(33 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Musculo-skeletal Conventional and Musculo-skeletal Superficial. Musculo-skeletal Superficial is defined as muscle, tendon, ligament, bursa, and other soft tissue in the vicinity of the shoulder, elbow, wrist, knee, and/or ankle.
The Fukuda Denshi model UF-4500 (K022208) and the model UF-3500 (K955543) are general-purpose ultrasound systems that have been previously found to be substantially equivalent under the Food and Drug Administration's 510(k) process. These devices have not been changed or modified in any way. All software and hardware, all portions of the device that control the acoustic power out are unchanged. The addition of both conventional and musculoskeletal imaging as intended uses require no changes to the operating instructions.
The provided text describes a 510(k) submission for adding new intended uses (conventional and superficial musculoskeletal imaging) to existing Fukuda Denshi ultrasound scanners (UF-3500 and UF-4500).
Here's an analysis of the acceptance criteria and study information, based only on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state numerical acceptance criteria for diagnostic performance or reported performance metrics in a typical table format. The "Testing" section broadly concludes the device's capability.
| Acceptance Criteria Category | Specific Criteria (from text) | Reported Device Performance (from text) |
|---|---|---|
| Acoustic Output Limits | Remains below maximums established for Track 1 devices by "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" (September 30, 1997). (Specific limits for Peripheral Vessel, Cardiac, Fetal Imaging & Other, Ophthalmic are provided in a table, e.g., ISPTA3 < 190 Mw/CM², MI < 1.9 for Cardiac; ISPTA3 < 28 Mw/CM², MI < 0.23 for Ophthalmic). | The devices' derated acoustic output limits remain below the established maximums. |
| Image Quality | Implicit criteria: Capable of accurately and reproducibly imaging musculoskeletal structures. | "these devises have exhibited the capability of accurately and reproducibly imaging the musculoskeletal structure." |
| Safety and Effectiveness | Device is safe and effective in obtaining conventional and superficial musculoskeletal images. | "Fukuda Denshi has demonstrated through this study that the device is safe and effective in obtaining conventional and superficial musculoskeletal images" |
| Substantial Equivalence | Equivalent to predicate devices (ATL model Level 10 HDI Ultrasound System (K961459) and GE Model LOGIQ 500 (K970901)) for the new intended use. | "is substantially equivalent to the predicate device." |
| Patient Contact Materials | No changes required to patient contact materials for the new intended use. | "Patient contact materials have not changed" |
| Software/Hardware Changes | No changes to hardware or software that control the device or acoustic output are required for the new intended use. | "No changes to the hardware or software that control the device or the acoustic output were required to support the claims for musculoskeletal imaging." |
| Operating Instructions | No changes to operating instructions are required for the new intended use. | "The addition of both conventional and musculoskeletal imaging as intended uses require no changes to the operating instructions." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified. The document states "Skilled sonographers using both the UF-3500 and the UF-4500 obtained images."
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
- Number of Experts: "a radiologist" (singular, implying one).
- Qualifications of Experts: The expert was a "radiologist." No specific tenure or sub-specialty experience is mentioned (e.g., "10 years of experience").
4. Adjudication Method for the Test Set:
- The document states, "All imaged were reviewed by a radiologist who rendered findings and clinical impression." This implies a single-reader review, not a formal adjudication method (like 2+1 or 3+1). There is no mention of disagreement resolution.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
- No MRMC study was mentioned. This submission is for an ultrasound scanner being used for new indications, not an AI-powered device or an AI assistance tool for human readers. Therefore, there is no information on human reader improvement with/without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
- Not applicable. The device in question is a diagnostic ultrasound scanner that is operated by a sonographer and interpreted by a radiologist. It is not an algorithm-only device. The study described involves human operators and interpreters.
7. The Type of Ground Truth Used:
- The ground truth was established by a "radiologist who rendered findings and clinical impression." This leans towards expert consensus/clinical impression, albeit from a single expert as described. There is no mention of pathology or outcomes data being used as ground truth.
8. The Sample Size for the Training Set:
- Not applicable. The description refers to a study performed to demonstrate the capability of existing ultrasound diagnostic equipment for new intended uses, not a machine learning model requiring a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no mention of a training set for a machine learning model.
{0}------------------------------------------------
MAY 2 0 1998
510(k) Summary
New Intended use ... Musculoskeletal Imaging
Fukuda Denshi General Purpose Ultrasound Scanners UF-3500 (K955543) and UF-4500 (K922208)
Submitter:
FUKUDA DENSHI AMERICA CORP. 17725 NE 65th St., Bldg C Redmond WA 98052 425/881-7737 Tel: Fax: 425/869-2018
Contact Person:
David J. Geraghty Regulatory Affairs Manager FUKUDA DENSHI AMERICA CORP. 17725 NE 65th St., Bldg C Redmond WA 98052 425/881-7737 Tel: 425/869-2018 Fax:
Date Prepared:
March 26, 1998
Device Name:
New Intended Use:
Conventional and Superficial Musculoskeletal Imaging for the
- Fukuda Denshi FF sonic model UF-3500 General . Purpose Ultrasound Scanner (K955543)and the
- Fukuda Denshi FF sonic model UF-4500 General . Purpose Ultrasound Scanner (K922208)
Common Name:
Conventional and Superficial Musculoskeletal Imaging
Classification Name:
Ultrasonic Pulsed Echo Imaging System (§892.1560) Diagnostic Ultrasonic Transducer (§892.1560)
Legally Marketed Device:
{1}------------------------------------------------
Description:
The Fukuda Denshi model UF-4500 (K022208) and the model UF-3500 (K955543) are general-purpose ultrasound systems that have been previously found to be substantially equivalent under the Food and Drug Administration's 510(k) process. These devices have not been changed or modified in any way. All software and hardware, all portions of the device that control the acoustic power out are unchanged.
The addition of both conventional and musculoskeletal imaging as intended uses require no changes to the operating instructions.
Intended Use:
As originally submitted, these devices are 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 (UF-4500 only), transrectal, transvaginal (UF-4500 only),, and peripheral vessel scanning. This submission adds conventional and superfical musculoskeletal imaging to both devices.
Both the UF-3500 and the UF-4500 are prescription devices intended to by used by or on the order of a physician or similarly qualified health care professional. Both are intended to be used in a doctor's office and all hospital environments; ER ICU, CCU, OR, etc. These devices are 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. These devices are not intended for home use.
{2}------------------------------------------------
Technological Characteristics
The UF-3500 and UF-4500 incorporate microprocessors in a manner similar to the predicate devices. No changes to the hardware or software that control the device or the acoustic output were required to support the claims for musculoskeletal imaging. Conventional and superficial musculoskeletal imaging is possible with linear probes in B-Mode. Patient contact materials have not changed
Both devices' derated acoustic output limits remain 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 |
Testing:
Skilled sonographers using both the UF-3500 and the UF-4500 obtained images. All imaged were reviewed by a radiologist who rendered findings and clinical impression.
Conclusion:
Based on the anatomical identification of musculoskeletal soft tissues and the diagnostic images obtained from the UF-3500 and the UF-4500, these devises have exhibited the capability of accurately and reproducibly imaging the musculoskeletal structure. Fukuda Denshi has demonstrated through this study that the device is safe and effective in obtaining conventional and superficial musculoskeletal images and is substantially equivalent to the predicate device.
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized eagle or bird in flight, with three curved lines forming the body and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 0 1998
David J. Geraghty Regulatory Affairs Manager Fukuda Denshi America Corp. 17725 NE 65th Street Redmond, WA 98052
Re: K981404 Fukuda Denshi Ultrasound Scanners Models UF-3500 and UF-4500 Dated: March 23, 1998 Received: April 17, 1998 Regulatory class: II 21 CFR 892.1560/Procode: 90 IYO 21 CFR 892.1570/Procode: 90 ITX
Dear Mr. Geraghty:
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 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. You may, therefore, market the device, subject to the general controls provisions Act (Act). The general controls provisions of the Act include requirements for registration, listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.
This determination of substantial equivalence applies to the following transducers intended for use with the Fukuda Denshi Ultrasound Scanners Models UF-3500 and UF-4500, as described in your premarket notification:
Transducer Model Number
FUT-L104 (5.0 MHz, 60mm) FUT-L106 (7.5 MHz, 40mm)
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.
{4}------------------------------------------------
Page 2 - David J. Geraghty
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 provision 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 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 Rodrigo C. Perez at (301) 594-1212.
Sincerely yours,
Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat. and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
{5}------------------------------------------------
Fill out one form for each ultrasound system or transducer
510(k) Number (if known):
Device Name:
Fukuda Denshi model UF-3500 System
Indications for Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows
| Clinical Application | A | B | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) |
|---|---|---|---|---|---|---|---|---|
| Ophthalmic | ||||||||
| Fetal | P | |||||||
| Abdominal | P | |||||||
| Intraoperative (Specify) | P | |||||||
| Intraoperative | ||||||||
| Neurological | ||||||||
| Pediatric | P | |||||||
| Small Organ (Specify) | P | |||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Cardiac | ||||||||
| Transesophageal | ||||||||
| Transrectal | P | |||||||
| Transvaginal | ||||||||
| Intravascular | ||||||||
| Peripheral Vessel | P | |||||||
| Laparoscopic | ||||||||
| Musculo-skeletalConventional | N | |||||||
| Musculo-skeletalSuperficial | N | |||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Intraoperative is defined as the abdominal region and the periphery Other Indication or Modes:
Small Organ is defined as thyroid, breast, and testes
Musculo-skeletal Superficial is defined as muscle, tendon, ligament, bursa, and other soft tissue in the vieinity of the shoulder, elbow, wrist, knee, and/or ankle.
(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 K981404
Prescription Use (Per 21 CRF 801.109)
Page: 1 of 6
{6}------------------------------------------------
Fill out one form for each ultrasound system or transducer
510(k) Number (if known):
Device Name:
Fukuda Denshi model UF-3500 w/ FUT-L104 Probe
Indications for Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows
| Clinical Application | A | B | Mode of Operation | ||||||
|---|---|---|---|---|---|---|---|---|---|
| CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (Specify) | Other (Specify) | ||||
| Ophthalmic | |||||||||
| Fetal | |||||||||
| Abdominal | P | ||||||||
| Intraoperative (Specify) | |||||||||
| Intraoperative | |||||||||
| Neurological | |||||||||
| Pediatric | P | ||||||||
| Small Organ (Specify) | P | ||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Cardiac | |||||||||
| Transesophageal | |||||||||
| Transrectal | |||||||||
| Transvaginal | |||||||||
| Intravascular | |||||||||
| Peripheral Vessel | P | ||||||||
| Laparoscopic | |||||||||
| Musculo-skeletal | N | ||||||||
| Conventional | |||||||||
| Musculo-skeletal | N | ||||||||
| Superficial | |||||||||
| 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
Musculo-skeletal Superficial is defined as muscle, tendon, ligament, bursa, and other soft tissue in the vicinity of the shoulder, elbow, wrist, knee, and/or ankle.
(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 Devic
510(k) Number
Prescription Use (Per 21 CRF 801.109)
Page: 2 of 6
{7}------------------------------------------------
Fill out one form for each ultrasound system or transducer
510(k) Number (if known):
Device Name:
Fukuda Denshi model UF-3500 w/ FUT-L106 Probe
Indications for Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) | ||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | P | |||||||||
| Intraoperative (Specify) | ||||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (Specify) | P | |||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vessel | P | |||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | N | |||||||||
| Musculo-skeletalSuperficial | N | |||||||||
| Other (specify) | ・・、 |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Small Organ is defined as thyroid, breast, and testes Other Indication or Modes:
Musculo-skeletal Superficial is defined as muscle, tendon, ligament, bursa, and other soft tissue in the vicinity of the shoulder, elbow, wrist, knee, and/or ankle.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Higgins
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Device
510(k) Number
Prescription Use (Per 21 CRF 801.109)
Page: 3 of 6
{8}------------------------------------------------
Fill out one form for each ultrasound system or transducer
510(k) Number (if known):
Device Name:
Fukuda Denshi model UF-4500 System
Indications for Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows
| Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (Specify) | Other (Specify) |
| Ophthalmic | ||||||||
| Fetal | P | |||||||
| Abdominal | P | |||||||
| Intraoperative (Specify) | P | |||||||
| Intraoperative | ||||||||
| Neurological | ||||||||
| Pediatric | P | |||||||
| Small Organ (Specify) | P | |||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Cardiac | P | |||||||
| Transesophageal | ||||||||
| Transrectal | P | |||||||
| Transvaginal | P | |||||||
| Intravascular | ||||||||
| Peripheral Vessel | P | |||||||
| Laparoscopic | ||||||||
| Musculo-skeletal Conventional | N | |||||||
| Musculo-skeletal Superficial | N | |||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Intraoperative is defined as the abdominal region and the periphery Other Indication or Modes:
Small Organ is defined as thyroid, breast, and testes
Musculo-skeletal Superficial is defined as muscle, tendon, ligament, bursa, and other soft tissue in the vicinity of the shoulder, elbow, wrist, knee, and/or ankle.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Timith le. Sefrom
(Division Sign Off)
(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological Devic
510(k) Number
Prescription Use (Per 21 CRF 801.109)
Page: 4 of 6
{9}------------------------------------------------
Fill out one form for each ultrasound system or transducer
510(k) Number (if known):
Device Name:
Fukuda Denshi model UF-4500 w/ FUT-L104 Probe
Indications for Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows
| Clinical Application | A | B | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) |
|---|---|---|---|---|---|---|---|---|
| Ophthalmic | ||||||||
| Fetal | P | |||||||
| Abdominal | P | |||||||
| Intraoperative (Specify) | ||||||||
| Intraoperative | ||||||||
| Neurological | ||||||||
| Pediatric | P | |||||||
| Small Organ (Specify) | P | |||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Cardiac | ||||||||
| Transesophageal | ||||||||
| Transrectal | ||||||||
| Transvaginal | ||||||||
| Intravascular | ||||||||
| Peripheral Vessel | P | |||||||
| Laparoscopic | ||||||||
| Musculo-skeletalConventional | N | |||||||
| Musculo-skeletalSuperficial | N | |||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Small Organ is defined as thyroid, breast, and testes Other Indication or Modes:
Musculo-skeletal Superficial is defined as muscle, tendon, ligament, bursa, and other soft tissue in the vicinity of the shoulder, elbow, wrist, knee, and/or ankle. ----------------------------------------------------------------------------------------------------------------------------------
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
David G. Flynn
(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological Devic
510(k) Number
Prescription Use (Per 21 CRF 801.109)
Page: 5 of 6
{10}------------------------------------------------
Fill out one form for each ultrasound system or transducer
510(k) Number (if known):
Device Name:
Fukuda Denshi model UF-4500 w/ FUT-L106 Probe
Indications for Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows
| Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) | |
| Ophthalmic | |||||||||
| Fetal | P | ||||||||
| Abdominal | P | ||||||||
| Intraoperative (Specify) | |||||||||
| Intraoperative | |||||||||
| Neurological | |||||||||
| Pediatric | |||||||||
| Small Organ (Specify) | P | ||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Cardiac | |||||||||
| Transesophageal | |||||||||
| Transrectal | |||||||||
| Transvaginal | |||||||||
| Intravascular | |||||||||
| Peripheral Vessel | P | ||||||||
| Laparoscopic | |||||||||
| Musculo-skeletalConventional | N | ||||||||
| Musculo-skeletalSuperficial | 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
Musculo-skeletal Superficial is defined as muscle, tendon, ligament, bursa, and other soft tissue in the vicinity of the shoulder, elbow, wrist, knee, and/or ankle.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David U. Hlyson
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT and Radiological Device
510(k) Number
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.