(63 days)
Not Found
No
The description focuses on automated and manual pressure-based leak detection, RFID for identification, and data storage. There is no mention of AI or ML algorithms being used for analysis or decision-making.
No
The device is designed to perform and record leakage testing on endoscopes, ensuring their proper function and integrity, rather than to deliver a medical therapy to a patient.
No
The device is used to detect leaks in endoscopes for maintenance purposes, acting as a testing tool for equipment rather than diagnosing a medical condition in a patient.
No
The device description clearly indicates the presence of hardware components such as a pressure detection mechanism, RFID function, internal memory, and interfaces for printing and USB transfer. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "perform and record leakage testing on Olympus flexible endoscopes." This is a test performed on a medical device (the endoscope) to assess its integrity, not a test performed on a biological sample (like blood, urine, or tissue) to diagnose a disease or condition in a patient.
- Device Description: The device description confirms it detects leaks from endoscopes using air pressure or by soaking the endoscope in water. This is a functional test of the endoscope itself.
- Lack of Biological Sample Testing: There is no mention of the device interacting with or analyzing any biological samples from a patient.
- Performance Studies: The performance studies focus on comparing the leak detection rate of the new method (ALT) to a conventional method (MLT) for testing endoscopes. They do not involve patient samples or diagnostic accuracy metrics.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
This equipment is intended to be used to perform and record leakage testing on Olympus flexible endoscopes.
Product codes (comma separated list FDA assigned to the subject device)
PCV
Device Description
The subject ALT-Y0003 is used to detect leaks from Olympus flexible endoscopes. It utilizes two testing modes; one is automated leak test mode (ALT mode) and the other is manual leak test mode (MLT mode). In ALT mode, it is not required to soak the tested endoscope in water. The ALT-Y0003 detects leak from the difference of air pressure. The ALT-Y0003 can also be used for conventional manual leak test by soaking an endoscope in water. The ALT-Y0003 has an RFID function to recognize endoscope and operator identification. It can store test results in its internal memory and this stored record can be printed out with the designated printer and/or transferred to deginated USB memory.
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)
Performance testing was conducted to confirm that the leak detecting rate of ALT is equivalent to that of conventional MLT. It has been demonstrated that there is no significant difference in leak detection rates between ALT and conventional MLT. Also, it has been confirmed that the detection threshold of the ALT-Y0003 can detect a leak which actually causes a water leak.
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
§ 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.
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K123704
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510(k) SUMMARY
AUTOMATED ENDOSCOPE LEAK TESTER ALT-Y0003
FEB 4 2013
November 30, 2012
1 General Information
■ Applicant: OLYMPUS MEDICAL SYSTEMS CORP. 2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan 192-8507 Establishment Registration No: 8010047
- Official Correspondent: Daphney Germain-Kolawole Regulatory Affairs Project Manager Regulatory Affairs & Quality Assurance Olympus America Inc. 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610, USA Phone: 484-896-5691 FAX: 484-896-7128 Email: daphney.germain-kolawole @olympus.com
트 Manufacturer:
■
SHIRAKAWA OLYMPUS CO., LTD. 3-1, Aza-Ookamiyama, Ooaza-Odakura, Nishigo-mura, Nishishirakawa-gun, Fukushima, Japan 961-8061 Establishment Registration No: 3002808148
2 Device Identification
- Device Trade Name: AUTOMATED ENDOSCOPE LEAK TESTER ALT-Y0003
- I Common Name: Leak Tester
- . Regulation Number: 876.1500
- B Regulation Name: Endoscope and accessories
ll
- . Regulatory Class:
-
트 Classification Panel:
- 마 Product Code: PCV
Gastroenterology and urology
1
K123704
Pozi 2 of 3
3 Predicate Device Information
| PD1 | PD2 | |
|---|---|---|
| Device Name: | Endoscope Leak Tester | |
| ZUTR-10003 | Maintenance Unit MU-1 | |
| 510(k) No. | K093718 | K051886 |
| Manufacturer | Zutron Medical | SHIRAKAWA OLYMPUS CO., |
| LTD. |
4 Device Description
The subject ALT-Y0003 is used to detect leaks from Olympus flexible endoscopes. It utilizes two testing modes; one is automated leak test mode (ALT mode) and the other is manual leak test mode (MLT mode). In ALT mode, it is not required to soak the tested endoscope in water. The ALT-Y0003 detects leak from the difference of air pressure. The ALT-Y0003 can also be used for conventional manual leak test by soaking an endoscope in water. The ALT-Y0003 has an RFID function to recognize endoscope and operator identification. It can store test results in its internal memory and this stored record can be printed out with the designated printer and/or transferred to deginated USB memory.
5 Indications for Use
This equipment is intended to be used to perform and record leakage testing on Olympus flexible endoscopes.
Comparison of Technological Characteristics റ്
The subject ALT-Y0003 is substantially equivalent to the predicate devices. Both the subject device and predicate devices are used for leak testing of endoscopes in combination with connecting tube by feeding air into endoscopes.
Compared to the predicate devices, the main differences of ALT-Y0003 are as follows:
- Automated leak test mode -
- . RFID
- Internal memory to store test results -
It has been confirmed that the ALT mode has equivalent detecting rate to conventional MLT in nonclinical testing. The subject device was also tested in compliance with electrical safety standard, EMC standard, and FCC Part 15 standard and confirmed there is no problem with safety and effectiveness.
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K123704
Page 3 of 3
7 Summary of Nonclinical Testing
Performance testing was conducted to confirm that the leak detecting rate of ALT is equivalent to that of conventional MLT. It has been demonstrated that there is no significant difference in leak detection rates between ALT and conventional MLT. Also, it has been confirmed that the detection threshold of the ALT-Y0003 can detect a leak which actually causes a water leak.
The software validation activities were performed in accordance with the FDA Guidance, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The device software is considered a "Minor Level of Concern."
As the ALT-Y0003 is considered to be an intentional radiator prescribed under Federal Communications Commission (FCC) 47 CFR Part 15 - Radio Frequency Devices, Subject C - Intentional Radiators, it has been evaluated to verify compliance with this regulation.
Basic safety and performance testing was performed in accordance with IEC 61010-1 and IEC 61326-1. In addition, verification was conducted to evaluate the mechanical and functional performance.
Risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007. The design verifications tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment.
The following standards have been applied to ALT-Y0003
- IEC 61010-1: 2001 .
- IEC 61326-1: 2005
- ISO 14971: 2007
Conclusion 8
When compared to the predicate devices, the AUTOMATED ENDOSCOPE LEAK TESTER ALT-Y0003 does not incorporate any significant changes in intended use, method of operation or design that could affect the safety or effectiveness of the device.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and 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-like figure with three stylized wing or feather shapes.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 4, 2013
OLYMPUS MEDICAL SYSTEMS CORP. % Ms. Daphney Germain-Kolawole Regulatory Affairs Project Manager Olympus America, Inc. 3500 Corporate Parkway CENTER VALLEY PA 18034-0610
Re: K123704
Trade/Device Name: AUTOMATED ENDOSCOPE LEAK TESTER ALT-Y0003 Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: PCV Dated: November 30, 2012 Received: December 3, 2012
Dear Ms. Germain-Kolawole:
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.
4
Page 2 - Ms. Daphney Germain-Kolawole
You must comply with all the Act's requirements, including, but not limited to: registration and I vu must compy with and 807); labeling (21 CFR Part 801); medical device 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 11 you desire specific ad rios court DA/Centers Offices/CDRH/CDRHOffices/ucm115809.htm for go to map. WWW. adiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 1000 and regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Benjamin/R._Fisher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): 123704 Device Name: AUTOMATED ENDOSCOPE LEAK TESTER ALT-Y0003 Indications For Use:
This equipment is intended to be used to perform and record leakage testing on Olympus flexible endoscopes.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Benjamin R. Fisher -S 2013.02.05 13:00:05 -05'00'
Page 1 of 1
(Division Sign-Off) Bivision of Reproductive, Gastro-Renal, and Urological Devices 510(k) Number
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