(110 days)
No
The document describes a system for non-imaging detection and localization of a marker, and there is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is used for temporary marking and localization of surgical sites, not for treating a disease or condition.
No
The device is described as a "precision surgical marking and guidance system for locating non-palpable lesions during surgery" and is used to temporarily mark a surgical site for removal. It aids in localization rather than diagnosing a condition.
No
The device description explicitly lists hardware components: a temporary marker, a marker delivery system, a detection wand, and a visualization tablet. The software (MOLLI 2 System) is part of a larger hardware system.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The MOLLI system is used to mark and locate a surgical site within the body.
- The intended use is for surgical marking and guidance. The device is used to help surgeons find a specific location for removal, not to diagnose a condition based on analyzing biological samples.
- The device description focuses on physical components for marking and detection. It describes a marker, delivery system, wand, and tablet, all designed for physical localization.
- There is no mention of analyzing biological samples or performing tests on specimens. The system relies on detecting a physical marker.
Therefore, the MOLLI system falls under the category of a surgical instrument or guidance system, not an In Vitro Diagnostic device.
N/A
Intended Use / 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 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 and localization of the MOLLI Marker that has been implanted in a site intended for surgical removal.
Product codes
NEU
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Using imaging guidance (such as ultrasound or radiography) or aided by non-imaging guidance (MOLLI 2 System)
Anatomical Site
soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K210600 MOLLI / MOLLI Surgical, Inc.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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
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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,
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
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Indications for Use
510(k) Number (if known) K223107
Device Name MOLLI 2
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)
| Prescription Use (Part 21 CFR 801 Subpart D) | ☑ |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) | ☐ |
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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
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.
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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 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 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.
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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.