The device is intended for the manipulation and displaying of medical images. It can show images from different modalities and interfaces to various image storage and printing devices using DICOM or similar interface standards. The device assists orthopedic surgeons when doing preoperative planning and post-operative follow-up. Typical users of this system are trained professionals, for example orthopedic surgeons, physicians, and radiologists.
Device Story
STARPACS Orthopedics System is a software module operating within a PACS environment; assists orthopedic surgeons with preoperative planning and post-operative follow-up. Inputs include radiological images from various modalities; utilizes DICOM or similar interface standards. Device provides tools for overlaying prosthesis templates on images, repositioning templates, and performing measurements. Operated by trained professionals (surgeons, physicians, radiologists) in clinical settings. System runs on Windows 2000 or similar configurations; does not control life-sustaining equipment; relies on human intervention for interpretation of displayed information. Benefits include standardized digital planning and measurement capabilities for orthopedic procedures.
Clinical Evidence
Bench testing only. No clinical data provided.
Technological Characteristics
Software-based image processing module; runs on Windows 2000 or similar OS; utilizes DICOM interface standards for image storage and printing; provides tools for image manipulation, template overlay, and measurement. Classified as minor level of concern for potential hazards.
Indications for Use
Indicated for manipulation and display of medical images for preoperative planning and post-operative follow-up by trained professionals including orthopedic surgeons, physicians, and radiologists.
Regulatory Classification
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.
Special Controls
*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).
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# JUN 2 1 2004
Image /page/0/Picture/1 description: The image shows the text "K041500" at the top, followed by a black rectangle with the word "INFINITT" in white letters. The text "K041500" appears to be a code or identifier. The word "INFINITT" is prominently displayed, suggesting it is a brand name or product name.
### 510(k) Summary of Safety and Effectiveness
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
Date Prepared: April 28, 2004
Submitter's Information: 21 CFR 807.92(a)(1) Mr. Samuel Choi, Director INFINITT CO.,LTD Taesuk Bldg. 9F, 275-5 Yangjae-Dong Seocho-Gu, Seoul, South Korea 137-943 Fax: 82-2-2194-1696 Email: switch@infinitt.com
Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2) STARPACS ™ Orthopedics System Trade Name: Picture Archiving Communications System Common Name: 892.2050 Device Classification: System, Image Processing Name:
Predicate Device: 21 CFR 807. 92(a)(3)
| Device Classification Name | system, image processing, radiological |
|-----------------------------------|----------------------------------------|
| 510(k) Number | K031590 |
| Regulation Number | 892.2050 Class II |
| Device Name | Sectra orthopedic package |
| Applicant | sectra-imtec ab |
| Product Code | LLZ |
| Decision Date | 10/02/2003 |
| Decision | Substantially equivalent (SE) |
| Classification Advisory Committee | Radiology |
| Review Advisory Committee | Radiology |
| Type | Traditional |
#### Device Description: 21 CFR 807 92(a)(4)
STARPACS ™ Orthopedics System handles and displays various objects in a Picture Archive and Communication System (PACS) environment and is intended to assist orthopedic surgeons when doing preoperative planning and post-operative follow-up. The device is used to overlaying prosthesis templates on radiological images, tools for repositioning the templates, and tools for measurements in the images.
#### Indications for Use: 21 CFR 807 92(a)(5)
battons for ous in of the manipulation and displaying of medical images. It can show images from different modalities and interfaces to various image storage and printing devices using DICOM or similar interface standards.
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Image /page/1/Picture/0 description: The image shows the word "INFINITT" in white letters against a black background. The letters are blocky and sans-serif. The word is centered in the image and takes up most of the space. The image is simple and high contrast.
The device assists orthopedic surgeons when doing preoperative planning and post-The device assists of this system are trained professionals, for operative form of one surgeons, physicians, and radiologists.
## Technological Characteristics: 21 CFR 807 92(a)(6)
STARPACS Orthopedics™ system is a software product that assists orthopedic surgeons STARPACS Onlinopedics - System is a sommer proative follow-up. It is a module that is used for when doing preoperative planning and people of a problem on images that are handled and displayed displaying and treming intern (K031013) Workstation. STARPACS ™ Orthopedics System by the STAN AGS - Oystem (1001818) vention systems, (depending upon system runs on Windows 2000 or Pintsont the patient, nor does it control any life sustaining Comiguration). This droviding ample opportunity for competent human intervention interprets images and information being displayed and printed.
#### Conclusion: 21 CFR 807 92(b)(1)
The 510(k) Pre-Market Notification for STARPACS Orthopedics™ system contains adequate The STO(K) FTe-Market Notinoution for CDRH to determine substantial equivalence to the predicate device.
STARPACS Orthopedics™ system has been and will be manufactured in accordance with STANT ACC Online and one of the enclosed voluntary standard survey. The submission the volumary standardo lieted in anolysis and the "Level of Concern for potential hazards have been classified as "minor".
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" around the perimeter of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 1 2004
Infinitt Co., Ltd. % Mr. N. E. Devine, Jr. Responsible Third Party Official Entela, Inc. 3033 Madison Ave. SE GRAND RAPIDS MI 49548
Re: K041500 Trade/Device Name: STARPACS Orthopedics™ System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ
Dated: June 4, 2004 Received: June 7, 2004
Dear Mr. Devine:
We have reviewed your Section 510(k) premarket notification of intent to market the device WE nave reviewed your beceibled the device is substantially equivalent (for the indications felerenced above unders develo legally marketed predicate devices marketed in interstate for use stated in the encreativent of to togens .
commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to conninered phos to May 20, 1777) 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). allu Costictle 71ct (71ct) market the device, subject to the general controls provisions of the Act. The I ou may, therefore, mances of the Act include requirements for annual registration, listing of general controls provisions or ractice, 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 If your device is classinod (600 as 010). Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations affecti may be subject to satil additions, Title 21, Parts 800 to 898. In addition, FDA may oc round in the 000 acements 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 that I DA has made a decermination administered by other Federal agencies. You must comply or any I-cocrar statures and regalanceding, but not limited to: registration and listing (21 CFR Part whill an the Act 3 requirements, metading, one manufacturing practice requirements as set forth in the 807), laocimig (21 CFR Part 820); and if applicable, the electronic product quality Systems (QD) rogential (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 Section 510(k) I his iciter will anow you to ogm haring of substantial equivalence of your device to a legally prematication. The Presults 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 If you desire spoolite at one of the following numbers, based on the regulation number at the top of the 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 Additionally, for questions 01 13 1-4639. Also, please note the regulation entitled, "Misbranding Other of Comphance at (301) 97 - 100 (21 Part 807.97) you may obtain. Other general by receibod to promative to promation the Act may be obtained from the Division of Small mormation on your responsible Consumer Assistance at its toll-free number (800) 638-2041 or Mandractors, International address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brydon
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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# Indications for Use
510(k) Number (if known):
Device Name: STARPACS Orthopedics™
Indications For Use:
The device is intended for the manipulation and displaying of medical images. It The device is intended for the manipalities and interfaces to various image Can show images from different model or similar interface standards.
The device assists orthopedic surgeons when doing preoperative planning and post-operative follow-up.
Typical users of this system are trained professionals, for example orthopedic surgeons, physicians, and radiologists.
Prescription Use -(Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use __ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel B. Szyfman
510kl 1
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
