(6 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal - OB/GYN, abdominal, intra-operative (abdominal organs, neurological, and vascular), laparoscopic, pediatric, small organ (breast, thyroid, testicles), neonatal cephalic, trans-rectal, transvaginal, musculoskeletal (conventional and superficial), cardiac (adult and pediatric), and peripheral vessel applications. The TITAN™ Ultrasound System has been additionally cleared for adult cephalic applications. The systems provide imaging for biopsy guidance, imaging to assist in the placement of needles and catheters in vascular or other anatomical structures, and imaging guidance for peripheral nerve block procedures.
The devices referenced in this Submission are highly portable. software-controlled, diagnostic ultrasound systems with accessories. This Submission does not include any technological or feature changes from the previously cleared SonoSite devices or transducers.
The provided text is a 510(k) summary for SonoSite ultrasound systems. It describes the addition of a new clinical application ("intra-operative (neurological)") to existing ultrasound devices. This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of device performance metrics like accuracy, sensitivity, or specificity for a diagnostic algorithm.
Instead, the "Testing" section (Section 7 on page 3) states:
- "Each of the referenced SonoSite systems has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness, as well as thermal, electrical and mechanical safety, and has been found to conform to applicable medical device safety standards, as referenced in Section 4. Reports were previously included in the referenced predicate submissions."
- "No additional clinical testing is required, as the added indication for use is not a novel indication as shown by the predicate devices in Section 3."
This indicates that the acceptance criteria for this 510(k) submission are related to:
- Compliance with general medical device safety standards (acoustic output, biocompatibility, cleaning/disinfection, thermal, electrical, mechanical safety). These were already met and documented in previous predicate submissions (K030949 and K014116), for which this document serves as an update adding a new indication for use.
- Substantial equivalence to predicate devices that already have 'intra-operative (neurological)' as a clinical application. The argument is that since the new indication is not novel and the anatomical site is amenable to the systems' existing technology, no additional clinical testing is needed to prove effectiveness for this specific added use.
Therefore, the requested information components (table of acceptance criteria and performance, sample size, ground truth, adjudication, MRMC studies, standalone performance, training set size, etc.) are not available in this document because the submission relies on substantial equivalence and prior safety testing, rather than a new performance study proving diagnostic accuracy for the added indication.
Specifically, for the questions asked:
- A table of acceptance criteria and the reported device performance: Not provided. The document focuses on regulatory compliance and substantial equivalence to predicate devices for the new indication, not a new performance study with specific metrics.
- Sample size used for the test set and the data provenance: Not applicable. No new clinical test set was used for the added indication. The submission relies on the fact that existing systems already meet safety standards, and the new indication is covered by predicate devices without requiring new clinical performance data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No new test set requiring expert ground truth was created for this submission.
- Adjudication method for the test set: Not applicable.
- 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: Not applicable. This submission is for an ultrasound system, not an AI-powered diagnostic device, and no MRMC study is mentioned.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for a new performance study in this submission.
- The sample size for the training set: Not applicable as this is not an AI/algorithm submission requiring a training set.
- How the ground truth for the training set was established: Not applicable.
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Image /page/0/Picture/0 description: The image shows the logo for SonoSite. The logo consists of a black square with a white, stylized "S" shape inside, followed by the word "SonoSite" in a bold, sans-serif font. A period is placed after the word "SonoSite".
SonoSite, Inc. 21919 30th Drive SE Botheil, WA 98021-3904 USA
Telephone: 1.425.951.1200 Facsimile: www.sonosite.com
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with 21 CFR, Part 807, Subpart E, Section 807.92.
Submitter's name, address, telephone number, contact person; 1)
Daina L. Graham Vice-President - Regulatory Affairs and Quality Assurance SonoSite, Inc. 21919 30th Drive SE Bothell, WA 98021-3904
(425) 951 - 1275
E-mail: daina.graham@sonosite.com
Date prepared: December 3, 2004
- Name of the device, including the trade or proprietary name if applicable, 2) the common or usual name, and the classification name, if known:
Common/ Usual Name
Diagnostic Ultrasound System with Accessories
Proprietary Names
TITAN™ High-Resolution Ultrasound System SonoSite® Ultrasound System
{1}------------------------------------------------
Classification Names
| Name | FR Number | Product Code |
|---|---|---|
| Ultrasonic Pulsed Doppler ImagingSystem | 892.1550 | 90-IYN |
| Ultrasonic Pulsed Echo ImagingSystem | 892.1560 | 90-IYO |
| Diagnostic Ultrasound Transducer | 892.1570 | 90-ITX |
ldentification of the predicate or legally marketed device: 3)
The SonoSite Ultrasound System that is the subject of this Submission is the collective term for the legally marketed TITAN™ High-Resolution Ultrasound System (K030949),and the SonoSite® Ultrasound System (K014116).
This 510(k) adds the clinical application 'intra-operative (neurological)' as a indication to the SonoSite Ultrasound Systems (K030949, K014116). No other change, including technological change were made to these systems. Predicate devices that have 'intra-operative (neurological)' as a clinical application or indication are Siemens SONOLINE Omnia X/XS Diagnostic Ultrasound System (K020353) and Advanced Technology Laboratories HDI 5000 Ultrasound System (K011224)
4) Device Description:
The devices referenced in this Submission are highly portable. software-controlled, diagnostic ultrasound systems with accessories. This Submission does not include any technological or feature changes from the previously cleared SonoSite devices or transducers.
By this Submission, the clinical application 'intra-operative (neurological)' is being added to previously cleared indications for use for each of these systems and to the following transducers:
{2}------------------------------------------------
| System | Transducer | TransducerType | FrequencyRange |
|---|---|---|---|
| TITAN™ High-ResolutionUltrasound System | C11/8-5 | Curved Array | 8.0 - 5.0 MHz |
| SonoSite® Ultrasound System | C11/7-4 | Curved Array | 7.0 - 4.0 MHz |
SonoSite ultrasound systems are designed, as applicable to their features, to comply with the standards listed below.
| EN 980 A1:2003 | IEC 60601-2-37 |
|---|---|
| AAMI/ANSI/ISO 10993-1:1997 | CAN/CSA C22.2, No. 601.1:1998 |
| AAMI/ANSI/ISO 10993-4:1992 | UL 2601-1:1999 |
| AAMI/ANSI/ISO 10993-5:1999 | UL 94, 5th ed. |
| AAMI/ANSI/ISO 10993-10:1995 | EN ISO 13485:1996 |
| AAMI/ANSI/ISO 10993-11:1993 | CISPR 11:2003 |
| AAMI/ANSI/ISO 10993-12:1996 | JIS-T-0601-1 |
| IEC 60601-1:1988 | RTCA/DO160D:1997 |
| IEC 60601-1/A1:1991 | ANSI/AAMI EC53:1995 |
| IEC 60601-1/A2:1995 | ASTM D5276-98 |
| IEC 60601-1-1:2000 | ASTM D999-96 |
| IEC 60601-1-2:2001 | NEMA PS3.15 2000 |
| IEC 60601-1-4:1996 | NEMA UD2-1998 |
| IEC 60601-2-25:1996 | NEMA UD3:1998 |
| AIUM Medical Ultrasound Safety,American Institute of Ultrasound in | Acoustic Output Measurement andLabeling Standard for Diagnostic |
| Medicine (1994) | Ultrasound Equipment, American Instituteof Ultrasound in Medicine. 1993 |
5) Intended Use:
As defined by FDA guidance documents, the intended uses of the SonoSite ultrasound systems referenced herein remain unchanged from previously cleared indications, except for the addition of 'intra-operative (neurological)' as a new intended use.
The SonoSite Ultrasound Systems are intended for use for ultrasound evaluation of fetal - OB/GYN, abdominal, intra-operative (abdominal organs, neurological, and vascular), laparoscopic, pediatric, small organ (breast, thyroid, testicles), neonatal cephalic, trans-rectal, transvaginal, musculoskeletal (conventional and superficial), cardiac (adult and pediatric), and peripheral vessel applications. The TITAN™ Ultrasound System has been additionally cleared for adult cephalic applications. The systems provide imaging for biopsy guidance, imaging to assist in the placement of needles and catheters in vascular or other anatomical structures, and imaging guidance for
{3}------------------------------------------------
peripheral nerve block procedures.
6) Technological Characteristics:
There are no technological or feature changes in this Submission to any of the legally marketed ultrasound systems, transducers, or accessories identified in Section 3 of this Summary.
7) Testing:
Each of the referenced SonoSite systems has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness, as well as thermal, electrical and mechanical safety, and has been found to conform to applicable medical device safety standards, as referenced in Section 4. Reports were previously included in the referenced predicate submissions. No additional clinical testing is required, as the added indication for use is not a novel indication as shown by the predicate devices in Section 3. The anatomical site is amenable to current transducer and post-processing ultrasound technology available with the SonoSite systems and predicate devices. Additionally, the modes of operation that are indicated with this clinical application for the SonoSite systems is consistent with those identified with the predicate devices. SonoSite has incorporated the specific labeling required by the FDA for the neurological intra-operative indication in its user guides to mitigate risk to that defined level.
8) Conclusion:
SonoSite believes that the testing and analysis described in Section 7 demonstrates that the TITAN™ High-Resolution Ultrasound System (K030949),and the SonoSite® Ultrasound System (K014116), incorporating the 'intra-operative (neurological) indication, are substantially equivalent with respect to safety and effectiveness to the predicate devices identified in Section 3.
{4}------------------------------------------------
Image /page/4/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 a stylized symbol that resembles an abstract human figure with three horizontal lines above it, possibly representing arms or outstretched hands.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 1 2004
SonoSite, Inc. % Mr. Mark Job Responsible Third Party Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K043452
Trade Name: TITAN™ High-Resolution Ultrasound System and SonoSite® 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: 90 IYN, IYO, and ITX Dated: December 10, 2004 Received: December 15, 2004
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 TITAN™ High-Resolution Ultrasound System and SonoSite® Ultrasound System, as described in your premarket notification:
{5}------------------------------------------------
Transducer Model Number
C11/8-5 8.0 - 5.0MHz Curved Array (TITANTM) C11/7-4 7.0 - 4.0MHz Curved Array (SonoSite®
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 or unly 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 Or the rate of 7) its 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
{6}------------------------------------------------
other general information on your responsibilities under the Act from the Division of Small other goleral international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.
Sincerely yours,
David C. Lyman
Nancy C. Brogdon W Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
{7}------------------------------------------------
| System: | SonoSite TITAN TM high-resolution ultrasound system | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Transducer: | N/A | ||||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | ||||||||
| Clinical Application | Mode of Operation | ||||||||
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler | Combined(Spec.) | Other(Spec.) | |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | P | P | P | P | B+M; B+PWD;B+CD | Note 1 | |||
| Abdominal | P | P | P | P | P | B+M; B+PWD;B+CWD; B+CD | Note 1 | ||
| Intra-operative (Abdominalorgans and vascular) | P | P | P | P | B+M; B+PWD;B+CD | Note 1 | |||
| Intra-operative (Neuro.) | N | N | N | N | B+M; B+PWD;B+CD | Note 1 | |||
| Fetal Imaging | Laparoscopic | P | P | P | B+M; B+PWD | Note 1 | |||
| B+M; B+PWD; | |||||||||
| & Other | Pediatric | P | P | P | P | P | B+CWD; B+CD | Note 1 | |
| Small Organ (breast,thyroid, testicles) | P | P | P | P | B+M; B+PWD;B+CD | Note 1 | |||
| B+M: B+PWD; | |||||||||
| Neonatal Cephalic | P | P | P | P | B+M; B+PWD;B+CD | Note 1 | |||
| B+M; B+PWD; | |||||||||
| Adult Cephalic | P | P | P | P | B+CD | Note 1 | |||
| B+M; B+PWD; | |||||||||
| Trans-rectal | P | P | P | P | B+CD | Note 1 | |||
| B+M; B+PWD; | |||||||||
| Trans-vaginal | P | P | P | P | B+CD | Note 1 | |||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skel. (Convent.) | P | P | P | B+M; B+PWD | Note 1 | ||||
| B+M; B+PWD; | |||||||||
| Musculo-skel. (Superfic.) | P | P | P | P | B+CD | Note 1 | |||
| Intra-luminal | |||||||||
| Other (spec.) | |||||||||
| B+M; B+PWD; | |||||||||
| Cardiac Adult | P | P | P | P | P | B+CWD; B+CD | Note 1 | ||
| B+M; B+PWD; | |||||||||
| Cardiac | Cardiac Pediatric | P | P | P | P | P | B+CWD; B+CD | Note 1 | |
| Trans-esophageal (card.) | |||||||||
| Other (spec.) | |||||||||
| B+M; B+PWD; | |||||||||
| PeripheralVessel | Peripheral vesselOther (spec.) | P | P | P | P | B+CD | Note 1 |
Table 4.3- 1 Diagnostic Ultrasound Indications for Use Form
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
Note 1: Other includes Color Power Doppler, combined B and Color Power Doppler, combined B and Directional Color Power Doppler, 3-D Imaging, Tissue Harmonic Imaging for guidance of biopsy. Color Doppler includes Velocity Color Doppler. Imaging to assist in the placement of needles and catheters in vascular or other anatomical structures, and picture archiving, communications and storage functionality were previously cleared in K030949. Imaging guidance for peripheral nerve block procedures was previously cleared in K033367.
Prescription Use (Per 21 CFR 801.109)
David A. Ingram
(Division Sign-Off) Division of Reproductive, Abdor and Radiological Device 510(k) Number
{8}------------------------------------------------
| Table 4.3- 2 Diagnostic Ultrasound Indications for Use Forn. | |||
|---|---|---|---|
| -- | -------------------------------------------------------------- | -- | -- |
| System: | SonoSite TITAN TM high-resolution ultrasound system | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Transducer: | C11/8-5 8.0 – 5.0 MHz Curved Array | ||||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | ||||||||
| Clinical Application | Mode of Operation | ||||||||
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler | Combined(Spec.) | Other(Spec.) | |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | P | P | P | P | P | B+M; B+PWD;B+CWD; B+CD | Note 1 | ||
| Intra-operative (Abdominalorgans and vascular) | P | P | P | P | P | B+M; B+PWD;B+CD | Note 1 | ||
| Intra-operative (Neuro.) | N | N | N | N | N | B+M; B+PWD;B+CD | Note 1 | ||
| Fetal Imaging& Other | Laparoscopic | ||||||||
| PediatricSmall Organ (breast,thyroid, testicles) | P | P | P | P | P | B+M; B+PWD;B+CWD; B+CD | Note 1 | ||
| Neonatal Cephalic | P | P | P | P | B+M; B+PWD;B+CD | Note 1 | |||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skel. (Convent.) | |||||||||
| Musculo-skel. (Superfic.) | |||||||||
| Intra-luminal | |||||||||
| Other (spec.) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac | Cardiac Pediatric | P | P | P | P | P | B+M; B+PWD;B+CWD; B+CD | Note 1 | |
| Trans-esophageal (card.) | |||||||||
| Other (spec.) | |||||||||
| PeripheralVessel | Peripheral vesselOther (spec.) | P | P | P | P | B+M; B+PWD;B+CD | Note 1 | ||
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
Note 1: Other includes Color Power Doppler, combined B and Color Power Doppler, combined B and Directional Color Power Noter : Only moldes Oolor Form Boppion, onlinem in the guidance of biopsy. Color Doppler includes Velocity Color Dopper, 3-D maging, Tissue hamono maging, and maging for ground of the range in the cludes, and picking and picking and picking a Dopper. This is a storage functionality were previously cleared in K030949. Imaging guidance for periotheral nerve block procedures was previously cleared in K033367.
Prescription Use (Per 21 CFR 801.109)
David A. Lyman
(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
{9}------------------------------------------------
| System: | SonoSite® Ultrasound System | |||||||
|---|---|---|---|---|---|---|---|---|
| Transducer: | N/A | |||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | |||||||
| Clinical Application | Mode of Operation | |||||||
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler | Combined(Spec.) | Other(Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal | P | P | P | B+M; B+PWD | Note 1 | |||
| Abdominal | P | P | P | P | B+M; B+PWD;B+CWD | Note 1 | ||
| Intra-operative(Abdominal organs andvascular) | P | P | P | B+M; B+PWD | Note 1 | |||
| Fetal Imaging | Intra-operative (Neuro.) | N | N | N | N | B+M; B+PWD;B+CD | Note 1 | |
| Laparoscopic | P | P | P | B+M; B+PWD | Note 1 | |||
| & Other | P | P | P | P | B+M; B+PWD;B+CWD | Note 1 | ||
| & Other | Pediatric | |||||||
| Small Organ (breast,thyroid, testicles) | P | P | P | B+M; B+PWD | Note 1 | |||
| Neonatal Cephalic | P | P | P | B+M; B+PWD | Note 1 | |||
| Adult Cephalic | ||||||||
| Trans-rectal | P | P | P | B+M; B+PWD | Note 1 | |||
| Trans-vaginal | P | P | P | B+M; B+PWD | Note 1 | |||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | P | P | P | B+M; B+PWD | Note 1 | |||
| Musculo-skel. (Superfic.) | P | P | P | B+M; B+PWD | Note 1 | |||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac | Cardiac Adult | P | P | P | P | B+M; B+PWD;B+CWD | Note 1 | |
| Cardiac Pediatric | P | P | P | P | B+M; B+PWD;B+CWD | Note 1 | ||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| PeripheralVessel | Peripheral vessel | P | P | P | B+M; B+PWD | Note 1 | ||
| Other (spec.) |
Table 4.3- 3 Diagnostic Ultrasound Indications for Use Form
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
Note 1: Other includes Color Power Doppler, combined B and Color Power Doppler, combined B and PowerMap™ Directional Color Now 1. One Tireducs Ooler Forwar Deption of Street of biopsy cleared in K014116. Imaging guidance Fower Dopper, o-d maging, Tissue Tiamonial in the placement of beedes and catheres in 1970 and cather anatomical structures was previously cleared in K033367.
Prescription Use (Per 21 CFR 801.109)
David R. Lyynn
(Division Sign-Off) Division of Reproductive, Abdom and Radiological Device 510(k) Number
000019
{10}------------------------------------------------
| System: | SonoSite® Ultrasound System | |||||||
|---|---|---|---|---|---|---|---|---|
| Transducer: | C11/7-4 7.0 - 4.0 MHz Curved Array | |||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | |||||||
| Clinical Application | Mode of Operation | |||||||
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler | Combined(Spec.) | Other(Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | P | P | P | P | B+M; B+PWD;B+CWD | Note 1 | ||
| Intra-operative (Abdominalorgans and vascular) | P | P | P | B+M; B+PWD | Note 1 | |||
| Intra-operative (Neuro.)Laparoscopic | N | N | N | N | B+M; B+PWD;B+CD | Note 1 | ||
| Fetal Imaging& Other | PediatricSmall Organ (breast,thyroid, testicles)Neonatal Cephalic | P | P | P | P | B+M; B+PWD;B+CWD | Note 1 | |
| Adult CephalicTrans-rectalTrans-vaginalTrans-urethralTrans-esoph. (non-Card.)Musculo-skel. (Convent.)Musculo-skel. (Superfic.)Intra-luminalOther (spec.)Cardiac Adult | ||||||||
| Cardiac | Cardiac PediatricTrans-esophageal (card.)Other (spec.) | P | P | P | P | B+M; B+PWD;B+CWD | Note 1 | |
| PeripheralVessel | Peripheral vesselOther (spec.) | P | P | P | B+M; B+PWD | Note 1 |
Table 4.3- 4 Diagnostic Ultrasound Indications for Use Form
previously cleared by FDA; E= added under Appendix E ew indication; F
Additional Comments:
Note 1: Other includes Color Power Doppler, combined B and Color Power Doppler, combined B and PowerMap™ Directional Color Power Doppler, 3-D Imaging, Tissue Harmonic Imaging for guidance of biopsy cleared in K014116. Imaging guidance for peripheral nerve block procedures and imaging to assist in the placement of needles and catheters in vascular or other anatomical structures was previously cleared in K033367.
Prescription Use (Per 21 CFR 801.109)
David A. Segerman
(Division Sign-Off) Division of Reproductive, Abdomina 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.