(431 days)
No
The device description focuses on mechanical components and their function in surgical procedures, with no mention of AI or ML technologies.
No
This device is described as an accessory to a uterine manipulator, designed to provide an anatomical marker and maintain pneumoperitoneum during laparoscopic surgical procedures. It does not directly treat or cure a disease or condition.
No
The device is described as an accessory to a uterine manipulator, intended to act as an anatomical marker during laparoscopic surgical procedures and maintain pneumoperitoneum. Its function is to assist in surgical procedures by delineating anatomy and sealing, not to diagnose a medical condition or disease.
No
The device description clearly details physical components made of plastic and silicone, including cups, sleeves, and a syringe, which are hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Koh Colpotomizer™ System is a surgical accessory used during a surgical procedure. Its function is to:
- Anatomically mark: Delineate the vaginal fornices for the surgeon's visual reference during laparoscopic surgery.
- Maintain pneumoperitoneum: Prevent gas leakage during laparoscopic procedures where an incision is made in the vagina.
- No Sample Analysis: The device does not analyze any biological samples from the patient. It is a physical tool used to manipulate and delineate anatomical structures and maintain surgical conditions.
Therefore, the Koh Colpotomizer™ System falls under the category of a surgical instrument or accessory, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Koh Colpotomizer™ System, comprised of the Koh Cup™ Vaginal Fornices Delineator and Colpo-Pneumo Occluder, are accessories to the RUMI uterine manipulator. K932115. These accessories are designed to attach to the RUMI uterine manipulator device and are intended to be used by the surgeon as an anatomical marker to locate the position of the vaginal fornices as viewed through uterine tissue from within the abdominal cavity (intracorporeal), and also to maintain pneumoperitoneum during laparoscopic surgical procedures in which a colpotomy or culdotomy incision is made. The Koh Colpotomizer™ System is used in conjunction with the RUMI uterine manipulator device.
Product codes
Not Found
Device Description
The Koh Colpotomizer™ System consists of two accessory devices: The Koh Cup™ Vaginal Fornices Delineator, and a Colpo-Pneumo Occluder, each of which are specifically designed to attach to and be used with the RUMI uterine manipulator device. The CooperSurgical RUMI device as described in K932115 is intended to be used as a uterine manipulator during pelvic laparoscopic procedures.
The Koh Cup™ Vaginal Fornices Delineator is a plastic cup-shaped device which fits over the distal end of the RUMI disposable tip and firmly attaches to the tip base. When attached to the RUMI, the Koh Cup™ becomes an extension of the uterine manipulator tip and is thus able to articulate up or down as the uterine manipulator is operated in the normal fashion.
With the RUMI and Koh Cup™ properly positioned inside the patient, the outer rim of the Koh Cup™ will surround the cervix and be located in the vaginal fornices. In this position the rim of the Koh Cup™ will extend or "stretch" the vaginal fornices, thus allowing the surgeon an anatomical marker to conveniently locate the position of the fornix when viewed from an intracorporeal position. The kit will include Koh Cups™ in three outer rim diameter sizes: 3.0 cm, 3.5 cm, and 4.5 cm. The surgeon or nurse will make the selection of the appropriate size Koh Cup™ by visual inspection of the cervix at the time of instrument insertion in the patient.
The Pneumo Occluder consists of a condom-like silicone sleeve whose proximal end is folded back and attached to the main shaft of the sleeve in order to form an inflatable cavity (the "occluding balloon"). Attached to the occluding balloon is an inflation catheter that is available to the surgeon outside the patient's body for inflating the occluding balloon during surgery. The occluding balloon should be inflated until it fully contacts the perimeter wall of the vagina. This creates a pressure barrier which prevents the pneumoperitoneum from leaking out of the patient through the vagina once the colpotomy or culdotomy incision is made. This occluding property allows the surgeon to maintain proper pneumoperitoneum pressure and continue the laparoscopic procedure.
In addition to the Koh Cup™ and Colpo-Pneumo Occluder, a 60 cc syringe is included in the proposed kit to be used for filling the occluding balloon with saline. Typically the occluding balloon will require inflation of approximately 100 cc of saline in order to adequately occlude the vagina.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vaginal fornices, cervix, uterus, vaginal cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon, nurse
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)
The Colpo-Pneumo Occluder was subjected to and passed a static burst test which consisted of inflating the balloons with 250 cc of water and left for 12 hours. None of the balloons burst at 10 minutes. 30 minutes or 12 hour time frames. The criteria for passing the test was maintaining the 250 cc of water for 30 minutes without loss. This is a factor of 2.5 times the inflation generally needed for use in surgery and has been found in practice to be an adequate design margin.
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.
Lubke Uterine Vacuum Cannula, SEMM Uterine Vacuum Cannula, Milex Inflato Ball
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.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
P 1073
NOV 1 9 1996
510(k) Summary Cooper Surgical Koh Colpotomizer System
Sponsor/Applicant 1.
CooperSurgical, Inc. 15 Forest Parkway Shelton, CT 06484 Telephone # (800) 645-3760 Telefax # (203) 925-0135
Contact Person: John Chapman
Date of Summary Preparation
September 14, 1995
Device Name 2.
| Proprietary Name: | The Koh Colpotomizer™ System |
|---|---|
| Common/Usual Name: | Uterine Manipulator/Injector and Accessories |
| Classification Name: | Uterine Elevator |
Identification of Predicate or Legally Marketed Device(s) to Which Equivalence is 3. Being Claimed
Lubke Uterine Vacuum Cannula, SEMM Uterine Vacuum Cannula and Milex Inflato Ball
Device Description 4.
The Koh Colpotomizer™ System consists of two accessory devices: The Koh Cup™ Vaginal Fornices Delineator, and a Colpo-Pneumo Occluder, each of which are specifically designed to attach to and be used with the RUMI uterine manipulator device. The CooperSurgical RUMI device as described in K932115 is intended to be used as a uterine manipulator during pelvic laparoscopic procedures.
1
The Koh Cup™ Vaginal Fornices Delineator is a plastic cup-shaped device which fits over the distal end of the RUMI disposable tip and firmly attaches to the tip base. When attached to the RUMI, the Koh Cup™ becomes an extension of the uterine manipulator tip and is thus able to articulate up or down as the uterine manipulator is operated in the normal fashion.
With the RUMI and Koh Cup™ properly positioned inside the patient, the outer rim of the Koh Cup™ will surround the cervix and be located in the vaginal fornices. In this position the rim of the Koh Cup™ will extend or "stretch" the vaginal fornices, thus allowing the surgeon an anatomical marker to conveniently locate the position of the fornix when viewed from an intracorporeal position. The kit will include Koh Cups™ in three outer rim diameter sizes: 3.0 cm, 3.5 cm, and 4.5 cm. The surgeon or nurse will make the selection of the appropriate size Koh Cup™ by visual inspection of the cervix at the time of instrument insertion in the patient.
The Pneumo Occluder consists of a condom-like silicone sleeve whose proximal end is folded back and attached to the main shaft of the sleeve in order to form an inflatable cavity (the "occluding balloon"). Attached to the occluding balloon is an inflation catheter that is available to the surgeon outside the patient's body for inflating the occluding balloon during surgery. The occluding balloon should be inflated until it fully contacts the perimeter wall of the vagina. This creates a pressure barrier which prevents the pneumoperitoneum from leaking out of the patient through the vagina once the colpotomy or culdotomy incision is made. This occluding property allows the surgeon to maintain proper pneumoperitoneum pressure and continue the laparoscopic procedure.
In addition to the Koh Cup™ and Colpo-Pneumo Occluder, a 60 cc syringe is included in the proposed kit to be used for filling the occluding balloon with saline. Typically the occluding balloon will require inflation of approximately 100 cc of saline in order to adequately occlude the vagina.
ર. Intended use
The Koh Colpotomizer™ System, comprised of the Koh Cup™ Vaginal Fornices Delineator and Colpo-Pneumo Occluder, are accessories to the RUMI uterine manipulator. K932115. These accessories are designed to attach to the RUMI uterine manipulator device and are intended to be used by the surgeon as an anatomical marker to locate the position of the vaginal fornices as viewed through uterine tissue from within the abdominal cavity
2
(intracorporeal), and also to maintain pneumoperitoneum during laparoscopic surgical procedures in which a colpotomy or culdotomy incision is made. The Koh Colpotomizer™ System is used in conjunction with the RUMI uterine manipulator device.
Technological Characteristics 6.
The Koh Cup™ Vaginal Fornices Delineator device (of the Koh Colpotomizer™ System) and the LUBKE and SEMM uterine cannula predicate device above are identical in technological characteristics in that they all consist of a cup-shaped perimeter that are used with a uterine manipulator. Both the Koh Cup™ and predicate devices consist of a cupshaped perimeter which fit outside the cervix in the vaginal fornices while the uterine manipulator "finger" goes up through the cervix and inside the uterus. .
The Colpo-Pneumo Occluder device is substantially equivalent to the Milex Inflato Ball and to several common techniques utilized during laparoscopic surgery to prevent loss of pneumoperitoneum. The common technique of inflating a surgical glove with air or to stuff it with surgical gauze, and pushing the glove into the vaginal cavity to occlude the passageway is similar in technological characteristics to the Colpo-Pneumo Occluder. The latex glove is inflated as the Pneumo-Occluder and used as the occluding device. The Pneumo-Occluder is a fixed device that is firmly held in place since it is attached to the uterine manipulator and acts as a vaginal occluding device during surgery. The technological characteristics of the Pneumo-Occluder are also similar to the MILEX Inflato Ball an inflatable pessary device since it is inflated and inserted into the vagina in order to prevent leakage of the pneumoperitoneum during laparoscopic surgery.
7. Performance Testing
The Colpo-Pneumo Occluder was subjected to and passed a static burst test which consisted of inflating the balloons with 250 cc of water and left for 12 hours. None of the balloons burst at 10 minutes. 30 minutes or 12 hour time frames. The criteria for passing the test was maintaining the 250 cc of water for 30 minutes without loss. This is a factor of 2.5 times the inflation generally needed for use in surgery and has been found in practice to be an adequate design margin.