(14 days)
The EG-3830UT, Ultrasound Video Gastroscope, is intended to provide optical visualization of, ultrasonic visualization of, and therapeutic access to, the Upper Gastrointestinal Tract. The Upper Gastrointestinal Tract includes but is not restricted to, the organ; tissues; and subsystems: Esophagus, Stomach, Duodenum, Small Bowel, and underlying areas. The instrument is introduced orally when indications consistent with the requirement for the procedure are observed in Adult and pediatric patient populations.
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intra-luminal, Endoscopy.
The EG-3830UT, Ultrasound Video Gastroscope, must be used with a Pentax Video Processor (software controlled device) and must be used with an Ultrasound Diagnostic Scanner. The endoscope has a Flexible Insertion Tube, a Control Body, a PV Connector, and a Scanner Umbilical Connector. The PV Connector is connected at the Video Processor, and the Scanner Connector is connected at the Ultrasound Scanner. The Control Body includes controls for up/down/left/right angulation, air/water delivery, suction selection/control, balloon insufflation, and an accessory inlet port. The device contains light carrying bundles for illumination, video signals, air/water and suction. The instrument contains a working channel through which biopsy devices, or other devices, may be introduced (the instrument is supplied with two biopsy forceps). The endoscope contains a charge couple device (CCD) to collect image data. The CCD is focused at the body cavity and the CCD collects image data for each strobe. The Video Processor stores the CCD information until all three color strobes are completed and a full color image is computed. The endoscope light carrying bundles present the color white light that is filtered, via a Red, Green, and Blue Color Wheel, at the Lightguide Prong. The ultrasound transducer delivers ultrasonic pulses, reflections of the pulses are processed by the Ultrasound Scanner for display. The instrument is immersable (That the Endoscope operator Manual cleaning instructions).
The provided text is a 510(k) summary for the Pentax EG-3830UT Ultrasound Video Gastroscope. It describes the device, its intended use, and a comparison to predicate devices, but it does not include detailed acceptance criteria or a study proving the device meets specific performance criteria.
Instead, the submission for substantial equivalence explicitly states: "The submission for substantial equivalence was not based on an assessment of clinical performance data." This indicates that a clinical study with acceptance criteria was not performed as part of this 510(k) submission. The FDA clearance is based on its substantial equivalence to previously cleared devices (K023401, K032503, K013722), meaning its technological characteristics and intended use are similar enough that it does not raise new questions of safety or effectiveness.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth establishment, or expert adjudication, as this information is not present in the provided document.
Here's a summary of what can be extracted from the document regarding the "study" context, and why most of your questions cannot be answered:
1. Table of Acceptance Criteria and Reported Device Performance
- Not applicable. The document explicitly states that the submission for substantial equivalence was not based on clinical performance data. Therefore, no acceptance criteria for performance and no reported performance against such criteria are provided.
2. Sample size used for the test set and the data provenance
- Not applicable. No test set or clinical study was conducted for this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. No ground truth was established from a test set as no clinical study was performed.
4. Adjudication method for the test set
- Not applicable. No test set or adjudication was performed.
5. 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 device is an Ultrasound Video Gastroscope, not an AI-powered diagnostic tool. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a hardware device (gastroscope with ultrasound capabilities), not an algorithm.
7. The type of ground truth used
- Not applicable. No ground truth for performance assessment was established as no clinical performance study was conducted. The clearance is based on substantial equivalence to predicate devices, meaning their safety and effectiveness characteristics are considered similar enough.
8. The sample size for the training set
- Not applicable. This refers to machine learning models. The device is a medical instrument.
9. How the ground truth for the training set was established
- Not applicable. This refers to machine learning models. The device is a medical instrument.
Key takeaway from the document: The 510(k) clearance for the EG-3830UT Ultrasound Video Gastroscope was based on its substantial equivalence to previously cleared predicate devices, as opposed to de novo clinical performance data and acceptance criteria specifically generated for this submission.
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JUN = 9 2004
510(k )Summary EG-3830UT, Ultrasound Video Gastroscope for use with EUB-5500 Ultrasound Diagnostic Scanner
Submitter Information:
Pentax Precision Instrument Corporation (PPIC) 30 Ramland Road Orangeburg, NY, 10962 Tel: (845)-365-0700
Name of Device:
| Trade Name: | EG-3830UT, Ultrasound Video Gastroscope |
|---|---|
| Classification Name: | Diagnostic Ultrasound Transducer (74JOP) {892.1570}, |
| Endoscope and Accessories (78KOG) {876.1500} |
Predicated Device(s) Information:
| Model, Description | Manufacturer | PMN# |
|---|---|---|
| EG-3830UT, Video Ultrasound Gastroscope | PPIC | K023401 |
| EUB-5500, Ultrasound Diagnostic Scanner | Hitachi America | K032503 |
| EUB-8500, Ultrasound Diagnostic Scanner | Hitachi America | K013722 |
The EG-3830UT, Ultrasound Video Gastroscope, must be used with a Pentax Video Device Description: Device Description: Processor (software controlled device) and miss be used with at Concector, and Scanner Umbilical The endoscope has a Flexible Insettion Tube, a Connections for illuminations for illumination, video Connector. The PV E Comector comector is connected at the Ultrasound Scanner. The Control Body
signals, air/water and suction. The Scanner Connector is connected at the Ultra includes controls for up/ down/ left/ right angulation, air/water delivery, suction selection/ control, balloon includes controls for up down tell Tight angulation, and was to libration of the body cavity, a
insufflation, and an accessory inlet port. The device contains light carry an insufflation, and an accessory met por. The device commitmasound transducer to other ultrasonic charge couple device (CCD) to concel mage cand through which biopsy devices, or other devices, may be image data. The instrument collains a working chainer in organ when a lamp hat novides and introduced (the instrument is supplied with two blopsy forceps). The ACD is foossed at the PVC Connector white light that is filtered, via a Red, Green, and Dide Color and the body canty and the CCD
Lightguide Prong. The endoscope light carrying bundles present the color watil a Lightguide Prong. The endoscope light carrying buildies processor stores the CCC information until all three color collects mage data for each stroit. The Video rroossol each and other screen display information strobes are completed and a full color mage trans is computs of the display. The ultrasound transducer are formatted and prescited to the video outputs of the Video I respassed to the Ultrasound Scamer for delivers ultrasone purses, reflections of the puses are roconical cleaning accessories except for the Ultrasound display. The instrument is immersable (That the Endoscope operator Manual cleaning instructions).
Intended Use: The EG-3830UT, Ultrasound Video Gastroscope, is intended to provide optical visualization of, Intended Use: The EU-383001, Ontasburg Vitto Castronomics inal Trac. The Upper Gastrointestinal Trace. The Upper Stall ultrasonic visualization of, and metapents access to, the Oper Stomages, Stomach, Duodenum, Small I ract includes but is not resurciou to, the organs, its date, and indications consistent with the Dowel, and underlying arouse the observed in adult and pediatric patient populations.
Comparison To Predicated Device(s):
Comparison for substantial equivalence included EG-3830UT literature including specifications, the The submission of substantal equivalence memore in secessories, companson tables were identification of standard set componens, and received devices in summary. The submission for substantial equivalence was not based on an assessment of clinical performance data.
Prepared by: Paul Silva
Signature: Paul Silva
Date: 11-25-2003
Control Number: EG-3830UT.EUB-5500&8500 page 1 of 1
Revision: a
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the top half of the circle. Inside the circle is a stylized image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 9 2004
PENTAX Precision Instrument Corporation % Mr. Matthias Heinze Division Manager, Medical Division TUV Rheinland of North America 12 Commerce Road NEWTOWN CT 06470
Re: K041397
Trade Name: EUB-5500 and EUB 8500 Ultrasound Diagnostic Scanners Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasound transducer Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: 90 ITX and 78 FDS Dated: May 21, 2004 Received: May 26, 2004
Dear Mr. Heinze:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your boomers and sextined 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 merslate commore prive to that have been reclassified in accordance with the provisions of the Amendinents, of to devices and in Act (Act). You may, therefore, market the device, subject to I cacral i ood, Drag, and Coomistic he Act. The general controls provisions of the Act include the general oonly be 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 This determination of subblamar equil Ultrasound Diagnostic Scanners, as described in your premarket notification:
Transducer Model Number
EG-3830UT
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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 it may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA can be louits in the Oous of events concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised hat I Dri 3 losame or our device complies with other requirements of the Act that IDA has made a decommission administered by other Federal agencies. You must of any I cactar statuted und regulations, including, but not limited to: registration and listing (21 Comply with an the 11ct 31cc 31cquirements,01); good manufacturing practice requirements as set Cr K 1 at 807), labeling (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
This determination of substantial equivalence is granted on the condition that prior to shipping I ms device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested information, merading accused of the Center's September 30, 1997 "Information for Manufacturers m Appendix U, (encrosous) of Diagnostic Ultrasound Systems and Transducers." If the special Secking Manceling Orcurans unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.
The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:
Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850
This letter will allow you to begin marketing your device as described in your premarket I his lotter vill and in your die and al 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 r you t the Office of Compliance at (301) 594-4591. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket 4057. Also," (21 CFR Part 807.97). Other general information on your responsibilities under the nothroution of the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
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Page 3 - Mr. Heinze
If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.
Sincerely yours,
Daniel A. Legron
for
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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5 10(k) Number (if known): Device Name:
Ultrasound Video Gastroscope EG-3830UT
Endoscope Intended Use Statement:
Endoscope Intended Use Statement
The EG-3830UT, Ultrasound Video Gastroscope, is intended to provide insualization of, ultrasonic The EG-3830UT, Ultrasound Video United Castrointestinal Tract. The Upper Gastrointestinal visualization of, and therapeutic access to, the opper casues; and subsystems: Esophagus, Stomach,
Tract includes but is not restricted to, the organ; tussuss; and subsystems Tract includes but is not restricted in the organism is introduced procedured post orally when indications
Duodenum, Small Bowel, and underlying areas. The instrument is intr Duodenum, Small Bowel, and underlying areas. The instrument is into dated by the first populations.
consistent with the requirement for the procedure are observed in Adult an
Diagnostic Ultrasound Indications For Use Statement
| Carl of the first of the county of the county of the county of the county of the county of the county of the county of the county of the county of the county of the county of | |
|---|---|
| System: | EUB-5500 |
| Probe: | EG-3830UT |
| Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows ______________________________________________________________________________ |
| Clinical Application | Mode of Operation | ||||||
|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Track I & III) | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler |
| Ophthalmic | |||||||
| Fetal Imaging& Other | Fetal | ||||||
| Abdominal | |||||||
| Intra-operative (Spec.) | |||||||
| Intra-operative (Neuro.) | |||||||
| Laproscopic | |||||||
| Pediatric | |||||||
| Small Organ | |||||||
| Neonatal Cephalic | |||||||
| Adult Cephalic | |||||||
| Trans-rectal | |||||||
| Trans-vagina | |||||||
| Trans-urethral | |||||||
| Trans-esoph. (non-Card.) | |||||||
| Musculo-skel. (Convent.) | |||||||
| Musculo-skel. (Superfic.) | |||||||
| Intra-luminal | N | N | |||||
| Endoscopy | N | N | N | ||||
| Cardiac | Cardiac Adult | ||||||
| Cardiac Pediatric | |||||||
| Trans-esophageal (card.) | |||||||
| Other (spec.) | |||||||
| PeripheralVessel | Peripheral vessel | ||||||
| Other (Spec.) |
V = new application: P = previously cleared by FDA. E = added under Appendix E
(Please do not write below this line - continue on another page if needed
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Ingram
(Division Sign-Off) Division of Reproductive, and Radiological Device 510(k) Number _
Prescription Use (Per 21 CFR 801.109)
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| 510(k) Number (if known): | |
|---|---|
| Device Name: | Ultrasound Video Gastroscope EG-3830UT |
Endoscope Intended Use Statement:
· · :
Endoscope Intended Use Statement:
The EG-3830UT, Ultrasound Video Gastrosope, is intended to provide optical visualization of , ultrasonic The EG-3830UT, Ultrasound Video Gastroscope, is ille Uper Gastrointestinal Tract. The Upper Gastrointestinal visualization of, and therapeutic access to, the organ; tissues; and subsystems: Essophagus, Stomach,
Tract includes but is not restricted to, the organ; tissues; and subsyst Tract includes but is not restricted to, the organs, undersed on order of ally when indications
Duodenum, Small Bowel, and underlying areas. The instrument in Millt and earli Duodenum, Small Bowel, and underlying areas. The mstranten is instauced por 14, 2017 and in the populations.
consistent with the requirement for the procedure are observed in
Diagnostic Ultrasound Indications For Use Statement
| System: | EUB-8500 |
|---|---|
| Probe: | EG-3830UT |
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows |
| Clinical Application | Mode of Operation | ||||||
|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler |
| (Track I only) | (Track I & III) | ||||||
| Ophthalmic | |||||||
| Fetal Imaging& Other | Fetal | ||||||
| Abdominal | |||||||
| Intra-operative (Spec.) | |||||||
| Intra-operative (Neuro.) | |||||||
| Laproscopic | |||||||
| Pediatric | |||||||
| Small Organ | |||||||
| Neonatal Cephalic | |||||||
| Adult Cephalic | |||||||
| Trans-rectal | |||||||
| Trans-vagina | |||||||
| Trans-urethral | |||||||
| Trans-esoph. (non-Card.) | |||||||
| Musculo-skel. (Convent.) | |||||||
| Musculo-skel. (Superfic.) | |||||||
| Intra-luminal | N | N | |||||
| Endoscopy | N | N | N | ||||
| Cardiac | Cardiac Adult | ||||||
| Cardiac Pediatric | |||||||
| Trans-esophageal (card.) | |||||||
| Other (spec.) | |||||||
| PeripheralVessel | Peripheral vessel | ||||||
| Other (Spec.) |
V = new application: P = previously cleared by FDA: E = added under Appendix E > = pleviously cicared by I Drin line - continue on another page if needed
(Please do not write below this line - continue on another page if necessary)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Lyman
(Division Sign-Off) Division of Reproductive, Abd and Radiological Device 510(k) Number ________________________________________________________________________________________________________________________________________________________________
Prescription Use (Per 21 CFR 801.109)
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.