(22 days)
Endoscopic real-time ultrasonic imaging, ultrasound guided needle aspiration and other endoscopic procedures as follows:
Clinical Application: Trans-esoph. (non-Card.), Other (spec.)
Mode of Operation: B, M, Combined (Spec.) B+M, Other (Spec.) Note 1
Note 1: Other includes Color Power Doppler, combined B and Color Power Doppler, combined B and PowerMap™ Directional Color Power Doppler, and imaging for guidance of biopsy.
Note 2: Specification for "Other" (1) the airways and tracheobronchial tree.
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application: Trans-esoph. (non-Card.), Other (spec.)
Mode of Operation: B, M, Combined (Spec.) B+M, Other (Spec.) Note 1
Note 1: Other includes Color Power Doppler, combined B and Color Power Doppler, combined B and PowerMap™ Directional Color Power Doppler, and imaging for guidance of biopsy.
Note 2: Specification for "Other" (1) the airways and tracheobronchial tree.
Not Found
This document is a 510(k) summary for the OLYMPUS BF type UC160F-OL8 EVS EXERA Ultrasonic Bronchofibervideoscope.
The provided document describes the intended use and clinical applications of the device, which are limited to Diagnostic Ultrasound Indications for Use.
However, it does not contain information about acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, or comparative effectiveness studies (MRMC or standalone).
Therefore, I cannot provide the requested information based on the provided text. The document is primarily a regulatory submission outlining the device's classification and intended uses for substantial equivalence to a predicate device, not a performance study report.
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K 060475
January 25. 2006
SMDA 510(k) SUMMARY
EVIS EXERA Ultrasonic Bronchofibervideoscope, OYMPUS BF type UC160F-OL8
A. GENERAL INFORMATION
| 1. Applicant: | OLYMPUS MEDICAL SYSTEMS CORP.2851 Ishikawa-cho, Hachioji-shi, Tokyo, Japan, 192-8507Registration No.: 8010047 |
|---|---|
| 2. Official Correspondent: | Laura Storms-TylerExecutive Director, Regulatory Affair and Quality AssuranceOlympus America IncTwo Corporate Center Drive,Melville, NY, 11747-9058, USATEL: 631-844-5688FAX: 631-844-5554E-mail:Laura.storms-tyler@olympus.comRegistration No.: 2429304 |
| 3. Manufacturer : | OLYMPUS MEDICAL SYSTEMS CORP.34-3 Hirai, Hinode-machi, Nishitama-gun, Tokyo,Japan, 190-0182,Registration No.:3003637092 |
B. DEVICE IDENTIFICATION
| 1. Device Name: | EVIS EXERA Bronchofibervideoscope, OLYMPUSBF type UC160F-OL8 |
|---|---|
| 2. Common Name: | Bronchoscope |
| 3. Regulation No.: | 21 CFR 876.1500 / 892.1570 |
| 4. Regulation Name: | Bronchoscope (flexible or rigid) and its accessories |
| 5. Regulatory Class: | II |
| 6. Product Code: | KOG / ITX |
| 7. Classification Panel: | Endoscope and accessories /Diagnostic Ultrasound Transducer |
| 8. Prescription Status: | Prescription Device |
| 9. Performance Standard: | None established under Section 514 of FDA forBronchoscope |
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Image /page/1/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three wavy lines converging to form a bird-like shape. The seal is rendered in black and white, with the text and emblem appearing in black against a white background.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 7 2006
Olympus Corporation % Mr. Neil E. Devine, Jr. Responsible Third Party Official Intertek Testing Services NA, Inc. 2307 East Aurora Road, Unit B7 TWINSBURG OH 44087
Re: K060475
Trade Name: EVIS EXERA Ultrasonic Bronchofibervideoscope OLYMPUS BF TYPE UC160F-OL8, Olympus EU-C60 EUS EXERA Compact Endoscopic Ultrasound Center Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: KOG and ITX Dated: February 22, 2006 Received: February 23, 2006
Dear Mr. Devine:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we 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). 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.
This determination of substantial equivalence applies to the following transducers intended for use with the Olympus BF-UC160F-OL8, as described in your premarket notification:
Transducer Model Number
Olympus BF-UC160F-OL8
Image /page/1/Picture/13 description: The image shows a circular logo with the text "1906-2006 FDA Centennial" inside. The logo features the FDA acronym in a stylized font. The word "Centennial" is written below the acronym. The logo is surrounded by a circular border with additional text, though the text is not legible.
Promoting Public Health
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If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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.
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 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 market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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
If you have any questions regarding the content of this letter, please contact Robert A. Phillips, Ph.D. at (301) 594-1212.
Sincerely yours,
Nancy C. Burgdor
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
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EVIS EXERA Ultrasonic Bronchofibervideoscope OLYMPUS BF type UC160F-OL8 Diagnostic Ultrasound Indications for Use Form
Endoscopic real-time ultrasonic imaging, ultrasound guided needle aspiration and other Intended Use: endoscopic procedures as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler | Combined(Spec.) | Other(Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging& Other | Fetal | |||||||
| Abdominal | ||||||||
| Intra-operative (Abdominalorgans and vascular) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (breast,thyroid, testicles.) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | N | N | B+M | Note 1 | ||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Other(spec.) | N | N | B+M | Note 1 | ||||
| (Note 2) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| PeripheralVessel | Peripheral vessel | |||||||
| Other (spec.) |
N = new indication
Additional Comments:
- Other includes Color Power Doppler, combined B and Color Power Doppler, combined B and Note 1: PowerMap™ Directional Color Power Doppler, and imaging for guidance of biopsy.
- Specification for "Other" Note 2:
(1) the airways and tracheobronchial tree.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801 Subpart D)
Nancy C. Davidson
(Division Sign-Off Division of Reproductive, Abdomin and Radiological Devices 510(k) Number _
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OLYMPUS EU-C60 EUS EXERA Compact Endoscopic Ultrasound Center Diagnostic Ultrasound Indications for Use Form
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler | Combined(Spec.) | Other(Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging& Other | Fetal | |||||||
| Abdominal | ||||||||
| Intra-operative (Abdominalorgans and vascular) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (breast,thyroid, testicles.) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | N | N | B+M | Note 1 | ||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Other (spec.)(Note 2) | N | N | B+M | Note 1 | ||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| PeripheralVessel | Peripheral vessel | |||||||
| Other (spec.) |
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use:
N = new indication
Additional Comments:
- Other includes Color Power Doppler, combined B and Color Power Doppler, combined B and Note 1: PowerMap™ Directional Color Power Doppler, and imaging for guidance of biopsy.
- Specification for "Other" Note 2:
- (1) the airways and tracheobronchial tree.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801 Subpart D)
Nancy C. Braaten
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K060475
§ 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.