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 System), the MOLLI Marker is located and surgically removed with the target tissue.

The MOLLI 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.

Device Description

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

This document is a 510(k) premarket notification from the FDA, and as such, it primarily focuses on demonstrating substantial equivalence to predicate devices based on non-clinical testing. It does not contain information about a clinical study involving human subjects to prove the device meets specific acceptance criteria based on performance metrics like accuracy, sensitivity, or specificity.

Therefore, I cannot provide the information requested in your prompt regarding acceptance criteria and a study proving device performance in a clinical context (e.g., sample size, expert ground truth, MRMC study, effect size of human reader improvement with AI, standalone performance, training set details).

Here's a breakdown of what can be extracted from the provided text, and what cannot:

Information NOT available in the document (and why):

Acceptance Criteria Table with Reported Performance: This document describes non-clinical bench testing and safety standards, not clinical performance metrics with pre-defined acceptance criteria.
Sample size used for the test set and data provenance: No clinical test set involving device performance on human subjects is described. The "test set" mentioned in this context refers to non-clinical bench testing.
Number of experts used to establish the ground truth for the test set and qualifications of those experts: There is no clinical data from human subjects requiring expert ground truth for performance evaluation.
Adjudication method for the test set: Not applicable as there's no clinical test set requiring adjudication.
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: This is a non-AI device (an implantable marker and detection system), and no clinical MRMC study is mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable for this device type.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for clinical performance as no clinical study is described. Ground truth for non-clinical tests would be established by physical measurements and engineering specifications.
The sample size for the training set: Not applicable as this is not an AI/machine learning device.
How the ground truth for the training set was established: Not applicable.

What the document does describe (relevant to your prompt but not directly answering all parts):

The document focuses on non-clinical testing to demonstrate the device's safety and effectiveness compared to predicate devices. This includes:

Summary of Non-Clinical Testing:
- Biocompatibility testing per ISO 10993-1
- Packaging validation testing per ISO 11607-1 and ASTM D4169-19
- EO sterilization validation per ISO 14937 and ISO 10993-7
- Software testing per IEC 62304
- Electrical safety testing per IEC 60601-1
- EMC testing per IEC 60601-1-2:2014
- MRI compatibility testing per ASTM standards F2052-15, F2119-07, F2182-11, and F2213-17.
- Non-clinical performance bench testing including V&V testing, MOLLI Marker displacement testing, tissue performance testing, and needle penetration testing (per ISO 7864)
- Human factor validation testing

The document concludes that "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." This is the core of a 510(k) submission: demonstrating substantial equivalence, often without the need for large-scale clinical trials if non-clinical data is sufficient to address safety and effectiveness concerns.

Summary

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April 16, 2021

MOLLI Surgical, Inc. % Pierre Bounaud Principal Consultant AcKnowlegde Regulatory Strategies, LLC 2251 San Diego Avenue, Suite B-257 San Diego, California 92110

Re: K210600

Trade/Device Name: Molli Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable Clip Regulatory Class: Class II Product Code: NEU Dated: February 26, 2021 Received: March 1, 2021

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

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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,

Cindy Chowdhury, Ph.D., M.B.A. Assistant Director 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

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Indications for Use

510(k) Number (if known)

K210600

Device Name MOLLI

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 Marker is located and surgically removed with the target tissue.

The MOLLI 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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510(k) Summary

DATE PREPARED

February 26, 2021

MANUFACTURER AND 510(k) OWNER

MOLLI Surgical, Inc. 22 St. Clair Ave. East, Suite #1500, Toronto, ON M4T 2S3, Canada Telephone: +1 (833) 665-5463 Official Contact: Fazila Seker, President & CEO

REPRESENTATIVE/CONSULTANT

Pierre Bounaud, Ph.D. Allison C. Komiyama, Ph.D., R.A.C. AcKnowledge Regulatory Strategies, LLC Telephone: +1 (619) 458-9547 Email: pbounaud@acknowledge-rs.com, akomiyama@acknowledge-rs.com Website: www.AcKnowledge-RS.com

DEVICE INFORMATION

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

PREDICATE DEVICE IDENTIFICATION

The MOLLI is substantially equivalent to the following predicate:

510(k) Number	Predicate Device Name / Manufacturer	Primary Predicate
K181007	Cianna Medical SAVI Scout Reflector and SAVI Scout System / Cianna Medical, Inc.	✓
K163541	Magseed Magnetic Marker System / Endomagnetics, Ltd

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

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DEVICE DESCRIPTION

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 System), the MOLLI Marker is located and surgically removed with the target tissue.

The MOLLI 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 believes that MOLLI is substantially equivalent to the predicate devices based on the information summarized here:

The subject device has a similar design and dimensions, and uses similar or identical materials as the devices cleared in K181007 and K163541. The subject device has the same intended use, similar technological characteristics, and similar instrumentation to the devices cleared in K181007 and K163541.

Technological differences of the subject device compared to the device cleared in K181007 include:

. Energy type used in the localization of the implantable marker.
. Reusable handheld probe.
. User calibration of the detection system.

These technological differences have undergone testing to ensure the device is substantially equivalent to the predicate.

SUMMARY OF NON-CLINICAL TESTING

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

. Biocompatibility testing per ISO 10993-1
. Packaging validation testing per ISO 11607-1 and ASTM D4169-19

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. EO sterilization validation per ISO 14937 and ISO 10993-7
. Software testing per IEC 62304
. Electrical safety testing per IEC 60601-1
. EMC testing per IEC 60601-1-2:2014
MRI compatibility testing per ASTM standards F2052-15, F2119-07, F2182-11, and F2213-17.
. Non-clinical performance bench testing including V&V testing, MOLLI Marker displacement testing, tissue performance testing, and needle penetration testing (per ISO 7864)
. Human factor validation testing

CONCLUSION

MOLLI is considered substantially equivalent to the predicate devices based on the testing performed, the identical indications for use, and similar technological characteristics. Based on the testing performed, including biocompatibility testing, packaging validation testing, sterilization validation testing, software testing, electrical safety testing, EMC testing, MRI compatibility testing, non-clinical performance bench testing, and human factor validation testing, 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.