(26 days)
No
The device description and performance studies focus on mechanical and material properties of a surgical instrument, with no mention of AI or ML capabilities.
No
The device is described as a uterine manipulator used during surgical procedures (hysterectomies) to aid in the delineation of anatomical structures and maintain pneumoperitoneum. Its function is to facilitate the surgical procedure, not to treat, cure, mitigate, or prevent disease directly, nor to affect the structure or function of the body in a therapeutic way.
No
This device is a surgical tool used to manipulate the uterus and delineate anatomy during hysterectomy procedures, not to diagnose a medical condition.
No
The device description clearly outlines a physical, single-use, disposable uterine manipulator with a shaft, balloon, colpotomy cup, and handle, indicating it is a hardware medical device.
Based on the provided information, the CooperSurgical Advincula Delineator Uterine Manipulator is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to physically manipulate the uterus and delineate anatomical structures during surgical procedures (hysterectomies). This is a surgical tool, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or treatment.
- Device Description: The description details a physical device with mechanical components (shaft, balloon, cup, handle) used for surgical manipulation and maintaining pneumoperitoneum. It does not describe any components or functions related to analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, tissue, urine, or any other biological specimen. There are no reagents, test strips, or analytical components typically associated with IVD devices.
In summary, the Advincula Delineator is a surgical instrument used during a procedure, not a device used to perform tests on biological samples.
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 Supracervical Hysterectomy (LSH).
Product codes
HEW
Device Description
The Advincula Delineator is a uterine manipulator that is intended for use during total laparoscopic hysterectomy (TLH), laparoscopic assisted vaginal hysterectomy (LAVH), and/or laparoscopic supracervical hysterectomy (LSH) procedures. It is single-use, disposable, and provided sterile. The device has a distal balloon built into the arched shaft, and a sliding colpotomy cup, called a Koh-Cup, that locks into place with a position lock. The handle at the proximal end allows the user to hold the device and to manipulate the uterus. When properly positioned, the outer rim of the Koh-Cup delineates the vaginal fornices and provides an anatomical landmark to facilitate uterine resection. An occluder balloon is used to maintain pneumoperitoneum during the procedure.
The Advincula Delineator is available with Koh-Cups sized 2.5cm, 3.5cm or 4.0cm in diameter. There are flexible plastic and Ultem plastic Koh-Cups available for use in electrocautery procedures, and a version with a stainless-steel outer rim for use in harmonic scalpel or laser procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vagina, uterus
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)
Non-Clinical Performance Testing:
- Design Verification Testing:
- Pull-Off Test: Verified that the modified Koh-Cup does not disassemble from the device when used as intended. Test results met the predetermined acceptance criterion.
- Compression Test: Verified that the modified Koh-Cup can withstand adequate compression force. Test results met the predetermined acceptance criterion.
- Design Validation Testing:
- Evaluated the use of the new Koh-Cup in a cadaveric model, validating that the Advincula Delineator with the modified Koh-Cup performs as intended and meets user needs.
- Biocompatibility Testing per ISO 10993-1:2009:
- Cytotoxicity per ISO 10993-5:2009; results demonstrated the new Koh-Cup was non-cytotoxic.
- Sensitization per ISO 10993-10:2010; results demonstrated the new Koh-Cup was non-sensitizing.
- Irritation per ISO 10993-10:2010; results demonstrated the new Koh-Cup was non-irritating.
- Shelf Life Testing per ASTM F1980-07 (Reapproved 2011):
- Design verification testing was performed after 1 year of accelerated aging. Devices met predetermined acceptance criteria.
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.
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March 14, 2018
CooperSurgical, Inc. Roaida Johnson Director, RA New Product Development 95 Corporate Drive Trumbull, CT 06611
Re: K180429
Trade/Device Name: Advincula Delineator™ Uterine Manipulator Regulation Number: 21 CFR§ 884.1640 Regulation Name: Culdoscope and Accessories Regulatory Class: II Product Code: HEW Dated: February 14, 2018 Received: February 16, 2018
Dear Roaida Johnson:
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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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 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.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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For Benjamin 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) K180429
Device Name
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 Supracervical 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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K180429 Advincula Delineator™ Uterine Manipulator Special 510(k) Summary
Submitter Information
| Company Name: | CooperSurgical Inc. |
|---|---|
| Company Address: | 95 Corporate Drive |
| Trumbull, CT 06611 | |
| Telephone: 203-601-5200 Ext. 3325 | |
| Fax: 203-601-9870 | |
| Contact Person: | Roaida Johnson |
March 13, 2018 Date Prepared:
Device Information
| Trade Names: | Advincula Delineator™ Uterine Manipulator |
|---|---|
| Common Name: | Uterine Manipulator |
| Classification: | Class II per 21 CFR 884.1640 |
| Classification Name: | Culdoscope and Accessories |
| Product Code: | HEW - Culdoscope (And Accessories) |
Predicate Device Information
The Advincula Delineator uterine manipulator is substantially equivalent to the following predicates:
Predicate: CooperSurgical Advincula Delineator Uterine Manipulator (K143650)
The predicate device has not been subject to a design-related recall.
Device Description
The Advincula Delineator is a uterine manipulator that is intended for use during total laparoscopic hysterectomy (TLH), laparoscopic assisted vaginal hysterectomy (LAVH), and/or laparoscopic supracervical hysterectomy (LSH) procedures. It is single-use, disposable, and provided sterile. The device has a distal balloon built into the arched shaft, and a sliding colpotomy cup, called a Koh-Cup, that locks into place with a position lock. The handle at the proximal end allows the user to hold the device and to manipulate the uterus. When properly positioned, the outer rim of the Koh-Cup delineates the vaginal fornices and provides an anatomical landmark to facilitate uterine resection. An occluder balloon is used to maintain pneumoperitoneum during the procedure.
The Advincula Delineator is available with Koh-Cups sized 2.5cm, 3.5cm or 4.0cm in diameter. There are flexible plastic and Ultem plastic Koh-Cups available for use in electrocautery procedures, and a version with a stainless-steel outer rim for use in harmonic scalpel or laser procedures.
4
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 Supracervical Hysterectomy (LSH).
Substantial Equivalence Discussion
Table 1 provides a comparison of the subject and predicate device. Table 1: Comparison of the Subject Advincula Delineator to the Predicate Devices
| Attribute | Subject Advincula Delineator | Predicate Advincula
Delineator |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|
| 510(k) Number | K180429 | K143650 |
| Manufacturer | CooperSurgical | Same |
| 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 Supracervical
Hysterectomy (LSH). | Same |
| Fundamental
Scientific
Technology | The device has a distal balloon built into the arched
shaft, and a sliding colpotomy cup, called a Koh-
Cup, that locks into place. The handle at the
proximal end allows the user to hold the device and
manipulate the uterus, and the Koh-Cup delineates
the vaginal fornices. An occluder balloon is used to
maintain pneumoperitoneum. | Same |
| Manipulator
Material(s) | Stainless steel, silicone, various plastics, adhesives
and inks | Same |
| Koh-Cup Materials | Stainless steel, plastic (soft and hard) | Different; this device
does not include a soft
plastic cup |
| Vaginal Occlusion
(pneumoperitoneum) | Occluder balloon with inflation capacity of 60-120cc | Same |
| Environment of use | Operating room | Same |
| Patient Contact | External communicating device, limited (