(250 days)
Not Found
No
The device description and performance studies focus solely on the physical properties and sterilization efficacy of metal sterilization trays, with no mention of AI or ML.
No.
The device is a sterilization tray intended to encase and protect reusable medical devices for sterilization, not to treat any medical condition or disease.
No
This device is a sterilization tray intended to encase and protect reusable medical devices during steam sterilization. It does not perform any diagnostic function.
No
The device description clearly states it is a physical sterilization tray made of stainless steel mesh with a lid and silicone instrument holders. It is a hardware device.
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 trays are for "encasing and protecting specific KARL STORZ reusable medical devices for sterilization." This is a function related to the preparation and maintenance of medical devices, not for performing diagnostic tests on biological samples.
- Device Description: The description details the physical characteristics of the trays (metal mesh, latches, silicone holders) and their purpose in facilitating steam sterilization. There is no mention of reagents, samples, or any components typically associated with in vitro diagnostic testing.
- Performance Studies: The performance studies focus on sterilization efficacy, dry time, and cleaning effectiveness. These are relevant to the sterilization process of medical devices, not to the performance of a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
In summary, the KARL STORZ Metal Sterilization Trays are accessories used in the sterilization process of reusable medical devices. They do not perform any diagnostic function on biological samples, which is the defining characteristic of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The KARL STORZ Metal Sterilization Trays are intended only for use to encase and protect specific KARL STORZ reusable medical devices for sterilization in pre-vacuum steam sterilization cycle (132ºC for four minutes with a 20 minute dry time).
When used in conjunction with an FDA cleared sterility of the enclosed medical device is maintained until used.
The system has been validated with devices with working channels >= 0.2mm and a maximum length of 240mm.
Product codes (comma separated list FDA assigned to the subject device)
KCT
Device Description
The KARL STORZ-ENDOSCOPE Metal Sterilization Trays are intended only for use to encase various KARL STORZ reusable medical devices for sterilization in steam 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 are all baskets, available in various sizes, which are designed to encase KARL STORZ medical devices, such as light cables, instruments, rigid telescopes, semi-rigid telescopes, etc. All systems consist of a stainless steel metal mesh base and lid. Lids are attached to the trays with assembled hardware.
The sterilization trays are constructed from mesh material to allow for permeation of sterilant during sterilization. The mesh basket design has a higher percentage of open cells than metal mesh allowing for complete permeation. The trays have latches designed to fasten the lid onto the base. Other tray components include silicone instrument holders to secure instruments and provide protection of the medical devices in the sterilization tray.
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)
Pre-vacuum sterilization efficacy:
Purpose: Demonstrate sterilization capabilities.
Acceptance Criteria: 10-6 SAL
Result: PASSED
Pre-vacuum dry time:
Purpose: To establish minimum dry time.
Acceptance Criteria: Pre and Post Sterilization weight difference
§ 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, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.
July 6, 2021
Karl Storz Endoscopy America Inc % David Furr Consultant Toscano Consulting 8708 Capehart Cove Austin, Texas 78733
Re: K203198
Trade/Device Name: KARL STORZ Metal Sterilization Trays Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: May 26, 2021 Received: June 1, 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,
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 Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K203198
Device Name KARL STORZ Metal Sterilization Trays
Indications for Use (Describe)
The KARL STORZ Metal Sterilization Trays are intended only for use to encase and protect specific KARL STORZ reusable medical devices for sterilization in pre-vacuum steam sterilization cycle (132ºC for four minutes with a 20 minute dry time).
When used in conjunction with an FDA cleared sterility of the enclosed medical device is maintained until used.
The system has been validated with devices with working channels ≥ 0.2mm and a maximum length of 240mm. Intended Load & Maximum Weight Trav Catalog Number Dimensions
| 11580A | 7"x5.31"x1.46" | Sterilization of probes and dilators 1lb. (Karl Storz Instruments Only) |
|---|---|---|
| 11580B | 10.8"x6.9"x1.46" | Telescope sterilization tray 2.4lbs. |
| 11580C | 13.5"x7"x1.38" | Telescope sterilization tray 5lbs. |
| 11580D | 10.8"x6.9"x1.46" | Telescope sterilization tray 2.75lbs. |
| 39501A1 | 11.4"x2.36"x2" | Cleaning/sterilization basket: Rigid scope 1.25lbs. |
| 39501A2 | 13.9"x4.92"x2.13" | Cleaning/sterilization basket: 2 rigid scopes and LT cable 3.75lbs. |
| 39501B2 | 19"x4.9"x2.1" | Cleaning/Sterilization basket; 2 rigid scopes/1 LT cable 5lbs. |
| 39501BEC | 18.9"x4.9"x2.1" | Cleaning/sterilization basket: Scope & LT cable 3lbs |
| 39501C | 26.3"x3.1"x2" | Cleaning/sterilization basket for telescopes up to 670mm 2.5lbs |
| 39501CEC | 23.8"x4.9"x2.1" | Cleaning/sterilization basket: Scope & LT cable 3lbs |
| 39501F | 22.4"x3.15x2.05" | Cleaning/sterilization basket: Rigid endoscope 3.5lbs. |
| 39501LC2 | 10.24"x4.72"x6.7" | Cleaning/sterilization basket: Laryngoscope blades and module 3.2lbs |
| 39501X | 25.3"x5.9"x3.1" | Cleaning/sterilization basket for telescopes up to 43cm 2.4lbs |
| 39501XK | 18.11"x5.9"x3.15" | Cleaning/sterilization basket: telescopes 2.4lbs |
| 39501XP | 18.11"x5.9"x3.15" | Cleaning/Sterilization basket for telescopes 2.4lbs |
| 39550A | 18.9"x9.84"x2.36" | Cleaning/Sterilization basket: shaver and cable 3.25lbs. |
l ype of Use elect 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 Pursuant to 21 CFR 807.92 K203198
Date: May 26, 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
8708 Capehart Cove
Austin, Texas 78733
512-906-9654 |
| 3. | Product: | KARL STORZ Sterilization Trays- Metal K203198
Product code: KCT - Class II (21 CFR 880.6850) |
| 4. | Common/Classification
Name:
Predicate devices: | Sterilization wrap/container
Symmetry Medical Polyvac Surgical Instrument Delivery
System K012105 |
Description:
The KARL STORZ-ENDOSCOPE Metal Sterilization Trays are intended only for use to encase various KARL STORZ reusable medical devices for sterilization in steam 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 are all baskets, available in various sizes, which are designed to encase KARL STORZ medical devices, such as light cables, instruments, rigid telescopes, semi-rigid telescopes, etc. All systems consist of a stainless steel metal mesh base and lid. Lids are attached to the trays with assembled hardware.
The sterilization trays are constructed from mesh material to allow for permeation of sterilant during sterilization. The mesh basket design has a higher percentage of open cells than metal mesh allowing for complete permeation. The trays have latches designed to fasten the lid onto the base. Other tray components include silicone instrument holders to secure instruments and provide protection of the medical devices in the sterilization tray.
5
510(k) Premarket Notification KARL STORZ Sterilization Travs- Metal
Intended Use:
The KARL STORZ Metal Sterilization Trays are intended to protect medical device instrumentation and facilitate the sterilization process by sterilant penetration and air removal. When used in conjunction with an FDA cleared sterilization wrap, sterility of the enclosed medical device is maintained until used.
KARL STORZ has validated the KARL STORZ Metal Sterilization Trays for use in steam sterilizers. Most of the metal sterilization trays are used with rigid telescopes, instruments and cables that do not have lumens. The system was validated with a miniature scope with an irrigation channel lumen diameter of 0.2mm and a length of 240mm.
Comparison of Technological Characteristics:
The KARL STORZ Metal Sterilization Trays are comparable to Symmetry Medical Polyvac Surgical Instrument Delivery System (K012105). The Symmetry Medical system also includes plastic and hybrid trays however only the Symmetry Medical metal tray are considered as a predicate.
Steam enters the KARL STORZ metal sterilization trays through mesh openings in the tray base and lid. After sterilization, sterility is maintained by the FDA cleared sterilization wrap. All of these characteristics are the same as the predicate device.
The devices and the predicate have essentially the same indications for use and perform in a similar manner.
| Element of
Comparison | 510(k) Device:
KARL STORZ Metal
Sterilization Trays | 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 | None |
| Indications for Use | The KARL STORZ Metal
Sterilization Trays are
intended only for use to
encase and protect
specific KARL STORZ
reusable medical devices
for sterilization in pre-
vacuum steam
sterilization cycles (132°C
for four minutes with a 20
minute dry time).
When used in conjunction
with an FDA cleared
sterilization wrap, sterility
of the enclosed medical
device is maintained until
used. | 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 | Similar |
6
| | The system has been
validated with devices
with working channels $\geq$
0.2mm and a maximum
length of 240mm.
(See IFU for table of part
numbers & contents) | 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 132°C 30
minutes minimum and
gravity steam 121°C 55
minutes minimum. | |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Principal Material of
Construction | Stainless steel metal
mesh | Thermoformed Radel
Polyphenylsulfone,
stainless steel or
aluminum | Different |
7
| KARL STORZ Model
| Numbers | 16 models 11580A 11580B 11580C 11580D 39501A1 39501A2 39501B2 39501BEC 39501C 39501CEC 39501F 39501LC2 39501X 39501XK 39501XP 39550A | N/A | Different |
|---|---|---|---|
| Dimensional | |||
| Configuration Range | Sizes available in inches: 7"x5.31"x1.46" 10.8"x6.9"x1.46" 13.5"x7"x1.38" 10.8"x6.9"x1.46" 11.4"x2.36"x2" 13.9"x4.92"x2.13" 19"x4.9"x2.1" 18.9"x4.9"x2.1" 26.3"x3.1"x2" 23.8"x4.9"x2.1" 22.4"x3.15x2.05" 10.24"x4.72"x6.7" 25.3"x5.9"x3.1" 18.11"x5.9"x3.15" 18.11"x5.9"x3.15" 18.9"x9.84"x2.36" | Approximate sizes | |
| available in inches: 7x2x1 7x3x1 8x4x1 11x7x1 21x10x4 17x10x4 17x8x2 15x10x1.5 20.5x9.7x5 20x10x3 26x9x6 17x3.5x1.5 And others | Similar | ||
| Device Manufacturer | Contract manufactured | ||
| for KARL STORZ by | |||
| Helmut Zepf | |||
| Medizintechnik GmbH | |||
| and HUPFER | |||
| Metallwerke GmbH | Manufactured by | ||
| Tecomet (formerly | |||
| Symmetry Medical) | Different | ||
| Sterilization Cycles | Prevacuum Steam 4 | ||
| minute cycle 132°C | |||
| Drying time 20 minutes | Prevacuum Steam 4 | ||
| minute cycle 132°C 20- | |||
| 40 minutes drying | |||
| time; gravity steam | |||
| 132°C for 30 minutes | |||
| or 121°C for 55 | |||
| minutes 20-50 minutes | |||
| drying time | Similiar | ||
| Load | Trays are to be loaded | ||
| with KARL STORZ | |||
| instruments | Various loads up to 25 | ||
| lbs. | KARL STORZ trays are used with | ||
| KARL STORZ instruments with a total | |||
| load of |