IOGYN ENDOSCOPE

K123330 · Iogyn, Inc. · HIH · Mar 19, 2013 · Obstetrics/Gynecology

Device Facts

• Record ID: K123330
• Device Name: IOGYN ENDOSCOPE
• Applicant: Iogyn, Inc.
• Product Code: HIH · Obstetrics/Gynecology
• Decision Date: Mar 19, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1690
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

The IOGYN Endoscope is a rigid, multi-channel endoscope designed for visualization and access during surgical procedures. It features a rod-lens optical system for image transmission and a light post for connection to standard endoscopic light sources. The device body, constructed of surgical steel, includes a working channel for the insertion of resection or coagulation instruments and two fluid channels for fluid management. It is intended for use by physicians in clinical settings, such as operating rooms or clinics, to perform diagnostic and therapeutic interventions. The physician views the surgical site through the eyepiece. By providing direct visualization and instrument access, the device facilitates minimally invasive procedures, potentially reducing patient trauma compared to open surgery.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including thermal testing and simulated use testing conducted in accordance with IEC 60601-2-18.

Technological Characteristics

Rigid multi-channel endoscope; materials: stainless steel, sapphire glass, fiberglass; rod-lens optical system; working channel for instruments; two fluid channels; non-sterile; reusable; compatible with standard endoscopic light sources.

Indications for Use

Indicated for patients requiring endoscopic diagnostic or therapeutic surgical procedures in urology and gynecology.

Regulatory Classification

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

• Hysteroscopic Resectoscope (K991563)

Reference Devices

• Foraminoscope (K082841)

Submission Summary (Full Text)

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K123330:
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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<br>Cupertino, CA 95014 |
| Contact Person: | Mary Edwards |
| Telephone: | [phone] |
| Fax: | [phone] |
| 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.<br>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 |

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K123330/S002
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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<br>Resectoscope [and<br>Accessories] | Foraminoscope |
| 510(k) Sponsor | IOGYN, Inc.<br>(Specification<br>Developer) | Henke-Sass Wolf of<br>America, Inc. | Blazejewski Medi-<br>Tech GmbH |
| Intended Use | To enable the viewing<br>and to provide access<br>for<br>resection/coagulation of<br>soft tissue encountered<br>in, but not limited to,<br>diagnostic and surgical<br>procedures in<br>gynecology and<br>urology. | To enable the viewing<br>and to provide access<br>for<br>resection/coagulation of<br>soft tissue encountered<br>in, but not limited to,<br>diagnostic and surgical<br>procedures in<br>gynecology and<br>urology. | For endoscopic<br>visualization and to<br>provide access for<br>surgical procedures of<br>the lumbar and<br>cervical spine. |
| Materials | Stainless Steel,<br>Sapphire Glass,<br>Fiberglass | Stainless Steel,<br>Titanium, Sapphire<br>Glass, Fiberglass | Stainless Steel,<br>Sapphire Glass,<br>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.

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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.

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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 [phone] or [phone] 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

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#### 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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