(172 days)
Not Found
No
The summary focuses on the mechanical design and lens cleaning method, with no mention of AI, ML, image processing, or related performance metrics.
No
The device is described as an instrument for endoscopy and endoscopic surgery, designed for visualization and access, rather than directly treating a disease or condition.
No
The text describes the device as being used for "endoscopy and endoscopic surgery," which are procedures for visualization and intervention, not solely for diagnosis. While diagnosis may occur during endoscopy, the device's primary stated purpose includes surgical functions.
No
The device description clearly describes a physical videoscope with an insertion tube, lens, and inner channels for irrigation, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as an instrument for endoscopy and endoscopic surgery within the thoracic and abdominal cavities. This involves direct visualization and manipulation within the body, which is an in vivo procedure, not an in vitro (outside the body) diagnostic test.
- Device Description: The description details a videoscope designed for surgical procedures, focusing on its physical structure and lens cleaning method. This aligns with a surgical instrument, not a device used for analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing diagnostic tests on these samples, or providing diagnostic information based on such analysis.
Therefore, this device falls under the category of a surgical endoscope, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
This instrument has been designed to be used with the VISERA Video System Center OTV-S7V, light source, documentation equipment, videomonitor, endo-thrapy accessories, electrosurgical unit, and other ancillary equipment for endoscopy and endoscopic surgery within the thoracic and abdominal cavities including female reproductive organs.
Product codes
GCJ, HET
Device Description
The subject device, LAPARO-THORACO VIDEOSCOPE XLTF-VAW is designed for endoscopy and endoscopic surgery within the thoracic and abdominal cavities including female reproductive organs. The subject device has a different lens cleaning method from the predicate Olympus LAPARO THORACO VIDEOSCOPE LTF-V. For the predicate device, air and water for lens cleaning are supplied through the sbace between the endoscope's insertion and a sheath attached to it. The subject device also uses a sheath but irrigation are performed through the inner channels of the videoscope. The basic structure of the inner channel is substantially equivalent to that of the predicate device, GIF-Q160Z.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic and abdominal cavities including female reproductive organs
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
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
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
0
MAY 26 2006
October xx, 2005
510(k) SUMMARY
LAPARO-THORACO VIDEOSCOPE XLTF-VAW
General Information 1.
- Applicant: 트
- Official Correspondent: ■
Manufacturer 199
Olympus Medical Systems Corp. 2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan 192-8507 Establishment Registration No: 8010047
Laura Storms-Tyler Executive Director Regulatory Affairs & Quality Assurance Olympus America Inc. Two Corporate Center Drive, Melville, NY 11747-9058, USA Phone: 631-844-5688 FAX: 631-844-5554 Email:Laura.storms-tyler@olympus.com Establishment Registration No: 2429304
Olympus Medical Systems Corp. 34-3 Hirai Hinode-machi, Nishitama-gun, Tokyo, 190-0812, Japan Establishment Registration Number: 3003637092
2. Device Identification
- LAPARO-THORACO VIDEOSCOPE XLTF-VAW I Device Name LAPARO-THORACOVIDEOSCOPE E Common Name 21 CFR 876.1500/884.1720 Regulation Number 1월 Endoscope and accessories Regulation Name 트 Gynecologic laparoscope and accessories II 1 Regulatory Class GCJ/HET ■ Product Code Classification Panel Laparoscope, general & plastic surgery 트
Laparoscope, gynecologic (and accessories)
1
Predicate Device Information 3.
- (1) Device Name: Common Name: 510(k) No. Manufacturer:
- (2) Device Name: Common Name: 510(k) No. Manufacturer:
(3) Device Name:
Common Name: 510(k) No. Manufacturer:
LTF-V LAPARO THORACO VIDEOSCOPE LAPARO THORACO VIDEOSCOPE K955403 Olympus Optical Co., Ltd.
A4907 LENS CLEANING SHEATH LENS CLEANING SHEATH K955403 Olymous Optical Co., Ltd.
GIF-Q160Z EVIS EXERA GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE K011151 Olympus Optical Co., Ltd.
Device Description 4.
The subject device, LAPARO-THORACO VIDEOSCOPE XLTF-VAW is designed for endoscopy and endoscopic surgery within the thoracic and abdominal cavities including female reproductive organs.
The subject device has a different lens cleaning method from the predicate Olympus LAPARO THORACO VIDEOSCOPE LTF-V. For the predicate device, air and water for lens cleaning are supplied through the sbace between the endoscope's insertion and a sheath attached to it. The subject device also uses a sheath but irrigation are performed through the inner channels of the videoscope. The basic structure of the inner channel is substantially equivalent to that of the predicate device, GIF-Q160Z.
5. Indications for Use
This instrument has been designed to be used with the VISERA Video System Center OTV-S7V, light source, documentation equipment, videomonitor, endo-thrapy accessories, electrosurgical unit, and other ancillary equipment for endoscopy and endoscopic surgery within the thoracic and abdominal cavities including female reproductive organs.
6. Comparison of Technological Characteristics
The XLTF-VAW is basically identical to the predicate device in intended use, and similar in specifications except for the addition of endoscope inner channel. Comparison between the subject and predicate devices is shown in Table 1.
2
K053382 p 3/3
. . .
:
| Specifications | Subject Device
XLTF-VAW | Predicate Device
LTF-V | Predicate Device
GIF-Q160Z |
|---------------------------------------|----------------------------|---------------------------|----------------------------------|
| Field of View | 90° | 70° | 140° (WIDE)
75° (TELE) |
| Depth of Field | 15100 mm | 18100 mm | 8100 mm(WIDE)3 mm(TELE) |
1.5
| Direction of View | 0° Forward Viewing | 0° Forward Viewing | 0° Forward Viewing |
| Outer Diameter of
Distal End | $ $\phi$ 10.5 mm | $ $\phi$ 11.0 mm | $ $\phi$ 10.8 mm |
| Bending Section
Angulation UP/DOWN | 100° /100° /60° /60° | 90° /90° /90° /90° | 210° /90° /100° /100° |
| Working Length | 330 mm | 330 mm | 1,030 mm |
| Endoscope inner
channel | Provided | Not provided | Provided |
7. Conclusion
:
.
.
:
11.00
.
:
:
When compared to the predicate device, the XLTF-VAW does not incorporate any significant changes in intended use, method of operation, material, or design that could affect the safety or effectiveness of the device.
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.
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3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and tail. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA", which is arranged in a circular fashion around the left side of the logo.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
MAY 26 2006
Olympus Medical Systems Corporation c/o Ms. Laura Storms-Tyler Executive Director, Regulatory Affairs and Quality Assurance Olympus America, Inc. Two Corporate Center Drive MELVILLE NY 11747-9058
Re: K053382
Trade/Device Name: Laparo-Thoraco Videoscope, Model XLTF-VAW Regulation Number: 21 CFR §884.1720 Regulation Name: Gynecologic laparoscope and accessories Product Code: HET Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Product Code: GCJ Regulatory Class: II Dated: May 5, 2006 Received: May 9, 2006
Dear Ms. Storms-Tyler:
We have reviewed your Section 510(k) premarket notification of intent to market the device w & nove and have and have determined the device is substantially equivalent (for the indications for reservated in the enclosure) to legally marketed predicate devices marketed in interstate commerce ass suited in also environment date of the Medical Device Amendments, or to devices that provision in the Just 1770, and cordance 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket A powal), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Image /page/3/Picture/10 description: The image shows the FDA Centennial logo, which includes the years 1906-2006. Below the logo is the text "Protecting and Promoting Public Health". The logo is circular in shape and contains the letters FDA in bold. The text is written in a decorative font.
4
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); 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.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known):
K05382
Device Name: LAPARO-THORACO VIDEOSCOPE XLTF-VAW
Indications For Use:
This instrument has been designed to be used with the VISERA Video System Center OTV-S7V, light source, documentation equipment, videomonitor, endo-thrapy accessories, electrosurgical unit, and other ancillary equipment for endoscopy and endoscopic surgery within the thoracic and abdominal cavities including female reproductive organs.
Prescription Use (Part 21 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)
Daniel A. Ingram
(Division Sign-Off) Division of Reproductive, Abdomin and Radiological Dev
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510(k) Number