(83 days)
HCP DICOM Net® is a software device intended to acquire and store medical images studies from catheterization laboratories, Echo cardiograms, CT & MRI and other such modalities. In addition, HCP DICOM Net® provides image enhancement and filtering tools for viewing of selected images. It also imports image studies from DICOM CD's/DVD's, makes copies of image studies and converts and exports image studies into DICOM3 and other commercial file formats. HCP DICOM Net® also integrates industry standard third party approved software within its application to allow for analysis of the acquired image.
HCP DICOM Net® is a computerized system that acquires images which are captured by cardiac catherterization laboratories and other modalities like Echocardiograms. MRI & CT. These images are acquired through a video source or a DICOM3 interface of the modality. These images are then stored in DICOM3 format on Hard Disk Drives, Magnetic Tape. CD-R or DVD. If images are acquired through a video source, in a non-DICOM3 format then these images are converted into a DICOM3 format before they are stored. After storage these images are retrieved and displayed on workstations for convenient review and analysis. Analysis of images is provided via approved industry standard third party software. These workstations are also capable of reading DICOM3 images from CD and DVD media and uploading them to the image store for retrieval, viewing and analysis at a later time.
The provided text is a 510(k) summary for the HCP DICOM Net® device. It details the device's intended use, comparison to predicate devices, and concludes with a substantial equivalence statement. However, it explicitly states "Discussion of Clinical Tests Performed: - Not applicable." This means that no clinical efficacy study was conducted for this device beyond non-clinical tests like risk analysis and software validation.
Therefore, there is no information available in the provided text to fulfill the request for acceptance criteria and the study that proves the device meets those criteria.
Specifically, the following information cannot be extracted because no clinical study was performed:
- A table of acceptance criteria and the reported device performance: No acceptance criteria related to clinical performance are mentioned, and therefore no reported performance relative to such criteria.
- Sample size used for the test set and the data provenance: No clinical test set was used.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical test set was used.
- Adjudication method for the test set: Not applicable as no clinical test set was used.
- 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 as no clinical study was performed.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as no clinical study was performed.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable as no clinical test involving ground truth was performed.
- The sample size for the training set: Not applicable as no clinical study involving a training set for an AI/algorithm was performed. The device is described as software that integrates "industry standard third party approved software within its application to allow for analysis of the acquired image," implying it's not a de novo AI algorithm from the submitter.
- How the ground truth for the training set was established: Not applicable as no clinical study involving a training set was performed by the submitter.
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K02 3467
EXHIBIT #1
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(k) number is:
1. Submitter's Identification:
Softlink International Inc. 199 Main Street Suite 314 White Plains, NY 10601
Contact: Mr. Praveen Lobo Softlink International Tel: 914-582-1047 Fax: 914-686-4666
Date Summary Prepared: October 14, 2002
October 8, 2002
2. Name of the Device:
HCP DICOM Net®
3. Predicate Device Information:
- Digital Imaging Systems, K#954159, Camtronics, Ltd., Hartland, WI 1. (892.2050, Product Code LLZ).
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- The TCS-Telecardiology System, Medcon Ltd., Efrat, Israel (892.1600, Product Code IZI).
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- WriteStar and ViewStar, K#964274, ComView Corp., Montrose, Ny (892.2010, Product Code LMB).
4. Device Description:
HCP DICOM Net® is a computerized system that acquires images which are captured by cardiac catherterization laboratories and other modalities like Echocardiograms. MRI & CT. These images are acquired through a video source or a DICOM3 interface of the
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modality. These images are then stored in DICOM3 format on Hard Disk Drives, Magnetic Tape. CD-R or DVD. If images are acquired through a video source, in a non-DICOM3 format then these images are converted into a DICOM3 format before they are stored. After storage these images are retrieved and displayed on workstations for convenient review and analysis. Analysis of images is provided via approved industry standard third party software. These workstations are also capable of reading DICOM3 images from CD and DVD media and uploading them to the image store for retrieval, viewing and analysis at a later time.
5. Intended Use:
HCP DICOM Net® is a software device intended to acquire and store medical images studies from catherterization laboratories. Echo cardiograms. CT & MRI and other such modalities. In addition, HCP its DICOM Net provides image enhancement and filtering tools for viewing of selected images. It also imports image studies from DICOM CD's/DVD's, makes copies of image studies and converts and exports image studies into DICOM3 and other commercial file formats. HCP DICOM Net® also integrates industry standard third party approved software within its application to allow for analysis of the acquired image.
6. Comparison to Predicate Devices:
HCP DICOM Net® provides convenient acquisition, storage and review of DICOM3 images like the ComView WriteStar and Medcon TCS-Cardiology System. HCP DICOM Net® unlike the Camtronics Digital Imaging System and ComView ViewStar and WriteStar, is a software only device that runs on industry standard PCs running windows based operating systems. HCP DICOM Net®, like the Camtronics Digital Imaging System and the ComView ViewStar/WriteStar System, can acquire analog images and convert them to a digital DICOM 3 image format and this functionality is intended to replace film.
7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
Testing information demonstrating safety and effectiveness of the HCP DICOM Net® device in the intended environment of use is supported by testing that was conducted in accordance with EN-1441 (Risk Analysis) and software validation and verifications testing. In addition, a DICOM Conformance Statement was provided with this submission to DICOM Voluntary Standards.
8. Discussion of Clinical Tests Performed:
- Not applicable
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9. Conclusions:
The HCP DICOM Net® device has similar intended uses and similar characteristics as the predicate devices. Moreover, software testing contained in this submission demonstrates that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. Thus, the HCP DICOM Net® device is substantially equivalent to the predicate devices.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three stripes forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 0 7 2003
SoftLink International, Inc. % Ms. Susan D. Goldstein-Falk mdi Consultants, Inc. 55 Northern Blvd. Suite 200 GREAT NECK NY 11021
Re: K023467 Trade/Device Name: HPC DICOM Net Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: October 14, 2002 Received: October 16, 2002
Dear Ms. Goldstein-Falk
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
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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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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 vours.
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Exhibit B
Page ________ of 1
510(k) Number (if known): _ Ko 2 3467
Device Name Softlink International Inc. HCP DICOM Net®
Indications For Use:
HCP DICOM Net® is a software device intended to acquire and store medical images studies from catheterization laboratories, Echo cardiograms, CT & MRI and other such modalities. In addition, HCP DICOM Net® provides image enhancement and filtering tools for viewing of selected images. It also imports image studies from DICOM CD's/DVD's, makes copies of image studies and converts and exports image studies into DICOM3 and other commercial file formats. HCP DICOM Net® also integrates industry standard third party approved software within its application to allow for analysis of the acquired image.
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| Concurrence of CDRH, Office of Device Evaluation (ODE) |
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| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K023467 |
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).