(426 days)
The HRT2000 system connected with a probe enables real time two dimensional diagnostic ultrasound imaging. The system offers optional probes each type optimized to image structure and orienation of tissues during specific opinical applications. These include general abdominal, small organ, gyneeological and urological, vascular and cardiac anatomy.
Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:
HRI 2000 Ultrasound System
This document is a 510(k) premarket notification from 1997 for the HRI 2000 Ultrasound System and its associated transducers. As such, it does not contain the detailed information requested for acceptance criteria and a study proving device performance in the context of AI/ML or clinical efficacy.
The FDA 510(k) clearance process primarily establishes substantial equivalence to a predicate device, focusing on safety and technological characteristics rather than requiring new clinical efficacy studies. The document only lists the indications for use for different transducers.
Therefore, I cannot provide the requested information from the provided text.
Here's a breakdown of why this information is not present in the document:
- Acceptance Criteria and Reported Device Performance (Table 1): The document does not define specific performance acceptance criteria (e.g., sensitivity, specificity, accuracy, dice score) that would be relevant for an AI/ML device, nor does it present a table of reported device performance against such criteria. The "performance" mentioned in a 510(k) for an ultrasound system typically refers to its imaging capabilities (e.g., resolution, penetration) which are qualitatively compared to a predicate, not quantified against acceptance metrics in a study.
- Sample Size for Test Set and Data Provenance: This information is not included as the document is not describing a study to establish performance metrics for an AI/ML algorithm.
- Number and Qualifications of Experts for Ground Truth: Not applicable, as there's no mention of a ground truth creation process for a performance study.
- Adjudication Method: Not applicable.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: There is no mention of such a study. The document predates widespread AI in medical imaging, and its purpose is not to evaluate human reader improvement with AI.
- Standalone Performance Study: No standalone algorithm performance study is described, as the device is an ultrasound system, not an AI algorithm.
- Type of Ground Truth Used: Not applicable.
- Sample Size for Training Set: Not applicable, as there's no AI algorithm being trained.
- How Ground Truth for Training Set was Established: Not applicable.
What the document does provide:
- Device Name: HRI 2000 Ultrasound System and several transducers (GA-3.5, TV-6.5, TR-6.5, PV-12.5).
- Indications for Use: General real-time two-dimensional diagnostic ultrasound imaging for specific clinical applications (general abdominal, small organ, gynecological and urological, vascular and cardiac anatomy). The separate forms (Pages 4-7) detail the applicable modes of operation (A, B, M, CWD, Color Doppler, etc.) for each transducer across various clinical applications.
- Regulatory Class: Class II.
- Submission Type: 510(k) Premarket Notification.
- Clearance Date: May 29, 1997.
- Acoustic Output Requirement: The FDA states that a post-clearance special report containing acoustic output measurements based on production line devices is required. This is a safety requirement, not a performance efficacy study.
In essence, this document grants market clearance for a conventional ultrasound imaging system based on its substantial equivalence to previously marketed devices, without requiring the types of performance studies associated with AI/ML devices.
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Image /page/0/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" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 9 1997
Raul Gutierrez, R.T., R.D.M.S. President International Ultrasound Corporation 14 West Forest Avenue Englewood. NJ 07631
Re: K961229 HRI 2000 Ultrasound System Dated: March 28, 1997 Received: March 28, 1997 Regulatory class: II 21 CFR 892,1560/Procode: 90 IYO
Dear Mr. Gutierrez:
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 Ultrasound Imaging System, as described in your premarket notification:
Transducer Model Number
| GA-3.5 | (CLI 7900) | 3.5 MHz | General Purpose |
|---|---|---|---|
| TV-6.5 | (CLI 4000) | 6.5 MHz | Transvaginal |
| TR-6.5 | (CLI 5000) | 6.5 MHz | Transrectal |
| PV-12.5 | (CLI 6000) | 12.5 MHZ | Peripheral Vascular |
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Page 2 - Raul Gutierrez
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 for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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.
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 provision of 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 February 17, 1993 "Revised 510(k) Diagnostic Ultrasound Guidance for 1993." 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-40) 9200 Corporate Boulevard Rockville, Marvland 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.
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Page 3 - Raul Gutierrez
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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 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,
for
Lilli
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Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation
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510(k) Number (if known): K961229
Device Name: HRI2000 Ultrasound System
ndications For Use:
The HRT2000 system connected with a probe enables real time two dimensional diagnostic ultrasound imaging. The system offers optional probes each type optimized to image structure and orienation of tissues during specific opinical applications. These include general abdominal, small organ, gyneeological and urological, vascular and cardiac anatomy.
(PLEASE DO NOT WRITE RELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use Per 21 CFR 801.109)
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Over-The-Couator Use
(Optional Formal 1-2-96)
ﺗﺒﺎﺭﻳﺲ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﺘﻲ ﺗﺘﻮ
Vainl. A. Severson
(Division Sign-Off) Division of Reproductive, Abdominal. ENT, and Radiological Dev 510(k) Number
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| 510(k) Number (if known): | K961229 |
|---|---|
| Device Name: | CLI 7900 GP 3.5 MHz Probe |
Fill out one form for each ultrasound system or transducer.
Diagnostic ultrasound imaging or Doppler analysis of the Indications For Use: human body as follows: Hode of Operatitees
| ClinicalApplication | A | B | H | M | CWD | ColorDoppler | Power(Amplitude)Doppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) |
|---|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | X | |||||||||
| Intra-operative(Specify) | ||||||||||
| Pediatric | ||||||||||
| Small Organ(Specify) | ||||||||||
| NeonatalCephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac Adult | X | |||||||||
| CardiacPediatric | X | |||||||||
| Trans-esophageal | ||||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Intra-luminal | ||||||||||
| Trans-urethral | ||||||||||
| Peripheralvessel | ||||||||||
| Laparoscopic |
CONTINUE ON ANOTHER PAGE IF NEBORD (PLEABER DO NOT HOTER DETON TITS LEAR 61 5 GET 300 17. Care Ista Elon (((1) == ) a of
Prescription Use (Fer 21 CPR 801.109)
Klim G. Degner
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number
{5}------------------------------------------------
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| 510(k) Number (if known): | K961229 |
|---|---|
| Device Name: | CLI 4000 TV 6.5 MHz Probe |
Pageour one form for each ultrasound system or transducer. געוו
Diagnostic ultrasound imaging or Doppler analysis of the Indications For Use: Tuman body as follows: Hode of Operacious
| Clinical Application | A | B | FMD | CMD | Color Doppler | Power (Amplitude) Doppler | Color Velocity Imaging | Combined (Specify) | Other (Specify) |
|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | |||||||||
| Fetal | |||||||||
| Abdominal | ✓ | ||||||||
| Intra-operative (Specify) | |||||||||
| Pediatric | |||||||||
| Small Organ (Specify) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Trans-esophageal | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | X | ||||||||
| Intra-luminal | |||||||||
| Trans-urethral | |||||||||
| Peripheral vessel | |||||||||
| Laparoscopic |
Other Indications or Modes:FLEASE DO NOT HOT WATER 6333
Prescription Use (Per 21 CFR 801.109)
David A. Segner
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices 510(k) Number
{6}------------------------------------------------
นี้ษั้น--08--87 คีร้า อัล--85
| 510(k) Number (if known): | K961129 |
|---|---|
| Device Name: | CLI 5000 6.5 MHz Probe |
Fill out one form for each ultrasound system or transducer.
Indications For Use: Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:
Mode με Operation
| ClinicalApplication | R | N | M | FWD | CWD | ColorDoppler | Power(Amplitude)Doppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) |
|---|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intra-operative(Specify) | ||||||||||
| Pediatric | ||||||||||
| Small Organ(Specify) | ||||||||||
| NeonatalCephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac Adult | ||||||||||
| CardiacPediatric | ||||||||||
| Trans-esophageal | ||||||||||
| Trans-rectal | X | |||||||||
| Trans-vaginal | ||||||||||
| Intra-luminal | ||||||||||
| Trans-urethral | ||||||||||
| Peripheralvessel | ||||||||||
| Laparoscopic |
FACE TELEVER DO ADE WATER BEYON THIS LEAST OF DELLOS OF DEALERS OF DEALERS
Prescription Use (Per 21 CPR 801.109)
大发生
Damil A. Seymm
1 (Uivision Sign-Off)
(Division of Reproductive, Abdominal, ENT,
Division of Reprodetive, Abdominal, ENT,
and Radiological Devision, Abdominal, ENT,
510(k) Number 510(k) Number
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INTL ULTRASOUND 97 FRI 03:42 PM
ﻪ ﺗ
Page ರ್
510(k) Number (if known) CLT 6000 Device Name :_________________________________________________________________________________________________________________________________________________________________
ີສອນອຸດສາມອິດ ແລະລັດ. aach altrascund syst Fill out one form for
Diagnostic ultrasound imaging or Doppler analysis of the Indications For Use:
human body as follows: E Aprimes 2016
| ClinicalApplication | A | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) |
|---|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | ||||||||||
| Focal | ||||||||||
| Abdominal | ||||||||||
| Intra-operative(Specify) | ||||||||||
| Pediatric | ||||||||||
| Small Organ(Specify) | X | |||||||||
| NeonatalCephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac Adult | ||||||||||
| CardiacPediatric | ||||||||||
| Trans-esophageal | ||||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Intra-luminal | ||||||||||
| Trans-urethral | ||||||||||
| Peripheralvessel | X | X | ||||||||
| Laparoscopic |
FLEASE DO ACE WRITE BETAN
Prescription Use (Fer 21 CPR 601.109)
David A. Segerson
(Division Sign-Off)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT. and Radiological Device 510(k) Number
§ 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.