The LSI Solutions® ForniSee™ is intended for use as a uterine manipulator in laparoscopic hysterectomy surgical procedures to identify the vaginal fornices and manipulate the uterus.

Device Description

LSI SOLUTIONS® ForniSee™ System will provide aid in the tissue manipulation typically encountered in patients requiring a hysterectomy. The ForniSee™ System provides single-patient use FS Devices and its companion reusable FS Sounds; these components are made from common surgical metals and polymers. Sterile disposable, mostly plastic, FS Device surgical hand tools will be offered in three different sizes designated as either FS-30, FS-35 or FS-40, with the number indicating the increasing diameter of the inside of the device's distal cervical cups. The FS Device is designed with an optional integrated vaginal illumination component. FS Sounds are reusable implements, which are essentially customized angled shafts or sounds constructed of cleanable and resterilizable surgical quality metal; the distal ends of these FS Sounds will be offered in four different sizes ranging in length from 6 to 8 to 10 to 12cm. FS Devices fit over FS Sounds to provide an effective means of uterine manipulation during laparoscopic surgery. FS Devices and FS Sounds will be manufactured at our facility in Victor, New York.

AI/ML Overview

The LSI SOLUTIONS® ForniSee™ System Uterine Manipulator and Accessories, a medical device intended for use as a uterine manipulator in laparoscopic hysterectomy surgical procedures, demonstrated its effectiveness and safety through various performance tests and clinical studies.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the LSI SOLUTIONS® ForniSee™ System are implicitly derived from the successful outcomes observed during its clinical performance testing and the comparison to the predicate device. The primary criteria revolve around safe and effective uterine manipulation and delineation of vaginal fornices during laparoscopic hysterectomy procedures, without causing device-related adverse events, maintaining pneumoperitoneum, and facilitating successful surgical outcomes.

Acceptance Criteria Category	Specific Criteria (Implicitly Derived from Study)	Reported Device Performance (Summary)
Safety	No device-related Adverse Events	Achieved: No device-related Adverse Events reported. Two non-device-related iatrogenic cystotomies, immediately recognized and repaired without sequelae.
	No ureteral injuries	Achieved: No ureteral injuries occurred.
	Acceptable blood loss	Achieved: Estimated Blood Loss (EBL) ranged from 20cc to 300cc, with an average of 124cc at one site and 60cc at the other, resulting in an average of 96cc for both sites combined. This range is generally considered acceptable for laparoscopic hysterectomies.
Effectiveness	Successful accomplishment of pre-planned hysterectomy procedure	Achieved: 49 of 50 hysterectomies (98%) were accomplished as pre-planned (38 Total Laparoscopic Hysterectomies and 11 Laparoscopic Supracervical Hysterectomies). One conversion to Total Abdominal Hysterectomy due to an extremely large uterus was noted.
	Maintenance of pneumoperitoneum	Achieved: Pneumoperitoneum was maintained throughout the procedure in 47 of 49 patients (96%), with only a slight loss in 2 patients.
	Effective uterine manipulation and forniceal exposure	Achieved: Both Principal Investigators (PIs) reported the use of the study devices as highly effective, especially in patients with challenging anatomy.
Post-operative Patient Outcome	Normal post-hysterectomy course	Achieved: All patients, except one with coincidental diverticulitis, were reported to have a normal post-hysterectomy course at follow-up. Other minor post-operative observations were considered non-attributable to the device or normal for recovery.
Biocompatibility	Meet ISO standards for biocompatibility	Achieved: ISO Vaginal Irritation, Guinea Pig Maximization, and MEM Elution cytotoxicity tests (ISO 10993-10:2002/A1:2006 and ISO 10993-5:2009) were completed.
Sterilization	Meet validation for steam/Sterrad/EO sterilization and residuals	Achieved: Steam and Sterrad sterilization validation (10^-6 SAL), EO Sterilization validation (ANSI/AAMI/ISO 11135-1:2007), and EO residuals testing (ISO 10993-7:2008) were completed.
Durability/Integrity	Meet accelerated aging and shipping standards	Achieved: Accelerated aging (ASTM F 1980-07) and Shipping testing (ASTM D4169-09) were completed.
	Functional, destructive, and life testing	Achieved: Bench testing included functional, destructive, and life testing, as well as thermal testing of the illumination feature.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: 50 elective hysterectomy patients.
Data Provenance: Prospective. The clinical performance testing was achieved through Institutional Review Board (IRB) approved studies. The studies were conducted at two separate medical centers within the USA, each with its own gynecological surgeon Principal Investigator (PI).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Number of Experts: At least two gynecological surgeon Principal Investigators (PIs) (one at each medical center) were involved in conducting the studies and evaluating the device's performance.
Qualifications: The experts were described as "gynecological surgeon Principal Investigator (PI)s." While specific experience levels (e.g., "10 years of experience") are not provided, their role as PIs in IRB-approved surgical studies implies significant clinical expertise in gynecological surgery and hysterectomy procedures.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method for the test set in the traditional sense of resolving discrepancies between multiple independent expert assessments of an outcome.

Instead, the clinical performance results were directly reported by the "gynecological surgeon Principal Investigator (PI)s" at each of the two medical centers. Observations and outcomes, including adverse events, estimated blood loss, pneumoperitoneum maintenance, and overall effectiveness, were reported by these PIs. For example, "Several minor intra-operative observations were noted but deemed by the PIs as expected in their patients or of no significant consequence." This suggests that the PIs' individual clinical judgment served as the primary basis for evaluating events and outcomes.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly described or performed. The study focused on the standalone performance of the ForniSee™ system in a clinical setting, without directly comparing its AI-assisted performance (as no AI component is mentioned) against human readers or human readers without AI assistance. The comparison was primarily against a predicate device's technological characteristics and overall intended use, not its clinical outcomes in a head-to-head MRMC trial.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

Yes, from the perspective of the device itself (not an algorithm in the AI sense), a standalone performance assessment was conducted through the clinical study. The ForniSee™ System was used by surgeons in a real-world surgical setting, and its direct performance (e.g., ability to manipulate the uterus, identify fornices, maintain pneumoperitoneum) was evaluated by the operating surgeons (PIs). The study assessed the device's efficacy and safety when used as intended, independent of a comparison to a human performing the task without the device.

7. Type of Ground Truth Used

The ground truth for the clinical performance testing was established by expert clinical assessment and surgical outcomes data. The PIs (gynecological surgeons) directly observed and assessed the device's performance during surgery, recorded clinical outcomes (e.g., successful hysterectomy, blood loss, pneumoperitoneum maintenance, adverse events), and conducted post-operative follow-ups. This involved:

Clinical observation: Direct assessment by operating surgeons of the device's functionality and impact during the procedure.
Surgical outcomes: Documentation of successful completion of the hysterectomy, conversion rates, and intra-operative issues.
Patient follow-up: Post-operative examinations and patient reports to assess recovery and any long-term complications.

8. Sample Size for the Training Set

The document does not mention a "training set" in the context of an algorithm or AI development. The device is a mechanical uterine manipulator, not an algorithm that requires a training set. The "development" of the product line involved "Cadaver research" and extensive "non-clinical tests" (biocompatibility, sterilization, aging, shipping, bench testing), which serve as pre-clinical development and validation phases, rather than a "training set" for an algorithm.

9. How the Ground Truth for the Training Set Was Established

Since the device is a mechanical instrument and not an AI algorithm, there is no "training set" in the conventional sense of machine learning, nor a "ground truth" to be established for such a training set. The development process, including "Cadaver research" and extensive "non-clinical tests," provided data and insights that informed the device's design and confirmed its physical and material properties, but this is distinct from establishing ground truth for algorithmic training.

Summary

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5. Premarket Notification [510(k)] Summary

Date: July 6, 2012

JUL 1 3 2012

Submitted By:

LSI SOLUTIONS®, Inc. 7796 Victor-Mendon Road Victor, New York 14564 Phone: (585) 869-6608 Fax: (585) 742-8086

Contact: Jude S. Sauer, M.D., President

Common Name: Uterine Manipulator

Trade Name: LSI SOLUTIONS® ForniSee™ System Uterine Manipulator and Accessories

Classification Name: Culdoscope and Accessories

21 CFR Part 884.1640

Predicate Device: The Koh Colpotomizer™ System (K954311)

Description: LSI SOLUTIONS® ForniSee™ System will provide aid in the tissue manipulation typically encountered in patients requiring a hysterectomy. The ForniSee™ System provides single-patient use FS Devices and its companion reusable FS Sounds; these components are made from common surgical metals and polymers. Sterile disposable, mostly plastic, FS Device surgical hand tools will be offered in three different sizes designated as either FS-30, FS-35 or FS-40, with the number indicating the increasing diameter of the inside of the device's distal cervical cups. The FS Device is designed with an optional integrated vaginal illumination component. FS Sounds are reusable implements, which are essentially customized angled shafts or sounds constructed of cleanable and resterilizable surgical quality metal; the distal ends of these FS Sounds will be offered in four different sizes ranging in length from 6 to 8 to 10 to 12cm. FS Devices fit over FS Sounds to provide an effective means of uterine manipulation during laparoscopic surgery. FS Devices and FS Sounds will be manufactured at our facility in Victor, New York.

Intended Use: The LSI SOLUTIONS® ForniSee™ System is intended for use as a uterine manipulator in laparoscopic hysterectory surgical procedures to identify the vaginal fornices and manipulate the uterus.

LSI SOLUTIONS® K111014

Section 5 - Page 1 of 3 (7/13/2012)

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Summary of Technological Characteristics Comparing Study Device to Predicate: Both the selected predicate, Koh Colpotomizer™ System, and the proposed subject, ForniSee™ System, share a common intended use. The predicate and subject devices are intended to be used sterile by a surgeon to assist in intra-operative transvaginal uterine manipulation and to aid in delineating the vaginal fornices region. Both systems assist in the maintenance of pneumoperitoneum after a colpotomy incision is made (Koh: using a balloon; FS: using the elastomeric vaginal occluder). Both systems incorporate durable components that can be reused repeatedly in patients and therefore require means for sufficient cleaning and resterilization. Both systems also incorporate single-patient use components that are provided sterile. Both systems have a plastic handle that remains outside of the patient in the perineal area for gripping and positioning by the operator. Both have a rigid section that passes through the vaginal canal and end in a cup shaped structure intended to engage the patient's cervix from within the vaginal fornices. Both systems provide a range of different size options for cervical engaging cups; cup size selection is typically made when using either system while the patient is in the operating room. Both systems provide several options over a comparable range of lengths for rigid, finger-like, members that enter and engage the uterine cavity; to mechanically anchor this rigid finger into the patient's uterus, the predicate device uses an inflatable balloon and the subject device uses a rotating metal anchor. With either system, rotation and movement of the handle outside of the patient causes reposition of the uterus and enhanced exposure of the area around the colpotomy site. The FS Device incorporates a passageway for the optional transmission of light for vaginal illumination to aid in colpotomy incisions. Both the predicate and subject systems have been demonstrated to be biocompatible and sterilizable. Both systems have been demonstrated in actual patient use to be effective for their intended use to aid in surgery through forniceal exposure and uterine manipulation, while also proving safe by not exposing patients to unacceptable risk.

Performance Testing: A substantial amount of ForniSee™ System performance testing was undertaken throughout the development of this product line. Cadaver research provided highly encouraging results.

The following non-clinical tests were completed:

. ISO Vaginal Irritation and Guinea Pig Maximization tests [ANSI/AAMI BE78:2002/A1:2006 (equivalent to ISO 10993-10:2002/A1:2006)]
MEM Elution cytotoxicity testing [ISO 10993-5:2009] .
Steam and Sterrad sterilization validation per "Overkill Method" (10" SAL) .
EO Sterilization validation per "Overkill Method" as recommended in . ANSI/AAMI/ISO 11135-1:2007
. Sterilization residuals testing [EO residual testing in accordance to ISO 10993-7:2008]
. Reusable component reprocessing [AAMI TIR No. 30]
Accelerated aging [ASTM F 1980-07 (2011)] .
Shipping testing [ASTM D4169-09] .
Bench testing including functional, destructive and life testing of FS™ System devices, . and thermal testing of the vaginal illumination feature.

LSI SOLUTIONS® K111014

Section 5 - Page 2 of 3 (7/13/2012)

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LSI SOLUTIONS® 510(k) Premarket Notification

Clinical performance testing was achieved through Institutional Review Board approved studies in 50 elective hysterectomy patients at two separate medical centers, each with their own gynecological surgeon Principal Investigator (PI). All hysterectomies were accomplished as pre-planned (38 Total Laparoscopic Hysterectomies and 11 Laparoscopic Supracervical Hysterectomies), except for 1 patient (2% of total) requiring conversion to a Total Abdominal Hysterectomy because of an extremely large uterus. There were no device related Adverse Events. No ureteral injuries occurred. Two patients, one at each site, with significant pre-existing pathologic scarring had inadvertent iatrogenic cystotomies, which were recognized immediately and sutured laparoscopically without any sequelae. Both bladder injuries were considered Not Device Related Adverse Events. The Estimated Blood Loss (EBL) range for this study was 20cc to 300cc with an average of 124cc at one site and 60cc at the other site, with an average of 96cc for both sites combined. Pneumoperitoneum was maintained throughout the procedure with no loss in 47 of 49 patients and a slight loss in 2 patients. Several minor intra-operative observations were noted but deemed by the PIs as expected in their patients or of no significant consequence. For example, one patient received an iatrogenic perforation in her previously therapeutically ablated uterus while dilating with a standard sound at the initiation of the operation. No bleeding or other observances were noted with this perforation. The uterine specimen was removed as planned. No other intra-operative problems or complications were encountered. All patients were reported by study Pls at post-operative follow up examinations to have a normal post-hysterectomy course except one patient who developed coincidental diverticulitis, requiring hospital admission and antibiotic therapy. Several other observations were made regarding study patients' post-operative recovery. For example, one patient complained of modest post-op transient vaginal bleeding or pathology was noted upon exam. Another patient required antibiotic therapy for a urinary tract infection. Another patient developed acute cholecystitis after her hysterectomy; this development was not considered attributable to her study procedure or an abnormal post-hysterectomy event by that site's PI. The use of these study devices reported by both PIs were proven to be highly effective especially in patients with challenging anatomy.

Conclusion:

Both the predicate and the subject systems offer many similar features and functions from comparable structural components. The bench top and clinical results affirm the effectiveness, safety and durability of the ForniSee™ System product. We believe that the predicate and the subject devices have been demonstrated to be substantially equivalent.

LSI SOLUTIONS® K111014

Section 5 - Page 3 of 3

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is depicted in a simple, black-and-white design.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Jude S. Sauer, M.D. President and CEO LSI SOLUTIONS®, Inc. 7796 Victor-Mendon Road VICTOR NY 14564

JUL 1 3 2012

Re: K11014

Trade/Device Name: LSI SOLUTIONS® ForniSee™ System Uterine Manipulator and Accessories Regulation Number: 21 CFR§ 884.1640 Regulation Name: Culdoscope and accessories Regulatory Class: II

Product Code: HEW, LKF Dated: July 6, 2012

Received: July 9, 2012

Dear Dr. Sauer:

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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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Page 2-

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Bayiano K-tush

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________ K111014

Device Name: LSI SOLUTIONS® ForniSee™ System Uterine Manipulator and Accessories

Indications For Use:

. . . .

The LSI Solutions® ForniSee™ is intended for use as a uterine manipulator in laparoscopic hysterectomy surgical procedures to identify the vaginal fornices and manipulate the uterus.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Norm M. Whang

Gastro-Renal, and

Page 1 of

Regulation Number and Section

§ 884.1640 Culdoscope and accessories.

(a)
Identification. A culdoscope is a device designed to permit direct viewing of the organs within the peritoneum by a telescopic system introduced into the pelvic cavity through the posterior vaginal fornix. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include trocar and cannula, instruments used through an operating channel, scope preheaters, light source and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for culdoscope accessories that are not part of a specialized instrument or device delivery system; do not have adapters, connectors, channels, or do not have portals for electrosurgical, laser, or other power sources. Such culdoscope accessory instruments include: lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable) scissors, and suction/irrigation probe. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.