(318 days)
Not Found
No
The summary describes an automated endoscope reprocessor with sensors and a touch-panel interface, but there is no mention of AI or ML capabilities for decision-making, image analysis, or process optimization beyond basic fault detection and automated cycles.
No.
The device is an automated endoscope reprocessor, designed for cleaning and disinfection of medical instruments, not for direct therapeutic treatment of patients.
No
The device is an automated endoscope reprocessor that cleans and disinfects medical instruments, it does not diagnose medical conditions.
No
The device description clearly indicates the OER-Mini is a physical automated endoscope reprocessor with hardware components such as a basin, sensors, a touch-panel user interface, and connections for external devices. While it includes software for operation and data communication, it is not solely software.
Based on the provided text, the OER-Mini is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the OER-Mini is for cleaning and high-level disinfection of medical devices (endoscopes, camera heads, etc.). It is a reprocessor for these devices.
- Device Description: The description reinforces its function as an automated endoscope reprocessor that performs cleaning, disinfection, and rinsing.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status, diagnosis, or treatment.
- Using reagents or assays to detect specific substances.
The OER-Mini is a device used to prepare other medical devices for use, not to perform diagnostic tests on patient samples.
N/A
Intended Use / Indications for Use
The OER-Mini is intended for use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes, camera heads, light guide cables, miniature light sources, and their accessories. Safe use requires detergent and an FDA-cleared high-level disinfectant/sterilant that Olympus has validated to be efficacious and compatible with the materials of the OER-Mini and Olympus flexible endoscopes, camera heads, light guide cables, miniature light sources, and their accessories. Use of a detergent or highlevel disinfectant/sterilant that has not been validated by Olympus may be ineffective and may damage the OER-Mini components and the endoscopes being reprocessed. Endoscopes must be subject to cleaning by the user prior to reprocessing; however, use of the OER-Mini enables the user to perform modified manual cleaning of the endoscope prior to automated cleaning and high-level disinfection in the OER-Mini.
Product codes
FEB
Device Description
The OER-Mini Endoscope Reprocessor is an automated endoscope reprocessor intended for cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes, camera heads, light guide cables, miniature light sources and their accessories. Use of the OER-Mini requires detergent and FDA cleared high-level disinfectant/sterilant that Olympus has validated to be efficacious and compatible with the materials of the OER-Mini and its compatible endoscopes/devices.
Use of the OER-Mini enables the user to perform modified manual cleaning of the endoscope prior to automated cleaning and high-level disinfection in the OER-Mini.
The OER-Mini has been developed to provide an AER that will suit reprocessing of endoscopes in the surgical field. The OER-Mini has a compact and smart-design for table-top use.
The OER-Mini is a one-basin table-top type automatic endoscope reprocessor that performs cleaning, disinfection, rinse to render a high-level disinfected endoscope, device and their accessories. The OER-Mini utilizes an immersion method for cleaning, disinfecting, and rinsing of endoscope/device and its accessory external surfaces, and connectors for endoscope channel cleaning, disinfecting, and rinsing.
The OER-Mini basically can reprocess one device at a time in one-basin, but the immersible certain combination of devices also can be reprocessed simultaneously at a time in a one-basin.
The OER-Mini is capable of automated disinfectant solution dispensing. The external 0.2-micron water filters are bacteria retentive and produce suitable rinse water for reprocessing. Built-in sensors detect fluid levels and temperatures in the reprocessing basin and disinfectant solution tank. If any abnormality/irregularity is detected, an error indicator lights up with an audible alarm and the reprocessing process is a stopped. The device utilizes a touch-panel user interface for program operation and settings. The disinfectant solution is automatically diluted by filtered water until specified quantity in the device. On the other hand, some functions are eliminated in order to realize compact table-top AER;
- No detergent dispensing system. User should manually pour detergent into the device.
- No compressor for air purge.
- No alcohol dispensing system. User should manually pour alcohol into the device.
The OER-Mini does not have RFID (Radio-Frequency Identification) function. Instead of RFID function, OER-Mini can connect the external-printer (MAJ-1937), which enables to generate hard copy reprocessing record (i.e. operation record, error history etc.). On the reprocessing record, the entered section of user and scope data has been added. Also, the OER-Mini has a built-in terminal for data communication, which enables the device to output specific information (i.e. operation record, error history, information for determining periodical maintenance timing etc.) to a computer with proprietary software installed for reprocessing record management. It is also possible to alter data and time settings of the OER-Mini from such a computer via this terminal.
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
The OER-Mini has been tested following the requirements in the FDA guidance document titled "Guidance on Premarket Notification [510(k)] Submissions for Automated Endoscope Washers, Washer/Disinfectors, and Disinfectors Intended for Use in Health Care Facilities", issued in August 1993. Test reports provided in this premarket notification include:
Process Parameter Test: The OER-Mini was tested to demonstrate that the device performs as intended. The test results showed that the OER-Mini achieves and maintains the specified physical process parameters, including detection of the defined fault conditions and execution of automatic response/ processing following fault detection.
Validation Testing - Cleaning: The OER-Mini was tested to evaluate its ability to clean its compatible devices in both simulated and in-use conditions. The test results demonstrate that the OER-Mini effectively reduced protein and carbohydrate levels in all sample sites.
Validation Testing - High-Level Disinfection: The OER-Mini was tested to evaluate its ability to high-level disinfect its compatible devices in both simulated and in-use conditions. The simulated use testing demonstrated a 6 Log10 reduction of M.terrae at all inoculated sites was achieved after reprocessing in the OER-Mini's disinfection cycle. In-use testing demonstrated no viable microorganisms were recovered from test samples following reprocessing in the OER-Mini.
Validation Testing - Full Cycle: The OER-Mini was tested to evaluate its effectiveness for full cycle reprocessing including both cleaning and disinfection under simulated use conditions. The simulated use testing demonstrated that OER-Mini effectively cleaned and achieved high-level disinfection for its compatible devices.
Simulated-Use Testing - Self-Disinfection: Simulated-use testing was performed to validate self-disinfection of the OER-Mini. Testing demonstrated that a greater than 6 log reduction in M. terrae was achieved for all sample locations after completion of routine reprocessing of endoscopes/devices within the OER-Mini.
Simulated-Use Testing - Water Line Disinfection: The simulated-use testing was performed to validate disinfection of the OER-Mini water line piping which does not contact high-level disinfectant during routine reprocessing. The test result showed that a greater than 6 log reduction in M. terrae was achieved for all sample locations after completion of the water line disinfection procedure.
Toxicological Evaluation of Residues: The safety of residual chemicals remaining on endoscopes/devices after reprocessing in the OER-Mini was evaluated. The test results showed that the OER-Mini reprocessing cycle removes detergent and disinfectant residues to non-toxic levels.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Page 1 of 5
510(k) Premarket Notification ENDOSCOPE REPROCESSOR OER-Mini
DEC 2 0 2012
510(k) Summary
0 Applicant Information
. Applicant
Official Correspondent .
Date Prepared: December 8, 2011
OLYMPUS MEDICAL SYSTEMS CORP. 2951 Ishikawa-cho, Hachioji-shi, Tokyo, 192-8507, Japan Establishment Registration No: 8010047
Stacy Abbatiello Kluesner, M.S., RAC Regulatory Affairs & Quality Assurance OLYMPUS AMERICA INC. 3500 Corporate Parkway, Center Valley, PA 18034-0610 Phone: (484)896-5405 Fax: (484) 896-7128 Email: stacy.kluesner@olympus.com Establishment Registration No: 2429304
AIZU OL YMPUS CO., LTD. 500 Aza-Muranishi, Ooaza-Iidera, Monden-cho, Aizuwakamatsu-shi, Fukushima, Japan 965-8520 Establishment Registration No: 9610595
Device Identification 0
- Device Trade Name .
ENDOSCOPE REPROCESSOR OER-Mini Endoscope washer/disinfector
876.1500 Endoscope and accessories FEB - Accessories, Cleaning, For Endoscope Gastroenterology/Urology None established under Section 514 of FD&C Act.
- Common Name .
- . Class
- Regulation Number/Name �
- . Product Code
- . Classification Panel
- . Performance Standard
- Predicate Device (PD) 0
- . Device Trade Name
- . 510(k) Number
- . Manufacturer
ENDOSCOPE REPROCESSOR OER-Pro K103264 AIZU OL YMPUS CO., LTD.
OLYMPUS AMERICA INC.
I I
3500 CORPORATE PARKWAY, P.O. BOX 610, CENTER VALLEY, PA 18034-0610 TELEPHONE (484) 896-5000
Manufacturer ●
1
Page 2 of 5
o Device Description
The OER-Mini Endoscope Reprocessor is an automated endoscope reprocessor intended for cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes, camera heads, light guide cables, miniature light sources and their accessories. Use of the OER-Mini requires detergent and FDA cleared high-level disinfectant/sterilant that Olympus has validated to be efficacious and compatible with the materials of the OER-Mini and its compatible endoscopes/devices.
Use of the OER-Mini enables the user to perform modified manual cleaning of the endoscope prior to automated cleaning and high-level disinfection in the OER-Mini.
The OER-Mini has been developed to provide an AER that will suit reprocessing of endoscopes in the surgical field. The OER-Mini has a compact and smart-design for table-top use.
The OER-Mini is a one-basin table-top type automatic endoscope reprocessor that performs cleaning, disinfection, rinse to render a high-level disinfected endoscope, device and their accessories. The OER-Mini utilizes an immersion method for cleaning, disinfecting, and rinsing of endoscope/device and its accessory external surfaces, and connectors for endoscope channel cleaning, disinfecting, and rinsing.
The OER-Mini basically can reprocess one device at a time in one-basin, but the immersible certain combination of devices also can be reprocessed simultaneously at a time in a one-basin.
The OER-Mini is capable of automated disinfectant solution dispensing. The external 0.2-micron water filters are bacteria retentive and produce suitable rinse water for reprocessing. Built-in sensors detect fluid levels and temperatures in the reprocessing basin and disinfectant solution tank. If any abnormality/irregularity is detected, an error indicator lights up with an audible alarm and the reprocessing process is a stopped. The device utilizes a touch-panel user interface for program operation and settings. The disinfectant solution is automatically diluted by filtered water until specified quantity in the device. On the other hand, some functions are eliminated in order to realize compact table-top AER;
- . No detergent dispensing system. User should manually pour detergent into the device.
- No compressor for air purge.
- No alcohol dispensing system. User should manually pour alcohol into the device.
OLYMPUS AMERICA INC.
3500 CORPORATE PARKWAY, P.O. BOX 610, CENTER VALLEY, PA 18034-0610 TELEPHONE (484) 896-5000
2
Page 3 of 5
The OER-Mini does not have RFID (Radio-Frequency Identification) function. Instead of RFID function, OER-Mini can connect the external-printer (MAJ-1937), which enables to generate hard copy reprocessing record (i.e. operation record, error history etc.). On the reprocessing record, the entered section of user and scope data has been added.
OLYMPUS
Also, the OER-Mini has a built-in terminal for data communication, which enables the device to output specific information (i.e. operation record, error history, information for determining periodical maintenance timing etc.) to a computer with proprietary software installed for reprocessing record management. It is also possible to alter data and time settings of the OER-Mini from such a computer via this terminal.
0 Indications for Use
The OER-Mini is intended for use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes, camera heads, light guide cables, miniature light sources, and their accessories. Safe use requires detergent and an FDA-cleared high-level disinfectant/sterilant that Olympus has validated to be efficacious and compatible with the materials of the OER-Mini and Olympus flexible endoscopes, camera heads, light guide cables, miniature light sources, and their accessories. Use of a detergent or highlevel disinfectant/sterilant that has not been validated by Olympus may be ineffective and may damage the OER-Mini components and the endoscopes being reprocessed. Endoscopes must be subject to cleaning by the user prior to reprocessing; however, use of the OER-Mini enables the user to perform modified manual cleaning of the endoscope prior to automated cleaning and high-level disinfection in the OER-Mini.
Comparison to Predicate Device 0
The OER-Mini is equivalent in indications and operational principles to the OER-Pro. Both devices are intended for high-level disinfection of flexible endoscopes, use an immersion system, flush water/disinfectant to endoscope channels via connectors, and utilize a detergent and FDA-cleared liquid chemical germicide. The major differences from the predicate device are as follows:
- Camera heads, miniature light sources, light guide cables also be added as compatible devices.
- . Structure of reprocessing basin is completely different.
- Shorter cleaning time without the ultrasonic cleaning function. י
- Does not have a detergent dispense system for detergent cleaning .
- Does not have a compressor used for air purge
- Does not have a drain pump used for forced drainage.
- Does not have an alcohol dispense system for alcohol flushing
- Does not have a RFID function
OLYMPUS AMERICA INC
3500 CORPORATE PARKWAY, P.O. BOX 610, CENTER VALLEY, PA 18034-0610 TELEPHONE (484) 896-5000
3
Image /page/3/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, black letters. The font is sans-serif and the letters are closely spaced together. The word is centered horizontally and takes up a significant portion of the image. The background is plain white.
Page 4 of 5.
Performance Data
The OER-Mini has been tested following the requirements in the FDA guidance document titled "Guidance on Premarket Notification [510(k)] Submissions for Automated Endoscope Washers, Washer/Disinfectors, and Disinfectors Intended for Use in Health Care Facilities", issued in August 1993. Test reports provided in this premarket notification include:
Process Parameter Test
The OER-Mini was tested to demonstrate that the device performs as intended. The test results showed that the OER-Mini achieves and maintains the specified physical process parameters, including detection of the defined fault conditions and execution of automatic response/ processing following fault detection.
Validation Testing - Cleaning
The OER-Mini was tested to evaluate its ability to clean its compatible devices in both simulated and in-use conditions. The test results demonstrate that the OER-Mini effectively reduced protein and carbohydrate levels in all sample sites.
Validation Testing - High-Level Disinfection
The OER-Mini was tested to evaluate its ability to high-level disinfect its compatible devices in both simulated and in-use conditions. The simulated use testing demonstrated a 6 Logio reduction of M.terrae at all inoculated sites was achieved after reprocessing in the OER-Mini's disinfection cycle. In-use testing demonstrated no viable microorganisms were recovered from test samples following reprocessing in the OER-Mini.
Validation Testing - Full Cycle
The OER-Mini was tested to evaluate its effectiveness for full cycle reprocessing including both cleaning and disinfection under simulated use conditions. The simulated use testing demonstrated that OER-Mini effectively cleaned and achieved high-level disinfection for its compatible devices.
Simulated-Use Testing - Self-Disinfection
Simulated-use testing was performed to validate self-disinfection of the OER-Mini. Testing demonstrated that a greater than 6 log reduction in M. terrae was achieved for all sample locations after completion of routine reprocessing of endoscopes/devices within the OER-Mini.
Simulated-Use Testing - Water Line Disinfection
The simulated-use testing was performed to validate disinfection of the OER-Mini water line piping which does not contact high-level disinfectant during routine reprocessing. The test result showed that a greater than 6 log reduction in M. terrae was achieved for all sample locations after completion of the water line disinfection procedure.
Toxicological Evaluation of Residues
The safety of residual chemicals remaining on endoscopes/devices after reprocessing in the OER-Mini was evaluated. The test results showed that the OER-Mini reprocessing cycle removes detergent and disinfectant residues to non-toxic levels.
OLYMPUS AMERICA INC.
3500 CORPORATE PARKWAY. P.O. BOX 610, CENTER VALLEY, PA 18034-0610 TELEPHONE (484) 896-5000
4
OLYMPUS
Page 5 of 5
ם Conclusion
.
イ
The information and performance data presented in this premarket notification supports that the OER-Mini is substantially equivalent to the predicate device.
·
· ·
・ ·
・
:
·
・
OLYMPUS AMERICA INC.
3500 CORPORATE PARKWAY, P.O. BOX 610, CENTER VALLEY, PA 18034-0610
(484) 896-5000 .
5
Image /page/5/Picture/0 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" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines. The logo is presented in black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service .
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 20, 2012
Olympus Medical Systems Corporation C/O Ms. Laura Storms-Tyler Olympus America Incorporated 3500 Corporate Parkway P.O. Box 610 CENTER VALLEY PA 18034-0610
Re: K120357
Trade/Device Name: Endoscope Reprocessor Oer-Mini Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FEB Dated: December 7, 2012 Received: December 10, 2012
Dear Ms. Storms-Tyler:
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.
6
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Anthom La m
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Indications for Use
510(k) Number (if known): K120357
Device Name: ENDOSCOPE REPROCESSOR OER-Mini
Indications For Use:
The OER-Mini is intended for use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes, camera heads, light guide cables, miniature light sources and their accessories. Safe use requires detergent and an FDA-cleared high-level disinfectant/sterilant that Olympus has validated to be efficacious and compatible with the materials of the OER-Mini and Olympus flexible endoscopes, camera heads, light guide cables, miniature light sources and their accessories. Use of a detergent or high-level disinfectant/sterilant that has not been validated by Olympus may be ineffective and may damage the OER-Mini components and the endoscopes being reprocessed. Endoscopes must be subject to cleaning by the user prior to reprocessing; however, use of the OER-Mini enables the user to perform modified manual cleaning of the endoscope prior to automated cleaning and high-level disinfection in the OER-Mini.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use_ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Elizabeth F. Claverie
2012.12.19 21:04:05 -05'00'
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K120357