(211 days)
Not Found
No
The document describes a hardware modification to a sterilizer and explicitly states there is no impact on the system software. There is no mention of AI or ML in the intended use, device description, or performance studies.
No.
Explanation: The device is a sterilizer for medical instruments and devices, not a device used for therapeutic purposes on patients.
No
Explanation: The device is a sterilizer designed to sterilize medical instruments. Its function is to kill microorganisms on medical devices, not to diagnose medical conditions or provide diagnostic information.
No
The device description explicitly states it is a "self-contained, stand-alone system of hardware and software" and details numerous hardware components like a sterilizer chamber, vacuum pump, and various materials. The modification described is a hardware change to the vacuum pump.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "sterilization of both metal and nonmetal medical devices at low temperatures." This is a process applied to medical devices themselves, not a test performed on biological samples to diagnose a condition.
- Device Description: The description details a system for sterilizing medical instruments using hydrogen peroxide vapor and plasma. This aligns with a sterilization process, not an in vitro diagnostic test.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The device is a sterilizer, which is a type of medical device used to prepare other medical devices for use.
N/A
Intended Use / Indications for Use
The STERRAD NX® Sterilizer is designed for sterilization of both metal and nonmetal medical devices at low temperatures. The STERRAD sterilization process is a multiphase sterilization process that utilizes a combination of exposure to hydrogen peroxide vapor and plasma to affect sterilization. The STERRAD NX Sterilize instruments which have diffusionrestricted spaces, such as the hinged portion of forceps and scissors.
Medical devices with the following materials and dimensions can be processed in the STERRAD NX Sterilizer STANDARD cycle:
Single channel stainless steel lumens with
- . An inside diameter of 1 mm or larger and a length of 150 mm or shorter-
. An inside diameter of 2 mm or larger and a length of 400 mm or shorter Medical devices, including most flexible endoscopes, with the following materials and dimensions can be processed in the STERRAD NX Sterilizer ADVANCED cycle:
Single channel stainless steel lumens with
An inside diameter of 1 mm or larger and a length of 500 mm or shorter1 ● Single channel polyethylene and Teflon (polytetrafluoroethylene) flexible endoscope with
- An inside diameter of 1 mm or larger and length of 850 mm or shorter2 ●
- With the exception of the 1 x 850 mm flexible endoscopes, validation studies were Note: performed using a validation load consisting of one instrument tray weighing 10.7 lbs. The 1 x 850 mm flexible endoscope was validated without any additional load.
Product codes (comma separated list FDA assigned to the subject device)
MLR
Device Description
The STERRAD NX Sterilizer is a self-contained, stand-alone system of hardware and software designed to sterilize medical instruments and devices using a patented hydrogen peroxide gas plasma process. Hydrogen peroxide vapor is generated by injecting a 59% aqueous hydrogen peroxide solution into the vaporizer subassembly where the solution is then concentrated and is vaporized at relatively low temperatures through a process that utilizes a combination of heating and sub-ambient pressures created by an on-board vacuum pump. The vaporized hydrogen peroxide is then introduced into the chamber under sub-ambient pressure to allow perfusion of the hydrogen peroxide throughout the chamber and, facilitating hydrogen peroxide contact with the surfaces to be sterilized. The vapor in the chamber is transformed into gas plasma using electrical energy. The chamber is then vented to allow the sterilization chamber to return to atmospheric pressure. This process is repeated an additional time to complete a full STERRAD NX Sterilization cycle (i.e., the full sterilization cycle is composed of two identical half-cycles). The STERRAD NX Sterilizer has two cleared sterilization cycles, the STANDARD and ADVANCED Cycles, both of which follow the general process described here.
The hardware for the STERRAD NX Sterilizer consists of a sterilizer chamber, constructed with aluminum, and a variety of instruments and components which are housed in a covered frame. Other major components of the system are constructed from passivated stainless steel. Viton (a copolymer of vinylidene fluoride and hexafluoropropylene), Ultem (polyetherimide), and structural foam. The sterilizer also uses accessories such as reusable instrument trays, printer paper, and an optional movable cart. The STERRAD NX Sterilizer can be placed directly on a table, counter top, or on the movable STERRAD NX cart.
The STERRAD NX Sterilizer uses a disposable sterilant cassette that contains a 59% nominal hydrogen peroxide solution in a plastic cell pack and cassette shells. As previously described, the hydrogen peroxide is concentrated before introduction into the sterilizer chamber and its concentration is monitored during the cycle. The sterilizer cancels the cycle if the hydrogen peroxide monitor data does not meet the pre-defined minimum concentration specification.
The modified STERRAD NX Sterilizer, which is the subject of this submission, incorporates a new vacuum pump and associated mounting components to improve the pump's durability. The new vacuum pump utilizes an oil warming element to maintain an optimum operating temperature range for the vacuum pump's oil during the periods of pump inactivation in-between reprocessing cycles. This modification will be implemented through hardware changes with no impact on the system software.
The technological characteristics associated with the sterilization process for the modified STERRAD NX Sterilizer are identical to those of the previously cleared STERRAD NX Sterilizer. In addition, the hardware changes associated with the described modification do not affect the cleared sterilization cycles or the manner by which the STERRAD NX Sterilizer is operated by the customer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Design verification testing was conducted to test the modified STERRAD NX Sterilizer (with new vacuum pump) design against applicable design inputs; all testing yielded passing results.
Verification of the new Vacuum Pump in the STERRAD NX System: This study conducted design verification to demonstrate that the new vacuum pump is able to meet applicable design inputs. Testing includes design input factors such as time to warm up across different power settings, pump startup across different power settings, pump current draw, environmental specifications, noise generation, time to pump an enclosed space to a defined pressure, fitment, weight and qualitative verification of the presence of certain features such as a drain valve, a feature by which the pump can be lifted. Result: Pass.
Verification of the STERRAD NX STANDARD and ADVANCED Cycles using STERRAD NX Sterilizers Built with the New Vacuum Pumps: This study conducted efficacy testing of the STANDARD and ADVANCED cycles in the modified STERRAD NX Sterilizer to verify that there is no impact to efficacy introduced by the use of the new vacuum pump. No growth was observed on the test BIs with a sterility assurance level (SAL) of 10-6 of Geobacillus stearothermophilus demonstrating no impact to efficacy. Result: Pass.
Biocompatibility testing data submitted in the predicate device 510(k) continues to be applicable to the modified STERRAD NX Sterilizer as no changes have been made to the sterilization process/cycle parameters or the sterilant (hydrogen peroxide) materials.
Electromagnetic compatibility (EMC) testing data submitted in the predicate device 510(k) continues to be applicable to the modified STERRAD NX Sterilizer. Upon review of the device modification TÜV SÜD America, Inc., the notified body that conducts EMC testing on the STERRAD NX Sterilizer, has concluded that there is no anticipated impact to the results of the previous EMC testing.
Electrical Safety testing was conducted to demonstrate that the modified STERRAD NX is electrically and mechanically safe when operated and maintained in accordance with the User's Guide and the Service Guide. Based upon this testing, the modified STERRAD NX Sterilizer conforms to the applicable sections of the following standards:
- CAN/CSA-C22.2 No. 61010-1:2004 + Update 1:2008 R: 2009 Safety Requirements O for Electrical Equipment for Measurement, Control, and Laboratory Use
- CAN/CSA-C22.2 No. 61010-2-040:2007-12 Safety requirements for electrical o equipment for measurement, control and laboratory use - Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials
- UL 61010-1/R:2008-10 Standard for Safety for Electrical Equipment for Laboratory o Use
- IEC/EN 61010-1:2001 Safety Requirements for Electrical Equipment for o Measurement, Control, and Laboratory Use
- IEC/EN 61010-2-40:2005 Particular Requirements for Sterilizers and Washer- O disinfectors used to Treat Medical Materials, First Edition
Software verification and validation testing data submitted in the predicate device's 510(k) continues to be applicable to the modified STERRAD NX Sterilizer as there are no modifications being made to the software of the system. Software verification and validation testing was previously conducted in accordance with Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, dated May 11, 2005.
No clinical data is being submitted in support of this Premarket Notification.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight, composed of three overlapping profiles.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 16, 2017
Advanced Sterilization Products Nazanin Yacobi Senior Regulatory Affairs Program Lead 33 Technology Dr. Irvine, California 92618
Re: K162007
Trade/Device Name: Sterrad Nx Sterilizer Regulation Number: 21 CFR 880.6860 Regulation Name: Ethylene Oxide Gas Sterilizer Regulatory Class: Class II Product Code: MLR Dated: July 18, 2016 Received: July 20, 2016
Dear Nazanin Yacobi:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices. good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (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" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name STERRAD NX® Sterilizer
Indications for Use (Describe)
The STERRAD NX Sterilizer is designed for sterilization of both metal medical devices at low temperatures. The STERRAD sterilization process is a multiphase sterilization process that utilizes a combination of exposure to hydrogen peroxide vapor and plasma to affect sterilization. The STERRAD NX Sterilizer can sterilize instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors.
Medical devices with the following materials and dimensions can be processed in the STERRAD NX Sterilizer STANDARD cycle:
Single channel stainless steel lumens with
- · An inside diameter of 1 mm or larger and a length of 150 mm or shorter*
- · An inside diameter of 2 mm or larger and a length of 400 mm or shorter*
Medical devices, including most flexible endoscopes, with the following materials and dimensions can be processed in the STERRAD NX Sterilizer ADVANCED cycle:
Single channel stainless steel lumens with
· An inside diameter of 1 mm or larger and a length of 500 mm or shorter*
Single channel polyethylene and Teflon (polytetrafluoroethylene) flexible endoscope with · An inside diameter of 1 mm or larger and length of 850 mm or shorter*
Note: With the exception of the 1 x 850 mm flexible endoscopes, validation studies were performed using a validation load consisting of one instrument tray weighing 10.7 lbs. The 1 x 850 mm flexible endoscope was validated without any additional load.
- The validation testing for this lumen size was conducted using a maximum of 10 lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing. * Only one flexible endoscope can be processed per sterilization cycle with or without a silicone mat. No additional load.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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Image /page/4/Picture/0 description: The image shows a logo with the letters "ASP" in white against a blue-green background. The "A" is represented by a triangle without a base, and the "S" and "P" are stylized with rounded edges. A small registered trademark symbol is visible in the upper right corner of the logo.
510(k) Summary
Advanced Sterilization Products STERRAD NX® Sterilizer with New Vacuum Pump
General Information
| Submitter Name: | Advanced Sterilization Products
Division of Ethicon, Inc., a Johnson & Johnson company |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 33 Technology Drive
Irvine, CA 92618 |
| Contact Person: | Nazanin Yacobi
Senior Regulatory Affairs Program Lead
Tel: (949) 789-8672
Fax: (949) 798-3900
Email: nyacobi@its.jnj.com |
Date Prepared: February 16, 2017
Device Name
| Proprietary Name: | STERRAD NX® Sterilizer |
|---|---|
| Common Name: | Hydrogen Peroxide Gas Plasma Sterilization System |
| Classification Name: | Ethylene oxide gas sterilizer |
| Device Class: | Class II |
| Product Code: | MLR |
| CFR Section: | 21 CFR 880.6860 |
Predicate Device
STERRAD NX Sterilizer originally cleared under K042116.
Description
The STERRAD NX Sterilizer is a self-contained, stand-alone system of hardware and software designed to sterilize medical instruments and devices using a patented hydrogen peroxide gas plasma process. Hydrogen peroxide vapor is generated by injecting a 59% aqueous hydrogen peroxide solution into the vaporizer subassembly where the solution is then concentrated and is vaporized at relatively low temperatures through a process that utilizes a combination of heating and sub-ambient pressures created by an on-board vacuum pump. The vaporized hydrogen
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Image /page/5/Picture/0 description: The image shows a logo with the letters ASP in a rounded, light blue rectangle. The letter A is represented by a triangle without a base, and the letters S and P are stylized. A registered trademark symbol is located in the upper right corner of the rectangle.
peroxide is then introduced into the chamber under sub-ambient pressure to allow perfusion of the hydrogen peroxide throughout the chamber and, facilitating hydrogen peroxide contact with the surfaces to be sterilized. The vapor in the chamber is transformed into gas plasma using electrical energy. The chamber is then vented to allow the sterilization chamber to return to atmospheric pressure. This process is repeated an additional time to complete a full STERRAD NX Sterilization cycle (i.e., the full sterilization cycle is composed of two identical half-cycles). The STERRAD NX Sterilizer has two cleared sterilization cycles, the STANDARD and ADVANCED Cycles, both of which follow the general process described here.
The hardware for the STERRAD NX Sterilizer consists of a sterilizer chamber, constructed with aluminum, and a variety of instruments and components which are housed in a covered frame. Other major components of the system are constructed from passivated stainless steel. Viton (a copolymer of vinylidene fluoride and hexafluoropropylene), Ultem (polyetherimide), and structural foam. The sterilizer also uses accessories such as reusable instrument trays, printer paper, and an optional movable cart. The STERRAD NX Sterilizer can be placed directly on a table, counter top, or on the movable STERRAD NX cart.
The STERRAD NX Sterilizer uses a disposable sterilant cassette that contains a 59% nominal hydrogen peroxide solution in a plastic cell pack and cassette shells. As previously described, the hydrogen peroxide is concentrated before introduction into the sterilizer chamber and its concentration is monitored during the cycle. The sterilizer cancels the cycle if the hydrogen peroxide monitor data does not meet the pre-defined minimum concentration specification.
The modified STERRAD NX Sterilizer, which is the subject of this submission, incorporates a new vacuum pump and associated mounting components to improve the pump's durability. The new vacuum pump utilizes an oil warming element to maintain an optimum operating temperature range for the vacuum pump's oil during the periods of pump inactivation in-between reprocessing cycles. This modification will be implemented through hardware changes with no impact on the system software.
The technological characteristics associated with the sterilization process for the modified STERRAD NX Sterilizer are identical to those of the previously cleared STERRAD NX Sterilizer. In addition, the hardware changes associated with the described modification do not affect the cleared sterilization cycles or the manner by which the STERRAD NX Sterilizer is operated by the customer.
Intended Use/Indications For Use
The intended use of the STERRAD NX Sterilizer, as described in the labeling, has not changed as a result of the modification nor are there any differences between the predicate STERRAD NX and modified STERRAD NX indications for use.
The STERRAD NX® Sterilizer is designed for sterilization of both metal and nonmetal medical devices at low temperatures. The STERRAD sterilization process is a multiphase sterilization process that utilizes a combination of exposure to hydrogen peroxide vapor and plasma to affect
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Image /page/6/Picture/0 description: The image features a logo with the letters 'ASP' in a stylized, sans-serif font. The 'A' is represented by a triangle, and the entire logo is enclosed within a rounded, pill-shaped border. A small registered trademark symbol is visible in the upper right corner of the border.
sterilization. The STERRAD NX Sterilize instruments which have diffusionrestricted spaces, such as the hinged portion of forceps and scissors.
Medical devices with the following materials and dimensions can be processed in the STERRAD NX Sterilizer STANDARD cycle:
Single channel stainless steel lumens with
- . An inside diameter of 1 mm or larger and a length of 150 mm or shorter-
. An inside diameter of 2 mm or larger and a length of 400 mm or shorter Medical devices, including most flexible endoscopes, with the following materials and dimensions can be processed in the STERRAD NX Sterilizer ADVANCED cycle:
Single channel stainless steel lumens with
An inside diameter of 1 mm or larger and a length of 500 mm or shorter1 ● Single channel polyethylene and Teflon (polytetrafluoroethylene) flexible endoscope with
- An inside diameter of 1 mm or larger and length of 850 mm or shorter2 ●
- With the exception of the 1 x 850 mm flexible endoscopes, validation studies were Note: performed using a validation load consisting of one instrument tray weighing 10.7 lbs. The 1 x 850 mm flexible endoscope was validated without any additional load.
Non-Clinical Data
- Design verification testing was conducted to test the modified STERRAD NX Sterilizer ● (with new vacuum pump) design against applicable design inputs; all testing yielded passing results. This testing is summarized in the following table.
| Verification Testing | Description | Pass/
Fail |
|--------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|
| Verification of the new
Vacuum Pump in the
STERRAD NX System | This study conducted design verification to demonstrate that the new
vacuum pump is able to meet applicable design inputs.
Testing includes design input factors such as time to warm up across
different power settings, pump startup across different power settings,
pump current draw, environmental specifications, noise generation, time
to pump an enclosed space to a defined pressure, fitment, weight and
qualitative verification of the presence of certain features such as a
drain valve, a feature by which the pump can be lifted. | Pass |
| Table 1: Summary of performance testing | ||
|---|---|---|
1 The validation testing for this lumen size was conducted using a maximum of 10 lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing.
2 Only one flexible endoscope can be processed per sterilization cycle with or without a silicone mat. No additional load.
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Image /page/7/Picture/0 description: The image shows a logo with the letters 'ASP' in a stylized font. The letters are white and are set against a blue-green background. The logo is enclosed in a rounded rectangle shape. There is a registered trademark symbol in the upper right corner of the logo.
| Verification Testing | Description | Pass/ Fail |
|---|---|---|
| Verification of the | ||
| STERRAD NX | ||
| STANDARD and | ||
| ADVANCED Cycles | ||
| using STERRAD NX | ||
| Sterilizers Built with the | ||
| New Vacuum Pumps | This study conducted efficacy testing of the STANDARD and ADVANCED cycles in the modified STERRAD NX Sterilizer to verify that there is no impact to efficacy introduced by the use of the new vacuum pump. No growth was observed on the test BIs with a sterility assurance level (SAL) of 10-6 of Geobacillus stearothermophilus demonstrating no impact to efficacy. | Pass |
- . Biocompatibility testing data submitted in the predicate device 510(k) continues to be applicable to the modified STERRAD NX Sterilizer as no changes have been made to the sterilization process/cycle parameters or the sterilant (hydrogen peroxide) materials.
- Electromagnetic compatibility (EMC) testing data submitted in the predicate device 510(k) continues to be applicable to the modified STERRAD NX Sterilizer. Upon review of the device modification TÜV SÜD America, Inc., the notified body that conducts EMC testing on the STERRAD NX Sterilizer, has concluded that there is no anticipated impact to the results of the previous EMC testing.
- . Electrical Safety testing was conducted to demonstrate that the modified STERRAD NX is electrically and mechanically safe when operated and maintained in accordance with the User's Guide and the Service Guide. Based upon this testing, the modified STERRAD NX Sterilizer conforms to the applicable sections of the following standards:
- CAN/CSA-C22.2 No. 61010-1:2004 + Update 1:2008 R: 2009 Safety Requirements O for Electrical Equipment for Measurement, Control, and Laboratory Use
- CAN/CSA-C22.2 No. 61010-2-040:2007-12 Safety requirements for electrical o equipment for measurement, control and laboratory use - Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials
- UL 61010-1/R:2008-10 Standard for Safety for Electrical Equipment for Laboratory o Use
- IEC/EN 61010-1:2001 Safety Requirements for Electrical Equipment for o Measurement, Control, and Laboratory Use
- IEC/EN 61010-2-40:2005 Particular Requirements for Sterilizers and Washer- O disinfectors used to Treat Medical Materials, First Edition
- Software verification and validation testing data submitted in the predicate device's 510(k) ● continues to be applicable to the modified STERRAD NX Sterilizer as there are no modifications being made to the software of the system. Software verification and validation testing was previously conducted in accordance with Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, dated May 11, 2005.
Clinical Data
No clinical data is being submitted in support of this Premarket Notification.
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Image /page/8/Picture/0 description: The image shows a logo with the letters ASP in a stylized font. The letters are white and are set against a rounded, light blue background. There is a registered trademark symbol in the upper right corner of the logo.
Summary
The modified STERRAD NX Sterilizer and its predicate device, the previously cleared STERRAD NX Sterilizer, have the same intended use and indications for use. Further, the modified STERRAD NX Sterilizer utilizes the same technology, performance characteristics, sterilant, and cycles as the predicate device to sterilize medical devices. As the only difference between the modified STERRAD NX and the predicate device is the vacuum pump and associated mounting components, no new questions of safety or efficacy are raised.
| Comparison of Device Characteristics | ||
|---|---|---|
| Characteristic | Predicate | |
| STERRAD NX Sterilizer | ||
| K042116, K142454 and K151725 | Modified | |
| STERRAD NX Sterilizer | ||
| Intended Use | Designed for sterilization of both metal and | |
| nonmetal medical devices at low temperatures. | ||
| Because the cycle operates within a dry | ||
| environment and at low temperatures, it is | ||
| especially suitable for instruments sensitive to | ||
| heat and moisture. | Same | |
| Sterilization Process | Hydrogen peroxide gas plasma | Same |
| Principle of operation | Combined use of hydrogen peroxide vapor and | |
| plasma safely and rapidly sterilizes most | ||
| medical instruments and materials without | ||
| leaving toxic residues. | Same | |
| Sterilization Cycles | STANDARD and ADVANCED | Same |
| Recommended Materials | Common materials found in reusable medical | |
| devices. All medical devices should be | ||
| processed in accordance with the medical | ||
| device manufacturer's recommendations. | Same | |
| Approximate Total Cycle | ||
| Time | ||
| Standard Cycle: | 28 minutes | Same |
| Advanced Cycle: | 38 minutes | Same |
| Approximate Sterilizer | ||
| Weight | 325 lb. | 335 lb. (new pump weighs |
| 10 lb. more) | ||
| Sterilizer External | ||
| Dimensions | 22.0" W x 33" H x 32" D | |
| (558.8 mm x 838.2 mm x 812.8 mm) | Same | |
| Sterilizer Internal | ||
| Dimensions | 12.6" W x 23.6" H x 6.2" L | |
| (320 mm x 600 mm x 157 mm) | Same | |
| Shelves | ||
| Shelf Dimensions | Upper & Lower: 23.6" L X 12.3" W (600 mm x | |
| 312 mm) | Same | |
| Shelf Weight Capacity | 24.3 lb (11 kg) | Same |
| Distance Between Shelves | 3.4" (86 mm) | Same |
| Comparison of Device Characteristics | ||
| Characteristic | Predicate | |
| STERRAD NX Sterilizer | ||
| K042116, K142454 and K151725 | Modified | |
| STERRAD NX Sterilizer | ||
| Chamber Volume | Usable: 30 liters (1.1 ft3) | |
| Total: 51.3 liters (1.8 ft3) | Same | |
| Major Component Materials | ||
| Chamber Components | Aluminum | Same |
| Shelves | Passivated stainless steel | Same |
| Chamber Door O-Ring | Viton | |
| (copolymer of vinylidene fluoride & | ||
| hexafluoropropylene) | Same | |
| Injector and Vaporizer | Aluminum, Ultem (Polyetherimide), Stainless | |
| steel, Viton | Same | |
| Exterior Panels | Structural Foam | Same |
| Operator Interface | ||
| Flat Panel Display | 6.4" touch screen | |
| TFT (thin-film transistor) LCD | Same | |
| Graphical User Interface | Geode SC2200 266 MHz | Same |
| Hydrogen Peroxide Monitor | Cancels sterilization cycle if the areas under the | |
| concentration-time curve or rate constant do not | ||
| meet predetermined specifications | Same | |
| Temperature Sensors | Chamber, chamber door and | |
| vaporizer/condenser thermistors | Same | |
| Pressure Sensors | Chamber pressure transducers | |
| Chamber atmospheric pressure switch | ||
| Vaporizer/condenser pressure transducer | Same | |
| Door Sensors | Lock sensor | |
| Closed sensor | Same | |
| Connectivity | DTI (Digital Transfer interface) | |
| Network connectivity software allows the | ||
| hospital IT department to connect the sterilizer | ||
| to a hospital local area network. | Same | |
| Accessories | STERRAD NX Cassette | |
| Test Pack | ||
| CycleSure® Biological Indicator | ||
| STERRAD Chemical Indicator Strip | ||
| STERRAD SealSure™ Chemical Indicator | ||
| Tape | ||
| Tyvek® Pouches | ||
| Instrument Trays | Same |
9
Image /page/9/Picture/0 description: The image shows a logo with the letters "ASP" in a stylized font. The letters are white and are set against a light blue background. The logo has a rounded shape, and there is a small "R" in a circle in the upper right corner, indicating that the logo is a registered trademark.
Conclusion
Based on the intended uses, technological characteristics and non-clinical performance data, the subject device of this special 510(k) is substantially equivalent to the predicate device cleared under K042116, K142454 and K151725.