(85 days)
No
The device description focuses on mechanical components for tissue collection and suction, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is described as collecting tissue samples for diagnostic purposes rather than providing direct therapy.
No
This device is designed to collect tissue samples, which are then used for diagnostic purposes. The device itself performs the sampling, not the diagnosis.
No
The device description clearly outlines multiple physical components (Biopsy Forceps, Suction Tube, Specimen Trap) and their mechanical functions for collecting tissue samples. There is no mention of software as a component or the primary function of the device.
Based on the provided information, the Olympus BIOPSY FORCEPS is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens taken from the human body in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This typically involves tests performed on blood, urine, tissue samples, etc., in a laboratory setting.
- The Olympus BIOPSY FORCEPS is a surgical instrument used in vivo (within the body) to collect tissue samples. Its primary function is the physical act of obtaining the sample from the patient's digestive tract.
- The description focuses on the mechanical aspects of tissue collection and extraction. It describes the forceps, suction tube, and specimen trap, all of which are involved in the process of acquiring the sample from the patient.
- There is no mention of any analysis or testing of the collected tissue sample by the device itself. The device's role ends once the tissue is collected and contained in the specimen trap. The subsequent analysis of the tissue would be performed separately, likely in a laboratory, using IVD devices or other diagnostic methods.
In summary, the Olympus BIOPSY FORCEPS is a tool for obtaining a biological sample, not a device that performs diagnostic testing on that sample.
N/A
Intended Use / 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.
Product codes
OCZ, FCF, FCF, FCT
Device Description
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:
-
- 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.
- Biopsv Forceps (XBO1-824-18/19/20)
-
- Suction Tube (XBO1-824-18C)
This device is for connecting the thumb ring valve to the suction source.
- Suction Tube (XBO1-824-18C)
-
- 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper and lower digestive tract, digestive tract
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
Not Found
Key Metrics
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
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
1
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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
2
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)
3
SEP 2 5 2001
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.
2-3-1 Shinjuku Monolis Nishi-shinjuku
Shinjuku-ku, Tokyo, 163-0914
Japan |
|--------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| Registration No : | 8010047 |
| Address, Phone and Fax Number
of R&D Department
Endoscope Division | 2951 Ishikawa-cho
Hachioji-shi, Tokyo 192-8507
Japan
TEL 81-426-42-5177
FAX 81-426-46-5613 |
| 2. Name of Contact Person | |
| Name : | Ms.Laura Storms-Tyler
Director, Regulatory Affairs
Olympus America Inc. |
Address, Phone and Fax :
Address, Phone and Fax :
B. Device Name, Common Name
-
- Device Name :
-
- Common/Usual Name :
-
- Classification Name :
XBO1-824-18/19/20 Biopsy Forceps
TEL (631)844-5688 FAX (631) 844-5416
Two Corporate Center Drive Melville, NY 11747-3157
Biopsy Forceps
21CFR 876.1075 21CFR 876.1500
4
K012074
pg 2087
C. Predicate Devices:
| Model | Device Description &
510(k)#/ Date Cleared | Manufacturer |
|----------------------------|-----------------------------------------------|----------------------|
| Multiple Biopsy Device MBx | #K911448
04/16/1991 | Triton Technology |
| FB Series Biopsy Forceps | #K955065
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:
-
- 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.
- Biopsv Forceps (XBO1-824-18/19/20)
-
- Suction Tube (XBO1-824-18C)
This device is for connecting the thumb ring valve to the suction source.
- Suction Tube (XBO1-824-18C)
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.