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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 ●

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.

This document is a 510(k) summary for a medical device (Micro Video Module (MVM) 7.5 French Flexible Hysteroscope) and does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.

The document discusses:

• Indications for Use: The medical conditions and procedures for which the hysteroscope is intended.
• Device Description: A brief overview of the device components and materials.
• Substantial Equivalence: A claim that the device is substantially equivalent to existing predicate devices, implying it has the same basic features, design, and intended uses.
• Regulatory Correspondence: The FDA's letter confirming the 510(k) clearance and the device's classification.

Therefore, I cannot provide the requested information as it is not present in the provided text. The document is focused on regulatory clearance based on substantial equivalence, not on performance testing against specific acceptance criteria.

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