SPEQ ULTRASOUND SYSTEM
Device Facts
| Record ID | K090505 |
|---|---|
| Device Name | SPEQ ULTRASOUND SYSTEM |
| Applicant | Signostics Pty, Ltd. |
| Product Code | IYO · Radiology |
| Decision Date | May 7, 2009 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1560 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
The Speq ultrasound system is for non-invasive imaging of the human body and is intended for the following applications: Fetal, Abdominal, Pediatric, Musculo-skeletal, Cardiac and Peripheral Vessel. Users must have ultrasound training before using the device. See the attached Indications for Use form for specific imaging modes and applications. The following warnings apply: Warning: Use in B-mode is not indicated where body structures are in rapid motion. Warning: Use in B-mode is not indicated where the application of pressure on the transducer will displace the tissue of interest. Warning: Use in B-mode is not indicated for catheter or needle placement where the real-time visualization of the structure of interest and needle is required.
Device Story
Speq is a hand-held diagnostic ultrasound system; acquires echo data via 3.5MHz or 7.5MHz transducers; displays B-Mode or M-Mode images on an integrated 18-bit color TFT LCD. Operated by trained clinicians in clinical settings. Device transforms ultrasonic echoes into anatomical images; allows manual measurements to aid diagnosis. Benefits include portable, non-invasive visualization of internal structures. System is battery-powered (Li-Ion) and compact (0.31 kg). Healthcare providers use on-screen images for diagnostic assessment.
Clinical Evidence
No clinical data provided. Substantial equivalence is based on bench testing, including electrical safety (IEC 60601-1, UL 2601-1), mechanical shock/vibration testing, and water resistance (IPX7 for transducers).
Technological Characteristics
Hand-held ultrasound system; 3.5MHz and 7.5MHz transducers; B-Mode and M-Mode operation. 18-bit TFT LCD display. Li-Ion battery powered. Safety standards: IEC 60601-1, UL 2601-1, Can/CSA C22.2 601.1-M90. Transducer IPX7 water resistance. Dimensions: 6.8 x 11.5 x 2.0 cm; weight 0.31 kg.
Indications for Use
Indicated for non-invasive diagnostic ultrasound imaging of fetal, abdominal, pediatric, musculo-skeletal, cardiac, and peripheral vessel structures. Contraindicated for B-mode imaging of rapidly moving structures, applications requiring transducer pressure that displaces tissue, and catheter/needle placement requiring real-time visualization.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
Submission Summary (Full Text)
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Kogoso5
## 510(k) Summary
1. Sponsor: Signostics Pty Ltd Lot 1, 40 - 46 West Thebarton Road PO Box 736, Torrensville Thebarton, SA 5031 Australia
Contact Person: 2. Charles F. Hottinger, Ph.D., RAC, Regulatory Affairs Consultant Telephone: (206) 780-7945
- Date Prepared: 3. April 21, 2009
- 4. Device Name: Speq
- Proprietary/Marketed Names: ડ. Signos Personal Ultrasound (subject to change) Signos (subject to change)
- Common/Usual Name: 6. Diagnostic ultrasound system and transducer
### 7. Classification
Regulatory Class: II
Review Category: Tier II
(21 CFR 892.1560, 90-1YO) Ultrasonic Pulsed Echo Imaging System
(21 CFR 892.1570, 90-ITX) Diagnostic Ultrasound Transducer
### Predicate Devices 8.
Pie Medical 50S Tringa (K020112)
Siemens Acuson P10 (K063761)
Sonosite iLook (K021628)
MAY - 7 2009
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K090505
### Basis for Substantial Equivalence 9.
Signostics Pty Ltd believes the Speq ultrasound system described in this Submission is substantially equivalent to the predicate devices as follows:
- a. Pie Medical 50S Tringa (K020112);
- b. Siemens Acuson P10 (K063761); and
- c. Sonosite iLook (K021628).
The Speq ultrasound system is substantially equivalent to the predicate devices listed above. All systems transmit ultrasonic energy into patients, then process received echoes to produce on-screen images of anatomic structures within the body. All systems allow for measurements of structures to aid in diagnosis.
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### Device Description 10.
The Signostics Pty Ltd Speq ultrasound system is a hand-held, diagnostic ultrasound system with an on-screen display. Its purpose is to acquire ultrasound echo data and display it in B-Mode or M-Mode on an LCD display.
Technical specifications for the Signostics Speq ultrasound system are as follows:
| System | | | | | |
|----------------------------|-------------------------------------------------|-------------------------|---------|------------|--|
| Transducer frequencies: | 3.5MHz & 7.5MHz | | | | |
| Frame rate: | 8Fps maximum (Imaging only) | | | | |
| Ultrasound lines/frame: | 360 lines for 90° frame | | | | |
| Fields of View: | 1-18 cm for 3.5MHz, 1-8.4cm for 7.5MHz | | | | |
| External Video Output: | No | | | | |
| Liquid-Crystal Display: | 18 bit, 262,000 Color, Active Matrix TFT LCD | | | | |
| Size: - | | | | | |
| Width: | 6.8 cm | | | | |
| Height: | 11.5 cm | | | | |
| Depth: | 2.0 cm | | | | |
| Weight: | 0.31 kg | | | | |
| Electrical | | | | | |
| External Power: | Input: | 100-240 VAC,<br>50-60Hz | Output: | 5 VDC @ 2A | |
| Battery: | Li-Ion battery pack (2 Whr) | | | | |
| Leakage Current: | 10 µA maximum | | | | |
| Primary Breakdown Voltage: | 6000VDC | | | | |
| Safety Standards: | IEC 60601-1, UL 2601-1, Can/CSA C22.2 601.1-M90 | | | | |
| Protection Class: | Class 11: per IEC 60601-1 | | | | |
| Degree of Protection: | Type BF: per IEC 60601-1 | | | | |
| Environmental | |
|--------------------------|--------------------------------------------------------------------|
| Mechanical Shock : | Drop Testing per IEC60601-1, Vibration Testing over 5Hz-5kHz/0-50G |
| Mechanical Vibration: | 5Hz-5kHz/0-50G |
| Drop Test (to concrete): | 1 meter |
| Operating Temperature: | 0 to 45 C |
| Humidity: | 0 to 90% RH, non-condensing |
| Water Resistance: | Transducer IPX7 degree of protection against water |
| Altitude: | 0.7 - 1.05 standard atmospheres (2500m or 8200 feet)operating |
| Storage | |
| Temperature: | -20 to 50 C |
| Humidity: | 0 to 90% RH, non-condensing |
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## DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal for the Department of Health & Human Services, USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. In the center of the seal is an image of an eagle.
### Public Health Service
MAY - 7 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Signostics Pty Ltd % Charles F. Hottinger, Ph.D., RAC Regulatory Affairs Consultant P.O. Box 10074, 13221 NE Teem Loop Road BAINBRIDGE ISLAND WA 98110
Re: K090505
Trade/Device Name: Speq Ultrasound System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed ccho imaging system Regulatory Class: II Product Code: IYO and ITX Dated: February 13, 2009 Received: February 26, 2009
Dear Dr. Hottinger:
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 Speq Ultrasound System, as described in your premarket notification:
### Transducer Model Number
## 3.5 MHz (P03010) 7.5 MHz (P03011)
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.
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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 (OS) 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 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 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 Lauren Hefner at (240) 276-3666.
Sincerely yours,
Colin M. Pollard
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
### Enclosure(s)
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## Indications For Use
510(k) Number (if known):
Device Name: Speq Ultrasound System
Indications For Use:
The Speq ultrasound system is for non-invasive imaging of the human body and is intended for the following applications: Fetal, Abdominal, Pediatric, Musculo-skeletal, Cardiac and Peripheral Vessel. Users must have ultrasound training before using the device. See the attached Indications for Use form for specific imaging modes and applications.
The following warnings apply:
Warning: Use in B-mode is not indicated where body structures are in rapid motion.
Warning: Use in B-mode is not indicated where the application of pressure on the transducer will displace the tissue of interest.
Warning: Use in B-mode is not indicated for catheter or needle placement where the real-time visualization of the structure of interest and needle is required.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE).
Colin M. Pollard
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 0905DF 510(k) Number
April 24, 2009
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Kogosas
### 1.3 Indications for Use
The Speq ultrasound system is intended for the uses described in the following Indications for Use Forms.
### 510(k) Indications for Use Form 1.3.1
## TABLE 1 - SPEQ ULTRASOUND SYSTEM INDICATIONS FOR USE FORM
| System: | Speq ultrasound system |
|---------------|-------------------------------------------------------------|
| Intended Use: | Diagnostic ultrasound imaging of the human body as follows: |
| Clinical Application | | Mode of Operation | | | | | | |
|---------------------------|------------------------------------|-------------------|---|-----|-----|------------------|-----------------------|---------------------|
| General<br>(Track 1 Only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | N | N | | | | | |
| | Abdominal | N | N | | | | | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (Specify) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| Fetal Imaging<br>& Other | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | N | N | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Specify) | | | | | | | |
| Cardiac | Cardiac Adult | | N | | | | | |
| | Cardiac Pediatric | | N | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | N | N | | | | | |
| | Other (Specify) | | | | | | | |
N= new indication; P= previously cleared by FDA; E= added under Appendix E Additional Comments:
Note 1: Use in B-mode is not indicated where body structures are in rapid motion.
Note 2: Use in B-mode is not indicated where the application of pressure on the transducer will displace the tissue of interest.
Note 3: Use in B-mode is not indicated for catheter or needle placement where the real-time visualization of the structure of interest and needle is required.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Prescription Use:_X
(Per 21 CFR 801.109) -
Colin M. Pillerd
April 24, 2009
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K090505
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K090505
## TABLE 2 - SPEQ ULTRASOUND SYSTEM INDICATIONS FOR USE FORM
System: Speq ultrasound system
3.5 MHz (P03010) Transducer:
Diagnostic ultrasound imaging of the human body as follows: Intended Use:
| Clinical Application | | Mode of Operation | | | | | | |
|---------------------------|------------------------------------|-------------------|---|-----|-----|------------------|-----------------------|---------------------|
| General<br>(Track I Only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | N | N | | | | | |
| | Abdominal | N | N | | | | | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | N | N | | | | | |
| | Small Organ (Specify) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| Fetal Imaging<br>& Other | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Specify) | | | | | | | |
| | Cardiac Adult | | N | | | | | |
| | Cardiac Pediatric | | N | | | | | |
| Cardiac | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Periphera vessel | | | | | | | |
| | Other (Specify) | | | | | | | |
N= new indication; P= previously cleared by FDA; E= added under Appendix E Additional Comments:
Note 1: Use in B-mode is not indicated where body structures are in rapid motion.
Note 2: Use in B-mode is not indicated where the application of pressure on the transducer will displace the tissue of interest.
- Note 3: Use in B-mode is not indicated for catheter or needle placement where the real-time visualization of the structure of interest and needle is required.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Prescription Use: ____ X
(Per 21 CFR 801.109)
April 24, 2009
Colm Pollard
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
Page 28
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Kogosbs
# Table 3 - Speq ultrasound system Indications For Use Form
System:
Speq ultrasound system
7.5 MHz (P03011) Transducer:
Diagnostic ultrasound imaging of the human body as follows: Intended Use:
| Clinical Application | | Mode of Operation | | | | | | |
|--------------------------|------------------------------------|-------------------|---|-----|-----|------------------|-----------------------|---------------------|
| General | Specific | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) |
| (Track I Only) | (Tracks I & III) | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | N | N | | | | | |
| | Abdominal | N | N | | | | | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | N | N | | | | | |
| | Small Organ (Specify) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| Fetal Imaging<br>& Other | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | N | N | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Specify) | | | | | | | |
| Cardiac | Cardiac Adult | | N | | | | | |
| | Cardiac Pediatric | | N | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | N | N | | | | | |
| | Other (Specify) | | | | | | | |
N= new indication; P= previously cleared by FDA; E= added under Appendix E Additional Comments:
Note 1: Use in B-mode is not indicated where body structures are in rapid motion.
Note 1: Use in B-mode is not indicated where body shocures are in rapa more.
Note 2: Use in B-mode is not indicated where the application of pressure on the transducer will of interest.
of interest.
Note 3: Use in B-mode is not indicated for catheter or needle placement where the real-time visualization of the structure of interest and needle is required.
(PLEASE DO NOT WRITE BELOW TITIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Prescription Use: | X |
|----------------------|---|
| (Per 21 CFR 801.109) | |
Colin M. Pollard
(Division Sign-Off)
Division of Reproductive, Abdominal and Radiological Devices
| April 24, 2009 | K090505 |
|----------------|---------------|
| | 510(k) Number |
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