Who is the manufacturer of V-PRO 60 LOW TEMPERATURE STERILIZATION SYSTEM?

STERIS Corporation filed the 510(k) submission for V-PRO 60 LOW TEMPERATURE STERILIZATION SYSTEM (K140498).

What is the FDA product code for V-PRO 60 LOW TEMPERATURE STERILIZATION SYSTEM?

MLR. It is classified under 21 CFR 880.6860 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for V-PRO 60 LOW TEMPERATURE STERILIZATION SYSTEM?

510(k) clearance (submission type: Traditional).

What are the predicate devices for V-PRO 60 LOW TEMPERATURE STERILIZATION SYSTEM?

Amsco V-PRO maX Low Temperature Sterilization System (K131120).

Who can help prepare an FDA 510(k) submission like V-PRO 60 LOW TEMPERATURE STERILIZATION SYSTEM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

V-PRO 60 LOW TEMPERATURE STERILIZATION SYSTEM

K140498 · STERIS Corporation · MLR · Jul 24, 2014 · General Hospital

Device Facts

Record ID	K140498
Device Name	V-PRO 60 LOW TEMPERATURE STERILIZATION SYSTEM
Applicant	STERIS Corporation
Product Code	MLR · General Hospital
Decision Date	Jul 24, 2014
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.6860
Device Class	Class 2
Attributes	Therapeutic, Real-World Evidence

Real-World Evidence

Submission	Device	Sponsor	RWD Sources	RWE Use Summary	Key Tags
K140498 · Jul 24, 2014	V-PRO 60 LOW TEMPERATURE STERILIZATION SYSTEM	STERIS Corporation	Patient-soiled, clinically-cleaned medical instruments	An 'In Use Test' was conducted to demonstrate the ability of the V-PRO 60 Sterilizer cycles to sterilize medical instruments that had been used in a clinical setting and subsequently cleaned via routine clinical procedures.	In-use testing; Sterilization efficacy; Routine clinical instruments

Clinical Evidence

Study Design	Population	Comparator	Key Endpoints
In Use Test; Performance testing using clinically-used instruments	Patient-soiled, clinically-cleaned medical instruments	Not applicable for this study	Sterilization efficacy on patient-soiled instruments

Indications for Use

The V-PRO 60 Low Temperature Sterilization System, with VAPROX® HC Sterilant, is a vaporized hydrogen peroxide sterilizer intended for use in the terminal sterilization of cleaned, rinsed and dried reusable metal and nonmetal medical devices used in healthcare facilities. The pre-programmed sterilization cycles (Lumen Cycle, Non Lumen Cycle, and Flexible Cycle) operate at low pressure and low temperature and are thus suitable for processing medical devices sensitive to heat and moisture.

Device Story

V-PRO 60 is a vaporized hydrogen peroxide (VHP) sterilizer for heat/moisture-sensitive reusable medical devices. Uses VAPROX HC Sterilant (59% hydrogen peroxide). Operates via three pre-programmed cycles: Lumen, Non Lumen, and Flexible. Each cycle includes conditioning, sterilization, and aeration phases; no post-cycle cool-down required. Used in healthcare facilities by clinical staff. System controlled by microcomputer board with memory backup for cycle settings. Provides terminal sterilization, ensuring devices are ready for immediate reuse. Benefits include rapid processing of delicate surgical instruments and endoscopes without thermal damage.

Clinical Evidence

Bench testing only. Studies included AOAC sporicidal testing (720 carriers), D-value determination, 1/2 cycle modified total kill endpoint verification, and 1/2 cycle sterilization verification for all lumen/non-lumen/flexible configurations. Additional testing covered mated surfaces, simulated use, in-use testing with patient-soiled instruments, biocompatibility (23 materials), and material compatibility. All tests passed.

Technological Characteristics

Vaporized hydrogen peroxide sterilizer. Materials: 23 compatible types. Energy: Electrical. Connectivity: Standalone with microcomputer control board. Sterilization: VAPROX HC (59% H2O2). Standards: EN 61010-1 (Safety), EN 61326-1 (EMC).

Indications for Use

Indicated for terminal sterilization of cleaned, rinsed, and dried reusable metal and nonmetal medical devices in healthcare facilities. Suitable for heat- and moisture-sensitive devices, including rigid/semi-rigid endoscopes (single, dual, triple channeled) and flexible endoscopes/bronchoscopes. Specific lumen diameter and length constraints apply per cycle type.

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

Amsco V-PRO maX Low Temperature Sterilization System (K131120)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the word "STERIS" in a large, bold font, with the registered trademark symbol next to it. Above the word "STERIS" is the code "K140498". Below the word "STERIS" is a graphic of several horizontal wavy lines stacked on top of each other. JUL 2 4 2014 # 510(k) Summary For V-PRO® 60 Low Temperature Sterilization System STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 357-9198 Bill Brodbeck Contact: Director, Regulatory Affairs Telephone: (440) 392-7690 Fax No: (440) 357-9198 July 24, 2014 Summary Date: STERIS Corporation = 5960 Heisley Road = Mentor, OH 44060-1834 USA = 440-354-2600 {1}------------------------------------------------ #### 1. Device Name | Trade Name: | V-PRO® 60 Low Temperature Sterilization System | |----------------------|-----------------------------------------------------------------------| | Common/usual Name: | Vapor Phase Hydrogen Peroxide Sterilizer | | Classification Name: | Sterilizer, Ethylene Oxide Gas 21 CFR 880.6860 Product Code MLR | | Device Class: | Class II | #### Predicate Devices 2. Amsco V-PRO maX Low Temperature Stetilization System (K131120). Please note that the predicate device was originally cleared under K102330. A comparison between the proposed V-PRO 60 Low Temperature Sterilization System to the predicate device is summarized in the table below. | Feature | V-PRO 60 Low Temperature Sterilization System (Proposed Device) | V-PRO maX Low Temperature Sterilization System (Predicate Device/K131120) | |-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | The V-PRO 60 Low Temperature Sterilization System, with VAPROX® HC Sterilant, is a vaporized hydrogen peroxide sterilizer intended for use in the terminal sterilization of cleaned, rinsed and dried reusable metal and nonmetal medical devices used in healthcare facilities. The pre-programmed sterilization cycles (Lumen Cycle, Non Lumen Cycle, and Flexible Cycle) operate at low pressure and low temperature and are thus suitable for processing medical devices sensitive to heat and moisture. | The Amsco V-PRO 1, V-PRO 1 Plus and V- PRO maX Low Temperature Sterilization Systems, with VAPROX® HC Sterilant, are vaporized hydrogen peroxide sterilizers intended for use in the terminal sterilization of cleaned, rinsed and dried reusable metal and nonmetal medical devices used in healthcare facilities. The three pre-programmed sterilization cycles (Lumen Cycle, Non Lumen Cycle, and Flexible Cycle) operate at low pressure and low temperature and are thus suitable for processing medical devices sensitive to heat and moisture. | | | The V-PRO 60 Sterilizer's Lumen Cycle can sterilize:a 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: a | The Amsco V-PRO 1, V-PRO 1 Plus and V- PRO maX Low Temperature Sterilization System's Lumen Cycle, can sterilize:a 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: a single channeled devices with a stainless steel lumen that is ≥ 0.77 mm internal diameter (ID) and < | | Feature | V-PRO 60 Low Temperature Sterilization System (Proposed Device) | V-PRO maX Low Temperature Sterlization System (Predicate Device/K131120) | | | o single or dual lumen devices with stainless lumens that are ■ ≥ 0.77 mm (~1/32") internal diameter (ID) and ≤ 410 mm (16-9/64") in length o triple lumen devices with stainless steel lumens that are ■ ≥ 1.2 mm (~3/64") ID and ≤ 275 mm (~10-55/64") in length ■ ≥ 1.8 mm (~5/64") ID and ≤ 310 mm (~12-13/64") in length or ■ ≥ 2.8 mm (~7/64") ID and ≤ 317 mm (12-31/64") in length | 500 mm in length o dual lumen devices with stainless lumens that are ≥ 0.77 mm ID and ≤ 527 mm in length o triple lumen 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 | | a | The validation studies for all lumen configurations were conducted using a maximum of twelve (12) 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 one instrument tray with instrument organizers and mat and two pouches for a total weight of 11 lbs (5.0 kg). | a The validation studies for all channel/ lumen configurations were conducted using a maximum of twenty (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. | | | The V-PRO 60 Sterilizer's Non Lumen Cycle can sterilize: b • 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. | The Amsco V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems' Non Lumen Cycle, cleared under K083097, K102394 and K111810, can sterilize:b • 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. | | | b The validation studies were performed using a validation load consisting of one instrument tray with instrument organizers and mat and one pouch for a total weight of 12 lbs (5.4 kg). | b The validation studies were conducted using a validation load consisting of two instrument trays and two pouches for a total weight of 19.65 lbs. | | | The V-PRO 60 Sterilizer's Flexible Cycle can sterilize: c • One flexible surgical endoscope or bronchoscope with a light cord (if not | The Amsco V-PRO maX Low Temperature Sterilization System's Flexible Cycle, cleared under K102330 and K112760, can sterilize single or dual lumen surgical flexible endoscopes (such as those used in ENT, Urology and Surgical Care) and bronchoscopes in either of two load configurations: 1.Two flexible endoscopes with a light cord (if not integral to endoscope) and mat with no additional load.c | | Feature | V-PRO 60 Low Temperature Sterilization System (Proposed Device) | V-PRO maX Low Temperature Sterlization System (Predicate Device/K131120) | | | integral to endoscope) and mat without any additional load. The flexible endoscope may be a: o single or dual lumen device with lumens that are ≥ 1 mm (~3/64") ID and ≤ 990 mm (38-63/64") in length c The validation studies were conducted with one flexible endoscope, packaged into a tray with silicone mat, instrument organizers and light cord (if not integral to scope) and no additional load. | The flexible endoscopes may contain either: o a single lumen that is ≥ 1 mm ID and ≤ 1050 mm in length o or two lumens with: one lumen that is ≥ 1 mm ID and ≤ 998 mm in length and the other lumen that is ≥ 1 mm ID and ≤ 850 mm in length c 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) and mat and additional non-lumened instruments including instruments with diffusion- restricted areas such as the hinged portion of forceps or scissors.d The flexible endoscope can contain either: • a single lumen that is ≥ 1 mm ID and ≤ 1050 mm in length • or two lumens with: a single lumen that is ≥ 1 mm ID and ≤ 998 mm in length and the other lumen that is ≥ 1 mm and ≤ 850 mm in length d The validation studies were conducted with a flexible endoscope in a tray with silicone mat and light cord (if not integral to endoscope). Also included in the load were an additional instrument tray and one pouch for a total load weight of 24.0 lbs. | | | | | | | The critical process parameters are: | The critical process parameters are: | | Process Parameters | • Time | • Time | | | • Chamber Temperature | • Chamber Temperature | | | • Vaporizer Temperature | • Vaporizer Temperature | | | • Chamber Pressure Prior to Injection | • Chamber Pressure Prior to Injection | | | • Sterilant Injection Weight | • Sterilant Injection Weight | | Feature | V-PRO 60 Low Temperature Sterilization System (Proposed Device) | V-PRO maX Low Temperature Sterilization System (Predicate Device/K131120) | | Software/ Firmware Controlled | Control system consists of a microcomputer control board and peripheral function circuit boards, located within the control housing. A memory backup system maintains cycle settings and current cycle information indefinitely. The software allows user selection of either the Lumen, Non Lumen, or Flexible pre-programmed cycle. | Programmable Logic Control (PLC). The software allows user selection of either the Lumen, Non Lumen, or Flexible pre- programmed cycle. | | Total Cycle Time | Lumen Cycle - 60 minutes Non Lumen Cycle - 28 minutes Flexible Cycle - 38 minutes | Lumen Cycle - 55 minutes Non Lumen Cycle - 28 minutes Flexible Cycle - 35 minutes | | Sterilant | VAPROX HC Sterilant (59% Hydrogen Peroxide). The same amount of sterilant is injected for each of the sterilization pulses for all three cycles. | VAPROX HC Sterilant (59% Hydrogen Peroxide). The same amount of sterilant is injected for each of the sterilization pulses for all three cycles. | | Accessories | Accessories were submitted under separate, individual, concurrent 510(k)s and cover the following: Self-contained biological indicator and biological indicator challenge pack Chemical indicator Trays & Tray Accessories Pouches | The following accessories are available for the V-PRO maX Low Temperature Sterilization System Self-contained biological indicator Biological indicator challenge pack Chemical indicator Trays & Tray Accessories Pouches | {2}------------------------------------------------ : 1 {3}------------------------------------------------ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ . . . {4}------------------------------------------------ The proposed device has an intended use similar to the predicate with the same technological characteristics. Although, the devices slightly differ, the provided descriptive characteristics and performance data demonstrate equivalence. Therefore, the proposed V-PRO 60 Low Temperature Sterilization System is substantially equivalent to the predicate device, the V-PRO maX Low Temperature Sterilization System. #### 3. Description of Device The V-PRO 60 Low Temperature Sterilization System is a new vaporized hydrogen peroxide sterilizer model to be added to the STERIS V-PRO family of sterilizers. The V-PRO product line currently consists of the Amsco V-PRO 1, Amsco V-PRO 1 Plus and Amsco V-PRO maX Sterilizers. As with the predicate device (K102330), the V-PRO 60 Sterilizer has three preprogrammed cycles: the Lumen Cycle, the Non Lumen Cycle and the Flexible Cycle. The V-PRO 60 Low Temperature Sterilization System is intended for terminal sterilization of cleaned, rinsed, dried and packaged reusable surgical instruments used in healthcare facilities. {5}------------------------------------------------ The V-PRO 60 Sterilizer uses VAPROX® HC Sterilant to sterilize the intended devices through exposure to vaporized hydrogen peroxide (VHP). Its three preprogrammed cycles all utilize 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 cvcle. #### 4. Intended Use 0 . The V-PRO 60 Low Temperature Sterilization System, with VAPROX HC Sterilant, is a vaporized hydrogen peroxide sterilizer intended for use in the terminal sterilization of cleaned, rinsed and dried reusable metal and nonmetal medical devices used in healthcare facilities. The pre-programmed sterilization cycles (Lumen Cycle, Non Lumen Cycle, and Flexible Cycle) operate at low pressure and low temperature and are thus suitable for processing medical devices sensitive to heat and moisture. The V-PRO 60 Sterilizer's Lumen Cycle can sterilize: 4 - · 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: 3 - single or dual lumen devices with stainless steel lumens that are o - = > 0.77 mm (~1/32") internal diameter (ID) and ≤ 410 mm (16-9/64") in length triple lumen devices with stainless steel lumens that are - . ≥ 1.2 mm (~3/64") ID and ≤ 275 mm (~10-55/64") in length - ≥ 1.8 mm (~5/64") ID and ≤ 310 mm (~12-13/64") in length = or - . ≥ 2.8 mm (~7/64") ID and ≤ 317 mm (12-31/64") in length 4 The validation studies for all lumen configurations were conducted using a maximum of twelve (12) 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 one instrument tray with instrument organizers and mat and two pouches for a total weight of 11 1bs (5.0 kg). The V-PRO 60 Sterilizer's Non Lumen Cycle can sterilize ° - · Non-lumened devices including non-lumened rigid, semi-rigid and flexible endoscopes and non-lumened devices with stainless steel or titanium diffusionrestricted spaces such as the hinged portion of forceps and scissors. {6}------------------------------------------------ - b The validation studies were performed using a validation load consisting of one instrument tray with instrument organizers and mat and one pouch for a total weight of 12 lbs (5.4 kg). The V-PRO 60 Sterilizer's Flexible Cycle can sterilize: 6 - One flexible surgical endoscope or bronchoscope with a light cord (if not integral to endoscope) and mat without any additional load. The flexible endoscope may be a: - single or dual lumen device with lumens that are ≥ 1 mm (~3/64") ID and ≤ 990 . O mm (38-63/64") in length - C The validation studies were conducted with one flexible endoscope, packaged into a tray with silicone mat, instrument organizers and light cord (if not integral to scope) and no additional load. #### 5. Summary of Nonclinical Tests The V-PRO 60 Low Temperature Sterilization System has the same or similar intended use and the same technological characteristics as compared to the predicate device. Performance testing to assess and demonstrate substantial equivalence to the predicate is summarized below. | Test | Result | Conclusion | |----------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | AOAC Sporicidal Test | All 720 carriers processed using 3 lots of EOSL sterilant were sterile. | PASS | | Determination of D- value and Total Kill Endpoint | Greater than a 12 log reduction of the most resistant organism is achieved within all cycle (Lumen Cycle, Non Lumen Cycle and Flexible Cycle) of the V-PRO 60 Sterilizer. | PASS | | ½ Cycle Modified Total Kill Endpoint Verification | Modified total kill end point analysis was demonstrated for all three V-PRO 60 Sterilizer cycles. The standard injection weight of 1.1 g and at least one lower injection weight resulted in all sterile results within the validation load used to qualify each sterilizer cycle. Partial positives or all survive results were seen at lower injection weights. | PASS | | ½ Cycle Sterilization Verification of Cycle Claims | • The Lumen Cycle reproducibly sterilizes single, dual and triple lumen devices under worst case conditions in ½ Cycle • The Flexible Cycle reproducibly sterilizes 1 x 990 mm flexible endoscope lumens under worst case conditions in ½ Cycle • The Non Lumen Cycle reproducibly sterilizes non-lumened devices under worst case conditions in ½ Cycle | PASS | {7}------------------------------------------------ | Test | Result | Conclusion | |---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | ½ Cycle Verification of Mated Surfaces | Sterile efficacy was demonstrated for mated surfaces under worst case conditions | PASS | | Simulated Use Test | Simulated use testing verified the ability of the V-PRO 60 Sterilizer cycles to sterilize medical devices under worst case processing conditions. | PASS | | In Use Test | The in use investigation demonstrated the ability of the V-PRO 60 Sterilizer cycles to sterilize patient- soiled, clinically-cleaned, medical instruments. | PASS | | Biocompatibility | Cytotoxicity and residue analysis of 23 materials have demonstrated biocompatibility after processing in the V-PRO 60 Sterilizer. | PASS | | Medical Device Material Compatibility | Evaluation of medical devices after multiple cycles in the V-PRO 60 Sterilizer has demonstrated compatibility with 23 materials of construction. | PASS | | Final Process Qualification | The V-PRO 60 Sterilizer final process qualification was successful for all three (3) sterilizer cycles. All three lots of CI exhibited complete color change. All three SCBI PIs exhibited a passing color change and all SCBIs were negative for growth. Manual inspection of the process parameter data confirmed that all cycle specifications were met. | PASS | The V-PRO 60 Low Temperature Sterilization System has been tested for conformity and is certified to the following standards: - . EN 61010-1:2001 Safety requirements for electrical equipment for measurement, control and laboratory use. General requirements; Part 1: General Requirements - . EN61326-1:2006 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General requirements #### ર્. Conclusion The V-PRO 60 Low Temperature Sterilization System's Lumen, Non Lumen and Flexible Cycles have been validated to meet the established performance criteria. The results of the V-PRO 60 Low Temperature Sterilization System verification studies demonstrate that the sterilizer performs as intended and the proposed device is substantially equivalent to the predicate device. {8}------------------------------------------------ ### DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-000 July 24, 2014 STERIS Corporation Dr. William Brodbeck Director, Regulatory Affairs 5960 Heisley Road Mentor, OH 44060 Re: K140498 Trade/Device Name: V-Pro 60 Low Temperature Sterilization System Regulation Number: 21 CFR 880.6860 Regulation Name: Sterilizer, Ethylene Oxide Gas Regulatory Class: II Product Code: MLR Dated: June 24, 2014 Received: June 25, 2014 Dear Dr. Brodbeck 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. {9}------------------------------------------------ Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours, ・・ Teiashri Purohi FOR Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {10}------------------------------------------------ # Indications for Use 510(k) Number (if known): K140498 Device Name: ## V-PRO® 60 Low Temperature Sterilization System Indications For Use: The V-PRO 60 Low Temperature Sterilization System, with VAPROX® HC Sterilant, is a vaporized hydrogen peroxide sterilizer intended for use in the terminal sterilization of cleaned, rinsed and dried reusable metal and nonmetal medical devices used in Healthcare facilities. The pre-programmed sterilization cycles (Lumen Cycle, Non Lumen Cycle, and Flexible Cycle) operate at low pressure and low temperature and are thus suitable for processing medical devices sensitive to heat and moisture. The V-PRO 60 Sterilizer's Lumen Cycle can sterilize: 4 - · 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: 4 - single or dual lumen devices with stainless steel lumens that are o ■ ≥ 0.77 mm (~1/32") internal diameter (ID) and ≤ 410 mm (16-9/64") in length - triple lumen devices with stainless steel lumens that are o - ≥ 1.2 mm (~3/64") ID and ≤ 275 mm (~10-55/64") in length . - ≥ 1.8 mm (~5/64") ID and ≤ 310 mm (~12-13/64") in length 1 or - ≥ 2.8 mm (~7/64") ID and ≤ 317 mm (12-31/64") in length 사 - a The validation studies for all lumen configurations were conducted using a maximum of twelve (12) 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 one instrument tray with instrument organizers and mat and two pouches for a total weight of 11 lbs (5.0 kg). The V-PRO 60 Sterilizer's Non Lumen Cycle can sterilize ° - · 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. Page 1 of 2 {11}------------------------------------------------ - b The validation studies were performed using a validation load consisting of one instrument tray with instrument organizers and mat and one pouch for a total weight of 12 lbs (5.4 kg). The V-PRO 60 Sterilizer's Flexible Cycle can sterilize: 6 - · One flexible surgical endoscope or bronchoscope with a light cord (if not integral to endoscope) and mat without any additional load. The flexible endoscope may be a: - single or dual lumen device with lumens that are ≥ 1 mm (~3/64") ID and ≤ 990 o mm (38-63/64") in length - E The validation studies were conducted with one flexible endoscope, packaged into a tray with silicone mat, instrument organizers and light cord (if not integral to scope) and no additional load. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR × Over-The-Counter Use (21 CFR 801 Subpart C) ## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Image /page/11/Picture/11 description: The image shows a digital signature of Sreekanth Gutala. The signature includes the name "Sreekanth Gutala -S" in a large font on the left side of the image. On the right side, there is information about the digital signature, including the date and time: 2014:07:24 12:48:52 -04'00'. Page 2 of 2

V-PRO 60 LOW TEMPERATURE STERILIZATION SYSTEM

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