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)

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.

AI/ML Overview

The provided text describes the acceptance criteria and study proving the performance of "Perforated Baskets" for sterilization.

Here's the breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

Test	Test Method (Standard)	Acceptance Criteria	Reported Device Performance
Manual Cleaning	AAMI TIR 30: 2011, ANSI/ AAMI ST98: 2022	1: Visible soil: not visible	1: passed
		2: Protein/cm2 [µg/cm2]: < 6.4 µg/cm2	2: passed
		3: Hemoglobin [µg/cm2]: < 2.2 µg/cm2	3: passed
Steam Sterilization	EN ISO 14937, Annex D	Sterilization assurance level (SAL) > 10^-6	passed

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the sample size for the test set or the data provenance (country of origin, retrospective/prospective). It mentions "For each device it was evaluated whether specific testing was necessary" and lists "all devices" in relation to the maximum validated load weight, implying that all listed "Perforated Baskets" were part of the evaluation for performance testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. The ground truth for cleaning and sterilization effectiveness is based on scientific standards and quantitative measurements (e.g., protein, hemoglobin levels, SAL), which do not typically require expert consensus in the same way as, for example, image interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The document does not mention any adjudication method. The tests conducted are objective, quantitative measurements against established standards.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a physical medical device (perforated baskets for sterilization), not an AI-powered diagnostic or interpretive tool that would involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

A standalone performance evaluation was conducted for the device's ability to facilitate cleaning and steam sterilization. This device does not involve an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth used for performance evaluation is based on established scientific and industry standards for cleaning effectiveness (AAMI TIR 30: 2011, ANSI/ AAMI ST98: 2022) and sterilization assurance (EN ISO 14937, Annex D). These standards define quantitative thresholds and methodologies for determining success.

8. The sample size for the training set

This information is not applicable and not provided. The "Perforated Baskets" are not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

This information is not applicable. The "Perforated Baskets" are not an AI/ML device that requires a training set.

Summary

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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"

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(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

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and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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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 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].

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Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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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	RegulationNumber andName	ProductCode	DeviceClass	ReviewPanel
PERFORATEDBASKETS	Sterilization Wrap Containers,Trays, Cassettes & OtherAccessories	880.6850General Hospital	KCT	II	GeneralHospital

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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

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 have no medical indications. Sterilization cycle times are as follow: Exposure time: 3 min Temperature: 132 °C Drying time: 20 min

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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)

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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 ofdifferences
510(k) number	K231291	K203198	N/A
Manufacturer	Richard Wolf GmbH	Karl Storz EndoscopyAmerica Inc	N/A
Product Code	KCT	KCT	None.
Regulation Number	880.6850	880.6850	None
Indications for Use	Perforated basketsThe products are used to storemedical devices before,during, and after sterilization.The products are intended toenable sterilization of theenclosed medical devices butare not intended to maintainsterility on their own; instead,they are used in conjunctionwith an FDA-approvedsterilization wrap that is legallyavailable on the market.The products have no medicalindications.Sterilization cycle times are asfollows:Exposure time: 3 minTemperature: 132 °CDrying time: 20 minThe maximum validated loadweight for all devices listedbelow is 4.5 kg (approx. 9.92lbs).All measurements are inmillimeter and are coded asfollows [WidthxHeightxLength].Authors note: At this positioncorresponding devices andtheir dimensions are listed inevery Instruction for use.	The KARL STORZ MetalSterilization Trays areintended only for use toencase and protect specificKARL STORZ reusablemedical devices forsterilization in prevacuumsteam sterilization cycles132°C for four minutes witha 20 minute dry time).When used in conjunctionwith an FDA clearedsterilization wrap, sterility ofthe enclosed medicaldevice is maintained untilused.	Similar.
Prescription/over-the-counter-use	Prescription Use	Over the Counter	Different
CleaningandSterilization methodfor the basket	Devices must be reprocessedbefore the first usage.	Information not available	Different
Item	Subject devices	Predicate devices	Explanation ofdifferences
ValidatedSterilization Cycle	Pre-VacuumExposure time: 3 min,Temperature: 132°C	Pre-VacuumExposure time: 4min,Temperature: 132°C	Similar
Load condition	Maximum weight and loadingconditions are either limited bythe place holders for theintended devices if thesubmitted can hold more thanone device, the loadingtemplate for specificinstruments sets or the weightof the individual medicaldevice if the submitted deviceis only intended to reprocessone item.	Maximum weight andloading conditions areeither limited by the placeholders for the intendeddevices if the predicatedevice can hold more thanone device, the loadingtemplate for specificinstruments sets or theweight of the individualmedical device if thepredicate device is onlyintended to reprocess oneitem.	Different
Maximum validatedload weight	Up to 4.5 kg (approx. 9.92 lbs)	5 lbs	Different

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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
ManualCleaning	AAMI TIR 30: 2011,ANSI/ AAMI ST98: 2022	1: Visible soil: not visible	1: passed
		2: Protein/cm2 [µg/cm2]:< 6.4 µg/cm2	2: passed
		3: Hemoglobin [µg/cm2]:< 2.2 µg/cm2	3: passed
SteamSterilization	EN ISO 14937, Annex D	Sterilization assurancelevel (SAL) > 10-6	passed

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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.

Regulation Number and Section

§ 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).