(28 days)
The HDI 1000 system is intended for opthalmic, fetal (OB/GYN), abdominal, intraoperative (abdominal organs, vasuclar, neurological,) pediatric, small organ, musculoskeletal (conventional, superficial,) neonatal cephalic, adult cephalic, cardiac, transrectal, transvaginal, and peripheral vessel indications for use.
Typical examinations shall include:
- General abdominal and pelvic studies including organ surveys and retroperitoneal cavity studies.
- Study of small parts including breasts, penis, testes, thyroid/parathyroid and the abdominal wall.
- Pediatric scans of organs. .
- Peripheral vascular applications including carotid arteries, legs, arms, feet, and penile artery.
- Monitoring procedures for infertility applications. .
- First, second and third trimester pregnancy studies. .
- Prostate, prostate biopsy guidance, and rectal wall studies. .
- Neonatal cephalic studies. .
- Transcranial studies of middle cerebral arteries, internal carotid artery, . and vertebral arteries.
- Cardiac studies in adults and children. .
- Biopsy guidance for tissue or fluid sampling. .
- Ophthalmic studies of the eye and surrounding structures and studies to . obtain blood flow information in the eye and surrounding structures.
- Conventional and superficial musculoskeletal studies. .
This 510(k) adds the musculoskeletal applications (superficial and conventional) to the HDI 1000 system.
The HDI 1000 system is a general purpose, mobile, software-controlled, diagnostic ultrasound systems with an on-screen display for thermal and mechanical values related to potential bioeffect mechanisms. The HDI 1000 system functions by acquiring ultrasound data and displaying it on a monitor in 2-D, M-mode, 2-D Color Flow Doppler, Color M-mode, Color Power Angio, Pulsed (PW) Doppler or in a combination of modes. An audio presentation of pulsed Doppler information is also available on the systems. The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnostic purposes.
The HDI 1000 system is designed to accept a large selection of scanheads with up to two being connected to the system at any one time. The operator may select between the two scanheads by means of a control located on the system control panel. All actions affecting the performance of the scanhead are activated from the main system control panel.
The HDI 1000 system is designed to accept scanheads of the following types and frequency:
frequency range: 2.0 - 11.0 MHz
scanhead types: flat linear array, curved linear array, phased array
Specific operating conditions (frame rate, line density, center frequency, number of active elements etc.) are automatically optimized by the system software in response to user inputs such as field of view, focal depth, image quality, power etc.
This 510(k) premarket notification (K980860) concerns the Atlantis Diagnostics International, Inc. (ADII) HDI® 1000 Ultrasound System, specifically for the addition of musculoskeletal (conventional and superficial) indications for use. The submission doesn't detail a specific study with acceptance criteria and performance metrics in the typical sense for an AI/CADe device. Instead, it focuses on demonstrating substantial equivalence to predicate ultrasound devices already on the market.
For ultrasound systems, the "acceptance criteria" are generally related to demonstrating that the device performs as intended for the specified clinical applications, meets safety standards (electromagnetic compatibility, acoustic output), and has technological characteristics that are substantially equivalent to legally marketed predicate devices. The "study" proving this is implicitly the comparison presented in the 510(k) submission, alongside adherence to relevant safety standards.
Here's a breakdown based on the provided text, addressing the requested points where information is available:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is an ultrasound system and not an AI/CADe product, the typical performance metrics like sensitivity, specificity, or AUC are not applicable here. The acceptance criteria and performance are focused on safety, functionality, and equivalence to predicate devices, particularly regarding acoustic output and imaging modes.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Acoustic Output Limits (Non-Ophthalmic Applications): | |
| - ISPTAd ≤ 720 mW/cm² | - ISPTAd: 720 mW/cm² (Maximum) |
| - TIS/TIB/TIC: 0.1 - 4.0 | - TIS/TIB/TIC: 0.1 - 4.0 (Range) |
| - Mechanical Index (MI) ≤ 1.9 | - Mechanical Index (MI): 1.9 (Maximum) |
| - ISPPAd: 0 - 700 W/cm² | - ISPPAd: 0 - 700 W/cm² (Range) |
| Acoustic Output Limits (Ophthalmic Applications): | |
| - ISPTAd ≤ 50 mW/cm² | - ISPTAd: 50 mW/cm² (Maximum) |
| - Thermal Index (TIC): 0.1 - 1.0 | - Thermal Index (TIC): 0.1 - 1.0 (Range) |
| - Mechanical Index (MI) ≤ 0.23 | - Mechanical Index (MI): 0.23 (Maximum) |
| - ISPPAd: 0 - 50 W/cm² | - ISPPAd: 0 - 50 W/cm² (Range) |
| Substantial Equivalence: | |
| - Imaging Modes (2-D, M-mode, Color Flow, Color M-mode, Color Power Angio, Pulsed Doppler) | - "The modes of these devices (2-D, M-mode, Color Flow, Color M-mode, Color Power Angio, and Pulsed Doppler) are the same as predicate devices." |
| - Scanhead Biocompatibility | - "Scanhead patient contact materials are biocompatible and are also the same as the identified predicate devices." |
| - Compliance with Safety Standards | - Designed to meet EN 60601-1, UL 2601-1, C22.2 No. 601.1, CEI/IEC 1157:1992, EN 60601-1-2. Conforms to AIUM/NEMA 1992 for on-screen display of thermal and mechanical acoustic output indices. Implicitly, the specified acoustic output limits are the performance metrics against which it was tested for compliance. |
| - Intended Use (including new musculoskeletal applications) | - The filing seeks to add musculoskeletal applications (conventional, superficial) to the existing range of indications, asserting that the HDI 1000 system, with its specified transducers, is substantially equivalent for these uses. The device's acoustic output limits for all applications (including musculoskeletal implicitly) are within the ranges of predicate Track 3 devices. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not describe a clinical performance study with a "test set" in the context of imaging performance for diagnosis. The assessment for this ultrasound system focuses on engineering and safety specifications, and comparison to predicate devices.
- Sample Size: Not applicable/not specified for a typical "test set" of diagnostic images.
- Data Provenance: Not applicable. The data presented relates to device specifications and compliance with standards, not patient data for diagnostic accuracy.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. As there is no diagnostic performance test set, there is no mention of experts or ground truth establishment in this context. The "ground truth" for an ultrasound system primarily revolves around its ability to produce images and Doppler information correctly and safely based on physical principles, as demonstrated through engineering tests and comparison to established predicate devices.
4. Adjudication Method for the Test Set
Not applicable. No diagnostic performance test set 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
Not applicable. This submission is for an ultrasound imaging system, not an AI or CADe device. Therefore, no MRMC study comparing human readers with and without AI assistance would be included.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithmic or AI device.
7. The Type of Ground Truth Used
The ground truth used in this submission is the engineering specifications, safety standards, and established performance characteristics of legally marketed predicate ultrasound devices. The applicant demonstrates that the HDI® 1000 Ultrasound System, particularly for its new musculoskeletal indications, adheres to these technical and safety "ground truths" and is substantially equivalent to the predicate devices in its operation and output.
- Ground Truth: Engineering specifications, acoustic output limits, compliance with international safety standards (e.g., EN 60601-1, AIUM/NEMA 1992), and functional characteristics (imaging modes, transducer types, frequency range) as defined by the industry and regulatory bodies for diagnostic ultrasound equipment.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that would require a training set of data.
9. How the Ground Truth for the Training Set was Established
Not applicable.
{0}------------------------------------------------
510(k) Premarket Notification Musculoskeletal Indication for Use HDI® 1000 Ultrasound System
APR - 2 1998
ATTACHMENT 1 510(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)
Terrence J. Sweeney Vice President, Worldwide Quality and Regulatory Affairs Atlantis Diagnostics International, Inc. (ADII) 19015 North Creek Parkway, Suite 105 Bothell WA 98011 (425) 487-7602
Date prepared: March 3, 1998
- Name of the device, including the trade or proprietary name if applicable, the 2) common or usual name, and the classification name, if known:
Common/ Usual Name
Diagnostic Ultrasound System with Accessories
Proprietary Name
HDI® 1000 Diagnostic Ultrasound System
Classification Names:
Ultrasonic Pulsed Doppler Imaging System, Product Code 90 IYN, 21 CFR 892.1550
Diagnostic Ultrasonic Transducer, Product Code 90 ITX, 21 CFR 892.1570
Ultrasonic Pulsed Echo Imaging System, Product Code 90IYO, 21 CFR 892.1560
- Identification of the predicate or legally marketed device:
ADII believes that HDI 1000 system is substantially equivalent to the currently-marketed ATL HDI 3000 diagnostic ultrasound system, ATL Ultramark® 9 diagnostic ultrasound system, Atlantis Atlas 1.0 system, Storz Renaissance A/B Scan, and the HDI 5000 diagnostic ultrasound system.
4) Device Description:
This 510(k) adds the musculoskeletal applications (superficial and conventional) to the HDI 1000 system.
The HDI 1000 system is a general purpose, mobile, software-controlled, diagnostic ultrasound systems with an on-screen display for thermal and mechanical values related to potential bioeffect mechanisms. The HDI 1000 system functions by acquiring ultrasound data and displaying it on a monitor in
{1}------------------------------------------------
K 980860
510(k) Premarket Notification Musculoskeletal Indication for Use HDI® 1000 Ultrasound System
2-D, M-mode, 2-D Color Flow Doppler, Color M-mode, Color Power Angio, Pulsed (PW) Doppler or in a combination of modes. An audio presentation of pulsed Doppler information is also available on the systems. The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnostic purposes.
The HDI 1000 system is designed to accept a large selection of scanheads with up to two being connected to the system at any one time. The operator may select between the two scanheads by means of a control located on the system control panel. All actions affecting the performance of the scanhead are activated from the main system control panel.
The HDI 1000 system is designed to accept scanheads of the following types and frequency:
frequency range: scanhead types:
2.0 - 11.0 MHz flat linear array curved linear array phased array
Specific operating conditions (frame rate, line density, center frequency, number of active elements etc.) are automatically optimized by the system software in response to user inputs such as field of view, focal depth, image quality, power etc.
The HDI 1000 system been designed to meet the following electromechanical safety standards:
- · EN 60601-1 European Norm, Medical Electrical Equipment
- · UL 2601-1, Underwriters Laboratories Standards, Medical Electrical Equipment
- · C22.2 No. 601.1, Canadian Standards Association, Medical Electrical Equipment
- · CEI/IEC 1157:1992, International Electrotechnical Commission, Requirements for the declaration of the acoustic output of medical diagnostic ultrasonic equipment
- · EN 60601-1-2, Collateral Standard: Electromagnetic Compatibility
- Intended Use:
The HDI 1000 system is intended for opthalmic, fetal (OB/GYN), abdominal, intraoperative (abdominal organs, vasuclar, neurological,) pediatric, small organ, musculoskeletal (conventional, superficial,) neonatal cephalic, adult cephalic, cardiac, transrectal, transvaginal, and peripheral vessel indications for use.
Typical examinations shall include:
- · General abdominal and pelvic studies including organ surveys and retroperitoneal cavity studies.
- · Study of small parts including breasts, penis, testes, thyroid/parathyroid and the abdominal wall.
- Pediatric scans of organs. .
{2}------------------------------------------------
510(k) Premarket Notification Musculoskeletal Indication for Use HDI® 1000 Ultrasound System
- Peripheral vascular applications including carotid arteries, legs, arms, feet, and penile artery.
- Monitoring procedures for infertility applications. .
- First, second and third trimester pregnancy studies. .
- Prostate, prostate biopsy guidance, and rectal wall studies. .
- Neonatal cephalic studies. .
- Transcranial studies of middle cerebral arteries, internal carotid artery, . and vertebral arteries.
- Cardiac studies in adults and children. .
- Biopsy guidance for tissue or fluid sampling. .
- Ophthalmic studies of the eye and surrounding structures and studies to . obtain blood flow information in the eye and surrounding structures.
- Conventional and superficial musculoskeletal studies. .
Technological Characteristics: 6)
This device operates identical to the predicate devices in that piezo material in the transducer is used as an ultrasound source to transmit sound waves into the body. Sound waves are reflected back to the transducer and converted to electrical signals that are processed and displayed as 2-D and M-mode images. Doppler shift caused by blood flow is displayed as Color Flow, or as spectrum analysis. The modes of these devices (2-D, M-mode, Color Flow, Color M-mode, Color Power Angio, and Pulsed Doppler) are the same as predicate devices identified in item 3. Scanhead patient contact materials are biocompatible and are also the same as the identified predicate devices.
These devices conform to the Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment (AIUM/NEMA, 1992) for an on-screen display feature that provides information on potential thermal and cavitation bioeffect mechanisms. A user education program provides additional information so users may moderate the system's acoustic output in accordance with the ALARA (as low as reasonably achievable) principle.
The device's acoustic output limits are:
All Applications Other Than Ophthalmic:
| ISPTAd | 720 mW/cm2 | (Maximum) |
|---|---|---|
| TIS/TIB/TIC | 0.1 - 4.0 | (Range) |
| Mechanical Index (MI) | 1.9 | (Maximum) |
| ISPPAd | 0 - 700 W/cm2 | (Range) |
Ophthalmic Applications:
| ISPTAd | 50 mW/cm2 | (Maximum) |
|---|---|---|
| Thermal Index (TIC) | 0.1 - 1.0 | (Range) |
| Mechanical Index (MI) | .23 | (Maximum) |
| ISPPAd | 0 - 50 W/cm2 | (Range) |
The limits are same as predicate Track 3 devices.
510(k) Summary of Safety and Effectiveness
{3}------------------------------------------------
Image /page/3/Picture/0 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 an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 2 1998
Terrence J. Sweeney Vice President Worldwide Quality and Regulatory Affairs Atlantis Diagnostics International, Inc. 19015 North Creek Parkway Bothell, WA 98011
Re: K980860 HDI 1000 Diagnostic Ultrasound System Dated: March 3, 1998 Received: March 5, 1998 Regulatory class: II 21 CFR 892.1560/Procode: 90 IYO 21 CFR 892.1550/Procode: 90 IYN 21 CFR 892.1570/Procode: 90 ITX
Dear Mr. Sweeney:
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 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. You may, therefore, market the device, subject to the general controls provisions Act (Act). The general controls provisions of the Act include requirements for registration, listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.
This determination of substantial equivalence applies to the following transducers intended for use with the HDI 1000 Diagnostic Ultrasound System, as described in your premarket notification:
Transducer Model Number
CL10-5/10.0.5.0 MHz/Linear Array L11-5/11.0.5.0 MHz/38mm/Linear Array L19-5/9.0-5.0 MHz/38mm/Linear Array
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. A 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 regulatory 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.
{4}------------------------------------------------
Page 2 - Terrence J. Sweeney
Please be advised that the determination above is based on the fact that no medical devices have been demonstrated to be safe and effective for in vitro fertilization or percutaneous umbilical blood sampling, nor have any devices been marketed for these uses in interstate commerce prior to May 28, 1976, or reclassified into class I (General Controls) or class II (Special Controls). FDA considers devices specifically intended for in vitro fertilization and percutaneous umbilical blood sampling to be investigational, and subject to the investigational device exemptions (IDE) regulations, 21 CFR, Part 812. Therefore, your product labeling must be consistent with FDA's position on this use.
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" (2) CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free 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 Paul Gammell, Ph.D. at (301) 594-1212.
Sincerely yours,
Yaind h. Sypon
Lillian Yin, Ph.D.
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal. Ear. Nose and Throat. and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
{5}------------------------------------------------
Section 4.3, page 1 of 4
Indications Statement for System
510(k) Number: Device Name:
HDI®1000 Ultrasound System
Indications for Use: Diagnostic ultrasound / Pulsed Doppler / Pulsed Echo imaging
(specify) of the human body as follows:
| Clinical Applications | A | B | M* | PWD* | CWD* | ColorDoppler* | Power(Amp)Doppler* | ColorVelocityImaging | Combined(Specify)* | Other(Specify) |
|---|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | P | P | P | P | ||||||
| Fetal | P | P | P | P | P | P (Note 1) | P (Note 2) | |||
| Abdominal | P | P | P | P | P (Note 1) | P (Note 2) | ||||
| Intra-operative :Abdominal organs &vascular | P | P | P | P | P (Note 1) | P (Note 2) | ||||
| Intra-operativeNeurological | P | P | P | P | P (Note 1) | |||||
| Pediatric | P | P | P | P | P (Note 1) | P (Note 2) | ||||
| Small OrganSee Note 3 | P | P | P | P | P (Note 1) | P (Note 2) | ||||
| Neonatal Cephalic | P | P | P | P | P (Note 1) | |||||
| Adult Cephalic | P | P | P | P | P (Note 1) | |||||
| Cardiac | P | P | P | P | P | P (Note 1) | ||||
| Trans-esophageal | ||||||||||
| Transrectal | P | P | P | P | P (Note 1) | P (Note 2) | ||||
| Transvaginal | P | P | P | P | P | P (Note 1) | P (Note 2) | |||
| Transurethral | ||||||||||
| Intavascular | ||||||||||
| Peripheral vessel | P | P | P | P | P (Note 1) | |||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | N | N | N | N | N (Note 1) | |||||
| Musculo-skeletalSuperficial | N | N | N | N | N (Note 1) |
Mode of Operation (*includes simultaneous B-Mode)
Other Indications or Modes:
Note 1: PWD/CD, PWD/PAD
Note 2: Includes imaging for guidance of biopsy
Note 3: Thyroid, parathyroid, breast, scrotum, penis in adult, pediatric and neonatal patients
P indicates previously cleared indication in K961073. N indicates new indication.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON-ANOTHER PAGE IF ---NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Simid h. Segerson
(Division Sign-Off) (Division Sign-Ott)
Division of Reproductive, Abdominal, EN and Radiological L 510(k) Number
Prescription Use (Per 21 CFR 801.109)
{6}------------------------------------------------
Ultrasound Device Indications Statement
K 980860
510(k) Number: Device Name: Transducer:
HDI®1000 Ultrasound System CL10-5/10.0-5.0 MHz/Linear Array
Indications for Use:
Diagnostic ultrasound / Pulsed Doppler / Pulsed Echo imaging (specify) of the human body as follows:
| Mode of Operation (*includes simultaneous B-Mode) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Applications | A | B | M* | PWD* | CWD* | ColorDoppler* | Power(Amp)Doppler* | ColorVelocityImaging | Combined(Specify)* | Other(Specify) |
| Ophthalmic | P | P | P | P | ||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intra-operative :Abdominal organs &vascular | P | P | P | P | P (Note 1) | |||||
| Intra-operative | ||||||||||
| Neurological | ||||||||||
| Pediatric | ||||||||||
| Small OrganSee Note 2 | P | P | P | P | P (Note 1) | |||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Trans-esophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intavascular | ||||||||||
| Peripheral vessel | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | N | N | N | N | N (Note 1) | |||||
| Musculo-skeletalSuperficial | N | N | N | N | N (Note 1) |
Mode of Operation (*includes simultaneous B-Mode)
Other Indications or Modes:
Note 1: PWD/CD, PWD/PAD
Note 2: Thyroid, parathyroid, breast, scrotum, penis in adult, pediatric and neonatal patients
P indicates previously cleared indication in K961073. N indicates new indication.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Schmid G. Syverson
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Dev
510(k) Number K980860
Prescription Use (Per 21 CFR 801.109)
{7}------------------------------------------------
Ultrasound Device Indications Statement
| 510(k) Number: | K980860 |
|---|---|
| Device Name: | HDI®1000 Ultrasound System |
| Transducer: | L11-5/11.0-5.0 MHz/38mm/Linear Array |
Indications for Use:
Diagnostic ultrasound / Pulsed Doppler / Pulsed Echo imaging (specify) of the human body as follows:
| Clinical Applications | A | B | M* | PWD* | CWD* | ColorDoppler* | Power(Amp)Doppler* | ColorVelocityImaging | Combined(Specify)* | Other(Specify) |
|---|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intra-operative :Abdominal organs,vascular | P | P | P | P | P (Note 1) | P (Note 2) | ||||
| Intra-operativeNeurological | ||||||||||
| Pediatric | P | P | P | P | P (Note 1) | P (Note 2) | ||||
| Small OrganSee Note 3 | P | P | P | P | P (Note 1) | P (Note 2) | ||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intavascular | ||||||||||
| Peripheral vessel | P | P | P | P | P (Note 1) | |||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | N | N | N | N | N (Note 1) | |||||
| Musculo-skeletalSuperficial | N | N | N | N | N (Note 1) |
Mode of Operation (*includes simultaneous B-Mode)
Other Indications or Modes:
Note 1: PWD/CD, PWD/PAD
Note 2: Includes imaging for guidance of biopsy.
Note 3: Thyroid, parathyroid, breast, scrotum, penis in adult, pediatric and neonatal patients.
P indicates previously cleared indication in K961073. N indicates new indication.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Syverson
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT and Radiologicai D
510(k) Number K980860
Prescription Use (Per 21 CFR 801.109)
{8}------------------------------------------------
Section 4.3, page 4 of 4
Ultrasound Device Indications Statement
K980860
| 510(k) Number: | K980860 |
|---|---|
| Device Name: | HDI®1000 Ultrasound System |
| Transducer: | LI9-5/9.0-5.0 MHz/38mm/Linear Array |
Indications for Use:
Diagnostic ultrasound / Pulsed Doppler / Pulsed Echo imaging (specify) of the human body as follows:
| Clinical Applications | A | B | M* | PWD* | CWD* | ColorDoppler* | Power(Amp)Doppler* | ColorVelocityImaging | Combined(Specify)* | Other(Specify) | |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intra-operative:Abdominal organs,vascular | P | P | P | P | P (Note 1) | P (Note 2) | |||||
| Intra-operative | |||||||||||
| Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ (specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral vessel | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletalConventional | N | N | N | N | N (Note 1) | N (Note 2) | |||||
| Musculo-skeletalSuperficial | N | N | N | N | N (Note 1) | N (Note 2) |
Mode of Operation (*includes simultaneous B-Mode)
Other Indications or Modes:
Note 1: PWD/CD, PWD/PAD
Note 2: Includes imaging for guidance of biopsy.
P indicates previously cleared indication in K961073. N indicates new indication.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) .
David G. Segerson
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number L980860
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.