(15 days)
Diagnostic Ultrasound Imaging and Doppler Analysis of the human body as follows: Musculo-skeletal Conventional, Musculo-skeletal Superficial, Small Parts (small organ), Peripheral Vascular. Diagnostic Ultrasound System: Fetal, Abdominal, Pediatric, Small Parts I (small organ), Neonatal Cephalic, Adult Cephalic, Cardiac, Transesophageal, Transrectal, Transvaginal, Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial.
This premarket notification describes modifications to the ImagePoint M2410A system. It adds two new intended uses to the operating platform covering Musculo-Skeletal and Adult Cephalic (Transcranial Doppler) imaging. It adds harmonic imaging mode for the following applications: fetal, abdominal, pediatric, adult cephalic and cardiac. Hewlett-Packard considers Harmonic imaging to be a subset of 2D / B-mode imaging. This premarket notification also adds a transducer with new patient contact materials indicated for musculo-skeletal, vascular and small parts imaging. The classification names for these devices are: Diagnostic Oltrasound Transducer, Ultrasonic Pulsed Echo Imaging System and Ultrasonic Pulsed Doppler Imaging System. The modification involves expanded intended uses to the M2410A system, as well as, the addition of a new transducer with new patient contact materials, to be known as the HP 21376A Transducer. The ImagePoint system, with new platform modes, new indications for use, and new transcucer, functions in the same way as its predicate devices, the M2410A K954028), M2424A (K964309 and K980687) and the Acuson Aspen System, with L7 probe, (K973079) by allowing ultrasound imaging of the humar anatomy. The subject platform and transqucer have the same functionality and intended uses as their bredicates. The M2410A platform and HP 21376A transducer on the M2410A are similar to the predicate devices in all respects except the transducer has new patient contact materials. This 510(k) Notification includes biocompatibility test results that demonstrate biocompatibility of the new materia s.
This document describes the 510(k) summary for modifications to the ImagePoint M2410A ultrasound system and a new transducer, the HP 21376A. The modifications include expanded intended uses for the platform and the addition of a new transducer with new patient contact materials.
1. Acceptance Criteria and Reported Device Performance
The provided text does not contain any specific acceptance criteria or reported device performance metrics for the ImagePoint M2410A system or the HP 21376A transducer. The document focuses on demonstrating substantial equivalence to predicate devices and expanding the indications for use.
The tables in the document (Diagnostic Ultrasound Indications for Use Form) primarily listed the "Mode of Operation" for various "Clinical Application" categories. The 'N' in the tables indicates a "new indication" and 'P' indicates "previously cleared by FDA". There are no numerical performance values or targets.
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not contain information about a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective or prospective data). The submission focuses on substantial equivalence based on the device's functionality and intended uses being similar to predicate devices. For biocompatibility, it states "biocompatibility test results that demonstrate biocompatibility of the new materials" were included, but details are absent here.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not mention any ground truth establishment by experts for a test set. This type of study detail is not typically found in a substantial equivalence claim for an ultrasound device based on expanded indications and new transducer materials.
4. Adjudication Method for the Test Set
As there is no mention of a test set or ground truth establishment, there is no adjudication method described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. There is no information on how human readers' performance might improve with or without AI assistance, as this submission predates widespread AI integration in medical imaging and focuses on fundamental device capabilities and safety/equivalence.
6. Standalone (Algorithm Only) Performance Study
The provided text does not include information about a standalone (algorithm only) performance study. The device described is a whole ultrasound imaging system and transducer.
7. Type of Ground Truth Used
Given the nature of the 510(k) submission (primarily focusing on expanded indications, new transducer materials, and substantial equivalence to predicate devices), there is no explicit mention of ground truth types (e.g., expert consensus, pathology, outcomes data) in the context of device performance evaluation. The "ground truth" in this context would likely be implicitly tied to the established safety and effectiveness of the predicate devices for similar applications.
8. Sample Size for the Training Set
The document does not mention a training set or its sample size. This type of information is relevant for AI/ML-based devices, which are not the focus of this 1999 ultrasound device submission.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set, there is no information on how its ground truth was established.
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2/4199
K 90400
510 (k) Summary
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical in Devices Act of 1990 and 21 C.F.R. 5807.92.
The submitter of this premarket notification is: 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Steve Singlar Regulatory Approvals Engineer Hewlett Packard Company 3000 Minuteman Road, MS C491 Andover, MA 01810 Tel: (978) 659-2101 Fax: Email: steve singlar@hp.com
This summary was prepared on January 12, 1999.
This premarket notification describes modifications to 2. the ImagePoint M2410A system. It adds two new intended uses to the operating platform covering Musculo-Skeletal and Adult Cephalic (Transcranial Doppler) imaging. It adds harmonic imaging mode for the following applications: fetal, abdominal, pediatric, adult cephalic and cardiac. Hewlett-Packard considers Harmonic imaging to be a subset of 2D / B-mode imaging. This premarket notification also adds a transducer with new patient contact materials indicated for musculo-skeletal, vascular and small parts imaging. The classification names for these devices are: Diagnostic Oltrasound Transducer, Ultrasonic Pulsed Echo Imaging System and Ultrasonic Pulsed Doppler Imaging System.
The modification involves expanded intended uses to the 3 . M2410A system, as well as, the addition of a new transducer with new patient contact materials, to be known as the HP 21376A Transducer.
The ImagePoint system, with new platform modes, new 4 . indications for use, and new transcucer, functions in the same way as its predicate devices, the M2410A K954028), M2424A (K964309 and K980687) and the Acuson Aspen System, with L7 probe, (K973079) by allowing ultrasound imaging of the humar anatomy.
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ເກ The subject platform and transqucer have the same functionality and intended uses as their bredicates.
6 -The M2410A platform and HP 21376A transducer on the M2410A are similar to the predicate devices in all respects except the transducer has new patient contact materials. This 510(k) Notification includes biocompatibility test results that demonstrate biocompatibility of the new materia s.
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Image /page/1/Picture/1 description: The image shows a circular seal with text around the perimeter and a stylized symbol in the center. The text around the perimeter appears to be "HEALTH & HUMAN SERVICES". The symbol in the center consists of three curved lines that resemble a bird in flight or a stylized representation of flowing water.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20650
FEB 2 4 1999
Hewlett-Packard Company C/o Carole Stamp TUV Product Service 1775 Old Highway 8 NW, Suite 104 New Brighton, MN 55112-1891
K990400 Re : Linear Array Transducer HP 21376A II/21 CFR 892.1570 Regulatory class: Procode: 90 ITX Dated: February 5, 1999 Bated: February 9, 1999
Dear Ms. Stamp:
We have reviewed your Section 510(k) notification of intent to market the We have reviewed above and we have determined the device is swastantially
device referenced above and we have determined the enclosures to legally device referenced above and we have decermined the developed to legally
equivalent (for the indications for use stated in interstate commerce prior to equivalent (for the indications for use scated in commence prior to marketed predicate davice marketed in Incelical Device Amendents, or to May 28, 1976, the enactment date of the mearch the provise of the provisions of the dederal Food, Drug, and Cosmetic Act (Act) . You may, therefore, market the Federal Food, Drug, and Cosmetic Acc (norola provisions of the Act.
device, subject to the not include requirements for annual l controls provisions of the Act include requirements for annual registration,
controls provisions of the Act include requirements for annual registration, controls provisions of the Act include requirements 201 comber 1998
listing of devices, good manufacturing practice, labeling, and prohibitions
of devices of the related and against misbranding and adulteration.
・・
This determination of substantial equivalence applies to the Linear Array Transducer HP 21376A intended for use with the M410A ImagePoint Ultrasound
Transducer HP 21376A intended for use with the M410A ImagePoint Ultrasound Transducer HP 21376A incended for see many fication.
If your device is classified (see above) into either class II (Special If your device is classified (see above) it may be subject to such Controls) or class III (Prematic Approvations affecting your device can be additional controls. External Regulations, Title 21, Parts 800 to 895.
found in the Code of Federal Regulations assumes compliance with the Good found in the Code of Federal Regulations, Isea compliance with the Good Manufacturing Practice requirement as set forth in the Quality System Manufacturing Practice requirement. As Bet Forch In Cho ation (21 CFR Part
Regulation (QS) for Medical Devices: General (GRP) will verify such Regulation (QS) for Medical Devices: Senetas (c.n.) e con will verify such Failure to comply with the GMP regulation may result in assumptions. In addition, the Food and Device Interestion (FDA) may regulatory action. In addition, the cool and device in the Federal Register.
publish further announcements concernary and if cation does not affect any publish further announcements concernming your fortication does not affect any
Please note: this response to your premarket not 542 of the Act for devices Please note: this response to your premations 531 and 542 of the Act for devices obligation you may have under sections 351 and 542 or one 100 million for other Federal laws or regulations.
This determination of substantial equivalence is granted on the condition that prior to shipping the first awice, you submit a postclearance special report.
prior to shipping the first arricts, you submit a postic output This report should contain complete information, including acoustic output
This report should contain complete information, requested in Annendix Gr measurements based on production line devices, requested in Appendix G,
measurements based on production 11se 19thersted in Appendix G, Manufacturers
(enclosed) of the Center (enclosed) of the Center's September 30, 1997 - Information of the Contributers."
{2}------------------------------------------------
Page 2 - Ms. Carole Stamp
If the special report is incomplete or contains unacceptable values (e.g.,
the special control than improved levels), then the 510 (k) clearance m If the special report is incomplete or contains unaceeptable have and may
acoustic output greater than approved levels), then the 510 (k) clearance may
or the succession wate acoustic output greater than approved levels), cher the out may be considered
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. Tt The special report should reference the manufacturer a 3101K, names of the submitted in duplicate to:
Food and Drug Administration Food and Drug Acadinad Radiological Health
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 This lotter will allow you to begin marketing of substant of your device to legally marketed predicate device results in a classification for
device to a legally marketed predicate device to proceed to market. device to a legally marketed predicate device to proceed to market.
If you desire specific advice for your device on our labeling regulation (21) I Fre Bol and additionally 809.10 for in vitro diagnostic devices in please
CFR Part B01 and additionally 809.10 for in vitro diagnostic devices in please cert Bol and additionally 809.10 for in vitro diagnostic dover, off, contact the Office of Compliance at (30) 394-device, please contact the
questions on the promotion and advertising of your device, please contact the questions on the promotion and advertising of your acourted the regulation
Office of Compliance at (301) 594-4639. Also, please note the regulation Compliance at (301) 594-4639. Premarket notification" (21 CFR "Misbranding of Small Manufacturers Assistancer the Act may
Other general information on your responsibilities under the Act may
on the fininian of Small Manufacturers Assist entitled, be obtained from the Division of Small Hanufacturers Assistance at tts tollbe obtained from the Division of Small Manufacturers Assistance at the Indian be obtained from the DIvision of Small Manufacturers (800) and 110)
free number (800) 638–2041 or at (301) 443–6597 or at 1ts internet address
(18) (18) and by ness(edremain. tree number (b00) 036 2041 01 00 (00 (10 ) "
If you have any questions regarding the content of this letter, please contact of
the contactions The Pact (301) 594-1212. Robert Phillips, Ph.D.at (301) 594-1212.
Sipcerely yours,
David G. Hyman
Capt. Daniel G. Schultz,
Capt. Daniel G. Schultz, M. D. Capt. Danier G. October of Reproductive, Cing Director, Nose, and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
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Diagnostic Ultrasound Indications for Use Form
510(k) Number: Device Name:
Transducer HP 21376A on the M2410A
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 | PowerAmplitudeDoppler | 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 | |
| Abdominal | NA | NA | NA | NA | NA | NA | NA | NA | NA | |
| Intraoperative | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| (specify)IntraoperativeNeurological | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Pediatric | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Small Parts(small organ) | NA | N | N | N | NA | N | N | NA | N | 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 | 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 | N | N | N | NA | N | N | NA | N | NA |
| Laparoscopic | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Musculo-skeletalConventional | NA | N | N | NA | NA | NA | NA | NA | NA | NA |
| Musculo-skeletalSuperficial | NA | N | N | 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+Color, B+Angio, B+PW, M+Color and , B+PW+Color (known as Triplex), are available in all HP 21376A applications as noted.
In the Small Parts application, the HP 21376A transducer supports imaging of the breast, thyroid and scrotum.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Seaman
Division Sign-Off) Division of Reproductive, Abdominal, El and Radiological De
510(k) Number
Prescription Use (Per 21 CFR 801.109)
3
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Diagnostic Ultrasound Indications for Use Form
Device Name: M2410A ImagePoint Ultrasound System
| MODE OF OPERATION | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | Color VelocityImaging | Combined(specify) | Other(harmonic imaging) |
| Ophthalmic | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Fetal | NA | P | P | P | NA | P | P | NA | P | N |
| Abdominal | NA | P | P | P | NA | P | P | NA | P | N |
| 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 | P | P | P | P | P | P | NA | P | N |
| Small Parts I(small organ) | NA | P | P | P | NA | P | P | NA | P | NA |
| Neonatal Cephalic | NA | P | P | P | NA | P | P | NA | P | NA |
| Adult Cephalic | NA | N | N | N | NA | N | N | NA | N | N |
| Cardiac | NA | P | P | P | P | P | P | NA | P | N |
| Transesophageal | NA | P | P | P | P | P | P | NA | P | NA |
| Transrectal | NA | P | P | P | NA | P | P | NA | P | NA |
| Transurethral | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Transvaginal | NA | P | P | P | NA | P | P | NA | P | NA |
| Intravascular | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Peripheral Vascular | NA | P | P | P | NA | P | P | NA | P | NA |
| Laparoscopic | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Musculo-skeletalConventional | NA | N | N | NA | NA | NA | NA | NA | NA | NA |
| Musculo-skeletalSuperficial | NA | N | N | NA | NA | NA | NA | NA | NA | NA |
| Other | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
Intended Use: Diagnostic Ultrasound System
M+Color are available in all applications as noted. +Color. B+Angio. B+PW.
Combined williation of B+PW+Color sis noted.
Transmode of B+PW+Color (Known as Triplex), is available on all applications EXCEPT Crrive and
18 - 11 D 1 Small Parts: breast scrotum and thyroid.
I'LEASEDO 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. Kenyon
(Division Sign-Off)
Division of Reproductive and Radiological D
510(k) Number K990400
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.