(85 days)
The Uterine Manipulators are intended for use by qualified surgeons to manipulate the uterus during laparoscopic procedures including laparoscopic assisted vaginal hysterectomy.
The Uterine Manipulators are manual reusable surgical devices. The KSEA Uterine Manipulators are intended for use by qualified surgeons to manipulate the uterus during laparoscopic procedures including laparoscopic assisted vaginal hysterectomy. The body contact materials are surgical grade stainless steel, PTFE, silicone.
This submission is for a Uterine Manipulator, which is a manual surgical device. The provided text is a 510(k) summary for a medical device and does not contain the kind of information typically found in a study proving a device meets acceptance criteria related to AI/ML performance.
Therefore, most of the requested information regarding acceptance criteria, study design, expert involvement, and AI performance metrics is not applicable to this type of device submission.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
This information is not present in the provided 510(k) summary. For a manual surgical device like a uterine manipulator, acceptance criteria would typically involve engineering specifications (e.g., material strength, dimension tolerances, biocompatibility, sterilization efficacy) and functional testing without specific performance metrics like sensitivity or specificity that are common for diagnostic AI tools.
2. Sample size used for the test set and the data provenance:
This information is not applicable as there is no "test set" in the context of an AI/ML-driven device evaluation. The device is a manual surgical tool.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable. Ground truth is not established for a manual surgical device in the same way it would be for an AI diagnostic device.
4. Adjudication method for the test set:
This information is not applicable. There is no "test set" requiring adjudication for this type of manual device.
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:
This information is not applicable. This device is a manual surgical instrument, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This information is not applicable. This device is entirely human-in-the-loop; it is a manual surgical instrument.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not applicable. Ground truth, in the context of AI/ML evaluation, is not a concept applied to the regulatory review of a manual surgical device. Safety and effectiveness are typically demonstrated through substantial equivalence to predicate devices, material testing, and functional assessments.
8. The sample size for the training set:
This information is not applicable. There is no "training set" for a manual surgical device.
9. How the ground truth for the training set was established:
This information is not applicable. There is no "training set" for this device.
Summary of the 510(k) Submission for this Device:
The 510(k) submission (K992027) for the KONINCKX, KECKSTEIN-SCHIFF, and CLERMONT Uterine Manipulators focuses on demonstrating Substantial Equivalence to legally marketed predicate devices.
- Intended Use: "The Uterine Manipulators are intended for use by qualified surgeons to manipulate the uterus during laparoscopic procedures including laparoscopic assisted vaginal hysterectomy."
- Device Description: "The Uterine Manipulators are manual reusable surgical devices. The body contact materials are surgical grade stainless steel, PTFE, silicone."
- Basis for Substantial Equivalence: The applicant states, "The KSEA Uterine Manipulators are substantially equivalent to the predicate devices since the basic features, design and intended uses are similar. The minor differences in design and dimensions between the KSEA Uterine Manipulators and the predicate devices raise no new issues of safety and effectiveness, as these design differences have no effect on the performance, function or intended use of these devices."
In the context of this 510(k), compliance with general controls provisions of the Act (e.g., annual registration, listing of devices, good manufacturing practice, labeling) and the Quality System Regulation (QS) for Medical Devices (21 CFR Part 820) are assumed for a substantial equivalence determination.
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SFF ্ৰ 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92. All data included in this document is accurate and complete to the best of KSEA's knowledge.
| Applicant: | Karl Storz Endoscopy - America, Inc.600 Corporate Pointe DriveCulver City, CA 90230(310) 558-1500 |
|---|---|
| Contact: | Kevin KennanSenior Regulatory Affairs Specialist |
| Device Identification: | Common Name:Uterine ManipulatorTrade Name: (optional)KONINCKX Uterine Manipulator |
KECKSTEIN-SCHIFF Uterine Manipulator CLERMONT Uterine Manipulator
Indication: The Uterine Manipulators are intended for use by qualified surgeons to manipulate the uterus during laparoscopic procedures including laparoscopic assisted vaginal hysterectomy.
Device Description: The Uterine Manipulators are manual reusable surgical devices. The KSEA Uterine Manipulators are intended for use by qualified surgeons to manipulate the uterus during laparoscopic procedures including laparoscopic assisted vaginal hysterectomy. The body contact materials are surgical grade stainless steel, PTFE, silicone.
Substantial Equivalence: The KSEAUterine Manipulators are substantially equivalent to the predicate devices since the basic features, design and intended uses are similar. The minor differences in design and dimensions between the KSEA Uterine Manipulators and the predicate devices raise no new issues of safety and effectiveness, as these design differences have no effect. on the performance, function or intended use of these devices.
Signed:
Larry Simmons
Kevin Kennan Senior Regulatory Affairs Specialist
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the top half of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SFP 9 1999
Mr. Kevin Kennan Senior Regulatory Affairs Specialist Karl Storz Endoscopy-America, Inc. 600 Corporate Pointe Culver City, CA 90230-7600
Re: K992027 KONINCKX, KECKSTEIN-SCHIFF, and CLERMONT Uterine Manipulators Dated: August 9. 1999 Received: August 10, 1999 Regulatory Class: II 21 CFR §884.1690/Procode: 85 HIH
Dear Mr. Kennan:
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 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, 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 (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 requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition. 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 the Electronic Product 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 questions on the promotion 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/dsma/dsmamain.html".
Sincerely yours,
CAPT Daniel G. Schultz, M.D. Acting 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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Device Name: KONINCKX Uterine Manipulator KECKSTEIN-SCHIFF Uterine Manipulator CLERMONT Uterine Manipulator
Indications for Use: The KSEA Uterine Manipulators are intended for use by qualified surgeons to manipulate the uterus during laparoscopic assisted vaginal hysterectomy (LAVH).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal, ENT, and Radiological Devices | |
| 510(k) Number | K992027 |
| Prescription Use: | OR Over-The-Counter Use: | ||
|---|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |
§ 884.1690 Hysteroscope and accessories.
(a)
Identification. A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization. This generic type of device may include obturators and sheaths, instruments used through an operating channel, scope preheaters, light sources and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for hysteroscope 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 hysteroscope accessory instruments include: lens cleaning brush, cannula (without trocar or valves), clamp/hemostat/grasper, curette, instrument guide, forceps, dissector, mechanical (noninflatable), and scissors. 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.