(442 days)
Not Found
No
The summary does not mention AI, ML, or any related terms, and the device description focuses on standard endoscope components and functions.
No
The device is a video endoscope intended for endoscopic surgery by capturing images/videos. It is an instrument used for observation, not to provide therapy.
No
Explanation: The intended use of this device is for endoscopic surgery within the thoracic and abdominal cavities, not for diagnosing conditions. It is described as a video endoscope for capturing images/videos, which are typically used for visualization during surgical procedures rather than for diagnosis itself.
No
The device description explicitly states it is a video endoscope consisting of physical parts (control section, insertion section, connector section) and uses an objective lens and light guide lens, indicating it is a hardware device with integrated software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the instrument is for "endoscopic surgery within the thoracic and abdominal cavities including female reproductive organs." This describes a device used in vivo (within the living body) for surgical procedures, not for testing samples in vitro (outside the living body).
- Device Description: The description of a "video endoscope" with an "insertion section" and "objective lens" further supports its use for internal visualization and procedures within the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostic testing.
Therefore, this device is a surgical endoscope, not an IVD.
N/A
Intended Use / Indications for Use
This instrument is intended to be used with a video system center, light source, documentation equipment, monitor, hand instruments, electrosurgical unit, and other ancillary equipment for endoscopic surgery within the thoracic and abdominal cavities including female reproductive organs.
Product codes
HET, GCJ, NWB
Device Description
This instrument has been designed to be used with a video system center, light source, documentation equipment, monitor, hand instruments, electrosurgical unit, and other ancillary equipment for endoscopy and endoscopic surgery within the thoracic and abdominal cavities including female reproductive organs.
The LTF-S190-5 is a video endoscope consisting of three parts: the control section, the insertion section, and the connector section. The device uses an objective lens and light guide lens for capturing images/videos from the distal end of the endoscope.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Video
Anatomical Site
thoracic and abdominal cavities including female reproductive organs
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Healthcare facility/hospital
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)
The following performance data were provided in support of the substantial equivalence determination:
- Reprocessing validation testing: All reprocessing methods including the Sterilizer/Sterilization process were validated in accordance with the FDA guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" issued on March 17, 2015. The acceptance criteria were met.
- Biocompatibility testing: Biocompatibility testing for the LTF-S190-5 final product was conducted in accordance with the FDA's Guidance for Industry and Food and Drug Administration Staff, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process''.
- Cytotoxicity Study Using the Colony Assay (ISO 10993-5:2009)
- Intracutaneous Study in Rabbits (ISO 10993-10:2010)
- Guinea Pig Maximization Sensitization Test (ISO 10993-10:2010)
- Acute Systemic Toxicity Study in Mice (ISO 10993-11:2006)
- Rabbit Pyrogen Study (USP , USP )
The device was shown to be non-cytotoxic, non-irritating, non-sensitizing, not systemically toxic, and non-pyrogenetic.
- Software verification and validation testing: Software verification and validation testing for the LTF-S190-5 was conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices". The device met all requirements.
- Electrical safety and electromagnetic compatibility (EMC): Electrical safety and EMC testing were conducted on the LTF-S190-5. The system complies with the ANSI/AAMI ES 60601-1:2005/(R)2012 and A1:2012 and IEC 60601-2-18:2009 standards for safety and the IEC 60601-1-2:2014 standards for EMC. The device met all requirements.
- Performance testing - Bench: Bench testing for the LTF-S190-5 as listed below was conducted to ensure that the subject device performs as intended and meet design specifications. Device performance was assessed the design requirements, and included process verification, design verification, and design validation. The device met all acceptance criteria.
- Thermal safety test
- Composite durability test
- Color (imaging) performance
- Photobiological Safety
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.1720 Gynecologic laparoscope and accessories.
(a)
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.(b)
Classification. (1) Class II (performance standards).(2) Class I for gynecologic laparoscope accessories that are not part of a specialized instrument or device delivery system, do not have adapters, connector channels, or do not have portals for electrosurgical, lasers, or other power sources. Such gynecologic laparosope accessory instruments include: the lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable), scissors, and suction/irrigation probe. 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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 17, 2021
Olympus Medical Systems Corp. % Jon Gilbert Regulatory Affairs Consultant for Olympus Olympus Corporation of the Americas 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610
K201832 Re:
Trade/Device Name: ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE OLYMPUS LTF-S190-5 Regulation Number: 21 CFR§ 884.1720 Regulation Name: Gynecologic Laparoscope and Accessories Regulatory Class: II Product Code: HET, GCJ, NWB Dated: August 13, 2021 Received: August 16, 2021
Dear Jon Gilbert:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jason Roberts -S
Jason R. Roberts, Ph.D. Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K201832
Device Name ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE OLYMPUS LTF-S190-5
Indications for Use (Describe)
This instrument is intended to be used with a video system center, light source, documentation equipment, monitor. hand instruments, electrosurgical unit, and other ancillary equipment for endoscopic surgery within the thoracic and abdominal cavities including female reproductive organs.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------------------------------ | ----------------------------------------------------------------------------------- |
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Image /page/3/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The word is positioned above a thick, horizontal, yellow line. The font is sans-serif and the letters are closely spaced together. There is a registered trademark symbol to the right of the word.
510(k) Summary
I. GENERAL INFORMATION
| ■ 510(k) Submitter: | OLYMPUS MEDICAL SYSTEMS CORP. |
|---|---|
| 2951 Ishikawa-cho, Hachioji-shi, Tokyo 192-8507, | |
| Japan |
- Contact Person: Jon Gilbert c/o Olympus Corporation of the Americas 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610, USA Phone: 906-361-3237 Fax: 484-896-7128 Email: jgilb.raca@gmail.com
- Aizu Olympus Co., Ltd., ■ Manufacturing site: 500 Muranishi, Niidera, Monden-machi, Aizuwakamatsu-shi, Fukushima 965-8520, Japan
Date Prepared: September 14, 2021
II. DEVICE IDENTIFICATION
| ■ Device Name | ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE
OLYMPUS LTF-S190-5 |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| ■ Common Name | VIDEOSCOPE |
| ■ Regulation Number | 21 CFR 884.1720 |
| ■ Regulation Name | Gynecologic laparoscope and accessories |
| ■ Regulatory Class | II |
| ■ Product Code | HET; Laparoscope, Gynecologic (And Accessories)
GCJ; Laparoscope, General & Plastic Surgery
NWB; Endoscope, Accessories, Narrow Band Spectrum |
- Classification Panel Obstetrics/Gynecology
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Image /page/4/Picture/0 description: The image shows the Olympus logo in blue, with a gold line underneath. To the right of the logo, the text "Traditional 510(k) Notification" is present. Below the logo, the text "ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE OLYMPUS LTF-S190-5" is displayed.
III. PREDICATE DEVICE
| Device name | 510(k) Submitter | 510(k) No. |
|---|---|---|
| ENDOEYE FLEX 3D | ||
| DEFLECTABLE VIDEOSCOPE | ||
| OLYMPUS LTF-190-10-3D | OLYMPUS MEDICAL | |
| SYSTEMS CORP. | K123365 |
The predicate device has not been subject to a design-related recall.
IV. DEVICE DESCRIPTION
■ General Description of the subject device
This instrument has been designed to be used with a video system center, light source, documentation equipment, monitor, hand instruments, electrosurgical unit, and other ancillary equipment for endoscopy and endoscopic surgery within the thoracic and abdominal cavities including female reproductive organs.
Principle of Operation
The LTF-S190-5 is a video endoscope consisting of three parts: the control section, the insertion section, and the connector section. The device uses an objective lens and light guide lens for capturing images/videos from the distal end of the endoscope.
V. INDICATIONS FOR USE
ENDOBYE ELEX DEFLECTABLE VIDEOSCOPE OLYMPUS LTF-S190-5
This instrument is intended to be used with a video system center, light source, documentation equipment, monitor, hand instruments, electrosurgical unit, and other ancillary equipment for endoscopy and endoscopic surgery within the thoracic and abdominal cavities including female reproductive organs
COMPARISON OF TECHNOLOGY CHARACTERISTICS WITH VI. THEPREDICATE DEIVCE
The detailed comparison chart between subject device and predicate devices are as follows.
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| Subject Device (SD) | Predicate Device (PD) | |
|---|---|---|
| Item | LTF-S190-5 | LTF-190-10-3D |
| Indications for Use | This instrument is intended to | |
| be used with a video system | ||
| center, light source, | ||
| documentation equipment, | ||
| monitor, hand instruments, | ||
| electrosurgical unit, and other | ||
| ancillary equipment for | ||
| endoscopy andendoscopic | ||
| surgery within the thoracic | ||
| and abdominal cavities | ||
| including female reproductive | ||
| organs. | 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. | ||
| Environment of use | Healthcare facility/hospital | Healthcare facility/hospital |
| Single/ Repeat use | Repeat use | Repeat use |
| Sterile/ Non-sterile | Non-sterile | Non-sterile |
| Sterilization method | Ethylene oxide, Autoclave, | |
| Hydrogen peroxide (Sterrad | ||
| 100S/ NX) | Ethylene oxide, Hydrogen peroxide | |
| (Sterrad NX) | ||
| Field of View | 85° | 80° |
| Direction of View | 0° (Forward viewing) | 0° (Forward viewing) |
| Depth of Field | 18-100 mm | 18-100 mm |
| Type of CCD | Color CCD | Color CCD |
| Number of CCD Chip | 1 | 2 |
| Narrow Band Imaging | ||
| observation | Available | Available |
| Insertion Tube | ||
| Diameter | Distal end size: Ø 5.4 mm | |
| Insertion tube outer Diameter | ||
| (Maximum): Ø5.4 mm | Distal end size: Ø 10 mm | |
| Insertion tube outer Diameter | ||
| (Maximum): Ø 10 mm | ||
| Working Length | 370 mm | 370 mm |
| Channel inner diameter | No instrument channel | No instrument channel |
| Angulation Range | U/D:100°/100° | |
| R/L:100°/100° | U/D:100°/100° | |
| R/L:100°/100° | ||
| Item | Subject Device (SD) | |
| LTF-S190-5 | Predicate Device (PD) | |
| LTF-190-10-3D | ||
| Patient contacting | ||
| material | Bending rubber: Fluoro Rubber | |
| Distal end/ Distal cover/ | ||
| Insertion tube/ Pin: Stainless steel | ||
| Glue: Epoxy Resin | ||
| Lens: Glass | Bending rubber: Fluoro Rubber | |
| Distal end / Insertion tube: Stainless steel | ||
| Glue: Epoxy Resin | ||
| Lens: Glass | ||
| Duration and type of | ||
| contact | External communicating device in contact with mucosal membranes, damaged mucosal membranes and tissue/bone/dentin. | |
| The contact duration is limited exposure (i.e. contact is up to 24 hours). | External communicating device in contact with mucosal membranes, damaged mucosal membranes and tissue/bone/dentin. | |
| The contact duration is limited exposure (i.e. contact is up to 24 hours). |
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K201832 Page 4 of 5
The indications for use of the subject device do not raise different questions of safety and effectiveness when compared to the predicate device. The subject and predicate devices have the same intended use of providing visualization during thoracic and abdominal surgery, including the female reproductive organs. The differences in technological characteristics do not raise new questions of safety and effectiveness.
VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
1) Reprocessing validation testing
All reprocessing methods including the Sterilizer/Sterilization process were validated in accordance with the FDA guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" issued on March 17, 2015. The acceptance criteria were met.
2) Biocompatibility testing
Biocompatibility testing for the LTF-S190-5 final product was conducted in accordance with the FDA's Guidance for Industry and Food and Drug Administration Staff, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process''.
- Cytotoxicity Study Using the Colony Assay (ISO 10993-5:2009) ।
- i Intracutaneous Study in Rabbits (ISO 10993-10:2010)
- Guinea Pig Maximization Sensitization Test (ISO 10993-10:2010) ।
- Acute Systemic Toxicity Study in Mice (ISO 10993-11:2006) i
7
- -Rabbit Pyrogen Study (USP , USP )
The device was shown to be non-cytotoxic, non-irritating, non-sensitizing, not systemically toxic, and non-pyrogenetic.
3) Software verification and validation testing
Software verification and validation testing for the LTF-S190-5 was conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices". The device met all requirements.
4) Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the LTF-S190-5. The system complies with the ANSI/AAMI ES 60601-1:2005/(R)2012 and A1:2012 and IEC 60601-2-18:2009 standards for safety and the IEC 60601-1-2:2014 standards for EMC. The device met all requirements.
5) Performance testing - Bench
Bench testing for the LTF-S190-5 as listed below was conducted to ensure that the subject device performs as intended and meet design specifications. Device performance was assessed the design requirements, and included process verification, design verification, and design validation. The device met all acceptance criteria.
- Thermal safety test
- Composite durability test
- Color (imaging) performance
- Photobiological Safety
VIII. CONCLUSIONS
The indications for use and technological characteristics of the LTF-S190-5 do not raise different questions of safety and effectiveness as compared to the predicate. The performance testing demonstrate that the subject device is as safe and effective as the predicate. Therefore, and the subject device is substantially equivalent to the predicate device.