(42 days)
The device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Abdomen;Pediatric;Small Organ(breast,tests,thyroid);heart soft tissue; Peripheral Vascular; Musculo-skeletal(conventional) ; Ob/Gyn and Urology.
The CGMC OPUS 5000 diagnostic doppler ultrasound system is a compact and portable diagnostic ultrasound device,have integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. The user interface includes a specialized control keyboard and color 15-inch LCD display. The all digital architecture with progressive dynamic receive focusing allows the system to maximize the utility of all imaging transducers to enhance the diagnostic utility and confidence provided by the system. The exam dependent default setting allows the user to have minimum adjustment for imaging the patient, while the in depth soft-menu control allows the advanced user to set the system for different situations. The architecture allows cost-effective system integration to a variety of upgrade-able options and features.
1. Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative acceptance criteria or a dedicated study demonstrating the device meets such criteria in terms of clinical performance (e.g., diagnostic accuracy, sensitivity, specificity). The submission is a 510(k) premarket notification, which primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed clinical performance studies.
However, the "Technological Characteristics" section can be interpreted as defining performance attributes related to the device's technical capabilities, which indirectly contribute to its overall performance. For a device like an ultrasound system, the acceptance criteria would typically align with the expected imaging modes, measurement capabilities, and acoustic output limits.
Here's a table summarizing the reported device performance based on the provided technical specifications, which would indirectly serve as acceptance criteria for functionality:
| Acceptance Criteria (Inferred from Technological Characteristics) | Reported Device Performance (CGMC OPUS 5000) |
|---|---|
| Display Modes: | |
| - Standard 2-D B-mode | Achieved |
| - M-mode | Achieved |
| - Harmonic Image | Achieved |
| - Color Doppler | Achieved |
| - Power Doppler | Achieved |
| - Pulsed Wave (PW) Doppler | Achieved |
| - Continuous Wave (CW) Doppler | Achieved |
| - Duplex 2-D/M-mode display | Achieved |
| - Duplex 2-D/Pulsed Doppler display | Achieved |
| - Triplex 2-D/CD/Pulsed Doppler display | Achieved |
| - Dual B and Color in real-time | Achieved |
| Measurement Capabilities: | Distance, area, circumference, calipers, velocity, PI, RI, Cardiac and Vascular package |
| Operating Controls: | |
| - TGC (8 slider, +/- 24dB) | Achieved |
| - Depth Range (3 to 24 cm) | Achieved |
| - Image Sector Size (32 lines to full B) | Achieved |
| - Dynamic Range (50-90 dB, 5 curves) | Achieved |
| - Grey Scale Control (8 Settings) | Achieved |
| - Focal Number (16 focal zone setting) | Achieved |
| - Persistence (30-90%) | Achieved |
| - Image Processing (Smoothing, edge enhancement) | Achieved |
| - PW sweeping speed (2,4,8 sec) | Achieved |
| - PW Wall filter setting (16 settings, 0.25 to 20% of PRF) | Achieved |
| - PW sample volume (0.5 to 10mm with 0.5mm step) | Achieved |
| - PW angle correction (0 to 70 degree) | Achieved |
| - Color ROI setting, steering, wall filter, packet size, filter | Achieved |
| - Zoom factor (1 to 10 continuously) | Achieved |
| Acoustic Output Limits: | |
| - Derated Ispta: 720mW/cm² maximum | Reported as 720mW/cm² maximum (implies compliance with limit) |
| - TIS/ITIB/TIC: 0.1-4.0 Range | Reported as 0.1-4.0 Range (implies compliance within range) |
| - Mechanical Index: 1.9 Maximum | Reported as 1.9 Maximum (implies compliance with limit) |
| - Derated Isppa: 190 W/cm²max | Reported as 190 W/cm²max (implies compliance with limit) |
The study that "proves" the device meets acceptance criteria for a 510(k) submission like this is typically a demonstration of substantial equivalence to a predicate device, rather than a de novo clinical trial with specific performance metrics. The document states:
"The SonoScape Ultrasound System SSI-1000 ( K042369 ) is of a comparable and substantially equivalent type. It has the same technological characteristics, key safety and effectiveness features, physical design, and has the same intended uses and basic operating modes as the predicate device."
This statement is the core "proof" for a 510(k). The manufacturer is asserting that their device's technical specifications and safety/effectiveness features are sufficiently similar to a previously cleared device, implying it will perform similarly.
2. Sample size used for the test set and the data provenance:
This document does not contain information about a specific "test set" in the context of a clinical performance study. The 510(k) submission relies on demonstrating substantial equivalence through technical characteristics and a comparison to a predicate device. There is no mention of a patient-based test set, its sample size, or its provenance (country of origin, retrospective/prospective). The closest equivalent of "testing" described would be engineering and acoustic output testing to confirm the device meets its stated specifications, but details about such testing are not provided in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
As there is no mention of a clinical "test set" requiring ground truth establishment by experts, this information is not available in the provided document.
4. Adjudication method for the test set:
Not applicable, as there is no mention of a clinical "test set" and thus no adjudication process for it.
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. The CGMC OPUS 5000 is a diagnostic ultrasound system, not an AI-powered image analysis tool, and the document predates widespread AI integration in such devices. Therefore, no MRMC study or AI-related effectiveness is mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. The CGMC OPUS 5000 is an ultrasound machine, not a standalone algorithm. Its performance is intrinsically tied to human operation and interpretation.
7. The type of ground truth used:
Not applicable, as there is no mention of a performance study requiring ground truth for clinical outcomes. The "ground truth" for this 510(k) relies on the established safety and effectiveness of the predicate device and the technical specifications of the new device.
8. The sample size for the training set:
Not applicable. This device is an ultrasound system and its approval is based on substantial equivalence, not on machine learning algorithms trained on specific datasets.
9. How the ground truth for the training set was established:
Not applicable, for the same reasons as point 8.
{0}------------------------------------------------
CGMC OPUS 5000 Diagnostic Doppler Ultrasound System
Chang Gung Medical Supplies & Equipment Corp.
PREMARKET NOTIFICATION [510(k)] Summary
| Company Name: | Chang Gung Medical Supplies & Equipment Corp.5F., No. 201-36, Dunhua N.Rd. Songshan DistrictTaipei, TAIWAN 10508 | MAR 1 3 2009 |
|---|---|---|
| U.S. Agent: | Bob LeikerLeiker Regulatory & Quality Consulting7263 Cronin Circle Dublin, CA 94568Telephone: (925) 556-1302 | |
| Device Name: | CGMC Diagnostic Doppler Ultrasound System OPUS 5000 withCGMC CLA35 Curved Linear Array 4-8MHz,CGMC LA75 Linear Array 5-10MHz,CGMC PA25 Phase Array 2-4MHz, andCGMC TV65 Transvaginal Micro-Curved Linear Array 4-8MHz. | |
| Classification Name: | Regulatory Class: IIReview Category: Tier IIClassification Panel: RadiologyUltrasonic Pulsed Echo Imaging System, 21 CFR 892.1560, 90-IYOUltrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550, 90-IYNDiagnostic Ultrasound Transducer 21 CFR 892.1570, Product Code 90-ITX |
Predicate Device:
The SonoScape Ultrasound System SSI-1000 ( K042369 ) is of a comparable and substantially equivalent type. It has the same technological characteristics, key safety and effectiveness features, physical design, and has the same intended uses and basic operating modes as the predicate device.
General Device Description:
The CGMC OPUS 5000 diagnostic doppler ultrasound system is a compact and portable diagnostic ultrasound device,have integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. The user interface includes a specialized control keyboard and color 15-inch LCD display. The all digital architecture with progressive dynamic receive focusing allows the system to maximize the utility of all imaging transducers to enhance the diagnostic utility and confidence provided by the system. The exam dependent default setting allows the user to have minimum adjustment for imaging the patient, while the in depth soft-menu control allows the advanced user to set the system for different situations. The architecture allows cost-effective system integration to a variety of upgrade-able options and features.
The major features of the CGMC OPUS 5000:
- 64 Channel all digital beam former .
- Progressive dynamic receive focusing .
- Wide band all digital demodulation .
- Native frequency digital scan converter
- . . OPUS 5000 can be hand carried for portable use
- Remote access image management through LAN port .
- USB2.0 flash drive for image transport and software upgrade .
- Supports 2D B-mode, M-mode, Harmonic Image, Color, Power Doppler, Pulse wave Doppler, and CW.
{1}------------------------------------------------
Intended Use:
The device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Abdomen;Pediatric;Small Organ(breast,tests,thyroid);heart soft tissue; Peripheral Vascular; Musculo-skeletal(conventional) ; Ob/Gyn and Urology.
Technological Characteristics:
| Display Modes | Single and dual 2-D; Display of Duplex 2-D/M-mode; 2-D/Pulsed Doppler andTriplex 2-D/CD/Pulsed Doppler image formats; Dual B and Color in real time. |
|---|---|
| Measurements | Distance; area; circumference; calipers; velocity, PI, RI. Cardiac and Vascular package. |
| Operating Controls | TGC 8 slider, +/- 24dB Depth Range: 3 to 24 cm Image sector size: 32 lines to full B (256 lines) Image Sector position: Steering within full maximum B orientation flip: L/R key with marking on the screen B Dynamic range control: preset 5 curves over 50-90 dB Gray Scale Control: 8 Settings Focal Number: 16 focal zone setting B persistence: 30-90% recursive Image Processing: Smoothing, edge enhancement PW sweeping speed 2,4,8 sec over display. PW Wall filter setting: 16 settings, 0.25 to 20% of PRF PW sample volume: 0.5 to 10mm with 0.5mm step size. PW/B update: with UPDATE key PW cursor steering: Steer soft key PW angle correction: 0 to 70 degree user control PW trace: Peak, Mean PW spectrum dynamic range: 5 preset curve over 15-48 dB Spectrum baseline shift and invert Color ROI setting: trackball and set key to control size and Color steering on flat probe: +, 0, - Color Wall Filter: Color wall filter with 16 selection, 0.25-20% Color & B priority: C-B priority soft menu Color Packet size: preset per Exam range from 8 to 12 Color spatial filter: preset per Exam, horizontal, vertical, off Zoom factor: 1 to 10 continuously Freeze control: Toggling freeze key Cine control: step, play backward, play continuously |
| Acoustic Output | Track 3; MI, TIS, TIC, TIBDerated Ispta: 720mW/cm2 maximum, TIS/ITIB/TIC: 0.1-4.0 Range,Mechanical Index: 1.9 Maximum, or Derated Isppa: 190 W/cm 2max |
{2}------------------------------------------------
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all capital letters and is evenly spaced around the circle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Chang Gung Medical Supplies & Equipment Corp. % Mr. Bob Leiker
Owner & Manager
Leiker Regulatory & Quality Consulting
7263 Cronin Circle
DUBLIN CA 94568
Re: K090229
Trade/Device Name: CGMC OPUS 5000 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: January 28, 2009 Received: January 30, 2009
Dear Mr. Leiker:
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 CGMC OPUS 5000 Diagnostic Ultrasound System, as described in your premarket notification:
Transducer Model Number
PA25 2.5 MHz Phased Array LA75 7.5 MHz Linear Array CLA35 3.5 MHz Curved Linear Array TV65 6.5 MHz Trans-Vaginal/Trans-Rectal Micro-Curved Linear Array
MAR Į 3 2009
{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 comply 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 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 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 Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
If you have any questions regarding the content of this letter, please contact Lauren Hefner at (240) 276-3666.
Sincerely yours,
C. Hecks Leum
ne M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
{4}------------------------------------------------
Indications For Use
510(k) Number (if known):__K090229
Device Name: CGMC OPUS 5000 Diagnostic Ultrasound System
Indications For Use:
The device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Abdomen; Cardiac, Small Organ (breast, testes, thyroid); heart soft tissue; Peripheral Vascular; Musculo-skeletal (conventional); OB/Gyn and Urology.
| Prescription Use | ✓ |
|---|---|
| (Part 21 CFR 801 Subpart D) |
AND/OR
| Over-The-Counter Use | __________ |
|---|---|
| (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal and | |
| Radiological Devices | |
| Indications For Use | 510(k) Number K090229 |
| Section 1.3 | Page 1 of 6 |
|---|---|
| ------------- | ------------- |
{5}------------------------------------------------
CGMC OPUS 5000 Diagnostic Ultrasound System
Diagnostic Ultrasound Indications For Use Format
System:
CGMC OPUS 5000 ാന്തം വി ലോ 3000
Diagnostic Ultrasound Pulsed Echo System Diagnostic Ultrasound Pulsed Doppler Imaging System
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(Track 1 Only) | Specific(Tracks 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | TissueHarmonicImaging |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal Imaging &Other | Fetal | ||||||||
| Abdominal | N | N | N | N | N | N | Note 1 | N | |
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | N | N | N | N | N | N | Note 1 | N | |
| Small Organ (breast, thyroid,testes) | N | N | N | N | N | N | Note 1 | N | |
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | N | N | N | N | N | N | Note 1 | N | |
| Trans-vaginal | N | N | N | N | N | N | Note 1 | N | |
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal (Conventional) | N | N | N | N | N | N | Note 1 | N | |
| Musculo-skeletal (Superficial) | |||||||||
| Intravascular | |||||||||
| Other (Ob/GYN) | N | N | N | N | N | N | Note 1 | N | |
| Cardiac | Cardiac Adult | N | N | N | N | N | N | Note 1 | N |
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (Specify) | |||||||||
| Peripheral Vessel | Peripheral vessel | N | N | N | N | N | N | Note 1 | N |
| Other (Specify) |
E = added under this appendix N = new indication; P = previously cleared by FDA;
Note 1: Combined includes: B/M; B/PWD; B/Color Doppler; B/Color Doppler; B/Color Doppler/PWD and B/Power Doppler/PWD
Additional Comments:
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices age 2 of 6 510(k) Number _
Prescription Use (Per 21 CFR 801.109) Section 1.3
Indications For Use
{6}------------------------------------------------
CGMC OPUS 5000 Diagnostic Ultrasound System Diagnostic Ultrasound Indications For Use Format
CGMC OPUS 5000 System: PA25 2.5 MHz Phased Array Transducer: Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(Track 1 Only) | Specific(Tracks 1 & 3) | B | M | PWD CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | TissueHarmonicImaging | |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal Imaging &Other | Fetal | ||||||||
| Abdominal | N | N | N | N | N | N | Note 1 | N | |
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (breast, thyroid,testes) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal (Conventional) | |||||||||
| Musculo-skeletal (Superficial) | |||||||||
| Intravascular | |||||||||
| Other (Ob/GYN) | |||||||||
| Cardiac | Cardiac Adult | N | N | N | N | N | N | Note 1 | N |
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (Specify) | |||||||||
| Peripheral Vessel | Peripheral vessel | ||||||||
| Other (Specify) |
E = added under this appendix N = new indication; P = previously cleared by FDA;
Note 1: Combined includes: B/M; B/PWD; B/Color Doppler; B/Color Doppler; B/Color Doppler/PWD and B/Power Doppler/PWD
Additional Comments:
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number
Page 3 of 6
K090229
Prescription Use (Per 21 CFR 801.109)
Section 1.3
Indications For Use
{7}------------------------------------------------
CGMC OPUS 5000 Diagnostic Uftrasound System Diagnostic Ultrasound Indications For Use Format
CGMC OPUS 5000 System: LA75 7.5 MHz Linear Array Transducer: Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(Track 1 Only) | Specific(Tracks 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | TissueHarmonicImaging |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal Imaging &Other | Fetal | ||||||||
| Abdominal | |||||||||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (breast, thyroid,testes) | N | N | N | N | N | N | Note 1 | N | |
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | N | N | Note 1 | N | |||||
| Musculo-skeletal (Conventional) | N | N | N | N | N | N | Note 1 | N | |
| Musculo-skeletal (Superficial) | |||||||||
| Intravascular | |||||||||
| Other (Ob/GYN) | |||||||||
| Cardiac | Cardiac Adult | ||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (Specify) | |||||||||
| Peripheral Vessel | Peripheral vessel | N | N | N | N | N | N | Note 1 | N |
| Other (Specify) |
P = previously cleared by FDA; E = added under this appendix N = new indication;
Note 1: Combined includes: B/M; B/PWD; B/Color Doppler; B/Color Doppler; B/Color Doppler;PWD and B/Power Doppler/PWD
Additional Comments:
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Section 1.3
Indications For Use
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
Page 4 of 6
510(k) Number
K090229
{8}------------------------------------------------
CGMC OPUS 5000 Diagnostic Ultrasound System Diagnostic Ultrasound Indications For Use Format
CGMC OPUS 5000 System: CLA35 3.5 MHz Curved Linear Array Transducer: Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(Track 1 Only) | Specific(Tracks 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | TissueHarmonicImaging |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal Imaging &Other | Fetal | ||||||||
| Other | Abdominal | N | N | N | N | N | Note 1 | N | |
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (breast, thyroid, | |||||||||
| testes) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal (Conventional) | |||||||||
| Musculo-skeletal (Superficial) | |||||||||
| Intravascular | |||||||||
| Other (Ob/GYN) | N | N | N | N | N | Note 1 | N | ||
| Cardiac | Cardiac Adult | ||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (Specify) | |||||||||
| Peripheral Vessel | Peripheral vessel | ||||||||
| Other (Specify) |
P = previously cleared by FDA; E = added under this appendix N = new indication;
Note 1: Combined includes: B/M; B/PWD; B/Color Doppler; B/Power Doppler; B/Color Doppler/PWD and B/Power Doppler/PWD
Additional Comments:
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Section 1.3
Indications For Use
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number
Page 5 of 6
K090229
{9}------------------------------------------------
Diagnostic Ultrasound Indications For Use Format
CGMC OPUS 5000 System: TV65 6.5 MHz Trans-Vaginal/Trans-Rectal Micro-Curved Linear Array Transducer: Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(Track 1 Only) | Specific(Tracks 1 & 3) | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Other*Combined | TissueHarmonicImaging |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal Imaging &Other | Fetal | ||||||||
| Other | Abdominal | ||||||||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (breast, thyroid,testes) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | N | N | N | N | N | N | Note 1 | N | |
| Trans-vaginal | N | N | N | N | N | N | Note 1 | N | |
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal (Conventional) | |||||||||
| Musculo-skeletal (Superficial) | |||||||||
| Intravascular | |||||||||
| Other (Ob/GYN) | N | N | N | N | N | N | Note 1 | N | |
| Cardiac | Cardiac Adult | ||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (Specify) | |||||||||
| Peripheral Vessel | Peripheral vessel | ||||||||
| Other (Specify) |
P = previously cleared by FDA; N = new indication;
E = added under this appendix
Note 1: Combined includes: B/M; B/PWD; B/Color Doppler; B/Color Doppler; B/Color Doppler/PWD and B/Power Doppler/PWD
Additional Comments:
Concurrence of CDRH, Office of Device Evaluation (ODE
ce Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices Page 6 of 6 510(k) Number
Section 1.3
Indications For Use
§ 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.