CooperSurgical Advincula Delineator Uterine Manipulator

K143650 · CooperSurgical, Inc. · HEW · Jul 21, 2015 · Obstetrics/Gynecology

Device Facts

• Record ID: K143650
• Device Name: CooperSurgical Advincula Delineator Uterine Manipulator
• Applicant: CooperSurgical, Inc.
• Product Code: HEW · Obstetrics/Gynecology
• Decision Date: Jul 21, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1640
• Device Class: Class 2

Intended Use

The CooperSurgical Advincula Delineator™ Uterine Manipulator is indicated to provide delineation of the vaginal fornices and maintain pneumoperitoneum as a uterine manipulator during Total Laparoscopic Hysterectomy (TLH), Laparoscopic Assisted Vaginal Hysterectomy (LAVH) and/or Laparoscopic Supra-Cervical Hysterectomy (LSH).

Device Story

Single-use sterile uterine manipulator; used in operating room by surgeons during laparoscopic hysterectomy procedures. Device features cup-shaped sliding colpo-pneumo occluder for vaginal fornix delineation and balloon for vaginal vault occlusion to maintain pneumoperitoneum. Surgeon inserts device to provide anatomical marker for uterine resection; balloon inflation maintains surgical field visibility. Benefits include improved visualization and maintenance of pneumoperitoneum during resection. No clinical data required; substantial equivalence established via bench testing.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing comparing subject device to predicate. Bench tests included distal/proximal balloon burst volume, leakage, fill tube tensile strength, and mechanical testing (bending, compression, tension forces) of the tube and locking mechanism of the colpo-pneumo occluder.

Technological Characteristics

Materials: stainless steel, silicone, plastics, adhesives, inks. Single-use, sterile (ETO, SAL 10^-6). Features sliding colpo-pneumo occluder and inflatable balloon (60-120cc capacity). External communicating device, tissue contact ≤ 24 hours.

Indications for Use

Indicated for patients undergoing Total Laparoscopic Hysterectomy (TLH), Laparoscopic Assisted Vaginal Hysterectomy (LAVH), or Laparoscopic Supra-Cervical Hysterectomy (LSH) requiring uterine manipulation and vaginal fornix delineation.

Regulatory Classification

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.

Predicate Devices

• Cooper Surgical Koh Colpotomizer System (K954311)

Submission Summary (Full Text)

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

July 21, 2015

Cooper Surgical Inc. % Tim Lohnes Senior Regulatory Consultant Orchid Design 80 Shelton Technology Center Shelton. CT 06484

Re: K143650

> Trade/Device Name: CooperSurgical Advincula Delineator™ Uterine Manipulator Regulation Number: 21 CFR 884.1640 Regulation Name: Culdoscope and accessories Regulatory Class: Class II Product Code: HEW Dated: June 16, 2015 Received: June 18, 2015

Dear Mr. Lohnes,

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 801); medical device reporting (reporting of medical device

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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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

## Benjamin R. Fisher -S

Benjamin Fisher, PhD. 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) K143650

#### Device Name

CooperSurgical Advincula Delineator™ Uterine Manipulator

Indications for Use (Describe)

The CooperSurgical Advincula Delineator™ Uterine Manipulator is indicated to provide delineation of the vaginal fornices and maintain pneumoperitoneum as a uterine manipulator during Total Laparoscopic Hysterectomy (TLH), Laparoscopic Assisted Vaginal Hysterectomy (LAVH) and/or Laparoscopic Supra-Cervical Hysterectomy (LSH).

Type of Use (Select one or both, as applicable)

| <span></span> | <span></span> |
|----------------------------------------------|---------------|
| <div></div> | <div></div> |
| Prescription Use (Part 21 CFR 801 Subpart D) | <div></div> |
| Over-The-Counter Use (21 CFR 801 Subpart C) | <div></div> |

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# Goper Surgical

### 07. 510(K) SUMMARY:

| 510(k) Summary of Safety and Effectiveness, (21 CFR 807.92): | |
|--------------------------------------------------------------|-------------------------------------------------------------|
| Submitter: | Cooper Surgical Inc., |
| | 95 Corporate Drive, |
| | Trumbull, CT 06611 |
| Contact Person: | Tim M. Lohnes |
| | Senior Regulatory Consultant, |
| | Orchid Design |
| | Phone: [phone] |
| | Fax: [phone] |
| | [e-mail] |
| Date Prepared: | December 15, 2014 |
| Name of Device:: | CooperSurgical Advincula Delineator™<br>Uterine Manipulator |
| Common/Usual Name: | Cannula, manipulator/injector, uterine |
| Classification Name: | 884.1640, Culdoscope and accessories |
| Device Class: | Class II |
| Product Code: | HEW |
| Predicate Device(s): | Cooper Surgical Koh Colpotomizer<br>System, K954311 |
| Device Description; | |

The CooperSurgical Advincula Delineator™ Uterine Manipulator is a single use device, supplied sterile to the end user. It includes a cup shaped sliding colpo-pneumo occluder used to delineate the vaginal fornices, providing an anatomical marker to facilitate resection of the uterus, and a balloon to occlude the vaginal vault to maintain pneumoperitoneum during uterine resection.

Intended Use:

The CooperSurgical Advincula Delineator ™Uterine Manipulator is indicated to provide delineation of the vaginal fornices and maintain pneumoperitoneum as a uterine manipulator during Total Laparoscopic Hysterectomy (TLH), Laparoscopic Assisted Vaginal Hysterectomy (LAVH) and/or Laparoscopic Supra-Cervical Hysterectomy (LSH).

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## Comparison of Technological Characteristics to the Predicate Device:

| Attribute | Cooper Surgical<br>Advincula<br>Delineator™ Uterine<br>Manipulator<br>(subject) | Cooper Surgical<br>Koh Colpotomizer<br>System, K954311 | Determination |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Body Contact Type | External<br>communicating, tissue, ≤<br>24 hours | External<br>communicating, tissue, ≤<br>24 hours | Substantially<br>Equivalent |
| Material(s) | Stainless steel, silicone,<br>various plastics,<br>adhesives and inks. | Stainless steel,<br>silicone, various<br>plastics, adhesives and<br>inks. | Substantially<br>Equivalent |
| Environment | Operating room | Operating room | Substantially<br>Equivalent |
| Vaginal Occlusion<br>(Pneumoperitoneum) | Occluder balloon with<br>inflation capacity of 60-<br>120cc | Occluder balloon with<br>inflation capacity of 90-<br>120cc | Different |
| Indications for Use | The CooperSurgical<br>Advincula Delineator™<br>Uterine Manipulator is<br>indicated to provide<br>delineation of the<br>vaginal fornices and<br>maintain<br>pneumoperitoneum as a<br>uterine manipulator<br>during Total<br>Laparoscopic<br>Hysterectomy (TLH),<br>Laparoscopic Assisted<br>Vaginal Hysterectomy<br>(LAVH) and/or<br>Laparoscopic Supra<br>Cervical Hysterectomy<br>(LAH). | The Koh Colpotomizer<br>System is indicated for<br>use in all laparoscopic<br>procedures where the use<br>of a uterine manipulator<br>is appropriate and the<br>surgeon intends to<br>remove or access<br>intraperitoneal tissue<br>through the vagina by<br>use of a colpotomy or<br>culdotomy incision. | Substantially<br>Equivalent |
| Biocompatibility | The patient contacting<br>components of the<br>Advincula Delineator™<br>Uterine Manipulator<br>have been evaluated for<br>biocompatibility as<br>appropriate for their<br>contact classification<br>(ext. communicating,<br>tissue/bone/dentin, ≤ 24<br>hours | The patient contacting<br>components of the<br>Koh Colpotomizer<br>System have been<br>evaluated for<br>biocompatibility as<br>appropriate for their<br>contact classification<br>(ext. communicating,<br>tissue/bone/dentin, ≤<br>24 hours | Substantially<br>Equivalent |

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Cooper Surgical Inc. Advincula Delineator

| Packaging | The Advincula<br>Delineator™ Uterine<br>Manipulator<br>is packaged in a 16 Mil<br>Flexible Blister pouch<br>with a heat-sealed<br>1073B Tyvek lid,<br>packed 3 to a carton. | The Koh-Efficient<br>device is packaged in a<br>.035" PETG Blister;<br>heat-sealed 1073<br>Tyvek lid, packaged 6<br>to a chipboard carton. | Substantially<br>Equivalent |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Stability/Shelf Life | The Advincula<br>Delineator™ Uterine<br>Manipulator is<br>sterilized by ETO to a<br>Assurance Level (SAL)<br>of 10-6, with an initial<br>shelf life of 1 year. | The sterile components<br>of the Koh-Effecent<br>System device are<br>sterilized by ETO gas<br>to a Assurance Level<br>(SAL) of 10-6, with a<br>shelf life of 2 years. | Substantially<br>Equivalent |

The basis of substantial equivalence of the CooperSurgical Advincula Delineator™ Uterine Manipulator is the similarities in materials, design, function, performance, sterilization, and indications for use in comparison to the predicate device. The primary technological difference between the subject and predicate devices is the inflation capacity of the vaginal occluder balloon. However, this minor difference does not raise different questions of safety or effectiveness as the maximum inflation pressure is the same for both the subject and predicate devices. In addition, burst volume testing was conducted to demonstrate that the difference in inflation pressure does not affect the safety and effectiveness of the subject device.

### Performance Data:

The Cooper Surgical Advincula Delineator™ Uterine Manipulator was tested in comparison to the predicate Cooper Surgical Koh Colpotomizer System K954311, with regards to;

- 1) Distal & proximal balloon burst volume
- 2) Distal & proximal balloon leakage
- 3) Distal & proximal balloon fill tube tensile strength

The Cooper Surgical Advincula Delineator™ Uterine Manipulator was also tested in regards to bending, compression, and tension forces applied to the tube, as well as the security of the sliding colpo-pneumo occluder when locked.

Clinical testing was not required to support the conclusion of substantial equivalence.

### Conclusion:

The substantial equivalence of the CooperSurgical Advincula Delineator™ Uterine Manipulator has been established by demonstrating the similarities in design, materials, function, performance, and Intended Use are equivalent to the previously cleared Cooper Surgical Koh Colpotomizer System, K954311.