(151 days)
Not Found
No
The device description and performance studies focus solely on the physical properties and sterilization efficacy 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, not to provide therapy directly to a patient.
No
The device is a sterilization tray used to encase and protect reusable medical devices during the pre-vacuum steam sterilization process; it does not perform any diagnostic function.
No
The device description clearly outlines physical components made of RADEL plastic, silicone rubber, and assembled hardware. It is a physical sterilization tray, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the trays are for "encase and protect specific KARL STORZ reusable medical devices for sterilization." This is a function related to the processing and handling of medical devices, not for performing tests on biological samples to diagnose conditions.
- Device Description: The description focuses on the physical characteristics of the trays and their purpose in holding and protecting instruments during sterilization. There is no mention of reagents, assays, or any components used for in vitro testing.
- 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.)
- Providing diagnostic information
- Using reagents or assays
- Measuring analytes
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 RADEL 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 4 minutes).
The KARL STORZ RADEL Sterilization Trays are intended to protect medical device instrumentation. When used in conjunction with an FDA cleared sterilization wrap.
KARL STORZ has validated the KARL STORZ RADEL Sterilization Trays for use in pre-vacuum steam sterilizers. The system was validated with a miniature scope with an irrigation chameter of 0.25mm and a length of 240mm and a semi-rigid ureteroscope with a channel lumen diameter of 0.77mm and a length of 420mm.
Product codes (comma separated list FDA assigned to the subject device)
KCT
Device Description
The KARL STORZ-ENDOSCOPE RADEL 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, available in various sizes, are designed to encase KARL STORZ medical devices, such as light cables, instruments, rigid telescopes, semi-rigid telescopes, etc. All systems consist of a RADEL plastic base and lid. Lids are attached to the trays with assembled hardware. Some trays have a RADEL inner tray and/or silicone rubber mat.
The sterilization trays are constructed with perforated/ventilated sides and lids to allow for permeation of sterilant during sterilization. The trays have latches designed to fasten the lid onto the base. Other tray components include silicone instrument holders to secure instruments and silicone mats to 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)
Non-Clinical Testing performed included:
- Pre-vacuum sterilization efficacy based on AAMI ST77 and ISO 17665-1, acceptance criteria was 10-6 SAL, result was PASSED.
- Pre-vacuum dry time based on AAMI ST77 and ISO 17665-1, acceptance criteria was 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 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.
May 7, 2021
Karl Storz Endoscopy America Inc % David Furr Consultant Toscano Consulting Group Inc. 8708 Capeheart Cove Austin, Texas 78733
Re: K203572
Trade/Device Name: Karl Storz Radel Sterilization Trays Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: April 15, 2021 Received: April 19, 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 (OS) 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 mediation-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, 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) K203572
Device Name KARL STORZ RADEL Sterilization Trays
Indications for Use (Describe)
The KARL STORZ RADEL 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 4 minutes).
The KARL STORZ RADEL Sterilization Trays are intended to protect medical device instrumentation. When used in conjunction with an FDA cleared sterilization wrap.
KARL STORZ has validated the KARL STORZ RADEL Sterilization Trays for use in pre-vacuum steam sterilizers. The system was validated with a miniature scope with an irrigation chameter of 0.25mm and a length of 240mm and a semi-rigid ureteroscope with a channel lumen diameter of 0.77mm and a length of 420mm.
| Tray Catalog Number | Intended Load Maximum Weight
(Karl Storz Instruments Only) |
|---------------------|---------------------------------------------------------------|
| 27717A | Trocar/Cannula 5.0 lbs. |
| 27717B | Take-Apart Instruments 5.0 lbs. |
| 39231XA | Karl Storz General Instruments 5.0 lbs. |
| 39301A | Two Rigid Telescopes 2.71lbs. |
| 39301C | Two Rigid Telescopes 3.21lbs. |
| 39301C1 | One Rigid Telescope/One Light Cable 3.17 lbs. |
| 39311A | Four Telescopes/One Light Cable 6.86 lbs. |
| 39317A | Three Telescopes/One Light Cable 6.86 lbs. |
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
510(k) Summary K203572
Date: May 5, 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 RADEL Sterilization Trays (K203572)
Product code: KCT - Class II (21 CFR 880.6850) |
| 4. | Common/Classification Name: | Sterilization wrap/container |
| | Predicate devices: | Symmetry Medical Polyvac Surgical Instrument Delivery
System K012105 |
Description:
The KARL STORZ-ENDOSCOPE RADEL 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, available in various sizes, are designed to encase KARL STORZ medical devices, such as light cables, instruments, rigid telescopes, semi-rigid telescopes, etc. All systems consist of a RADEL plastic base and lid. Lids are attached to the trays with assembled hardware. Some trays have a RADEL inner tray and/or silicone rubber mat.
The sterilization trays are constructed with perforated/ventilated sides and lids to allow for permeation of sterilant during sterilization. The trays have latches designed to fasten the lid onto the base. Other tray components include silicone instrument holders to secure instruments and silicone mats to provide protection of the medical devices in the sterilization tray.
4
Intended Use:
The KARL STORZ RADEL 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℃ 4 minutes).
The trays are to be used in conjunction with an FDA cleared sterilization wrap.
KARL STORZ has validated the KARL STORZ RADEL Sterilization Trays for use in pre-vacuum steam sterilizers. The system was validated with a miniature scope with an irrigation channel lumen diameter of 0.25mm and a length of 240mm and a semi-rigid ureteroscope with a channel lumen diameter of 0.77mm and a length of 420mm.
| Tray Catalog Number | Intended Load Maximum Weight
(Karl Storz Instruments Only) |
|---------------------|---------------------------------------------------------------|
| 27717A | Trocar/Cannula 5.0 lbs. |
| 27717B | Take-Apart Instruments 5.0 lbs. |
| 39231XA | Karl Storz General Instruments 5.0 lbs. |
| 39301A | Two Rigid Telescopes 2.71lbs. |
| 39301C | Two Rigid Telescopes 3.21lbs. |
| 39301C1 | One Rigid Telescope/One Light Cable 3.17 lbs. |
| 39311A | Four Telescopes/One Light Cable 6.86 lbs. |
| 39317A | Three Telescopes/One Light Cable 6.86 lbs. |
Technological Characteristics Comparison Table:
Provided below is the comparison of the technological differences and similarities of the subject device and the predicate device.
5
| Element of
Comparison | 510(k) Device:
KARL STORZ
RADEL Sterilization
Trays | Predicate Device:
Symmetry Medical
Polyvac Surgical
Instrument Delivery
System (K012105) | Comparison |
|--------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Regulation and
Product Classification
Code | 21 CFR 880.6850
KCT | 21 CFR 880.6850
KCT | Same |
| Indications for Use | The KARL STORZ
RADEL 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
4 minutes).
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 RADEL
Sterilization Trays for use
in pre-vacuum steam
sterilizers. The system
was validated with a
miniature scope with an
irrigation channel lumen
diameter of 0.25mm and a
length of 240mm and a
semi-rigid ureteroscope
with a channel lumen
diameter of 0.77mm and a
length of 420mm. | 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,
132ºC 4 minutes
minimum, gravity
steam 132°C 30
minutes minimum and
gravity steam 121℃ 55
minutes minimum. | Similar |
| Principal Material of
Construction | Thermoformed Radel
Polyphenylsulfone, | Thermoformed Radel
Polyphenylsulfone,
stainless steel or
aluminum | Different |
| KARL STORZ Model
Numbers | 8 models | N/A | Different |
| Dimensional
Configuration Range | Approximate sizes
available in inches:
21.2x9.8x4.3 21.2x9.8x1.9 19.8x8.9x1.8 12.18x3.22x1.2 21.48 x 3.53x 1.75 21.48 x 3.53x 1.75 13.36 x 9.31x 1.9 20.24x9.30x3.1 | 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 | Manufactured by
Tecomet (formerly
Symmetry Medical) | Manufactured by
Tecomet (formerly
Symmetry Medical) | Same |
| Sterilization Cycles | Prevacuum Steam 4
minute cycle 132°C | Prevacuum steam and
gravity steam | Similiar |
| Load | Trays are to be loaded
with KARL STORZ
instruments; maximum
weights as indicated | Various loads up to 25
lbs. | Similar |
6
7
Summary of Non-Clinical Testing:
Shown below is the non-clinical testing performed with the subject device and the standards and test method used to demonstrate the subject device met the acceptance criteria of each standard..
| Type of Testing | Purpose | Acceptance
Criteria | Result |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|---------------------------------------------------------------------------------------|----------------------------------|
| 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 | Demonstrate sterilization
capabilities. | 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 | To establish minimum dry
time. | Pre and Post
Sterilization weight
difference