The MOLLI 2 System is intended only for the non-imaging detection of the MOLLI Marker that has been implanted in a site intended for surgical removal.

Device Description

The MOLLI Marker is intended to be placed percutaneously in soft tissue to temporarily mark a surgical site intended for surgical removal. The MOLLI Marker can only be implanted for less than 30 days. Using imaging guidance (such as ultrasound or radiography) or aided by nonimaging guidance (MOLLI 2 System), the MOLLI Marker is located and surgically removed with the target tissue. The MOLLI 2 System is intended only for the non-imaging detection and localization of the MOLLI Marker that has been implanted in a site intended for surgical removal.

AI/ML Overview

This FDA 510(k) summary focuses on design modifications to an existing device, the MOLLI 2 System, specifically introducing new MOLLI Wand configurations (MOLLI OncoPen, MOLLI OncoPen Prime, MOLLI OncoPen Elite) and corresponding software/hardware updates. As such, the submission primarily relies on non-clinical testing to demonstrate substantial equivalence, rather than a full de novo clinical study with detailed performance outcomes like sensitivity and specificity.

Therefore, many of the requested detailed points regarding acceptance criteria, study design for performance metrics like sensitivity/specificity, expert consensus, and effects on human reader performance are not explicitly available or described in this type of submission. The provided text outlines what non-clinical tests were conducted to support the changes.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document broadly states that "Performance Testing including Multi Marker Localization System Accuracy, Wand Essential Performance (Accuracy and Feedback) and Multi Tissue Accuracy Testing" was performed. However, it does not provide specific acceptance criteria values (e.g., "accuracy must be > 95%") nor the reported numerical performance values. It only concludes that "The results of these reports indicate that the subject device is substantially equivalent to the predicate device."

2. Sample Size Used for the Test Set and Data Provenance

Not specified in the provided text. The testing was non-clinical (laboratory/benchtop) rather than human subject testing, so "country of origin of the data" and "retrospective or prospective" do not apply in the typical sense of clinical trials.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

Not applicable/specified. For non-clinical performance testing, the ground truth would typically be established by calibrated instruments or predefined scenarios, not human experts.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 typically apply to clinical studies where human readers interpret data, not for non-clinical device performance testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a MRMC comparative effectiveness study was not done. The submission focuses on non-clinical testing for design changes.

6. Standalone (Algorithm Only) Performance

The "MOLLI 2 System" is a device that includes hardware (wands, tablet) and software. The performance testing described (Multi Marker Localization System Accuracy, Wand Essential Performance, Multi Tissue Accuracy) would be considered standalone performance of the device's ability to detect and localize markers, without a human "interpretation" component in the clinical sense. However, the exact metrics and results are not provided.

7. Type of Ground Truth Used

For the non-clinical performance testing, the ground truth would typically be established through:

Engineering specifications / Known values: For accuracy tests, the true position or characteristics of the marker would be precisely known or set.
Calibrated measurement tools: Instruments used to measure the output of the device would be calibrated to provide true values.
Controlled experimental setups: Scenarios designed to simulate real-world use with known parameters.

8. Sample Size for the Training Set

Not applicable. This is a 510(k) for device modifications, not an AI/ML algorithm development submission requiring a "training set" in the machine learning sense. The software modifications are to support communication and compatibility with new hardware, implying changes to control logic rather than a learning algorithm.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no mention of a training set for an AI/ML algorithm.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA acronym and name on the right. The FDA acronym and name are in blue, with the acronym in a larger font size than the name. The name is written as "U.S. FOOD & DRUG ADMINISTRATION".

September 26, 2024

MOLLI Surgical, Inc. John Dillon Chief Technology Officer 50 Wellington Street East Suite 400 Toronto, ON M5E 1C8 Canada

Re: K234149

Trade/Device Name: MOLLI 2 System Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable Clip Regulatory Class: Class II Product Code: NEU Dated: August 27, 2024 Received: August 28, 2024

Dear John Dillon:

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.

{1}------------------------------------------------

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).

Your device is also subject to, among other requirements, the Quality System (OS) 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 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-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 the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory

{2}------------------------------------------------

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,

Tek N. Digitally signed by Tek N. Lamichhane -S Lamichhane - Date: 2024.09.26 S 16:04:09 -04'00' Tek N. Lamichhane, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

The following is a list of all reprocessed single use device (SUD) models that are cleared in this submission.

510(k) Number	Model number	Model Name
K234149	MP2015A	MOLLI OncoPen
K234149	MP2040S	MOLLI OncoPen Elite
K234149	MP2025S	MOLLI OncoPen Prime

{4}------------------------------------------------

Indications for Use

510(k) Number (if known) K234149

Device Name MOLLI 2 System

Indications for Use (Describe)

The MOLLI 2 System is intended only for the non-imaging detection of the MOLLI Marker that has been implanted in a site intended for surgical removal.

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."

{5}------------------------------------------------

510(k) Summary

DATE PREPARED

September 24, 2024

MANUFACTURER AND 510(k) OWNER

MOLLI Surgical, Inc.
50 Wellington Street East, Suite 400
Toronto, ON
M5E 1C8, Canada
Telephone:	+1-416-805-7582
Official Contact:	John Dillon, Chief Technology Officer
Email:	jdillon@mollisurgical.com

DEVICE INFORMATION

Proprietary Name/Trade Name:	MOLLI 2 System
Common Name:	Implantable radiographic marker
Regulation Number:	21 CFR 878.4300
Class:	II
Product Code:	NEU
Premarket Review:	OPEQ/OHT4/Infection Control and Plastic Surgery Devices(DHT4B)
Review Panel:	General & Plastic Surgery

PREDICATE DEVICE IDENTIFICATION

MOLLI 2 is substantially equivalent to the following predicate:

510(k) Number	Predicate Device Name / Manufacturer	Primary Predicate
K231579	MOLLI 2 / MOLLI Surgical, Inc.	✓

The predicate devices have not been subject to a design-related recall.

DEVICE DESCRIPTION

{6}------------------------------------------------

The purpose of this 510(k) premarket notification is to introduce the following changes:

Additional MOLLI Wand Configurations (MOLLI OncoPen, MOLLI OncoPen Prime, MOLLI OncoPen Elite)
. Modifications to the MOLLI 2 Tablet hardware and software to support communication with the new MOLLI Wands.

INDICATIONS FOR USE

The MOLLI 2 System is intended only for the non-imaging detection and localization of the MOLLI Marker that has been implanted in a site intended for surgical removal.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

MOLLI Surgical, Inc. believes that the subject device is substantially equivalent to the predicate device. The subject device has the same design and technological characteristics as the predicate device cleared in K231579. Minor modifications to the subject device as compared to the predicate devices include:

. Additional MOLLI Wand Configurations (MOLLI OncoPen, MOLLI OncoPen Prime, MOLLI OncoPen Elite)
. Modifications to the MOLLI 2 Tablet hardware and software to support compatibility with the new MOLLI Wands.

SUMMARY OF NON-CLINICAL TESTING

Due to the changes, additional non-clinical testing was performed.

The following reports are included in this submission to demonstrate safety and effectiveness based on current industry standards:

Cleaning and Sterilization (Reprocessing)
Biocompatibility testing
Electromagnetic Compatibility
Electrical Safety
Software Verification
Cybersecurity

{7}------------------------------------------------

Performance Testing including Multi Marker Localization System Accuracy, Wand Essential Performance (Accuracy and Feedback) and Multi Tissue Accuracy Testing
The results of these reports indicate that the subject device is substantially equivalent to the predicate device.

CONCLUSION

Based on the testing performed, it can be concluded that the subject device does not raise new issues of safety or effectiveness compared to the predicate device.

Regulation Number and Section

§ 878.4300 Implantable clip.

(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.