(82 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Pediatric, Small Organ (Thyroid, Breast and Testicles), Neonatal Cephalic, Adult Cephalic, Cardiac, Transesophageal, Peripheral Vascular.
ESAOTE's Mod.7200 is a compact ultrasound system used to perform non-invasive diagnostic general ultrasound studies. Its primary modes of operation are the following: B-Mode, M-Mode, Doppler and Color Flow Mapping. The MOD.7200 can be equipped with an LCD Color Display (Portable Configuration) or with a 15" Color Monitor and a cart (Mainframe Configuration). The full alphanumeric keyboard allows complete onscreen data entry of patient information and on-screen annotations. The MOD. 7200 uses annular phased array probes; its design provides a dynamically focused ultrasound beam. The MOD.7200 offers a vast selection of calculations and measurements which can be performed quickly and easily. The MOD. 7200 is designed for ease of use. The user interface allows the operator to perform an examination quickly and efficiently. Clearly labeled mode selection keys are easily accessed, and the system's "pop-up" menus allow the operator to change parameters with ease. The user may also access special function menus and perform calculations with a minimal number of key strokes. The MOD.7200 is equipped with a 3.5" floppy disk drive to simplify software modifications and provides fast, cost effective system upgrades. This drive can also be used for image storage. In addition, this system can be equipped with recording devices, including a S-VHS video recorder and a black-and-white or color page printer, which are controlled through the keyboard.
The provided document is a 510(k) premarket notification for the Biosound Esaote 7200 Ultrasound Imaging System, submitted in 1998. This type of submission focuses on demonstrating substantial equivalence to a predicate device already on the market, rather than on proving de novo safety and effectiveness through clinical trials with defined acceptance criteria and performance studies for an AI/ML device.
Therefore, the document does not contain the following information typically found in submissions for AI/ML devices:
- A table of acceptance criteria and reported device performance for an AI/ML algorithm.
- Sample sizes used for a test set or data provenance for AI/ML evaluation.
- Number of experts used to establish ground truth for a test set, or their qualifications.
- Adjudication method for a test set.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study results or effect sizes.
- Standalone performance for an AI algorithm.
- Type of ground truth used (e.g., expert consensus, pathology, outcomes data) in the context of an AI/ML performance study.
- Sample size for a training set.
- How ground truth for a training set was established.
Summary of the Document's Content Regarding Safety and Effectiveness:
The document establishes "substantial equivalence" of the 7200 Ultrasound Imaging System to a predicate device, the 7050 (AU3) Ultrasound Imaging System (K944287). This is the primary method described to demonstrate safety and effectiveness for conventional medical devices of this type at the time of submission.
Key points from the document:
- Predicate Device: 7050 (AU3) Ultrasound Imaging System (K944287).
- Demonstration of Safety and Effectiveness: The submission relies on establishing substantial equivalence to the legally marketed predicate device. This is achieved through a "Comparison Chart for Substantial Equivalence" (pages 1-2), which compares the technical characteristics and intended uses of the 7200 system with the 7050 system.
- Specific Comparisons: The comparison covers aspects like electrical safety (EN60601-1), ultrasound safety (Track 3 Acoustic Output Display), intended uses for various clinical applications (e.g., Cardiac, Vascular, Abdominal, Fetal), probe technology (Annular Array, Electronic Array, Doppler Probes), modes of operation (2D, M-Mode, PW, CW, CFM), imaging frequencies, display type, digital archival capabilities, VCR/page printer, and M&A capabilities.
- New vs. Previously Cleared Indications: The "Diagnostic Ultrasound Indications for Use Form" for the new 7200 system and its various transducers (pages 6-10) explicitly indicates which clinical applications are "N" (new indication) and which are "P" (previously cleared by FDA, meaning they are covered by the predicate device's clearance). The focus is on ensuring that the new device does not introduce new safety or effectiveness questions compared to the predicate for similar indications.
- Post-Clearance Requirement: The FDA letter (page 4) requires a post-clearance special report containing "acoustic output measurements based on production line devices." This ensures the device, once manufactured, continues to meet safety standards related to acoustic output. This is a safety check, not a performance study compared to a benchmark.
In conclusion, this document does not contain the information requested for AI/ML device acceptance criteria and performance studies because it relates to a conventional ultrasound imaging system from 1998, for which the regulatory pathway involved demonstrating substantial equivalence to a predicate device rather than a performance study specifically testing an AI/ML algorithm against defined metrics.
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K981293 page 1 of 3
JUN 3 0 1998
Safety and Effectiveness Summary 7200 Ultrasound Imaging System Biosound Esaote
Safety and Effectiveness Summary
The following safety and effectiveness summary has been prepared pursuant to requirement for 510(k) summaries specified in 21CFR 807.92(a).
807.92(a)(1)
Submitter Information
Colleen Hittle, Official Correspondent 8000 Castleway Drive Indianapolis, IN 46250 Phone: (317) 849-1916 Facsimile: (317) 577-9070
Colleen Hittle Contact Person:
March 13, 1998 Date:
807.92(a)(2)
Esaote
| Trade Name: | 7200 Ultrasound Imaging System | |
|---|---|---|
| Common Name: | Ultrasound Imaging System | |
| Classification Name(s): | Ultrasonic pulsed doppler imaging systemUltrasonic pulsed echo imaging system | 892.1550892.1560 |
| Classification Number: | 90IYN90IYO | |
| 807.92(a)(3) | Predicate Device(s) |
Additional Substantial Equivalence Information is provided in the following substantial Equivalence Comparison Table.
7050 (AU3)
{1}------------------------------------------------
Safety and Effectiveness Summary 7200 Ultrasound Imaging System Biosound Esaote
Comparison Chart for Substantial Equivalence
| 7200 | 7050 | |
|---|---|---|
| Electrical Safety | EN60601-1 | EN60601-1 |
| Ultrasound Safety | Track 3 (Acoustic Output Display) | Track 3 (Acoustic Output Display) |
| Intended Use | ||
| • Cardiac (Transthoracic) | YES | YES |
| • Cardiac (Transesophageal) | YES | YES |
| • Vascular | YES | YES |
| • Abdominal | YES | YES |
| • Fetal | YES | YES |
| • Adult Transcranial | YES | YES |
| • Neonatal Head/Small parts | YES | YES |
| • Endovaginal | NO | YES |
| • Endorectal | NO | YES |
| Biopsy Guidance | NO | YES |
| Probe Technology | ||
| • Annular Array | YES | YES |
| • Electronical Array | NO | YES |
| • Doppler Probes | YES | YES |
| Modes of operation | 2D, M-Mode, PW, CW, CFM | 2D, M-Mode, PW, CW, CFM |
| Imaging Frequencies | 2.5, 3.5, 5.0, 7.5, 10 MHz | 2.5, 3.5, 5.0, 7.5, 10 MHz |
| CFM/Doppler Frequencies | 2.0, 2.5, 3.3, 5.0, 6.6 MHz | 2.0, 2.5, 3.3, 5.0, 6.6 MHz |
| Display Type | SVGA | RGB |
| Digital Archival Capabilities | YES | YES |
| VCR / Page Printer | YES | YES |
| M&A Capabilities | Cardiac, Vascular, OB and general purpose measurements | Cardiac, Vascular, OB and general purpose measurements |
{2}------------------------------------------------
Safety and Effectiveness Summary 7200 Ultrasound Imaging System Biosound Esaote
807.92(a)(4)
Device Description
ESAOTE's Mod.7200 is a compact ultrasound system used to perform non-invasive diagnostic general ultrasound studies. Its primary modes of operation are the following: B-Mode, M-Mode, Doppler and Color Flow Mapping. The MOD.7200 can be equipped with an LCD Color Display (Portable Configuration) or with a 15" Color Monitor and a cart (Mainframe Configuration). The full alphanumeric keyboard allows complete onscreen data entry of patient information and on-screen annotations.
The MOD. 7200 uses annular phased array probes; its design provides a dynamically focused ultrasound beam. The MOD.7200 offers a vast selection of calculations and measurements which can be performed quickly and easily.
The MOD. 7200 is designed for ease of use. The user interface allows the operator to perform an examination quickly and efficiently. Clearly labeled mode selection keys are easily accessed, and the system's "pop-up" menus allow the operator to change parameters with ease. The user may also access special function menus and perform calculations with a minimal number of key strokes.
The MOD.7200 is equipped with a 3.5" floppy disk drive to simplify software modifications and provides fast, cost effective system upgrades. This drive can also be used for image storage.
In addition, this system can be equipped with recording devices, including a S-VHS video recorder and a black-and-white or color page printer, which are controlled through the keyboard.
807.92(a)(5)
Intended Use(s)
The 7200 Ultrasound Imaging System is a compact ultrasound system used to perform non-invasive diagnostic general ultrasound studies.
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 3 0 1998
Collen Hittle Official Correpondent Biosound Esaote, Inc. 8000 Castleway Dr. Indianapolis, IN 46250
K981293 Re: 7200 Ultrasound Imaging System Dated: April 7, 1998 Received: April 9, 1998 Regulatory class: II 21 CFR 892.1550/Procode: 90 IYN 21 CFR 892.1560/Procode: 90 IYO 21 CFR 892.1570/Procode: 90 ITX
Dear Ms. Collen:
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 The general controls provisions of the Act include provisions Act (Act). 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 7200 Ultrasound Imaging System, as described in your premarket notification:
Transducer Model Number
| 2535 | AA-C |
|---|---|
| 3550 | AA-C |
| 7510 | AA-C |
| 5 MHz | TEE |
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such Existing major regulations affecting your device can be additional controls. found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਜੋ 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 Reqister. 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 - Collen Hittle
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 Therefore, your product labeling must be consistent with FDA's CFR, Part 812. 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 Radioloqical 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 (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 requlation 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 tollfree number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
{5}------------------------------------------------
Page 3 - Collen Hittle
If you have any questions regarding the content of this letter, please contact
Paul Gammell, Ph.D. 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
{6}------------------------------------------------
Diagnostic Ultrasound Indications for Use Form
Mod.7200
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 | N | N | N | |||||
| Abdominal | N | N | N | N | N | |||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | N | N | N | N | N | |||||
| Small Organ (specify) [1] | N | N | N | N | N | |||||
| Neonatal Cephalic | N | N | N | N | N | |||||
| Adult Cephalic | N | N | N | N | N | |||||
| Cardiac | N | N | N | N | N | |||||
| Transesophageal | N | N | N | N | N | |||||
| Transrectal | ||||||||||
| Transvaginal | - | |||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | N | N | N | N | N | |||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculoskeletal Superficial | ||||||||||
| Other (specify) |
N=new indication; P=previously cleared by FDA; E= added under Appendix E
Additional Comments: [1] Small organs include Thyroid, Breast and Testicles.
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED
concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Seignem
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT and Radiological D 510(k) Number
10
{7}------------------------------------------------
Diagnostic Ultrasound Indications for Use Form
Transducer: 2535 AA-C
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other (specify) |
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | P | P | P | P | P | P | ||||
| Cardiac | P | P | P | P | P | P | ||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculoskeletal Superficial | ||||||||||
| Other (specify) |
N=new indication; P=previously cleared by FDA; E= added under Appendix E
Additional Comments: This transducer has been previously cleared by FDA with the AU3 unit (K944287).
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED
concurrence of CDRH, Office of Device Evaluation (ODE)
Thint h. Symm
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Device 510(k) Number
11
{8}------------------------------------------------
Diagnostic Ultrasound Indications for Use Form
Transducer: 3550 AA-C
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 | N | N | N | ||||||
| Abdominal | N | N | N | N | N | ||||||
| Intraoperative (specify) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Pediatric | P | P | P | P | P | ||||||
| Small Organ (specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | P | P | P | P | P | ||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal | |||||||||||
| Conventional | |||||||||||
| Musculoskeletal Superficial | |||||||||||
| Other (specify) |
N=new indication; P=previously cleared by FDA; E= added under Appendix E
Additional Comments: This transducer has been previously cleared by FDA with the AU3 unit (K944287) for uses indicated as "P".
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED
concurrence of CDRH, Office of Device Evaluation (
Givil A. Lynn
Division Sign-Off
e, Abdominal, EN
12
{9}------------------------------------------------
Diagnostic Ultrasound Indications for Use Form
Transducer: 7510 AA-C
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other (specify) |
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | P | P | P | P | P | |||||
| Small Organ (specify) [1] | P | P | P | P | P | |||||
| Neonatal Cephalic | P | P | P | P | P | |||||
| Adult Cephalic | ||||||||||
| Cardiac | P | P | P | P | P | |||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | P | P | P | P | P | |||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculoskeletal Superficial | ||||||||||
| Other (specify) |
N=new indication; P=previously cleared by FDA; E= added under Appendix E
Additional Comments: [1] Small organs include Thyroid, Breast and Testicles. This transducer has been previously cleared by FDA with the AU3 unit (K944287).
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED
concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel A. Kyser
n-Off) ivision of Reproductive, Abdominal, B and Radiological D
510(k) Number K981293 13
{10}------------------------------------------------
Diagnostic Ultrasound Indications for Use Form
Transducer: 5 MHz TEE
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other (specify) |
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | P | P | P | P | P | P | ||||
| Transrectal | ||||||||||
| Transvaqinal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculoskeletal Superficial | ||||||||||
| Other (specify) |
N=new indication; P=previously cleared by FDA; E= added under Appendix E
Additional Comments: This transducer has been previously cleared by the FDA for use with the GenesisCFM and
for use with the AU3 (K913209 and K953579)
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED
concurrence of CDRH, Office of Device Evaluation (ODE)
510(k) Number
Vorst le. Sijmm
Sign-Off) Division of Reproductive, Abdominal and Radiological I
§ 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.