(58 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Trans-rectal
Trans-urethral
Trans-esoph. (non-Card.)
Gastrointestinal tract, biliary, pancreatic duct and surrounding organs.
Intraluminal ultrasound for upper airways and tracheobronchial tree
3-D Imaging
The combination of the XEU-M60A Endoscopic Ultrasound Center, UM-2R/3R Ultrasonic Probes, UM-DP12/20-25R Ultrasonic Probes, GF-UM130 Ultrasonic Gastrovideoscope, GF-UM160 Ultrasonic Gastrovideoscope, XGF-UM180 Ultrasonic Gastrovideoscope, GF-UE160-AL5 Uftrasonic Gastrovideoscope, GF-UC140P-AL5 Ultrasonic Gastrovideoscope, and GF-UCT140-AL5 Ultrasonic Gastrovideoscope enables the acquisition and display of high-resolution and high-penetration, real-time ultrasound B-mode endoscopic images,
This is a premarket notification (510(k)) for the Olympus XEU-M60A Endoscopic Ultrasound Center and associated ultrasonic probes and gastrovideoscopes. A 510(k) submission primarily demonstrates substantial equivalence to a legally marketed predicate device rather than conducting a full clinical study to establish new acceptance criteria. Therefore, the document does not contain acceptance criteria or study results in the typical sense of a de novo clinical trial for a novel device.
The submission focuses on comparing the new device's technical characteristics and intended use to existing, cleared devices.
Here's an analysis of the provided text in the context of your request:
1. A table of acceptance criteria and the reported device performance
The provided document, a 510(k) submission, does not specify explicit acceptance criteria (e.g., minimum sensitivity, specificity, accuracy) for device performance or present a table of such criteria against reported performance. This type of information is typically reserved for clinical trials designed to prove safety and effectiveness for novel devices, or for performance studies of AI/ML-enabled devices that introduce new diagnostic capabilities.
For a 510(k) submission, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to predicate devices. The performance is assessed by confirming that the new device operates similarly and performs as expected for its intended use, aligning with the performance of the predicate devices. The document implies that the device works by stating: "The XEU-M60A Endoscopic Ultrasound Center operates identically to the predicate devices in that piezoelectric material in the transducer is used as an ultrasound source to transmit sound waves into the body. Sound waves are reflected back to the transducer and converted to electrical signals that are processed and displayed as images. Doppler shift caused by blood flow is displayed as Color Flow, or as spectrum analysis."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not describe a clinical test set with a specific sample size, data provenance, or retrospective/prospective design. This information is generally found in clinical performance studies, which are not typically part of a 510(k) that relies on substantial equivalence for an established technology.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Since there is no described clinical test set, there is no mention of experts used to establish ground truth or their qualifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
As there is no described clinical test set, there is no information on an adjudication method.
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
The document does not describe an MRMC comparative effectiveness study. This device is a diagnostic ultrasound system and associated components, not an AI/ML-enabled device, and therefore this type of study showing human readers' improvement with AI assistance would not be applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to the performance of an algorithm without human intervention, which is relevant for AI/ML devices. The XEU-M60A is a diagnostic ultrasound system, not an AI/ML algorithm, so a "standalone algorithm" performance study is not applicable or discussed. The device's performance is inherently tied to human operation and interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
As there is no described clinical test set, there is no information on the type of ground truth used. The submission relies on the established performance of the predicate devices.
8. The sample size for the training set
The document does not refer to a training set. This is typically applicable for AI/ML devices, where a model is trained on a specific dataset. This device is a traditional diagnostic ultrasound system.
9. How the ground truth for the training set was established
As there is no described training set, there is no information on how its ground truth would have been established.
Summary of what the document implies about meeting acceptance criteria:
The "acceptance criteria" in the context of this 510(k) submission are met by demonstrating that the Olympus XEU-M60A Endoscopic Ultrasound Center and its associated ultrasonic probes and gastrovideoscopes are substantially equivalent to legally marketed predicate devices.
Study/Evidence that proves the device meets the acceptance criteria (Substantial Equivalence):
The document explicitly states:
- Identical Mode of Operation: "The XEU-M60A Endoscopic Ultrasound Center operates identically to the predicate devices in that piezoelectric material in the transducer is used as an ultrasound source to transmit sound waves into the body."
- Identical Technological Characteristics: "Technological Characteristics of this device is identical to the predicate devices identified in item 3."
- Predicate Device Comparison: The submission includes a table of predicate devices for comparison (listed in Section 3, titled "Predicate Device Information"). For both the Ultrasound System and Ultrasonic Gastrovideoscopes and Probes, specific predicate devices with control numbers (K-numbers) are cited.
- XEU-M60A Endoscopic Ultrasound Center is compared to EU-M60 (K043275) and EU-C60 (K010591).
- Various Ultrasonic Probes and Gastrovideoscopes (UM-2R/3R, UM-DP12/20-25R, GF-UM130, GF-UM160, XGF-UM180, GF-UE160-AL5, GF-UC140P-AL5, GF-UCT140-AL5) are compared to their respective previously cleared versions, often citing multiple K-numbers. For some, like UM-DP12/20-25R, it's mentioned that Olympus determined no new 510(k) was required for device changes based on earlier clearances.
- Indications for Use: The document outlines the intended uses (e.g., Transrectal, Transurethral, Transesophageal, Gastrointestinal tract, biliary, pancreatic duct and surrounding organs, Intraluminal ultrasound for upper airways and tracheobronchial tree, 3-D Imaging) in sections 4.3.1 through 4.3.9, noting which are "new indications" (N) but implying they fall within the scope of predicate devices or generally accepted ultrasound diagnostic capabilities. The new indications appear to be for specific anatomical sites (e.g., Trans-rectal, Trans-urethral, Trans-esoph. (non-Card.) and "Other" (e.g., Gastrointestinal tract, biliary, pancreatic duct and surrounding organs. Intraluminal ultrasound for upper airways and tracheobronchial tree), and 3-D Imaging capabilities.
In essence, the "study" demonstrating the device meets "acceptance criteria" here is the analysis of substantial equivalence conducted by Olympus and reviewed by the FDA, concluding that the new device has the same technological characteristics and intended use, or minor differences that do not raise new questions of safety or effectiveness, as its predicates. No independent clinical performance study data would typically be presented in such a 510(k) unless a new indication or technology significantly deviated from predicates.
{0}------------------------------------------------
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Olympus Medical Systems Corporation % Ms. Laura Storms-Tyler Olympus America, Inc. 3500 Corporate Parkway, PO Box 610 Center Valley, PA 18034-0610
JUL 2 7 2015
Re: K063683
Trade/Device Name: XEU-M60A Endoscopic Ultrasound Center Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX and ODG Dated (Date on orig SE ltr): December 5, 2006 Received (Date on orig SE ltr): December 14, 2006
Dear Ms. Storms-Tyler,
This letter corrects our substantially equivalent letter of February 8, 2007.
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}------------------------------------------------
Page 2 -
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 (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.
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/ReportalProblem/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
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4.3.1 DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM
XEU-M60A ENDOSCOPIC ULTRASOUND CENTER
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(Tracks I & III) | B | M | PWD | CWD | ColorDoppler | Combined(Spec.) | Other(Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | ||||||||
| Intra-operative (specify) | ||||||||
| Intraoperative (Neuro.) | ||||||||
| Fetal Imaging& Other | Laparoscopic | |||||||
| Pediatric | ||||||||
| Small Organ (specify) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | N | N | Note 2 | |||||
| Trans-vaginal | ||||||||
| Trans-urethral | N | N | Note 2 | |||||
| Trans-esoph. (non-Card.) | N | N | Note 2 | |||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Other (spec.) (Note 1) | N | N | Note 2. | |||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| PeripheralVessel | Peripheral vessel | |||||||
| Other (spec.) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
Note 1: Specification for "Other" :
Gastrointestinal tract, biliary, pancreatic duct and surrounding organs. Intraluminal ultrasound for upper airways and tracheobronchial tree
Note 2: 3-D Imaging
David A. Simpson
(Division Sign-Off) Division of Reproductive, Abdo and Radiological Devices 510(k) Number
Prescription Use (Per 21 CFR 801.109)
{3}------------------------------------------------
4.3.2 DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM
UM-2R / 3R ULTRASONIC PROBES
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(Tracks I & III) | B | M | PWD | CWD | ColorDoppler | Combined(Spec.) | Other(Spec.) | ||
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intra-operative (specify) | ||||||||||
| Intraoperative (Neuro.) | ||||||||||
| Fetal Imaging& Other | Laparoscopic | |||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Trans-rectal | N | |||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | N | |||||||||
| Trans-esoph. (non-Card.) | N | |||||||||
| Musculo-skel. (Convent.) | ||||||||||
| Musculo-skel. (Superfic.) | ||||||||||
| Other (spec.) (Note 1) | N | |||||||||
| Cardiac Adult | ||||||||||
| Cardiac | Cardiac Pediatric | |||||||||
| Trans-esophageal (card.) | ||||||||||
| Other (spec.). | ||||||||||
| PeripheralVessel | Peripheral vessel | |||||||||
| Other (spec.) |
N= new indication; P= previously cleared by FDA ; E= added under Appendix E
Additional Comments:
.
Note 1: Specification for "Other" :
Gastrointestinal tract, billiary, pancreatic duct and surrounding organs. Intraluminal ultrasound for upper airways and tracheobronchial tree
Dennis K. Ingram
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number __
Prescription Use (Per 21 CFR 801 109)
{4}------------------------------------------------
4.3.3 DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM
UM-DP12/20-25R ULTRASONIC PROBES
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(Tracks I & III) | B | M | PWD | CWD | ColorDoppler | Combined(Spec.) | Other(Spec.) | ||
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intra-operative (specify) | ||||||||||
| Intraoperative (Neuro.) | ||||||||||
| Fetal Imaging.& Other | Laparoscopic | |||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Trans-rectal | N | |||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | N | |||||||||
| Trans-esoph. (non-Card.) | N | |||||||||
| Musculo-skel. (Convent.) | ||||||||||
| Musculo-skel. (Superfic.) | ||||||||||
| Other (spec.) (Note 1) | N | |||||||||
| Cardiac Adult | ||||||||||
| Cardiac | Cardiac Pediatric | |||||||||
| Trans-esophageal (card.) | ||||||||||
| Other (spec.) | ||||||||||
| Peripheral | Peripheral vessel | |||||||||
| Vessel | Other (spec.) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
Note 1: Specification for "Other" :
Gastrointestinal tract, billary, pancreatic duct and surrounding organs. Intraluminal ultrasound for upper airways and tracheobronchial tree
David B. Leggison
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number __
Prescription Use (Per 21 CFR 801.109) -
. .
{5}------------------------------------------------
4.3.4 DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM
ULTRASONIC GASTROVIDEOSCOPE GF TYPE UM130
| 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 | FetalAbdominalIntra-operative (specify)Intraoperative (Neuro.)LaparoscopicPediatricSmall Organ (specify)Neonatal CephalicAdult CephalicTrans-rectalTrans-vaginalTrans-urethralTrans-esoph. (non-Card.)Musculo-skel. (Convent.)Musculo-skel. (Superfic.)Other (spec.) (Note 1) | N | ||||||||
| Cardiac | Cardiac AdultCardiac PediatricTrans-esophageal (card.)Other (spec.) | N | ||||||||
| PeripheralVessel | Peripheral vesselOther (spec.) |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
Note1: Specification for "Other"
Gastrointestinal tract, biliary, pancreatic duct and surrounding organs.
Daniela Segmen
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
Prescription Use (Per 21 CFR 801, 109)
.
{6}------------------------------------------------
4.3.5 DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM
EUS EXERA ULTRASONIC GASTROVIDEOSCOPE OLYMPUS GF TYPE UM160
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(Tracks I & III) | B | M | PWD | CWD | ColorDoppler | Combined(Spec.) | Other(Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging& Other | Fetal | |||||||
| Abdominal | ||||||||
| Intra-operative (specify) | ||||||||
| Intraoperative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (specify) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | N | |||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Other (spec.) (Note 1) | N | |||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| PeripheralVessel | Peripheral vessel | |||||||
| Other (spec.) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
Note 1: Specification for "Other"
Gastrointestinal tract, biliary, pancreatic duct and surrounding organs.
Daniel R. Seymore
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number_
Prescription Use (Per 21 CFR 801.109)
{7}------------------------------------------------
4.3.6 DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM
ULTRASONIC GASTROVIDEOSCOPE OLYMPUS XGF TYPE UM180
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(Tracks I & III) | B | M | PWD | CWD | ColorDoppler | Combined(Spec.) | Other(Spec.) | ||
| Ophthalmic | Ophthalmic | |||||||||
| Fetal Imaging& Other | Fetal | |||||||||
| Abdominal | ||||||||||
| Intra-operative (specify) | ||||||||||
| Intraoperative (Neuro.) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card.) | N | |||||||||
| Musculo-skel. (Convent.) | ||||||||||
| Musculo-skel. (Superfic.) | ||||||||||
| Other (spec.) (Note 1) | N | |||||||||
| Cardiac | Cardiac Adult | |||||||||
| Cardiac Pediatric | ||||||||||
| Trans-esophageal (card.) | ||||||||||
| Other (spec.) | ||||||||||
| PeripheralVessel | Peripheral vessel | |||||||||
| Other (spec.) |
N= new Indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
Note 1: Specification for "Other"
Gastrointestinal tract, biliary, pancreatic duct and surrounding organs.
David h. Segner
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _
Prescription Use (Per 21 CFR 801.109)
{8}------------------------------------------------
4.3.7 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 | |||||||||
| Abdominal | |||||||||
| Intra-operative (specify) | |||||||||
| Intraoperative (Neuro.) | |||||||||
| Fetal Imaging& Other | Laparoscopic | ||||||||
| Pediatric | |||||||||
| Small Organ (specify) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | N | N | |||||||
| Musculo-skel. (Convent.) | |||||||||
| Musculo-skel. (Superfic.) | |||||||||
| Other (spec.) (Note 1). | N | N | |||||||
| Cardiac Adult | |||||||||
| Cardiac | Cardiac Pediatric | ||||||||
| Trans-esophageal (card.) | |||||||||
| Other (spec.) (Note 1) | |||||||||
| PeripheralVessel | Peripheral vessel | ||||||||
| Other (spec.) |
GF-UE160-AL5 ULTRASONIC GASTROVIDEOSCOPE
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N= new Indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
Note 1: Specification for "Other"
Gastrointestinal tract, biliary, pancreatic duct and surrounding organs.
David h. Segerson
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
Prescription Use (Per 21 CFR 801.109)
{9}------------------------------------------------
4.3.9 DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM
GF-UCT140-AL5 ULTRASONIC GASTROVIDEOSCOPE
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(Tracks I & III) | B | M | PWD | CWD | ColorDoppler | Combined(Spec.) | Other(Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging& Other | Fetal | |||||||
| Abdominal | ||||||||
| Intra-operative (specify) | ||||||||
| Intraoperative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (specify) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | N | N | ||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Other (spec.) (Note 1) | N | N | ||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| PeripheralVessel | Peripheral vessel | |||||||
| Other (spec.) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
Note1: Specification for "Other"
mana ana mana mana mana mananta na mana d
Gastrointestinal tract, billiary, pancreatic duct and surrounding organs.
Gerral H. Leggott
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices ്ച് 1 | 14:1 Pumber .........................................................................................................................................................
Prescription Use (Per 21 CFR 801 109)
{10}------------------------------------------------
4.3.8 DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM
GF-UC140P-AL5 ULTRASONIC GASTROVIDEOSCOPE
Intended Use: Diagnostic utrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PWD | CWD | ColorDoppler | Combined(Spec.) | Other(Spec.) |
| (Track I only) | (Tracks I & II) | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | ||||||||
| Intra-operative (specify) | ||||||||
| Intraoperative (Neuro.) | ||||||||
| Fetal Imaging& Other | Laparoscopic | |||||||
| Pediatric | ||||||||
| Small Organ (specify) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | N | N | ||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Other (spec.) (Note 1) | N | N | ||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| PeripheralVessel | Peripheral vessel | |||||||
| Other (spec.) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
Note1: Specification for "Other"
Gastrointestinal tract, biliary, pancreatic duct and surrounding organs.
David A. Seppon
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________ 11
Prescription Use (Per 21 CFR 801.109)
. .
{11}------------------------------------------------
11063683
510(k) SUMMARY
8 2007 FEB
December X, 2006
ﮩ General information
- 트 Applicant:
OLYMPUS MEDICAL SYSTEMS CORP. 2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan 192-8507
Establishment Registration No: 8010047
- 를 Official Correspondent:
Laura Storms-Tyler Executive Director Regulatory Affairs & Quality Assurance Olympus America Inc. 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610, USA Phone: 484-896-5688 FAX: 484-896-7128 Email:Laura.storms-tyler@olympus.com Establishment Registration No: 2429304
Manufacturer: 트
OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT 34-3 Hirai Hinode-Machi, Nishitama-gun, Tokyo Japan, 190-0182 Establishment Registration No:8010047
2 Device Identification
- Device Trade Name:
| Model Name | Device Name |
|---|---|
| XEU-M60A | ENDOSCOPIC ULTRASOUND CENTER |
| UM-2R/3R | ULTRASONIC PROBES |
| UM-DP12/20-25R | ULTRASONIC PROBES |
| GF-UM130 | ULTRASONIC GASTROVIDEOSCOPE |
| GF-UM160 | EUS EXERA ULTRASONIC GASTROVIDEOSCOPE |
| XGF-UM180 | ULTRASONIC GASTROVIDEOSCOPE |
| GF-UE160-AL5 | ULTRASONIC GASTROVIDEOSCOPE |
| GF-UC140P-AL5 | ULTRASONIC GASTROVIDEOSCOPE |
| GF-UCT140-AL5 | ULTRASONIC GASTROVIDEOSCOPE |
- Common Name: 版
Diagnostic Ultrasound System
II
Regulation Number: 트
892.1550 Ultrasound Puised Doppler Imaging System 892.1560 Ultrasonic Pulsed Echo Imaging System 892.1570 Diagnostic Ultrasound Transducer 876.1500 Endoscope and Accessories
Regulatory Class:
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I Product Code:
.
.
90-1YN/90-1YO/90-1TX/78-KOG
3 Predicate Device Information
:
Ultrasound System
| Subject device | Predicate device | |
|---|---|---|
| Name | Controlnumber | |
| XEU-M60AENDOSCOPIC ULTRASOUNDCENTER | EU-M60EUS EXERA ENDOSCOPICULTRASOUND CENTER | K043275 |
| EU-C60EUS EXERA COMPACTENDOSCOPIC ULTRASOUNDCENTER | K010591 |
Ultrasonic Gastrovideoscopes and Probes
| Subject device | Predicate device Name | Control number |
|---|---|---|
| UM-2R/3RULTRASONIC PROBES | UM-2R/3RULTRASONIC PROBES | K944610K982323K982610 |
| UM-DP12/20-25RULTRASONIC PROBES | UM-2R/3RULTRASONIC PROBES | BaseduponK944610,K982323,K982610,Olympusdeterminedthat no510(k) wasrequiredfor devicechanges. |
| GF-UM130ULTRASONICGASTROVIDEOSCOPE | GF-UM130ULTRASONIC GASTROVIDEOSCOPE | K971660K011886 |
| GF-UM160EUS EXERA ULTRASONICGASTROVIDEOSCOPE | GF-UM160EUS EXERA ULTRASONICGASTROVIDEOSCOPE | K011886 |
| XGF-UM180ULTRASONICGASTROVIDEOSCOPE | GF-UM160ULTRASONIC GASTROVIDEOSCOPE | Thissubmission |
| GF-UE160-AL5ULTRASONICGASTROVIDEOSCOPE | GF-UE160-AL5ULTRASONIC GASTROVIDEOSCOPE | K051541 |
| GF-UC140P-AL5ULTRASONICGASTROVIDEOSCOPE | GF-UC140P-AL5ULTRASONIC GASTROVIDEOSCOPE | K011314 |
| GF-UCT140-AL5ULTRASONICGASTROVIDEOSCOPE | GF-UCT140-AL5ULTRASONIC GASTROVIDEOSCOPE | K012080 |
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4 Device Description
The combination of the XEU-M60A Endoscopic Ultrasound Center, UM-2R/3R Ultrasonic Probes, UM-DP12/20-25R Ultrasonic Probes, GF-UM130 Ultrasonic Gastrovideoscope, GF-UM160 Ultrasonic Gastrovideoscope, XGF-UM180 Ultrasonic Gastrovideoscope, GF-UE160-AL5 Uftrasonic Gastrovideoscope, GF-UC140P-AL5 Ultrasonic Gastrovideoscope, and GF-UCT140-AL5 Ultrasonic Gastrovideoscope enables the acquisition and display of high-resolution and high-penetration, real-time ultrasound B-mode endoscopic images,
5 Indications for Use
The indications for use for the XEU-M60A Endoscopic Ultrasound Center are as follows:
- Transrectal 제
- 1 Transurethral
- 199 Transesophageal(non-cardiac) .
- 17 Gastrointestinal tract, biliary, pancreatic duct and surrounding organs
- Intraluminal ultrasound for upper airways and tracheobronchial tree 1
- 18 3-D Imaging
ర్ Comparison of Technological Characteristics
The XEU-M60A Endoscopic Ultrasound Center operates identically to the predicate devices in that piezoelectric material in the transducer is used as an ultrasound source to transmit sound waves into the body. Sound waves are reflected back to the transducer and converted to electrical signals that are processed and displayed as images. Doppler shift caused by blood flow is displayed as Color Flow, or as spectrum analysis.
Technological Characteristics of this device is identical to the predicate devices identified in item 3.
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.