(87 days)
No
The summary describes an automated system for washing and disinfecting endoscopes, focusing on chemical processes and mechanical functions. There is no mention of AI, ML, image processing, or data analysis that would indicate the use of such technologies.
No
The device is described as a high-level disinfection system for endoscopes, which means it cleans and disinfects medical devices rather than directly treating a patient's disease or condition.
No
The device is described as a high-level disinfection system for endoscopes, which cleans and disinfects medical devices rather than diagnosing medical conditions.
No
The device description clearly indicates it is a "high level disinfection system" that washes and disinfects endoscopes, utilizing a "proprietary, safe, and dry peracetic acid generating oxidative chemistry." This describes a physical system with hardware components and chemical processes, not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for washing and high-level disinfection of medical devices (endoscopes and accessories). This is a process applied to medical equipment, not a test performed on biological samples from a patient to diagnose or monitor a condition.
- Device Description: The description focuses on the system's function in processing endoscopes using a chemical germicide. It doesn't mention analyzing biological samples or providing diagnostic information.
- 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.)
- Providing diagnostic, prognostic, or monitoring information about a patient's health
- Using reagents or assays to detect specific substances in a sample
The device is clearly intended for the reprocessing of medical equipment to ensure it is safe for subsequent use on patients. This falls under the category of medical device reprocessing, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Reliance Endoscope Processing System is intended for washing and high level disinfection of up to two manually pre-cleaned, immersible, reusable, heat-sensitive, semi-critical devices such as bronchoscopes including duodenoscopes, and their accessories. High level disinfection is achieved within the 50 - 57°C HLD Phase of the endoscope processing cycle (4 minute generation sequence followed by a 6-minute exposure sequence).
Product codes (comma separated list FDA assigned to the subject device)
NZA
Device Description
The Reliance Endoscope Processing System is a high level disinfection system that can wash and high level disinfect up to two manually precleaned, immersible, reusable, heatsensitive, semi-critical devices such as GI flexible endoscopes and related accessories.
The system utilizes Reliance™ DG Dry Germicide, a proprietary, safe, and dry peracetic acid generating oxidative chemistry. The Reliance Endoscope Processing System was designed to be versatile in meeting the growing demands of the modern flexible endoscope processing department, while offering the highest level of patient and staff safety. The Reliance Endoscope Processing System is a combination of products that are used to wash and high level disinfect flexible endoscopes and their accessories.
- The Reliance Endoscope Processor is an electromechanical washer/high level . disinfector with a microprocessor-based controller that provides for automated endoscope processing cycles and processor self-decontamination cycles.
- . Reliance DG Dry Germicide is a proprietary, two-part, dry, single-use oxidative chemistry, designed to generate the high level disinfection solution upon automatic dilution in water within the Reliance Endoscope Processor.
- Optional washing is provided through the automated delivery of Klenzyme Enzymatic ● Presoak and Cleaner during the wash phase of the cycle.
- . CIP 200 Acid-Based Process and Research Cleaner, a general cleaning agent, is used in one of the two self-decontamination cycles provided by the processor.
- . Various accessories are available to accommodate the processing needs of specific endoscopes and endoscopic accessories.
- . VERIFY Reliance CI Process Indicator is available to monitor for the presence of the Reliance DG active ingredient, peracetic acid.
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)
New testing was performed to evaluate the modified device and the results are summarized in Table 3.
Test: High level disinfection efficacy of selected worst-case duodenoscope models, representing multiple manufacturers and distal tip designs. Acceptance Criteria: >6 log reduction of Mycobacterium terrae per site under worst case processing conditions. Result: Pass
Test: Biocompatibility of Reliance Dry Germicide made with a proprietary component from an alternate source. Acceptance Criteria: Medical devices shall be non-cytotoxic after exposure to Reliance DG made with a proprietary component from an alternate source. Result: Pass
Test: Stability of Reliance Dry Germicide made with a proprietary component from an alternate source. Acceptance Criteria: Reliance Dry Germicide shall meet acceptance criteria after 18 months storage. Result: Pass
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.
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
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.
January 28, 2021
Steris Marcia Benedict Senior Director, Regulatory Affairs 5960 Heislev Rd Mentor, Ohio 44060
Re: K203223
Trade/Device Name: Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: NZA Dated: October 30, 2020 Received: November 2, 2020
Dear Marcia Benedict:
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) 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 (OS) 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,
For CAPT Elizabeth Claverie, M.S. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K203223
Device Name
Reliance Endoscope Processing System
Indications for Use (Describe)
The Reliance Endoscope Processing System is intended for washing and high level disinfection of up to two manually pre-cleaned, immersible, reusable, heat-sensitive, semi-critical devices such as bronchoscopes including duodenoscopes, and their accessories. High level disinfection is achieved within the 50 - 57°C HLD Phase of the endoscope processing cycle (4 minute generation sequence followed by a 6-minute exposure sequence).
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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"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."
3
Image /page/3/Picture/0 description: The image shows the logo for STERIS. The word "STERIS" is written in a serif font in all capital letters. Below the word is a graphic of several horizontal wavy lines stacked on top of each other. The lines are blue.
510(k) Summary For Reliance Endoscope Processing System
STERIS 5960 Heisley Road Mentor, OH 44060 Telephone: 440-354-2600 Fax No: 440-357-9198
Contact: Marcia Benedict Senior Director, Regulatory Affairs Telephone: 440-392-7063 Fax No: 440-357-9198
January 15, 2021 Summary Date:
Premarket Notification number: K203223
STERIS ▪ 5960 Heisley Road ▪ Mentor, OH 44060-1834 USA ▪ 440-354-2600
4
1. Device Name
Trade Name: Reliance Endoscope Processing System Device Classification: Class II Common/usual Name: Automated Endoscope Reprocessor Classification Name: Accessories, Germicide, Cleaning, For Endoscopes Classification Number: 21 CFR 876.1500 Product Code: NZA
Predicate Device 2.
Reliance Endoscope Processing System, K200989
3. Description of Device
The Reliance Endoscope Processing System is a high level disinfection system that can wash and high level disinfect up to two manually precleaned, immersible, reusable, heatsensitive, semi-critical devices such as GI flexible endoscopes and related accessories.
The system utilizes Reliance™ DG Dry Germicide, a proprietary, safe, and dry peracetic acid generating oxidative chemistry. The Reliance Endoscope Processing System was designed to be versatile in meeting the growing demands of the modern flexible endoscope processing department, while offering the highest level of patient and staff safety. The Reliance Endoscope Processing System is a combination of products that are used to wash and high level disinfect flexible endoscopes and their accessories.
- The Reliance Endoscope Processor is an electromechanical washer/high level . disinfector with a microprocessor-based controller that provides for automated endoscope processing cycles and processor self-decontamination cycles.
- . Reliance DG Dry Germicide is a proprietary, two-part, dry, single-use oxidative chemistry, designed to generate the high level disinfection solution upon automatic dilution in water within the Reliance Endoscope Processor.
- Optional washing is provided through the automated delivery of Klenzyme Enzymatic ● Presoak and Cleaner during the wash phase of the cycle.
- . CIP 200 Acid-Based Process and Research Cleaner, a general cleaning agent, is used in one of the two self-decontamination cycles provided by the processor.
- . Various accessories are available to accommodate the processing needs of specific endoscopes and endoscopic accessories.
- . VERIFY Reliance CI Process Indicator is available to monitor for the presence of the Reliance DG active ingredient, peracetic acid.
5
The Reliance Endoscope Processing Cycle has the following features:
- The first part of this cycle is an optional programmable washing phase. This phase consists of a wash that uses Klenzyme, followed by a rinse. The washing phase can be programmed on or off. In the "on" mode, the user can choose either one or two washing phases per processing cycle, and the wash time can be adjusted to be between 5 and 10 minutes. The Reliance washing phase does not replace manual cleaning by the user.
- . The second part is a high level disinfection phase that is non-optional and the parameters cannot be changed by the user. In this phase, the proprietary Reliance DG components, provided in a single use container, are dissolved with water at ~50°C for four minutes of generation time and circulated throughout the processor and through device lumens for a 6 minutes of high level disinfecting solution exposure time.
- . Following the high level disinfection phase, the Reliance Endoscope Processor removes the high level disinfecting solution through a rinse phase which is nonoptional and the parameters cannot be changed by the user. The processor filters the rinse water (as well as all of the water used throughout the cycle) through a 0.2 micron bacterial-retentive filter. It also incorporates an automatic internal integrity check of this filter at the end of each processing cycle. If the integrity check fails, an alarm alerts the user, and the processor does not complete the cycle.
- . The last step in the processing cycle is an air purge phase using HEPA-filtered air. The air purge helps to remove excess rinse water from the processed devices. The final air purge is preset to run for 4 minutes; additional air purge time may be selected by the operator.
- . The processor will print a detailed cycle summary at the end of each cycle that includes information such as processor number, cycle date, start and stop times, as well as phase parameters. With an optional bar code reader, the printouts can also include identification numbers for the operator, patient, device, doctor and procedure.
The processor features two decontamination cycles that are to be used without endoscopes in the processor:
- The first, called D-SHORT, consists of hot water circulating through the processor for ● 10 minutes, followed by a 10-minute hot air purge. This cycle is to be run every 54 hours. D-SHORT is intended to prevent biofilm from forming.
- . The second, called D-LONG, consists of a cycle in which CIP 200 Acid-Based Process and Research Cleaner is added to hot water. The cleaning solution is then circulated through the processor for 20 minutes; this is followed by three rinses to remove the solution from the processor and a 10-minute hot air purge. D-LONG is to be used on those occasions when the D-SHORT cycle has not been run within the past 54 hours.
6
4. Intended Use
The Reliance Endoscope Processing System is intended for washing and high level disinfection of up to two manually pre-cleaned, immersible, reusable, heat-sensitive, semicritical devices such as bronchoscopes, GI flexible endoscopes including duodenoscopes, and their accessories. High level disinfection is achieved within the 50-57℃ HLD phase of the endoscope processing cycle (4-minute generation sequence followed by a 6-minute exposure sequence).
5. Technological Characteristic Comparison Tables
The Reliance Endoscope Processing System (EPS) is the same as the predicate device; this submission is provided to demonstrate the validity of the system's ongoing use to process duodenoscopes, and to qualify a new source for a proprietary component of Reliance DG Dry Germicide. There were no changes to the Reliance EPS.
A comparison between the predicate and proposed devices can be found in Tables 1 and 2.
| Feature | Proposed Device
Reliance EPS | Predicate Device
Reliance EPS
K200989 | Comparison |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|
| Intended Use | The Reliance Endoscope
Processing System is intended
for washing and high level
disinfection of up to two
manually pre-cleaned,
immersible, reusable, heat-
sensitive, semi-critical devices
such as bronchoscopes, GI
flexible endoscopes including
duodenoscopes, and their
accessories. High level
disinfection is achieved within
the 50-57°C HLD phase of the
endoscope processing cycle (4-
minute generation sequence
followed by a 6-minute
exposure sequence). | The Reliance Endoscope
Processing System is intended
for washing and high level
disinfection of up to two
manually pre-cleaned,
immersible, reusable, heat-
sensitive, semi-critical devices
such as GI flexible endoscopes,
bronchoscopes and their
accessories. High level
disinfection is achieved within
the 50-57°C HLD phase of the
endoscope processing cycle (4-
minute generation sequence
followed by a 6-minute
exposure sequence). | Mentions
duodenoscopes
specifically for
user clarity. |
| Operating
Principles/
Technology | The Reliance EPS and its
integrated endoscope processing
support provide for delivery of
solutions and fluids to
endoscopes and their
accessories. Klenzyme and
Reliance DG are introduced into
the Reliance EPS to provide
washing and high level | The Reliance EPS and its
integrated endoscope processing
support provide for delivery of
solutions and fluids to
endoscopes and their
accessories. Klenzyme and
Reliance DG are introduced into
the Reliance EPS to provide
washing and high level | Identical |
| Feature | Proposed Device
Reliance EPS | Predicate Device
Reliance EPS
K200989 | Comparison |
| | disinfection. Decontamination
cycles (D-Long with CIP-200
and D-Short) are used to
prevent biofilm formation in the
Reliance EPS Processor and
ensure effective processing
following periods of processor
inactivity. | disinfection. Decontamination
cycles (D-Long with CIP-200
and D-Short) are used to prevent
biofilm formation in the
Reliance EPS Processor and
ensure effective processing
following periods of processor
inactivity. | |
| Process
Parameters | Standardized cycle parameters
cannot be altered by operator.
The critical process parameters
are:
• Contact Time
• Use Dilution Temperature
• Cleaning solution and
Reliance DG concentration
• Water filter integrity | Standardized cycle parameters
cannot be altered by operator.
The critical process parameters
are:
• Contact Time
• Use Dilution Temperature
• Cleaning solution and
Reliance DG concentration
• Water filter integrity | Identical |
| Process
Monitors | • Control Handle Boot
pressure alarms if pressure
too low to process, or if too
high and could potentially
damage scopes
(specification 6.5 - 10.5
PSI).
• Detection of a fresh
Reliance DG container in
every processing cycle
Cleaning Solution level
monitored; alarm indicates
when container does not
have sufficient amount to
complete cycle
• Temperature alarms if
outside of range
• Water filter integrity test at
end of each high level
disinfection cycle. | • Control Handle Boot
pressure alarms if pressure
too low to process, or if too
high and could potentially
damage scopes
(specification 6.5 - 10.5
PSI).
• Detection of a fresh
Reliance DG container in
every processing cycle
Cleaning Solution level
monitored; alarm indicates
when container does not
have sufficient amount to
complete cycle
• Temperature alarms if
outside of range
• Water filter integrity test at
end of each high level
disinfection cycle. | Identical |
| Design
Features | • Intended for use with
Reliance DG only
• Microprocessor controlled
• Internal components
constructed of stainless
steel, silicone,
polypropylene and PVDF.
• Processor provides 0.2
micron filtered water for | • Intended for use with
Reliance DG only
• Microprocessor controlled
• Internal components
constructed of stainless
steel, silicone,
polypropylene and PVDF.
• Processor provides 0.2
micron filtered water for | Identical |
| Feature | Proposed Device
Reliance EPS | Predicate Device
Reliance EPS
K200989 | Comparison |
| Cycle
Description | washing, disinfection and
rinsing Automated injection of
cleaning solutions Automated generation and
delivery of high level
disinfecting solution Air intake for Air Purge is
HEPA filtered Optional: Wash 1 with 1
rinse or Wash 2 with 1
rinse Wash time can be
adjusted to be between
5 and 10 minutes, 40
second rinse Additional "smart rinse"
occurs after optional wash
if boot pressure ! Block, S. ed., Disinfection, Sterilization, and Preservation. 5ª edition, 2001
² Clapp et al., Free Rad. Res., (1994) 21:147-167
³ Maillard et al., J. Appl. Breriol. (1996)
11
12
Summary of Non-Clinical Testing 6.
The proposed device and its predicate have the same intended use and technological characteristics. New testing was performed to evaluate the modified device and the results are summarized in Table 3.
| Test | Acceptance Criteria | Result |
|---|---|---|
| High level disinfection efficacy of | ||
| selected worst-case duodenoscope | ||
| models, representing multiple | ||
| manufacturers and distal tip designs. | >6 log reduction of | |
| Mycobacterium terrae per site | ||
| under worst case processing | ||
| conditions. | Pass | |
| Biocompatibility of Reliance Dry | ||
| Germicide made with a proprietary | ||
| component from an alternate source | Medical devices shall be non- | |
| cytotoxic after exposure to | ||
| Reliance DG made with a | ||
| proprietary component from an | ||
| alternate source | Pass | |
| Stability of Reliance Dry Germicide | ||
| made with a proprietary component | ||
| from an alternate source | Reliance Dry Germicide shall | |
| meet acceptance criteria after 18 | ||
| months storage. | Pass |
| Table 3. Summary of verification activities. | ||||
|---|---|---|---|---|
| ---------------------------------------------- | -- | -- | -- | -- |
7. Conclusion
Based on the intended use, technological characteristics and non-clinical performance data, the subject device is as safe, as effective and performs as well or better than the legally marketed predicate device (K200989), Class II (21 CFR 876.1500), product code NZA.