(87 days)
The ConMed VCARE® Retractor/Elevator is indicated for manipulation of the uterus and injection of fluids or gases during laparoscopic procedures such as Laparoscopic Assisted Vaginal Hysterectomy (LAVH), Total Laparoscopic Hysterectomy (TLH), minilap, laparoscopic tubal occlusion, or diagnostic laparoscopy and also maintains pneumoperitoneum by sealing the vagina once colpotomy is performed.
The CONMED VCARE® (Vaginal-Cervical Ahluwalia's Retractor-Elevator) Retractor/Elevator is a disposable, single-use device for manipulation of the uterus and cervix during surgical and diagnostic procedures. The device consists of a rigid, anatomically curved manipulator tube having at its proximal end an inflatable (intrauterine) balloon for insertion into the uterus to manipulate and maintain the proper attitude of the uterus during procedures snch as hysteroscopy, Laparoscopic Assisted Vaginal Hysterectory (LAVH), and Total Laparoscopic Hysterectomy (TLH). The intrauterine balloon is inflated by passing air from a syringe through a pilot balloon located at the distal end of the device and via a lumen internal to the manipulator (main) tube. Inflation is maintained by a one-way valve positioned in the pilot balloon. The pilot balloon also serves as an indicator of intrauterine balloon inflation. VCARE® incorporates a system of cone-like components of which the forward or cervical cone surrounds and supports the cervix and the rear cone/fiexible tube or vaginal cone is slid along the main tube to adjust the depth of balloon insertion and seal the vaginal cavity from within to maintain pneumoperitoneum and prevent abdominal deflation once the vagina is entered during laparoscopic procedures such as during a colpotomy. The rear cone/flexible tube component is secured at its proper depth with a locking mechanism situated at the rear of the flexible tube and external to the patient. At the rear of the device is a molded handle which allows the surgeon to manipulate the uterus to the position most desirable for the procedure being performed. At the extreme rear of the device is a standard male luer lock connection suitable for attachment of a standard syringe for injection of fluids or gases into the uterus through the main tube when diagnostic procedures are prescribed.
The provided text {0} describes the ConMed VCARE® (Vaginal-Cervical Ahluwalia's Retractor-Elevator) Retractor/Elevator.
Here's an analysis of your questions based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional Criteria | Passed |
| Biocompatibility | Passed |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document states, "Performance of the ConMed VCARE® (Vaginal-Cervical Ahluwalia's Retractor-Elevator) Retractor/Elevator was tested and passed all functional and biocompatibility criteria." However, it does not specify:
- The sample size used for the test set.
- The data provenance (country of origin, retrospective or prospective nature of the data).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not provided in the document. The document refers to functional and biocompatibility testing, not an expert-driven evaluation for establishing ground truth or performance against a clinical gold standard.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided in the document. The testing described appears to be engineering/functional and biocompatibility testing, not a clinical trial requiring adjudication of results based on expert consensus.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
An MRMC study was not performed as this device is a physical surgical tool, not an AI or imaging diagnostic device. Therefore, there is no AI assistance or human reader improvement effect size to report.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a physical surgical retractor/elevator, not an algorithm or software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document indicates "functional and biocompatibility criteria" were used as the basis for evaluation. For functional criteria, this would likely involve engineering specifications and tests (e.g., inflation pressure maintained, locking mechanism integrity, material strength). For biocompatibility, it would involve standard biological safety tests (e.g., cytotoxicity, sensitization) in accordance with relevant standards. These are not typically described as "ground truth" in the same way clinical outcomes or expert consensus would be for diagnostic AI.
8. The sample size for the training set
This question is not applicable as the device is a physical surgical retractor/elevator, not a computational model requiring a training set.
9. How the ground truth for the training set was established
This question is not applicable for the same reason as above.
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K671907
Pg. 1 of 2
ConMed VCARE® (Vaginal-Cervical Ahluwalia's Retractor-Elevator) RetractorA
This summary of 510(k) Safety and Effectiveness is being submitted in accordance with the requirements of 21 CR 807.92.
Submitter:
ConMed Corporatuion 525 French Road Utica, NY 13502 USA
OCT 5 % 2007
Contact:
Brian Killoran Manager, Regulatory Affairs ConMed Corporation 525 French Road Utica, NY 13502 USA
Phone: 315-624-3219 Facsimile: 315-624-3225 e-mail: brian_killoran@mail.conmed.com
Date Prepared:
July 2, 2007
Name of Device:
VCARE® (Vaginal-Cervical Ahluwalia's Retractor-Elevator) Retractor/Elevator
Classification Name:
Cannula, Manipulator/Injector, Uterine
Device Classification:
Regulatory Class: Unclassified, but presumed to be Class II PROCODE: LKF Classification Panel: Obstetrics/Gynecology Panel Regulation Number: Unknown
Predicate Device:
VCARE® (Vaginal-Cervical Ahluwalia's Retractor-Elevator) Retractor/Elevator
ConMed Corp.
Description of Device:
The CONMED VCARE® (Vaginal-Cervical Ahluwalia's Retractor-Elevator) Retractor/Elevator is a disposable, single-use device for manipulation of the uterus and cervix during surgical and diagnostic procedures. The device consists of a rigid, anatomically curved manipulator tube having at its proximal end an inflatable (intrauterine) balloon for insertion into the uterus to manipulate and maintain the proper attitude of the uterus during procedures snch as hysteroscopy, Laparoscopic Assisted Vaginal Hysterectory (LAVH), and Total Laparoscopic Hysterectomy (TLH). The intrauterine balloon is inflated by passing air from a syringe through a pilot balloon located at the distal end of the device and via a lumen internal to the manipulator (main) tube. Inflation is maintained by a one-way valve positioned in the pilot balloon. The pilot balloon also serves as
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an indicator of intrauterine balloon inflation. VCARE® incorporates a system of cone-like components of which the forward or cervical cone surrounds and supports the cervix and the rear cone/fiexible tube or vaginal cone is slid along the main tube to adjust the depth of balloon insertion and seal the vaginal cavity from within to maintain pneumoperitoneum and prevent abdominal deflation once the vagina is entered during laparoscopic procedures such as during a colpotomy. The rear cone/flexible tube component is secured at its proper depth with a locking mechanism situated at the rear of the flexible tube and external to the patient. At the rear of the device is a molded handle which allows the surgeon to manipulate the uterus to the position most desirable for the procedure being performed. At the extreme rear of the device is a standard male luer lock connection suitable for attachment of a standard syringe for injection of fluids or gases into the uterus through the main tube when diagnostic procedures are prescribed.
Indications For Use:
The ConMed VCARE® Retractor/Elevator is indicated for manipulation of the uterus and injection of fluids or gases during laparoscopic procedures such as Laparoscopic Assisted Vaginal Hysterectomy (LAVH), Total Laparoscopic Hysterectomy (TLH), minilap, laparoscopic tubal occlusion, or diagnostic laparoscopy and also maintains pneumoperitoneum by sealing the vagina once a colpotomy is performed.
Performance:
Performance of the ConMed VCARE® (Vaginal-Cervical Ahluwalia's Retractor-Elevator) Retractor/Elevator was tested and passed all functional and biocompatibility criteria.
Conclusion:
The ConMed VCARE® (Vaginal-Cervical Ahluwalia's Retractor-Elevator) Retractor/Elevator is substantially equivalent to the ConMed VCARE® Retractor/Elevator of 510(k) K955446.
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Image /page/2/Picture/1 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" around the perimeter. Inside the circle is a stylized symbol of a human figure with three arms raised, representing health and well-being.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 5 * 2007
Mr. Brian Killoran Manager, Regulatory Affairs ConMed Corporation 525 French Road UTICA NY 13502
Re: K071907
Trade Name: ConMed VCARE® Retractor/Elevator Regulatory Class: Unclassified Product Code: LKF Dated: September 7, 2007 Received: September 10, 2007
Dear Mr. Killoran:
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, 1796, 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Nancy C Brogdon
Nancy C. Brogdon Director. Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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Page 3 -
Indications for Use
510(k) Number (if known): K071907
Device Name: VCARE® (Vaginal-Cervical Ahluwalia's Retractor-Elevator) Retractor/Elevator
Indications For Use:
The ConMed VCARE® Retractor/Elevator is indicated for manipulation of the uterus and injection of fluids or gases during laparoscopic procedures such as Laparoscopic Assisted Vaginal Hysterectomy (LAVH), Total Laparoscopic Hysterectomy (TLH), minilap, laparoscopic tubal occlusion, or diagnostic laparoscopy and also maintains pneumoperitoneum by sealing the vagina once colpotomy is performed.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Helven Remer
(Division Sign-Off) Division of Reproductive, Abdominal, a Radiological Devices 510(k) Number
Page 1 of 1
§ 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.