The ClearView Total is intended for use in laparoscopic procedures where it is desirable to delineate the vaginal fornices and the surgeon intends to remove or access intraperitonial tissue through the vagina by use of a colpotomy or culdotomy incision; such as laparoscopically assisted vaginal hysterectomies, total laparoscopic hysterectomies, while maintaining pneumoperitoneum by sealing the vagina while a colpotomy is performed.

Device Description

Clinical Innovations' ClearView Total is a single-use sterile device used for uterine manipulation. Uterine manipulation is essential for laparoscopies involving the female pelvic organs (uterus, tubes, ovaries) when a uterus is present. Uterine manipulators may be helpful when clinicians perform tubal ligations, diagnostic laparoscopies for evaluating pelvic pain and infertility, treatment of endometriosis, removal of pelvic scars (adhesions) involving the uterus, fallopian tubes and ovaries, treatment of ectopic pregnancy, removal of uterine fibroids, removal of ovarian cysts, removal of ovaries, tubal repair, laparoscopic hysterectomy, laparoscopic repair of pelvic bowel or bladder, sampling of pelvic lymph nodes, laparoscopic bladder suspension procedures for treatment of incontinence, and biopsy of pelvic masses.

The ColpoCup accessory is a plastic cup which is mechanically screwed into the uterine manipulator. The ColpoCup is compatible with typical surgical devices, including harmonics and electrosurgical tools. Three different sizes of ColpoCups will be included with the device; 3.0cm, 3.5cm. and 4.0cm. Each ColpoCup will be a high contrast color in order to provide the surgeon with clear visibility during laparoscopic dissection.

At the base of the ColpoCup, past the tip pivot point, is a pre-attached Occluder constructed of an inflatable balloon and will be included to seal off the vagina and prevent pnuemoperitoneum loss. The Occluder Balloon is connected to a separate inflation valve which is located proximally from the balloon and allows for inflation after placement.

AI/ML Overview

The provided text is a 510(k) Summary for a medical device called the "ClearView Total," a uterine manipulator. It describes the device, its intended use, and the studies conducted to demonstrate its substantial equivalence to predicate devices, but it does not outline specific acceptance criteria or report performance in the format of a clinical study assessing a device against predefined performance metrics.

Instead, the document focuses on demonstrating that the ClearView Total is "substantially equivalent" to existing, legally marketed predicate devices through comparison of indications for use, technical characteristics, and various integrity and biocompatibility tests.

Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC study, ground truth type, training set size) are not applicable or cannot be extracted from this document, as the study described is not a clinical effectiveness study with performance metrics in the way these questions imply for an AI/diagnostic device.

However, I can extract information related to the device integrity and biocompatibility testing that served as the "study" for this submission.

Here's a breakdown of the information available based on your request, with relevant sections marked as "Not Applicable" or "Not Provided" where the document does not contain the specific information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present quantitative acceptance criteria or device performance in the typical format of a clinical study for diagnostic or AI devices. Instead, it states that all tests "met the specified requirements" or "met the appropriate acceptance criteria."

Acceptance Criteria (Stated as met)	Reported Device Performance
Accelerated Age Testing requirements	Met specified requirements
Balloon Leak/Burst Testing requirements	Met specified requirements
Cup Security and Cup Break requirements	Met specified requirements
Cytotoxicity standards	Met appropriate acceptance criteria
Intracutaneous Reactivity Irritation standards	Met appropriate acceptance criteria
Sensitization standards	Met appropriate acceptance criteria

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

This document describes engineering and biocompatibility tests, not a clinical test set with patient data.

Sample Size: Not specified (refers to device units tested for engineering and biocompatibility).
Data Provenance: Not applicable (these are laboratory/bench tests on device components/materials).

3. Number of Experts Used to Establish Ground Truth and Qualifications

Number of Experts: Not applicable.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. (Testing results would likely be determined by laboratory technicians or engineers against predefined test specifications.)

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

MRMC Study Done: No. This document describes a submission for a physical medical device, not an AI or diagnostic algorithm, so an MRMC study is not relevant here.
Effect Size of Human Readers with vs. without AI: Not applicable.

6. Standalone (Algorithm Only) Performance Study

Standalone Study Done: No. This device is a physical surgical instrument, not an algorithm.

7. Type of Ground Truth Used

Type of Ground Truth: For the engineering tests (Accelerated Age, Balloon Leak/Burst, Cup Security/Break), the "ground truth" would be the pre-defined engineering specifications and performance limits for the device's physical properties. For biocompatibility tests, the "ground truth" would be established by industry standards (e.g., ISO 10993 series) for material safety.

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This is not an AI/machine learning device.

9. How Ground Truth for the Training Set Was Established

How Ground Truth Was Established: Not applicable.

Summary of the Study Description:

The "study" described in the 510(k) summary involves device integrity testing and biocompatibility testing.

Device Integrity Testing: Included Accelerated Age Testing, Balloon Leak/Burst Testing, and Cup Security and Cup Break tests. The document states that "All device integrity tests for the ClearView Total met the specified requirements." These tests would assess the physical and mechanical performance of the device under various conditions to ensure its structural integrity and functionality.
Biocompatibility Testing: Included Cytotoxicity, Intracutaneous Reactivity Irritation, and Sensitization tests. The document states that "All testing met the appropriate acceptance criteria." These tests are conducted to ensure that the device materials are safe for contact with human tissue and do not elicit adverse biological reactions.

The purpose of these studies was to support the claim that the ClearView Total is "substantially equivalent" to predicate devices, meaning it is as safe and effective as devices already on the market, without introducing new questions of safety or effectiveness.

Summary

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510(k) Summary (As Required by 21 CFR 807.92)

22 May 2014

This 510(k) Summary of safety and effectiveness for the Clinical Innovations ClearView Total is submitted with the requirements of the SMDA 1990 and following guidance concerning the organization and content of a 510(k) summary.

Submitter Information

Company Name: Company Address:

Company Phone: Company Fax:

Device Identification

Device trade name: Device Common Name: Classification: Product Code: Device Class: Establishment Registration Number: Clinical Innovations 747 West 4170 South Murray, UT 84123 801-268-8200 801-266-7373

ClearView Total Cannula, Manipulator/Injector, Uterine Unclassified per Pre-Amendment LKF Unclassified 1722684

Contact Person

Tom Haueter Director, Quality Assurance and Regulatory Affairs 801-260-6028 T.Haueter@clinicalinnovations.com

Predicate Devices:

Clinical Innovations ClearView® (K940681)

ConMed VCARE (K071907)

The Koh Colpotomizer™ System (K954311)

Device Description:

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Indications for Use:

The ClearView Uterine Manipulator Device with ColpoCup and Occluder is intended for use in laparoscopic procedures where it is desirable to delineate the vaginal fornices and the surgeon intends to remove or access intraperitoneal tissue through the vagina by use of a colpotomy or culdotomy incision; such as laparoscopically assisted vaginal hysterectomies, total laparoscopic hysterectomies, while maintaining pneumoperitoneum by sealing the vagina while a colpotomy is performed.

Indications for Use Comparison:

Property	Result
Laparoscopic procedures where it isdesirable to delineate the vaginalfornices and the surgeon intends toremove or access intraperitoneal tissuethrough the vagina by use of acolpotomy or culdotomy incision	Similar to predicate device, The Koh Colpotomizer™ SystemSimilar to predicate device, Clinical Innovations® ClearView
Laparoscopically assisted vaginalhysterectomies.	Similar to predicate device, the ConMed VCARESimilar to predicate device, Clinical Innovations® ClearView
Total laparoscopic hysterectomies	Similar to predicate device, the ConMed VCARE

Technical Characteristics Comparison:

Property	Result
Sterile, Single-use	Similar to predicate device, ConMed VCARE
	Similar to predicate device, Clinical Innovations * ClearView
Distal holes that allow suture fixation if	Similar to predicate device, ConMed VCARE
desired
Three different cup sizes; 3.5cm, 4.0cm,	Similar to predicate device, The Koh Colpotomizer™ System
4.5cm
Distal handle for uterus manipulation	Similar to predicate device, The Koh Colpotomizer™ System
	Similar to predicate device, Clinical Innovations ClearView
Occluding balloon to maintain proper	Similar to predicate device, The Koh Colpotomizer™ System
peumoperitoneum pressure during
surgery.
Inflatable (saline-filled) balloon for	Similar to predicate device, ConMed VCARE
insertion into uterus	Similar to predicate device. Clinical Innovations "ClearView

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Summary of Studies

Clinical Innovations performed device integrity testing to support the claim that the device is substantially equivalent to the predicate devices. All device integrity tests for the ClearView Total met the specified requirements, which consisted of:

Accelerated Age Testing ●
Balloon Leak/Burst Testing .
. Cup Security and Cup Break

Clinical Innovations conducted the following biocompatibility testing in accordance to relevant industry standards:

Cytotoxicity .
Intracutaneous Reactivity Irritation .
. Sensitization

All testing met the appropriate acceptance criteria.

Basis for Substantial Equivalence:

Clinical Innovations believes that the ClearView Total is substantially equivalent based on the similarities to the predicate devices in indications and technical properties. Further, the ClearView Total introduces no new intentions, indications, or technical properties than exist currently in the previously cleared predicate devices.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized emblem of an abstract human figure with three flowing lines, representing life, knowledge, and service. The emblem is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

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

May 28, 2014

Clinical Innovations, LLC Tom Haueter Director, Quality and Regulatory Affairs 747 West 4170 South Murray, UT 84123

Re: K131781

Trade/Device Name: ClearView Total Regulation Number: None Regulation Name: None Regulatory Class: Unclassified Product Code: LKF Dated: May 1, 2014 Received: May 2, 2014

Dear Tom Haueter,

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.

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Page 2 - Tom Haueter

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 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,

Image /page/4/Picture/7 description: The image shows the name "Herbert P. Lerner - S" in a bold, sans-serif font. The letters are large and clearly legible. There is a circular emblem between the "P." and "Lerner" which appears to be a seal or logo, adding a formal touch to the presentation of the name. The overall impression is clean and professional.

for Beniamin 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): K131781 Device Name: ClearView Total

Indications for Use:

Prescription Use X AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D)(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) Page 1

Herbert P. Lerner -S 2014.05.28 13:13:53 -04'00'

Regulation Number and Section

§ 884.4530 Obstetric-gynecologic specialized manual instrument.

(a)
Identification. An obstetric-gynecologic specialized manual instrument is one of a group of devices used during obstetric-gynecologic procedures to perform manipulative diagnostic and surgical functions (e.g., dilating, grasping, measuring, and scraping), where structural integrity is the chief criterion of device performance. This type of device consists of the following:(1) An amniotome is an instrument used to rupture the fetal membranes.
(2) A circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision of a male infant.
(3) An umbilical clamp is an instrument used to compress the umbilical cord.
(4) A uterine curette is an instrument used to scrape and remove material from the uterus.
(5) A fixed-size cervical dilator is any of a series of bougies of various sizes used to dilate the cervical os by stretching the cervix.
(6) A uterine elevator is an instrument inserted into the uterus used to lift and manipulate the uterus.
(7) A gynecological surgical forceps is an instrument with two blades and handles used to pull, grasp, or compress during gynecological examination.
(8) A cervical cone knife is a cutting instrument used to excise and remove tissue from the cervix.
(9) A gynecological cerclage needle is a looplike instrument used to suture the cervix.
(10) A hook-type contraceptive intrauterine device (IUD) remover is an instrument used to remove an IUD from the uterus.
(11) A gynecological fibroid screw is an instrument used to hold onto a fibroid.
(12) A uterine sound is an instrument used to determine the depth of the uterus by inserting it into the uterine cavity.
(13) A cytological cervical spatula is a blunt instrument used to scrape and remove cytological material from the surface of the cervix or vagina.
(14) A gynecological biopsy forceps is an instrument with two blades and handles used for gynecological biopsy procedures.
(15) A uterine tenaculum is a hooklike instrument used to seize and hold the cervix or fundus.
(16) An internal pelvimeter is an instrument used within the vagina to measure the diameter and capacity of the pelvis.
(17) A nonmetal vaginal speculum is a nonmetal instrument used to expose the interior of the vagina.
(18) A fiberoptic nonmetal vaginal speculum is a nonmetal instrument, with fiberoptic light, used to expose and illuminate the interior of the vagina.
(b)
Classification. (1) Class II (special controls). The device, when it is an umbilical clamp with or without a cutter, a uterine tenaculum which is sterile and does not use suction and is intended for single use, a nonmetal vaginal speculum, or a fiberoptic nonmetal vaginal speculum, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.(2) Class I for the amniotome, uterine curette, cervical dilator (fixed-size bougies), cerclage needle, IUD remover, uterine sound, and gynecological biopsy forceps. 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.