The MultiCut Solo Morcellator is intended for use under endoscopic visualization for the transurethral mechanical morcellation and removal of the adenoma after enucleation of the prostate during endoscopic surqical procedures in urology.

Device Description

MultiCut Solo consists of a special endoscopic handpiece in which a blade is inserted which mechanically shreds the tissue. The blade is driven by a dc motor, which is integrated in the handpiece. The motor itself is driven by a motor driver PCB. The blade can rotate at different speeds and thereby change the direction of rotation periodically (so called oscillation). The morcellator handpiece is also connected by an aspiration tube set to a peristaltic aspiration pump. By this pump the crushed tissue can be transported through a hollow channel in the handpiece to a waste container. The device is available with either sterile single use blades and non-sterile reusable blades.

AI/ML Overview

The provided text is related to a medical device submission (K240831) for the MultiCut Solo Morcellator. This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria in a clinical study for a new device.

Therefore, the requested information regarding acceptance criteria, device performance tables, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, is not available in the provided text.

The document states that the MultiCut Solo Morcellator is a modification of an already cleared device (K213597), with the specific modification being the addition of sterile single-use blades. The submission focuses on non-clinical performance data to support the substantial equivalence.

Here's what can be extracted from the text regarding the device's assessment:

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

No specific acceptance criteria or performance metrics related to diagnostic accuracy or clinical outcomes are provided. The submission focuses on product safety and function rather than a software algorithm's diagnostic performance.
The document mentions that the device "successfully passed the following testing" and "is in compliance with all applicable sections of the above-mentioned performance standards." These relate to the safety and functionality of the device and its components, particularly the new sterile single-use blades. The "performance" in this context refers to meeting engineering and safety standards, not clinical diagnostic accuracy.

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

Not applicable. The document describes non-clinical performance data (e.g., sterilization validation, biocompatibility) rather than a test set for diagnostic performance.

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)

Not applicable. There is no mention of expert-established ground truth for a diagnostic test set.

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

Not applicable. No test set requiring adjudication is described.

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

Not applicable. The MultiCut Solo is a mechanical morcellator, not an AI diagnostic device, and thus no MRMC study would be relevant.

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

Not applicable. This is not an algorithm-based device.

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

Not applicable. The assessments made (e.g., sterilization effectiveness, biocompatibility) are based on established scientific methods and standards (e.g., EN/ISO 10993, IEC 60601 series) rather than a clinical ground truth for diagnostic accuracy.

8. The sample size for the training set

Not applicable. The device is not based on machine learning or AI that would require a training set.

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

Not applicable.

In summary, the provided FDA 510(k) summary focuses on the technical safety and performance of a medical device (a morcellator) and its components, specifically regarding modifications and substantial equivalence to a predicate device, rather than on the diagnostic accuracy or clinical efficacy that would involve the type of acceptance criteria and study designs typically associated with AI/software-as-a-medical-device (SaMD) clearances.

Summary

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November 6, 2024

Asclepion Laser Technologies GmbH Tom Gruender RA Manager Bruesseler Strasse 10 Jena, 07745 GERMANY

K240831 Re: Trade/Device Name: MultiCut Solo Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ

Dear Tom Gruender:

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" (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).

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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 QS 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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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 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

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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,

Mark J. Antonino -S

Mark J. Antonino, M.S. Assistant Director DHT3B: Division of Reproductive, Gynecology, and Urology Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K240831

Device Name

MultiCut Solo

Indications for Use (Describe)

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

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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K240831 Page 1 of 3

510(K) SUMMARY

Applicant /ManufacturerName and Address:	Asclepion Laser Technologies GmbHBruesseler Strasse, 1007745 JenaGermany
510(k) Contact Person:	Mr. Tom GruenderRegulatory Affairs ManagerTel.: 0049 3641 7700 201E-Mail: tom.gruender@asclepion.com
Date Prepared:	02/28/2024
Common name:	Soft Tissue Morcellator and Accessories
Device name:	MultiCut Solo
Regulatory Class:	Class II
Classification Name:	Endoscope and Accessories
Regulation Number:	21 CER 876.1500
Product Code:	GCJ
Basis for Submission:	modifications to the already cleared device
Predicate Devices:	MultiCut Solo (K213597)
Performance Standards:

There are no mandatory performance standards for this device.

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Description of the device:

The device is available with either sterile single use blades and non-sterile reusable blades.

Description of the modifications:

Compared to the unmodified device, the subject device includes single use blades in addition to the reusable ones.

Single use blades are supplied sterile, following Ethylene Oxide sterilization process.

The subject device has the same intended use of the unmodified device. Moreover the the intended use of the modified device, as described in its labeling, has not changed as a result of the modifications.

Based on the nature of the changes implemented, the device underwent and successfully passed the following testing:

-Sterile barrier validation
-Sterilization validation
-Measurement of sterilant residuals that remain on the device

Intended Use/Indications for Use

Nonclinical Performance Data:

The following performance data were applied in support of the substantial equivalence determination:

. EN 60601-1: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
. IEC 60601-1-2: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests
. IEC 62304: Medical Device Software - Software life cycle processes
ISO 14971: Medical devices - Applications of risk management to medical devices
. IEC 60601-2-18 Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment

Biocompatibility testing was also conducted for the MultiCut Blades in accordance with:

o EN/ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

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ISO 10993-5: Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity ●
0 ISO 10993-18: Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process
ISO 10993-11 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
o ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization

Software verification and validation testing was conducted, and documentation is provided in this submission, as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".

The MultiCut Solo System passed all of the required testing and is in compliance with all applicable sections of the above-mentioned performance standards.

Comparison with predicate device:

The subject and predicate devices have intended use and the same fundamental scientific technology. Any minor difference does not raise concern about safety and effectiveness.

Summary

The non-clinical performance testing conducted supports that the device can be used safely and effectively. The differences in technological characteristics between the subject and predicate device do not raise new types of questions regarding safety and effectiveness, and the subject device is as safe, as effective, and performs as well as the legally marketed predicate device.

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.