(210 days)
Not Found
No
The summary describes a mechanical uterine manipulator and does not mention any AI or ML components or functionalities.
No
The device is used to delineate anatomical structures and maintain pneumoperitoneum during surgical procedures, which are assistive functions rather than directly treating or preventing a disease or condition.
No
The device is described as a uterine manipulator used during hysterectomy procedures to delineate the vaginal fornices and maintain pneumoperitoneum. Its function is to facilitate surgical resection rather than to diagnose a condition or disease.
No
The device description clearly indicates it is a physical, single-use device with components like a cup-shaped occluder and a balloon, and the performance studies involve testing physical properties like burst volume, leakage, and tensile strength.
Based on the provided information, 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 CooperSurgical Advincula Delineator™ Uterine Manipulator is a surgical instrument used during a surgical procedure (hysterectomy). It physically manipulates the uterus and delineates anatomical structures.
- Lack of Biological Sample Analysis: The device does not analyze any biological samples from the patient. Its function is mechanical and structural within the surgical field.
Therefore, the device's intended use and description clearly place it outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for 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).
Product codes
HEW
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Uterus, vaginal fornices, vaginal vault
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Operating room
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 Cooper Surgical Advincula Delineator™ Uterine Manipulator was tested in comparison to the predicate Cooper Surgical Koh Colpotomizer System K954311, with regards to;
-
- Distal & proximal balloon burst volume
-
- Distal & proximal balloon leakage
-
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
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
1
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
2
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)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
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: (203) 922 0105 | |
| Fax: (203) 922 0130 | |
| tim.lohnes@orchid-ortho.com | |
| Date Prepared: | December 15, 2014 |
| Name of Device:: | CooperSurgical Advincula Delineator™ |
| 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 |
| 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).
4
Comparison of Technological Characteristics to the Predicate Device:
| Attribute | Cooper Surgical
Advincula
Delineator™ Uterine
Manipulator
(subject) | Cooper Surgical
Koh Colpotomizer
System, K954311 | Determination |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Body Contact Type | External
communicating, tissue, ≤
24 hours | External
communicating, tissue, ≤
24 hours | Substantially
Equivalent |
| Material(s) | Stainless steel, silicone,
various plastics,
adhesives and inks. | Stainless steel,
silicone, various
plastics, adhesives and
inks. | Substantially
Equivalent |
| Environment | Operating room | Operating room | Substantially
Equivalent |
| Vaginal Occlusion
(Pneumoperitoneum) | Occluder balloon with
inflation capacity of 60-
120cc | Occluder balloon with
inflation capacity of 90-
120cc | Different |
| Indications for 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
(LAH). | The Koh Colpotomizer
System is indicated for
use in all laparoscopic
procedures where the use
of a uterine manipulator
is appropriate and the
surgeon intends to
remove or access
intraperitoneal tissue
through the vagina by
use of a colpotomy or
culdotomy incision. | Substantially
Equivalent |
| Biocompatibility | The patient contacting
components of the
Advincula Delineator™
Uterine Manipulator
have been evaluated for
biocompatibility as
appropriate for their
contact classification
(ext. communicating,
tissue/bone/dentin, ≤ 24
hours | The patient contacting
components of the
Koh Colpotomizer
System have been
evaluated for
biocompatibility as
appropriate for their
contact classification
(ext. communicating,
tissue/bone/dentin, ≤
24 hours | Substantially
Equivalent |
5
Cooper Surgical Inc. Advincula Delineator
| Packaging | The Advincula
Delineator™ Uterine
Manipulator
is packaged in a 16 Mil
Flexible Blister pouch
with a heat-sealed
1073B Tyvek lid,
packed 3 to a carton. | The Koh-Efficient
device is packaged in a
.035" PETG Blister;
heat-sealed 1073
Tyvek lid, packaged 6
to a chipboard carton. | Substantially
Equivalent |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Stability/Shelf Life | The Advincula
Delineator™ Uterine
Manipulator is
sterilized by ETO to a
Assurance Level (SAL)
of 10-6, with an initial
shelf life of 1 year. | The sterile components
of the Koh-Effecent
System device are
sterilized by ETO gas
to a Assurance Level
(SAL) of 10-6, with a
shelf life of 2 years. | Substantially
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;
-
- Distal & proximal balloon burst volume
-
- Distal & proximal balloon leakage
-
- 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.