 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 inlength• Rigid non-metallic lumen (such as those used inendoscope 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 conductedusing a maximum of 20 lumens per load. Hospitalloads should not exceed the maximum number oflumens validated by this testing. The validation studieswere performed using a validation load consisting oftwo instrument trays and two pouches for a total weightof 19.65 lbs (8.9 kg).	Medical devices with the following configurations:• Single, dual or triple channeled stainless steel lumenthat 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 inlength• Rigid non-metallic lumen (such as those used inendoscope 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 conductedusing a maximum of 20 lumens per load. Hospitalloads should not exceed the maximum number oflumens validated by this testing. The validation studie-were performed using a validation load consisting oftwo instrument trays and two pouches for a total weighof 19.65 lbs (8.9 kg).

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Feature	V-PRO maX 2 Low Temperature SterlizationSystem (Predicate Device/K222093)	V-PRO maX 2 Low Temperature SterlizationSystem (Proposed Device/ K223476)
		The Specialty Cycle can sterilize:Non-lumened instruments including non-lumenedgeneral medical instruments, non-lumened rigid, semi-rigid and flexible endoscopes. The validation studies were conducted using avalidation load consisting of one pouched instrumenttray or one pouch with guide(s)/model(s) (with orwithout tray) for a total weight of 11 lbs (5 kg).orPatient-specific surgical guides (e.g. osteotomy,shoulder, hip, knee, spine) or anatomical modelsfabricated via additive manufacturing (3D printing)processes and intended for single-use during operativeprocedures. The validation studies were conducted using avalidation load consisting of pouchedguide(s)/model(s) (with or without tray) for a totalweight of 5 lbs (2.3 kg) 3D printed material. Devicesused in validation studies were prepared in accordancewith printer manufacturers' instructions for use, toinclude printing, curing, removal of support materialand cleaning.
		Material Manufacturer SpecialtyCycle Lumens Surgical GuideResin Formlabs F ≥3 mm ID x<30 mm L BioMed AmberResin Formlabs F ≥3 mm ID x<30 mm L Dental LT ClearV2 Resin Formlabs D ≥3 mm ID x<30 mm L BioMed ClearResin Formlabs D ≥3 mm ID x<30 mm L BiocompatibleClear MED610 Stratasys E ≥3 mm ID x<20 mm L BiocompatibleOpaqueMED615RGD Stratasys E ≥3 mm ID x<20 mm L VeroGlaze™MED620 Stratasys E ≥3 mm ID x<20 mm L
ProcessParameters	The critical process parameters are:• Time• Chamber Temperature• Vaporizer Temperature• Chamber Pressure Prior to Injection• Sterilant Injection Weight	The critical process parameters are:• Time• Chamber Temperature• Vaporizer Temperature• Chamber Pressure Prior to Injection• Sterilant Injection Weight
Software/FirmwareControlled	Control system consists of a proprietarymicrocomputer control board and peripheral functioncircuit boards, located within the control housing. Amemory backup system maintains user settings andcalibration data indefinitely. Up to 300 cycle data filescan be stored for review or downloading by the user.The software allows user selection of either the Lumen,Non Lumen, Flexible or Fast Non Lumen pre-programmed cycle.	Control system consists of a proprietarymicrocomputer control board and peripheral functioncircuit boards, located within the control housing. Amemory backup system maintains user settings andcalibration data indefinitely. Up to 300 cycle data filescan be stored for review or downloading by the user.The software allows user selection of either the Lumen,Non Lumen, Flexible, Fast Non Lumen or Specialtypre-programmed cycle.

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Feature	V-PRO maX 2 Low Temperature SterlizationSystem (Predicate Device/K222093)	V-PRO maX 2 Low Temperature SterlizationSystem (Proposed Device/ K223476)
Sterilant	VAPROX HC Sterilant (59% Hydrogen Peroxide).The same amount of sterilant is injected for each of thesterilization pulses for all four cycles.Sterilant Cup is read by an RFID reader.	VAPROX HC Sterilant (59% Hydrogen Peroxide).The same amount of sterilant is injected for each of thesterilization pulses for all Five cycles.Sterilant Cup is read by an RFID reader.
TotalCycleTime	Lumen Cycle - 52 minutesNon Lumen Cycle - 28 minutesFlexible Cycle - 35 minutesFast Non Lumen Cycle – 16 minutes	Lumen Cycle - 52 minutesNon Lumen Cycle - 28 minutesFlexible Cycle - 35 minutesFast Non Lumen Cycle - 16 minutesSpecialty CycleSpecialty Cycle A – 1 hr.Specialty Cycle B – 2 hr.Specialty Cycle C - 4 hr.Specialty Cycle D – 8 hr.Specialty Cycle E – 16 hr.Specialty Cycle F - 21 hr.
Accessories	Accessories were submitted under separate, individual,concurrent 510(k)s and cover the following:• Self-contained biological indicator• Biological indicator challenge pack• Fast Acting Biological Indicator• Chemical indicator• Trays & Tray Accessories• Pouches• Tape	Accessories were submitted under separate, individual,concurrent 510(k)s and cover the following:• Self-contained biological indicator• Biological indicator challenge pack• Fast Acting Biological Indicator• Chemical indicator• Trays & Tray Accessories• Pouches• Tape

The proposed and predicate device are identical in all ways except their indications for use and consequently their labeling (operator manual).

3. Description of Device

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

Intended Use / Indications for Use 4.

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There is no change to the intended use. The Indications for use are detailed in Table 5.1. The differences between the proposed devices and predicate are only the addition of the Specialty Cycle to the V-PRO maX 2 Sterilizer.

ട. Technological Characteristics

The proposed and predicate device are identical in all technological characteristics including but not limited to: fundamental scientific technology, composition, mechanism of action, components and accessories. No physical changes were made to the devices for this modification other than labeling (operator manual).

6. Summary of Testing to Support Substantial Equivalence

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

Test	Result	Conclusion
½ Cycle(Sterilization)Efficacy	The standard injection weight of 2.1 g resulted in all sterile results within the validation load used to qualify each sterilizer cycle.	PASS
MaterialCompatibility	Material evaluations verified the compatibility of tested materials in the V-PRO max 2 Sterilizer's Specialty Cycle	PASS
Biocompatibility	Testing in accordance with ISO 10993-1 have demonstrated biocompatibility of identified materials after processing in three (3) consecutive cycles of the V-PRO maX 2 Sterilizer's Specialty Cycle.	PASS
Final ProcessQualification	The V-PRO maX 2 Sterilizer final process qualification was successful for the Specialty Cycle.	PASS

6. Conclusions

The conclusion drawn from the nonclinical tests demonstrates that the subject device in this 510(k) submission, the 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 device cleared under K222093, Class II (21 CFR 880.6860), product code MLR.

Regulation Number and Section

§ 880.6860 Ethylene oxide gas sterilizer.

(a)
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.(b)
Classification. Class II (performance standards).