(106 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Pediatric, Neonatal Cephalic, Adult Cephalic, Cardiac, Peripheral Vascular. Intended for use in military field settings in addition to hospital/clinic settings.
The TERATECH Model 2000 is a portable ultrasound imaging system with grayscale or brightness (B-Mode) imaging. The Model 2000 consists of a laptop computer and a 3 MHz linear array ultrasonic probe.
This document is a 510(k) premarket notification for the TERATECH Model 2000 Imaging System, a diagnostic ultrasound system from 1999. It focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and conducting a study to prove performance against those criteria in the way contemporary AI/ML medical devices do.
Here's an analysis based on the provided text, highlighting what is (and isn't) present as per your request:
1. Table of Acceptance Criteria and Reported Device Performance
This type of information is not present in the provided document. For a 510(k) submission of a diagnostic ultrasound system from 1999, the "acceptance criteria" primarily revolved around demonstrating that the device meets safety standards (electrical safety, acoustic output) and performance specifications that are comparable to legally marketed predicate devices, rather than clinical performance metrics typical of AI/ML or more advanced diagnostic devices today.
The "reported device performance" in this context refers to the technical specifications of the device itself, such as:
| Specification | TERATECH Model 2000 Performance |
|---|---|
| System Frequencies | 2-4 MHz |
| Frame Rate | 15-30 fps (imaging only) |
| Number of Ultrasound Lines per Frame | 128 |
| Fields of View | 2-27 cm |
| Mode of Operation | 2D imaging |
| Image Display | Rectangular and trapezoidal |
| Video | S-VHS Output, External VGA Monitor |
| LCD Size | 14.1" |
| Gray Shades | 256 |
| Image Magnification | 1X-4X, probe dependent |
| Image Presentation | black/white, left/right, up/down |
| Image Processing | gamma correction, dynamic range, speckle noise reduction |
| Input Power | 115 VAC, A/C adapter rated @ 60 W |
| Power Consumption | <20 W |
| Leakage Current | 50 μA max |
| Primary Breakdown Voltage | 2500 V AC min |
| Size | Width: 12.2", Height: 10", Depth: 2" |
| Weight | 12 lb (laptop and probe) |
2. Sample Size Used for the Test Set and Data Provenance
This information is not applicable/not present in the context of this 1999 510(k) submission for a diagnostic ultrasound imaging system. The submission relies on comparative data to predicate devices and technical specifications rather than a clinical "test set" and associated performance metrics typical for AI/ML devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not applicable/not present. As noted above, there isn't a "test set" in the sense of a collection of cases requiring expert annotations for ground truth as would be needed for an AI/ML device.
4. Adjudication Method for the Test Set
This information is not applicable/not present.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Readers Improve with AI vs without AI Assistance
This information is not applicable/not present. This device is a standalone diagnostic ultrasound imaging system, not an AI-assisted device. Therefore, no MRMC study involving AI assistance would have been conducted or required.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
This information is not applicable/not present. This is not an algorithmic device in the modern sense. Its performance is inherent in its hardware and basic signal processing capabilities. The closest equivalent is that the device itself is "standalone" in its function as an imaging system, but not as an "algorithm" being evaluated.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
This information is not applicable/not present in the context of a clinical performance study using a test set. For a diagnostic ultrasound system from this era, "ground truth" for proving substantial equivalence was primarily established by demonstrating that the images produced were of diagnostic quality comparable to predicate devices, and that the device met established safety and performance standards. This would be inferred from technical specifications and comparisons, not from a direct clinical outcome study with pathology or expert consensus.
8. The Sample Size for the Training Set
This information is not applicable/not present. The TERATECH Model 2000 is a hardware-based diagnostic imaging system, not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not present.
Summary of the Study (as presented in the 510(k) submission):
The "study" presented in this 510(k) is a demonstration of substantial equivalence to predicate diagnostic ultrasound devices based on:
- Identical Intended Use: The TERATECH Model 2000 has the same intended uses (abdominal, pelvic, cardiac, peripheral vascular, neurovascular, and fetal imaging) as the predicate devices.
- Similar Operating Features: The device offers comparable B-Mode imaging capabilities and other listed technical specifications (system frequencies, frame rate, number of lines, fields of view, display, image processing, etc.) to the predicate devices.
- Safety Compliance: The submission implicitly or explicitly (through adherence to general controls and FDA review) indicates compliance with electrical safety (leakage current, breakdown voltage) and acoustic output standards (as evidenced by the post-clearance special report requirement in the FDA letter).
The document states: "The TERATECH Model 2000 is substantially equivalent to other diagnostic ultrasound devices currently in commercial distribution in the United States. Examples of these devices are the ATL High-Definition Imaging UltraMark-9 (K903603), the B & K 3535 (K914945), and the Tetrad 2300 E/U (K946277). The Model 2000 has the same intended uses as each of these predicates and offers similar operating features. The main differences between the Model 2000 and the predicate devices are the compact size and low power consumption of the Model 2000."
The FDA's clearance letter confirms this finding of substantial equivalence based on the provided information, with a condition for submitting a post-clearance special report on acoustic output measurements.
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510(k) Summary for TERATECH Model 2000 Imaging System
1. SPONSOR
Teratech Corporation 223 Middlesex Turnpike Burlington, MA 01803
| Contact Person: | Alice Chiang, President |
|---|---|
| Telephone: | 781-270-4143 |
July 26, 1999 Date Prepared:
2. DEVICE NAME
| Proprietary Name: | TERATECH Model 2000 Imaging System |
|---|---|
| Common/Usual Name: | Diagnostic Ultrasound Imaging System |
| Classification Name: | Ultrasonic Pulsed Echo Imaging System (21 CFR 892.1560, 90-IYO) |
| Diagnostic Ultrasound Transducer (21 CFR 892.1570, 90-ITX) |
3. PREDICATE DEVICES
ATL High-Definition Imaging UltraMark-9 (K903603) B&K 3535 (K914945) Tetrad 2300 E/U (K946277)
4. INTENDED USE
The TERATECH Model 2000 is intended for abdominal, pelvic, cardiac, peripheral vascular, neurovascular, and fetal imaging.
ട്. DEVICE DESCRIPTION
The TERATECH Model 2000 is a portable ultrasound imaging system with grayscale or brightness (B-Mode) imaging. The Model 2000 consists of a laptop computer and a 3 MHz linear array ultrasonic probe. Technical specifications for the Model 2000 are as follows:
7/26/99
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| System frequencies: | 2-4 MHz |
|---|---|
| Frame rate: | 15-30 fps (imaging only) |
| Number of ultrasound linesper frame: | 128 |
| Fields of view: | 2-27 cm |
| Mode of Operation: | 2D imaging |
| Image display: | Rectangular and trapezoidal |
| Video: | S-VHS Output, External VGA Monitor |
| LCD size: | 14.1" |
| Gray shades: | 256 |
| Image magnification: | 1X-4X, probe dependent |
| Image presentation: | black/white, left/right, up/down |
| Image processing: | gamma correction, dynamic range, speckle noisereduction |
| Input power: | 115 VAC, A/C adapter rated @ 60 W |
| Power consumption: | <20 W |
| Leakage current: | 50 μA max |
| Primary breakdown voltage: | 2500 V AC min |
| Size: | Width: 12.2"Height: 10"Depth: 2" |
| Weight: | 12 lb (laptop and probe) |
6. BASIS FOR SUBSTANTIAL EQUIVALENCE
The TERATECH Model 2000 is substantially equivalent to other diagnostic ultrasound devices currently in commercial distribution in the United States. Examples of these devices are the ATL High-Definition Imaging UltraMark-9 (K903603), the B & K 3535 (K914945), and the Tetrad 2300 E/U (K946277). The Model 2000 has the same intended uses as each of these predicates and offers similar operating features. The main differences between the Model 2000 and the predicate devices are the compact size and low power consumption of the Model 2000.
7/26/99
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or movement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 0 1898
Teratech Corporation Sheila Hemeon-Heyer Senior Staff Consultant c/o Medical Device Consultants, Inc. 49 North Plain Street North Attleboro, MA 02740
K992505 Re: Teratech Model 2000 Imaging System Dated: September 29, 1999 Received: September 30, 1999 Requlatory Class: II 21 CFR 892.1560/Procode: 90 IYO
Dear Ms. Hemeon-Heyer:
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 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, qood manufacturing practices, labeling, and prohibitions against misbranding and adulteration.
This determination of substantial equivalence applies to the following transducers intended for use with the Teratech Model 2000 Imaging System, as described in your premarket notification:
Transducer Model Number
L3 (3 MHz Linear Array)
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 Failure to comply with the GMP regulation may result in assumptions. In addition, the Food and Drug Administration (FDA) may regulatory action. 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.
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Page 2 - Sheila Hemeon-Heyer
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. Tt 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 Other general information on your responsibilities under the Act may 807.97) . . be obtained from the Division of Small Manufacturers Assistance at its tollfree number (800) 638-2041 or at (301) 443-6597 or at its internat 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.
and
Sincerely yours,
APT 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
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Dlagnostic Ultrasound Indications for Use Form Teratech Model 2000 Imaging System
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 | ||||||||||
| Abdominal | N | ||||||||||
| Intraoperative (Specify) | |||||||||||
| IntraoperativeNeurological | |||||||||||
| Pediatric | N | ||||||||||
| Small Organ(Specify) | |||||||||||
| Neonatal Cephalic | N | ||||||||||
| Adult Cephalic | N | ||||||||||
| Cardiac | N | ||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | N | ||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletalConventional | |||||||||||
| Musculo-skeletalConventional | |||||||||||
| Musculo-skeletalSuperficial | |||||||||||
| Other (Specify) |
N = new Indication; P = previously cleared by FDA; E=added under Appendix E
For use with 3 MHz Model L3 Transducer. Additional Comments: Intended for use in military field settings in addition to hospital/clinic settings.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation
Prescription Use (Per CFR 801.108)
..
Emil A. Severson
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological D 510(k) Number
a comments paparticipal
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. . . . . .
Diagnostic Ultrasound Indications for Use Form 3 MHz Model L3 Transducer for Teratech Model 2000 Imaging System
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 | |||||||||
| Abdominal | N | |||||||||
| Intraoperative (Specify) | ||||||||||
| IntraoperativeNeurological | ||||||||||
| Pediatric | N | |||||||||
| Small Organ(Specify) | ||||||||||
| Neonatal Cephalic | N | |||||||||
| Adult Cephalic | N | |||||||||
| Cardiac | N | |||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | N | |||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | ||||||||||
| Musculo-skeletalSuperficial | ||||||||||
| Other (Specify) |
N = now indication; P = previously cleared by FDA; E=added under Appendix E
Intended for use in military field settings in addition to hospital/clinic Additional Comments: settings.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PADE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation
Prescription Use (Per CFR 801.108)
David A. Kyman
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number
: 上
§ 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.