(299 days)
Not Found
No
The device description and intended use clearly define the device as an instrument basket for sterilization and storage, with no mention of AI or ML capabilities. The performance studies focus on sterilization efficacy, biocompatibility, and mechanical protection.
No
Explanation: This device is an instrument basket designed for holding and protecting medical instruments during sterilization, storage, and transport. It does not directly provide a therapeutic effect on a patient.
No
This device is an instrument basket designed for sterilizing and storing medical instruments, specifically Olympus video telescopes. It does not perform any diagnostic function.
No
The device is a physical instrument basket designed for enclosing and protecting medical devices during sterilization and storage. It is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the instrument basket is for enclosing and protecting a video telescope for sterilization. This is a process related to the reprocessing of a medical device, not for performing a diagnostic test on a biological sample.
- Device Description: The description focuses on the physical characteristics of the basket and its function in holding and protecting the telescope during sterilization and storage. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition
- Reagents, calibrators, or controls
The device is a containment device used in the sterilization process of a medical instrument (a video telescope). This falls under the category of medical devices used in the reprocessing of other medical devices, not IVDs.
N/A
Intended Use / Indications for Use
The instrument basket is intended to be used to enclose and protect one Olympus video telescope for sterilization in a prevacuum steam sterilizer or STERRAD® sterilizer using the following parameters or cycles:
• Prevacuum steam sterilization
- Exposure time at a temperature of 132 °C (269.6 °F:): Wrapped instruments 4 min., Immediate-use non-porous instruments 3 min.
- Exposure time at a temperature of 135 °C (275 °F:): Wrapped instruments 3 min., Immediate-use non-porous instruments 3 min.
- Drying time 30 min.
After steam sterilization, let the instrument basket cool down at room temperature. - Cool-down time 30 min.
• STERRAD® sterilization
- STERRAD® 100S cycle
- STERRAD® 100NX™: standard cycle and express cycle
The instrument basket is not intended to maintain sterility. It is intended to be used in conjunction with a 510K cleared sterilization wrap to maintain sterility of the enclosed Olympus video telescope and accessories.
Validated worst-case load
The instrument basket which is double-wrapped in a sterilization wrap with one enclosed Olympus video telescope and accessories must not exceed 8.708 lb (3950 g).
Product codes
KCT
Device Description
The instrument basket, for ENDOEYE is specifically designed for enclosure of Olympus video telescopes and accessories during sterilization and storage of Olympus video telescopes and accessories after sterilization as well as enclosure during transport within the reprocessing cycle.
The Olympus instrument basket is autoclavable and delivered in non-sterile condition to the customer. It is reusable and has to be reprocessed before first and each subsequent use according to defined reprocessing methods in the Instructions for Use.
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
Risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007.
Performance tests were carried out to ensure that the system functions as intended and meets design specifications. The following performance tests and usability studies were conducted:
Biocompatibility testing
The biocompatibility evaluation for the subject device was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing,'" May 1, 1995.
The testing included the following tests:
- Biological Safety toxicology: AAMI ANSI ISO 10993-1:2009; Biological . Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process
- Cytotoxicity: AAMI ANSI ISO 10993-5:2009; Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- Chemical Analysis: AAMI ANSI ISO 10993-12:2012; Biological evaluation of medical devices - Part 12: Sample Preparation and Reference Materials
Performance Bench Testing
The instrument basket is specifically designed for enclosure of Olympus video telescopes and accessories during sterilization and storage of Olympus video telescopes and accessories after sterilization process.
Its main performance characteristics are:
- The mechanical protection of the enclosed video telescopes ensured by adaptive holding retainers and closeable basket design
- Enabling automated cleaning/disinfection of loaded video telescopes (validated combinations only as outlined in the respective device IFU's)
- Enabling use with sterilization wrap (maintaining sterility is secured by the sterilization wrap which is not part of this submission)
- Enabling sterilization of loaded video telescopes (validated combinations only as outlined in the respective device IFU's)
To outline that these performance characteristics have been met the submission contains the respective validations, tests and an outline of the design as required by the recognized standard AAMI / ANSI ST77:2013, containment devices for reusable medical device sterilization. (Sterility) (recognition number: 14-396) assigned to the product code KCT.
The following standards have been applied to the Instrument Basket:
- ISO 10993-1:2009
- ISO 10993-5:2009
- ISO 10993-12:2012
- ISO 14971:2007
- AAMI ANSI ST77:2013
- AAMI ANSI IEC 62366-1:2015
For the above mentioned ISO standards, identical DIN EN ISO standards have been used by the recognized test laboratories.
Key Metrics
Not Found
Predicate Device(s)
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
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized depiction of three human profiles facing right, arranged in a cascading manner. The profiles are rendered in black and white. Encircling the profiles is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 2, 2018
Sheri L. Musgnung Regulatory Affairs Manager Olympus Corporation of the Americas 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610
Re: K171692
Trade/Device Name: Instrument basket, for ENDOEYE Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: March 01, 2018 Received: March 05, 2018
Dear Sheri L. Musgnung:
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. 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
1
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 contact the Division of Industry and Consumer Education 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. 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
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 Industry and Consumer Education 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,
Michael J. Ryan -S
for Tina Kiang, Ph.D.
Acting Director Division of Anesthesiology, General Hospital. Respiratory. Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K171692
Device Name Instrument basket, for ENDOEYE
Indications for Use (Describe)
The instrument basket is intended to be used to enclose and protect one Olympus video telescope for sterilization in a prevacuum steam sterilizer or STERRAD® sterilizer using the following parameters or cycles:
• Prevacuum steam sterilization
| - Exposure time at a temperature of 132 °C (269.6 °F:) | |
|---|---|
| Wrapped instruments | 4 min. |
| Immediate-use non-porous instruments | 3 min. |
| - Exposure time at a temperature of 135 °C (275 °F:) | |
|---|---|
| Wrapped instruments | 3 min. |
| Immediate-use non-porous instruments | 3 min. |
| - Drying time | 30 min. |
|---|---|
| --------------- | --------- |
After steam sterilization, let the instrument basket cool down at room temperature.
| - Cool-down time | 30 min. |
|---|---|
| ------------------ | --------- |
• STERRAD® sterilization
-
STERRAD® 100S cycle
-
STERRAD® 100NX™: standard cycle and express cycle
The instrument basket is not intended to maintain sterility. It is intended to be used in conjunction with a 510K c
The instrument basket is not intended to maintain sterility. It is intended to be used in conjunction with a 510K cleared sterilization wrap to maintain sterility of the enclosed Olympus video telescope and accessories.
Validated worst-case load
The instrument basket which is double-wrapped in a sterilization wrap with one enclosed Olympus video telescope and accessories must not exceed 8.708 lb (3950 g).
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.
3
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4
510(k) Summary K171692
1. General information
■
- Manufacturer/Holder Olympus Winter & Ibe GmbH Kuehnstr. 61 22045 Hamburg Germany
- 트 Establishment Registration No.: 9610773
- . Official Correspondent: Sheri L. Musqnung Regulatory Affairs Olympus Corporation of the Americas 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610 484-896-3147 Phone: FAX: 484-896-7128 Email: sheri.musgnung@olympus.com Establishment Registration No.: 2429304
March 29, 2018
Submission Date:
2. Device identification
- 트 Proprietary name:
- Common name:
- 트 Requlation Number:
- I Regulation Description:
- I Device Class:
- Product Code:
- Review Panel:
Instrument basket, for ENDOEYE Sterilization wrap containers, trays, cassettes & other accessories 21 CFR 880.6850 Sterilization wrap ll КСТ General Hospital
5
3. Predicate device
K033222, Olympus Instrument Tray, for video telescopes
4. Description of device
The instrument basket, for ENDOEYE is specifically designed for enclosure of Olympus video telescopes and accessories during sterilization and storage of Olympus video telescopes and accessories after sterilization as well as enclosure during transport within the reprocessing cycle.
The Olympus instrument basket is autoclavable and delivered in non-sterile condition to the customer. It is reusable and has to be reprocessed before first and each subsequent use according to defined reprocessing methods in the Instructions for Use
5. Indications of use
The instrument basket is intended to be used to enclose and protect one Olympus video telescope for sterilization in a prevacuum steam sterilizer or STERRAD® sterilizer using the following parameters or cycles:
Prevacuum steam sterilization
| Exposure time at a temperature of 132 °C (269.6 °F): Wrapped instruments | 4 min. |
|---|---|
| Immediate-use non-porous instruments | 3 min. |
| Exposure time at a temperature of 135 °C (275 °F): Wrapped instruments | 3 min. |
| Immediate-use non-porous instruments | 3 min. |
| Drying time | 30 min. |
| After steam sterilization, let the instrument basket cool down at room temperature. | |
| Cool-down time | 30 min. |
STERRAD® sterilization
-
STERRAD® 100S cycle
-
STERRAD® 100NXTM: standard cycle and express cycle
The instrument basket is not intended to maintain sterility. It is intended to be used in conjunction with a 510K cleared sterilization wrap to maintain sterility of the enclosed Olympus video telescope and accessories.
6
Validated worst-case load
The instrument basket which is double-wrapped in a sterilization wrap with one enclosed Olympus video telescope and accessories must not exceed 8.708 Ib (3950 g).
5.1 Comparison of Indications for Use statement to the predicate:
The subject device has a similar intended Use as the legally-marketed Instrument tray, for EndoEYE cleared via K033222 (August 2, 2004) since both are sterilization trays. Also the predicate device and new Instrument basket, for ENDOEYE can undergo steam sterilization with the same enclosed devices. The main difference between the subject device and the predicate is that the new Instrument basket, for ENDOEYE can also be used during STERRAD® sterilization.
| Item of
Comparison | Predicate
Device | Subject Device | Comparison |
|---------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General
technology | Perforated rigid
enclosure
designed to
enclose Olympus
video telescopes
and accessories
while allowing for
sufficient
penetration of
reprocessing
agents. | Perforated rigid
enclosure
designed to
enclose Olympus
video telescopes
and accessories
while allowing for
sufficient
penetration of
reprocessing
agents. | Identical |
| Intended to be
reused | Yes | Yes | Identical |
| Design | Rigid
containment
device consisting
of a base with lid
which can be
fastened by a
latching
mechanism. The
device is
perforated in
order to enable
reprocessing of
enclosed medical
devices held in | Rigid containment
device consisting
of a base with lid
which can be
fastened by a
latching
mechanism. The
device is
perforated in
order to enable
reprocessing of
enclosed medical
devices held in
place by silicone | Identical |
| | place by silicone
retainers. | retainers. | |
| Percentage of
surface
perforation | About 3.3% | About 72% | The increased surface
perforation does not
introduce any
additional risks since
the main
characteristics (fit
geometry trough
design, base with
closeable lid) remain
identical. |
| Microbial barrier
properties | To be used with
FDA cleared
sterilization wrap | To be used with
FDA cleared
sterilization wrap | Identical |
| Toxicological
properties | Materials are
biocompatible | Materials are
biocompatible | Identical |
| Material | Thermoplastic,
silicone | Stainless steel,
silicone | The materials used
are different. All
materials used in the
subject device have
been validated to be
biocompatible and
verified to be
compatible with the
intended
reprocessing
methods. Therefore,
the use of different
materials in the
subject device does
not raise different
questions of safety
and effectiveness
compared to the
predicate device. |
| Autoclavability
(steam
sterilization) of
empty basket/tray | yes | yes | Identical |
| STERRAD®
sterilization
(gas plasma) of
empty basket/tray | no | STERRAD®
100S cycle
STERRAD®
100NXTM:
standard cycle
and express
cycle | STERRAD
sterilization was
added as an
additional
sterilization option
for the subject
device |
| Drying time
(steam
sterilization) | 15-30 minutes | 30 minutes | Identical |
6. Comparison of technological characteristics
7
8
7. Performance Data
Risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007.
Performance tests were carried out to ensure that the system functions as intended and meets design specifications. The following performance tests and usability studies were conducted:
Biocompatibility testing
The biocompatibility evaluation for the subject device was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing,"" May 1, 1995.
The testing included the following tests:
- Biological Safety toxicology: AAMI ANSI ISO 10993-1:2009; Biological . Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process
- . Cytotoxicity: AAMI ANSI ISO 10993-5:2009; Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- . Chemical Analysis: AAMI ANSI ISO 10993-12:2012; Biological evaluation of medical devices - Part 12: Sample Preparation and Reference Materials
Performance Bench Testing
The instrument basket is specifically designed for enclosure of Olympus video telescopes and accessories during sterilization and storage of Olympus video telescopes and accessories after sterilization process.
Its main performance characteristics are:
- The mechanical protection of the enclosed video telescopes ensured by adaptive holding retainers and closeable basket design
- -Enabling automated cleaning/disinfection of loaded video telescopes (validated combinations only as outlined in the respective device IFU's)
- Enabling use with sterilization wrap (maintaining sterility is secured by the sterilization wrap which is not part of this submission)
- -Enabling sterilization of loaded video telescopes (validated combinations only as outlined in the respective device IFU's)
To outline that these performance characteristics have been met the submission contains the respective validations, tests and an outline of the design as required by the recognized standard AAMI / ANSI ST77:2013, containment devices for reusable medical device sterilization. (Sterility) (recognition number: 14-396) assigned to the product code KCT.
9
The following standards have been applied to the Instrument Basket:
Rec. No. Standard
| 2-220 | ISO 10993-1:2009 |
|---|---|
| 2-245 | ISO 10993-5:2009 |
| 2-191 | ISO 10993-12:2012 |
| 5-40 | ISO 14971:2007 |
| 14-396 | AAMI ANSI ST77:2013 |
| 5-96 | AAMI ANSI IEC 62366-1:2015 |
For the above mentioned ISO standards, identical DIN EN ISO standards have been used by the recognized test laboratories.
8 Conclusion
Based on the intended use, technological characteristics, performance data, and nonclinical tests performed, subject Instrument basket, for ENDOEYE is substantially equivalent to, and is as safe and as effective as, the legally marketed predicate device, Olympus sterilization trays cleared under K033222 under regulation 21 CFR 880.6850, product code KCT.