The Symani® Surgical System is intended for soft tissue manipulation to perform anastomosis, suturing, and ligation microsurgery techniques on small blood vessels and lymphatic ducts between 0.1 and 2.5 mm in open free-flap surgery of the breast and extremities and open lymphatic surgery of the extremities. The Symani® Surgical System is indicated for use during microsurgical procedures when use of a motion scaling function is deemed appropriate by the surgeon. The System is indicated for use in adults. It is intended to be used by trained physicians in an appropriate operating environment in accordance with the Instructions for Use.

Device Description

Symani is designed to provide surgeons with increased precision while leveraging the surgeon's own surgical experiences. The Symani Surgical System consists of three components, the CMM, Console, and Instruments, with selectable scaling factors between 7x to 20x to improve motion control and scale down any physiological tremor of the operator in a similar fashion to conventional robotic-assisted surgical device (RASD) systems, and the instruments with wristed end-effectors to improve dexterity for tissue manipulation and suturing. The subject device has the same intended use and indications for use, and same technological characteristics as the predicate device, DEN230032. The Supermicro Needle Holder Suture Cut instrument has been added to the NanoWrist Instruments' portfolio.

AI/ML Overview

This document describes a 510(k) submission for the Symani Surgical System, specifically for the addition of a new instrument called the Supermicro Needle Holder Suture Cut.

Here's an analysis of the acceptance criteria and study information provided, noting what is and isn't available in the document:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present acceptance criteria in a table format with specific quantitative thresholds. Instead, it describes performance tests conducted to demonstrate that the new instrument maintains the safety and effectiveness of the existing system. The reported performance is an overall conclusion of substantial equivalence.

Implied Acceptance Criteria and Reported Performance from the Text:

Acceptance Criteria Category	Reported Device Performance
Functional Equivalence	The Supermicro Needle Holder Suture Cut design is the same as the current Supermicro Needle holder with the additional features of a small (micro) blade mounted on the driving tip.
Simulated Use	Performance tests (including simulated use) demonstrated that use of the Symani Surgical System with the new instrument is as safe and effective as the predicate device.
Gripping Force & Torque	Performance tests (including gripping force & torque) demonstrated that use of the Symani Surgical System with the new instrument is as safe and effective as the predicate device.
Structural Integrity	Performance tests (including structural integrity tests) demonstrated that use of the Symani Surgical System with the new instrument is as safe and effective as the predicate device.
Overall Safety & Effectiveness	The subject device is deemed to be substantially equivalent to the legally commercialized predicate device (DEN230032).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not specified. The document only lists "Simulated use test," "Gripping force & torque," and "Structural integrity tests" without detailing the number of test runs, materials used, or specific data points.
Data Provenance: Not specified. It's implied that the testing was conducted by Medical Microinstruments, Inc. in Pisa, Italy, as that's their location, but no direct statement on data origin is provided. The study appears to be prospective testing of the new instrument's performance characteristics.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This device is a surgical instrument and the performance tests described (simulated use, gripping force & torque, structural integrity) are engineering and functional tests, not clinical studies requiring expert interpretation or ground truth establishment in the traditional sense of diagnostic imaging or AI performance. The assessment is against established device performance parameters and comparison to a predicate.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. As described above, this is not a study requiring human adjudication of results in the context of diagnostic interpretation. The performance tests would be evaluated against engineering specifications and comparison to the predicate.

5. 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

Not applicable. This is not an AI-powered diagnostic device, but a surgical instrument. Therefore, MRMC studies and AI-assistance effect sizes are not relevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical surgical instrument, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. The "ground truth" for the performance tests of a surgical instrument involves engineering specifications, material properties, mechanical testing standards, and comparison to the functionally equivalent predicate device's performance. There is no biological or diagnostic "ground truth" in this context.

8. The sample size for the training set

Not applicable. As noted, this is a physical medical device, not an AI/ML algorithm requiring a training set.

9. How the ground truth for the training set was established

Not applicable. No training set is involved.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health and Human Services and the U.S. Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 27, 2025

Medical Microinstruments, Inc. Zainab Amini RA Specialist Via Egidio Giannessi 54 Pisa, Italy 56121 Italy

Re: K250014

Trade/Device Name: Symani Surgical System (820-03830) Regulation Number: 21 CFR 878.4963 Regulation Name: Electromechanical System For Open Microsurgery Regulatory Class: Class II Product Code: SAQ Dated: January 2, 2025 Received: January 2, 2025

Dear Zainab Amini:

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 (QS) 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Digitally signed by Mark Mark Trumbore -S Trumbore -S Date: 2025.01.27
11:55:04-05'00' Mark Trumbore, Ph.D. Assistant Director DHT4A: Division of General 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

Submission Number (if known)

K250014

Device Name

Symani Surgical System (820-03830)

Indications for Use (Describe)

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

1. SUBMITTER INFORMATION

Submitter:	MEDICAL MICROINSTRUMENTS, INC.Via Egidio Giannessi 54Pisa, IT 56121
Contact :	Zainab Amini(904) 896-6812Zainab.amini@mmimicro.com
Date :	22 January 2025

II. SUBJECT DEVICE INFORMATION

Device Trade Name:	Symani® Surgical System
Classification Name:	Electromechanical System For Open Microsurgery (21CFR §878.4963)
Regulatory Class:	II
Product Code:	SAQ
Submission Type:	Special 510(k)

III. PREDICATE DEVICE INFORMATION:

Predicate Device: Symani Surgical System, DEN230032

ıv. DEVICE DESCRIPTION:

The Supermicro Needle Holder Suture Cut instrument has been added to the NanoWrist Instruments' portfolio.

v. INDICATIONS FOR USE

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vi. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The technological characteristics of the subject and predicate devices remain the same in this submission. As the instruments are similar to the predicate device, the differences between the subject and predicate devices are the addition of the small blade and reduced size for the current Symani instruments (Micro Needle Holder Suture Cut and Supermicro Needle Holder), therefore, the addition of the new Instrument to the Symani Surgical System range of Instruments (i.e., the Supermicro Needle Holder Suture Cut). More specifically, the Supermicro Needle Holder Suture Cut design is the same as the current Supermicro Needle holder with the addition features of the small (micro) blade mounted on the driving tip.

vii. PERFORMANCE DATA

The following performance tests were conducted and submitted within this submission for a determination of substantial equivalence of the new Supermicro Needle Holder Suture Cut compared to the current instruments:

-Simulated use test
-Gripping force & torque
Structural integrity tests -

villi. CONCLUSION

Based on the information provided within this submission, and comparison of the subject vs. predicate device, the subject device Symani Surgical System has the same intended use and indications for use, and technological characteristics as the predicate device. The performance testing provided within this submission for the introduction of Symani Surgical System's new instrument Supermicro Needle Holder Suture Cut demonstrated that use of the Symani Surgical System is as safe and effective as the predicate device, DEN230032. Therefore, the subject device is deemed to be substantially equivalent to the legally commercialized predicate device.

Regulation Number and Section

N/A