(345 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI/ML capabilities, image processing, or data analysis.
No.
A therapeutic device is one that treats a disease or condition. This device is used to assist in surgical procedures by delineating the vaginal fornices, sealing the vagina, and manipulating the uterus, which are all described as surgical assistant actions, not direct therapeutic interventions.
No
The device is described as a surgical instrument for uterine manipulation and sealing the vagina during laparoscopic procedures, not for identifying or diagnosing a disease or condition.
No
The device description clearly details physical components such as a single-use sterile device, a plastic cup accessory, and an inflatable balloon occluder. The performance studies also focus on physical device integrity and biocompatibility testing, not software validation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used during surgical procedures (laparoscopic procedures, hysterectomies, etc.) to manipulate the uterus, delineate anatomical structures, and maintain pneumoperitoneum. This is a surgical tool, not a diagnostic test performed in vitro (outside the body) on biological samples.
- Device Description: The description details a mechanical device with components like a cup, balloon, and inflation valve, designed for physical manipulation and sealing during surgery. This aligns with a surgical instrument, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
- Performance Studies: The performance studies focus on device integrity (leak/burst testing, security, break) and biocompatibility, which are typical for surgical devices, not IVDs. IVD performance studies would typically involve metrics like sensitivity, specificity, accuracy, etc., related to the diagnostic capability.
In summary, the ClearView Total is a surgical instrument used for uterine manipulation and sealing during laparoscopic procedures. It does not perform any diagnostic testing on biological samples, which is the defining characteristic of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
LKF
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Uterus, tubes, ovaries, vagina.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Clinicians (surgeons) performing laparoscopic procedures. The device is for Prescription Use.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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:
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.
1
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.
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 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 | Similar to predicate device, The Koh Colpotomizer™ System |
| Similar to predicate device, Clinical Innovations® ClearView | |
| Laparoscopically assisted vaginal | |
| hysterectomies. | Similar to predicate device, the ConMed VCARE |
| Similar 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 |
2
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.
3
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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.
4
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
5
Indications for Use 510(k) Number (if known): K131781 Device Name: ClearView Total
Indications for Use:
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.
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'