(15 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Ophthalmic, Fetal, Abdominal, Intraoperative (vascular/epicardial), Pediatric, Small Organ (thyroid, scrotum and breast), Neonatal Cephalic, Adult Cephalic, Cardiac (Adult & Pediatric), Transesophageal, Transrectal, Transvaginal, Peripheral Vascular.
Diagnostic Ultrasound Imaging and Doppler Analysis of the human body as follows: Abdominal, Adult Cephalic.
Diagnostic Ultrasound Imaging and Doppler Analysis of the human body as follows: Fetal, Small Organ (prostate), Transrectal, Transvaginal.
Diagnostic Ultrasound Imaging and Doppler Analysis of the human body as follows: Intraoperative (vascular/epicardial), Pediatric, Cardiac, Peripheral Vascular.
This premarket notification describes modifications to the indications for the Sonos 5500 M2424A system with the 21330A probe, and the addition of two probes. The common names for these devices are the Phased Array, Endocavity Probe and Intraoperative Probe for Sonos 5500 Ultrasound Imaging System. The classification names for these devices are: Ultrasonic Pulsed Doppler Imaging System, Ultrasonic Pulsed Echo imaging System and Diagnostic Ultrasound Transducer.
The provided text is a 510(k) summary for modifications to the Sonos 5500 Ultrasound Imaging System and its transducers. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study with acceptance criteria and performance data for a new AI/CADe device.
Therefore, the document does not contain the information required to fill out the table and answer the study-related questions (items 1 through 9). The approval is based on the devices functioning "in the same way as their predicate devices" and having "no new technological changes" except for patient contact materials. The provided "Indications for Use Form" lists clinical applications and modes of operation, indicating whether they are "new," "previously cleared," or "added under Appendix E," but these are intended use statements, not performance data or acceptance criteria for a study.
Specifically:
- A table of acceptance criteria and the reported device performance: Not available. The document asserts substantial equivalence without providing specific performance metrics or acceptance criteria for the new indications or probes against a defined standard.
- Sample size used for the test set and the data provenance: Not applicable, as there is no mention of a diagnostic performance study, test set, or data provenance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method: Not applicable.
- If a multi-reader, multi-case (MRMC) comparative effectiveness study was done: No, this is not mentioned.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: No, this is not mentioned.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable, as there is no mention of a training set for an algorithm.
- How the ground truth for the training set was established: Not applicable.
The 510(k) summary primarily focuses on regulatory compliance, outlining the modifications and asserting that the modified devices are substantially equivalent to existing, legally marketed predicate devices. The "study" mentioned pertains to biocompatibility testing for new patient contact materials, not clinical performance for diagnostic accuracy.
This document is a 510(k) summary for modifications to an existing ultrasound system and its transducers. It *does not contain* information about a study proving a device meets acceptance criteria related to diagnostic performance for a new AI/CADe device. The approval is based on substantial equivalence to predicate devices. Therefore, the requested information cannot be extracted from the provided text.
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510 (k) Summary
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 C.F.R. §807.92.
- The submitter of this premarket notification is:
Name: Ann Fay Michaels ార్యం Title Regulatory Enqineer
Hewlett Packard Company 3000 Minuteman Road Andover, MA 01810 (978) 659-2980 Tel: (978) 683-6337 Fax: Email: annmich@an.hp.com
This summary was prepared on December 09, 1998.
-
This premarket notification describes modifications to the indications for the Sonos 5500 M2424A system with the 21330A probe, and the addition of two probes. The common names for these devices are the Phased Array, Endocavity Probe and Intraoperative Probe for Sonos 5500 Ultrasound Imaging System. The classification names for these devices are: Ultrasonic Pulsed Doppler Imaging System, Ultrasonic Pulsed Echo imaging System and Diagnostic Ultrasound Transducer.
-
The modification involves expanded indications for use on the M2424A system to allow endocavity imaging using HP's endocavity transducer 21336A (K972348). Additionally, a new intraoperative transducer (21390A) that has new patient contact materials, is being added to the M2424A system. Also, the indications for the 21330A probe (K980687) are being expanded to include abdominal and adult cephalic applications with the harmonic tissue imaging option. Note: The HP M2424A platform has been previously cleared for harmonic tissue imaging for abdominal applications.
4 . When connected to the Sonos 5500 system, all three transducers function in the same way as their predicate devices by allowing ultrasound imaging of the human anatomy.
- The subject transducers have the same intended use as their predicates. The 21336A was cleared for endocavity applications on the M2410A (K972348). The 21390A has the same intended use as its predicate device 21380A cleared for intraoperative use on the M2424A system (K971116). The 21330A has the same intended use as Acuson Corporation's 3V2c
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transducer on its Sequoia Ultrasound System (K973767) with respect to abdominal and adult cephalic applications.
.
- The modifications to the M2424A system and its probes result in no new technological changes with respect to currently marketed predicate devices. As a new probe, the 21390A is similar to predicate devices in all respects except patient contact materials, and this 510(k) Notification includes biocompatibility test results that demonstrate biocompatibility of the new materials.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the logo is an abstract symbol that resembles an eagle or bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 8 1999
Hewlett-Packard Company c/o Carole Stamp TUV Product Service 1775 Old Highway 8 NW, Suite 104 New Brighton, MN 55112-1891
K990339 Re: Sonos 5500 Imaging System M2424 Version B.0 Requlatory Class: II Product Code: 90 IYN 21 CFR 892.1550 90 İYQ 21 CFR 892.1560 21 CFR 892.1570 90 ITX Dated: February 2, 1999 February 3, 1999 Received:
Dear Ms. Stamp:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
This determination of substantial equivalence applies to the following transducers intended for use with the Sonos 5500 Imaging System M2424A Version B.0, as described in your premarket notification:
Transducer Model Number
Phased Array Model 21330A Endocavity Model 21336A Phased Array Model 21390A
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਜੋ substantially equivalent determination assumes compliance with the Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic QS inspections, the FDA will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you may have under sections 531 and 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Carole Stamp
This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.
The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:
Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850
This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4591. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Other general information on your responsibilities under the Act may 807.97). be obtained from the Division of Small Manufacturers Assistance at its tollfree number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
If you have any questions regarding the content of this letter, please contact Robert A. Phillips, Ph.D. at (301) 594-1212.
Sincerely yours,
David A. Symm
Capt. Daniel 6. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
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DUPLICATE
Diagnostic Ultrasound Indications for Use Form
510(k) Number:
Device Name:
Intended Use:
Sonos 5500 Ultrasound Imaging System (M2424A) 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 | ColorVelocityImaging | Combined(specify) | Other(specify) |
| Ophthalmic | NA | P | NA | P | NA | P | P | P | P | NA |
| Fetal | NA | P | P | P | P | P | P | P | P | NA |
| Abdominal | NA | P | P | P | P | P | P | P | P | P |
| Intraoperative(vascular/epicardial) | NA | P | P | P | P | P | P | P | P | NA |
| IntraoperativeNeurological | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Pediatric | NA | P | P | P | P | P | P | P | P | P |
| Small Organ(thyroid, scrotumand breast) | NA | P | P | P | P | P | P | P | P | P |
| Neonatal Cephalic | NA | P | P | P | P | P | P | P | P | P |
| Adult Cephalic | NA | P | P | P | P | P | P | P | P | N |
| Cardiac (Adult &Pediatric) | NA | P | P | P | P | P | P | P | P | P |
| Transesophageal | NA | P | P | P | P | P | P | P | P | P |
| Transrectal | NA | N | N | NA | N | N | NA | N | N | NA |
| Transvaginal | NA | N | N | NA | N | N | NA | N | N | NA |
| Transurethral | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Intravascular | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Peripheral Vascular | NA | P | P | P | P | P | P | P | P | P |
| Laparoscopic | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Musculo-skeletalConventional | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Musculo-skeletalSuperficial | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Other (specify) | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| N = new indication; P = previously cleared by FDA: E = added under Appendix E |
Additional Comments: __Combined modes are B+M, B+M+color (CV1), B+W Other: Harmonic Imaging of tissue was cleared under K980687. Harmonic Imaging of contrast agents was cleared under K964309.
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)
Thind A. Segmen
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT and Radiological Device
510(k) Number
{5}------------------------------------------------
Diagnostic Ultrasound Indications for Use Form
| MODE OF OPERATION | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other(tissueharmonics) |
| Ophthalmic | NA | E | NA | E | NA | E | E | E | E | NA |
| Fetal | NA | E | E | E | E | E | E | E | E | NA |
| Abdominal | NA | E | E | E | E | E | E | E | E | N |
| Intraoperative | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| IntraoperativeNeurological | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Pediatric | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Small Organ | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Neonatal Cephalic | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Adult Cephalic | NA | E | E | E | E | E | E | E | E | N |
| Cardiac | NA | P | P | P | P | P | P | P | P | P |
| Transesophageal | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Transrectal | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Transvaginal | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Transurethral | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Intravascular | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Peripheral Vascular | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Laparoscopic | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Musculo-skeletalConventional | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Musculo-skeletalSuperficial | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Other (specify) | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
Device Name: Phased Array Transducer (21330A) on the M2424A
follows:
Device Name: Phased Array Transducer (21330A) on the M2424A
Intended Use: Diagnostic Ultrasound Imaging and Doppler Analysis of the human body as
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Additional Comments: Other indications or modes: Combined modes are B+M, B+M+Color, and B+PW. Harmonic imaging of tissue was cleared under K980687. Harmonic imaging of
N = new indication; P = previously cleared by FDA; E = added under Appendix E.
Prescription Use (Per 21 CFR 801.109)
agents was cleared under K964309.
contrast
Daniel A. Benson
Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological Devi
510(k) Number K990339
{6}------------------------------------------------
Diagnostic Ultrasound Indications for Use Form
510(k) Number:
Device Name:
Intended Use:
Endocavity Transducer 21336A on the M2424A Diagnostic Ultrasound Imaging and Doppler Analysis of the human body as follows:
| MODE OF OPERATION | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other(specify) |
| Ophthalmic | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Fetal | NA | E | E | E | NA | E | E | NA | E | NA |
| Abdominal | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Intraoperative(specify) | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| IntraoperativeNeurological | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Pediatric | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Small Organ(prostate) | NA | E | E | E | NA | E | E | NA | E | NA |
| Neonatal Cephalic | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Adult Cephalic | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Cardiac | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Transesophageal | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Transrectal | NA | N | N | N | NA | N | N | NA | N | NA |
| Transvaginal | NA | N | N | N | NA | N | N | NA | N | NA |
| Transurethral | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Intravascular | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Peripheral Vascular | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Laparoscopic | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Musculo-skeletalConventional | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Musculo-skeletalSuperficial | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Other (specify) | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
N = new indication; P = previously cleared by FDA; E = added under Appendix E. Additional Comments: Combined modes are: B+M, and B+PW.
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 A. Severson
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K990339
{7}------------------------------------------------
Diagnostic Ultrasound Indications for Use Form
Device Name: Phased Array Transducer (21390A) on the M2424A
Intended Use: Diagnostic Ultrasound Imaging and Doppler Analysis of the human body as follows:
| MODE OF OPERATION | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other(specify) | |
| Ophthalmic | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | |
| Fetal | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | |
| Abdominal | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | |
| Intraoperative(vascular/epicardial) | NA | P | P | P | NA | P | P | P | P | NA | |
| IntraoperativeNeurological | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | |
| Pediatric | NA | P | P | P | P | P | P | P | P | NA | |
| Small Organ | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | |
| Neonatal Cephalic | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | |
| Adult Cephalic | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | |
| Cardiac | NA | P | P | P | P | P | P | P | P | NA | |
| Transesophageal | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | |
| Transrectal | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | |
| Transvaginal | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | |
| Transurethral | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | |
| Intravascular | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | |
| Peripheral Vascular | NA | P | P | P | P | P | P | P | P | NA | |
| Laparoscopic | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | |
| Musculo-skeletalConventional | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | |
| Musculo-skeletalSuperficial | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | |
| Other (specify) | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | |
| N = new indication; P = previously cleared by FDA; E = added under Appendix E. |
Additional Comments: Other indications or modes: Combined modes are B+M, B+M+Color, and B+PW. and B+PW. "P" refers to 21380A (K971116).
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 A. Seppam
(Division Sign-Off) Division of Reproductive, Abdormal, ENT and Radiological Device
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.