OLYMPUS LTF-190-10-3D, MAJ-Y0154, OLYMPUS CV-190
Device Facts
| Record ID | K123365 |
|---|---|
| Device Name | OLYMPUS LTF-190-10-3D, MAJ-Y0154, OLYMPUS CV-190 |
| Applicant | Olympus Medical Systems Corp. |
| Product Code | HET · Obstetrics/Gynecology |
| Decision Date | Mar 1, 2013 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 884.1720 |
| Device Class | Class 2 |
Indications for Use
This instrument is intended to be used with Olympus video system center, light source, documentation equipment, 3D processor, monitor, hand instruments, electrosurgical unit and other ancillary equipment for endoscopy and endoscopic surgery. This instrument is indicated for use within the thoracic and abdominal cavities including female reproductive organs. This instrument must not be used for observation or treatment of the heart and must not contact the heart or any area near the heart. In addition, this instrument must not come into contact with any device or therapeutic accessory that contacts the heart or any area near the heart.
Device Story
System provides 3D endoscopic visualization for surgery. Input: dual-channel video signals from two CCDs at distal end of LTF-190-10-3D deflectable videoscope. Processing: CV-190 video system center converts signals; MAJ-Y0154 3D processor synthesizes 3D video signal. Output: 3D stereoscopic image displayed on compatible monitor (e.g., LMD-2451MT) using passive polarization. Used in clinical settings (OR/clinic) by physicians. 3D view aids depth perception during endoscopic procedures, potentially improving surgical precision. System supports NBI observation and 2D/3D switching.
Clinical Evidence
No clinical data. Substantial equivalence supported by bench testing, including mechanical durability, electrical safety, electromagnetic compatibility, and thermal safety testing performed per ISO 14971:2007 and relevant IEC standards.
Technological Characteristics
Flexible deflectable videoscope with dual CCD sensors. System includes 3D processor and video system center. Connectivity: 3G-SDI output, GenLock synchronization. Standards: IEC 60601-1, IEC 60601-1-1, IEC 60601-2-18, IEC 60601-1-2, ISO 14971, ISO 10993-7, ISO 11135-1. Software: Moderate level of concern.
Indications for Use
Indicated for endoscopic surgery and observation within thoracic and abdominal cavities, including female reproductive organs. Contraindicated for use near or in contact with the heart or cardiac-related therapeutic accessories.
Regulatory Classification
Identification
A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.
Predicate Devices
- LTF-Y0009 3D Laparo-Thoraco Videoscope (K102379)
- LTF-S190-10 ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (K111425)
- MAJ-Y0041 3D Video Mixer (K102379)
- CV-190 EVIS EXERA III VIDEO SYSTEM CENTER (K112680)
- OTV-S190 VISERA ELITE VIDEO SYSTEM CENTER (K111425)
Reference Devices
- LMD-2451MT (K113203)
Submission Summary (Full Text)
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### 510(k) SUMMARY
### MAR 0 1 2013
### OLYMPUS LTF-190-10-3D, ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE MAJ-Y0154, 3D PROCESSOR OLYMPUS CV-190, EVIS EXERA III VIDEO SYSTEM CENTER
November 12, 2012
#### 1 General Information
- Applicant: OLYMPUS MEDICAL SYSTEMS CORP. 2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan 192-8507 Establishment Registration No: 8010047
- l Official Correspondent: Sheri L. Musgnung Regulatory Affairs & Quality Assurance Olympus America Inc. 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610, USA Phone: 484-896-3147 FAX: 484-896-7128 Email: sheri.musgnung@olympus.com
- Manufacturer: .
(LTF-190-10-3D, MAJ-Y0154) OLYMPUS MEDICAL SYSTEMS CORP. Hinode Plant 34-3 Hirai, Hinode-cho, Nishitama-gun, Tokyo, 190-0182, Japan Establishment Registration No.:3003637092
(CV-190) SHIRAKAWA OLYMPUS CO., LTD. 3-1. Aza-Ookamiyama, Ooaza-Odakura, Nishigo-mura, Nishirakawa-gun, Fukushima, Japan 961-8061 Establishment Registration No: 3002808148
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#### 2 Device Identification
3D 를 Device Trade Name: OLYMPUS LTF-190-10-3D ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE 3D PROCESSOR MAJ-Y0154 3D PROCESSOR OLYMPUS CV-190 EVIS EXERA III VIDEO SYSTEM CENTER ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE ■ Common Name: 3D PROCESSOR EVIS EXERA III VIDEO SYSTEM CENTER 21 CFR 884.1720 트 Regulation Number: 21 CFR 876.1500 ■ Gynecologic laparoscope and accessories Regulation Name: Endoscope and Accessories 제 ll Regulatory Class: ■ Classification Panel: General and plastic surgery, Obstetrics/Gynecology Gastroenterology and urology ■ FGB, HET, GCJ, and NWB Product Code:
#### Predicate Device Information 3
| Subject Device<br>(Part of this submission) | Predicate Device | PD's<br>510(k)<br>No. |
|------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|-----------------------|
| OLYMPUS LTF-190-10-3D<br>ENDOEYE FLEX 3D DEFLECTABLE<br>VIDEOSCOPE<br>(Hereinafter referred to as LTF-190-10-3D) | LTF-Y0009<br>3D Laparo-Thoraco Videoscope | K102379 |
| | LTF-S190-10<br>ENDOEYE FLEX DEFLECTABLE<br>VIDEOSCOPE | K111425 |
| MAJ-Y0154<br>3D PROCESSOR<br>(Hereinafter referred to as MAJ-Y0154) | MAJ-Y0041<br>3D Video Mixer | K102379 |
| OLYMPUS CV-190<br>EVIS EXERA III VIDEO SYSTEM CENTER<br>(Hereinafter referred to as CV-190) | CV-190<br>EVIS EXERA III VIDEO SYSTEM<br>CENTER | K112680 |
| | OTV-S190<br>VISERA ELITE VIDEO SYSTEM CENTER | K111425 |
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#### 4 Device Description
The subject system is intended for endoscopy and endoscopic surgery with three-dimensional view of endoscopic images and the system is mainly composed of following devices.
- LTF-190-10-3D (ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE)
- MAJ-Y0154 (3D PROCESSOR)
- CV-190 (EVIS EXERA III VIDEO SYSTEM CENTER)
The ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE OLYMPUS LTF-190-3D is a flexible video endoscope used for endoscopy and endoscopic surgery within the thoracic and abdominal cavities including female reproductive organs.
The subject device, LTF-190-3D is utilized with the MAJ-Y0154, 3D Processor and the CV-190, EVIS EXERA III VIDEO SYSTEM CENTER. The connection of the devices enables the system for endoscopic observation in 3D view of the image.
The 3D video observation of this system is implemented with following process.
The captured signals from two CCDs which correspond to left and right eye incorporated in the distal end of the subject LTF-190-10-3D are transferred to the MAJ-Y0154 via two CV-190s convert the captured signals into video image signals, and transmits them to the MAJ-Y0154. The MAJ-Y0154 converts the video image signals into 3D video signal and transfers it to the LMD-2451MT, (K113203). On the LMD-2451MT, 3D video image is displayed as passive stereo type which has different polarizing angle in the left and right; therefore, the 3D glasses for LMD-2451MT are required to obtain 3D video image.
#### 5 Indications for Use
LTF-190-10-3D
This instrument is intended to be used with Olympus video system center, light source, documentation equipment, 3D processor, monitor, hand instruments, electrosurgical unit and other ancillary equipment for endoscopy and endoscopic surgery. This instrument is indicated for use within the thoracic and abdominal cavities including female reproductive organs.
This instrument must not be used for observation or treatment of the heart and must not contact the heart or any area near the heart. In addition, this instrument must not contact with any device or therapeutic accessory that contacts the heart or any area near the heart.
### CV-190
This video system center is intended to be used with Olympus camera heads, endoscopes, light source, monitors, endo-therapy accessories and other ancillary equipment for endoscopic diagnosis, treatment and video observation.
### MAJ-Y0154
This 3D processor is intended to be used with 3D videoscope and video system center for 3D observation.
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#### Comparison of Technological Characteristics હ
The OLYMPUS LTF-190-10-3D, MAJ-Y0154, OLYMPUS CV-190 are basically identical to the predicate device in intended use, and similar in specifications.
The subject LTF-190-10-3D is nearly identical to the predicate LTF-Y0009. It has identical spefications to the predicate device except for, (1) addition information in a memory, (2) NBI observation in 3D view and (3) addition of sterilization method.
Compared to the predicate device, the MAJ-Y0154 incorporates the following features: (1) Communication with the video system center, (2) 3G-SDI image signal output, (3) Recognition of synchronization of input image signals, (4) Menu, (5) Automatic switching of 20/3D view of endoscopic image, (6) Switching of 2D/3D output for recording .
The subject CV-190 has almost the same in design and function to its predicate CV-190 except for following features: (1)Link between the video system centers. (2)Synchronization with the 3D processor MAJ-Y0154 (GenLock). (3)Communication with the 3D processor MAJ-Y0154.
#### 7 Summary of non-clinical testing
Risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007. The design verifications tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment.
The software validation activities were performed in accordance with the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The device software is considered a "Moderate Level of Concern."
The following bench tests were conducted to demonstrate the substaintal equivalence and safety and effectiveness of the subject devices:
- Mechanical durability testing .
- Electrical safety testing .
- . Electromagnetic compatibility testing
- Thermal safety testing .
- Bench testing to support promotional claims .
The following standards have been applied to the subject system :
- · IEC 60601-1
- · IEC 60601-1-1
- · IEC 60601-2-18
- · IEC 60601-1-2
- · ISO 14971
- · ISO 10993-7 ·
- ANSI/AAMI/ISO 11135-1
#### 8 Conclusion
-
When compared to the predicate device, the OLYMPUS LTF-190-10-3D, MAJ-Y0154 and OLYMPUS CV-190 do not incorporate any significant changes in intended use, method of operation, material, or design that could affect the safety or effectiveness of the device and therefore is Substantially Equivalent to the identified predicate devices.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 1, 2013
OLYMPUS MEDICAL SYSTEMS CORP. % Ms. Sheri L. Musgnung Regulatory Affairs & Quality Assurance Olympus Corporation of the Americas 3500 Corporate Parkway, P.O. Box 610 CENTER VALLEY PA 18034-0610
Re: K123365
### Trade/Device Name: OLYMPUS LTF-190-10-3D ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE MAJ-Y0154, 3D PROCESSOR OLYMPUS CV-190, VIDEO SYSTEM CENTER
Regulation Number: 21 CFR& 884.1720 Regulation Name: Gynecologic laparoscope and accessories Regulatory Class: II Product Code: HET, GCJ, NWB, FGB Dated: January 29, 2013 Received: January 30, 2013
Dear Ms. Musgnung:
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. Iisting 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.
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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. 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 (OS) 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,
HerbertPLerner-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): K123365
Device Name:
OLYMPUS LTF-190-10-3D, ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE Indications For Use:
This instrument is intended to be used with Olympus video system center, light source, documentation equipment, 3D processor, monitor, hand instruments, electrosurgical unit and other ancillary equipment for endoscopy and endoscopic surgery. This instrument is indicated for use within the thoracic and abdominal cavities including female reproductive organs.
This instrument must not be used for observation or treatment of the heart and must not contact the heart or any area near the heart. In addition, this instrument must not come into contact with any device or therapeutic accessory that contacts the heart or any area near the heart.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use_ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 3 of _ 1
## Herbert P. Lerner -S
(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices K123365 510(k) Number _
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### Indications for Use
510(k) Number (if known): K123365
Device Name: MAJ-Y0154, 3D PROCESSOR
Indications For Use:
This 3D processor is intended to be used with 3D videoscope and video system center for 3D observation
Prescription Use______________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
2
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
# Herbert P. Lerner -S
(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices K123365 510(k) Number
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### Indications for Use
K123365 510(k) Number (if known): Device Name: OLYMPUS CV-190, VIDEO SYSTEM CENTER Indications For Use:
This video system center is intended to be used with Olympus camera heads, endoscopes, light source, monitors, endo-therapy accessories and other ancillary equipment for endoscopic diagnosis, treatment and video observation.
Prescription Use_ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use_ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Herbert Prefect Prefection (ODE)
(Division Sign-Off) Division of Reproductive, Gastro-Renal, and 30 30 _3 Urological Devices K123365 510(k) Number
