← Product Code [HIH](/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIH) · K961688 # MICROSPAN HYSTEROSCOPE (K961688) _Imagyn Medical, Inc. · HIH · Oct 15, 1996 · Obstetrics/Gynecology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIH/K961688 ## Device Facts - **Applicant:** Imagyn Medical, Inc. - **Product Code:** [HIH](/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIH.md) - **Decision Date:** Oct 15, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 884.1690 - **Device Class:** Class 2 - **Review Panel:** Obstetrics/Gynecology ## Indications for Use The MicroSpan Hysteroscope is used to permit viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures. ## Device Story MicroSpan Hysteroscope; small-diameter, rigid, fiberoptic endoscope; no through lumens. Components: stainless steel shaft, illumination fibers, imaging fiber bundle, distal lens, rotatable eyepiece. Operation: connects to external endoscopic light source via light cables; transmits light to distal end; distal lens focuses image onto fibers; proximal lens magnifies image for eyepiece viewing or camera coupling. Used in clinical settings by physicians for visualization of cervical canal and uterine cavity. Facilitates diagnostic and surgical procedures by providing direct visual access to uterine anatomy. ## Clinical Evidence Bench testing only. Evaluated optical and mechanical characteristics, effects of simulated reuse, thermal characteristics, and biocompatibility. ## Technological Characteristics Rigid, fiberoptic hysteroscope. Materials: stainless steel shaft. Illumination: external light source (e.g., xenon) via fiber bundles. Imaging: distal/proximal lens systems with fiber bundle transmission. Connectivity: compatible with standard video cameras/monitors via optical coupler. Non-powered, non-electronic device. ## Regulatory 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. ## Predicate Devices - Imagyn Hysteroscope - Imagyn MicroLap Laparoscope - Karl Storz Miniscope Straight Forward Telescope - Optim ed Technologies Rigid Fiber Optic Hysteroscope ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} Imagyn OCT 15 1996 # 510(k) Summary K9616 88 Submitter: Imagyn Medical, Inc. 27651 La Paz Road Laguna Niguel, CA 92656-3917 (714) 362-2500 Contact: Debra A. Rinderer Summary Preparation: April 30, 1996 Device: MicroSpan Hysteroscope Predicate Devices: Imagyn Hysteroscope Imagyn MicroLap Laparoscope Karl Storz Miniscope Straight Forward Telescope Optim ed Technologies Rigid Fiber Optic Hysteroscope Device Description: The MicroSpan Hysteroscope is a small diameter, rigid, fiberoptic hysteroscope without through lumens. The device consists of an outer stainless steel shaft, inner illumination fibers, and an imaging fiber bundle. At one end of the imaging bundle is the distal lens and at the other is the rotatable eyepiece. An endoscopic light source is connected to the light post of the hysteroscope through compatible light cables. If desired, the eyepiece can be connected through a focusing optical coupler to a camera head which carries the image by cable to the camera. Intended Use of Device: The MicroSpan Hysteroscope is used to permit viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures. Technological Comparisons: Light from a high intensity light source (e.g. xenon) is transmitted through illumination fibers to the distal end of the hysteroscope in order to illuminate the target object. The distal lens system focuses the image of the object onto image fibers, which then transmits the image to the proximal lens system. The proximal lens system magnifies and focuses the image onto an eyepiece at the proximal end of the hysteroscope for viewing and/or directly to standard video cameras, monitors and recording equipment. The MicroSpan Hysteroscope and the predicate devices all have equivalent technological characteristics. Performance Summary Non-clinical tests were performed to demonstrate that the device performed according to its description. Testing included evaluation of optical and mechanical characteristics of the device and the effect of simulated reuses on these characteristics. The device was also evaluated for its thermal characteristics and biocompatibility. Imagyn Medical, Inc. 27651 La Paz Road Laguna Niguel, CA 92677 Tel: (714) 362-2500 Fax: (714) 362-2520 --- **Source:** [https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIH/K961688](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIH/K961688) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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