(248 days)
This device is intended to be used for applications in fetal. abdominal, intraoperative (defined as the abdominal region and periphery), pediatric, small organ (defined as thyroid, breast and testes), cardiac, transrectal, transvaginal, and peripheral vessel scanning. Ultrasonic probes are available to obtain images either from the surface of the skin, transrectally, transvaginally or intraoperatively. The UF-5800A incorporates built-in measurement and calculation packages that are to be used by competent health care professionals. The UF-5800A with optional Doppler (UF-5800DU) is a prescription device intended to by used by or on the order of a physician or similarly qualified health care professional. The UF-5800 is intended to be used in a doctor's office and all hospital environments; ER ICU, CCU, OR, etc. This device is intended to be use on any patient; neonate, pediatric, or adult; where the placement and positioning of the transducer does not interfere with or complicate the treatment of the patient. This device is not intended for home use.
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Intraoperative (Abdominal region and periphery), Pediatric, Small Organ (thyroid, breast, and testes), Cardiac, Transrectal, Transvaginal, Peripheral Vessel, Musculo-skeletal Conventional, Musculo-skeletal Superficial.
The model UF-5800 is a portable, General Purpose Ultrasound Scanning System. The unit will be marketed as the UF-5800A General Purpose Ultrasound Scanner without Doppler. The addition of the optional UF-5800DU Doppler unit will add black and white Doppler capability to the UF-5800A. This ultrasonic device is designed to project ultrasound waves into body tissue and to present the returned echo information on its gray scale monitor. The resulting information is displayed in M-mode, B-Mode, Doppler (both CW and pulsed) modes, or in combinations of modes on the system's 7 inch diagonal video monitor as a 16 level grayscale or black and white image.
The Fukuda Denshi FF sonic model UF-5800A is a general-purpose ultrasound scanner with an optional Doppler unit (UF-5800DU). Here's an analysis of its acceptance criteria and the study that proves it meets those criteria, based on the provided document.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Fukuda Denshi FF sonic model UF-5800A are primarily based on demonstrating substantial equivalence to predicate devices and adherence to established safety and performance standards. The "reported device performance" section directly addresses how the device meets these criteria through various tests.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Substantial Equivalence | The device must be as safe, as effective, and perform as well as or better than the legally marketed predicate devices (Fukuda Denshi models UF-4500 and UF-3500, and Medison SonoAce 4800). This includes technological characteristics not raising new safety/efficacy issues. | Laboratory testing was conducted to validate and verify that the UF-5800A and UF-5800DU "met all design specifications and is substantially equivalent to the currently marketed FUKUDA DENSHI models UF-4500 and UF-3500 as well as the Medison SonoAce 4800." The technological characteristics, including the microprocessor, linear and convex probes (same as predicate Fukuda Denshi devices), and acceptance of sector and CW Doppler probes (similar to Medison SonoAce 4800), were deemed not to raise new safety or efficacy issues. |
| Environmental Safety | Compliance with environmental testing identified in the FDA's DCRND November 1993 "Reviewer Guidance Document for Premarket notification Submissions" Draft Guidance Document. | Environmental testing, as per the specified FDA guidance document, was performed. (Specific results are not detailed in this summary, but the conclusion states "demonstrate that the device is as safe..."). |
| Acoustic Output | Derated acoustic output limits must be below the maximums established for Track 1 devices as listed in the "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" issued September 30, 1997. Specific limits provided in the table: - Peripheral Vessel: ISPTA3 < 720 Mw/CM², MI < 1.9 - Cardiac: ISPTA3 < 430 Mw/CM², MI < 1.9 - Fetal Imaging & Other: ISPTA3 < 94 Mw/CM², MI < 1.9 - Ophthalmic: ISPTA3 < 17 Mw/CM², MI < 0.23 | "The device's derated acoustic output limits are below the maximums established for Track 1 devices as listed" in the specified guidance document. Additional testing was performed to demonstrate "compliance with the voluntary NEMA/AIUM 'Acoustic Output Measurement and Labeling Standard for Diagnostic Ultrasound Equipment,' 1992." The FDA approval also requires a post-clearance special report containing "complete information, including acoustic output measurements based on production line devices," to verify these limits for production units. |
| Electrical Safety | Compliance with ANSI/AAMI ES1-1993, "safe current limits for electromedical apparatus." | Testing was performed to demonstrate "compliance with... ANSI/AAMI ES1-1993, 'safe current limits for electromedical apparatus.'" (Specific results are not detailed, but the conclusion states "demonstrate that the device is as safe..."). |
| Biocompatibility & Thermal | Patient contact materials must be biocompatible and meet thermal requirements. | "Patient contact materials were confirmed to be biocompatable and met thermal requirements." (Specific details or reports are not provided in this summary). |
| System Operation & Software | Hazard analysis of the system and its software, and testing conducted to verify the system's overall operation. Addressed safety issues of software-controlled medical devices similar to predicate devices. | "A hazard analysis of the system and its software was performed and testing was conducted to verify the systems overall operation." Safety issues related to software-controlled medical devices were stated to be "the same issues already addressed by the predicate devices and are addressed in the system's hazard analysis and in the system validation." (Specific details of the hazard analysis or validation are not provided). |
| Intended Use | Device must be suitable for the specified clinical applications (fetal, abdominal, intraoperative, pediatric, small organ, cardiac, transrectal, transvaginal, peripheral vessel scanning) and modes of operation (M-mode, B-Mode, Doppler, combinations). This includes appropriate probes and measurement packages. | The device is described as "intended to be used for applications in fetal, abdominal, intraoperative..., pediatric, small organ..., cardiac, transrectal, transvaginal, and peripheral vessel scanning." It displays in "M-mode, B-Mode, Doppler (both CW and pulsed) modes, or in combinations of modes." Various probes (linear, convex, sector, CW Doppler) are described as available and compatible for obtaining images from various surfaces/cavities. Built-in measurement and calculation packages are included. The Indications for Use forms for each probe (FUT-L104, FUT-L106, FUT-C111, FUT-TV36-5, FUT-TR31-5, FUT-IO07, FUT-IO03, FUT-IO10, FUT-IO17, FUT-SM181-35A, FUT-SM121-50A, FUT-SM201-25A, FUT-ID121-25A) explicitly list the accepted clinical applications and modes of operation for each specific probe. "N" indicates a new indication, implying these were evaluated and accepted. |
2. Sample Size Used for the Test Set and Data Provenance
The documentation does not provide details on the sample size used for the test set in terms of patient data or clinical images. The testing described focuses on engineering validation and verification of the device itself (environmental, acoustic, electrical, biocompatibility, software operation) rather than a performance study involving a specific clinical test set.
- Sample Size: Not specified for clinical data. The "test set" primarily refers to the device and its components undergoing laboratory tests.
- Data Provenance: Not applicable in the traditional sense of a clinical outcomes study. The testing is laboratory-based and device-centric.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided. The study detailed is a technical validation and verification of the ultrasound system's safety and performance against engineering standards and substantial equivalence criteria, not a clinical trial requiring expert ground truth for diagnostic accuracy.
4. Adjudication Method for the Test Set
Not applicable. There is no mention of a clinical test set requiring expert adjudication for ground truth establishment. The evaluation is based on engineering conformity and regulatory standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done, and therefore, no effect size of human readers improving with AI vs. without AI assistance is reported. This submission predates widespread AI integration in medical devices and focuses on foundational device safety and performance.
6. Standalone (Algorithm Only) Performance
Not applicable. This device is a general-purpose ultrasound scanner, a hardware and software system for image acquisition and display, not an AI-driven algorithm with standalone diagnostic capabilities.
7. Type of Ground Truth Used
The "ground truth" for this submission is established through:
- Engineering Specifications and Design Documents: The UF-5800A/DU met "all design specifications."
- Regulatory Standards: Compliance with FDA guidance documents, NEMA/AIUM standards (for acoustic output), and ANSI/AAMI standards (for electrical safety).
- Predicate Device Performance: The device was deemed "as safe, as effective, and performs as well as or better than the legally marketed predicate devices."
- Biocompatibility and Thermal Requirements: Verified through specific testing.
- Hazard Analysis and System Validation: For overall operation and software safety.
There is no mention of ground truth established from expert consensus, pathology, or outcomes data in the context of a clinical performance study.
8. Sample Size for the Training Set
Not applicable. This device does not involve machine learning or AI models that require a "training set" of data in the contemporary sense. The "training" here would refer to the engineering design and development process based on established ultrasound physics and medical imaging principles.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the context of machine learning. The device's "training" and development were based on established scientific principles of ultrasound technology, engineering standards, and the successful designs of predicate devices.
{0}------------------------------------------------
OCT 1 5 1999
510(k) Summarv Fukuda Denshi FF sonic model UF-5800A
General Purpose Ultrasound Scanner with Doppler (UF-5800DU)
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR part 807.92.
Submitter:
FUKUDA DENSHI AMERICA CORP. 17725 NE 65th St., Bldg C Redmond WA 98052 Tel: 425/881-7737 Fax: 425/869-2018
Contact Person:
David J. Geraghtv Regulatory Affairs Manager FUKUDA DENSHI AMERICA CORP. 17725 NE 65th St., Bldg C Redmond WA 98052 Tel: 425/881-7737 Fax: 425/869-2018
Date Prepared:
January 20, 1998
Device Name:
Proprietary Name:
Fukuda Denshi FF sonic model UF-5800A General Purpose Ultrasound Scanner with Doppler option (UF-5800DU)
Common Name:
General Purpose Ultrasound Scanner with Doppler Option
Classification Name:
Ultrasonic Pulsed Doppler Imaging System (§892.1550) Ultrasonic Pulsed Echo Imaging System (§892.1560) Diagnostic Ultrasonic Transducer (§892.1560)
Legally Marketed Device:
- FUKUDA DENSHI FF sonic model UF-4500 General ● Purpose Ultrasound Scanner (K922208)
- FUKUDA DENSHI FF sonic model UF-3500 General . Purpose Ultrasound Scanner (K955543)
- Medison model SonoAce 4800 (K925582) .
{1}------------------------------------------------
Description:
The model UF-5800 is a portable, General Purpose Ultrasound Scanning System. The unit will be marketed as the UF-5800A General Purpose Ultrasound Scanner without Doppler. The addition of the optional UF-5800DU Doppler unit will add black and white Doppler capability to the UF-5800A
This ultrasonic device is designed to project ultrasound waves into body tissue and to present the returned echo information on its gray scale monitor. The resulting information is displayed in M-mode, B-Mode, Doppler (both CW and pulsed) modes, or in combinations of modes on the system's 7 inch diagonal video monitor as a 16 level grayscale or black and white image.
Intended Use:
This device is intended to be used for applications in fetal. abdominal, intraoperative (defined as the abdominal region and periphery), pediatric, small organ (defined as thyroid, breast and testes), cardiac, transrectal, transvaginal, and peripheral vessel scanning. Ultrasonic probes are available to obtain images either from the surface of the skin, transrectally, transvaginally or intraoperatively. The UF-5800A incorporates built-in measurement and calculation packages that are to be used by competent health care professionals. The UF-5800A with optional Doppler (UF-5800DU) is a prescription device intended to by used by or on the order of a physician or similarly qualified health care professional. The UF-5800 is intended to be used in a doctor's office and all hospital environments; ER ICU, CCU, OR, etc. This device is intended to be use on any patient; neonate, pediatric, or adult; where the placement and positioning of the transducer does not interfere with or complicate the treatment of the patient. This device is not intended for home use.
UF-5800 510(k) Submission 510(k) Summary.doc
January 20, 1998 Page 2 of S 4
{2}------------------------------------------------
Technological Characteristics
The UF-5800 incorporates a microprocessor in the same manner as the predicate devices. The linear and convex, probes, the same probes available for the Fukuda Denshi predicate device, are applicable to the UF-5800A. The UF-5800A will accept sector probes and, with the Doppler option, the CW Doppler probe in a manner similar to the Medison SonoAce 4800 predicate device. Patient contact materials are biocompatable and identical to the predicate Fukuda Denshi devices.
The technological characteristics do not raise new issues with the safety or efficacy of the device. Any safety issues that may be raised by a software controlled medical device are the same issues already addressed by the predicate devices and are addressed in the system's hazard analysis and in the system validation.
The device's derated acoustic output limits are below the maximums established for Track 1 devices as listed in the "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" issued September 30, 1997, and restated below:
| Use | ISPTA3(Mw/CM²) | ISPTA3(Mw/CM²) | MI |
|---|---|---|---|
| Peripheral Vessel | 720 | 190 | 1.9 |
| Cardiac | 430 | 190 | 1.9 |
| Fetal Imaging & Other* | 94 | 190 | 1.9 |
| Ophthalmic | 17 | 28 | 0.23 |
{3}------------------------------------------------
Testing:
Laboratory testing was conducted to validate and verify the FUKUDA DENSHI FF sonic model UF-5800A General Purpose Ultrasound Scanner with Doppler option (UF-5800DU) met all design specifications and is substantially equivalent to the currently marketed FUKUDA DENSHI models UF-4500 and UF-3500 as well as the Medison SonoAce 4800. This testing consisted of the environmental testing identified in the FDA's DCRND November 1993 "Reviewer Guidance Document for Premarket notification Submissions" Draft Guidance Document. Additional testing was performed to demonstrate compliance with the voluntary NEMA/AIUM "Acoustic Output Measurement and Labeling Standard for Diagnostic Ultrasound Equipment," 1992 and ANSI/AAMI ES1-1993, "safe current limits for electromedical apparatus." Patient contact surfaces were confirmed to be biocompatable and met thermal requirements. Finally, a hazard analysis of the system and its software was performed and testing was conducted to verify the systems overall operation.
Conclusion:
The conclusions drawn from the testing of the FUKUDA DENSHI FF sonic model UF-5800A General Purpose Ultrasound Scanner with Doppler option (UF-5800DU) demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed predicate devices, the FUKUDA DENSHI models UF-4500 (K92208) and UF-3500 (K955543) or the Medison SonoAce 4800 (K925582).
{4}------------------------------------------------
Image /page/4/Picture/1 description: The image is a black and white circular logo for the Department of Health & Human Services - USA. The logo features the department's name in a circular arrangement around an emblem. The emblem is a stylized image of three human profiles facing right, with flowing lines beneath them, resembling a bird or a ribbon.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 5 1999
Fukuda Denshi America Corporation c/o Susan D. Goldstein-Falk mdi Consultants, Inc. 55 Northern Blv. Suite 200 Great Neck, NY 11021
Re: K990401
Trade Name: Fukuda Denshi FF sonic UF-5800 General Purpose Ultrasound Scanning System with Doppler Regulatory Class: II
21CFR892.1550/Procode: 90 IYN 21CFR892.1560/Procode: 90 IYO 21CFR892.1570/Procode: 90 ITX Dated: August 12, 1999 Received: August 16, 1999
Dear Ms. Goldstein-Falk:
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 sonic UF-5800 General Purpose Ultrasound Scanning System, as described in your premarket notification:
Transducer Model Number
FUT-L104, FUT-L106, FUT-C111, FUT-TV36-5, FUT-TR31-5, FUT-io07, FUT-io10, FUT-io17, FUT-SM181-35A, FUT-SM121-50A, FUT-SM201-25A, FUT-ID121-25A,
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 regulation 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 - Ms. Susan D. Goldstein-Falk
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 investigational device exemptions (IDE) regulations, 21 CFR, Part 812. Therefore, your product labeling must be consistent with FDA's position on this use.
This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.
The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:
Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850
This letter will allow you to begin marketing your device as described in your premarket 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 general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
If you have any questions regarding the content of this letter, please contact Paul M. Gammell, Ph.D. at (301) 594-1212.
Sincerely vours.
Thos A. Segman
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
{6}------------------------------------------------
510(k) Number (if known):
Attachment #1
EXHIBIT D
(Revised)
Ultrasound Device Indications Statement
Fill out one form for each ultrasound system or transducer
4990401
Device Name:
Fukuda Denshi model UF-5800 System
Indications for Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) | |
| Ophthalmic | ||||||||||
| Fetal | N | N | B/M | |||||||
| Abdominal | N | N | B/M | |||||||
| Intraoperative (Specify) | N | N | B/M | |||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | N | N | N | B/M/D | ||||||
| Small Organ (Specify) | N | N | B/M | |||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | N | N | N | N | B/M/D | |||||
| Transesophageal | ||||||||||
| Transrectal | N | N | B/M | |||||||
| Transvaginal | N | N | B/M | |||||||
| Intravascular | ||||||||||
| Peripheral Vessel | N | N | N | B/M/D | ||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | N | |||||||||
| Musculo-skeletal | ||||||||||
| Superficial | N | |||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Other Indication or Modes:
Small Organ is defined as thyroid, breast, and testes.
Intraonerative is defined as the abdominal region and the periphery.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Seaman
Prescription Use (Per 21 CFR 801.109) (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number
Indications Statement revised
{7}------------------------------------------------
Fill out one form for each ultrasound system or transducer
Fukuda Denshi model UF-5800A w/ FUT-L104 Probe Device Name:
| Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows | ||
|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) |
|---|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | ||||||||||
| Fetal | N | N | B/M | |||||||
| Abdominal | N | N | • | B/M | ||||||
| Intraoperative (Specify) | ||||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | N | N | B/M | |||||||
| Small Organ (Specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vessel | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | N | B | ||||||||
| Musculo-skeletalSuperficial | N | B | ||||||||
| Laparoscopic |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Other Indication or Modes:
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of GDRH, Office of Device Evaluation (ODE)
David A. Leggett
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K990401
UF-5800 510(k) Submission Special Report REV B.doc
Prescription Use (Per 21 CFR 801.109) August 25, 1997
{8}------------------------------------------------
Fill out one form for each ultrasound system or transducer .
Fukuda Denshi model UF-5800A w/ FUT-L106 Probe Device Name:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (Specify) | Other (Specify) |
| Ophthalmic | ||||||||||
| Fetal | N | N | B/M | |||||||
| Abdominal | ||||||||||
| Intraoperative (Specify) | ||||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | N | N | B/M | |||||||
| Small Organ (Specify) | N | N | B/M | |||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vessel | N | N | B/M | |||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal Conventional | N | B | ||||||||
| Musculo-skeletal Superficial | N | B | ||||||||
| Laparoscopic |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Small Organ is defined as thyroid, breast, and testes.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Daniel A. Bergman
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K990401
Other Indication or Modes:
{9}------------------------------------------------
K 990401
Ultrasound Device Intended Use Form
Fill out one form for each ultrasound system or transducer
Fukuda Denshi model UF-5800A w/ FUT-C111 Probe Device Name:
| 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 | N | N | B/M | |||||||
| Abdominal | N | N | • | B/M | ||||||
| Intraoperative (Specify) | ||||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (Specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vessel | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | ||||||||||
| Musculo-skeletalSuperficial | ||||||||||
| Laparoscopic |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Other Indication or Modes:
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CPRH, Office of Device Evaluation (ODE)
Yamil C. Leyva
(Division Sign-Off)
( Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K992401
(Prescription Use (Per 21 CRF 801.109)
{10}------------------------------------------------
Fill out one form for each ultrasound system or transducer
Fukuda Denshi model UF-5800A w/ FUT-TV36-5 Probe Device Name:
| 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 | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | N | N | B/M | |||||||
| Intravascular | ||||||||||
| Peripheral Vessel | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Laparoscopic |
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
Other Indication or Modes:
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Oavid A. Sezenn
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devic 510(k) Number
Prescription Use (Per 21 CRF 801.109)
Page: 9 of 16
{11}------------------------------------------------
Fill out one form for each ultrasound system or transducer
Fukuda Denshi model UF-5800A w/ FUT-TR31-5 Probe Device Name:
Intended Use: Diagnostic ultrasound imaging or fluid Small Organ is defined as thyroid, breast, and testes 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 | ||||||||||
| Transrectal | N | N | B/M | |||||||
| Transvaginal | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vessel | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Laparoscopic |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Other Indication or Modes:.
(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, ENT,
and Radiological Devices
510(k) Number K990401
Prescription Use (Pep 21 CRF 801.109)
{12}------------------------------------------------
K990401
Ultrasound Device Intended Use Form
Fill out one form for each ultrasound system or transducer
Device Name: Fukuda Denshi model UF-5800A w/ FUT-1007 Probe
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) | |
| Ophthalmic | |||||||||||
| Fetal | N | N | B/M | ||||||||
| Abdominal | . | ||||||||||
| Intraoperative (Specify) | N | N | B/M | Abdominal | |||||||
| Intraoperative | |||||||||||
| Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ (Specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vessel | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal | |||||||||||
| Conventional | |||||||||||
| Musculo-skeletal | |||||||||||
| Superficial | |||||||||||
| Laparoscopic |
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
Other Indication or Modes:
Intraoperative is defined as the abdominal region and the periphery
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel A. Seggern
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Numbe
Prescription Use (Per 21 CRF 801.109)
{13}------------------------------------------------
99,040
Fill out one form for each ultrasound system or transducer
Fukuda Denshi model UF-5800A w/ FUT-IO03 Probe Device Name:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) |
| Ophthalmic | ||||||||||
| Fetal | N | N | B/M | |||||||
| Abdominal | ||||||||||
| Intraoperative (Specify) | N | N | B/M | Abdominal | ||||||
| IntraoperativeNeurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (Specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vessel | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | ||||||||||
| Musculo-skeletalSuperficial | ||||||||||
| Laparoscopic |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows
indication; P = previously cleared by FDA; E = added under Appendix E
Other Indication or Modes.
Intraoperative is defined as the abdominal region and the periphery
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel A. Severson
(Division Sign-Off) 4 Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number
Prescription Use (Per 21 CRF 801.109)
{14}------------------------------------------------
990401
Ultrasound Device Intended Use Form
Fill out one form for each ultrasound system or transducer
Fukuda Denshi model UF-5800A w/ FUT-IO10 Probe Device Name:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) |
| Ophthalmic | ||||||||||
| Fetal | N | N | B/M | |||||||
| Abdominal | ||||||||||
| Intraoperative (Specify) | N | N | B/M | Abdominal | ||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | N | N | B/M | |||||||
| Small Organ (Specify) | N | N | B/M | |||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vessel | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletalSuperficial | ||||||||||
| Laparoscopic |
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
Other Indication or Modes: Intraoperative is defined as the abdominal region and the periphery. Small Organ is defined as thyroid, breast, and testes.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Bergman
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number
Prescription Use (Per 21 CRF 801.109)
Page: 14 of 16
{15}------------------------------------------------
Fill out one form for each ultrasound system or transducer
Device Name: Fukuda Denshi model UF-5800A w/ FUT-IO17 Probe
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (Specify) | Other (Specify) |
| Ophthalmic | ||||||||||
| Fetal | N | N | B/M | |||||||
| Abdominal | • | B/M | ||||||||
| Intraoperative (Specify) | N | N | B/M | Abdominal | ||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | N | N | B/M | |||||||
| Small Organ (Specify) | N | N | B/M | |||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vessel | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Laparoscopic |
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
Other Indication or Modes: Intraoperative is defined as the abdominal region and the periphery Small Organ is defined as thyroid, breast, and testes.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel A. Szymm
on Sign-Off) Division of Reproductive, Abdominal, ENT, iological Device
Prescription Use (Per 21 CRF 801.109)
{16}------------------------------------------------
EXHIBIT D
(Revised)
Ultrasound Device Indications Statement
Fill out one form for each ultrasound system or transducer
|<990401
510(k) Number (if known): Device Name:
1.33.1
Device Name:
- b. 1.
Fukuda Denshi model UF-5800 w/ FUT-SM181-35A Probe
Indications for 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 | N | N | B/M | |||||||
| Abdominal | N | N | B/M | |||||||
| Intraoperative (Specify) | ||||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (Specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | N | N | N | B/M/D | ||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vessel | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | ||||||||||
| Musculo-skeletalSuperficial | ||||||||||
| Laparoscopic |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Other Indication or Modes:
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David h. Segerson
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
Indications Statement revised
{17}------------------------------------------------
EXHIBIT D (Revised)
Ultrasound Device Indications Statement
Fill out one form for each ultrasound system or transducer
K990401 510(k) Number (if known):
Device Name:
Fukuda Denshi model UF-5800 w/ FUT-SM121-50A Probe
Indications for 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 | N | N | B/M | |||||||
| Abdominal | N | N | B/M | |||||||
| Intraoperative (Specify) | ||||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | N | N | B/M | |||||||
| Small Organ (Specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | N | N | N | B/M/D | ||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vessel | N | N | N | B/M/D | ||||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | ||||||||||
| Musculo-skeletalSuperficial | ||||||||||
| Laparoscopic |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Other Indication or Modes:
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Segner
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number JC990
Prescription Use (Per 21 CFR 801.109)
2
Indications Statement revised
{18}------------------------------------------------
Fill out one form for each ultrasound system or transducer
Fukuda Denshi model UF-5800A w/ UF-5800DU and Device Name: FUT-SM201-25A Probe
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) |
| Ophthalmic | ||||||||||
| Fetal | N | N | B/M | |||||||
| Abdominal | N | N | B/M | |||||||
| Intraoperative (Specify) | ||||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (Specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | N | N | N | B/M/D | ||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vessel | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Laparoscopic |
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
Other Indication or Modes:
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Segerson
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological
imhar
tescription Use (Per 21 CRF 801.109)
{19}------------------------------------------------
K 990401
EXHIBIT D (Revised)
Ultrasound Device Indications Statement
Fill out one form for each ultrasound system or transducer
510(k) Number (if known):
Device Name:
Fukuda Denshi model UF-5800 w/ FUT-ID121-25A Probe
Indications for 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 | N | |||||||||
| Small Organ (Specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | N | |||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vessel | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Laparoscopic |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Other Indication or Modes:
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
David a. Leyem
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K190401
(Per 21 CFR 801.109)
Indications Statement revised
§ 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.