(87 days)
Demarcation of the cervical/vaginal junction during laparoscopy, laparoscopic-assisted vaginal hysterectomy, laparoscopic bladder surgery and other laparoscopic procedures where delineation of the junction is desired.
The Colpo cup is an accessory to the ClearView Uterine Manipulator that is used to demarcate the cervical/vaginal junction during laparoscopy. This product is a sterile, single patient use device.
Here's a breakdown of the acceptance criteria and study information based on the provided text, formatted as requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety: | |
| Mechanical Integrity (no parts loose) | Laboratory testing and basic design assure no parts will come loose. |
| Biocompatibility (safe material) | Independent lab testing shows material is safe. |
| Clinical Safety | Clinical evaluation verified safe nature. |
| Effectiveness: | |
| Ease of Use (compared to predicate) | Clinical trials showed it was as effective as the predicate. |
| Device Retention (compared to predicate) | Clinical trials showed it was as effective as the predicate. |
2. Sample Size Used for the Test Set and Data Provenance
The document states "clinical evaluation" and "clinical trials" but does not explicitly mention the sample size or the country of origin for these clinical studies. It also doesn't specify if the data was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided in the document. The document refers to "clinical evaluation" and "clinical trials" but does not detail how the ground truth for these evaluations was established, nor does it mention the number or qualifications of experts involved.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned. The document describes clinical trials comparing the Colpo Cup to a predicate device, focusing on "ease of use" and "device retention," but not on human reader performance with or without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done
No, a standalone algorithm-only study was not performed. The Colpo Cup is a mechanical medical device, not an AI or algorithm-based product.
7. The Type of Ground Truth Used
The ground truth for the effectiveness claims ("ease of use" and "device retention") appears to be based on clinical evaluation/observation during "clinical trials," comparing the device's performance directly to the predicate device. For safety, it was based on laboratory testing and clinical evaluation.
8. The Sample Size for the Training Set
This information is not applicable and not provided. The Colpo Cup is a physical medical device, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided, as there is no training set for this type of device.
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Section 6.0 510(k) Summary
8192
MAR - 2 1998
974563
510(k) Summarv
| Submitter: | Clinical Innovations, Inc. |
|---|---|
| Name: | Wm. Dean Wallace |
| Address: | 6477 So. Cottonwood St., Murray, UT 84107 |
| Telephone: | (801) 268-8200 |
| Fax: | (801) 266-7373 |
Proprietary Name:
Common/Usual Name:
Classification Name:
Colpo Cup Uterine Manipulator/Injector and Accessories Uterine Elevator
The legally marketed devices to which equivalence is claimed is the KOH Cup™ Vaginal Fornices Delineator from Cooper Surgical.
Description of the device: The Colpo cup is an accessory to the ClearView Uterine Manipulator that is used to demarcate the cervical/vaginal junction during laparoscopy. This product is a sterile, single patient use device.
Intended use: This accessory is used with the ClearView Uterine Manipulator to demarcate the cervical/vaginal junction during laparoscopy, laparoscopic-assisted vaginal hysterectorny, and other laparoscopic procedures where delineation of the junction is desired.
The Colpo Cup is substantially equivalent to the predicate device because:
It has the same intended uses, namely, to demarcate the cervical/vaginal junction during laparoscopy
It has the same basic technological characteristics as predicate devices, namely, it is a mechanical disc attached to the base of a uterine manipulator
It uses a similar material which has been shown to be biocompatible and to function well in the intended application,
The safety and effectiveness are similar or better than existing devices as demonstrated in the laboratory and clinical testing.
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Safety
82-02 Laboratory testing has shown that in the following areas the Colpo Cup is safe:
- Mechanical integrity: laboratory testing and basic design assure that no . parts will come loose and be left in the patient.
- Biocompatibility: independent lab testing shows that the material used in . the Colpo Cup is safe for this application.
In addition, clinical evaluation verified the safe nature of the Colpo Cup.
Effectiveness
The clinical trials showed that the Colpo Cup was as effective as the predicate device in the following areas:
- . ease of use
- device retention .
Wm. Wm. Wallace
Wm. Dean Wallace, M.D., Ph.D.
1-6-98
Date
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health and Human Services. The logo is a stylized image of an eagle with three lines representing the bird's head, body, and tail. The words "DEPARTMENT OF HEALTH" are written vertically along the left side of the logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 2 1998
Wm. Dean Wallace, M.D., Ph.D. President Clinical Innovations, Inc. 6477 South Cottonwood Street Murray, UT 84107
Re: K974563 Colpo Cup CVC - 2000 Dated: December 2, 1997 Received: December 5, 1997 Regulatory Class: II 21 CFR 884.4530/Procode: 85 HDP
Dear Dr. Wallace:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, subject to the general controls provisions of the general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranion.
If your device is classified (see above) into either class III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions. or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
hJliau Yin
Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Colpo Cup 510(k) Clinical Innovations, Inc.
11.0 Indications For Use
510(k) Number: K974563
Device Name: Colpo Cup (Accessory for Uterine Manipulator)
Indications for use: Demarcation of the cervical/vaginal junction during laparoscopy, laparoscopic-assisted vaginal hysterectomy, laparoscopic bladder surgery and other laparoscopic procedures where delineation of the junction is desired.
(PLEASE NO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Robert R. Rutting/
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K974563
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)
§ 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.