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Found 78 results
510(k) Data Aggregation
(250 days)
The DISPOSABLE BALLOON CATHETER B5-2Q, B7-2Q/2LA have been designed to be used with Olympus endoscopes to inject contrast medium into the biliary or pancreatic track. They can also be used for retrieval of biliary or pancreatic stones.
The Balloon Catheters are constructed of an inflatable balloon, tube, branch, injection port, air feeding port, and stopcock.
Prior to use, a sterile syringe is attached to the air feeding port and injects air into the tube to inflate the balloon to the specified volume to confirm that the balloon inflates properly. The balloon is then deflated completely, and the tube is inserted into the instrument channel of the endoscope and advanced to the target area, where the balloon is inflated to allow for biliary or pancreatic stone removal or contrast medium injection through the injection port. When the procedure is completed, the balloon is deflated and the tube is removed from the patient.
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(90 days)
The Single Use Injector NM-400/401 Series is intended to be used to perform endoscopic vascular or submucosal injection in the digestive tract with an endoscope.
The Olympus Single-Use Injector NM-400/NM-401 is a sterile, disposable injection needle designed for use with Olympus endoscopes to perform endoscopic vascular or submucosal injections in the digestive tract. The device comprises a handle section, needle section, and sheath section, and operates via a slider mechanism that extends and retracts the needle. The needle is connected to an injection port through which fluids can be delivered to targeted tissue. The NM-400/NM-401 series includes various models with needle gauges ranging from 21G to 25G and working lengths from 1650 mm to 2700 mm, accommodating different clinical needs and endoscope compatibilities. The device is constructed from biocompatible materials including stainless steel (SUS304), polypropylene (PP), and perfluoroalkoxy (PFA), and is sterilized using ethylene oxide (EtO). It is intended for single use only.
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(245 days)
The Single Use Electrosurgical Knife KD-612 Series is intended to be used to cut tissue using high-frequency current within the digestive tract in combination with an endoscope and electrosurgical units.
The Single Use Electrosurgical Knife KD-620UR is intended to be used to cut tissue using high-frequency current within the digestive tract in combination with an endoscope and electrosurgical units.
The Single Use Electrosurgical Knife KD-650 Series is intended to be used to cut tissue using high-frequency current within the digestive tract in combination with an endoscope and electrosurgical units.
The Single Use Electrosurgical Knife was designed to be used with compatible Olympus endoscopes, A-Cord (power cable), and electrosurgical units to cut tissue using high-frequency current within the digestive tract. The subject device is inserted endoscopically into the body cavity and tissue is cut by applying a high frequency current. The subject device is a sterile (EO) single use electrosurgical knife comprised of a handle and an insertion portion. The handle portion consists of the body and the slider. The insertion portion consists of the distal end with one lumen for the stainless-steel cutting knife and the sheath portion. The slider extends the cutting knife from the distal end of the sheath/tube when pushed and retracts the cutting knife into the sheath/tube when the slider is pulled.
The Single Use Electrosurgical Knife is available in three different models: KD-612, KD-620UR, and KD-650. The primary difference between the models is the tip shape of the distal end.
The subject device has the same technological characteristics and similar design as the applicable predicate device.
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(90 days)
The Electrosurgical & Ultrasonic Generator (USG-410) is intended to be used with the THUNDERBEAT Transducer, the SONICBEAT Transducer, the THUNDERBEAT or the SONICBEAT for open, laparoscopic (including single-site surgery), and endoscopic surgery to cut (dissect) or coagulate soft tissue or to ligate (seal and cut) vessels.
The Reusable Cordless Transducer (TD-410) is intended to be used for open, laparoscopic (including single-site surgery), and endoscopic surgery to cut (dissect) or coagulate soft tissue or to ligate (seal and cut) vessels.
The THUNDERBEAT II Shears with Ultrasonic Mode (TB2-0520FC, TB2-0525FC, TB2-0535FC, TB2-0545FC) are intended to be used for open, laparoscopic, and endoscopic surgery to cut, seal, coagulate, grasp, and dissect.
The THUNDERBEAT II Shears with Ultrasonic Mode are indicated for general, plastic and reconstructive, gynecologic, urologic, thoracic, and other open, laparoscopic and endoscopic procedures.
The THUNDERBEAT II Shears with Ultrasonic Mode have been designed to seal and cut vessels up to and including 7mm in diameter, tissue bundles and lymphatics using with the Seal & Cut mode or the Seal mode.
The THUNDERBEAT II shears with Ultrasonic Mode have been designed to seal and cut vessels up to and including 3mm in diameter, tissue bundles and lymphatics using with the Ultrasonic mode.
The following devices are the subject of this premarket (510(k)) submission:
• THUNDERBEAT II (Model Numbers: TB2-0545FC, TB2-0535FC, TB2-0525FC, TB2-0520FC) – Hand instruments used with an ultrasonic generator and transducer capable of sealing, cutting, grasping and dissecting vessels, tissue bundles, and lymphatic tissue up to 7mm in diameter during open, laparoscopic, and endoscopic surgical procedures. THUNDERBEAT II hand instruments are available in four (4) shaft sizes: 20cm, 25cm, 35cm, and 45cm.
• Reusable Cordless Transducer (Model Number: TD-410) – A transducer used with the THUNDERBEAT II hand instruments and ultrasonic generator to dissect and/or coagulate soft tissue, or ligate (seal and cut) soft tissue.
• Ultrasonic Bipolar Generator (Model Number: USG-410) – An ultrasonic bipolar generator used with the compatible hand instruments and transducers to dissect and/or coagulate soft tissue, or ligate (seal and cut) soft tissue. Identical and unchanged from K211838, but modified when accessory MAJ-2467 is used to upgrade USG-410 software version to allow compatibility with THUNDERBEAT II hand instruments.
- Update Tool for USG-410 (Model Number: MAJ-2467) – A function activation portable memory key accessory used to upgrade the software version of USG-410 to allow compatibility with THUNDERBEAT II hand instruments.
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(258 days)
The DISPOSABLE HOT BIOPSY FORCEPS FD-210U/FD-230U are intended to be used to collect tissue samples within the digestive tract using high-frequency current under endoscopic observation in combination with an endoscope.
The Disposable Hot Biopsy Forceps have been designed to collect tissue endoscopically within the digestive tract using high-frequency current under endoscopic observation. The Disposable Hot Biopsy Forceps consists of a handle section and insertion portion. The cups in the distal end of insertion portion are activated in the open and closed position by maneuvering the slider in the handle. The cup shapes are provided in either alligator jaw-step (FD-210U) or oval type (FD-230U).
The subject device is connected to a compatible electrosurgical device by an A-cord. The A-cord jack is connected to the plug on the handle of the subject device. The target tissue is held by the cups. The tissue is subjected to high frequency electric current transmitted from the plug which allows for collecting tissue.
The subject device has the same technological characteristics and similar design as the applicable predicate device.
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(108 days)
The EVIS EUS ULTRASOUND GASTROINTESTINAL VIDEOSCOPE OLYMPUS GF-UE190 has been designed to be used with diagnostic ultrasound system, video system center, light source, documentation equipment, monitor, endoscopic therapy accessories and other ancillary equipment.
The EVIS EUS ULTRASOUND GASTROINTESTINAL VIDEOSCOPE OLYMPUS GF-UE190 is designed for endoscopic real-time ultrasound imaging, and other endoscopic procedures within the upper gastrointestinal tract and surrounding organs.
The EVIS EUS ULTRASOUND GASTROINTESTINAL VIDEOSCOPE OLYMPUS GF-UE190 has been designed to be used with diagnostic ultrasound system, video system center, light source, documentation equipment, monitor, endoscopic therapy accessories and other ancillary equipment.
The EVIS EUS ULTRASOUND GASTROINTESTINAL VIDEOSCOPE OLYMPUS GF-UE190 is designed for endoscopic real-time ultrasound imaging, and other endoscopic procedures within the upper gastrointestinal tract and surrounding organs.
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(91 days)
The AUXILIARY WATER TUBE MAJ-855 is intended to be used to provide sterile water, detergent solution, disinfectant solution, water, and alcohol for irrigation through the auxiliary water channel of compatible endoscopes.
The Auxiliary Water Tube MAJ-855 is used in endoscopic procedures to flush sterile water through the auxiliary water channel to wash the endoscopic field of view. Sterile water for washing the mucosa can be provided either manually by use of a syringe or automatically via a flushing pump. The MAJ-855 can be used both during an endoscopic procedure and reprocessing (i.e. pre-cleaning, manual cleaning and manual disinfection).
The Auxiliary Water Tube MAJ-855 is a reusable device, provided to the user in a non-sterile condition and must be reprocessed prior to first use and following each use (i.e., after each patient exam).
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(90 days)
The SINGLE USE BIOPSY VALVE MAJ-1555 has been designed to be attached to the instrument channel port of the endoscopes and to provide access for endoscopic device passage and exchange, help maintain insufflation, minimize leakage of biomaterial from the biopsy port throughout the endoscopic procedure, and provide access for irrigation.
The Olympus Single Use Biopsy Valve MAJ-1555 is a sterile, disposable device designed to attach to the instrument channel port of Olympus endoscopes. It facilitates the passage and exchange of endoscopic devices, helps maintain insufflation, minimizes leakage of biomaterial, and prevents reflux of body fluids. The device consists of a cap and inner rubber made of silicone rubber, and a housing made of polyethylene. A lever mechanism prevents reuse after detachment.
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(178 days)
The ULTRASONIC PROBE UM-3R has been designed to be used with an Olympus endoscopic ultrasound center, a probe driving unit, other ancillary equipment and an endoscope for intraluminal ultrasonic imaging of the gastrointestinal tract, biliary tract (common bile, cystic, intrahepatic), pancreatic ducts and surrounding organs. This product is intended for use in adults.
[Modes of operation]
The Mode of Operation is B mode.
[Operator qualifications]
Appropriately trained healthcare professionals.
[Device use settings]
Professional healthcare facility (no domestic or special environments)
The ULTRASONIC PROBE UM-G20-29R has been designed to be used with an Olympus endoscopic ultrasound center, a probe driving unit, other ancillary equipment and an endoscope for intraluminal ultrasonic imaging of the gastrointestinal tract, biliary tract (common bile, cystic, intrahepatic), pancreatic ducts and surrounding organs. This product is intended for use in adults.
[Modes of operation]
The Mode of Operation is B mode.
[Operator qualifications]
Appropriately trained healthcare professionals.
[Device use settings]
Professional healthcare facility (no domestic or special environments)
The Ultrasonic Probes have been designed to be used with an Olympus Endoscopic Ultrasound Center, a Probe Driving Unit, other ancillary equipment and an endoscope for intraluminal ultrasonic imaging of the gastrointestinal tract, biliary (common bile, cystic, intrahepatic), pancreatic ducts and surrounding organs.
OLYMPUS Ultrasonic Probes UM-3R and UM-G20-29R are designed to be used in conjunction with gastrointestinal scopes, colonoscopes and duodenoscopes. The Probes are inserted into the patient through a channel of the endoscope.
The Ultrasonic Probes consist of an insertion tube and a connector section. The connector section is connected to the Probe Driving Unit and the Probe Driving Unit is connected to the Ultrasound Center.
The Ultrasonic Probe sends and receives electrical signals to and from the Ultrasound Center through the Probe Driving Unit. The Probes use a 20MHz frequency piezoelectric transducer and produce B-mode scan. They produce 360-degree mechanical/radial sonograms.
The transducer is built into the insertion tube at the tip of the Probe. The transducer is rotated by the Probe Driving Unit within the insertion tube.
The transducer converts the electrical signal to the ultrasound wave, sends it to the object, receives the reflected wave from the object and converts it to the electrical signal. The electrical signal is input to the Endoscopic Ultrasound Center and the ultrasound image is generated by the Endoscopic Ultrasound Center.
UM-3R is used with the direct contact method and the sterile de-aerated water immersion method. UM-G20-29R is used with the direct contact method only.
The Subject devices submitted for clearance each include one (1) major component: the Ultrasonic Probe, which is packaged with a Probe Holder (MH-245) and a Water-resistant Cap (MH-244).
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(60 days)
The Single Use Aspiration Needle NA-201SX-4021 is intended to be used for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree in combination with an ultrasound endoscope.
The Single Use Aspiration Needle NA-201SX-4022 is intended to be used for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree in combination with an ultrasound endoscope.
The Olympus Single Use Aspiration Needle NA-201SX-4021 and NA-201SX-4022 are designed for use with ultrasound endoscopes for ultrasound-guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree. These devices are single-use, disposable, sterile (Ethylene Oxide) needles available in two models with different specifications:
• NA-201SX-4021:
- Working Length: 700mm
- Maximum Insertion Portion Diameter: 1.9mm
- Needle Width: 21G
- Normal Needle Length: 20mm
- Maximum Needle Length: 40mm
• NA-201SX-4022:
- Working Length: 700mm
- Maximum Insertion Portion Diameter: 1.8mm
- Needle Width: 22G
- Normal Needle Length: 20mm
- Maximum Needle Length: 40mm
Both models feature an adjustable sheath length and are intended for single use.
This document is a 510(k) clearance letter for a physical medical device (Single Use Aspiration Needle), not an AI/Software-as-a-Medical-Device (SaMD). Therefore, the requested information pertaining to AI/SaMD performance evaluation criteria (such as test set size, data provenance, expert ground truth, MRMC studies, standalone performance, training set details, etc.) is not applicable and is not present in the provided document.
The document discusses the substantial equivalence of the new aspiration needles to a predicate device based on their physical and functional characteristics. The performance data section refers to bench testing of physical attributes, not computational performance or diagnostic accuracy.
Therefore, I cannot provide the requested information as it relates to AI/SaMD. I can, however, extract the acceptance criteria and reported device performance for the physical device based on the provided text.
Acceptance Criteria and Reported Device Performance (Physical Device)
This section summarizes the performance data for the Single Use Aspiration Needle (NA-201SX-4021 and NA-201SX-4022), based on the provided FDA 510(k) summary. These criteria relate to the physical and functional performance of the device, not an AI algorithm.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Test | Acceptance Criteria (Implied/Stated) | Reported Device Performance |
|---|---|---|
| Insertion performance into the endoscope | Smooth insertion and effective tissue penetration | All results met acceptance criteria for smooth insertion and effective tissue penetration |
| Piercing performance of the needle | Effective tissue penetration | All results met acceptance criteria for effective tissue penetration |
| Ultrasound visibility of the needle | Visibility of the needle under ultrasound imaging | All results met acceptance criteria for visibility of the needle under ultrasound imaging |
| Needle extraction and retraction performance | Safe and effective needle extraction and retraction | The device met all predefined criteria for safe and effective needle extraction and retraction |
| Needle aspiration performance | Successful aspiration of target material under test conditions | The device successfully aspirated target material under test conditions |
| Withdrawal performance from the endoscope | Smooth and safe withdrawal from the endoscope | The needle was withdrawn smoothly and safely from the endoscope |
| Needle slider performance | Reliable functioning for needle deployment and retraction | The slider mechanism functioned reliably for needle deployment and retraction |
| Limitation of needle depth | Effective limitation of needle extension to within specified parameters | The device effectively limited needle extension to within specified parameters |
| Needle-to-luer joint pull strength | Withstood required tensile forces without failure | The joint withstood required tensile forces without failure |
| Sheath-to-handle joint pull strength | Connection between sheath and handle remained secure under stress | The connection between sheath and handle remained secure under stress |
| Needle breakage strength | Sufficient structural integrity under load | The needle demonstrated sufficient structural integrity under load |
| Coil separation | Coil remained intact and did not separate under test conditions | The coil remained intact and did not separate under test conditions |
| Biocompatibility (various tests per ISO 10993-1) | Met acceptance criteria for cytotoxicity, sensitization, irritation, acute systemic toxicity, material-mediated pyrogenicity, hemocompatibility, and aged cytotoxicity | All tests met acceptance criteria, confirming biological safety and biocompatibility |
| Sterilization (Ethylene Oxide) | Achieved a sterility assurance level of 10⁻⁶ and met endotoxin limits | Achieved a sterility assurance level of 10⁻⁶ and met endotoxin limits |
| Shelf-life | Validated a three-year shelf life through accelerated aging and simulated distribution, with packaging integrity and product performance tests passing acceptance criteria | Validated a three-year shelf life, with all packaging integrity and product performance tests passing acceptance criteria |
Regarding the AI/SaMD specific questions:
As stated previously, the provided document is for a physical medical device (Single Use Aspiration Needle), not an AI/SaMD device. Therefore, the following information is not applicable and not provided in the source text:
- Sample size used for the test set and the data provenance: Not applicable. Performance testing was physical bench testing, not data-driven AI evaluation.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device's performance is typically established by engineering specifications and direct measurement, not expert review of AI outputs.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This applies to AI-assisted diagnostic or interpretive systems.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This applies to AI algorithms.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for a physical needle refers to its engineered specifications and expected mechanical/biological performance, verified through bench testing.
- The sample size for the training set: Not applicable. This applies to machine learning models.
- How the ground truth for the training set was established: Not applicable. This applies to machine learning models.
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