(454 days)
Not Found
No
The document describes a chemical sterilization system with automated, computer-controlled processes, but there is no mention of AI or ML technologies being used for decision-making, image analysis, or any other function. The control appears to be based on pre-programmed parameters for temperature, time, and chemical concentration.
No.
The device is described as a "Liquid Chemical Sterilant Processing System" intended for the sterilization of medical devices, not for diagnosing, treating, or preventing disease in a patient.
No
The device is a sterilizing system for medical equipment, not a diagnostic device. Its purpose is to chemically sterilize heat-sensitive medical devices.
No
The device description clearly outlines a physical system including a processor, sterilant concentrate, trays, containers, and quick connects, all of which are hardware components. While the processor is computer-controlled, the device is not solely software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the liquid chemical sterilization of medical devices (critical and semi-critical heat-sensitive devices). This is a process for making medical devices safe for use, not for diagnosing a condition or providing information about a patient's health.
- Device Description: The description focuses on the mechanism of sterilization using peracetic acid and the system's components for processing and rinsing medical devices. There is no mention of 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.)
- Detecting or measuring analytes (biomarkers, pathogens, etc.)
- Providing diagnostic, prognostic, or screening information about a patient.
The device is clearly intended for the reprocessing of medical equipment, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The SYSTEM 1E Liquid Chemical Sterilant Processing System is intended for liquid chemical sterilization of cleaned, immersible, and reusable critical and semi-critical heat-sensitive medical devices in healthcare facilities.
The SYSTEM 1E Processor dilutes the S40 Sterilant Concentrate to its use dilution (>1820 mg/L peracetic acid), liquid chemically sterilizes the load during a controlled 6-minute exposure at 46 to 55°C, and rinses the load with extensively treated* potable water. The processed load should be used immediately.
The SYSTEM 1E Processor uses only S40 Sterilant Concentrate to liquid chemically sterilize medical devices.
- The extensive treatment of EPA potable water consists of: *
-
- Pre-filtration through two pre-filters:
- · Pre-filter 1 is a gross depth filter that removes approximately 5 micron or larger particles/contaminants.
- · Pre-filter 2 is a surface filter that removes particles/contaminants > 0.1 micron.
-
- UV Irradiation:
- · During transit through the UV Water Treatment Chamber, a UV dose sufficient to achieve a > 6-log reduction of MS2 virus is delivered to the water.
-
- 0.1 micron filtration:
- · The water prepared by pre-filtration and UV irradiation is filtered through redundant, 0.1-micron (absolute rated) membranes to remove bacteria, fungi and protozoa > 0.1 micron.
-
Product codes
MED
Device Description
The SYSTEM 1E Liquid Chemical Sterilant Processing System is a liquid chemical sterilization system, utilizing peracetic acid to process totally immersible, heat sensitive, flexible and rigid endoscopes and their accessories, and microsurgical instruments. The system consists of the SYSTEM 1E Processor and the S40 Sterilant Concentrate, interchangeable processing trays/containers and Quick Connects.
The SYSTEM 1E Processor is an automated, self-contained device which creates and maintains the conditions necessary for liquid chemical sterilization in 6 minutes. Following the processing, the liquid chemically sterilized articles are rinsed with extensively treated water produced by passing EPA potable tap water through pre-filters, an ultraviolet light treatment system, and then through two 0.1 micron filter membranes. The processor, which is computer controlled and continually monitored, provides printed documentation of each cycle.
S40 Sterilant Concentrate is a single use chemical sterilant concentrate developed exclusively for use in the SYSTEM IE Processor. The active ingredient in S40, peracetic acid, is combined with inert ingredients to form a use dilution which inhibits corrosion of metals, polymers and other materials.
The interchangeable processing trays/containers are made to accommodate a variety of instrument types, models and procedure specific sets. Each container is designed to maintain instruments in appropriate position while specific Quick Connects ensure thorough circulation of the sterilant solution and rinses.
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
healthcare facilities.
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)
Non-clinical and clinical tests described. Demonstrated efficacy in:
Sporicidal Activity of Disinfectants AOAC Official Method 966.04: Meets efficacy requirements. Bacillus subtilis, Clostridium sporogenes. Testing conducted in vitro.
Confirmatory Sporicidal Activity of Disinfectants AOAC Official Method 966.04: Meets efficacy requirements. Bacillus subtilis, Clostridium sporogenes. Testing conducted in vitro.
Fungicidal Activity of Disinfectants AOAC Official Method 955.17: Solution is fungicidal. Trichophyton mentagrophytes. Testing conducted in vitro.
Use Dilution Method AOAC, Official Methods 955.14, 955.15, 964.02: Solution is bactericidal. Salmonella choleraesuis, Staphylococcus aureus, Pseudomonas aeruginosa. Testing conducted in vitro.
EPA Virucidal Testing (DIS/TSS-7, Nov. 1981): Solution is virucidal. Herpes simplex Type 1, Adenovirus Type 5, Poliovirus Type 1. Testing conducted in vitro.
Tuberculocidal Activity Ascenzi Quantitative Suspension Test: Solution is tuberculocidal. Mycobacterium terrae. Testing conducted in vitro.
Simulated-Use Test: Meets efficacy requirement. ≥ 6 log10 reduction Geobacillus stearothermophilus spores.
Clinical In-Use: No surviving microorganisms on representative medical devices tested.
Biocompatibility: Two rinses with UV treated, dual 0.1 micron membrane filtered water effectively reduces sterilant residues to safe levels.
Device Material Compatibility: Compatible with medical devices as established by testing finished flexible endoscopes through 300 cycles and rigid devices through 150 cycles. No functional changes occurred to flexible devices; some cosmetic changes noted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
§ 880.6885 Liquid chemical sterilants/high level disinfectants.
(a)
Identification. A liquid chemical sterilant/high level disinfectant is a germicide that is intended for use as the terminal step in processing critical and semicritical medical devices prior to patient use. Critical devices make contact with normally sterile tissue or body spaces during use. Semicritical devices make contact during use with mucous membranes or nonintact skin.(b)
Classification. Class II (special controls). Guidance on the Content and Format of Premarket Notification (510(k)) Submissions for Liquid Chemical Sterilants/High Level Disinfectants, and user information and training.
0
Appendix 2
APR - 5 2010
Revised 510(k) Summary
1
Image /page/1/Picture/0 description: The image shows the word "STERIS" in a serif font. The letters are all capitalized and evenly spaced. Below the word is a graphic of several horizontal lines that are slightly curved, resembling waves.
510(k) Summary For SYSTEM 1E Liquid Chemical Sterilant Processing System
STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 639-4459
Contact:
Peter A. Burke, Ph. D. Senior Vice President and Chief Technology Officer Tel: 440-392-7787 Fax: 440-392-8978
Summary Date: April 1, 2010
·
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
2
1. Device Name
| Trade Name: | SYSTEM 1E Liquid Chemical Sterilant
Processing System |
|------------------------|-------------------------------------------------------------------------|
| Common/usual Name: | Liquid Chemical Sterilizer |
| Classification Name: | Sterilant, Medical devices, Liquid Chemical
Sterilants/Disinfectants |
| Classification Number: | 21 CFR 880.6885 |
| Product Code: | MED |
2. Predicate Device
.
STERIS SYSTEM 1 PROCESSOR and STERIS 20 STERILANT, K875280, cleared September 13, 1988.
Sterilox Liquid Chemical High Level Disinfection System, K013280, cleared September 18, 2002
Description of Device 3.
The SYSTEM 1E Liquid Chemical Sterilant Processing System is a liquid chemical sterilization system, utilizing peracetic acid to process totally immersible, heat sensitive, flexible and rigid endoscopes and their accessories, and microsurgical instruments. The system consists of the SYSTEM 1E Processor and the S40 Sterilant Concentrate, interchangeable processing trays/containers and Quick Connects.
The SYSTEM 1E Processor is an automated, self-contained device which creates and maintains the conditions necessary for liquid chemical sterilization in 6 minutes. Following the processing, the liquid chemically sterilized articles are rinsed with extensively treated water produced by passing EPA potable tap water through pre-filters, an ultraviolet light treatment system, and then through two 0.1 micron filter membranes. The processor, which is computer controlled and continually monitored, provides printed documentation of each cycle.
S40 Sterilant Concentrate is a single use chemical sterilant concentrate developed exclusively for use in the SYSTEM IE Processor. The active ingredient in S40, peracetic acid, is combined with inert ingredients to form a use dilution which inhibits corrosion of metals, polymers and other materials.
3
The interchangeable processing trays/containers are made to accommodate a variety of instrument types, models and procedure specific sets. Each container is designed to maintain instruments in appropriate position while specific Quick Connects ensure thorough circulation of the sterilant solution and rinses.
4. Intended Use
The SYSTEM 1E Liquid Chemical Sterilant Processing System is intended for liquid chemical sterilization of cleaned, immersible, and reusable critical and semi-critical heat-sensitive medical devices in healthcare facilities.
The SYSTEM 1E Processor dilutes the S40 Sterilant Concentrate to its use dilution (>1820 mg/L peracetic acid), liquid chemically sterilizes the load during a controlled 6-minute exposure at 46 to 55°C, and rinses the load with extensively treated* potable water. The processed load should be used immediately.
The SYSTEM 1E Processor uses only S40 Sterilant Concentrate to liquid chemically sterilize medical devices.
- The extensive treatment of EPA potable water consists of: *
-
- Pre-filtration through two pre-filters:
- Pre-filter 1 is a gross depth filter that removes approximately 5 micron . or larger particles/contaminants.
- Pre-filter 2 is a surface filter that removes particles/contaminants > . 0.1 micron.
-
- UV Irradiation:
- During transit through the UV Water Treatment Chamber, a UV dose . sufficient to achieve a > 6-log reduction of MS2 virus is delivered to the water.
-
- 0.1 micron filtration:
- The water prepared by pre-filtration and UV irradiation is filtered . through redundant, 0.1-micron (absolute rated) membranes to remove bacteria, fungi and protozoa > 0.1 micron.
-
Description of Safety and Substantial Equivalence ડ.
The SYSTEM 1E Processor and S40 Sterilant Concentrate are substantially equivalent in function and intended use to the STERIS SYSTEM 1 and STERIS 20 Sterilant and Sterilox Liquid Chemical High Level Disinfection System.
4
Device Comparison Table
| Feature | SYSTEM 1E Processor | SYSTEM 1 Processor(K875280) |
|---|---|---|
| Indications for Use | The SYSTEM 1E Liquid Chemical | |
| Sterilant Processing System is intended | ||
| for liquid chemical sterilization of | ||
| cleaned, immersible, and reusable | ||
| critical and semi-critical heat-sensitive | ||
| medical devices in healthcare facilities. |
The SYSTEM 1E Processor
automatically dilutes the S40 Sterilant
Concentration to its use dilution (≥1820
mg/L peracetic acid) and liquid
chemically sterilizes the load during a
controlled 6-minute exposure at 46 to
55°C and rinses the load with
extensively treated potable water. The
processed load should be used
immediately.
The SYSTEM 1E Processor uses only
S40 Sterilant Concentrate to liquid
chemically sterilize medical devices. | The SYSTEM 1 is a liquid chemical
sterilization system used for the rapid
liquid chemical sterilization of clean
reusable immersible medical devices
such as flexible and rigid endoscopes,
and other medical and dental devices
in hospitals, medical, surgical and
dental clinics/offices. |
| Operating
Principles/
Technology | A microprocessor controlled unit with interchangeable processing
trays/containers. The processor lid opens to reveal the processing chamber in
which the load is placed. Devices with internal lumens are interfaced with the
processor using connectors. Sterilant is placed in a specialized compartment and
when the processor fills with water, it creates the sterilant use dilution from the
single use sterilant cup. The processor monitors and controls the use dilution
temperature and contact time. The processor automatically rinses the load with
extensively treated potable water to remove sterilant residuals. | |
| Process Parameters | Standardized cycle parameters cannot
be altered by operator. The critical
process parameters are:
● Contact Time
● Use Dilution Temperature
● Peracetic acid concentration
● Dual membrane, 0.1 micron water
filter integrity
● UV irradiation | Standardized cycle parameters cannot
be altered by operator. The critical
process parameters are:
● Contact Time
● Use Dilution Temperature
● Peracetic acid concentration
● 0.2 micron water filter integrity |
| Feature | SYSTEM 1E Processor | SYSTEM 1 Processor(K875280) |
| Process Monitors: | Cycle Printout documents successful cycle completion or identifies fault if cycle aborts Alarms if thermocouples indicate temperature out of specification Alarms if pressure switch indicates that high pressure pump is not operating Alarms if conductivity probe indicated conductivity specification not met Alarms if pressure transducer indicates circulation pressure is out of specification during Diagnostic cycle Alarms if pressure transducer indicates dual membrane 0.1 micron water filter failed integrity test during liquid chemical sterilization processing and Diagnostic cycles Alarms if UV monitor indicates UV intensity out of specification | Cycle Printout documents successful cycle completion or identifies fault if cycle aborts Alarms if thermocouples indicate temperature out of specification Alarms if pressure switch indicates that high pressure pump is not operating Alarms if conductivity probe indicated conductivity specification not met Alarms if pressure transducer indicates circulation pressure is out of specification during Diagnostic cycle Alarms if pressure transducer indicates sterile water filter failed integrity test during Diagnostic cycle |
| Design Features | Microprocessor controlled unalterable and standardized liquid chemical sterilization and diagnostic cycles Intended for use with S40 Sterilant Concentrate Processor provides dual 0.1 micron membrane filtered, UV treated water for liquid chemical sterilization and rinsing Automated dilution and delivery of sterilant Make up air for processor during drain sequences is filtered through a 0.2 micron membrane air filter. | Microprocessor controlled unalterable and standardized liquid chemical sterilization and diagnostic cycles Intended for use with STERIS 20 Sterilant Concentrate only. Processor provides 0.2 micron filtered water for liquid chemical sterilization and rinsing Automated dilution and delivery of sterilant Make up air for processor during drain sequences is filtered through a 0.2 micron membrane air filter. |
| Liquid Chemical Sterilization Cycle | | |
| Incoming water
temperature | $\geq 43°C$ | $\geq 42°C$ |
| Temperature to
start sterilant
exposure | $\geq 46°C$ | $\geq 50°C$ |
| Temperature alarm
point during the
sterilant exposure | 60°C | 60°C |
| Feature | SYSTEM 1E Processor | SYSTEM 1 Processor(K875280) |
| Temperature range during a typical
Liquid Chemical Sterilization Cycle | 46 - 55°C | 50 - 55°C |
| Sterilant Exposure Time | 6 minutes | 12 minutes |
| Rinse water preparation | Hot potable tap water is:
• pre-filtered
• flown through a UV Light treatment chamber to achieve ≥ a 6-log reduction of MS2 virus
• Filtered through redundant 0.1 micron filter membranes | Hot potable tap water is:
• pre-filtered
• Filtered through 0.2 micron filter membrane |
| Number of rinses | 2 | 4 |
| Air Purge | Aids in removing excess water from instrument lumens after rinsing | |
| Water Filter Integrity Test | Conducted at the end of every liquid chemical sterilization s cycle and during the Diagnostic cycle | Conducted during the Diagnostic cycle only |
| Approximate Cycle time | 25 minutes | 30 minutes |
| Diagnostic Cycle | Performs 15 tests on processor's systems confirming proper function (same tests as predicate device except for an added UV monitor test). Recommended to perform every 24 hours. After a failed Diagnostic cycle a liquid chemical sterilization processing cycle can not be performed until the problem is rectified and a successful Diagnostic cycle has been completed. | Performs 14 tests on processor's systems confirming proper function. Recommended to perform every 24 hours. After a failed Diagnostic cycle a liquid chemical sterilization processing cycle can not be performed until the problem is rectified and a successful Diagnostic cycle has been completed. |
| Accessories | | |
| Sterilant | Uses S40 Sterilant Concentrate (see Table 5-2 for predicate comparison) | Uses STERIS 20 Sterilant |
| Processing Tray/Containers | Uses interchangeable processing trays/containers | |
| Quick Connects | Uses Quick Connects to adapt instrument lumens to the Tray/Container ports | |
| Operator Maintenance Requirements | Periodic replacement of printer tape, water filters and air filter | |
Table 5-1. Processor Device Comparison Table
5
6
.
.
7
:
.
| Feature | S40 Sterilant
Concentrate | STERIS 20
STERILANT
(K875280) | Sterilox Liquid
Chemical HLD System
(013280) |
|---------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | S40 Sterilant
Concentrate is for use
only with the SYSTEM
IE Liquid Chemical
Sterilant Processing
System | STERIS 20 Sterilant
Concentrate is for use
only in the SYSTEM 1
Sterile Processing
System | Sterilox is for use
with manual or
automated endoscope
reprocessing
protocols |
| Germicidal claim | Liquid Chemical
Sterilant | Liquid Chemical
Sterilant | High Level Disinfectant |
| Germicide
Exposure Time
(min) for intended
use | 6 | 12 | 10 |
| Use Temperature | 45.5-60°C - allowable
46-55°C - typical
Potency and simulated
use evaluations
conducted at 1 Block, S. ed., Disinfection, Sterilization, and Preservation. 5th edition, 2001.
2 Clapp et al., Free Rad. Res., (1994) 21:147-167.
3 Maillard et. al., J. Med. Microbiol (1995) 42:415-420.
4 Maillard et. al., J. Appl Bacteriol (1996) 80:540-554.
S Pieterson et al., Water SA (1996) 22(1); 43-48.
6 McDonnell et al., J. AOAC International (2000) 83:269-276.
9
r
.
:
10
Conclusion -
Based on the non-clinical and clinical tests described above, the SYSTEM 1E Dased on the non ontenteate demonstrate demonstrate that the device is as safe, as effective, and performs as well as or better than the predicate device.
11
Image /page/11/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
APR - 5 2010
Dr. Peter A. Burke Senior Vice President STERIS Corporation 5960 Heisley Road Mentor, Ohio 44060
Re: K090036
Trade/Device Name: SYSTEM 1E Liquid Chemical Sterilant Processing System Regulation Number: 21CFR 880.6885 Regulation Name: Liquid Chemical Sterilants / High Level Disinfectants Regulatory Class: II Product Code: MED Dated: March 16, 2010 Received: March 17, 2010
Dear Dr. Burke:
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.
12
Page 2- Dr. Burke
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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 vours.
Cintron D. Ruiz
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
13
Indications for Use
510(k) Number (if known): K090036
SYSTEM 1E Liquid Chemical Sterilant Processing System Device Name:
Indications for Use:
The SYSTEM 1E Liquid Chemical Sterilant Processing System is intended for liquid chemical sterilization of cleaned, immersible, and reusable critical and semi-critical heatsensitive medical devices in healthcare facilities. .
The SYSTEM 1E Processor dilutes the S40 Sterilant Concentrate to its use dilution (>1820 mg/L peracetic acid), liquid chemically sterilizes the load during a controlled 6minute exposure at 46 to 55℃, and rinses the load with extensively treated* potable water. The processed load should be used immediately.
The SYSTEM 1E Processor uses only S40 Sterilant Concentrate to liquid chemically sterilize medical devices.
- The extensive treatment of EPA potable water consists of: *
-
- Pre-filtration through two pre-filters:
- · Pre-filter 1 is a gross depth filter that removes approximately 5 micron or larger particles/contaminants.
- · Pre-filter 2 is a surface filter that removes particles/contaminants > 0.1 micron.
-
- UV Irradiation:
- · During transit through the UV Water Treatment Chamber, a UV dose sufficient to achieve a > 6-log reduction of MS2 virus is delivered to the water.
-
- 0.1 micron filtration:
-
{{ D In
-
.
-
The water prepared by pre-filtration and UV irradiation is filtered through redundant, 0.1-micron (absolute rated) membranes to remove bacteria, fungi and protozoa > 0.1 micron. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
AND/OR Prescription Use (Part 21 CFR 801 Subpart D)
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)
| Jfi) | |
| on of Anesthesiology, General Hospital | |
| Infection Control, Dental Devices | |
| 510(k) Number: | K090036 |
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