(21 days)
Diagnostic Ultrasound
Fetal, Abdominal, Pediatric, Small Organ (Testes, adult female breast, and thyroid), Neonatal Cephalic, Cardiac, Peripheral Vascular
Model 1.0 Diagnostic Ultrasound System
The provided document is a 510(k) clearance letter from the FDA for a diagnostic ultrasound system, Model 1.0, and its transducers (214U and 218PA). It primarily focuses on the regulatory clearance for the device's intended uses, comparing it to legally marketed predicate devices.
This document does NOT contain information about acceptance criteria, device performance, study details (like sample size, data provenance, expert ground truth, or adjudication methods), or any comparative effectiveness studies (MRMC) or standalone algorithm performance studies.
The "Indications for Use Form" tables (pages 2-4) list various clinical applications and the modes of operation available for the Model 1.0 system and its transducers. "P" indicates a previously cleared indication, and "N" indicates a new indication (for the system or transducer). "E" means "Added under Appendix E," suggesting an expanded indication.
Therefore, I cannot provide the requested information. The document serves as an FDA clearance letter and the associated intended use statements, not a detailed technical report on a study proving device performance against acceptance criteria.
{0}------------------------------------------------
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo 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.
AUG - 7 199
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Jim Mundell Vice President Volumetrics Medical Imaging, Inc. 700*West Main Street Durham, NC 27701
K982498 Re: Model 1.0 Diagnostic Ultrasound System Requlatory Class: II/21 CFR 892.1550 Product Code: 90 IYN July 16, 1998 Dated: July 17, 1998 Received:
Dear Mr. Mundell:
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 Model 1.0 Diagnostic Ultrasound System, as described in your premarket notification:
Transducer Model Number
214U 218PA
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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. 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) requlation (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.
{1}------------------------------------------------
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 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 tollfree number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
If you have any questions regarding the content of this letter, please contact 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
{2}------------------------------------------------
THIS PAGE CONTAINS INFORMATION CONFIDENTIAL TO: VOLUMETRICS Medical Imaging Inc.
| Device Name: | Model 1.0 | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Intended Use: | Diagnostic Ultrasound | |||||||||
| Clinical | Mode of Operation | |||||||||
| Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocity | Combined(specify) | Other(specify) |
| Ophthalmic | ||||||||||
| Fetal | P | N | N | N | N | (1) | ||||
| Abdominal | P | N | N | N | N | (1) | ||||
| Intraoperative(specify) | ||||||||||
| IntraoperativeNeurological | ||||||||||
| Pediatric | P | N | N | N | N | (1) | ||||
| Small Organ(specify) | P | N | N | N | N | (1) | ||||
| Neonatal Cephalic | P | N | N | N | N | (1) | ||||
| Adult Cephalic | ||||||||||
| Cardiac | P | N | N | N | N | (1) | ||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| PeripheralVascular | P | N | N | N | N | (1) | ||||
| Laparoscope | ||||||||||
| Musculo-skeletelConventional | ||||||||||
| Musculo-skeletelSuperficial | ||||||||||
| Other (specify) |
Diagnostic Ultrasound Indications for Use Form
N = new indication; P = previously cleared by FDA; E = Added under Appendix E Additional Comments:
- (1) Single B mode or multi-B mode will operate in single combination with M-Mode, or PWD, or color Doppler, or amplitude Doppler (see 4.4.1.1 Transducer Operation table I for a complete listing of combinations).
Small organ (specify) - Testes, adult female breast, and thyroid.
Model 1.0 was previously cleared under 510(k) K963863, or K952551
Division Sign Off
(Division Sign-Off)
Division of Reproductive, Abdominal/ENT,
and Radiological Devices
510(k) Number K982498
Per 21 CFR 801.109)
Prescription Use.
{3}------------------------------------------------
THIS PAGE CONTAINS INFORMATION CONFIDENTIAL TO: VOLUMETRICS Medical Imaging Inc.
| Device Name: | Transducer Model 214U | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Intended Use: | Diagnostic Ultrasound | ||||||||||
| Clinical | Mode of Operation | ||||||||||
| Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocity | Combined(specify) | Other(specify) | |
| Ophthalmic | |||||||||||
| Fetal | P | N | N | N | N | (1) | |||||
| Abdominal | P | N | N | N | N | (1) | |||||
| Intraoperative(specify) | |||||||||||
| IntraoperativeNeurological | |||||||||||
| Pediatric | P | N | N | N | N | (1) | |||||
| Small Organ(specify) | P | N | N | N | N | (1) | |||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | P | N | N | N | N | (1) | |||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| PeripheralVascular | P | N | N | N | N | (1) | |||||
| Laparoscope | |||||||||||
| Musculo-skeletel | |||||||||||
| ConventionalMusculo-skeletel | |||||||||||
| Superficial | |||||||||||
| Other (specify) |
Diagnostic Ultrasound Indications for Use Form
N = new indication; P = previously cleared by FDA; E = Added under Appendix E Additional Comments:
(1) Single B mode or multi-B mode will operate in single combination with M-Mode, or PWD, or color Doppler, or amplitude Doppler (see 4.4.1.1 Table I for a complete listing of combinations).
Small organ (specify) - Testes, adult female breast, thyroid.
Prescription Use
(Per 21 CFR 801.109)
William
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K982498
{4}------------------------------------------------
THIS PAGE CONTAINS INFORMATION CONFIDENTIAL TO: VOLUMETRICS Medical Imaging Inc.
| Device Name: | Transducer Model 218PA | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Intended Use: | Diagnostic Ultrasound | |||||||||
| Clinical Application | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity | Combined (specify) | Other (specify) |
| Ophthalmic | ||||||||||
| Fetal | E | |||||||||
| Abdominal | E | |||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | E | |||||||||
| Small Organ (specify) | E | |||||||||
| Neonatal Cephalic | E | |||||||||
| Adult Cephalic | ||||||||||
| Cardiac | E | |||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | E | |||||||||
| Laparoscope | ||||||||||
| Musculo-skeletel Conventional | ||||||||||
| Musculo-skeletel Superficial | ||||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA; E = Added under Appendix E
Diagnostic Ultrasound Indications for Use Form
new indication; P N previously cleared by FDA; E = Added under Appendix E Additional Comments:
Prescription Use
(Per 21 CFR 801.109)
Lilian 4/2
Division Sign-Off
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devic 510(k) Number
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.