ACUSON P10 DIAGNOSTIC ULTRASOUND SYSTEM
Device Facts
| Record ID | K063761 |
|---|---|
| Device Name | ACUSON P10 DIAGNOSTIC ULTRASOUND SYSTEM |
| Applicant | Siemens Medical Solutions USA, Inc. |
| Product Code | IYN · Radiology |
| Decision Date | Jan 4, 2007 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric, 3rd-Party Reviewed |
Indications for Use
Diagnostic imaging or fluid flow analysis of the human body as follows: The P10 ultrasound imaging system is intended for the following applications: General Radiology, Abdominal, OB/GYN, Fetal, Pediatric, Adult Cephalic, and Cardiac applications. The system also provides for the measurement of anatomical structures that provide information that is used for clinical diagnosis purposes.
Device Story
Hand-held, software-controlled diagnostic ultrasound system; acquires primary/secondary harmonic ultrasound echoes; displays B-Mode, Color Doppler, and Harmonic Imaging on integrated LCD. Used by clinicians for anatomical imaging and fluid flow analysis; provides measurements for clinical diagnosis. Operates via P4-2 (2-4 MHz) phased array transducer. System adheres to ALARA principles for acoustic output; displays thermal/mechanical indices. Benefits include portable, point-of-care diagnostic visualization of internal structures.
Clinical Evidence
Bench testing only. Compliance with safety and performance standards including UL 60601-1, NEMA UD-2 (acoustic output), NEMA UD-3 (thermal/mechanical indices), and ISO 10993 (biocompatibility). No clinical data presented.
Technological Characteristics
Hand-held diagnostic ultrasound system; P4-2 (2-4 MHz) phased array transducer. Modes: B-Mode, Color Doppler, Harmonic Imaging. Integrated LCD display. Software-controlled. Standards: UL 60601-1, CSA C22.2 No. 60601-1, NEMA UD-2, NEMA UD-3, IEC 61157, ISO 10993. Operates on ALARA principle.
Indications for Use
Indicated for diagnostic ultrasound imaging and fluid flow analysis in fetal, abdominal, pediatric, adult cephalic, and cardiac applications. Prescription use only.
Regulatory Classification
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.
Predicate Devices
- ACUSON Cypress Diagnostic Ultrasound System (K052331)
- ACUSON Sequoia Diagnostic Ultrasound System (K052410)
- SONOLINE G50 & G60 S Diagnostic Ultrasound System (K020353)
- Sonosite SonoHeart Hand-Carried Echocardiography System (K994096)
Submission Summary (Full Text)
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### 510(K) SUMMARY
# JAN - 4 2007
### ACUSON P10TM Diagnostic Ultrasound System
This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with the Safe Medical Device Act of 1990 revisions to 21 CFR, Part 807.92, Content and Format of a 510(k) Summary.
#### 1. Submitted By:
Siemens Medical Solutions USA, Inc., Ultrasound Division 1230 Shorebird way Mountain View, CA 94043
### Contact Person:
Michaela Mahl Regulatory Affairs Specialist Phone: (650) 694 5653 (650) 943 7053 FAX:
### Date Prepared:
11/15/2006
#### 2. Proprietary Name:
ACUSON P10™ Ultrasound System
### Common/ Usual Name:
Diagnostic Ultrasound System with Accessories
### Classification Name;
Requiatory Class: II Review Category: Tier II Classification Panel: Radiology
| Ultrasonic Pulsed Doppler Imaging System: | FR # 892.1550 | Product Code 90-IYN |
|-------------------------------------------|---------------|---------------------|
| Ultrasonic Pulsed Echo Imaging System: | FR # 892.1560 | Product Code 90-IYO |
| Diagnostic Ultrasound Transducer: | FR # 892.1570 | Product Code 90-ITX |
#### 3. Predicate Device:
- . K052331, 11/9/2005, ACUSON Cypress™ Diagnostic Ultrasound System
- 트 K052410, 9/22/2005, ACUSON Sequoia™ Diagnostic Ultrasound System
- K020353, 2/13/2002, SONOLINE G50 & G60 S Diagnostic Ultrasound System
- K994096, 12/20/1999, Sonosite SonoHeart™ Hand-Carried Echocardiography System
#### 4. Device Description:
The ACUSON P10™ is a general purpose, hand-held, software-controlled, diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bioeffect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo and display it in B-Mode, Color Doppler Mode, a combination of these modes, and Harmonic Imaging, on an LCD display.
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The ACUSON P10 has been designed to meet the following product safety standards:
- . UL 60601-1, Medical Electrical Equipment, Part 1: General Requirements for Safety
- . CSA C22.2 No. 60601-1, Safety Requirements for Medical Equipment
- NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound .
- NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output . Indices on Diagnostic Ultrasound Equipment
- 93/42/EEC Medical Devices Directive .
- . Safety and EMC Requirements for Medical Equipment
- EN 60601-1 .
- . EN 60601-1-1
- EN 60601-1-2 .
- EN 60601-1-2-37 .
- . EN 60601-1-4
- IEC 61157 Declaration of Acoustic Power .
- t ISO 10993 Biocompatibility
- The system's acoustic output is in accordance with ALARA principle (as low as reasonably . achievable)
#### 5. Intended Uses:
The P10 ultrasound imaging system is intended for the following applications: General Radiology, Abdominal, OB/GYN, Fetal, Pediatric, Adult Cephalic, and Cardiac applications.
The system also provides for the measurement of anatomical structures that provide information that is used for clinical diagnosis purposes.
#### 6. Technological Comparison to Predicate Device:
The ACUSON P10™ is substantially equivalent to the predicate devices listed in paragraph 3 above. All systems transmit ultrasonic energy into patients, then perfood in partiging of received echoes to generate on-screen display of anatomic structures and fluid flow within the body. All systems allow for specialized measurements of structures to and in dingw wis.
End of 510(k) Summary
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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" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a bird-like figure, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
# JAN 0 4 2007
Siemens Medical Solutions USA, Inc. Ultrasound Group % Mr. Mark Job Responsible Third Party Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K063761
Trade Name: ACUSON P10 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: IYO, IYN, and ITX Dated: December 16, 2006 Received: December 20, 2006
Dear Mr. Job:
We have reviewed your Section 510(k) premarket 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 ACUSON P10 Diagnostic Ultrasound System, as described in your premarket notification:
Image /page/2/Picture/11 description: The image is a circular logo or emblem. The text "1906-2006" is at the top of the logo. The letters "FDA" are in the center of the logo in a stylized font. The word "Centennial" is below the letters "FDA". There are three stars below the word "Centennial".
*Protecting and Promoting Public Health*
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### Transducer Model Number
### P4-2 (2-4 MHz Phased Array)
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain
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other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
If you have any questions regarding the content of this letter, please contact Andrew Kang at (240) 276-3666.
Sincerely yours,
David A. Tyson
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
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### Diagnostic Ultrasound Indications for Use Form
510(k) Number (if known):
K063761
Device Name: Intended Use:
## ACUSON P10™ Diagnostic Ultrasound System
Diagnostic imaging or fluid flow analysis of the human body as follows:
| | | Mode of Operation | | | | | | | | |
|----------------------------------|---|-------------------|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|----------------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Tissue Harmonic<br>Imaging |
| Ophthalmic | | | | | | | | | | |
| Fetal | | N | | | | N | | | BC | N |
| Abdominal | | N | | | | N | | | BC | N |
| Intraoperative | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | N | | | | N | | | BC | N |
| Small Organ | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | N | | | | N | | | BC | N |
| Cardiac | | N | | | | N | | | BC | N |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | |
| Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
N = new indication
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
David C. Segrest
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
Section 4.3
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### Diagnostic Ultrasound Indications for Use Form
510(k) Number (if known):
K063761
Device Name:
P4-2 (2-4MHz Phased Array) Transducer for use with: ACUSON P10™ Diagnostic Ultrasound System
Intended Use:
Diagnostic imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | | | |
|-------------------------------|-------------------|---|---|-----|-----|---------------|-------------------|------------------------|--------------------|-------------------------|
| | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (Specify) | Tissue Harmonic Imaging |
| Ophthalmic | | | | | | | | | | |
| Fetal | | N | | | | N | | | BC | N |
| Abdominal | | N | | | | N | | | BC | N |
| Intraoperative Abdominal | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | N | | | | N | | | BC | N |
| Small Organ | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | N | | | | N | | | BC | N |
| Cardiac | | N | | | | N | | | BC | N |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | |
N = new indication
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
David W. Chapman
(Division Sign-Off) Division of Reproductive, Abdomin and Radiological Devices 510(k) Number __
Section 4.3
