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 non-imaging 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 of the MOLLI Marker that has been implanted in a site intended for surgical removal.

Device Description

MOLLI 2 is a precision surgical marking and guidance system for locating non-palpable lesions during surgery. MOLLI 2 consists of a temporary marker (MOLLI Marker), a marker delivery system (MOLLI Introducer), a detection wand (MOLLI Wand 2), and a visualization tablet (MOLLI Tablet 2). The MOLLI 2 Wand and MOLLI 2 Tablet constitute the MOLLI 2 system. The MOLLI 2 is intended 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

The provided text is a 510(k) summary for the MOLLI 2 device. It describes modifications to an already cleared device and the testing performed to demonstrate substantial equivalence. However, it does not contain the specific detailed information for acceptance criteria, device performance, sample sizes, expert qualifications, or ground truth establishment that you requested.

The document states that updates to the MOLLI Introducer and the user guide were made, and non-clinical testing was performed to address these changes. This testing included "Biocompatibility testing to demonstrate safety of MOLLI Introducer" and "Bench testing to demonstrate effectiveness of MOLLI Introducer." It also mentions "Justification for updating cardiac device contraindication to a warning."

Here's what can be extracted based on the lack of information about a clinical study demonstrating performance against acceptance criteria for the entire system for specific clinical outcomes:

1. Table of acceptance criteria and reported device performance:
* Not explicitly provided. The document focuses on demonstrating safety and effectiveness for minor modifications (siliconized needle, updated contraindication to warning) through non-clinical testing. It does not present a table of measurable acceptance criteria for the overall device performance in a clinical context (e.g., accuracy of lesion localization) and corresponding performance metrics from a study.

2. Sample size used for the test set and data provenance:
* Not applicable / Not provided for an effectiveness study. The document refers to "Biocompatibility testing" and "Bench testing" for the MOLLI Introducer and a "Justification for updating cardiac device contraindication to a warning." These are not typically described with "test sets" in the context of clinical performance data provenance. There is no mention of a human subject test set or data provenance (country of origin, retrospective/prospective) for clinical performance.

3. Number of experts used to establish the ground truth for the test set and qualifications of those experts:
* Not applicable / Not provided. Since there's no mention of a clinical test set or a study involving human subjects to establish clinical performance, there's no information on experts establishing ground truth for such a study.

4. Adjudication method for the test set:
* Not applicable / Not provided. As no clinical test set for overall device performance is discussed, an adjudication method is irrelevant in this context.

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:
* No, it was not. This document describes a surgical marking and guidance system. It does not appear to involve AI or a multi-reader multi-case comparative effectiveness study in the context of diagnostic interpretation or AI assistance. The "MOLLI 2 System" is described as for "non-imaging detection of the MOLLI Marker."

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
* Not applicable. The MOLLI 2 System is a medical device for surgical guidance, not an AI algorithm performing a diagnostic task in a standalone manner. Its function is to assist in localizing a marker.

7. The type of ground truth used:
* Not applicable / Not provided for clinical performance. For the non-clinical tests mentioned, the "ground truth" would be established by the testing standards and specifications (e.g., for biocompatibility, the reference standards for cytotoxicity, irritation, sensitization; for bench testing, engineering specifications for force, stiffness, etc.). There is no mention of clinical ground truth (e.g., pathology, outcomes data) as part of this submission for evaluating clinical device performance.

8. The sample size for the training set:
* Not applicable. The device described is a physical medical device (marker, introducer, wand, tablet) for surgical guidance, not a machine learning or AI model that requires a training set of data.

9. How the ground truth for the training set was established:
* Not applicable. As above, this is not an AI/ML device requiring a training set.

In summary, the provided FDA 510(k) summary focuses on demonstrating that minor modifications to an already cleared device do not raise new safety or effectiveness concerns, primarily through non-clinical (bench and biocompatibility) testing and justification. It does not present data from a clinical study evaluating the device's performance against specific clinical acceptance criteria, nor does it involve AI or large datasets for training and testing as one might find in an AI/ML medical device submission.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" stacked on top of each other.

October 26, 2023

MOLLI Surgical, Inc. Joseph De Croos Director. Ouality Assurance & Regulatory Affairs 50 Wellington Street East Suite 400 Toronto, ON M5E 1C8 Canada

Re: K231579

Trade/Device Name: Molli 2 Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable Clip Regulatory Class: Class II Product Code: NEU Dated: September 29, 2023 Received: September 29, 2023

Dear Joseph De Croos:

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.

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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 (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.

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).

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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-devices/deviceadvice-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.

Digitally signed by Tek Tek N. N. Lamichhane -S Lamichhane -S Pate: 2023.10.26 16:08:14 -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

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Indications for Use

510(k) Number (if known) K231579

Device Name MOLLI 2

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)

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Image /page/4/Picture/1 description: The image shows the logo for Molli. The word "molli" is written in a dark blue font, with a light blue dot above the second "i". Below the word "molli" is the phrase "precision surgery made simpler" in a smaller font, with the word "simpler" in light blue and the rest of the phrase in dark blue.

K231579 - 510(k) Summary

DATE PREPARED

October 25, 2023

MANUFACTURER AND 510(k) OWNER

MOLLI Surgical, Inc. 50 Wellington Street East Suite 400 Toronto ON M5E 1C8 Canada Telephone: +1-833-665-5463 Dr. Joseph De Croos, Director of Quality Assurance and Regulatory Affairs Official Contact: Email: jdecroos@mollisurgical.com

DEVICE INFORMATION

Proprietary Name/Trade Name:	MOLLI 2
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
K223107	MOLLI 2 / MOLLI Surgical, Inc.	✓

The predicate device has not been subject to a design related recall.

DEVICE DESCRIPTION

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Image /page/5/Picture/1 description: The image shows the logo for Molli, a company that specializes in precision surgery. The logo consists of the word "molli" in a dark blue sans-serif font, with a small light blue circle above the "i". Below the word "molli" is the tagline "precision surgery made simpler" in a smaller font, with the word "simpler" in light blue and the rest of the tagline in dark blue.

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

. Modification to the MOLLI Introducer
Update to contraindications and warning in the MOLLI Marker & Introducer user guide

INDICATIONS FOR USE

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.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

MOLLI Surgical, Inc. believes that the subject device is substantially equivalent to the predicate device based on the information summarized here:

The subject device has the same intended use, design, and technological characteristics as the predicate device cleared in K223107. Minor modifications to the subject device as compared to the predicate device include:

MOLLI Introducer needle cannula is siliconized
. Update to contraindication and warning in the MOLLI Marker & Introducer user guide
- o Current Contraindication: "The MOLLI Marker must not be placed in the same breast as an implanted cardiac device. If placing the MOLLI Marker in the contralateral breast, it must be a minimum of 20 mm away from an implanted cardiac device".
- Change cardiac device contraindication to a warning: "Caution should be o exercised when using the MOLLI Marker on patients with magnetically susceptible implanted devices, including active implantable and wearable medical devices, and devices using a permanent maqnet (e.q., pacemakers, implantable defibrillators, cochlear implants, nerve stimulators, deep brain stimulators, infusion pumps, or any implantable or body worn permanent magnet). The MOLLI Marker must be implanted at a minimum of 40 mm away from magnetically susceptible implanted devices."

790 Estate Drive · 2nd Floor Deerfield · Illinois · 60015 United States

50 Wellington Street E. · Suite 400 Toronto · Ontario · M5E 1C8 Canada

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Image /page/6/Picture/0 description: The image shows the logo for Molli, a company that specializes in precision surgery. The word "molli" is written in a bold, sans-serif font, with a small blue circle above the "i". Below the word "molli" is the tagline "precision surgery made simpler®", with the word "simpler" in a lighter shade of blue. The logo is clean and modern, and the tagline suggests that Molli's products and services are designed to make surgery more efficient and effective.

SUMMARY OF NON-CLINICAL TESTING

Due to the changes in the processing of the patient-contacting components of the MOLLI 2 (i.e., the MOLLI Introducer) and the updates to the MOLLI Marker & Introducer user guide, additional non-clinical testing was performed.

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

. Biocompatibility testing to demonstrate safety of MOLLI Introducer
. Bench testing to demonstrate effectiveness of MOLLI Introducer
. Justification for updating cardiac device contraindication to a warning

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. The same indications for use, technological characteristics, and performance characteristics for the proposed MOLLI 2 are assessed to be substantially equivalent 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.