(300 days)
Not Found
No
The device is an instrument tray for sterilization and storage, with no mention of AI or ML in its description or intended use.
No
The device, an instrument tray, is used for sterilizing, transporting, and storing medical instruments (specifically Olympus semi-rigid ureteroscopes and accessories), not for directly treating or diagnosing patients.
No
This device is an instrument tray primarily used for sterilization, transport, and storage of Olympus semi-rigid ureteroscopes and accessories. It does not perform any diagnostic function.
No
The device is an instrument tray, which is a physical hardware component used for sterilization and transport of medical instruments. The description focuses on its material properties, sterilization compatibility, and durability, not software functionality.
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 tray is for enclosing and protecting medical instruments (ureteroscopes and accessories) during sterilization, transport, and storage. It does not mention any use in the examination of specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or treatment.
- Device Description: The description focuses on the physical characteristics of the tray and its function in the reprocessing cycle of medical instruments.
- Performance Studies: The performance studies listed are related to the sterilization efficacy, cleaning validation, biocompatibility, and durability of the tray itself, not the analysis of biological samples.
- Lack of IVD Characteristics: There is no mention of reagents, calibrators, controls, or any other components typically associated with in vitro diagnostic devices.
The device is a medical device used in the reprocessing of other medical devices, specifically endoscopes.
N/A
Intended Use / Indications for Use
The instrument tray is intended to be used to enclose and protect one Olympus semi-rigid ureteroscope, models WA2UR11A, WA2UR12A, WA2UR14A, WA2UR21A, WA2UR22A, WA2UR22A, WA2UR23A WA2UR31A, and WA2UR32A (K200369), and accessories during sterilization in a prevacuum steam 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.
- Unwrapped non-porous instruments: 3 min.
- Exposure time at a temperature of 135 °C (275 °F:) Wrapped instruments .......................................................................................................................................................... Unwrapped non-porous instruments ................ 3 min.
- Drying time.........................................................................................................................30 min.
After steam sterilization, let the instrument tray cool down at room temperature.
- Cool-down time...............................................................................................................................30 min.
The instrument tray is also intended for the enclosure of Olympus semi-rigid ureteroscopes and accessories during transport and storage within the reprocessing cycle. The instrument tray is not compatible with flexible ureteroscopes.
The instrument tray is to be used in conjunction with a FDA cleared sterilization wrap. Maintenance of sterility depends on the sterilization wrap.
Worst case load:
The instrument tray containing a ureteroscope, attachments, light-guide cable adapters, sealing caps and stopcocks must not exceed a weight of 3300 grams (7.27 lb) altogether.
Product codes (comma separated list FDA assigned to the subject device)
KCT
Device Description
The instrument tray, for semi-rigid ureteroscope is specifically designed for enclosure of Olympus ureteroscopes and accessories during sterilization and storage of Olympus ureteroscopes and accessories after sterilization, as well as enclosure during transport within the reprocessing cycle. A loaded instrument tray cannot be used for automated cleaning of the contained devices.
The Olympus instrument tray 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The following performance data were provided in support of the equivalence determination. All standards applied are FDA recognized international standards.
| Name | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ISO 10993-5:2009 | Demonstration of biocompatibility for materials that contact the loaded devices | Non-cytotoxic under the conditions of the study | Pass |
| ISO 10993-12:2012 | Chemical analysis, and sample preparation | Non-cytotoxic under the conditions of the study | Pass |
| Cleaning validation | Demonstration of the efficacy of the cleaning procedure | Visibly clean Residual protein content less than 3 microgram/cm2 Residual TOC less than 12 microgram/cm2 | Pass |
| Half-cycle sterilization validation | Demonstration of 6 log reduction of stearothermophilus Geobacillus under half cycle conditions | No viable growth | Pass |
| Verification of tray durability after repeated sterilization cycles | Demonstration of tray durability over 400 sterilization cycles | No visible degradation No corrosion Legibility of markings | Pass |
| Evaluation of residual moisture | Demonstrate adequate drying time | No visible condensation or pooling on the wrap and contents free of visible condensation | Pass |
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
§ 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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG ADMINISTRATION" in blue as well. The FDA is a federal agency responsible for regulating and supervising the safety of food, drugs, and other products.
September 15, 2021
Olympus Winter & Ibe GmbH % Dolan Mills Principal Specialist. Regulatory Affairs Olympus Surgical Technologies America 118 Turnpike Road Southborough, Massachusetts 01772
Re: K203492
Trade/Device Name: Instrument tray, for semi-rigid ureteroscope Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: August 9, 2021 Received: August 10, 2021
Dear Dolan Mills:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Clarence W. Murray III -S
Clarence W. Murray, III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K203492
Device Name Instrument tray, for semi-rigid ureteroscope
Indications for Use (Describe)
The instrument tray is intended to be used to enclose and protect one Olympus semi-rigid ureteroscope, models WA2UR11A, WA2UR12A, WA2UR14A, WA2UR21A, WA2UR22A, WA2UR22A, WA2UR23A WA2UR31A, and WA2UR32A (K200369), and accessories during sterilization in a prevacuum steam 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. |
| Unwrapped non-porous instruments | 3 min. |
-
Exposure time at a temperature of 135 °C (275 °F:) Wrapped instruments .......................................................................................................................................................... Unwrapped non-porous instruments ................................ 3 min.
-
Drying time.........................................................................................................................30 min.
After steam sterilization, let the instrument tray cool down at room temperature. - Cool-down time...............................................................................................................................30 min.
The instrument tray is also intended for the enclosure of Olympus semi-rigid ureteroscopes and accessories during transport and storage within the reprocessing cycle. The instrument tray is not compatible with flexible ureteroscopes.
The instrument tray is to be used in conjunction with a FDA cleared sterilization wrap. Maintenance of sterility depends on the sterilization wrap.
Worst case load:
The instrument tray containing a ureteroscope, attachments, light-guide cable adapters, sealing caps and stopcocks must not exceed a weight of 3300 grams (7.27 lb) altogether.
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
2 510(k) Summary, K203492
2.1 General Information
| Manufacturer: | Olympus Winter & Ibe GmbH
Kuehnstr. 61
22045 Hamburg
Germany |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Establishment Registration Number: 9610773 |
| Official Correspondent: | Dolan Mills
Program Manager, Regulatory Affairs
Gyrus ACMI, Inc.
800 West Park Drive
Westborough, MA 01581
Phone: (901) 373-0236
Email: dolan.mills@olympus.com |
| | Establishment Registration Number: 3003790304 |
| Date Prepared: | Sept 15, 2021 |
2.2 Device Identification
| Proprietary name: | Instrument tray, for semi-rigid ureteroscope |
|---|---|
| Device Classification name: | Sterilization Wrap Containers, Trays, Cassettes & |
| Other Accessories | |
| Regulation Medical Specialty: | General Hospital |
| Regulation Number; Name: | 21CFR 880.6850; Sterilization wrap. |
| Product code; name; class: | KCT; Sterilization Wrap Containers, Trays, Cassettes |
| & Other Accessories; class II |
2.3 Predicate Device
The applicant device, Instrument tray, for semi-rigid ureteroscope, is considered substantially equivalent to legally marketed device of K171692, KCT, 21CFR 880.6850:
Instrument basket, for ENDOEYE
No reference devices were used in this submission.
5
2.4 Product Description
The instrument tray, for semi-rigid ureteroscope is specifically designed for enclosure of Olympus ureteroscopes and accessories during sterilization and storage of Olympus ureteroscopes and accessories after sterilization, as well as enclosure during transport within the reprocessing cycle. A loaded instrument tray cannot be used for automated cleaning of the contained devices.
The Olympus instrument tray 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.
2.5 Indications for Use
The instrument tray is intended to be used to enclose and protect one Olympus semirigid ureteroscope, models WA2UR11A, WA2UR12A, WA2UR13A, WA2UR14A, WA2UR21A, WA2UR22A, WA2UR23A, WA2UR31A, and WA2UR32A (K200369), and accessories during sterilization in a prevacuum steam sterilizer using the following parameters or cycles:
Prevacuum steam sterilization - Exposure time at a temperature of 132 °C (269.6 °F:) Wrapped instruments ..........................................................................................................................................................
Unwrapped non-porous instruments ......................................3 min.
-
Exposure time at a temperature of 135 °C (275 °F:) Wrapped instruments .......................................................................................................................................................... Unwrapped non-porous instruments ..................................3 min.
-
Drying time..........................................................................................................................30 min.
After steam sterilization, let the instrument tray cool down at room temperature. - Cool-down time....................................................................................................................30 min.
The instrument tray is also intended for the enclosure of Olympus semi-rigid ureteroscopes and accessories during transport and storage within the reprocessing cycle. The instrument tray is not compatible with flexible ureteroscopes.
The instrument tray is to be used in conjunction with a FDA cleared sterilization wrap. Maintenance of sterility depends on the sterilization wrap.
Worst case load:
6
The instrument tray containing a ureteroscope, attachments, light-guide cable, lightguide cable adapters, sealing caps and stopcocks must not exceed a weight of 3300 grams (7.27 lb) altogether.
2.6 Technological Characteristic Comparison with Predicate
Provided below is a technological comparison of the subject device with the predicate device.
| Item of
Comparison | Subject Device,
K203492 | Predicate Device,
K171692 | Evaluation of Differences |
|------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| General
technology | Perforated rigid
enclosure designed to
enclose Olympus
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. | Same |
| Indications for
Use | The instrument tray is
intended to be used to
enclose and protect one
Olympus semi-rigid
ureteroscope, models
WA2UR11A,
WA2UR12A,
WA2UR13A,
WA2UR14A,
WA2UR21A,
WA2UR22A,
WA2UR23A,
WA2UR31A, and
WA2UR32A
(K200369), and
accessories during
sterilization in a
prevacuum steam
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. | 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 | Similar |
| Item of
Comparison | Subject Device,
K203492 | Predicate Device,
K171692 | Evaluation of Differences |
| | Unwrapped non-porous
instruments .............3
min. -
Exposure time at a
temperature of 135 °C
(275 °F:)
Wrapped instruments
............3
min.
Unwrapped non-porous
instruments ............3
min. -
Drying
time............30 min.
After steam sterilization,
let the instrument tray
cool down at room
temperature. -
Cool-down
time............30 min.
The instrument tray is
also intended for the
enclosure of Olympus
semi-rigid ureteroscopes
and accessories during
transport and storage
within the reprocessing
cycle. The instrument
tray is not compatible
with flexible
ureteroscopes.
The instrument tray is to
be used in conjunction
with a FDA cleared
sterilization wrap.
Maintenance of sterility
depends on the
sterilization wrap.
Worst case load: The
instrument tray
containing a
ureteroscope,
attachments, light-guide
cable, light-guide cable | - 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). | |
| Item of | Subject Device, | Predicate Device, | Evaluation of Differences |
| Comparison | K203492 | K171692 | |
| | and stopcocks must not
exceed a weight of 3300
grams (7.27 lb)
altogether. | | |
| Intended to be
reused | Yes | Yes | Same |
| Device Setup | Consists of base with lid
(lid can be fastened by a
latching mechanism) | Consists of base with lid,
lid can be fastened by a
latching mechanism | Same |
| Percentage of
surface
perforation | About 39% | About 72% | Different |
| Microbial
barrier
properties | To be used with FDA
cleared sterilization
wrap | To be used with FDA
cleared sterilization
wrap | Same |
| Toxicological
properties | Under conditions of
the study, the
materials are non-
cytotoxic | Under conditions of
the study, the
materials are non-
cytotoxic | Same |
| Autoclavability
(steam
sterilization) of
empty
basket/tray | yes | yes | Same |
| Validated
Drying time
(steam
sterilization) | 30 minutes | 30 minutes | Same |
| Material | Stainless steel,
Silicone | Stainless steel,
Silicone | Same |
7
8
2.7 Summary of Non-clinical Testing
The following performance data were provided in support of the equivalence determination. All standards applied are FDA recognized international standards.
| Name | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ISO 10993-5:2009 | Demonstration of biocompatibility for materials that contact the loaded devices | Non-cytotoxic under the conditions of the study | Pass |
| ISO 10993-12:2012 | Chemical analysis, and sample preparation | Non-cytotoxic under the conditions of the study | Pass |
| Cleaning validation | Demonstration of the efficacy of the cleaning procedure | Visibly clean | |
| Residual protein content less than 3 microgram/cm2 | |||
| Residual TOC less than 12 microgram/cm2 | Pass |
9
| Name | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| Half-cycle | |||
| sterilization | |||
| validation | Demonstration of 6 log | ||
| reduction of | |||
| stearothermophilus | |||
| Geobacillus under half cycle | |||
| conditions | No viable growth | Pass | |
| Verification of tray | |||
| durability after | |||
| repeated sterilization | |||
| cycles | Demonstration of tray | ||
| durability over 400 | |||
| sterilization cycles | No visible degradation | ||
| No corrosion | |||
| Legibility of markings | Pass | ||
| Evaluation of residual | |||
| moisture | Demonstrate adequate drying | ||
| time | No visible condensation or | ||
| pooling on the wrap and | |||
| contents free of visible | |||
| condensation | Pass |
2.7.1 Applied standards
| Standard No. | Standard Title | FDA-Recognition
no + date |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| ISO
10993-1
Fourth Edition
2009 | Biological evaluation of medical devices - Part 1:
Evaluation and testing within a risk management process
[Including: Technical Corrigendum 1 (2010)] | 2-220
07/26/2016 |
| ISO
10993-5
Third Edition
2009 | Biological evaluation of medical devices -- Part 5: Tests
for In Vitro cytotoxicity | 2-245
12/23/2016 |
| ISO
10993-12
Fourth Edition
2012 | Biological evaluation of medical devices - Part 12:
Sample preparation and reference materials | 2-191
07/26/2016 |
| IEC
62366-1
Edition 1.0
2015-02 | Medical devices - Part 1: Application of usability
engineering to medical devices [Including
CORRIGENDUM 1 (2016)] | 5-114
12/23/2016 |
| ANSI AAMI
ST77
2013/(R)2018 | Containment devices for reusable medical device
sterilization | 14-396
01/14/2019 |
| ISO
14971
Second edition
2007 | Medical devices - Application of risk management to
medical devices | 5-40
06/27/2016 |
Table 2.1: Applied standards
2.8 Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the subject Instrument tray, for semi-rigid ureteroscope, is as safe, as effective and performs as
10
well as or better than the legally marketed predicate device, Instrument basket, for ENDOEYE (K171692).