MOLLI 2 System

K234149 · Molli Surgical, Inc. · NEU · Sep 26, 2024 · General, Plastic Surgery

Device Facts

• Record ID: K234149
• Device Name: MOLLI 2 System
• Applicant: Molli Surgical, Inc.
• Product Code: NEU · General, Plastic Surgery
• Decision Date: Sep 26, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4300
• Device Class: Class 2

Intended 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 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 Story

MOLLI 2 System facilitates surgical localization of implanted MOLLI Markers; system comprises MOLLI Marker, MOLLI Wand (OncoPen, OncoPen Prime, OncoPen Elite), and MOLLI 2 Tablet. Marker placed percutaneously in soft tissue; system provides non-imaging detection of marker location during surgery. Surgeon uses wand to scan tissue; tablet processes signal to provide feedback, guiding excision of target tissue. System aids in precise removal of surgical sites; benefits include improved surgical accuracy and workflow efficiency. Used in clinical settings by surgeons/staff. Tablet hardware/software updated to support new wand configurations.

Clinical Evidence

Bench testing only. Includes performance testing (multi-marker localization accuracy, wand essential performance, multi-tissue accuracy), cleaning and sterilization (reprocessing) validation, biocompatibility, electromagnetic compatibility, electrical safety, software verification, and cybersecurity assessment.

Technological Characteristics

System includes implantable markers and handheld wands (OncoPen, Prime, Elite) with tablet interface. Non-imaging detection principle. Software-controlled signal processing. Reprocessable components. Compliance with electrical safety and EMC standards. Connectivity between wand and tablet for data communication.

Indications for Use

Indicated for patients requiring temporary percutaneous marking of soft tissue surgical sites for up to 30 days. Used for localization and surgical removal of the marked tissue via non-imaging detection.

Regulatory Classification

Identification

An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.

Predicate Devices

• MOLLI 2 (K231579)

Submission Summary (Full Text)

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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.

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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 (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

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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] 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

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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 |

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# Indications for Use

510(k) Number (if known) K234149

Device Name MOLLI 2 System

Indications for Use (Describe)

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.

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------|--|
| <span style="font-size: 100%;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | |
| <span style="font-size: 100%;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) | |

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## 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: | [phone] |
| Official Contact: | John Dillon, Chief Technology Officer |
| Email: | [e-mail] |

### 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<br>(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

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.

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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 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. 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

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- 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.