(396 days)
Not Found
No
The device description and performance studies focus on the physical properties and sterilization capabilities of metal baskets, with no mention of AI or ML.
No.
The product explicitly states "The products have no medical indications," and their purpose is to store medical devices for sterilization, which is a process to prepare devices for use, not to treat a condition itself.
No
The product description states that the PERFORATED BASKETS are used to store and enable sterilization of medical devices and "[h]ave no medical indications." There is no mention of the device being used to diagnose a disease or condition.
No
The device description clearly indicates it is a physical metal basket with a lid and locking mechanism, used for holding medical devices during sterilization. There is no mention of software components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as storing medical devices before, during, and after sterilization, and enabling sterilization in conjunction with a sterilization wrap. This is a function related to the processing and handling of medical devices, not the diagnosis of diseases or conditions.
- No Medical Indications: The document explicitly states that the products have "no medical indications." IVDs are used to provide information for the diagnosis, treatment, or prevention of disease or other conditions.
- Function: The device is a physical container (basket) designed to facilitate the sterilization process of other medical devices. It does not perform any tests on biological samples or provide diagnostic information.
IVDs are typically devices, instruments, reagents, or systems intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease or other conditions. This device does not fit that description.
N/A
Intended Use / Indications for Use
The products are used to store medical devices before, during, and after sterilization.
The products are intended to enable sterilization of the enclosed medical devices but are not intended to maintain sterility on their own; instead, they are used in conjunction with an FDA-approved sterilization wrap that is legally available on the market.
The products have no medical indications. Sterilization cycle times are as follow: Exposure time: 3 min Temperature: 132 ℃ Drying time: 20 min
The maximum validated load weight for all devices listed below is 4.5 kg (approx. 9.92 lbs).
All measurements are in millimeter and are coded as follows [WidthxHeightxLength].
UNIVERSAL PERFORATED BASKET 1 (33001); 732x117x282) UNIVERSAL PERFORATED BASKET 2 (33002); (743x200x282) UNIVERSAL PERFORATED BASKET 3 (33003); (538x117x250) UNIVERSAL PERFORATED BASKET 4 (33004); (538x117x250) UNIVERSAL PERFORATED BASKET 5 (33005); (549x200x250) PERFORATED BASKET FOR SMALL PARTS (33006); (128x40x121) PERF. BASKET – KNEE ARTHROSC. BASIC SET (33007); (549x150x250) PERF. BASKET - KNEE ARTHROSC. ACL/PCL 1 (33008); (549x150x250) PERF. BASKET - KNEE ARTHROSC. ACL/PCL 2 (33009); (549x150x250) PERF. BASKET FOR KNEE ARTHROSC. PREP TAB (33010); (549x150x250) PERF. BASKET FOR VERTEBRIS LUMBAR (33011); (549x150x250) PERF. BASKET FOR SHOULDER ARTHROSCOPY (33012); (538x117x250) PERF. BASKET FOR VERTEBRIS FORAMINOTOMY (33013); (525x65x255) PERF. BASKET FOR VERTEBRIS STENOSIS (33015); (549x150x250) PERFORATED BASKET FOR CAMERA HEAD (38002); (448x73x200) PERFORATED BASKET, UPPER URINARY TRACT 1 (38003); (635x75x132) PERF. BASKET FOR CYSTOSCOPE/TELESCOPE (38004); (467x75x132) PERFORATED BASKET FOR DISCOSCOPE (38005): (467x75x132) PERFORATED BASKET FOR HYSTEROSCOPE 1 (38006); (467x75x132) PERF. BASKET FOR VIDEO MEDIASTINOSCOPE (38007); (256x85x250) PERFORATED BASKET FOR TELESCOPE (38008); (467x75x132) PERFORATED BASKET FOR HYSTEROSCOPE 2 (38009); (467x90x132) PERFORATED BASKET FOR STEREO TELESCOPE (38010); (477x139x196) PERFORATED BASKET FOR NEPHROSCOPE (38011); (467x75x172) PERFORATED BASKET FOR MORCESCOPE (38012); (467x75x172) PERFORATED BASKET FOR CYSTO-URETHROSCOPE (38013); (451x64x80) PERFORATED BASKET FOR 3D TELESCOPE (38014); (583x80x200) PERF. BASKET FOR STANDARD TELESCOPE 1 (38015); (297x54x59) PERF. BASKET FOR STANDARD TELESCOPE 2 (38016); (481x54x59) PERF. BASKET FOR STANDARD TELESCOPE 3 (38017); (619x54x59) PERFORATED BASKET FOR PAIN THERAPY (33014); (525x95x255)
Product codes (comma separated list FDA assigned to the subject device)
KCT
Device Description
The PERFORATED BASKETS all have the same basic configuration, a metal basket base and a basket lid, with optional product specific instrument carriers (for multiple levels) or adapters and an additional basket for small parts. The base part and the lid of the PERFORATED BASKET are connected by a locking mechanism, which assures a tight connection of both parts.
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
PERFORATED BASKETS are used for professional use only.
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 devices are delivered in a non-sterile status. All devices need to be processed before each usage. Thus, the cleaning process was validated in compliance with the relevant standards and guidelines and the device was found to be suitable for the described procedures. A sterilization validation for the device was also conducted to validate their performance. The performance of the devices in regards to their capability to be used for steam sterilization was tested. This sterilization process was validated in compliance with the relevant standards and quidelines and the device was found to be suitable for the described procedure.
Manual Cleaning: Test Method (Standard) AAMI TIR 30: 2011, ANSI/ AAMI ST98: 2022. Acceptance Criteria: 1: Visible soil: not visible, 2: Protein/cm2 [µg/cm2]: 10-6. Results: passed.
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, 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.
June 3, 2024
Richard Wolf Medical Instruments Corporation Mike McAndrew US Head of Regulatory - OA/OC 353 Corporate Woods Parkway Vernon Hills, Illinois 60061
Re: K231291
Trade/Device Name: Perforated Baskets Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: April 30, 2024 Received: May 1, 2024
Dear Mike McAndrew:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
Christopher K. Dugard -S
Christopher K. Dugard, M.S. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical
2
and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K231291
Device Name Perforated Baskets
Indications for Use (Describe)
The products are used to store medical devices before, during, and after sterilization.
The products are intended to enable sterilization of the enclosed medical devices but are not intended to maintain sterility on their own; instead, they are used in conjunction with an FDA-approved sterilization wrap that is legally available on the market.
The products have no medical indications. Sterilization cycle times are as follow: Exposure time: 3 min Temperature: 132 ℃ Drying time: 20 min
The maximum validated load weight for all devices listed below is 4.5 kg (approx. 9.92 lbs).
All measurements are in millimeter and are coded as follows [WidthxHeightxLength].
UNIVERSAL PERFORATED BASKET 1 (33001); 732x117x282) UNIVERSAL PERFORATED BASKET 2 (33002); (743x200x282) UNIVERSAL PERFORATED BASKET 3 (33003); (538x117x250) UNIVERSAL PERFORATED BASKET 4 (33004); (538x117x250) UNIVERSAL PERFORATED BASKET 5 (33005); (549x200x250) PERFORATED BASKET FOR SMALL PARTS (33006); (128x40x121) PERF. BASKET – KNEE ARTHROSC. BASIC SET (33007); (549x150x250) PERF. BASKET - KNEE ARTHROSC. ACL/PCL 1 (33008); (549x150x250) PERF. BASKET - KNEE ARTHROSC. ACL/PCL 2 (33009); (549x150x250) PERF. BASKET FOR KNEE ARTHROSC. PREP TAB (33010); (549x150x250) PERF. BASKET FOR VERTEBRIS LUMBAR (33011); (549x150x250) PERF. BASKET FOR SHOULDER ARTHROSCOPY (33012); (538x117x250) PERF. BASKET FOR VERTEBRIS FORAMINOTOMY (33013); (525x65x255) PERF. BASKET FOR VERTEBRIS STENOSIS (33015); (549x150x250) PERFORATED BASKET FOR CAMERA HEAD (38002); (448x73x200) PERFORATED BASKET, UPPER URINARY TRACT 1 (38003); (635x75x132) PERF. BASKET FOR CYSTOSCOPE/TELESCOPE (38004); (467x75x132) PERFORATED BASKET FOR DISCOSCOPE (38005); (467x75x132) PERFORATED BASKET FOR HYSTEROSCOPE 1 (38006); (467x75x132) PERF. BASKET FOR VIDEO MEDIASTINOSCOPE (38007); (256x85x250) PERFORATED BASKET FOR TELESCOPE (38008); (467x75x132) PERFORATED BASKET FOR HYSTEROSCOPE 2 (38009); (467x90x132) PERFORATED BASKET FOR STEREO TELESCOPE (38010); (477x139x196) PERFORATED BASKET FOR NEPHROSCOPE (38011); (467x75x172) PERFORATED BASKET FOR MORCESCOPE (38012); (467x75x172) PERFORATED BASKET FOR CYSTO-URETHROSCOPE (38013); (451x64x80) PERFORATED BASKET FOR 3D TELESCOPE (38014); (583x80x200) PERF. BASKET FOR STANDARD TELESCOPE 1 (38015); (297x54x59) PERF. BASKET FOR STANDARD TELESCOPE 2 (38016); (481x54x59) PERF. BASKET FOR STANDARD TELESCOPE 3 (38017); (619x54x59) PERFORATED BASKET FOR PAIN THERAPY (33014); (525x95x255)
4
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
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5
Image /page/5/Picture/1 description: The image is a logo for Richard Wolf. The text "RICHARD WOLF" is displayed in a bold, sans-serif font. The word "RICHARD" is in black, while the word "WOLF" is in red. To the right of the text is a square with rounded corners, containing a stylized image of a wolf with a nail in its mouth. The wolf is drawn in black lines, and the nail is pointing downwards.
K231291 510(k)
Summary
Submitter
Richard Wolf Medical Instruments Corporation 353 Corporate Woods Parkway Vernon Hills, IL 60061
Phone:(847) 913 1113
Contact Person, Title: Mike McAndrew, US Head of Regulatory -QA/QC Date Prepared:05/30/2024
Legal Manufacturer
Richard Wolf GmbH Pforzheimer Straße 32 75438 Knittlingen, Germany
1. Devices
| Device Trade Name | Device classification name | Regulation
Number and
Name | Product
Code | Device
Class | Review
Panel |
|-----------------------|---------------------------------------------------------------------------|----------------------------------|-----------------|-----------------|---------------------|
| PERFORATED
BASKETS | Sterilization Wrap Containers,
Trays, Cassettes & Other
Accessories | 880.6850
General Hospital | KCT | II | General
Hospital |
6
Image /page/6/Picture/1 description: The image contains the words "RICHARD WOLF" in a stylized font. The word "RICHARD" is in black, while the word "WOLF" is in red. To the right of the words is a logo of a wolf's head with a medical instrument going through it, all enclosed in a rounded square.
2. Predicate Device
Name of Predicate Device: KARL STORZ Metal Sterilization Trays 510(k) Number: K203198 Regulatory Class: II Product Code: KCT Manufacturer: Karl Storz Endoscopy America Inc
3. Device Description
3.1. Subject Device Identification
The PERFORATED BASKETS all have the same basic configuration, a metal basket base and a basket lid, with optional product specific instrument carriers (for multiple levels) or adapters and an additional basket for small parts. The base part and the lid of the PERFORATED BASKET are connected by a locking mechanism, which assures a tight connection of both parts.
3.2. Subject device characteristics
User
PERFORATED BASKETS are used for professional use only.
Delivered sterile / non-sterile
PERFORATED BASKETS are delivered in a non-sterile state.
Single use / reusable
PERFORATED BASKETS are reusable.
Software
PERFORATED BASKETS do not have software.
Materials with patient contact
PERFORATED BASKETS do not have direct or indirect contact with the patient.
4. Indications for Use
The products are used to store medical devices before, during, and after sterilization.
The products are intended to enable sterilization of the enclosed medical devices but are not intended to maintain sterility on their own; instead, they are used in conjunction with an FDA-approved sterilization wrap that is legally available on the market.
The products have no medical indications. Sterilization cycle times are as follow: Exposure time: 3 min Temperature: 132 °C Drying time: 20 min
7
Image /page/7/Picture/1 description: The image shows the logo for Richard Wolf. The words "RICHARD" and "WOLF" are stacked on top of each other, with "RICHARD" in a smaller font size than "WOLF". The word "WOLF" is in a bold, red font. To the right of the text is a square with rounded corners, inside of which is a stylized drawing of a wolf's head and a nail.
The maximum validated load weight for all devices listed below is 4.5 kg (approx. 9.92 lbs).
All measurements are in millimeter and are coded as follows [WidthxHeightxLength].
UNIVERSAL PERFORATED BASKET 1 (33001); 732x117x282) UNIVERSAL PERFORATED BASKET 2 (33002); (743x200x282) UNIVERSAL PERFORATED BASKET 3 (33003); (538x117x250) UNIVERSAL PERFORATED BASKET 4 (33004); (538x117x250) UNIVERSAL PERFORATED BASKET 5 (33005); (549x200x250) PERFORATED BASKET FOR SMALL PARTS (33006); (128x40x121) PERF. BASKET - KNEE ARTHROSC. BASIC SET (33007); (549x150x250) PERF. BASKET – KNEE ARTHROSC. ACL/PCL 1 (33008); (549x150x250) PERF. BASKET – KNEE ARTHROSC. ACL/PCL 2 (33009); (549x150x250) PERF. BASKET FOR KNEE ARTHROSC. PREP TAB (33010); (549x150x250) PERF. BASKET FOR VERTEBRIS LUMBAR (33011); (549x150x250) PERF. BASKET FOR SHOULDER ARTHROSCOPY (33012); (538x117x250) PERF. BASKET FOR VERTEBRIS FORAMINOTOMY (33013); (525x65x255) PERF. BASKET FOR VERTEBRIS STENOSIS (33015); (549x150x250) PERFORATED BASKET FOR CAMERA HEAD (38002); (448x73x200) PERFORATED BASKET, UPPER URINARY TRACT 1 (38003); (635x75x132) PERF. BASKET FOR CYSTOSCOPE/TELESCOPE (38004); (467x75x132) PERFORATED BASKET FOR DISCOSCOPE (38005): (467x75x132) PERFORATED BASKET FOR HYSTEROSCOPE 1 (38006); (467x75x132) PERF. BASKET FOR VIDEO MEDIASTINOSCOPE (38007); (256x85x250) PERFORATED BASKET FOR TELESCOPE (38008); (467x75x132) PERFORATED BASKET FOR HYSTEROSCOPE 2 (38009); (467x90x132) PERFORATED BASKET FOR STEREO TELESCOPE (38010); (477x139x196) PERFORATED BASKET FOR NEPHROSCOPE (38011); (467x75x172) PERFORATED BASKET FOR MORCESCOPE (38012); (467x75x172) PERFORATED BASKET FOR CYSTO-URETHROSCOPE (38013); (451x64x80) PERFORATED BASKET FOR 3D TELESCOPE (38014); (583x80x200) PERF. BASKET FOR STANDARD TELESCOPE 1 (38015); (297x54x59) PERF. BASKET FOR STANDARD TELESCOPE 2 (38016); (481x54x59) PERF. BASKET FOR STANDARD TELESCOPE 3 (38017); (619x54x59) PERFORATED BASKET FOR PAIN THERAPY (33014); (525x95x255)
8
Image /page/8/Picture/1 description: The image is a logo for "Richard Wolf". The words "Richard Wolf" are stacked on top of each other, with "Richard" in a smaller, thinner font than "Wolf". To the right of the text is a square with rounded corners, inside of which is a stylized drawing of a wolf's head with a nail being hammered into the wolf's head.
5. Comparison of Technological Characteristics with the Predicate Device
The PERFORATED BASKETS are comparable to KARL STORZ Metal Sterilization Trays. Sterilization occurs through the perforated structure in the tray base and lid. After sterilization, the FDA cleared sterilization wrap maintains sterility. 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.
| Item | Subject devices | Predicate devices | Explanation of
differences |
|-----------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|
| 510(k) number | K231291 | K203198 | N/A |
| Manufacturer | Richard Wolf GmbH | Karl Storz Endoscopy
America Inc | N/A |
| Product Code | KCT | KCT | None. |
| Regulation Number | 880.6850 | 880.6850 | None |
| Indications for Use | Perforated baskets
The products are used to store
medical devices before,
during, and after sterilization.
The products are intended to
enable sterilization of the
enclosed medical devices but
are not intended to maintain
sterility on their own; instead,
they are used in conjunction
with an FDA-approved
sterilization wrap that is legally
available on the market.
The products have no medical
indications.
Sterilization cycle times are as
follows:
Exposure time: 3 min
Temperature: 132 °C
Drying time: 20 min
The maximum validated load
weight for all devices listed
below is 4.5 kg (approx. 9.92
lbs).
All measurements are in
millimeter and are coded as
follows [WidthxHeightxLength].
Authors note: At this position
corresponding devices and
their dimensions are listed in
every Instruction 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 prevacuum
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. | Similar. |
| Prescription/
over-
the-counter-use | Prescription Use | Over the Counter | Different |
| Cleaning
and
Sterilization method
for the basket | Devices must be reprocessed
before the first usage. | Information not available | Different |
| Item | Subject devices | Predicate devices | Explanation of
differences |
| Validated
Sterilization Cycle | Pre-Vacuum
Exposure time: 3 min,
Temperature: 132°C | Pre-Vacuum
Exposure time: 4min,
Temperature: 132°C | Similar |
| Load condition | Maximum weight and loading
conditions are either limited by
the place holders for the
intended devices if the
submitted can hold more than
one device, the loading
template for specific
instruments sets or the weight
of the individual medical
device if the submitted device
is only intended to reprocess
one item. | Maximum weight and
loading conditions are
either limited by the place
holders for the intended
devices if the predicate
device can hold more than
one device, the loading
template for specific
instruments sets or the
weight of the individual
medical device if the
predicate device is only
intended to reprocess one
item. | Different |
| Maximum validated
load weight | Up to 4.5 kg (approx. 9.92 lbs) | 5 lbs | Different |
9
K231291 510(k) Summary
Image /page/9/Picture/1 description: The image contains the words "RICHARD WOLF" in a stylized font. The word "RICHARD" is in a smaller, sans-serif font above the word "WOLF", which is in a larger, bolder, red font. To the right of the words is a logo featuring a stylized drawing of a wolf's head with a vertical line through it, enclosed in a rounded square.
6. Performed evaluation of impact of differences
The following testing was performed in order to support device performance. For each device it was evaluated whether specific testing was necessary. The following subsections present an overview including the decision whether specific testing was deemed necessary or not.
6.1. Cleaning and Sterilization
The devices are delivered in a non-sterile status. All devices need to be processed before each usage. Thus, the cleaning process was validated in compliance with the relevant standards and guidelines and the device was found to be suitable for the described procedures. A sterilization validation for the device was also conducted to validate their performance.
6.2. Performance Testing Bench
The performance of the devices in regards to their capability to be used for steam sterilization was tested. This sterilization process was validated in compliance with the relevant standards and quidelines and the device was found to be suitable for the described procedure.
| Test | Test Method (Standard) | Acceptance Criteria | Results |
|---|---|---|---|
| Manual | |||
| Cleaning | AAMI TIR 30: 2011, | ||
| ANSI/ AAMI ST98: 2022 | 1: Visible soil: not visible | 1: passed | |
| 2: Protein/cm2 [µg/cm2]: | |||
| 10-6 | passed |
10
Image /page/10/Picture/1 description: The image is a logo for Richard Wolf. The words "RICHARD WOLF" are stacked on top of each other, with "RICHARD" in black and "WOLF" in red. To the right of the text is a white square with rounded corners, inside of which is a black line drawing of a wolf's head and a medical instrument.
7. Conclusion
The conclusions drawn from the nonclinical testing demonstrate the device in 510(k) K231291, the PERFORATED BASKETS, is as safe, as effective and performs as well, or better, than the legally market predicate device, cleared via 510(k) K203198.