(15 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal - OB/GYN, Abdominal, Small Organs (breast, thyroid, testicle), Pediatric, Neonatal Cephalic, Trans-Vaginal, Trans-Rectal, Peripheral Vascular. Typical examinations performed using the system are: General abdominal and pelvic studies including organ surveys. assessment, and retroperitoneal cavity studies. Study of small parts and superficial structures including breasts, shoulders, thyroid, and the abdominal wall. Pediatric scans of organs, superficial, and bony structures. Monitoring procedures for infertility studies (other than in vitro fertilization). First, second and third trimester pregnancy studies. Neonatal head studies. Podiatry scans of superficial structures including muscles, tendons and bones. Prostate, bladder and rectum visualization. Tissue Harmonic Imaging (THI) is a B-Mode imaging technique that enables a dramatic reduction in naturally occurring artifacts caused by interaction of certain tissue types and low frequency soundwaves. Seven of the twelve probes offered with the system will be indicated for Tissue Harmonic Imaging (THI-Mode). The THI-Mode will be used for fetal, abdominal, pediatric, and small organ clinical applications.
The Combison® 530/Voluson® 530D scanner is a multiple-mode, multipleapplication ultrasound imaging system. The cart-mounted console contains an ultrasound generator/receiver offering a full complement of conventional operating modes, software-based parameter controls, and recording. The selection of twelve transducers offered with the system permits a wide range of clinical applications. In addition to the initial operational settings for each transducer preprogrammed in the system, user-customized parameter settings for each transducer may be inserted by the operator and stored for recall as needed via the system control panel. Customization includes transmit focusing, filtering, image enhancement processing, dynamic window curve selection. Controls are also provided to select display format (single and various combinations), to activate zoom features, and to utilize the cine loop function. The Combison® 530/Voluson® 530D uses digital beamforming technology. The Combison® 530/Voluson® 530D supports a variety of linear and convex probes for wide variety of applications. It is an ultrasound scanner, which provides high resolution, high penetration performance, and various measurement functions. Probes are supported in frequencies from 3.5 MHz to 7.5 MHz. The Combison® 530/Voluson® 530D provides high quality images and various measuring functions. Biopsy guidelines are provided on screen to assist in the collection of tissue samples, using biopsy guide adapters offered as an optional accessory. Operating Modes of the Combison® 530/Voluson® 530D are B, B/B, B/M, M and, Doppler, Volume and Power Doppler Mode. Management of patient history is possible by image-filing function. High-resolution images are provided by utilizing a technology called digital dynamic receive focusing. The Tissue Harmonic Imaging (THI-Mode) Option consists of a software add-on.
This 510(k) Premarket Notification is for the addition of a Tissue Harmonic Imaging (THI-Mode) option to the Combison® 530/Voluson® 530D Diagnostic Ultrasound System. The submission claims substantial equivalence to the Medison SA8800/HDI 1500 System (K974269), which also features THI-Mode.
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly present a table of acceptance criteria or reported device performance in the typical sense of quantitative metrics. Instead, the acceptance is based on demonstrating substantial equivalence to a predicate device (Medison SA8800/HDI 1500 System with THI-Mode, K974269) by showing that:
- Intended Use is the same: The THI-Mode is intended for fetal, abdominal, pediatric, and small organ clinical applications, which aligns with the predicate device.
- Technological Characteristics are similar: The device operates identically to predicate devices in principle (piezoelectric material, sound wave reflection, electrical signal conversion) and the THI-Mode is a software add-on.
- Acoustic Output Limits are within acceptable ranges:
- TIS/TIB/TIC: 0.0 - 4.0 (Range)
- ISPTA.3: 720 mW/cm² (Maximum)
- MI: 1.9 (Maximum)
These limits are stated to be the same as "predicate Track 3 devices." This implicitly means the reported performance in terms of acoustic output meets the established safety limits for such devices, which is a form of acceptance criteria for safety.
- New Indications for Use (with THI) are cleared: The FDA clearance explicitly lists several transducers (S-AB, S-ACP 3-5, S-ACP 4-7, S-NLP, S-VAW 3-5, S-VAW 4-7, S-VNW) for which Tissue Harmonic Imaging (N) is a new indication, indicating that the device has been found safe and effective for these applications when using THI.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not provide information on a specific test set, its sample size, or data provenance (country of origin, retrospective/prospective). The submission relies on demonstrating substantial equivalence to an already cleared device, implying that the safety and effectiveness of THI technology were established with the predicate device (K974269).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not provided in the document. As there is no explicitly defined "test set" and a study demonstrating performance is not detailed, there is no mention of experts for ground truth establishment.
4. Adjudication Method for the Test Set:
This information is not provided. Given the absence of a detailed study with a test set, adjudication methods are not discussed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with and without AI (THI-Mode in this case) assistance was not conducted or reported in this document. The submission focuses on substantial equivalence based on the technological characteristics and safety data of the device and its predicate.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
The document describes the THI-Mode as a "software add-on" that is a "B-Mode imaging technique that enables a dramatic reduction in naturally occurring artifacts." While this describes the algorithmic function, the submission does not present a standalone performance evaluation of the algorithm separate from the overall ultrasound system and its clinical use by a human operator. The focus is on the integrated system's safety and intended use.
7. The Type of Ground Truth Used:
Ground truth for the performance of the THI-Mode itself is not explicitly defined or used within the context of a dedicated performance study in this document. The approval seems to be based on the established safety and effectiveness of the existing THI technology (as demonstrated by the predicate device K974269) and the physical and technical specifications being within acceptable ranges. The "ground truth" for the overall device's safety and effectiveness implicitly comes from established medical practice for diagnostic ultrasound and previous FDA clearances for the base system and the predicate THI-enabled system.
8. The Sample Size for the Training Set:
The document does not mention a training set or its sample size. The THI-Mode is described as a "software add-on," implying an algorithmic approach. However, there's no detail provided on how this algorithm was developed or "trained."
9. How the Ground Truth for the Training Set Was Established:
This information is not provided, as there is no mention of a training set in the document.
{0}------------------------------------------------
510(k) Premarket Notification Tissue Harmonic Imaging (THI)
Image /page/0/Picture/1 description: The image shows a sequence of handwritten digits. The digits are '993517'. The numbers are written in a dark ink on a white background. The handwriting is somewhat messy, but the numbers are still legible.
Nov - 2 1999
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with 21 CFR, Part 807, Subpart E, Section 807.92.
Submitter's name, address, telephone number, contact person: 1) Medison America, Inc. 6616 Owens Drive Pleasanton, CA 94588 Gary J. Allsebrook Regulatory Affairs Telephone: (925) 463-1830 Prepared September 8, 1999
- Name of the device, including the trade or proprietary name if 2) applicable, the common or usual name, and the classification name, if known:
Common/Usual Name: Diagnostic Ultrasound System and Accessories
Proprietary Name:
Combison ® 530/Voluson® 530D Diagnostic Ultrasound System, Tissue Harmonic Imaging (THI-Mode) Option.
Classification Names:
| FR Number | Product Code | |
|---|---|---|
| Ultrasound Pulsed Echo Imaging System | 892.1560 | 90-IYO |
| Diagnostic Ultrasound Transducer | 892.1570 | 90-ITX |
510(k) Summary of Safety and Effectiveness
{1}------------------------------------------------
510(k) Premarket Notification Tissue Harmonic Imaging (THI)
Identification of the predicate or legally marketed device: 3)
Medison America, Inc believes that Combison® 530/Voluson® 530D Tissue Harmonic Imaging (THI-Mode) Option is substantially equivalent to the same feature introduced in the Medison, SA8800/HDI 1500 System (K974269).
Device Description: 4)
Combison® 530/Voluson 530D:
The Combison® 530/Voluson® 530D scanner is a multiple-mode, multipleapplication ultrasound imaging system. The cart-mounted console contains an ultrasound generator/receiver offering a full complement of conventional operating modes, software-based parameter controls, and recording. The selection of twelve transducers offered with the system permits a wide range of clinical applications. In addition to the initial operational settings for each transducer preprogrammed in the system, user-customized parameter settings for each transducer may be inserted by the operator and stored for recall as needed via the system control panel. Customization includes transmit focusing, filtering, image enhancement processing, dynamic window curve selection. Controls are also provided to select display format (single and various combinations), to activate zoom features, and to utilize the cine loop function.
Patient contact materials were tested for biocompatibility in accordance with their intended use and are used for each individual transducer.
The Combison® 530/Voluson® 530D uses digital beamforming technology. The Combison® 530/Voluson® 530D supports a variety of linear and convex probes for wide variety of applications. It is an ultrasound scanner, which provides high resolution, high penetration performance, and various measurement functions. Probes are supported in frequencies from 3.5 MHz to 7.5 MHz. The Combison® 530/Voluson® 530D provides high quality
{2}------------------------------------------------
images and various measuring functions. Biopsy guidelines are provided on screen to assist in the collection of tissue samples, using biopsy guide adapters offered as an optional accessory. Operating Modes of the Combison® 530/Voluson® 530D are B, B/B, B/M, M and, Doppler, Volume and Power Doppler Mode. Management of patient history is possible by image-filing function. High-resolution images are provided by utilizing a technology called digital dynamic receive focusing. The clinical uses were previously cleared for the Combison® 530/Voluson® 530D, K940942, K974813 and K992155 respectively.
Please note that the scanner and probes are not the subject of this submission as they are all covered under various 510(k) submissions and/or letters to file where applicable. The above information is provided for informative purposes. The following is the subject of this 510(k) submission:
Tissue Harmonic Imaging (THI-Mode) Option: Tissue Harmonic Imaging (THI) is a B-Mode imaging technique that enables a dramatic reduction in naturally occurring artifacts caused by interaction of certain tissue types and low frequency soundwaves. Seven of the twelve probes offered with the system will be indicated for Tissue Harmonic Imaging (THI-Mode). The THI-Mode will be used for fetal, abdominal, pediatric, and small organ clinical applications. The THI-Mode was previously cleared for use on the SA 8800/HDI 1500 system in K974269. The actual option consists of a software add-on.
5) Intended Use(s):
!
- . Fetal - OB/GYN
- Abdominal .
- Small Organs (breast, thyroid, testicle) ●
- Pediatric ●
- . Neonatal Cephalic
{3}------------------------------------------------
- . Trans-Vaginal
- . Trans-Rectal
- . Peripheral Vascular
Typical examinations performed using the system are:
- . General abdominal and pelvic studies including organ surveys. assessment, and retroperitoneal cavity studies.
- . Study of small parts and superficial structures including breasts, shoulders, thyroid, and the abdominal wall.
- Pediatric scans of organs, superficial, and bony structures, .
- Monitoring procedures for infertility studies (other than in vitro . fertilization).
- First, second and third trimester pregnancy studies.
- . Neonatal head studies.
- Podiatry scans of superficial structures including muscles, tendons and . bones.
- Prostate, bladder and rectum visualization. .
5) Technological Characteristics:
This device operates identical 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. Scanhead patient contact materials are biocompatible.
The device's acoustic output limits are:
All Applications:
| TIS/TIB/TIC | 0.0 - 4.0 | Range |
|---|---|---|
| ISPTA.3 | 720mW/cm² | Maximum |
| MI | 1.9 | Maximum |
The limits are the same as predicate Track 3 devices.
{4}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing.
Nov - 2 1999
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
TUV Product Service 1775 Old Highway 8 New Brighton, MN 55112-1891 Re: K993517 Combison530/Voluson 530D Diagnostic System with Tissue Harmonic Imaging Dated: October 15, 1999 Received: October 18, 1999 Regulatory class: II 21 CFR 892.1560/Procode: 90 IYO 90 IYN 21 CFR 892.1550/Procode: 21 CFR 892.1570/Procode: 90 ITX
Dear Mr. Carole:
Medison America, Inc.
510 (k) Program Manager
c/o Carole Stamp
We have reviewed your Section 510(k) 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 Combison530/Voluson 530D Ultrasound System with Tissue Harmonic Imaging, as described in your premarket notification:
Transducer Model Number
2-5 Abdominal Curved Array S-AB S-ACP 3-5 Abdominal Curved Array S-ACP 4-7 Abdominal Curved Array S-NLP 5-10 Small Parts Linear Array S-VAW 3-5 Abdominal Volume S-VAW 4-7 Abdominal Volume S-VNW 5-10 Small Parts Volume
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic QS inspections, the FDA will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you may have under sections 531 and 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
{5}------------------------------------------------
Page 2 - Carole Stamp
Please be advised that the determination above is based on the fact that no medical devices have been demonstrated to be safe and effective for in vitro fertilization or percutaneous umbilical blood sampling, nor have any devices been marketed for these uses in interstate commerce prior to May 28, 1976, or reclassified into class I (General Controls) or class II (Special Controls). FDA considers devices specifically intended for in vitro fertilization and percutaneous umbilical blood sampling to be investigational, and subject to the provísion of the investigational device exemptions (IDE) regulations, 21 CFR, Part 812. Therefore, your product labeling must be consistent with FDA's position on this use.
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 and additionally 809.10 for in vitro diagnostic devices), please contact 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 notification" (21 CFR 807.97). Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its tollfree number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html" .
If you have any questions regarding the content of this letter, please contact Robert A. Phillips, Ph.D. at (301) 594-1212.
Sincerely yours,
Center for Devices and Radiological Health
fr
CAPT. Daniel G. Schultz, M.D.
Acting Director, Division of Reproductive,
Abdominal and Radiological Devices
Office of Device Evaluation
Enclosure
{6}------------------------------------------------
Indications for Use 4.3.
| 510(k) Number: | K940942 and K974813 |
|---|---|
| Device Name: | Combison 530D Ultrasound System |
| Summary of previously cleared Indications for Use |
Indications for Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation (*includes simultaneous B-mode) | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M* | PWD* | ColorDoppler* | Power(Amplitude)Doppler* | ColorVelocityImaging | Combined(Specify)* | Other(Specify) |
| Ophthalmic | |||||||||
| Fetal | P | P | P | P | P1 | Note 1 | Notes 2,3,5 | ||
| Abdominal | P | P | P | P | P1 | Note 1 | Notes 2,3,5 | ||
| Intra-Operative(Specify) | |||||||||
| IntraoperativeNeurological | |||||||||
| Pediatric | P | P | P | P | P1 | Note 1 | Notes 2,3,5 | ||
| Small Organ(Specify) See Note4 | P | P | P | P | P1 | Note 1 | Notes 2,3,5 | ||
| Neonatal Cephalic | P | P | P | P | P1 | Note 1 | Note 2 | ||
| Adult Cephalic | |||||||||
| Cardiac | |||||||||
| Transesophageal | |||||||||
| Transrectal | P | P | P | P | P1 | Note 1 | Notes 2,3 | ||
| Transvaginal | P | P | P | P | P1 | Note 1 | Notes 2,3 | ||
| Transurethral | |||||||||
| Intravascular | |||||||||
| Peripheral Vascular | P | P | P | P | P1 | Note 1 | Notes 2,3,5 | ||
| Laparascopic | |||||||||
| Muscular-SkeletalConventional | P | P | P | P | P1 | Note 1 | Notes 2,3,5 | ||
| Muscular-SkeletalSuperficial | |||||||||
| Others(Specify) |
N = new indication; P = previously cleared in K940942 Combison 530D Ultrasound System,
P = nreviously cleared in K974813 Combison 530D System with Power Doppler, E= added under Appendix E
Other Indications or Modes:
Note 1: PWD/Color Doppler, PWD/Power Doppler (P)
Note 2: 3D Volume Imaging Mode (P)
Note 3: Includes imaging for guidance of biopsy (P)
Note 4: For example: thyroid, testicles, salivary gland, breast, lymph nodes and pediatric patients (P) Note 5: Tissue Harmonic Imaging (N)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use.
(Per 21 CFR 801.109)
(Division Sign-Off)
Indications For Use
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K993517
Section 4.3, Page 1 of 8
{7}------------------------------------------------
Combison 530D Ultrasound System S-AB 2-5 Abdominal Curved Array Transducer
Indications for Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| A | B | M* | PWD* CWD* | Color Doppler* | Power (Amplitude) Doppler* | Color Velocity Imaging | Combined (Specify)* | Other (Specify) | |
| Ophthalmic | |||||||||
| Fetal | E | E | E | E | E | Note 1 | Notes 3,5 | ||
| Abdominal | E | E | E | E | E | Note 1 | Notes 3,5 | ||
| Intra-Operative (Specify) | |||||||||
| Intraoperative Neurological | |||||||||
| Pediatric | |||||||||
| Small Organ (Specify) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Cardiac | |||||||||
| Transesophageal | |||||||||
| Transrectal | |||||||||
| Transvaginal | |||||||||
| Transurethral | |||||||||
| Intravascular | |||||||||
| Peripheral Vascular | |||||||||
| Laparascopic | |||||||||
| Muscular-Skeletal Conventional | |||||||||
| Muscular-Skeletal Superficial | |||||||||
| Others (Specify) |
N = new indication; P = previously cleared in K940942 Combison 530D Ultrasound System,
P =previously cleared in K974813 Combison 530D System with Power Doppler, E=added under Appendix E
Other Indications or Modes:
Note 1: PWD/Color Doppler, PWD/ Power Doppler (E) Note 3: Includes imaging for guidance of biopsy (E) Note 5: Tissue Harmonic Imaging (N)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
|---|---|---|
| Prescription Use | ||
| (Per 21 CFR 801.109) | ||
| (Division Sign-Off) | ||
| Division of Reproductive, Abdominal, ENT, | ||
| Indications For Use | and Radiological Devices | Section 4.3, Page |
510(k) Number
Section 4.3, Page 2 of 8
{8}------------------------------------------------
Combison 530D Ultrasound System S-ACP 3-5 Abdominal Curved Array Transducer
Indications for Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation (*includes simultaneous B-mode) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M* | PWD* | CWD* | ColorDoppler* | Power(Amplitude)Doppler* | ColorVelocityImaging | Combined(Specify)* | Other(Specify) |
| Ophthalmic | ||||||||||
| Fetal | E | E | E | E | P1 | Note 1 | Notes 3,5 | |||
| Abdominal | E | E | E | E | E | P1 | Note 1 | Notes 3,5 | ||
| Intra-Operative(Specify) | ||||||||||
| IntraoperativeNeurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ(Specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparascopic | ||||||||||
| Muscular-SkeletalConventional | ||||||||||
| Muscular-SkeletalSuperficial | ||||||||||
| Others(Specify) |
N = new indication; P = previously cleared in K940942 Combison 530D Ultrasound System, P =previously cleared in K974813 Combison 530D System with Power Doppler, E=added under Appendix E
Other Indications or Modes:
Note 1: PWD/Color Doppler, PWD/ Power Doppler (E) Note 3: Includes imaging for guidance of biopsy (E) Note 5: Tissue Harmonic Imaging (N)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
Indications For Use
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K993517
Section 4.3, Page 3
Section 4.3, Page 3 of 8
{9}------------------------------------------------
Combison 530D Ultrasound System S-ACP 4-7 Abdominal Curved Array Transducer
Indications for Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation (*includes simultaneous B-mode) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M* | PWD* | CWD* | ColorDoppler* | Power(Amplitude)Doppler* | ColorVelocityImaging | Combined(Specify)* | Other(Specify) |
| Ophthalmic | ||||||||||
| Fetal | E | E | E | E | E | Note 1 | Notes 3,5 | |||
| Abdominal | E | E | E | E | E | Note 1 | Notes 3,5 | |||
| Intra-Operative(Specify) | ||||||||||
| IntraoperativeNeurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ(Specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparascopic | ||||||||||
| Muscular-SkeletalConventional | ||||||||||
| Muscular-SkeletalSuperficial | ||||||||||
| Others(Specify) |
N = new indication; P = previously cleared in K940942 Combison 530D Ultrasound System, P =previously cleared in K974813 Combison 530D System with Power Doppler, E=added under Appendix E
Other Indications or Modes:
Note 1: PWD/Color Doppler, PWD/ Power Doppler (E) Note 3: Includes imaging for guidance of biopsy (E) Note 5: Tissue Harmonic Imaging (N)
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| -------------------------------------------------------- |
| Prescription Use | ✓ |
|---|---|
| (Per 21 CFR 801.109) |
| (Division Sign-Off) |
|---|
| Division of Reproductive, Abdominal, ENT, |
Indications For Use
and Radiological Devic 510(k) Number
Section 4.3, Page 4 of 8
{10}------------------------------------------------
Combison 530D Ultrasound System S-NLP 5-10 Small Part Linear Array Transducer
Indications for Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | A | B | M* | PWD* | CWD* | Color Doppler* | Power (Amplitude) Doppler* | Color Velocity Imaging | Combined (Specify)* | Other (Specify) |
|---|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intra-Operative(Specify) | ||||||||||
| IntraoperativeNeurological | • | |||||||||
| Pediatric | E | E | E | E | P1 | Note 1 | Notes 3,5 | |||
| Small Organ(Specify) See Note4 | E | E | E | E | P1 | Note 1 | Notes 3,5 | |||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | E | E | E | E | P1 | Note 1 | Notes 3,5 | |||
| Laparascopic | ||||||||||
| Muscular-SkeletalConventional | E | E | E | E | P1 | Note 1 | Notes 3,5 | |||
| Muscular-SkeletalSuperficial | ||||||||||
| Others(Specify) |
N = new indication; P = previously cleared in K940942 Combison 530D Ultrasound System,
P =previously cleared in K974813 Combison 530D System with Power Doppler, E=added under Appendix E
Other Indications or Modes:
Note 1: PWD/Color Doppler, PWD/ Power Doppler (E)
Note 3: Includes imaging for guidance of biopsy (E)
Note 4: For example: thyroid,testicles, salivary gland, breast, lymph nodes and pediatric patients Note 5: Tissue Harmonic Imaging (N)
Concurrence of CORH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
✓
David G. Seggern
Division of Reproductive, Abdominal, EN and Rac
{11}------------------------------------------------
510(K) Number:
Device Name: Transducer:
Combison 530D Ultrasound System S-VAW 3-5 Abdominal Volume Transducer
Indications for Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation (*includes simultaneous B-mode) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M* | PWD* | CWD* | ColorDoppler* | Power(Amplitude)Doppler* | ColorVelocityImaging | Combined(Specify)* | Other(Specify) |
| Ophthalmic | ||||||||||
| Fetal | E | E | E | E | E | Note 1 | Notes 2,3,5 | |||
| Abdominal | E | E | E | E | E | Note 1 | Notes 2,3,5 | |||
| Intra-Operative(Specify) | ||||||||||
| IntraoperativeNeurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ(Specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparascopic | ||||||||||
| Muscular-SkeletalConventional | ||||||||||
| Muscular-SkeletalSuperficial | ||||||||||
| Others(Specify) |
N = new indication; P = previously cleared in K940942 Combison 530D Ultrasound System,
P =previously cleared in K974813 Combison 530D System with Power Doppler, E=added under Appendix E
Other Indications or Modes: Note 1: PWD/Color Doppler, PWD/ Power Doppler (E) Note 2: 3D Volume Imaging Mode (E) Note 3: Includes imaging for guidance of biopsy (E) Note 5: Tissue Harmonic Imaging (N)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109) ✓
Daniel A. Slayton
(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological De 510(k)
Section 4.3, Page 6 of 8
{12}------------------------------------------------
Combison 530D Ultrasound System S-VAW 4-7 Abdominal Volume Transducer
| Mode of Operation (* includes simultaneous B-mode) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M* | PWD* | CWD* | ColorDoppler* | Power(Amplitude)Doppler* | ColorVelocityImaging | Combined(Specify)* | Other(Specify) |
| Ophthalmic | ||||||||||
| Fetal | P | P | P | P | P | Note 1 | Notes 2,3,5 | |||
| Abdominal | P | P | P | P | P | Note 1 | Notes 2,3,5 | |||
| Intra-Operative(Specify) | ||||||||||
| IntraoperativeNeurological | • | |||||||||
| Pediatric | P | P | P | P | P | Note 1 | Notes 2,3,5 | |||
| Small Organ(Specify)See Note4 | P | P | P | P | P | Note 1 | Notes 2,3,5 | |||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparascopic | ||||||||||
| Muscular-SkeletalConventional | ||||||||||
| Muscular-SkeletalSuperficial | ||||||||||
| Others (Specify) |
Indications for Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P = previously cleared in K992155 with Combison 530D Ultrasound System, P = previously cleared in K974813 Combison 530D System with power Doppler, E= added under Appendix E
Other Indications or Modes:
Note 1: PWD/Color Doppler, PWD/Power Doppler (P)
Note 2: 3D Volume Imaging Mode (P)
Note 3: Includes imaging for guidance of biopsy (P)
Note 4: For example: thyroid testicles, salivary gland, breast, lymph nodes and pediatric patient Note 5: Tissue Harmonic Imaging (N)
Concurrence of CDRH, Office of Dev
Prescription Use
(Per 21 CFR 801.109)
(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological D 510(k) Number
{13}------------------------------------------------
510(K) Number:
Device Name: Transducer:
Combison 530D Ultrasound System S-VNW 5-10 Small Part Volume Transducer
Indications for Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation (* includes simultaneous B-mode) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M* | PWD* | CWD* | ColorDoppler* | Power(Amplitude)Doppler* | ColorVelocityImaging | Combined(Specify)* | Other(Specify) | |
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intra-Operative(Specify) | |||||||||||
| IntraoperativeNeurological | |||||||||||
| Pediatric | P | P | P | P | P | Note 1 | Notes 2,3,5 | ||||
| Small Organ(Specify)See Note3 | P | P | P | P | P | Note 1 | Notes 2,3,5 | ||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | P | P | P | P | P | Note 1 | Notes 2,3,5 | ||||
| Laparascopic | |||||||||||
| Muscular-SkeletalConventional | P | P | P | P | P | Note 1 | Notes 2,3,5 | ||||
| Muscular-SkeletalSuperficial | |||||||||||
| Others (Specify) |
N = new indication; P = previously cleared in K992155 with Combison 530D Ultrasound System, P = previously cleared in K974813 Combison 530D System with power Doppler, E= added under Appendix E
Other Indications or Modes:
Note 1: PWD/Color Doppler, PWD/Power Doppler (P)
Note 2: 3D Volume Imaging Mode (P)
Note 3: Includes imaging for guidance of biopsy (P)
Note 4: For example: thyroid testicles, salivary gland, breast, lymph nodes and pediatric patient Note 5: Tissue Harmonic Imaging (N)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | |
|---|---|
| (Per 21 CFR 801.109) |
Indications For Use
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K993517
Section 4.3, Page 8 of 8
§ 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.