(126 days)
The SONIX MDP Ultrasound System is intended for the following applications: Ophthalmic, Abdominal, Cardiac, Intraoperative (specific), Intraoperative Neurological, Fetal, Pediatric, Small Parts, Neonatal/ Adult Cephalic, OB/GYN, Transesophageal, Transrectal, Transvaginal, Peripheral Vascular, Musculoskeletal conventional, Musculoskeletal superficial, Pelvic, Nerve Block, Vascular Access.
The system also provides the ability to measure anatomical structures {fetal, abdominal, pediatric, small organ, cardiac, transvaginal, peripheral vessel, musculoskeletal} and provides calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
The SONIX MDP Ultrasound System indication(s) for use are the same as the predicate devices.
The ultrasound plateform is similar to the predicate devices in terms of operation. A transducer is applied to the patient and the system generates ultrasound waves then transmit the wave into human body. The system then receives echoes back from human body, processes them to yield an image on a display.
The provided document is a 510(k) summary for the "Sonix MDP Ultrasound Scanner". This type of document is a premarket notification to the FDA to demonstrate that the device is at least as safe and effective as a legally marketed predicate device.
**Key sections that are usually part of a study proving acceptance criteria and device performance (like clinical trials or performance studies) are explicitly stated as "N/A" or simply not present in this 510(k) summary because: **
- This submission is for a "New product clearance" for an ultrasound system and its transducers, where the primary pathway to clearance is demonstrating substantial equivalence to predicate devices, not by conducting independent clinical efficacy studies in the same way a novel therapeutic or diagnostic device would.
- The approval is based on comparison to existing, legally marketed ultrasound systems and transducers.
- For diagnostic ultrasound systems, the "device performance" in a 510(k) is usually about technical specifications (e.g., acoustic output, image quality parameters, safety standards compliance) rather than diagnostic accuracy against a ground truth.
- A "Name change request" is also part of this submission, further indicating a focus on equivalence rather than new performance claims. The clearance is granted conditional on submission of a post-clearance special report with acoustic output measurements, which are technical performance criteria, not clinical.
Therefore, the typical metrics for an AI/ML device (sensitivity, specificity, accuracy, etc., against a ground truth) and the experimental setup to test them (sample size, expert ground truth, adjudication, MRMC studies) are not applicable or detailed in this 510(k) summary. The "acceptance criteria" here refer to the criteria for substantial equivalence to predicate devices and adherence to relevant standards.
Based on the provided text, here's a breakdown of what can be extracted, acknowledging the limitations for an ultrasound scanner 510(k):
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied by 510(k) process) | Reported Device Performance (Summary) |
|---|---|
| Substantial Equivalence: Device must be at least as safe and effective as legally marketed predicate devices. | The FDA reviewed the premarket notification and "determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." This is the primary "performance" metric for a 510(k) of this nature. |
| Indications for Use: Device must support a specified range of clinical applications and modes of operation, consistent with predicate devices. | The SONIX MDP Ultrasound System is intended for a broad range of applications including Ophthalmic, Abdominal, Cardiac, Intraoperative, Fetal, Pediatric, Small Parts, Neonatal/Adult Cephalic, OB/GYN, Transesophageal, Transrectal, Transvaginal, Peripheral Vascular, Musculoskeletal, Pelvic, Nerve Block, and Vascular Access. It supports various modes: B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Color Velocity Doppler, and Combined modes. The indications for use "are the same as the predicate devices." Specific transducers (SA4-2/24, C5-2/60, EC9-5/10, L14-5/38) also have detailed, "new" (N) indications, meaning these specific applications and modes are being claimed for these new transducers within this new system. |
| Acoustic Output & Safety Standards Compliance: Device must meet established safety limits for acoustic output. | The FDA grants substantial equivalence "on the condition that prior to shipping the first device, you submit a postclearance special report" containing "complete information, including acoustic output measurements based on production line devices." This indicates that initial clearance relies on meeting these future safety criteria. The submission would have included declarations of conformity to relevant electrical safety and biocompatibility standards, though these are not detailed in the summary. |
| Technical Specifications: Transducers must meet specified technical parameters (e.g., frequency ranges, dimensions, focal lengths, scan depths, etc.). | Tables detailing transducer specifications (e.g., SA4-2/24 Phased Array 2.8 MHz, C5-2/60 Convex 3.2 MHz 60mm Radius, EC9-5/10 Microconvex Endocavity 6.6 MHz 10mm Radius, L14-5/38 Linear 8 MHz 38mm) are implicitly accepted as meeting the technical requirements for ultrasound systems. |
| General Controls Provisions: Compliance with annual registration, device listing, GMP, labeling, and prohibitions against misbranding and adulteration. | The FDA states the manufacturer "must comply with all the Act's requirements" regarding general controls. |
2. Sample size used for the test set and the data provenance:
- Not applicable (N/A) / Not provided. This 510(k) summary for an ultrasound system does not describe a "test set" in the context of clinical images or data being analyzed by the device for diagnostic accuracy. The substantial equivalence determination is based on the device's technical specifications, design, and intended uses being comparable to previously cleared devices. Device performance tests would involve engineering and safety verification rather than clinical data sets.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A / Not provided. There is no mention of experts establishing a ground truth for a test set, as this is not a study focused on diagnostic accuracy of an AI/ML algorithm against a ground truth. The 'ground truth' here is essentially the technical and clinical performance established for the predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A / Not provided. No test set requiring adjudication of findings is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is a clearance for a diagnostic ultrasound imaging system itself, not an AI-assisted diagnostic tool. Therefore, no MRMC study or AI assistance effect size is mentioned or applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No. This device is an ultrasound scanner, which is inherently a human-operated imaging tool. It does not perform "standalone" algorithmic diagnosis.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- N/A / Not provided. As no diagnostic accuracy study is described, no specific "ground truth" for diagnostic evaluation exists in this document. The "ground truth" for substantial equivalence is the existing, legally marketed predicate devices and their established safety and effectiveness.
8. The sample size for the training set:
- N/A / Not provided. This is not a submission for an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
- N/A / Not provided. As no AI/ML device or training set is discussed, this information is not applicable.
In summary, the provided 510(k) is for a new general-purpose ultrasound imaging system. The "study" proving it meets acceptance criteria is the 510(k) process itself, which involves demonstrating substantial equivalence to predicate devices through technical comparisons, adherence to performance standards (like acoustic output), and verifying that its indications for use are consistent with those of already cleared devices. It is not an AI/ML device, and therefore, typical AI/ML clinical study metrics are not relevant here.
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K080935
AUG - 6 2008
510 (k) Summary for the Sonix MDP Ultrasound Scanner
This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with the Safe Medical Devices Act of 1990 revisions to 21 CFR, Part 807.92, Content and format of a 510(k) summary.
1.0 Submitter Information
1.1 Submitter
Ultrasonix Medical Corporation 130-4311 Viking Way Richmond, British Columbia Canada V6V 2K9 (t) 604-437-9500 (f) 604-437-9502
1.2 Contact
Chas Yu Quality Assurance Manager Tel. (604) 279-8550 ext 152 Fax. (604) 279-8559 Email: chas.yu@ultrasonix.com
1.3 Date Prepared
April 1, 2008
2.0 Device Name
2.1 Common Name
Ultrasound Imaging System
2.2 Proprietary Name
Sonix MDP Ultrasound Scanner
2.3 Classification Name
| FR Number | Product Code | |
|---|---|---|
| Ultrasonic Pulsed Doppler Imaging System | 892.1550 | 90-IYN |
| Ultrasonic Pulsed Echo Imaging System | 892.1560 | 90-IYO |
| Diagnostic Ultrasound Transducer | 892.1570 | 90-ITX |
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2.4 Classification
Class II
2.5 Predicate Device:
SonoSite MicroMaxx High Resolution Ultrsound System (K053069) Ultrasonix Ergosonix 500 Ultrasound Scanner (K042326) SONIX Ultrasound Scanner (K061827) Philips HD 11 Diagnostic Ultrasound System (K062247) GE Logiq P5 and A5 (K060993)
2.6 Reason for submission:
Name change request
N/A
New product clearance for:
| SONIX MDP Ultrasound Scanner and Transducers: | L14-5/38C5-2/60EC9-5/10SA4-2/24 |
|---|---|
| ----------------------------------------------- | --------------------------------------------- |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three abstract shapes that resemble a bird in flight or flowing ribbons.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Chas Yu Quality Assurance Manager Ultrasonix Medical Corporation 130-4311 Viking Way Richmond, BC, V6V 2K9 CANADA
AUG - 6 2008
Re: K080935
Trade/Device Name: SONIX MDP Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: June 10, 2008 Received: June 19, 2008
Dear Mr. Yu:
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 SONIX MDP Ultrasound System, as described in your premarket notification: .
Transducer Model Number
SA/24mm Phased Array 2.8 MHz C5-2/60 Convex 3.2 MHz 60mm Radius EC9-5/10 Microconvex Endocavity 6.6 MHz 10mm Radius L14-5/38 Linear 8 MHz 38mm
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
{3}------------------------------------------------
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 promincntly 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 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.
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
{4}------------------------------------------------
Indications for Use
510(k) Number (if known): K080935
Device Name: SONIX MDP Ultrasound System
Indications For Use:
The SONIX MDP Ultrasound System is intended for the following applications: Ophthalmic, Abdominal, Cardiac, Intraoperative (specific), Intraoperative Neurological, Fetal, Pediatric, Small Parts, Neonatal/ Adult Cephalic, OB/GYN, Transesophageal, Transrectal, Transvaginal, Peripheral Vascular, Musculoskeletal conventional, Musculoskeletal superficial, Pelvic, Nerve Block, Vascular Access.
The system also provides the ability to measure anatomical structures {fetal, abdominal, pediatric, small organ, cardiac, transvaginal, peripheral vessel, musculoskeletal} and provides calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
The SONIX MDP Ultrasound System indication(s) for use are the same as the predicate devices. Please see attached IFU comparison chart between SONIX MDP and the predicate devices.
The ultrasound plateform is similar to the predicate devices in terms of operation. A transducer is applied to the patient and the system generates ultrasound waves then transmit the wave into human body. The system then receives echoes back from human body, processes them to yield an image on a display.
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)
(Division Division of Reproductive, Abdominal and Radiological Devices 510(k) Number _
Page 1 of 1
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ULTRASOUND INDICATIONS FOR USE TABLES
SONIX MDP Ultrasound Scanner – Diagnostic Ultrasound Indications for Use Form
Intended use:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityDoppler | Combined(Specify) | Other(Specify) | ||
| Ophthalmic | |||||||||||
| Fetal | N | N | N | N | N | N | N | N (*1) | N (*2) | ||
| Abdominal | N | N | N | N | N | N | N | N (*1) | N (*2) | ||
| Intraoperative (specify) | N | N | N | N | N | N | N | N (*1) | N (*2) | ||
| Intraoperative Neurological | N | N | N | N | N | N | N | N (*1) | N (*2) | ||
| Pediatric | N | N | N | N | N | N | N | N | N (*1) | N (*2) | |
| Small Organ (specify) | N | N | N | N | N | N | N | N (*1) | N (*2) | ||
| Neonatal Cephalic | N | N | N | N | N | N | N | N (*1) | N (*2) | ||
| Adult Cephalic | N | N | N | N | N | N | N | N (*1) | N (*2) | ||
| Cardiac | N | N | N | N | N | N | N | N | N (*1) | N (*2) | |
| Transesophageal | N | N | N | N | N | N | N | N (*1) | N (*2) | ||
| Transrectal | N | N | N | N | N | N | N | N (*1) | N (*2) | ||
| Transvaginal | N | N | N | N | N | N | N | N (*1) | N (*2) | ||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | N | N | N | N | N | N | N | N (*1) | N (*2) | ||
| Laparoscopic | |||||||||||
| MSK Conventional | N | N | N | N | N | N | N | N (*1) | N (*2) | ||
| MSK Superficial | N | N | N | N | N | N | N | N (*1) | N (*2) | ||
| Vascular Access | N | N | N | N | N | N | N | N (*1) | N (*2, *4) | ||
| Nerve Block | N | N | N | N | N | N | N | N (*1) | N (*2, *3) | ||
| Other (specify) |
N = New indication; P = Previously cleared
Additional Comments:
Small Organ: Breast, Thyroid, Testicle
Intraoperative: Abdominal organs and vascular
- *1. B/M, B/PWD, B/CWD, B/CFM/PWD, B/AD/PWD, B/DPD/PWD, B/CFM/CWD, B/AD/CWD, B/DPD/CWD
- Directional Power Doppler (DPD), Imaging for guidance of biopsy *2.
-
- Oneonomic for guidance of nerve block injections
*4. I maging for guidance of central or peripheral lines.
- Oneonomic for guidance of nerve block injections
| SONIX MDP User Manual | |
|---|---|
| ----------------------- | -- |
00.040.051, Revision A
Appendix C: Transdcuer Specifications
Hulda Reimer
1
(Division Sign-Off) Division of Reproductive, Abdomina Radiological D 510(k) Number
{6}------------------------------------------------
Diagnostic ULTRASOUND INDICATIONS FOR USE Form SA/24mm phased array 2.8 MHz transducer
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 | ColorVelocityDoppler | Combined(Specify) | Other(Specify) |
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | N | N | N | N | N | N | N | N (*1) | N (*2) | |
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | N | N | N | N | N | N | N | N (*1) | N (*2) | |
| Small Organ (specify) | ||||||||||
| Neonatai Cephalic | N | N | N | N | N | N | N (*1) | N (*2) | ||
| Adult Cephalic | N | N | N | N | N | N | N | N (*1) | N (*2) | |
| Cardiac | N | N | N | N | N | N | N | N (*1) | N (*2) | |
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| MSK Conventional | ||||||||||
| MSK Superficial | ||||||||||
| Vascular Access | ||||||||||
| Nerve Block | ||||||||||
| Other (specify) |
N = New indication; P = Previously cleared
Additional Comments:
- *1. B/M, B/PWD, B/CFM/PWD, B/AD/PWD, B/AD/PWD, B/CFM/CWD, B/AD/CWD, B/DPD/CWD
*2. Directional Power Doppier (DPD)
- Directional Power Doppler (DPD)
Appendix C: Transdcuer Specifications
00.040.051, Revision A
SONIX MDP User Manual
2
Hulu Lesem
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
{7}------------------------------------------------
Diagnostic ULTRASOUND INDICATIONS FOR USE Form Č5-2/60 convex 3.2 MHz 60mm radius transducer
Intended use:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityDoppler | Combined(Specify) | Other(Specify) | ||
| Ophthalmic | |||||||||||
| Fetal | N | N | N | N | N | N | N | N (*1) | N (*2) | ||
| Abdominal | N | N | N | N | N | N | N | N (*1) | N (*2) | ||
| Intraoperative (specify) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Pediatric | N | N | N | N | N | N | N | N (*1) | N (*2) | ||
| Small Organ (specify) | N | N | N | N | N | N | N | N (*1) | N (*2) | ||
| Neonata! Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | N | N | N | N | N | N | N | N (*1) | N (*2) | ||
| Laparoscopic | |||||||||||
| MSK Conventional | N | N | N | N | N | N | N | N (*1) | N (*2) | ||
| MSK Superficial | N | N | N | N | N | N | N | N (*1) | N (*2) | ||
| Vascular Access | |||||||||||
| Nerve Block | |||||||||||
| Other (specify) |
N = New indication; P = Previously cleared
Additional Comments:
Small Organ: Breast, Thyroid, Testicle
- *1. B/M, B/PWD, B/CWD, B/CFM/PWD, B/AD/PWD, B/DPD/PWD, B/CFM/CWD, B/AD/CWD, B/DFD/CWD
*2. Directional Power Doppler (DPD), Imaging for guidance of biopsy
- Directional Power Doppler (DPD), imaging for guidance of biopsy
| SONIX MDP User Manual | 00.040.051, Revision A | Appendix C: Transdcuer Specifications |
|---|---|---|
| 3 |
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
| 510(k) Number | K080935 |
|---|---|
| --------------- | --------- |
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Diagnostic ULTRASOUND INDICATIONS FOR USE Form EC9-5/10 microconvex endocavity 6.6 MHz 10mm radius transducer
Intended use:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityDoppler | Combined(Specify) | Other(Specify) | |
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | N | N | N | N | N | N | N (*1) | N (*2) | ||
| Transvaginal | N | N | N | N | N | N | N (*1) | N (*2) | ||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| MSK Conventional | ||||||||||
| MSK Superficial | ||||||||||
| Vascular Access | ||||||||||
| Nerve Block | ||||||||||
| Other (specify) |
N = New indication; P = Previously cleared
Additional Comments:
*1. B/M, B/PWD, B/CWD, B/CFM/PWD, B/AD/PWD, B/DPD/PWD, B/CFM/CWD, B/D/CV/D, B/DPD/CWD
*2. Directional Power Doppler (DPD), Imaging for guidance of biopsy
| Appendix C: Transdcuer Specifications | 00.040.051, Revision A | SONIX MDP User Manual |
|---|---|---|
| 4 | ||
| (Division Sign-Off) | ||
| Division of Reproductive, Abdominal and | ||
| Radiological Devices | ||
| 510(k) Number | 2080935 |
{9}------------------------------------------------
Diagnostic ULTRASOUND INDICATIONS FOR USE Form L14-5/38 linear 8 MHz 38mm transducer
Intended use:
Diagnostic uitrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityDoppler | Combined(Specify) | Other(Specify) |
| Ophthalmic | ||||||||||
| Fetal | N | N | N | N | N | N | N (*1) | N (*2) | ||
| Abdominal | N | N | N | N | N | N | N (*1) | N (*2) | ||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | N | N | N | N | N | N | N (*1) | N (*2) | ||
| Small Organ (specify) | N | N | N | N | N | N | N (*1) | N (*2) | ||
| Neonatal Cephalic | N | N | N | N | N | N | N (*1) | N (*2) | ||
| Adult Cephalic | N | N | N | N | N | N | N (*1) | N (*2) | ||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | N | N | N | N | N | N | N (*1) | N (*2) | ||
| Laparoscopic | ||||||||||
| MSK Conventional | N | N | N | N | N | N | N (*1) | N (*2) | ||
| MSK Superficial | N | N | N | N | N | N | N (*1) | N (*2) | ||
| Vascular Access | N | N | N | N | N | N | N (*1) | N (*2, *4) | ||
| Nerve Block | N | N | N | N | N | N | N (*1) | N (*2, *3) | ||
| Other (specify) |
N = New indication; P = Previously cleared
Additional Comments:
Small Organ: Breast, Thyroid, Testicle
-
*1. B/M, B/PWD, B/CFM/PWD, B/AD/PWD, B/OPD/PWD, B/OFM/CWD, B/AD/CWD, B/DPD/CWD
*2. Directional Power Dopbler (DPD), Imaging for guidance of biopsy
*3. Imaging for guidan
*2. Directional Power Doppler (DPD), Imaging for guidance of biops -
*4. Imaging for guidance of central or peripheral lines.
00.040.051, Revision A
5
Appendix C: Transdcuer Specifications
Hecho Leuer
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 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.