XBO1-824-18/19/20 BIOPSY FORCEPS

K012074 · The Olympus Optical Co. · OCZ · Sep 25, 2001 · Gastroenterology, Urology

Device Facts

• Record ID: K012074
• Device Name: XBO1-824-18/19/20 BIOPSY FORCEPS
• Applicant: The Olympus Optical Co.
• Product Code: OCZ · Gastroenterology, Urology
• Decision Date: Sep 25, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Indications for Use

Olympus BIOPSY FORCEPS has been designed to be used with an Olympus endoscope to collect tissue samples within the upper and lower digestive tract and to extract the tissue samples though the biopsy forceps with suction.

Device Story

Biopsy forceps used with endoscopes for tissue collection in upper/lower digestive tract; enables collection of up to 5 samples sequentially. Device utilizes water injection to move tissue into a specimen trap; suction applied via suction tube to extract samples through aspiration lumen. Specimen trap features five serial filters; individual filters holding specimens are snapped off for retrieval. Used in clinical settings by physicians; facilitates diagnostic tissue sampling; benefits patient by allowing multiple biopsies during single endoscopic procedure.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Mechanical biopsy forceps with integrated suction tube and multi-filter specimen trap. Components include biopsy forceps, suction tube, and specimen trap with five serial filters. Manual operation via endoscope channel. No electronic or software components.

Indications for Use

Indicated for use with an Olympus endoscope to collect tissue samples from the upper and lower digestive tract in patients requiring biopsy.

Regulatory Classification

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.

Special Controls

*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.

In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls: 1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following: 1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures. 2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use. 3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use. 2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes. 3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches 4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error. 5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program. (6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms. (7) Labeling must include: (i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified; (ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA; (iii) Identification of compatible devices; (iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification; (v) Reprocessing instructions for reusable components; (vi) A shelf life for any sterile components; (vii) A description of the device-specific use training program; (viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and (ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance. (8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include: (i) Device motion accuracy and repeatability; (ii) System testing; (iii) Instrument reliability; (iv) Crosstalk; (v) Table motion control; (vi) Thermal effects on tissue; (vii) User-device interface performance; (viii) Workspace access testing; and (ix) Performance testing with compatible devices. (9) Software verification, validation, and hazard analysis must be performed. (10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed. (11) Performance data must demonstrate the sterility of all patient-contacting device components. (12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life. (13) Performance data must validate the reprocessing instructions for the reusable components of the device. (14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible. (15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic. (16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information: (i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and (ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.

Predicate Devices

• Multiple Biopsy Device MBx (K911448)
• FB Series Biopsy Forceps (K955065)

Submission Summary (Full Text)

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Public Health Service

Re:

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Olympus America, Inc. Laura Storms-Tyler Director, Regulatory Affairs Two Corporate Center Drive Melville, NY 11747-3157

.JUL 2 7 2015

K012074 Trade/Device Name: XBO1-824-18/19/20 Biopsy Forceps Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: OCZ, FCF, FCF, FCT Dated (Date on orig SE ltr): June 29, 2001 Received (Date on orig SE Itr): July 2, 2001

Dear Ms. Storms-Tyler,

This letter corrects our substantially equivalent letter of September 25, 2001.

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

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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); 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 contact 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/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

# Benjamin R. Fisher -S

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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K012074

510(k) Number (if known):

Device Name: BIOPSY FORCEPS

Indications for Use:

Olympus BIOPSY FORCEPS has been designed to be used with an Olympus endoscope to collect tissue samples within the upper and lower digestive tract and to extract the tissue samples though the biopsy forceps with suction.

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K012074

Nancy brogdon
Concurrence of CDRH, Office of Device Evaluation ODE

OR

**Prescription Use**
(Per 21 CFR 876.4400)

Over-The-Counter Use

(Optional Format 1-2-96)

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SEP 2 5 2001

K012074-

510(k) SUMMARY

## XB01-1-824-18/19/20 Biopsy Forceps

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR, Section807.92.

#### A. Submitter's Name, Address, Phone and Fax Number

#### 1. Manufacturer of the subject device

.

| Name & Address of Manufacturer; | Olympus Optical Co,. Ltd.<br>2-3-1 Shinjuku Monolis Nishi-shinjuku<br>Shinjuku-ku, Tokyo, 163-0914<br>Japan |
|--------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| Registration No : | 8010047 |
| Address, Phone and Fax Number<br>of R&D Department<br>Endoscope Division | 2951 Ishikawa-cho<br>Hachioji-shi, Tokyo 192-8507<br>Japan<br>TEL [phone]<br>FAX [phone] |
| 2. Name of Contact Person | |
| Name : | Ms.Laura Storms-Tyler<br>Director, Regulatory Affairs<br>Olympus America Inc. |

Address, Phone and Fax :

**Address, Phone and Fax :**

### B. Device Name, Common Name

- 1. Device Name :
- 2. Common/Usual Name :
- 3. Classification Name :

XBO1-824-18/19/20 Biopsy Forceps

TEL [phone] FAX [phone]

Two Corporate Center Drive Melville, NY 11747-3157

Biopsy Forceps

21CFR 876.1075 21CFR 876.1500

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K012074
pg 2087

#### C. Predicate Devices:

| Model | Device Description &<br>510(k)#/ Date Cleared | Manufacturer |
|----------------------------|-----------------------------------------------|----------------------|
| Multiple Biopsy Device MBx | #K911448<br>04/16/1991 | Triton Technology |
| FB Series Biopsy Forceps | #K955065<br>01/24/1996 | Olympus Optical Co., |

#### D. Description of the Device

This instrument has been designed to be used with an Olympus endoscope to collect tissue within the upper and lower digestive tract and to extract the tissue sample through the biopsy forceps with suction.

The Olympus Biopsy Forceps XBO1-824-18/19/20 are composed with three major components as follows:

- 1. Biopsv Forceps (XBO1-824-18/19/20)
The mechanism of subject device for collecting blopsied tissue is that biopsled tissue is caught onto Specimen trap by injected water through the biopsy forceps and it is possible to collect 5 samples continually.

- 2. Suction Tube (XBO1-824-18C)
This device is for connecting the thumb ring valve to the suction source.

#### 3. Specimen Trap (XBO1-824-18D)

The Specimen Trap has a fitter for the specimen to be aspirated through the Aspiration Lumen, which can be attached onto the proximal section of the Biopsy Forceps. The Specimen Trap is comprised with five independent filters, which are arrayed serially. After it catches the specimen, the filter that holds the specimen, is extruded from the proximal handle of the Biopsy Forceps, and snapped off into an individual section. To avoid unexpected breakage of the Trap, the Trap Support guides the sections of the Traps. When the section of the Specimen Trap is inserted into the proximal handle, it will make a "click" sound, and the first Trap will be centered at the axis of the Aspiration automatically.

#### E. Intended Use of the device

This instrument has been designed to be used with an Olympus endoscope to collect tissue within the digestive tract and to extract the tissue sample through the biopsy forceps with suction.

#### F. Reason for not requiring clinical data

Compared to the predicate devices, "Biopsy Forceps XBO1-824-18/19/20" does not incorporate any significant changes in intended use, methods of operations, materials, or design that could affect the safety and effectiveness.