(112 days)
No
The device description and intended use clearly define the device as a physical tray for sterilization, with no mention of software, data processing, or AI/ML capabilities.
No
The device is an instrument tray used for sterilizing other medical devices (endoscopes) and does not directly treat or diagnose a medical condition.
No
The device is described as an instrument tray for holding and sterilizing medical devices, not for diagnosing medical conditions.
No
The device description clearly states it is a "polymer tray with a perforated lid," indicating it is a physical hardware device used for sterilization, not software.
Based on the provided text, the Olympus MAJ-172 Instrument Tray for LTF Videoscope is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is clearly described as a container for holding medical devices (endoscopes and accessories) during transport and sterilization. It facilitates the sterilization process of other medical devices.
- Device Description: The description confirms it's a polymer tray with a perforated lid designed to secure devices during sterilization.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment. Its function is purely related to the reprocessing of other medical devices.
- Performance Studies: The performance studies focus on the tray's ability to withstand sterilization processes, physical stress (drop testing), and chemical exposure, which are relevant to a sterilization accessory, not a diagnostic device.
Therefore, the Olympus MAJ-172 Instrument Tray for LTF Videoscope is a medical device, but it falls under the category of a sterilization accessory or container, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Olympus MAJ-172 Instrument Tray for LTF Videoscope is intended to be used to enclose Olympus medical devices including hand instruments, trocars, camera heads, adapter, and endoscopes to be sterilized by a health care provider. It is intended to allow steam or ethylene oxide sterilization of the enclosed medical device. The Olympus MAJ-172 Instrument Tray for LTF Videoscope is a purpose designed transport and sterilization case indicated for use in medical facilities to accommodate an endoscope from the Olympus LTF range of videoscopes, plus certain identified accessories, for reprocessing by autoclaving (steam) or ETO sterilization (depending on the model). LTF Type 160 and VH videoscopes are compatible with Steam and ETO sterilization cycles. LTF Type V3 and VP are compatible only with ETO sterilization cycles.
The Olympus MAJ-172 Instrument Tray for LTF Videoscope is designed to secure and store a single videoscope and its accessories for sterilization at a healthcare facility. Refer to the instrument tray instructions for use for the proper orientation of the videoscope and accessories within the instrument tray. The recommended sterilization cycles for the LTF videoscopes are as follows:
ETO Sterilization .. . .. 100% ETO concentration: 735 mg/L Temp: 57 °C -------------Relative Humidity: 70% Processing (Hold) Time: 1 hour Aeration Time: 12 hours
Steam Sterilization: Vacuum: 0.016 MPa minimum Pressure: 0.101 MPa minimum Temp: 135 °C Exposure Time: 3 minutes Drying Time: 20 minutes
Product codes
KCT
Device Description
The Olympus MAJ-172 Instrument Tray for LTF Videoscope is a polymer tray with a perforated lid intended to secure an endoscope and accessories during exposure to gaseous sterilization methods.
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 provider / medical facilities, healthcare facility
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
A series of non-clinical studies were completed to assess the performance of the Olympus MAJ-172 Instrument Tray for LTF Videoscope. These included simulated use tests, drop testing, resistance to chemicals, cleaning, steam sterilization and ethylene oxide sterilization studies. The device met the requirements of all required design specification testing.
Key Metrics
Not Found
Predicate Device(s)
Olympus Sterilization Trays (K033222), Gyrus ACMI Flexible Endoscope Storage-Sterilization Tray (K092682)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.6850 Sterilization wrap.
(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).
0
510(k) Summary for the Olympus MAJ-172 Instrument Tray for LTF Videoscope (per 21CFR 807.92)
4 2013 JAN
1. SUBMITTER/510(K) HOLDER
KeyMed (Medical & Industrial) Ltd. Stock Road Southend-On-Sea Essex SS2 5QH United Kingdom
2. CONSULTANT/CONTACT
Aptiv Solutions Inc. 11440 West Bernardo Drive, Suite 300 San Diego, CA 92127 Telephone: 858-753-1961 Facsimile: 858-753-1962
Primary Contact: Ron Warren Date Prepared: October 15, 2012
3. DEVICE NAME
Proprietary Name: Olympus MAJ-172 Instrument Tray for LTF Videoscope Common/Usual Name: Sterilization container Classification Name: Sterilization wrap, containers, trays, cassettes and other accessories
4. PREDICATE DEVICES
- Olympus Sterilization Trays (K033222) .
- Gyrus ACMI Flexible Endoscope Storage-Sterilization Tray (K092682) .
1
5. DEVICE DESCRIPTION
The Olympus MAJ-172 Instrument Tray for LTF Videoscope is a polymer tray with a perforated lid intended to secure an endoscope and accessories during exposure to gaseous sterilization methods.
6. INDICATION FOR USE/INTENDED USE
The Olympus MAJ-172 Instrument Tray for LTF Videoscope is intended to be used to enclose Olympus medical devices including hand instruments, trocars, camera heads, adapter, and endoscopes to be sterilized by a health care provider. It is intended to allow steam or ethylene oxide sterilization of the enclosed medical device. The Olympus MAJ-172 Instrument Tray for LTF Videoscope is a purpose designed transport and sterilization case indicated for use in medical facilities to accommodate an endoscope from the Olympus LTF range of videoscopes, plus certain identified accessories, for reprocessing by autoclaving (steam) or ETO sterilization (depending on the model). LTF Type 160 and VH videoscopes are compatible with Steam and ETO sterilization cycles. LTF Type V3 and VP are compatible only with ETO sterilization cycles.
The Olympus MAJ-172 Instrument Tray for LTF Videoscope is designed to secure and store a single videoscope and its accessories for sterilization at a healthcare facility. Refer to the instrument tray instructions for the proper orientation of the videoscope and accessories within the instrument tray. The recommended sterilization cycles for the LTF videoscopes are as follows:
ETO Sterilization: Steam Sterilization: 100% ETO concentration: 735 mg/L Vacuum: 0.016 MPa minimum Temp: 57 °C Pressure: 0.101 MPa minimum Relative Humidity: 70% Temp: 135 ℃ Processing (Hold) Time: 1 hour Exposure Time: 3 minutes Aeration Time: 12 hours Drying Time: 20 minutes
7. SUMMARY OF TECHNOLOGICAL CHARACTERISTICS COMPARED TO THE PREDICATE DEVICE/S
The Olympus MAJ-172 Instrument Tray for LTF Videoscope has identical technological characteristics compared to the Olympus Sterilization Trays (K033222) which are cleared for steam sterilization of endoscopic devices and accessories. . The sterilization trays are made of the high performance thermoplastic Polyphenylsulfone [PPSU (RADEL®)], each consisting of a natural colored lid, including four stainless steel clips and two stainless steel handles, as well as of a beige base with middle-blue
2
multipoint silicone stripes and a laser marking. Each tray is customized for specific instruments, which ensures their safekeeping during sterilization, storage and transportation. The instrument trays do not require any maintenance and service and have an expected useful life of five years.
The Olympus MAJ-172 Instrument Tray for LTF Videoscope is also similar to the Gyrus ACMI Flexible Endoscope Storage-Sterilization Tray (K092682) which is constructed of Radel-R Polyphenylsulphone and cleared for ETO sterilization of Gyrus flexible endoscopes. Under K092682, the Gyrus storage-sterilization tray was found substantially equivalent to the Olympus Sterilization Trays (K033222). The clearance allowed for the use of ETO sterilization while the predicate device was cleared for steam sterilization only. The Olympus MAJ-172 Instrument Tray for LTF Videoscope is intended for both ETO and steam sterilization methods (depending on the endoscope model).
8. SUMMARY OF NON-CLINICAL PERFORMANCE TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE
A series of non-clinical studies were completed to assess the performance of the Olympus MAJ-172 Instrument Tray for LTF Videoscope. These included simulated use tests, drop testing, resistance to chemicals, cleaning, steam sterilization and ethylene oxide sterilization studies. The device met the requirements of all required design specification testing.
9. SUMMARY OF CLINICAL TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE
No clinical testing was conducted or required in support of this premarket clearance notification.
10. SUMMARY OF OTHER INFORMATION
This submission included comparison of intended use statements, proposed product labeling and summary information and labeling on predicate devices.
11. CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL TESTS
Based on the information provided in this 510(k), KeyMed believes that the proposed sterilization tray is substantially equivalent to the previously cleared Olympus instrument trays. The proposed device is one of a family of Olympus sterilization trays already cleared and marketed for steam sterilization. The Olympus MAJ-172 Instrument Tray for LTF Videoscope is also substantially equivalent to the Gyrus storage-sterilization tray which is comprised of a similar Polyphenlysulfone
3
thermoplastic and is cleared for ETO sterilization of several models of Gyrus flexible endoscopes. The proposed device raises no new issues of safety and effectiveness. The non-clinical testing performed demonstrates that the proposed device met all test specifications and is suitable for its intended use.
·
4
Image /page/4/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
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
January 4, 2013
KeyMed (Medical & Industrial Equipment) Limited C/O Mr. Ronald S. Warren, RAC Director, Medical Device Regulatory Services Aptiv Solutions, Incorporated 11440 West Bernardo Court, Suite 300 SAN DIEGO CA 92127
Re: K122818
Trade/Device Name: Olympus MAJ-172 Instrument Tray for LTF Videoscope Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: KCT Dated: December 3, 2012 Received: December 4, 2012
Dear Mr. Warren:
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.
5
Page 2 - Mr. Warren
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 yours,
Anthong Lo mia
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
6
Indications for Use
510(k) Number (if known): K122818
Olymous MAJ-172 Instrument Tray for LTF Videoscope Device Name:
Indications for Use:
The Olympus MAJ-172 Instrument Tray for LTF Videoscope is intended to be used to enclose Olympus medical devices including hand instruments, trocars, camera heads, adapter, and endoscopes to be sterilized by a health care provider. It is intended to allow steam or ethylene oxide sterilization of the enclosed medical device. The Olympus MAJ-172 Instrument Tray for LTF Videoscope is a purpose designed transport and sterilization case indicated for use in medical facilities to accommodate an endoscope from the Olympus LTF range of videoscopes, plus certain identified accessories, for reprocessing by autoclaving (steam) or ETO sterilization (depending on the model). LTF Type 160 and VH videoscopes are compatible with Steam and ETO sterilization cycles. LTF Type V3 and VP are compatible only with ETO sterilization cycles.
The Olympus MAJ-172 Instrument Tray for LTF Videoscope is designed to secure and store a single videoscope and its accessories for stenlization at a healthcare facility. Refer to the instrument tray instructions for use for the proper orientation of the videoscope and accessories within the instrument tray. The recommended sterlization cycles for the LTF videoscopes are as follows:
ETO Sterilization .. . .. 100% ETO concentration: 735 mg/L Temp: 57 °C -------------Relative Humidity: 70% Processing (Hold) Time: 1 hour Aeration Time: 12 hours
Steam Sterilization: Vacuum: 0.016 MPa minimum Pressure: 0.101 MPa minimum Temp: 135 °C Exposure Time: 3 minutes Drving Time: 20 minutes
Prescription Use (Part 21 CFR 801 Subpart D)
510(k) Number:
AND/OR
Over-The-Counter Use_x (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)
| Elizabeth F. Glaverie | ||
|---|---|---|
| 2013.01.02, 16:49:24 -05'00' | ||
| (Division Sign-Off) | ||
| Division of Anesthesiology, General Hospital | ||
| Infection Control, Dental Devices (Industrial & Medical) Ltd Supplement 1 - K122818 | October 16, 2012 | Confidential Page 14 |