(46 days)
No
The description focuses on a physical marker and a detection system based on non-imaging localization, with no mention of AI or ML in the device description, intended use, or performance studies.
No
The device is described as a surgical marking and guidance system for locating non-palpable lesions, not for treating a disease or condition. Its purpose is to aid in the surgical removal of tissue.
No
The device is a surgical marking and guidance system used to locate non-palpable lesions for surgical removal, not to diagnose a condition.
No
The device description explicitly states that the MOLLI system consists of hardware components including a marker, introducer, wand, and tablet, in addition to any software that may be present.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- MOLLI System Function: The MOLLI system is a surgical marking and guidance system. It involves implanting a physical marker (MOLLI Marker) into soft tissue and then using a separate system (MOLLI System) to locate that marker for surgical removal.
- No Analysis of Biological Samples: The MOLLI system does not analyze any biological samples from the patient. Its function is purely mechanical (marker placement) and electromagnetic (marker detection).
The device's intended use and description clearly indicate it's a tool for surgical localization, not for analyzing biological samples to diagnose or monitor a condition.
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 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.
Product codes
NEU
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound or radiography
Anatomical Site
Soft tissue, for locating non-palpable lesions
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
Non-clinical testing demonstrated safety based on current industry standards. This included:
- 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
Key results: 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.
Key Metrics
Not Found
Predicate Device(s)
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/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 acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.
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)
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
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.
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.