(88 days)
The MicroSpan Gold Hysteroscope is used to permit viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.
The MicroSpan Hysteroscope Sheath is used to provide access to the uterine cavity for the MicroSpan Gold Hysteroscope or other hysteroscopic instruments during diagnostic and operative hysteroscopic procedures.
The MicroSpan-Gold 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.
The MicroSpan Hysteroscope Sheath is offered with irrigation/insufflation and aspiration ports and an instrument channel. The device is provided sterile for single use, and is made from both metal and plastic components.
The provided text describes a 510(k) submission for the Imagyn MicroSpan Gold Hysteroscope and MicroSpan Hysteroscope Sheath. However, it does not include detailed information regarding acceptance criteria, specific performance metrics, clinical study design, sample sizes, expert qualifications, or ground truth establishment.
The "Performance Summary" section only states: "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 electrical safety, thermal characteristics, and biocompatibility." This indicates that the proof of meeting acceptance criteria was based on bench testing (non-clinical) rather than a clinical study with human patients.
Therefore, many of the requested details cannot be extracted from the provided document.
Here's a breakdown of what can and cannot be answered based on the input:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Optical Characteristics | "demonstrate that the device performed according to its description" via non-clinical tests. (Specific metrics like resolution, field of view, illumination intensity are not provided.) |
| Mechanical Characteristics | "demonstrate that the device performed according to its description" via non-clinical tests. (Specific metrics like shaft diameter, bending strength, insertion force are not provided.) |
| Effect of Simulated Reuses | Evaluated via non-clinical tests to "demonstrate that the device performed according to its description." (Specific metrics on degradation over reuse cycles are not provided.) |
| Electrical Safety | Evaluated via non-clinical tests. (Specific standards met or results are not provided.) |
| Thermal Characteristics | Evaluated via non-clinical tests. (Specific temperature ranges or stability data are not provided.) |
| Biocompatibility | Evaluated via non-clinical tests. (Specific tests performed or results (e.g., cytotoxicity, sensitization) are not provided.) |
| Substantial Equivalence | The FDA determined the device is substantially equivalent to predicate devices (Imagyn MicroSpan Hysteroscope, Imagyn MicroLap-Gold Laparoscope, Optimed Technologies Rigid Fiber Optic Hysteroscope) for its stated intended use. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not applicable. The performance summary explicitly states "Non-clinical tests were performed." This implies bench testing of devices, not a test set of patient cases.
- Data Provenance: Not applicable, as no clinical patient data was used for performance evaluation in this summary.
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 clinical expert review or ground truth establishment for patient cases is mentioned, as the evaluation was non-clinical.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical test set or adjudication process is mentioned.
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
- No. This device is a rigid fiberoptic hysteroscope and sheath, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is a physical medical instrument, not an algorithm, so standalone algorithm performance is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the non-clinical tests, the "ground truth" would be engineering specifications, established physical properties, and safety standards (e.g., ISO, ASTM standards for materials, electrical safety, optical performance). The document does not specify which exact standards were used.
8. The sample size for the training set
- Not applicable. This is a physical medical device, not a machine learning algorithm.
9. How the ground truth for the training set was established
- Not applicable. This is a physical medical device, not a machine learning algorithm.
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K972426
p192
Imágyn
ﺔ ﻣﻤﻤﻠ
SEP 2 3 1997
510(k) Summary
| Submitter: | Imagyn Medical, Inc.27651 La Paz RoadLaguna Niguel, CA 92677-3917(714) 362-2500Contact: Debra A. Rinderer |
|---|---|
| Summary Preparation: | June 25, 1997 |
| Device: | MicroSpan Gold Hysteroscope and MicroSpan Hysteroscope Sheath |
| Predicate Devices: | Imagyn MicroSpan HysteroscopeImagyn MicroLap-Gold LaparoscopeOptimed Technologies Rigid Fiber Optic Hysteroscope |
| Device Description: | The MicroSpan-Gold Hysteroscope is a small diameter, rigid, fiberoptichysteroscope without through lumens. The device consists of an outerstainless 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 therotatable eyepiece. An endoscopic light source is connected to the light postof the hysteroscope through compatible light cables. If desired, the eyepiececan be connected through a focusing optical coupler to a camera head whichcarries the image by cable to the camera.The MicroSpan Hysteroscope Sheath is offered with irrigation/insufflation and aspiration ports and an instrument channel. The device is providedsterile for single use, and is made from both metal and plastic components. |
| Intended Use of Device: | The MicroSpan Gold Hysteroscope is used to permit viewing of the cervicalcanal and the uterine cavity for the purpose of performing diagnostic andsurgical procedures.The MicrSpan Hysteroscope Sheath is indicated for use in providing accessto the uterine cavity for the Imagyn Hysteroscope or other hysteroscopicinstruments during diagnostic and operative hysteroscopic procedures. |
| Technological Comparisons: | Light from a high intensity light source (e.g. xenon) is transmitted throughillumination fibers to the distal end of the hysteroscope in order to illuminatethe target object. The distal lens system focuses the image of the object ontoimage fibers, which then transmits the image to the proximal lens system.The proximal lens system magnifies and focuses the image onto an eyepieceat the proximal end of the hysteroscope for viewing and/or directly tostandard video cameras, monitors and recording equipment. The MicroSpanGold Hysteroscope and the predicate devices all have equivalenttechnological characteristics. |
Imagyn Medical, Inc. 27651 La Paz Road Laguna Niguel, CA 92677 Tel: (714) 362-2500 Fax: (714) 362-2520
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510(k) Summary MicroSpan Gold Hysteroscope and MicroSpan Hysteroscope Sheath Page 2 of 2
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K 972426
p292
| Technological Comparisons(continued) | The MicroSpan Hysteroscope Sheath is identical in all respects exceptmaximum outer diameter to the previously cleared MicroSpan HysteroscopeSheath. The device is designed to achieve hysteroscope and/or hysteroscopicinstrument insertion without loss of uterine distention. |
|---|---|
| Performance Summary | Non-clinical tests were performed to demonstrate that the device performedaccording to its description. Testing included evaluation of optical andmechanical characteristics of the device and the effect of simulated reuses onthese characteristics. The device was also evaluated for its electrical safety,thermal characteristics, and biocompatibility. |
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Image /page/2/Picture/1 description: The image is a circular seal or logo. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. In the center of the seal is a stylized image of an eagle or bird-like figure, depicted with flowing lines to suggest movement or flight. The overall design is simple and monochromatic, using black lines on a white background.
SEP 2 3 1997
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Debra A. Rinderer Regulatory Affairs Specialist Imagyn Medical, Inc. 27651 La Paz Road Laguna Niguel, California 92677 Re: K972426
MicroSpan Gold Hysteroscope and MicroSpan Hysteroscope Sheath Dated: June 26, 1997 Received: June 27, 1997 Regulatory class: II 21 CFR §884.1690/Product code: 85 HIH
Dear Ms. Rinderer:
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 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, 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 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 (OS) 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 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/dsmamain.html"
Sincerely yours.
William 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
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INDICATIONS FOR USE
510(k) Number (if known): K972426
Device Name: MicroSpan Gold Hysteroscope and MicroSpan Hysteroscope Sheath
Indications for Use:
The MicroSpan Gold Hysteroscope is used to permit viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.
The MicroSpan Hysteroscope Sheath is used to provide access to the uterine cavity for the MicroSpan Gold Hysteroscope or other hysteroscopic instruments during diagnostic and operative hysteroscopic procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Robert D. Natting/
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number_16972426
Prescription Use
OR
Over-The-Counter Use
§ 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.