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 Wand 2 and MOLLI Tablet 2 constitute the MOLLI 2 System. The MOLLI 2 System is intended for the nonimaging 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 details the device, its intended use, and a comparison to a predicate device (MOLLI, K210600). The primary purpose of this submission is to introduce minor changes to the previously cleared MOLLI device, specifically:

Addition of a new needle length for the MOLLI Introducer.
Hardware and software updates to the guidance system components (MOLLI Wand 2, MOLLI Tablet 2).

The document does not contain information related to acceptance criteria for an AI/algorithm-driven device's performance, nor does it describe a study to prove the device meets such criteria. The MOLLI 2 System is described as a "non-imaging detection" system for a marker, implying a physical detection mechanism rather than an algorithmic analysis of images.

Therefore, I cannot fulfill the request to provide:

A table of acceptance criteria and reported device performance.
Sample size and data provenance for a test set.
Number and qualifications of experts for ground truth establishment.
Adjudication method for a test set.
MRMC comparative effectiveness study details or effect size.
Standalone algorithm performance.
Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
Sample size for the training set.
How ground truth for the training set was established.

The document focuses on demonstrating substantial equivalence to a predicate device primarily through non-clinical bench testing, sterilization validation, and electrical/software safety testing to address the minor hardware and software updates. It states: "These changes have undergone testing to ensure the device is as safe and effective as the predicate device," and "The results of these tests indicate that MOLLI 2 is substantially equivalent to the predicate device."

Specifically, the non-clinical testing performed includes:

EO sterilization validation per ISO 14937 and ISO 10993-7
Software testing per IEC 62304
Electrical safety testing per IEC 60601-1 and IEC 60601-1-6
EMC testing per IEC 60601-1-2
Non-clinical performance bench testing

These are standard engineering and safety tests, not clinical performance studies for an AI/algorithm.

Summary

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

Image /page/0/Picture/2 description: The image shows the logo for 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 logo on the right. The FDA logo has a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 18, 2023

MOLLI Surgical, Inc % Pierre Bounaud Principal consultant Ram+ 2251 San Diego Ave, B-257 San Diego, California 92110

Re: K223107

Trade/Device Name: MOLLI 2 Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: Class II Product Code: NEU Dated: December 7, 2022 Received: December 20, 2022

Dear Pierre Bounaud:

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 (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 located 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.

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

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

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 803) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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,

Deborah A. Fellhauer -S

Deborah Fellhauer, RN, BSN Assistant Director Plastic Surgery Implant Dvices Team DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known) K223107

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)	☐

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."

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

Image /page/3/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 in dark blue, with a small light blue circle above the "i". Below the logo, the tagline "precision surgery made simpler" is written in a smaller, lighter blue font. 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.

510(k) Summary

DATE PREPARED

September 30, 2022

MANUFACTURER AND 510(k) OWNER

MOLLI Surgical, Inc. 50 Wellington Street East Suite 400 Toronto ON M5E 1C8 Canada +1 (519) 897-6654 Telephone: Official Contact: Dr. Joseph De Croos, Director of Quality Assurance and Regulatory Affairs Email: jdecroos@mollisurgical.com

REPRESENTATIVE/CONSULTANT

Pierre Bounaud, Ph.D. Allison C. Komiyama, Ph.D., R.A.C. RQM+ Telephone: +1 (412) 816-8139 Email: pbounaud@rqmplus.com, akomiyama@rqmplus.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
K210600	MOLLI / MOLLI Surgical, Inc.	✓

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

DEVICE DESCRIPTION

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

Image /page/4/Picture/0 description: The image shows the logo for Molli. The word "molli" is written in a sans-serif font, with the letters in a dark blue color. There is a light blue circle above the "i" in the word "molli". The logo is simple and modern.

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

Addition of a new needle length for the MOLLI Introducer ●
Hardware and software updates to the guidance system components (MOLLI Wand 2, MOLLI ● Tablet 2)

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 MOLLI 2 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 K210600. Minor modifications to the subject device as compared to the predicate device include:

MOLLI Introducer: addition of a longer needle (12 cm) .
MOLLI Wand 2: new circuit board, minor changes to internal components, cosmetic changes, firmware update
MOLLI Tablet 2: component update (new screen, battery and speakers) and software update

These changes have undergone testing to ensure the device is as safe and effective as the predicate device.

SUMMARY OF NON-CLINICAL TESTING

The materials/formulation and processing of the patient-contacting components of the MOLLI 2 are the same as for the predicate device. Therefore, MOLLI 2 is considered to have met the requirements of ISO 10993-1 and FDA's Guidance for Industry and Food and Drug Administration Staff – Use of International ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process.

The following tests were performed to demonstrate safety based on current industry standards:

EO sterilization validation per ISO 14937 and ISO 10993-7 ●
. Software testing per IEC 62304
Electrical safety testing per IEC 60601-1 and IEC 60601-1-6
EMC testing per IEC 60601-1-2
Non-clinical performance bench testing

The results of these tests indicate that MOLLI 2 is substantially equivalent to the predicate device.

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

precision surgery made simpler®

CONCLUSION

Based on the testing performed, including sterilization testing, software testing, electrical safety testing, EMC testing, and non-clinical performance bench testing, 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.