Ensizor® Monopolar Endoscopic Scissors are designed to cut and dissect tissue, cut sutures and cut nonmetallic materials during all flexible endoscopic procedures.
Ensizor® Monopolar Endoscopic Scissors are designed to cut and dissect tissue, cauterize tissue, cut sutures and cut non-metallic materials during all flexible endoscopic procedures.

Device Description

The Ensizor Monopolar Endoscopic Scissors is a single-use ethylene oxide sterile electrosurgical scissors. This device is designed to be used with an electrosurgical monopolar HF generator to cut and dissect tissue, cauterize tissue, cut sutures and cut non-metallic materials during all flexible endoscopic procedures.

The device is compatible with flexible endoscopes with a minimum channel diameter of 2.8 mm. The maximum insertion portion diameter is 2.6 mm, and insertion lengths are 165 cm and 235 cm. The patented Edge Flex™ technology used for the Scissor Blades ("Blades") enhances the cutting performance of this flexible endoscopic scissors. The Ensizor's rotation feature enables accurate-radial positioning, and the nitinol actuator wire allows for tortuous endoscopic paths while minimizing loss of distal control. The Blades are designed with blunt tips to enable the atraumatic dissection of tissue planes and when closed, make a non-sharp rounded cauterizing surface.

AI/ML Overview

The provided text does not contain information about the acceptance criteria or a study that proves a device meets those criteria, as requested in the prompt's outlined structure. Instead, the text is a 510(k) summary for the Ensizor Monopolar Endoscopic Scissors, comparing its technological characteristics and performance data to predicate devices to demonstrate substantial equivalence.

Specifically, the document includes:

Trade/Device Name: Ensizor® Monopolar Endoscopic Scissors
Indications for Use: Designed to cut and dissect tissue, cut sutures and cut non-metallic materials during all flexible endoscopic procedures, and also cauterize tissue.
Predicate Devices: Ensizor® Endoscopic Scissors (K150939) and the Apollo Endosurgery Endoscopic Scissors (K090583).
Performance Data: Nonclinical testing was performed to evaluate substantial equivalence. This involved "Product Attribute Testing," "Product Performance Testing," "Sample Cutting" various materials (rubber, polyethylene, different types of sutures), and an "Insulation Test." In all listed tests, both the Ensizor® Monopolar Endoscopic Scissors and the Apollo Endosurgery Endoscopic Monopolar Scissors "All units passed."
Conclusion: Based on non-clinical performance data, the device is concluded to be as safe, as effective, and performs as well as or better than the predicate devices.

However, the summary does not provide:

A table of specific acceptance criteria (e.g., minimum tensile strength, maximum cutting force) and the reported device performance against those predefined criteria. Instead, it states "All units passed" for broad test categories and material cutting.
Sample size used for the test set or data provenance beyond "nonclinical testing."
Number of experts used or their qualifications.
Adjudication method.
Information on a multi-reader multi-case (MRMC) comparative effectiveness study or effect sizes of human readers with/without AI assistance (this device is a surgical instrument, not an AI diagnostic tool).
Standalone performance (while non-clinical testing was done, the "acceptance criteria" against which it was measured are not detailed).
The specific type of ground truth used (e.g., pathology, outcomes data), beyond stating "raw chicken for electrocautery functionality test." The "All units passed" suggests qualitative or pass/fail criteria rather than quantitative ground truth.
Sample size for the training set (not applicable as this is not an AI/machine learning device).
How the ground truth for the training set was established (not applicable).

Therefore, I cannot fulfill the request using the provided input as the necessary information is not present.

Summary

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June 29, 2018

Slater Endoscopy, LLC % Craig Pagan Consultant C2C Development, LLC 1135 W NASA Blvd. Suite 500 Melbourne, Florida 32901

Re: K180134

Trade/Device Name: Ensizor Monopolar Endoscopic Scissors Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: Class II Product Code: KGE, OCZ Dated: Mav 30, 2018 Received: May 30, 2018

Dear Craig Pagan:

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

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801); medical device reporting of medical 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.

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 medical devices and radiation-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.

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)

K180134

Device Name Ensizor® Monopolar Endoscopic Scissors

Indications for Use (Describe)

Ensizor® Monopolar Endoscopic Scissors are designed to cut and dissect tissue, cut sutures and cut nonmetallic materials during all flexible endoscopic procedures ..

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

Submitter's name, address, telephone number, a contact person and date (1) summary was prepared:

Slater Endoscopy, LLC 14000 NW 58 Court Miami Lakes, FL 33014 Telephone: (305) 889-3350 Contact: John Starkey, COO / VP Quality Assurance Jan 10, 2018

Name(s) of device: (2)

Proprietary/Trade Name:	Ensizor® Monopolar Endoscopic Scissors
Common Name:	Forceps, Biopsy, Electric
Regulation Number:	876.4300
Regulation Name:	Endoscopic electrosurgical unit and accessories
Classification Panel:	Gastroenterology/Urology
Product Code:	KGE, OCZ
Regulatory Class:	II

Legally Marked Predicate Device to which the submitter claims substantial (3) equivalence:

The Ensizor® Monopolar Endoscopic Scissors is substantially equivalent to the Ensizor® Endoscopic Scissors (K150939) and the Apollo Endosurgery Endoscopic Scissors (K090583).

Description of device(s): (4)

Ensizor® Monopolar Endoscopic Scissors

Cat # MES-26165 2.6 mm Monopolar Endoscopic Scissors x 165cm insertion length
Cat # MES-26235 2.6 mm Monopolar Endoscopic Scissors x 235cm insertion ● length

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scissors. The Ensizor's rotation feature enables accurate-radial positioning, and the nitinol actuator wire allows for tortuous endoscopic paths while minimizing loss of distal control. The Blades are designed with blunt tips to enable the atraumatic dissection of tissue planes and when closed, make a non-sharp rounded cauterizing surface.

Statement of intended use: (5)

Ensizor® Monopolar Endoscopic Scissors are designed to cut and dissect tissue, cauterize tissue, cut sutures and cut non-metallic materials during all flexible endoscopic procedures.

Comparison of Technological Characteristics to Predicate Device: (6)

The Ensizor® Monopolar Endoscopic Scissors have the same technological characteristics as the predicate devices as described below:

Devices are designed to dissect, cut and cauterize tissue during endoscopic procedures.
. Devices consist principally of an actuation handle and a flexible shaft body terminating in a pair of cutting Scissors.
. Scissors function just like standard scissors for mechanical cutting. By operating the handle, the Scissors open and close.

(7) Performance Data:

The following nonclinical testing was performed in order to evaluate the substantial equivalence of the Ensizor® Monopolar Endoscopic Scissors to the predicate devices.

	Test	EnsizorMonopolarEndoscopicScissors
Product Attribute Testing	All units passed	All units passed
Product Performance Testing	All units passed	All units passed
Sample Cutting
.008 In. thickness rubber (Dental Dam)	All units passed	All units passed
.002 In. thickness LDPE PolyethyleneSheet	All units passed	All units passed
2-0 Polydioxanone Suture	All units passed	All units passed
3-0 Polydioxanone Suture	All units passed	All units passed
2-0 Polypropylene Suture	All units passed	All units passed

Table 2 510(k) Summary - Testing Summary

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Test	EnsizorMonopolarEndoscopicScissors	ApolloEndosurgeryEndoscopicMonopolarScissors
3-0 Polypropylene Suture	All units passed	All units passed
2-0 Silk Sutures	All units passed	All units passed
3-0 Silk Sutures	All units passed	All units passed
2-0 Vicryl Sutures	All units passed	All units passed
3-0 Vicryl Sutures	All units passed	All units passed
Raw chicken for the electrocauteryfunctionality test (cut at least 10 times eachsample material and 10 tissue cauterizationtests).	All units passed	All units passed
Insulation Test	All units passed	All units passed

(8) Conclusions:

Based on the non-clinical performance data performed comparing the Ensizor® Monopolar Endoscopic Scissors to the predicate devices, it is concluded that the device is as safe, as effective, and performs as well as or better than the predicate devices.

Regulation Number and Section

§ 876.4300 Endoscopic electrosurgical unit and accessories.

(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).