The Polygon Resection Device is intended for intrauterine use by a trained gynecologist to hysteroscopically resect and remove tissue, including focal lesions such as endometrial polyps and retained products of conception.

Device Description

The Polygon Resection Device is a handheld manually operated device designed for the hysteroscopic removal of intrauterine tissue. The device is provided sterile. The shaft of the device is design to fit into the working channel of any hysteroscope that includes a 3.0 mm (Fr) straight working channel. The device is activated by the physician by squeezing the trigger. A rotation knob is provided to enable the physician to rotate the cutting bay into an orientation that aligns with the desired specimen. The barb fitting provides an attachment port for a vacuum system. The vacuum system pulls the specimen into the cutting window where it can be resected and aspirated out of the patient. There are no electrical or powered connections necessary for operation of the device.

AI/ML Overview

The provided text describes the Polygon Resection Device, a hysteroscopic tissue removal device, and its supporting studies for FDA 510(k) clearance. Here's an analysis of the acceptance criteria and supporting studies based on the provided information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document implicitly states that a range of tests were conducted and that "All test samples met the acceptance criteria for each test." However, the specific numerical acceptance criteria for most tests are not explicitly detailed. The reported performance is generally qualitative, confirming successful completion or compliance.

Acceptance Criterion (Implicit)	Reported Device Performance
Sterilization Efficacy (in accordance with ISO 11135-1: 2014)	-Validated in accordance with ISO 11135-1: 2014. -All test samples met acceptance criteria.
Shelf Life (including package integrity and functional testing)	-Validated. -All test samples met acceptance criteria.
Biocompatibility (in accordance with ISO 10993-1: 2009)	-Evaluated including Cytotoxicity, Guinea Pig Maximization Sensitization, Irritation, and Acute Systemic Toxicity testing. -All test samples met acceptance criteria.
Design Verification - Joint Connection Strength	-Tested. -All test samples met acceptance criteria.
Design Verification - Visual Inspection	-Inspected. -All test samples met acceptance criteria.
Design Verification - Tissue Trap Removal Force	-Tested. -All test samples met acceptance criteria.
Functional Performance - Hysteroscope Compatibility	-Tested in a simulated use model. -All test samples met acceptance criteria.
Functional Performance - Vacuum System Compatibility	-Tested in a simulated use model. -All test samples met acceptance criteria.
Functional Performance - Device Cutting Performance	-Tested in a simulated use model (successful removal of tissue without clogging, cutting rate, and fluid usage). -All test samples met acceptance criteria.
Clinical Usability (Ease of use, successful tissue removal without clogging, number of activations)	-Evaluated through a clinical usability study with 5 physicians and 32 cases. -Demonstrated that the subject device can be used per the Instructions for Use as intended (successful removal of tissue without clogging, ease of use, appropriate number of activations for procedure completion).

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

Sample Size for Clinical Usability Study: 32 cases.
Data Provenance: The document does not explicitly state the country of origin or if it was retrospective or prospective. Given it is a "clinical usability study" to evaluate "ease of use" and "successful removal of tissue," it strongly implies a prospective study involving human subjects.

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

Number of Experts: 5 physicians.
Qualifications: "a range of experience." Specific experience levels (e.g., years as a gynecologist) are not provided. The study indicates these physicians were trained gynecologists.

4. Adjudication Method for the Test Set:

The document does not describe an explicit adjudication method (e.g., 2+1, 3+1). The "clinical usability study" setup suggests that the physicians themselves were the evaluators of usability and successful tissue removal in their respective cases. There's no mention of independent reviewers or a consensus process for the 32 cases to establish a 'ground truth' in the typical sense of diagnostic accuracy. The assessment of successful removal "without clogging" and "ease of use" was likely based on the performing physician's assessment during the procedure.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with AI assistance versus without AI assistance was not done. The device is a physical hysteroscopic tissue removal device, not an AI-driven diagnostic or assistive imaging tool that typically undergoes MRMC studies.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

No, a standalone algorithm performance study was not done. This device is a surgical instrument requiring direct human operation, not an autonomous algorithm.

7. Type of Ground Truth Used:

For the non-clinical tests (sterilization, shelf life, biocompatibility, design verification, functional performance), the ground truth was established by adherence to standards (ISO 11135-1, ISO 10993-1) and internal design specifications/acceptance criteria for each test.
For the clinical usability study, the "ground truth" for usability and performance (successful tissue removal without clogging) was implicitly established by the treating physicians' assessment during the procedures against the intended use and expected device performance. This isn't "pathology" or "outcomes data" in the sense of a diagnostic classification, but rather procedural success and ease of operation.

8. Sample Size for the Training Set:

The document describes a physical medical device, not an AI/ML algorithm. Therefore, there is no concept of a training set in the context of machine learning. The "training" for the device would be the design, manufacturing, and quality control processes.

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

As there is no training set for an AI/ML algorithm, this question is not applicable to the Polygon Resection Device.

Summary

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January 4, 2019

Polygon Medical, Inc. % Christine Santagate Director. Northeast Regional Operations R&Q Solutions 15 Standish Rd Norfolk, Massachusetts 02056

Re: K182675

Trade/Device Name: Polygon Resection Device Regulation Number: 21 CFR 884.1690 Regulation Name: Hysteroscope and accessories Regulatory Class: Class II Product Code: HIH Dated: December 4, 2018 Received: December 6, 2018

Dear Christine Santagate:

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.

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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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Sharon M. Andrews -S

for 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) K182675

Device Name Polygon Resection Device

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(K) SUMMARY

In accordance with 21 CFR 807.92(a) the following summary of information is provided:

Submitter Information

Submitter's Name:	Ronald Adams
Address:	Polygon Medical, Inc.18 Hillside DriveHolliston, MA 01746
Telephone:	775-800-7300
Fax:	844-225-4600
Contact Person:	Christine Santagate
Telephone :	339-237-8122
Date Prepared:	January 2, 2019
Device Trade Name:	Polygon Resection Device

Date Prepared:	January 2, 2019
Device Trade Name:	Polygon Resection Device
Common/Usual Name:	Hysteroscopic Tissue Removal Device
Class:	II
Product Code(s):	HIH, Hysteroscope and Accessories
Regulation Number(s):	884.1690 (Hysteroscope and Accessories)

Predicate Device(s):

K173901 Device Name: MyoSure MANUAL Tissue Removal Device Manufacturer: Hologic, Inc.

The predicate device has not been subject to a design related recall.

Device Description:

The device is activated by the physician by squeezing the trigger. A rotation knob is provided to enable the physician to rotate the cutting bay into an orientation that aligns with the desired specimen. The barb fitting provides an attachment port for a vacuum system. The vacuum system pulls the specimen into the cutting window where it can be resected and aspirated out of the patient.

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Image /page/4/Figure/1 description: The image shows a diagram of a surgical tool with labels pointing to different parts. The parts labeled are the barb fitting, rotation knob, shaft, cutting window, handle, and trigger. The tool has a handle with a trigger that is connected to a shaft with a cutting window at the end. The rotation knob is located near the handle and is used to rotate the shaft.

There are no electrical or powered connections necessary for operation of the device.

Figure 1. Polygon Resection Devic

Indications for Use:

The subject device intended use is identical to the predicate device.

Comparison of Technological Characteristics:

The Polygon Resection Device is similar in design, materials, and construction to the Hologic Myosure Manual (predicate device). The principal of operation for both devices is the same.

The primary differences between the subject and predicate devices are as follows:

The morcellator working length is 36cm for the subject device vs. 32cm for the predicate device.
. The cutting window dimensions are 7mm for the subject device vs. 10mm for the predicate device.
The subject device has an in-line trigger orientation, while the predicate device has a ● perpendicular trigger design.
The subject and predicate devices contain different patient-contacting materials. ●

These differences in technological characteristics between the subject and predicate devices do not raise different questions of safety or effectiveness.

Non-Clinical Testing Summary:

The following data were provided to demonstrate substantial equivalence and functional performance of the subject device:

Sterilization validation was conducted in accordance with ISO 11135-1: 2014. ●

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Shelf life validation testing was conducted including package integrity testing and functional testing.
Biocompatibility evaluation in accordance with ISO 10993-1:2009 Biological . evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process.
- o Cytotoxicity testing
- Guinea Pig Maximization Sensitization testing o
- O Irritation testing
- Acute Systemic Toxicity testing o
Design verification testing: ●
- 0 Joint connection strength
- Visual Inspection O
- Tissue trap removal force O
Functional performance testing was conducted in a simulated use model: ●
- Hysteroscope compatibility O
- o Vacuum system compatibility
- Device cutting performance (successful removal of tissue without clogging, O cutting rate, and fluid usage)

All test samples met the acceptance criteria for each test.

Clinical Usability Testing Summary:

Usability and human factors were assessed through a clinical usability study. The subject device was used to remove intrauterine tissue by five physicians with a range of experience in a total of 32 cases. The usability study evaluated ease of use, successful removal of tissue without clogging, and number of device activations required to complete the procedure. The usability testing demonstrated the subject device can be used per the Instructions for Use as intended.

Conclusion:

Based on the intended use, descriptive information and performance provided in this submission, the Polygon Resection Device has been shown to be substantially equivalent to the predicate MyoSure Manual Tissue Removal Device.

Regulation Number and Section

§ 884.1690 Hysteroscope and accessories.

(a)
Identification. A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization. This generic type of device may include obturators and sheaths, instruments used through an operating channel, scope preheaters, light sources and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for hysteroscope 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 hysteroscope accessory instruments include: lens cleaning brush, cannula (without trocar or valves), clamp/hemostat/grasper, curette, instrument guide, forceps, dissector, mechanical (noninflatable), and scissors. 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.