(13 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Transesophageal, Transrectal, Transvaginal, Transurethral, Gastrointestinal tract, biliary, pancreatic duct and the surrounding Organs, Intraluminal ultrasound for upper airways and tracheobronchial tree, Urinary tract, Female reproductive tract, 3D imaging.
The OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CENTER makes a endoscopic ultrasound imaging system used to acquire and to display high-resolution and high-penetration, real-time ultrasound B-mode 2D and 3D images.
The provided document is a 510(k) summary for the OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CENTER, cleared in 2004. This document is a premarket notification for a medical device seeking substantial equivalence to a legally marketed predicate device. As such, it does not contain acceptance criteria in the usual sense of performance metrics or a study demonstrating the device meets those criteria.
Instead, the document primarily focuses on establishing substantial equivalence to existing predicate devices. This is a regulatory pathway where the new device is shown to be as safe and effective as a device already on the market (the predicate device). The "study" here is essentially the demonstration of similar technological characteristics and intended uses.
Therefore, many of the requested categories cannot be populated from the provided text because they relate to performance studies and ground truth establishment, which are typically not part of a 510(k) submission that relies on substantial equivalence.
Here's an analysis based on the available information:
Acceptance Criteria and Device Performance
No explicit acceptance criteria or performance metrics (e.g., sensitivity, specificity, accuracy) are reported in this 510(k) summary.
The primary "acceptance criterion" for a 510(k) submission is establishing substantial equivalence to a legally marketed predicate device. This is demonstrated by showing:
- Same intended use as the predicate.
- Same technological characteristics as the predicate OR different technological characteristics that do not raise new questions of safety and effectiveness, and are demonstrated to be as safe and effective as the predicate.
In this case, the document states: "Technological Characteristics of this device is identical to the predicated devices identified in item C." and the intended uses are largely carried over from the predicate (K011886) with some new additions (indicated by 'E').
Explanation for Non-Applicable Sections:
Since this is a 510(k) summary focused on substantial equivalence rather than a clinical performance study with quantitative metrics, the following sections are not applicable or cannot be extracted from this document:
- Sample size used for the test set and the data provenance: Not applicable. No test set for performance evaluation is described. The "test" is the comparison to predicate devices, not a clinical study to generate performance metrics.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth for a test set is established or required for a substantial equivalence determination based on identical technological characteristics and similar intended use.
- 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 device is an ultrasound system, not an AI or imaging assistance device, and no MRMC study is mentioned.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no performance study generating such data is described.
- The sample size for the training set: Not applicable, as this is not an AI/machine learning device.
- How the ground truth for the training set was established: Not applicable.
{0}------------------------------------------------
K0+3275
DEC = 9 2004
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21CFR, Part 807, Subpart E, Section 807.92.
A. GENERAL INFORMATION
-
- Applicant: Olympus Medical Systems Corp. (Former Name: Olympus Corporation) Hinode Plant Address: 34-3 Hirai, Hinode-machi, Nishitama-gun Tokyo, Japan, 190-0182 Establishment Registration No.: 3003637092
| 2. Submission Correspondent: Takashi Yagi | |
|---|---|
| Olympus Medical Systems Corp.(Former Name: Olympus Corporation) | |
| Address: | 2951 Ishikawa-cho Hachioji-shi, Tokyo 192-8507, Japan |
| Telephone: | 81-426-42-2891 |
| Facsimile: | 81-426-42-3174 |
| E-mail address: | takashi_yagi@ot.olympus.co.jp |
| Establishment Registration No.: | 8010047 |
| 3. Official Correspondent: | Laura Storms-Tyler |
|---|---|
| Title: | Director, Regulatory Affairs and Quality Assurance |
| OLYMPUS AMERICA INC. | |
| Address: | Two Corporate Center Drive, Melville, NY 11747-9058 |
| Telephone: | 631-844-5688 |
| Facsimile: | 631-844-5554 |
| E-mail address: | Laura.Storms-Tyler@olympus.com |
| Establishment Registration No.: | 2429304 |
B. Device Name, Common Name
-
- Common/Usual Name
Diagnostic Ultrasound System with Accessories
- Common/Usual Name
-
- Device Name
OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CENTER
- Device Name
3.Classification Name
| FR Number | Product Code | Class | |
|---|---|---|---|
| Endoscope and accessories | 876.1500 | 78KOG | II |
| Ultrasonic pulsed echo imaging system | 892.1560 | 90IYO | II |
C. Identification of the predicate or legally marketed device
The following devices information demonstrates that this device is considered substantially equivalent to a legally marketed, predicate medical device.
{1}------------------------------------------------
1. Ultrasound System
| Device Name | #K |
|---|---|
| OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CENTER | K011886 |
| ATL HDI 5000 Ultrasound System | K961459 |
D. Device Description
1. Summary
The OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CENTER makes a endoscopic ultrasound imaging system used to acquire and to display high-resolution and high-penetration, real-time ultrasound B-mode 2D and 3D images.
2. Design
The EU-M60 is designed to comply with the standards listed below.
| IEC 60601-1 | 1988 : Amendment 1 (1992) and Amendment (1995) |
|---|---|
| IEC 60601-1-1 | 2000 |
| IEC 60601-1-2 | 1993 |
| IEC 60601-2-18 | 1996 |
| CISPR11 | 1990 |
E. Intended Use:
The intended uses of the EU-M60, as defined by FDA guidance documents, are:
| Transesophageal | Transrectal |
|---|---|
| Transvaginal | Transurethral |
| Other | |
| 1) Gastrointestinal tract, biliary, pancreatic duct and the surrounding Organs | |
| 2) Intraluminal ultrasound for upper airways and tracheobronchial tree | |
| 3) Urinary tract | |
| 4) Female reproductive tract | |
| 5) 3D imaging |
F. Technological Characteristics:
This device operates identically to the predicate devices in that the transducer of the endoscope or the ultrasonic probe that is inserted into the body cavity mechanically scans the targeted site. The piezoelectric material in the transducer is used as an ultrasound source to transmit sound waves. Sound waves are reflected back to the transducer and converted to electrical signals that are processed and displayed as images.
Technological Characteristics of this device is identical to the predicated devices identified in item C.
{2}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 9 2004
Olympus Medical Systems Corp. % Mr. N. E. Devine, Jr. Responsible Third Party Official Entela, Inc. 3033 Madison Ave. SE GRAND RAPIDS MI 49548
Re: K043275
Trade Name: Olympus EU-M60 EUS EXERA Endoscopic Ultrasound Center Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Product Code: 78 KOG Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasound transducer Regulatory Class: II
Product Code: 90 IYO and ITX
Dated: November 23, 2004
Received: November 26, 2004
Dear Mr. Devine:
We have reviewed your Section 510(k) premarket notification of intent to market the device ' referenced above and we 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). 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.
: This determination of substantial equivalence applies to the following transducers intended for use with the Olympus EU-M60 EUS EXTERA Endoscopic Ultrasound Center, as described in vour premarket notification:
Transducer Model Number
GF Type UM160 UM-DP12/20-35R
UM-2R/3R GF UM 130
{3}------------------------------------------------
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 can be 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 or mply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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.
This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed nredicate 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 contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Marv Sacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.
Sincerely yours,
David le. Lazaro
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
{4}------------------------------------------------
4.3.1 Indications for Use Form for 4.5.1 maileations for SSC Formal :
OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CENTER
Diagnostic Ultrasound Indications for Use Form
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other(specify) | |
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative (specify) | |||||||||||
| Intraoperative | |||||||||||
| Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ (specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Transesophageal | P | Note2(E) | |||||||||
| Transrectal | P | Note2(E) | |||||||||
| Transvaginal | P | Note2(E) | |||||||||
| Transurethral | P | Note2(E) | |||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletalConventional | |||||||||||
| Musculo-skeletalSuperficial | |||||||||||
| Other (specify)Note1 | P | Note2(E) |
Other (specif)
N= new indication; P= previously cleared by FDA in K011886; E= added under Appendix E
Additional Comments:
| Note1: Specification for "Other": |
|---|
| Gastrointestinal tract, biliary, pancreatic duct and surrounding organs. |
| Intraluminal ultrasound for upper airways and tracheobronchial tree |
| Urinary tract |
| Female reproductive tract: |
| Note2:3D Imaging |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
David A. Seymour
(Division Sion-Off Division and Radiolor 510(k) Num
{5}------------------------------------------------
4.3.2 Indications for U se Form for EUS EXERA Ultrasonic Gastrovideoscope OLYMPUS GF TYPE UM160
Diagnostic Ultrasound Indications for Use Form
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other(specify) |
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | P | Note2(E) | ||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other (specify) | Note1 | P | Note2(E) |
N= new indication; P= previously cleared by FDA in K011886; E= added under Appendix E
Additional Comments:
Note1: Specification for "Other"
Gastrointestinal fract billiary, pancreatic duct and surrounding organs, Note2:3D Imaging
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Daniel A. Legum
(Division Sign-Off) Division of Reproductive. Abdominal and Radiological Devices 510(k) Number _
{6}------------------------------------------------
4.3.3 Indications for U se Form for OLYMPUS UM-DP12/20-35R Ultrasonic Probes
Diagnostic Uitrasound Indications for Use Form
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other(specify) | |
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative (specify) | |||||||||||
| Intraoperative | |||||||||||
| Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ (specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Transesophageal | P | Note2(E) | |||||||||
| Transrectal | P | Note2(E) | |||||||||
| Transvaginal | P | Note2(E) | |||||||||
| Transurethral | P | Note2(E) | |||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletalConventional | |||||||||||
| Musculo-skeletalSuperficial | |||||||||||
| Other (specify)Note1 | P | Note2(E) |
Other (epocition; P= previously cleared by FDA in K011886; E= added under Appendix E
Additional Comments:
Note1: Specification for "Other" :
| Gastrointestinal tract, biliary, pancreatic duct and surround organs |
|---|
| Intraluminal ultrasound for upper airways and tracheobronchial tree |
| Urinary tract |
| Female reproductive tract: |
| Note2:3D Imaging |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
David Ch. Seegman
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
{7}------------------------------------------------
4.3.4 Indications for U se For OLYMPUS UM-2R/3R Ultrasonic Probes
Diagnostic Ultrasound Indications for Use Form
intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other(specify) | ||
| Ophthalmic | ||||||||||||
| Fetal | ||||||||||||
| Abdominal | ||||||||||||
| Intraoperative (specify) | ||||||||||||
| IntraoperativeNeurological | ||||||||||||
| Pediatric | ||||||||||||
| Small Organ (specify) | ||||||||||||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Cardiac | ||||||||||||
| Transesophageal | P | Note2(E) | ||||||||||
| Transrectal | P | Note2(E) | ||||||||||
| Transvaginal | P | Note2(E) | ||||||||||
| Transurethral | P | Note2(E) | ||||||||||
| Intravascular | ||||||||||||
| Peripheral Vascular | ||||||||||||
| Laparoscopic | ||||||||||||
| Musculo-skeletalConventional | ||||||||||||
| Musculo-skeletalSuperficial | ||||||||||||
| Note 1Other (specify) | P | Note2(E) |
N= new indication; P= previously cleared by FDA in K011886; E= added under Appendix E
Additional Comments:
| Note1: Specification for "Other": | |
|---|---|
| Gastrointestinal tract, biliary, pancreatic duct and surround organs | |
| Intraluminal ultrasound for upper airways and tracheobronchial tree | |
| Urinary tract | |
| Female reproductive tract: | |
| Note2:3D Imaging |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
David A. Logam
(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
{8}------------------------------------------------
4.3.5 Indications for U se for OLYMPUS GF UM130 Ultrasound Gastrovideoscope
Diagnostic Ultrasound Indications for Use Form
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other(specify) |
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | P | Note2(E) | ||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | ||||||||||
| Musculo-skeletalSuperficial | ||||||||||
| Note1Other (specify) | P | Note2(E) |
N= new indication; P= previously cleared by FDA in K011886; E= added under Appendix E
Additional Comments:
Note1: Specification for "Other"
Gastrointestinal tract, biliary, pancreatic duct and surrounding organs, Note2:3D Imaging
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ... ANOTHER PAGE IF NEEDED.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Daniel A. Leyson
(Division Sign-Off) Division of Reproductive, Abdomi and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.