(115 days)
Not Found
No
The device description and performance studies focus on mechanical manipulation and fluid injection, with no mention of AI or ML capabilities.
No
The device is described as a uterine manipulator/injector cannula used for physical manipulation of the uterus and fluid injection during gynecological procedures. It is an instrument for surgical assistance, not a device that treats or prevents disease or affects the structure or function of the body in a therapeutic manner.
No
The device is described as a uterine manipulator/injector cannula used for manipulation and fluid injection during laparoscopic gynecological procedures. While "diagnostic laparoscopy" is mentioned as a procedure it can be used for, the device itself is an instrument for manipulation and injection, not for diagnosing a condition.
No
The device description clearly details a physical, sterile, disposable medical device consisting of a tube, balloon, handle, and other hardware components for manipulating the uterus. There is no mention of software as a component or function of the device.
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 for the manipulation and injection of fluids within the uterus during surgical procedures. This is a direct interaction with the patient's body for a therapeutic or diagnostic procedure performed in vivo (within a living organism).
- Device Description: The description details a physical device designed for insertion into the uterus, with features for manipulation, inflation, and fluid injection. These are all actions performed directly on the patient.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnostic purposes. This device does not perform any such analysis of specimens.
Therefore, the VCARE Dx uterine manipulator/injector cannula is a surgical instrument used in vivo, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
VCARE Dx uterine manipulator/injector cannula is indicated for manipulation of the uterus, and injection of fluids during laparoscopic gynecologic procedures such as laparoscopic supracervical hysterectomy, minilap tubal ligation, laparoscopic tubal occlusion or diagnostic laparoscopy.
Product codes
LKF
Device Description
VCARE Dx uterine manipulator/injector cannula is a sterile, disposable, single-patient use device which consists of a hollow, rigid, insulated, anatomically curved manipulator tube (OD: 5mm; length: 48cm (19") including handle) with an inflatable PVC intrauterine balloon at the proximal end, graduations (cm) along the shaft measuring distance from the proximal end and a molded handle at the distal end for maintaining proper attitude of the uterus. The graduations on the shaft of the VCARE Dx can be used as a guide for comparison to a graduated uterine sound, if one is used. The intrauterine balloon is inflated by passing air via a standard syringe (not included) through the distally located pilot balloon/valve assembly. The internal tip of the manipulator tube is open to allow direct intrauterine introduction of dye/contrast media via the injector port on the rear of the handle, when prescribed. VCARE Dx incorporates a component that seats against the cervix providing a positive stop from over-penetration of the uterine cavity and counter traction with the intrauterine balloon for effective manipulation. The rear portion of the device is secured at its proper depth with a locking mechanism situated at the rear of the main tube and external to the patient.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Uterus, Intrauterine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
A comparison test was performed between VCARE Dx (subject device) and VCARE (predicate device) to test similar performance specifications.
The documented evidence showed that VCARE Dx is substantially equivalent to VCARE due to a significant number of identical parts. All results are favorable in establishing substantial equivalence between the design of VCARE Dx and the predicate device VCARE.
The design of VCARE Dx is substantially equivalent to VCARE with regards to function and specifications.
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
§ 884.4530 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.
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510(k) Summary of Safety and Effectiveness
Applicant: Address:
Contact Person:
Telephone Number: Fax Number:
Date Prepared:
ConMed Corporation 525 French Road Utica, NY 13502
MAR ] 2 2010
Sarah Rizk Regulatory Affairs Specialist (315) 624-3219 (315) 624-3225
November 13, 2009
Proprietary Name: Common/Classification Name: Product Code: Regulation Number: Predicate Device(s):
VCARE Dx uterine manipulator/injector cannula Cannula, Manipulator/Injector, Uterine LKF unknown (Class II) VCARE Rectractor/Elevator K955446
Device Description
VCARE Dx™ uterine manipulator/injector cannula is a sterile, disposable, single-patient use device which consists of a hollow, rigid, insulated, anatomically curved manipulator tube (OD: 5mm; length: 48cm (19") including handle) with an inflatable PVC intrauterine balloon at the proximal end, graduations (cm) along the shaft measuring distance from the proximal end and a molded handle at the distal end for maintaining proper attitude of the uterus. The graduations on the shaft of the VCARE Dx™ can be used as a guide for comparison to a graduated uterine sound, if one is used. The intrauterine balloon is inflated by passing air via a standard syringe (not included) through the distally located pilot balloon/valve assembly. The internal tip of the manipulator tube is open to allow direct intrauterine introduction of dye/contrast media via the injector port on the rear of the handle, when prescribed. VCARE DxTM incorporates a component that seats against the cervix providing a positive stop from over-penetration of the uterine cavity and counter traction with the intrauterine balloon for effective manipulation. The rear portion of the device is secured at its proper depth with a locking mechanism situated at the rear of the main tube and external to the patient.
Indications for Use
VCARE Dx uterine manipulator/injector cannula is indicated for manipulation of the uterus, and injection of fluids during laparoscopic gynecologic procedures such as laparoscopic supracervical hysterectomy, minilap tubal ligation, laparoscopic tubal occlusion or diagnostic laparoscopy.
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Risk Mitigation Table
Below is a summary of risks common to uterine manipulators and how this submission addresses those risks.
| Identified Risk | Mitigation Measures |
|---|---|
| Inadequate Device Performance | Performance Testing (Section 8) |
| Adverse Material Reactivity | Biocompatibility Information (Section 9) |
| Contamination | Sterilization and Packaging (Section 10) |
| Improper Use | Labeling (Section 7) |
An in-depth risk management analysis, including mitigation measures, was performed on VCARE Dx. The results are provided under Section 5.
Performance Verification
A comparison test was performed between VCARE Dx (subject device) and VCARE (predicate device) to test similar performance specifications.
The documented evidence showed that VCARE Dx is substantially equivalent to VCARE due to a significant number of identical parts. All results are favorable in establishing substantial equivalence between the design of VCARE Dx and the predicate device VCARE.
The design of VCARE Dx is substantially equivalent to VCARE with regards to function and specifications.
Conclusion
Supporting information per this premarket submission confirms that the ConMed VCARE Dx uterine manipulator/injector cannula is substantially equivalent to its predicate device, VCARE K955446.
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Ms. Sarah Rizk Regulatory Affairs Specialist ConMed Corporation . 525 French Road UTICA NY 13502
MAR 1 2 2010
Re: K093556
Trade/Device Name: VCARE Dx Uterine Manipulator/Injector Cannula Regulation Number: 21 CFR §884.4530 Regulation Name: Obstetric-gynecologic specialized manual instrument Regulatory Class: II Product Code: LKF Dated: February 24, 2010 Received: February 26, 2010
Dear Ms. Rizk:
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 of medical device-related
3
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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.html 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/ReportalProblem/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Janine M. Morris
Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known): K093556
Device Name: VCARE Dx uterine manipulator/injector cannula
Indications for Use:
VCARE Dx uterine manipulator/injector cannula is indicated for manipulation of the uterus, and injection of fluids during laparoscopic gynecologic procedures such as laparoscopic supracervical hysterectomy, minilap tubal ligation, laparoscopic tubal occlusion or diagnostic laparoscopy.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal, and
Radiological Devices
| 510(k) Number | K093556 |
|---|---|
| --------------- | --------- |
510(k) Number ________________________________________________________________________________________________________________________________________________________________
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