(90 days)
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No
The provided text describes a flexible fiber optic endoscope and a video module for hysteroscopy. There is no mention of AI, ML, image processing, or any other technology that would suggest the use of AI/ML. The description focuses on the physical components and intended uses of the device.
Yes
The device's "Operative Hysteroscopy" indications include procedures like "removal of submucous fibroids and large polyps," "submucous myomectomy," and "endometrial ablation," which are therapeutic interventions.
Yes
The "Intended Use / Indications for Use" section explicitly lists "Diagnostic Hysteroscopy" for various conditions, indicating its use in diagnosing medical conditions related to the cervix and uterus.
No
The device description explicitly states it is comprised of a video module and an endoscope module, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for direct visualization and surgical procedures within the cervix and uterus. This is an in vivo procedure, meaning it is performed within the living body.
- Device Description: The description details a flexible endoscope and a video module, consistent with a device used for internal examination and intervention.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.) outside the body, which is the hallmark of an in vitro diagnostic device.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used to directly visualize and treat structures within the body.
N/A
Intended Use / Indications for Use
The KSEA MVM 7.5 French Hysteroscope is indicated for examination of the cervix and uterus and, using additional accessories, to perform various diagnostic and therapeutic procedures including; Diagnostic Hysteroscopy - abnormal uterine bleeding - infertility and pregnancy wastage - evaluation of abnormal hysterosalpingegram . - . intrauterine foreign body - . amenortiea - . polvic pain - evaluation of abnormalities of the endometrium - . monitoring IUD status; Operative Hysteroscopy - directed biopsy - removal of submucous fibroids and large polps - . submucous myomectomy - transection of intrauterine adhesions - . transection of intrauterine septa - endometrial ablation.
Product codes
85 HIH
Device Description
The KSEA MVM 7.5 French Hysteroscope is comprised of a video module, and a endoscope module. The endoscope module is a flexible, fiber optic endoscope. The video module is an imaging device which connects to a camera control unit. The body contact portions of the KSEA MVM 7.5 French Hysteroscope are composed of medical grade polyurethane, which is commonly used in medical devices for a wide range of applications and has a long history of biocompatibility for human use.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
cervix and uterus
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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Image /page/0/Picture/0 description: The image contains a sequence of handwritten characters, which appear to be a combination of letters and numbers. The sequence reads 'K990411'. The characters are written in a bold, sans-serif style, and they are the primary focus of the image.
MAY 1 1 1999
510(Is) 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 Drive
Culver City, CA 90230
(310) 558-1500 |
|------------------------|---------------------------------------------------------------------------------------------------------------|
| Contact: | Kevin Kennan
Senior Regulatory Affairs Specialist |
| Device Identification: | Common Name:
Video Endoscope |
| | Trade Name: (optional)
Karl Storz Micro Video Module (MVM) 7.5 French Hysteroscope |
Indication: The KSEA MVM 7.5 French Hysteroscope is indicated for examination of the cervix and uterus and, using additional accessories, to perform various diagnostic and therapeutic procedures including;
Diagnostic Hysteroscopy
- abnormal uterine bleeding ◀
- infertility and pregnancy wastage ●
- evaluation of abnormal hysterosalpingegram .
- . intrauterine foreign body
- . amenortiea
- . polvic pain
- � evaluation of abnormalities of the endometrium
- . monitoring IUD status
Operative Hysteroscopy
- directed biopsy
- removal of submucous fibroids and large polps
- . submucous myomectomy
- transection of intrauterine adhesions
- . transection of intrauterine septa
- endometrial ablation
1
Device Description: The KSEA MVM 7.5 French Hysteroscope is comprised of a video module, and a endoscope module. The endoscope module is a flexible, fiber optic endoscope. The video module is an imaging device which connects to a camera control unit. The body contact portions of the KSEA MVM 7.5 French Hysteroscope are composed of medical grade polyurethane, 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 7.5 French Hysteroscope 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 7.5 French Hysteroscope and the predicate devices raise no now issues of safety and effectiveness, as these design differences have no affect on the performance, function or intended use of the devices.
Signed:
kevin kennan
Senior Regulatory Affairs Specialist
2
Public Health Service
Image /page/2/Picture/17 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the top half of the circle. Inside the circle is a stylized image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 1 1999
Mr. Kevin Kennan Senior Regulatory Affairs Specialist Karl Storz Endoscopy 600 Corporate Pointe Culver City, CA 90230-7600
Re: K990411
Micro Video Module (MVM) 7.5 French Flexible Hysteroscope Dated: February 4, 1999 Received: February 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 (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 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 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 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
3
510(k) Number (if known): 990411
Device Name: Micro Video Module MVM 7.5 French Flexible Hysteroscope
Indications for Use: This instrument is indicated for examination of the cervix and uterus and, using additional accessories, to perform various diagnostic and therapeutic procedures including;
Diagnostic Hysteroscopy
- abnormal uterine bleeding .
- infertility and pregnancy wastage .
- evaluation of abnormal hysterosalpingogram .
- intrauterine foreign body .
- . amenorrhea
- . pelvic pain
- . evaluation of abnormalities of the endometrium
- . monitoring IUD status
Operative Hysteroscopy
- directed biopsy ●
- . removal of submucous fibroids and large polps
- . submucous myomectomy
- transection of intrauterine adhesions ●
- transection of intrauterine septa .
- endometrial ablation ●