(144 days)
No
The device description focuses on the physical components and optical system of a rigid endoscope. There is no mention of image processing, AI, ML, or any software-based analysis of the visual data. The performance studies described are related to physical and thermal testing, not algorithmic performance.
Yes
The Indications for Use state the device is intended for "therapeutic surgical procedures" and the Device Description mentions a working channel for "resection/coagulation instruments," which are therapeutic applications.
Yes
The "Intended Use / Indications for Use" section explicitly states that the endoscope is "intended to provide the physician with a means for endoscopic diagnostic and therapeutic surgical procedures. It is indicated for use in diagnostic examination and therapeutic surgical procedures".
No
The device description clearly describes a physical, rigid endoscope made of surgical steel with optical and fluid channels, a light post, and an eyepiece. This is a hardware device, not software only.
Based on the provided information, the IOGYN Endoscope is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for "endoscopic diagnostic and therapeutic surgical procedures" performed on the patient (in vivo). IVD devices are used to examine specimens from the body (in vitro), such as blood, urine, or tissue samples, to diagnose conditions.
- Device Description: The description details a device used for visualization and surgical procedures within the body, not for analyzing samples outside the body.
- Anatomical Site: The specified anatomical sites (urology and gynecology) are within the body, consistent with an in vivo procedure.
Therefore, the IOGYN Endoscope is a surgical endoscope used for direct visualization and intervention within the body, not an IVD device used for testing samples outside the body.
N/A
Intended Use / Indications for Use
The IOGYN Endoscope is intended to provide the physician with a means for endoscopic diagnostic and therapeutic surgical procedures. It is indicated for use in diagnostic examination and therapeutic surgical procedures of, but not limited to, urology and gynecology.
To enable the viewing and to provide access for resection/coagulation of soft tissue encountered in, but not limited to, diagnostic and surgical procedures in gynecology and urology.
Product codes (comma separated list FDA assigned to the subject device)
HIH
Device Description
The IOGYN Endoscope is a rigid multi-channel endoscope provided with a rod lens system to transmit light and images, a working channel, and two fluid channels. The body consists of an outer and an inner tube of surgical steel. The light fibers, rod-lens optical system, and two fluid channels are sandwiched between these tubes. The inner tube serves as a working channel to provide access for resection/coagulation instruments. The fluid channels are intended to move fluid. At the proximal end, the endoscope is provided with a light post that is compatible with standard endoscopic light sources, and with an eyepiece intended for visualization. The IOGYN Endoscope is dimensionally compatible with the IOGYN System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urology, gynecology
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing was performed according to IEC 60601-2-18. Thermal testing and simulated use testing were performed to support safety and effectiveness and substantial equivalence to the predicate device. The IOGYN Endoscope met all specified design and performance requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
K123330:
page 1 of 2
MAR 1 9 2013
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
| Date: | March 14, 2013 |
|---|---|
| Submitter: | |
| Name: | IOGYN, Inc. |
| Address: | 20195 Stevens Creek Blvd., Ste. 120 |
| Cupertino, CA 95014 | |
| Contact Person: | Mary Edwards |
| Telephone: | (952) 227-3394 |
| Fax: | (952) 884-6518 |
| Product: | |
| Trade Name: | IOGYN Endoscope |
| Common Name: | Endoscope |
| Classification Name: | Hysteroscope |
| Predicate Device: | K991563 – Hysteroscopic Resectoscope |
| Device Description: | The IOGYN Endoscope is a rigid multi-channel endoscope provided with a rod lens system to transmit light and images, a working channel, and two fluid channels. The body consists of an outer and an inner tube of surgical steel. The light fibers, rod-lens optical system, and two fluid channels are sandwiched between these tubes. The inner tube serves as a working channel to provide access for resection/coagulation instruments. The fluid channels are intended to move fluid. At the proximal end, the endoscope is provided with a light post that is compatible with standard endoscopic light sources, and with an eyepiece intended for visualization. |
| The IOGYN Endoscope is dimensionally compatible with the IOGYN System. | |
| Indications for Use: | The IOGYN Endoscope is intended to provide the physician with a means for endoscopic diagnostic and therapeutic surgical procedures. It is indicated for use in diagnostic examination and therapeutic surgical procedures of, but not limited to, urology and gynecology. |
| Performance Data: | Testing was performed according to IEC 60601-2-18. Thermal testing and simulated use testing were performed to support safety and effectiveness and substantial equivalence to the predicate device. The |
.
1
K123330/S002
page 2 of 2
IOGYN Endoscope met all specified design and performance requirements.
Technological Characteristics
.
The technological and performance characteristics of the device are similar to those of the predicate devices, as shown by the following summary table:
| Subject Device | Predicate Device | Reference Device | |
|---|---|---|---|
| 510(k) No. | Pending | K991563 | K082841 |
| Device | Endoscope | Hysteroscopic | |
| Resectoscope [and | |||
| Accessories] | Foraminoscope | ||
| 510(k) Sponsor | IOGYN, Inc. | ||
| (Specification | |||
| Developer) | Henke-Sass Wolf of | ||
| America, Inc. | Blazejewski Medi- | ||
| Tech GmbH | |||
| Intended Use | To enable the viewing | ||
| and to provide access | |||
| for | |||
| resection/coagulation of | |||
| soft tissue encountered | |||
| in, but not limited to, | |||
| diagnostic and surgical | |||
| procedures in | |||
| gynecology and | |||
| urology. | To enable the viewing | ||
| and to provide access | |||
| for | |||
| resection/coagulation of | |||
| soft tissue encountered | |||
| in, but not limited to, | |||
| diagnostic and surgical | |||
| procedures in | |||
| gynecology and | |||
| urology. | For endoscopic | ||
| visualization and to | |||
| provide access for | |||
| surgical procedures of | |||
| the lumbar and | |||
| cervical spine. | |||
| Materials | Stainless Steel, | ||
| Sapphire Glass, | |||
| Fiberglass | Stainless Steel, | ||
| Titanium, Sapphire | |||
| Glass, Fiberglass | Stainless Steel, | ||
| Sapphire Glass, | |||
| Fiberglass | |||
| Sterility | Non-sterile | Non-sterile | Non-sterile |
| Reusable | Yes | Yes | Yes |
Conclusion:
The information provided in this 510(k) submission provides reasonable assurance that the subject device IOGYN Endoscope is safe and effective and that it is substantially equivalent to the predicate and reference devices with respect to intended use and technological characteristics.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 19, 2013
IOGYN, Inc. % Ms. Mary J. Edwards Regulatory Consultant Regulatory & Clinical Research Institute, Inc. 5353 Wayzata Boulevard, Suite 505 MINNEAPOLIS MN 55416
Re: K123330
Trade/Device Name: IOGYN ENDOSCOPE Regulation Number: 21 CFR& 884.1690 Regulation Name: Hysteroscope and accessories Regulatory Class: II Product Code: HIH Dated: March 7, 2013 Received: March 11, 2013
Dear Ms. Edwards:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
3
You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Herber P. Berner -S
for
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
510(k) Number (if known): 〈イノスるろ○
Device Name: IOGYN ENDOSCOPE
Indications for Use: The IOGYN Endoscope is intended to provide the physician with a means for endoscopic diagnostic and therapeutic surgical procedures. It is indicated for use in diagnostic examination and therapeutic surgical procedures of, but not limited to, urology and gynecology.
Prescription Use × (Part 2) CFR 801 Subpart D) AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
HerbertPDLer -S
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ion Sian-