(227 days)
Not Found
No
The device description and performance studies focus on the physical properties and sterilization compatibility of the trays, with no mention of AI or ML.
No
The device is a sterilization tray used to encase and protect medical devices during sterilization; it does not directly treat or diagnose medical conditions.
No
Explanation: The device, KARL STORZ UDEL Sterilization Trays, is intended to encase and protect reusable medical devices for sterilization. It does not perform any diagnostic function.
No
The device is a physical sterilization tray made of Udel plastic and silicone, designed to hold and protect medical devices during sterilization. It is not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "to encase and protect specific KARL STORZ reusable medical devices for sterilization". This is a function related to the processing and sterilization of medical devices, not for performing diagnostic tests on biological samples.
- Device Description: The description details the physical components and materials of the trays, designed for holding and protecting instruments during sterilization. There is no mention of reagents, assays, or any components used for analyzing biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances or markers
- Providing information for diagnosis, monitoring, or treatment decisions based on sample analysis.
The device is a sterilization accessory, designed to facilitate the sterilization of other medical devices.
N/A
Intended Use / Indications for Use
The KARL STORZ UDEL Sterilization Trays are intended only for use to encase and protect specific KARL STORZ reusable medical devices for sterilization in STERRAD and steam sterilization systems as indicated in the attached table. The system may be used with flexible endoscopes with lumen diameters ≥ 1.2mm and a maximum length of 845mm. KARL STORZ UDEL Sterilization Trays must be used in conjunction with an FDA cleared sterilization wrap or container.
Product codes
KCT
Device Description
The KARL STORZ UDEL Sterilization Trays are intended only for use to encase specific KARL STORZ reusable medical devices for sterilization in steam and specified STERRAD Sterilization System cycles. The sterilization trays are not intended to maintain sterility by themselves. Prior to sterilization, the trays must be double-wrapped with an appropriate FDA-cleared sterilization wrap to provide a microbial barrier which allows sterilant to permeate throughout the interior of the loaded tray.
The tray configurations, available in various sizes, are designed to encase specific KARL STORZ medical devices, such as fiber optic light cable, flexible endoscopes, and camera heads. Some of the trays are specifically molded to fit and accommodate KARL STORZ light cables, flexible endoscopes, camera heads and rigid telescopes, allowing the instruments to be arranged in an organized manner when placed in the tray. All systems consist of a Udel plastic base and Udel plastic lid. Lids are attached to the trays with assembled hardware. Baskets are injection molded and trays are thermoformed from Udel polysulfone polymer (sourced from Solvay Specialty Polymers), which is compatible with all indicated sterilization modes.
The sterilization trays are constructed with a perforated lid and base to allow for permeation of sterilant during sterilization. Some of the tray configurations are simply molded into the form of a mesh. The trays have latches designed to fasten the lid onto the base. Other tray components include silicone holders and mats (depending on the tray type) to secure instruments and provide protection of the medical devices in the sterilization tray. The holders and mats are manufactured from silicone material, which is also compatible with all sterilization modes.
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 testing was conducted or is referenced to establish efficacy. Worst case tray configurations were used to represent all trays.
- STERRAD 100S sterilization efficacy: AAMI ST77 Containment Devices for Reusable Medical Device Sterilization; ISO 14937 Sterilization of Health Care Products – General Requirements for the Characterization of a Sterilizing Agent and the Development, Validation and Routine Control of a Sterilization Process for Medical Devices. Test Result: 10-6 SAL PASSED.
- STERRAD NX standard and advanced cycle sterilization efficacy: AAMI ST77 Containment Devices for Reusable Medical Device Sterilization; ISO 14937 Sterilization of Health Care Products – General Requirements for the Characterization of a Sterilizing Agent and the Development, Validation and Routine Control of a Sterilization Process for Medical Devices. Test Result: 10-6 SAL PASSED.
- STERRAD 100NX flex cycle sterilization efficacy: AAMI ST77 Containment Devices for Reusable Medical Device Sterilization; ISO 14937 Sterilization of Health Care Products – General Requirements for the Characterization of a Sterilizing Agent and the Development, Validation and Routine Control of a Sterilization Process for Medical Devices. Test Result: 10-6 SAL PASSED.
- Pre-vacuum sterilization efficacy: AAMI ST77 Containment Devices for Reusable Medical Device Sterilization; ISO 17665-1 Sterilization of Health Care Products – Moist Heat - Part 1 Requirements for the Development, Validation, and Routine Control of a Sterilization Process for Medical Devices. Test Result: 10-6 SAL PASSED.
- Pre-vacuum dry time: AAMI ST77 Containment Devices for Reusable Medical Device Sterilization; ISO 17665-1 Sterilization of Health Care Products – Moist Heat - Part 1 Requirements for the Development, Validation, and Routine Control of a Sterilization Process for Medical Devices. Test Result: Establish Minimum Dry Time ESTABLISHED.
- Gravity sterilization efficacy: AAMI ST77 Containment Devices for Reusable Medical Device Sterilization; ISO 17665-1 Sterilization of Health Care Products – Moist Heat - Part 1 Requirements for the Development, Validation, and Routine Control of a Sterilization Process for Medical Devices. Test Result: 10-6 SAL PASSED.
- Gravity dry time: AAMI ST77 Containment Devices for Reusable Medical Device Sterilization; ISO 17665-1 Sterilization of Health Care Products – Moist Heat - Part 1 Requirements for the Development, Validation, and Routine Control of a Sterilization Process for Medical Devices. Test Result: Establish Minimum Dry Time ESTABLISHED.
- Manual Cleaning – Protein, Hemoglobin: AAMI TIR 30 A Compendium of Processes, Materials, Test Methods, and Acceptance Criteria for Cleaning Reusable Medical Devices. Test Result:
§ 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 contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 25, 2021
Karl Storz EndoscopyAmerica Inc % David Furr Consultant Toscano Consulting 8708 Capehart Cove Austin, Texas 78733
Re: K201945
Trade/Device Name: KARL STORZ UDEL Sterilization Trays Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: January 26, 2021 Received: January 28, 2021
Dear David Furr:
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,
for Clarence W. Murray, III, Ph.D Acting 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) K201945
Device Name KARL STORZ UDEL Sterilization Trays
Indications for Use (Describe)
The KARL STORZ UDEL Sterilization Trays are intended only for use to encase and protect specific KARL STORZ reusable medical devices for sterilization in STERRAD and steam sterilization systems as indicated table. The system may be used with flexible endoscopes with lumen diameters ≥ 1.2mm and a maximum length of 845mm. KARL STORZ UDEL Sterilization Trays must be used in conjunction with an FDA cleared sterilization wrap or container.
| 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)
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3
| Tray Name | Intended Content
KARL STORZ Instruments Only | STERRAD® 100S | STERRAD® NX
Standard Cycle | STERRAD® NX
Advanced Cycle | STERRAD® 100NX
Standard Cycle | STERRAD® 100NX
Flex Cycle | Steam
Pre-vacuum 132°C 4 minutes
See Dry Time in Table | Steam
Gravity Cycle 121°C 30 minutes
See Dry Time in Table | Product Load and Maximum Weight |
|----------------------------------------------------------------------------------------------------|-------------------------------------------------|----------------|-------------------------------|---------------------------------|----------------------------------|------------------------------|---------------------------------------------------------------------------|---------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| Flexible Endoscope Tray,
P/N 39401AS | Flexible Endoscope | Non-Lumen Only | | Note: Tray does not fit chamber | | | Note: Flexible endoscopes cannot be autoclaved | Note: Flexible endoscopes cannot be autoclaved | 1 flexible fiberscope
5.76 lbs. |
| Flexible Endoscope Tray,
P/N 39402AS | Flexible Endoscope | Non-Lumen Only | | ✓ | | ✓ | Note: Flexible endoscopes cannot be autoclaved | Note: Flexible endoscopes cannot be autoclaved | 1 flexible fiberscope
1 fiber optic light cable
8.18 lbs. |
| Flexible Video Endoscope Tray,
P/N 39403AS | Flexible CCD Video Endoscope | Non-Lumen Only | | ✓ | | ✓ | Note: Flexible video endoscopes cannot be autoclaved | Note: Flexible video endoscopes cannot be autoclaved | 1 flexible CCD video endoscope
5.28 lbs. |
| Flexible Endoscope Tray,
P/N 39406AS | Flexible CMOS Video Endoscope | Non-Lumen Only | | ✓ | | ✓ | Note: Flexible video endoscopes cannot be autoclaved | Note: Flexible video endoscopes cannot be autoclaved | 1 flexible CMOS video endoscope
5.23 lbs. |
| Camera Trays
P/N 39301HCTS
P/N 39301PHTS
P/N 39301BCTS | Non-autoclave-able camera heads | | ✓ | ✓ | | ✓ | Note: Steam is not indicated when used with non-autoclavable camera heads | Note: Steam is not indicated when used with non-autoclavable camera heads | 1 camera head
2.82 lbs. (HCTS)
2.64 lbs. (PHTS)
4.32 lbs. (BCTS) |
| Camera Trays
P/N 39301HCTS
P/N 39301ACTS
P/N 39301PHTS | Autoclave-able camera heads | | ✓ | ✓ | | ✓ | Minimum Dry Time 50 minutes | Minimum Dry Time 80 minutes | 1 camera head
2.82 lbs. (HCTS)
3.08 lbs. (ACTS)
2.64 lbs. (PHTS) |
| Rigid Telescope Trays
P/N 39301AS
P/N 39301BS
P/N 39301CS
P/N 39301DS | Rigid Telescopes
(Non-Lumen only) | | ✓ | ✓ | | ✓ | Minimum Dry Time 30 minutes | Minimum Dry Time 80 minutes | 2 Telescopes
2.71 lbs. (AS)
3.21 lbs. (CS)
3.71 lbs. (DS)
4 Telescopes
6.86 lbs. (BS) |
| Rigid Telescope Tray
P/N 39301C1S | Rigid Telescopes
(Non-Lumen only) | | ✓ | ✓ | | ✓ | Pre-Vacuum Only Minimum Dry Time 30 minutes | | 1 rigid telescope
1 fiber optic cable
3.17 lbs. |
| Rigid Telescope Trays
P/N 39311AS
P/N 39314FS | Rigid Telescopes
(Non-Lumen only) | | ✓ | ✓ | | ✓ | Pre-Vacuum Only Minimum Dry Time 30 minutes | | 4 rigid telescopes
1 fiber optic cable
6.86 lbs. (AS)
8.12 lbs. (FS) |
| Rigid Telescope Tray,
P/N 39311BS | Rigid Telescopes
(Non-Lumen Only) | | ✓ | ✓ | | ✓ | Pre-Vacuum Only Minimum Dry Time 30 minutes | | 2 rigid telescopes
1 fiber optic cable
4.9 lbs. |
| Basket-Style Rigid Telescope Trays
P/N 39305C1S
P/N 39305C2S
P/N 39305L1S
P/N 39305L2S | Rigid Telescopes
(Non-Lumen only) | | ✓ | ✓ | | ✓ | Pre-Vacuum Only Minimum Dry Time 30 minutes | | 1 rigid telescope
1.58 lbs (C1S)
1.58 lbs (L1S)
2 rigid telescopes
2.56 lbs. (C2S)
2.56 lbs. (L2S) |
4
510(k) Summary - K201945
Date: February 24, 2021
| 1. | Submitted By: | KARL STORZ Endoscopy-America, Inc.
2151 E. Grand Ave.
El Segundo, California 90245
424-218-8376 |
|----|------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. | Contact: | David C. Furr
Toscano Consulting Group, Inc.
8708 Capehart Cove
Austin, Texas 78733
512-906-9654 |
| 3. | Product: | KARL STORZ UDEL Sterilization Trays
Product code: KCT - Class II (21 CFR 880.6850) |
| 4. | Common/Classification
Name:
Predicate devices: | Sterilization wrap/container
KARL STORZ- Endoscope Sterilization Trays K090818
Symmetry Medical Polyvac Surgical Instrument Delivery System K012105 |
Description:
The KARL STORZ UDEL Sterilization Trays are intended only for use to encase specific KARL STORZ reusable medical devices for sterilization in steam and specified STERRAD Sterilization System cycles. The sterilization trays are not intended to maintain sterility by themselves. Prior to sterilization, the trays must be double-wrapped with an appropriate FDA-cleared sterilization wrap to provide a microbial barrier which allows sterilant to permeate throughout the interior of the loaded tray.
The tray configurations, available in various sizes, are designed to encase specific KARL STORZ medical devices, such as fiber optic light cable, flexible endoscopes, and camera heads. Some of the trays are specifically molded to fit and accommodate KARL STORZ light cables, flexible endoscopes, camera heads and rigid telescopes, allowing the instruments to be arranged in an organized manner when placed in the tray. All systems consist of a Udel plastic base and Udel plastic lid. Lids are attached to the trays with assembled hardware. Baskets are injection molded and trays are thermoformed from Udel polysulfone polymer (sourced from Solvay Specialty Polymers), which is compatible with all indicated sterilization modes.
The sterilization trays are constructed with a perforated lid and base to allow for permeation of sterilant during sterilization. Some of the tray configurations are simply molded into the form of a mesh. The trays have latches designed to fasten the lid onto the base. Other tray components include silicone holders and mats (depending on the tray type) to secure instruments and provide protection of the medical devices in the sterilization tray. The holders and mats are manufactured from silicone material, which is also compatible with all sterilization modes.
5
Intended Use:
The KARL STORZ UDEL Sterilization Trays are intended only for use to encase and protect specific KARL STORZ reusable medical devices for sterilization in STERRAD and steam sterilization systems as indicated in the attached table. The system may be used with flexible endoscopes with lumen diameters ≥ 1.2mm and a maximum length of 845mm.
KARL STORZ UDEL Sterilization Trays must be used in conjunction with an FDA cleared sterilization wrap or container.
| Tray Name | Intended
Content | STERRAD®
100S | STERRAD® NX | | STERRAD®
100NX | | Steam
Pre-vacuum
132°C 4 minutes
See Dry Time in
Table | Steam
Gravity Cycle
121°C 30
minutes
See Dry Time in
Table | Product Load and
Maximum Weight |
|-------------------------------------------------------------------------------------------------------------|--------------------------------------------|----------------------------------------------------------------|-------------------------------------------|-------------------------------------------|-------------------------------------------|-------------------------------------------|----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| | KARL STORZ
Instruments
Only | | Standard
Cycle | Advanced
Cycle | Standard
Cycle | Flex
Cycle | | | |
| Flexible Endoscope
Tray,
P/N 39401AS | Flexible
Endoscope | ✓
Non-Lumen
Only | | Note: Tray
does not fit
chamber | | ✓ | Note:
Flexible endoscopes
cannot be autoclaved | Note:
Flexible endoscopes
cannot be autoclaved | 1 flexible fiberscope
5.76 lbs. |
| Flexible Endoscope
Tray, P/N 39402AS | Flexible
Endoscope | ✓
Non-Lumen
Only | | ✓ | | ✓ | Note:
Flexible endoscopes
cannot be autoclaved | Note:
Flexible endoscopes
cannot be autoclaved | 1 flexible fiberscope
1 fiber optic light
cable
8.18 lbs. |
| Flexible Video
Endoscope Tray,
P/N 39403AS | Flexible CCD
Video
Endoscope | ✓
Non-Lumen
Only | | ✓ | | ✓ | Note:
Flexible video
endoscopes cannot
be autoclaved | Note:
Flexible video
endoscopes cannot
be autoclaved | 1 flexible CCD video
endoscope
5.28 lbs. |
| Flexible Endoscope
Tray,
P/N 39406AS | Flexible
CMOS Video
Endoscope | ✓
Non-Lumen
Only | | ✓ | | ✓ | Note:
Flexible video
endoscopes cannot
be autoclaved | Note:
Flexible video
endoscopes cannot
be autoclaved | 1 flexible CMOS
video endoscope
5.23 lbs. |
| Camera Trays
P/N 39301HCTS
P/N 39301PHTS
P/N 39301BCTS | Non-
autoclave-able
camera heads | ✓ | ✓ | ✓ | ✓ | ✓ | Note: Steam is not
indicated when used
with non-
autoclavable camera
heads | Note: Steam is not
indicated when used
with non-
autoclavable camera
heads | 1 camera head
2.82 lbs (HCTS)
2.64 lbs. (PHTS)
4.32 lbs. (BCTS) |
| Camera Trays
P/N 39301HCTS
P/N 39301ACTS
P/N 39301PHTS | Autoclave-able
camera heads | ✓ | ✓ | ✓ | ✓ | ✓ | Minimum Dry Time
50 minutes | Minimum Dry Time 80
minutes | 1 camera head
2.82 lbs (HCTS)
3.08 lbs. (ACTS)
2.64 lbs. (PHTS) |
| Rigid Telescope
Trays
P/N
39301AS
P/N
39301BS
P/N
39301CS
P/N 39301DS | Rigid
Telescopes
(Non-Lumen only) | ✓ | ✓ | ✓ | ✓ | ✓ | Minimum Dry Time
30 minutes | Minimum Dry Time 80
minutes | 2 Telescopes
2.71 lbs. (AS)
3.21 lbs. (CS)
3.71 lbs. (DS) 4
Telescopes
6.86 lbs. (BS) |
| Rigid Telescope
Tray
P/N
39301C1S | Rigid
Telescopes
(Non-Lumen only) | ✓ | ✓ | ✓ | ✓ | ✓ | Pre-Vacuum Only
Minimum Dry Time
30 minutes | | 1 rigid telescope 1
fiber optic cable
3.17 lbs. |
| Rigid Telescope
Trays
P/N 39311AS
P/N 39314FS | Rigid
Telescopes
(Non-Lumen only) | ✓ | ✓ | ✓ | ✓ | ✓ | Pre-Vacuum Only
Minimum Dry Time
30 minutes | | 4 rigid telescopes 1
fiber optic cable
6.86 lbs. (AS)
8.12 lbs. (FS) |
| Rigid Telescope
Tray,
P/N 39311BS | Rigid
Telescopes
(Non-Lumen
Only) | ✓ | ✓ | ✓ | ✓ | ✓ | Pre-Vacuum Only
Minimum Dry Time
30 minutes | | 2 rigid telescopes
1 fiber optic cable
4.9 lbs. |
| Basket-Style Rigid
Telescope Trays
P/N 39305C1S
P/N
39305C2S
P/N
39305L1S
P/N 39305L2S | Rigid
Telescopes
(Non-Lumen only) | ✓ | ✓ | ✓ | ✓ | ✓ | Pre-Vacuum Only
Minimum Dry Time
30 minutes | | 1 rigid telescope
1.58 lbs (C1S)
1.58 lbs (L1S)
2 rigid telescopes
2.56 lbs. (C2S)
2.56 lbs. (L2S) |
6
Comparison of Technological Characteristics:
The KARL STORZ UDEL Sterilization Trays are intended to protect medical device instrumentation and facilitate the sterilization process by sterilant penetration and air removal.
The KARL STORZ UDEL Sterilization Trays are predicated on the original KARL STORZ Endoskope Sterilization Trays (K090818). Three of the devices, 39301HCTC, 39402AS and 39301BS, are identical to this predicate with the exception of additional indications. In addition the Symmetry Medical Polyvac Surgical Instrument Delivery System (K012105) is included as a predicate for steam applications.
Tray configurations and loads are the same as the devices which were included in KARL STORZ previous 510(k) K090818. Additional tray configurations have been added and validated based on comparison of worst-case vent to volume factors and load.
Sterilant enters the KARL STORZ UDEL sterilization trays through perforations in the tray base and lid. After sterilization, sterility is maintained by an FDA cleared sterilization wrap. All of these characteristics are the same as the predicate devices.
All trays including all the predicate devices are manufactured by the same supplier using the same manufacturing processes.
7
| Element of
Comparison | 510(k) Device:
KARL STORZ UDEL
Sterilization Trays | Predicate Device:
KARL STORZ
Endoskope Sterilization
Trays (K090818) | Predicate Device:
Symmetry Medical Polyvac
Surgical Instrument
Delivery System
(K012105) | Explanation of Differences |
|-----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation
and Product
Classification
Code | 21 CFR 880.6850
KCT | 21 CFR 880.6850
KCT | 21 CFR 880.6850
KCT | None |
| Indications
for Use | The KARL STORZ
UDEL Sterilization Trays
are intended only for use
to encase and protect
specific KARL STORZ
reusable medical devices
for sterilization in
STERRAD and steam
sterilization systems as
indicated in the attached
table. The system may be
used with flexible
endoscopes with lumen
diameters ≥ 1.2mm and a
maximum length of
845mm.
KARL STORZ UDEL
Sterilization Trays must
be used in conjunction
with an FDA cleared
sterilization wrap or
container. | The KARL STORZ
Endoskope Sterilization
Trays are intended only
for use to encase and
protect specific KARL
STORZ reusable medical
devices for sterilization in
STERRAD 100S and NX
sterilization systems as
indicated. STERRAD
Sterilization Systems are
pre-set and cycle
parameters cannot be
adjusted. Table 1
provides sterilization
compatibility for
STERRAD Sterilization
Cycles and max load with
KARL STORZ-
Endoskope Sterilization
Trays & Instruments.
(Table provided in IFU) | Polyvac's Delivery Systems
consist of perforated trays
with lids, which are
intended to enclose and
protect medical device
instrumentation, and to
facilitate the sterilization
processing by allowing
steam penetration and air
removal, when used in
conjunction with an
approved sterilization wrap.
Sterility of the enclosed
medical devices maintained
until used. Polyvac's
Delivery Systems are to be
sterilized in one of the
following cycles: pre
vacuum steam, 132°C 4
minutes minimum, gravity
steam 132ºC 30 minutes
minimum and gravity steam
121°C 55 minutes
minimum. | The new system can be used for
any of the three sterilization
methods cited in the predicates.
The new indications for use
includes all three methods. |
| Principal
Material of
Construction | Thermoformed or
injection molded Udel
Polysulfone | Thermoformed or
injection molded Udel
Polysulfone | Thermoformed Radel
Polyphenylsulfone or
aluminum | Udel trays are made from the
identical material as the KARL
STORZ predicate; Most
Symmetry Medical predicates are
made from Radel, a similarly
performing polymer in steam
cycles |
| Element of
Comparison | 510(k) Device:
KARL STORZ
UDEL
Sterilization Trays | Predicate Device:
KARL STORZ
Endoskope Sterilization
Trays (K090818) | Predicate Device:
Symmetry Medical Polyvac
Surgical Instrument
Delivery System
(K012105) | Explanation of Differences |
| KARL
STORZ
Model
Numbers | 20 models
• 39301PHTS
• 39301HCTS
• 39301ACTS
• 39301BCTS
• 39401AS
• 39402AS
• 39403AS
• 39406AS
• 39311BS
• 39301DS
• 39314FS
• 39311AS
• 39301C1S
• 39301CS
• 39301AS
• 39301BS
• 39305C1S
• 39305C2S
• 39305L1S
• 39305L2S | 3 models
• 39301HCTS
• 39402AS
• 39301BS | N/A | Additional models have been
added for this submission.
Symmetry Medical model
numbers from previous
submissions are not related. |
| Dimensional
Configuration
Range | Approximate sizes
available in inches (see
product description chart
Section 4.2 for exact
dimensions by catalog
number):
• 15x10x2.5
• 27x7x4
• 21x10x4
• 21x10x3
• 26x4x3
• 20x9x4
• 13x9x2
• 21x3.5x2
• 12x3.5x2
• 17x3.5x2
• 19x4x9 | Approximate sizes
available in inches:
• 15x10x2.5
• 22x10x4
• 17x3.5x2 | Approximate sizes
available in inches:
• 7x2x1
• 7x3x1
• 8x4x1
• 11x7x1
• 21x10x4
• 17x10x4
• 17x8x2
• 15x10x1.5
• 20.5x9.7x5
• 20x10x3
• 26x9x6
• 17x3.5x1.5
• And others | 3 of the KARL STORZ trays are
identical to the KARL STORZ
predicate and the others fall into
very similar size ranges. |
| Device
Manufacturer | Contract manufactured
for KARL STORZ by
Tecomet | Contract manufactured
for KARL STORZ by
Tecomet | Manufactured by Tecomet
(formerly Symmetry
Medical) | None. All trays are manufactured
in the same location by Tecomet |
| Sterilization
Cycles | Prevacuum Steam
4 minute cycle 132°C,
Gravity Steam 30 mins
121 °C
STERRAD 100S, NX,
and 100NX cycles | STERRAD 100S, NX,
and 100NX cycles | Prevacuum Steam and
Gravity Steam Cycles | Subject device can be used in the
predicate device cycles as
specified in the Indications. |
| Load | Trays are to be loaded
with specific KARL
STORZ instruments | Trays are to be loaded
with specific KARL
STORZ instruments | Various loads up to 25 lbs. | KARL STORZ trays are used with
specific instruments and
Symmetry predicates are general |
8
510(k) Premarket Notification
9
Summary of Non-Clinical Testing:
The following testing was conducted or is referenced to establish efficacy. Worst case tray configurations were used to represent all trays.
| Type of Testing | Primary Standard(s) Used
(as applicable) | Test Criteria
and Result |
|----------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| STERRAD 100S sterilization efficacy | AAMI ST77 Containment Devices for Reusable Medical Device Sterilization
ISO 14937 Sterilization of Health Care Products – General Requirements for the Characterization of a Sterilizing Agent and the Development, Validation and Routine Control of a Sterilization Process for Medical Devices | 10-6 SAL
PASSED |
| STERRAD NX standard and advanced cycle sterilization efficacy | AAMI ST77 Containment Devices for Reusable Medical Device Sterilization
ISO 14937 Sterilization of Health Care Products – General Requirements for the Characterization of a Sterilizing Agent and the Development, Validation and Routine Control of a Sterilization Process for Medical Devices | 10-6 SAL
PASSED |
| STERRAD 100NX flex cycle sterilization efficacy | AAMI ST77 Containment Devices for Reusable Medical Device Sterilization
ISO 14937 Sterilization of Health Care Products – General Requirements for the Characterization of a Sterilizing Agent and the Development, Validation and Routine Control of a Sterilization Process for Medical Devices | 10-6 SAL
PASSED |
| Pre-vacuum sterilization efficacy | AAMI ST77 Containment Devices for Reusable Medical Device Sterilization
ISO 17665-1 Sterilization of Health Care Products – Moist Heat - Part 1 Requirements for the Development, Validation, and Routine Control of a Sterilization Process for Medical Devices | 10-6 SAL
PASSED |
| 510(k) Premarket Notification
KARL STORZ UDEL Sterilization Trays | | |
| Type of Testing | Primary Standard(s) Used
(as applicable) | Test Result |
| Pre-vacuum dry time | AAMI ST77 Containment Devices for
Reusable Medical Device Sterilization
ISO 17665-1 Sterilization of Health
Care Products – Moist Heat - Part 1
Requirements for the Development,
Validation, and Routine Control of a
Sterilization Process for Medical
Devices | Establish
Minimum Dry
Time
ESTABLISHED |
| Gravity sterilization efficacy | AAMI ST77 Containment Devices for
Reusable Medical Device Sterilization
ISO 17665-1 Sterilization of Health
Care Products – Moist Heat - Part 1
Requirements for the Development,
Validation, and Routine Control of a
Sterilization Process for Medical
Devices | 10-6 SAL
PASSED |
| Gravity dry time | AAMI ST77 Containment Devices for
Reusable Medical Device Sterilization
ISO 17665-1 Sterilization of Health
Care Products – Moist Heat - Part 1
Requirements for the Development,
Validation, and Routine Control of a
Sterilization Process for Medical
Devices | Establish
Minimum Dry
Time
ESTABLISHED |
| Manual Cleaning – Protein,
Hemoglobin | AAMI TIR 30 A Compendium of
Processes, Materials, Test Methods, and
Acceptance Criteria for Cleaning
Reusable Medical Devices |