(61 days)
The EchoLive™ medical image management device family is designed for use in all medical specialties including, but not limited to, radiology, cardiology, gynecology, ENT, neurology, pediatrics, podiatry, chiropractic, general surgery, oral surgery and dentistry. The device may be used in medical offices and health care facilities, to facilitate access to clinical images and information, both archived and dynamic, in distributed locations over intranets, LANs, Internet, direct or dial dial-up telephone lines. The system may transmit a wide range of data including, but not limited to, Sonographs (Ultrasound images), Computer Tomography (CT), Magnetic Resonance Imaging (MRI), Positron Emission Tomography (PET). In addition the device may communicate standard audio, video and digital transmissions and recordings, providing complete clinical imaging handling, providing direct capture, retrieval, storage, and direct transmission and printing of images, reports, and patient information.
The EchoLive™ medical image management device family is a PACS capable of digital real-time simulcast transmission of medical images. Each model varies in the particular features and capabilities it offers the medical professional.
The provided document is a 510(k) summary for a PACS device (EchoLive™). It does not contain information about acceptance criteria or a study proving the device meets specific performance metrics.
510(k) submissions typically focus on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting new clinical performance studies with specific acceptance criteria as would be common for novel, high-risk devices or AI/CAD systems requiring performance validation.
Therefore, I cannot provide the requested information from this document.
Here's why and what information is missing:
- Acceptance Criteria and Reported Device Performance: This document states the device is a "Medical Image Management Device" and a "PACS." Its function is to transmit, store, and manage medical images. For such a device, "performance" would relate to its ability to handle various image formats, transmission speeds, storage capabilities, and display quality – none of which are quantifiable with specific acceptance criteria or results in this summary.
- Sample Size for Test Set and Data Provenance: Not applicable as no performance study is described.
- Number of Experts and Qualifications: Not applicable.
- Adjudication Method: Not applicable.
- MRMC Comparative Effectiveness Study: Not applicable. This is a PACS, not an AI/CAD system designed to assist human readers in diagnosis.
- Standalone Performance Study: No standalone performance study is mentioned as this is a PACS, not an AI algorithm intended for diagnostic interpretation.
- Type of Ground Truth Used: Not applicable.
- Sample Size for Training Set: Not applicable.
- How Ground Truth for Training Set Was Established: Not applicable.
In summary, this 510(k) summary is for a Picture Archiving and Communication System (PACS), which is a device for managing and transmitting medical images. It relies on demonstrating substantial equivalence to existing PACS devices rather than presenting a clinical performance study with specific acceptance criteria as would be expected for a diagnostic AI device.
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8 1999 FEB
IntraCom Corporation EchoLive™ PACS Pre-Market Notification
510(K) SUMMARY STATEMENT
Applicant:
IntraCom Corporation 1309 S. Mary Avenue Sunnyvale, ČA 94087
| Contact | James A. Nations |
|---|---|
| Phone: | 408 569-3860 |
| Phone: | 408 735-6810 |
| Fax: | 408 735-6816 |
| E-mail: | nations@qpt.com |
| Manufacturing Facility: | IntraCom Corporation1309 S. Mary AvenueSunnyvale, CA 94087 |
| EstablishmentRegistration Number: | Applied for, not yet received |
| Device Name: | EchoLive™ FamilyModels: ZL-1010ZL-2000ZL-2100ZL-3000ZL-4000 |
| Common Name: | Medical Image Management DevicePicture Archiving and Communication Systems (PACS) |
| Device Class: | II |
| Panel: | RadiologyLMD21 CFR 892.2050 |
| Performance Standards: | 21 CFR 820 et.seq.IEC Medical Device Directive EN60001UL 544The Society of Motion Picture and Television Engineers(SMPTE)The National Electrical Manufacturers Association (NEMA)American College of Radiology (ARC)Digital Imaging and Communications in Medicine (DICOM)IISO/IEC 10918-1 Digital Compression and Coding ofContinuous-Tone Still ImagesJoint Photographic Experts Group (JPEG) |
| Reason for submission: | New PACS with substantial equivalence. |
| Product Description: | The EchoLive™ medical image management device family is aPACS capable of digital real-time simulcast transmission of |
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IntraCom Corporation EchoLive™ PACS Pre-Market Notification
.. ..
medical images. Each model varies in the particular features and capabilities it offers the medical professional.
| Predicate Devices: | IntraCom CorporationEastman KodakStorCOMM, Inc.Sterling Diagnostic ImagingA.L.I. Technologies, Inc.Algotec Systems Ltd.Access Radiology CorporationOlicon Imaging Systems, Inc.Autocytgroup, Inc. | Class I Device, 21CFR892.2020(K981053)(K973805)(K980220) (K980970) (K973206)(K964250)Unknown(K971347) (K980648)(K972925) (K954691)(K973959)(K970064) |
|---|---|---|
| Indications For Use: | The EchoLive™ medical image management devicefamily is designed for use in all medical specialties including, butnot limited to, radiology, cardiology, gynecology, ENT, neurology,pediatrics, podiatry, chiropractic, general surgery, oral surgeryand dentistry. The device may be used in medical offices andhealth care facilities, to facilitate access to clinical images andinformation, both archived and dynamic, in distributed locationsover intranets, LANs, Internet, direct or dial dial-up telephonelines. The system may transmit a wide range of data including,but not limited to, Sonographs (Ultrasound images), ComputerTomography (CT), Magnetic Resonance Imaging (MRI), PositronEmission Tomography (PET). In addition the device maycommunicate standard audio, video and digital transmissionsand recordings, providing complete clinical imaging handling,providing direct capture, retrieval, storage, and directtransmission and printing of images, reports, and patient |
information.
દર્ભ
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 8 1999
James A. Nations, Esq. Director, Regulatory Affairs IntraCom Corporation 1309 S. Mary Avenue Sunnyvale, CA 94087
Re:
K984405 EchoLive Family Models ZL-1010, 2000, 2100. 3000, 4000 Dated: November 25, 1998 Received: December 9, 1998 Regulatory class: I 21 CFR 892.2010/Procode: 90 LMB 21 CFR 892.2020/Procode: 90 LMD
Dear Mr. Nations:
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). 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.
If your device is classified (see above) into either class III (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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) 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 the 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) 594-4613. 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 requlation 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 (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
J.R. Reid, M.D.
Capt. Daniel G. 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
Enclosure
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19844405 510(k) number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name:
INDICATION FOR USE:
The EchoLive medical image management device family is designed for use in all medical specialties including, but not limited to, radiology, cardiology, gynecology, ENT, neurology, pediatrics, podiatry, chiropractic, general surgery, oral surgery and dentistry. The device may be used in medical offices and health care facilities, to facilitate access to clinical images and information, both archived and dynamic, in distributed locations over intranets, LANs. Internet. direct or dial dial-up telephone lines. The system may transmit a wide range of data including, but not limited to, Sonographs (Ultrasound images), Computer Tomography (CT), Magnetic Resonance Imaging (MRI), Positron Emission Tomography (PET). In addition the device may communicate standard audio, video and digital transmissions and recordings, providing complete clinical imaging handling, providing direct capture, retrieval, storage, and direct transmission and printing of images, reports, and patient information.
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| Concurrence of CDRH, Office of Device Evaluation (ODE) |
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| Prescriptions Use | |
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| (per 21 CFR 801.109) |
OR
| Over-The-Counter Use |
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| (Division Sign-Off) |
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| Division of Reproductive, Abdominal, ENT, and Radiological Devices |
| 510(k) Number | K984405 |
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| --------------- | --------- |
| (OPTIONAL Format 1-2-96) |
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§ 892.2010 Medical image storage device.
(a)
Identification: A medical image storage device is a hardware device that provides electronic storage and retrieval functions for medical images. Examples include electronic hardware devices employing magnetic and optical discs, magnetic tapes, and digital memory.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.