The i-Cut consists of a rotating cutting tube with a trocar that provides protection against the cutting blade when locked in the "CLOSED" position. The device comes with an obturator for placement into the patient's body and a locking clip that keeps the trocar in the "closed" position during insertion. The activation button must be pressed to cut tissue.

The lumen of the device is designed for use with a standard grasper or Tenaculum forceps with a diameter between 10 to 14 mm. The i-Cut is designed to be used with surgical instruments of diameters between 10 to 14 mm. The lumen is fitted with a silicone valve to prevent gas loss during use of the device.

The i-Cut is electrically operated by a DC Motor which is powered by a 24V AC/DC mains adapter. The non-sterile i-Cut Power Supply with power cord is supplied separately to power the device.

AI/ML Overview

This 510(k) clearance letter pertains to the i-Cut, a single-use laparoscopic power morcellator. The provided text details regulatory information, device description, indications for use, and non-clinical performance testing. However, it does not include information about clinical studies with human participants, acceptance criteria tables, sample sizes for test sets (in the context of clinical performance), expert ground truth establishment, or multi-reader multi-case (MRMC) comparative effectiveness studies.

The document primarily focuses on non-clinical bench testing to demonstrate substantial equivalence to a predicate device (LiNA eXcise, K101458). Therefore, I cannot address most of the requested points related to clinical study acceptance criteria and performance as this information is not present in the provided text.

Here's an analysis of what can be extracted from the provided text, and where gaps exist:

Preamble:

The provided 510(k) clearance letter for the i-Cut device focuses on demonstrating substantial equivalence through non-clinical performance testing (bench testing) rather than clinical trials with human participants. Therefore, many of the requested details pertaining to clinical study design, human reader performance, and expert consensus for ground truth are not present in this document. The "acceptance criteria" and "device performance" discussed here apply to the bench testing conducted, not clinical outcomes in human subjects.

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

Based on the provided non-clinical performance testing section, we can infer some "acceptance criteria" as implied by the successful completion of each test. The "reported device performance" is generally stated as "passed" or "met requirements." No numerical data for specific criteria are provided beyond the stated specifications (e.g., cutting rate, speed).

Acceptance Criteria (Inferred from Test Purpose)	Reported Device Performance
Sterilization Validation (ANSI/AAMI/ISO 11135:2014)	Passed sterilization validation
Shelf-life Validation (ASTM F1980-21:2023, etc.)	Supports 5-year shelf life (package integrity and device performance)
Simulated Shipping (ASTM D4332-22:2022, etc.)	Passed simulated shipping tests
Biocompatibility (ISO 10993-5, -10, -11, -23)	Passed biocompatibility tests (Cytotoxicity, Sensitization, Intracutaneous irritation, Acute systemic toxicity)
Electrical Safety (IEC 60601-1:2020)	Passed electrical safety
Electromagnetic Compatibility (EMC) (IEC 60601-1-2:2020)	Passed EMC
Load Test (Withstand expected load without failure)	Passed load test
Gas Tightness Test (Maintain pneumoperitoneum)	Passed gas tightness test
Obturator Abrasion Test (No visible wear marks)	Passed obturator abrasion test (no abrasion occurs)
Liquid Tightness Test (Meet requirements after load test)	Passed liquid tightness test
Grip of the Housing Surface Test (Surgeon's ability to properly grip)	Passed grip of the housing surface test
Surface Reflection Test (Cutting blade not cause reflections impeding visibility)	Passed surface reflection test
Trocar Sleeve – Pull-off Force Test (Connection suitable for application)	Passed pull-off force test
Functional Test (Morcellate and extract tissue in model specimen)	Passed functional test
Insertion Test (Force needed to expose cutting blade in "Closed" position)	Passed insertion test
Usability testing (Compatibility with containment system, integrity assessment)	Passed usability testing
Cutting Rate (Stated Specification)	>21.5 g/min
Speed (Stated Specification)	1100 rpm

2. Sample sizes used for the test set and the data provenance

Sample Size: The document does not specify the sample sizes (e.g., number of devices, number of tests) for each of the non-clinical performance tests. It only states that the tests were performed and passed.
Data Provenance: The data provenance is from non-clinical bench testing conducted by the manufacturer, A.M.I. Agency for Medical Innovations GmbH. The country of origin of the manufacturer is Austria. This data is inherently prospective as it involves new testing for the device's clearance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This was a non-clinical bench testing study. "Ground truth" in this context pertains to engineering specifications and performance metrics rather than clinical diagnoses established by medical experts. Usability testing involved "surgeons of different experience with laparoscopic morcellators," but it was to assess device compatibility and integrity, not to establish a clinical ground truth for a diagnostic AI.

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

Not applicable. This was a non-clinical bench testing study. Adjudication methods are typically used in clinical studies where multiple human readers interpret data to establish a consensus ground truth.

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. No MRMC comparative effectiveness study was performed or described. The clearance is based on substantial equivalence demonstrated through non-clinical bench testing. The device is a physical surgical tool, not an AI.

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

Not applicable. This device is a physical surgical tool and does not employ a standalone algorithm for diagnostic or interpretative purposes.

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

For non-clinical bench testing, the "ground truth" is defined by engineering specifications, regulatory standards (e.g., ISO, ASTM, IEC), and predefined pass/fail criteria for device performance (e.g., measuring force, checking for wear, verifying electrical safety compliance). There is no "expert consensus" or "pathology" in the medical sense for these tests.

8. The sample size for the training set

Not applicable. This device is a mechanical/electrical surgical tool, not an AI/ML algorithm that requires a training set.

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

Not applicable, as there is no training set for this device.

Summary

U.S. Food & Drug Administration 510(k) Clearance Letter

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.07.05

April 24, 2025

A.M.I. Agency for Medical Innovations GmbH
Anke Ristow
Regulatory Affairs Specialist
Im Letten 1
Feldkirch, 6800
AUSTRIA

Re: K243821
Trade/Device Name: i-Cut
Regulation Number: 21 CFR 884.1720
Regulation Name: Gynecologic Laparoscope and accessories
Regulatory Class: II
Product Code: HET
Dated: December 10, 2024
Received: March 27, 2025

Dear Anke Ristow:

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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K243821 - Anke Ristow Page 2

(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 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 (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-reporting-combination-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 Rule"). 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-devices/device-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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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K243821 - Anke Ristow Page 3

the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/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,

Jason Roberts -S

Jason R. Roberts, Ph.D.
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

Page 4

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

510(k) Number (if known): K243821

Device Name: i-Cut

Indications for Use (Describe):
The i-Cut system is indicated for morcellating and extracting tissue in laparoscopic, gynecologic surgical procedures.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF

Page 5

510(k) Summary

K243821

K243821
Page 1 of 4

SUBMITTER INFORMATION

A.M.I. Agency for Medical Innovations GmbH
Im Letten 1
6800 Feldkirch, Vorarlberg, Austria
Telephone: +43 5522 90505-0
Official Contact: Tanja Kinzl, Regulatory Affairs Specialist, PRRC
DATE PREPARED: April 24, 2025

DEVICE INFORMATION

Proprietary Name/Trade Name: i-Cut
Common Name: Power Morcellator
Regulation Name: Gynecologic Laparoscope And Accessories
Regulation Number: 21 CFR § 884.1720
Regulatory Class: Class II
Product Code: HET
Review Panel: Obstetrics/Gynecology

PREDICATE DEVICE IDENTIFICATION

510(k) Number	Predicate Device Name / Manufacturer	Primary Predicate
K101458	LiNA eXcise / LiNA Medical ApS	yes

A search for recalls was performed in the FDA recall database (Medical Device Recalls, advanced search). For the predicate device, no design-related or safety recall was identified.

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K243821
Page 2 of 4

DEVICE DESCRIPTION

The i-Cut is a single use laparoscopic power morcellator. It is provided sterile.

The i-Cut is electrically operated by a DC Motor which is powered by a 24V AC/DC mains adapter. The non-sterile i-Cut Power Supply with power cord is supplied separately to power the device.

INDICATIONS FOR USE

The i-Cut system is indicated for morcellating and extracting tissue in laparoscopic, gynecologic surgical procedures.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

Device & Predicate Device(s):	K243821	K101458	Comparison
Device Name	i-Cut	LiNA Xcise
Design features	Hand controlled mains powered morcellator with cutting tube. 2 Trocar positions: closed, cut handle button control. Build in gearing and motor	Hand controlled battery powered morcellator with cutting tube. 3 Trocar positions: Safe, Cut1, Cut2 handle button control. Build in battery package, gearing and motor	Different
Inner diameter	Ø14.95mm	Ø14.6mm	Different
Outer diameter	Ø19mm	Ø17mm	Different
Shaft length	100mm	155mm	Different
Speed	1100rpm	650rpm	Different
Cutting rate	>21.5g/min	---	No data available for the predicate device
Power source	24V DC (mains)	9V Battery	Different
Use life	Motor/gear lifetime approx. 60min (continuous operation)	Battery lifetime no load: 150 min	Different

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K243821
Page 3 of 4

The differences in technological characteristics do not raise different questions of safety and effectiveness.

SUMMARY OF NON-CLINICAL PERFORMANCE TESTING

The following non‐clinical testing has been performed on the i-Cut in order to demonstrate equivalence to the predicate device:

Sterilization validation per ANSI/AAMI/ISO 11135:2014
Shelf-life validation per ASTM F1980-21:2023 (package integrity and device performance support 5 year shelf life)
Simulated shipping per ASTM D4332-22:2022, ASTM D4169-22:2022, ASTM F1886/F1886-16:2017
ASTM F88/F88M-21:2022, ASTM F1929-15:2015, and ASTM F2096-11:2013
Biocompatibility testing:
- Cytotoxicity per ISO 10993‐5:2009
- Sensitization per ISO 10993‐10:2021
- Intracutaneous irritation per ISO 10993‐23:2021
- Acute systemic toxicity per ISO 10993‐11:2017
Electrical Safety and electromagnetic compatibility (EMC)
- Electrical safety per IEC 60601-1:2020
- EMC per IEC 60601-1-2:2020
Performance testing (bench): The subject device passed the following tests:
- Load test: Evaluate if the morcellator can withstand expected load without failure
- Gas tightness test: Determine if pneumoperitoneum is maintained in clinical use conditions
- Obturator abrasion test: Demonstrate that no abrasion of obturator occurs during insertion and removal from the device (no visible wear marks)
- Liquid tightness test: Evaluate if liquid tightness requirements were met after load test
- Grip of the housing surface test: Assess the surgeon's ability to properly grip the device during use
- Surface reflection test: Determine whether the cutting blade caused reflections under bright light that impeded visibility during morcellation
- Trocar sleeve – pull-off force test: Evaluate pull-off force of the trocar sleeve to demonstrate the connection of trocar sleeve and device is suitable for the application
- Functional test: Simulated use testing to evaluate if the device can morcellate and extract tissue in a model specimen within a containment system under expected use conditions.
- Insertion test: Measure of the force needed to expose the cutting blade when the device is in the "Closed" position to prevent accidental exposure of the cutting surface
- Usability testing: Simulated use testing with surgeons of different experience with laparoscopic morcellators to demonstrate compatibility of the morcellator with the

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K243821
Page 4 of 4

labeled containment system. The test evaluated device use related to potential containment system failures as well as assessment of containment system integrity.

CONCLUSION

The performance testing summarized above support that the subject device is as safe and effective as the predicate device.

The similar intended use, technological characteristics, and performance characteristics for the proposed i-Cut device are substantially equivalent to the predicate device.

Regulation Number and Section

§ 884.1720 Gynecologic laparoscope and accessories.

(a)
Identification. A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for gynecologic laparoscope accessories that are not part of a specialized instrument or device delivery system, do not have adapters, connector channels, or do not have portals for electrosurgical, lasers, or other power sources. Such gynecologic laparosope accessory instruments include: the lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable), scissors, and suction/irrigation probe. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.