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.

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.

AI/ML Overview

The provided K093556 document describes a 510(k) submission for the VCARE Dx uterine manipulator/injector cannula. The regulatory pathway for this device is based on demonstrating substantial equivalence to a predicate device. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are framed within the context of substantial equivalence rather than explicit performance targets.

Here's an analysis of the document's information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly define quantitative "acceptance criteria" for the VCARE Dx in terms of specific performance metrics or thresholds. Instead, the "acceptance criteria" were implied to be the performance specifications and functional design of the predicate device, VCARE (K955446). The study aimed to demonstrate that the VCARE Dx performed similarly to the predicate.

Acceptance Criteria (Implied)	Reported Device Performance
Similar performance specifications to VCARE (predicate device)	"All results are favorable in establishing substantial equivalence between the design of VCARE Dx and the predicate device VCARE."
Similar function and specifications to VCARE (predicate device)	"The design of VCARE Dx is substantially equivalent to VCARE with regards to function and specifications."
Effective in manipulating the uterus	(Implied by substantial equivalence to predicate)
Effective in injection of fluids during laparoscopic procedures	(Implied by substantial equivalence to predicate)
Addressing identified risks (e.g., inadequate device performance)	"Performance Testing (Section 8)"

2. Sample Size Used for the Test Set and Data Provenance:

The document states: "A comparison test was performed between VCARE Dx (subject device) and VCARE (predicate device) to test similar performance specifications."

Sample Size: The document does not specify the sample size used for this comparison test.
Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It is a performance verification test likely conducted by the manufacturer.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not provided in the document. Given that the study was a comparison of performance specifications between two devices, it's unlikely that external medical experts were used to "establish ground truth" in the way they would for, say, diagnostic accuracy. The assessment would have been against engineering specifications or functional outputs.

4. Adjudication Method for the Test Set:

This information is not provided in the document. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, which doesn't appear to be the primary focus of this engineering comparison.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

An MRMC comparative effectiveness study was not performed, nor is it applicable to this device. The VCARE Dx is a physical medical device (uterine manipulator/injector cannula), not an AI algorithm or diagnostic tool that assists human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

A standalone performance study in the context of an "algorithm only" or "AI" is not applicable to this device. It is a physical medical device. The "performance verification" was a comparison of the device itself to its predicate.

7. The Type of Ground Truth Used:

For the performance verification, the "ground truth" was effectively the established performance specifications and functional design of the legally marketed predicate device (VCARE). The study aimed to show that VCARE Dx met these same functional and specification standards. It was not a diagnostic device where pathology or outcome data would be the ground truth.

8. The Sample Size for the Training Set:

This is not applicable as the VCARE Dx is a physical medical device and does not involve a "training set" in the context of machine learning or AI algorithms.

9. How the Ground Truth for the Training Set Was Established:

This is not applicable for the reasons stated above.

Summary

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K093556
pg. 1 of 2

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

Indications for Use

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K093556
Pg. 2 of 2

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.

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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

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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

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Indications for Use Statement

510(k) Number (if known): K093556

Device Name: VCARE Dx uterine manipulator/injector cannula

Indications for Use:

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
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510(k) Number ________________________________________________________________________________________________________________________________________________________________

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Regulation Number and Section

§ 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.