(90 days)
This instrument is indicated for use during gynecologic laparoscopic murgical procedures, and, using additional accessories, to perform various diagnostic and therapeutic procedures.
Specific Indications for Use
- unexplained pelvic pain (acute, chronic) .
- infertility work-up ●
- tubal sterilization .
- unexplained primary or secondary amenorthea .
- diagnosis and/or treatment of ectopic pregnancy ●
- evaluation, diagnosis and/or treatment of small pelvic turnors, including ● myomata
- evaluation of congenital anomalies of the pelvic organs .
- retrieval of foreign bodies ●
- determination of the presence and extent of pelvic endometriosis .
- determination of the presence and extent of pelvic inflammatory disease ●
- laparoscopic assisted vaginal hysterectomy ◆
- evaluation of ovarian endocrinopathy ●
- visualization, diagnosis and/or treatment of perforate abdominal organs .
The KSEA MVM 3.3 mm Microendoscope is comprised of a video module, and a endoscope module. The endoscope module is a rigid, panoramic telescope which utilizes rod lens technology. The video module is an imaging device which connects to a camera control unit. The body contact portions of the KSEA MVM 3.3 mm Microendoscope are composed of surgical grade stainless steel, which is commonly used in medical devices for a wide range of applications and has a long history of biocompatibility for human use.
The provided document is a 510(k) summary for the Karl Storz MVM 3.3 mm Microendoscope. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study proving the device meets those criteria.
Therefore, the information requested below cannot be fully extracted from the provided text, as it describes a clearance process based on substantial equivalence, not a performance study against predefined acceptance criteria for AI/diagnostic devices.
Here's an attempt to answer based on the available information and highlight what is missing:
1. A table of acceptance criteria and the reported device performance
No explicit acceptance criteria or reported device performance metrics (e.g., sensitivity, specificity, accuracy) are provided in this 510(k) summary. The document states that "minor differences between the KSEA MVM 3.3 mm Microendoscope and the predicate devices raise no new issues of safety and effectiveness, as these design differences have no affect on the performance, function or intended use of the devices." This implies that the device's performance is considered to be equivalent to the predicate devices, but no specific performance data is given.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is not a performance study against a test set with clinical 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)
Not applicable. No ground truth establishment for a test set is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set or adjudication method is described.
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
Not applicable. This device is a video endoscope, not an AI-powered diagnostic tool. No MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a video endoscope, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No ground truth for a performance study is described. The "ground truth" in 510(k) for substantial equivalence often refers to the understanding and performance of the predicate devices.
8. The sample size for the training set
Not applicable. This document is not describing an AI/machine learning model where a training set would be used.
9. How the ground truth for the training set was established
Not applicable. No training set or associated ground truth establishment is described.
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Image /page/0/Picture/0 description: The image shows the logo for Karl Storz Endoscopy. The word "STORZ" is written in large, bold letters at the top of the logo. Below the word "STORZ" is the text "Karl Storz Endoscopy". The logo is white against a black background.
510(k) SUMMARY OF SAFETY AND EFFECTIVE
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 | DEC - 2 1997 | |
|---|---|---|---|
| Contact: | Kevin KennanRegulatory Affairs Specialist | ||
| Device Identification: | Common Name:Video Endoscope | ||
| Trade Name: (optional)Karl Storz MVM 3.3 mm Microendoscope |
Indication: The KSEA MVM 3.3 mm Microendoscope is designed to be used by qualified surgeons and physicians for gynecologic laparoscopic surgical procedures.
Device Description: The KSEA MVM 3.3 mm Microendoscope is comprised of a video module, and a endoscope module. The endoscope module is a rigid, panoramic telescope which utilizes rod lens technology. The video module is an imaging device which connects to a camera control unit. The body contact portions of the KSEA MVM 3.3 mm Microendoscope are composed of surgical grade stainless steel, which is commonly used in medical devices for a wide range of applications and has a long history of biocompatibility for human use.
Substantial Equivalence: The KSEA MVM 3.3 mm Microendoscope is substantially equivalent to the predicate devices since the basic features, design and intended uses are the same. The minor differences between the KSEA MVM 3.3 mm Microendoscope and the predicate devices raise no new issues of safety and effectiveness, as these design differences have no affect on the performance, function or intended use of the devices.
Signed:
ed:
Kevin Kennan
Regulatory Affairs Specialist
000063
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Image /page/1/Picture/0 description: The image shows the 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's head is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 2 1997
Mr. Kevin Kennan Senior Regulatory Affairs Specialist Karl Storz Endoscopy-America, Inc. 600 Corporate Pointe Culver City, California 90230-7600 Re: K973304 MVM 3.3 mm Microendoscope Dated: September 2, 1997 Received: September 3, 1997 Regulatory Class: II 21 CFR 8884.1720/Product Code: 85 HET
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 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, market the device, 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 misbranding and adulteration.
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 (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 regulatory 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 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 vours.
W. Liao Yu
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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510(k) Number (if known): K973304
Device Name: MVM 3.3 mm Microendoscope
Indications for Use: This instrument is indicated for use during gynecologic laparoscopic murgical procedures, and, using additional accessories, to perform various diagnostic and therapeutic procedures.
Specific Indications for Use
- unexplained pelvic pain (acute, chronic) .
- infertility work-up ●
- tubal sterilization .
- unexplained primary or secondary amenorthea .
- diagnosis and/or treatment of ectopic pregnancy ●
- evaluation, diagnosis and/or treatment of small pelvic turnors, including ● myomata
- evaluation of congenital anomalies of the pelvic organs .
- retrieval of foreign bodies ●
- determination of the presence and extent of pelvic endometriosis .
- determination of the presence and extent of pelvic inflammatory disease ●
- laparoscopic assisted vaginal hysterectomy ◆
- evaluation of ovarian endocrinopathy ●
- visualization, diagnosis and/or treatment of perforate abdominal organs .
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Concurrence of CDRH, Office of Device Evaluation (ODE)
Polor R. Anthing
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
| 510(k) Number | K973304 |
|---|---|
| --------------- | --------- |
| Prescription Use: | ✓ | OR Over-The-Counter Use: | |
|---|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |
§ 884.1720 Gynecologic laparoscope and accessories.
(a)
Identification. A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for gynecologic laparoscope accessories that are not part of a specialized instrument or device delivery system, do not have adapters, connector channels, or do not have portals for electrosurgical, lasers, or other power sources. Such gynecologic laparosope accessory instruments include: the lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable), scissors, and suction/irrigation probe. 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.