BRIGIT Surgical Device is a computer controlled electromechanical multi-jointed arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide to be used by the surgeon to manually guide orthopedic instruments. It is indicated for any orthopedic medical condition in which the use of stereotaxic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a long bone, can be identified relative to digitized landmarks of the anatomy. Example orthopedic procedures for these instruments include, but are not limited to: - Total Knee Arthroplasty (Primary and Revision) - Unicompartmental Knee Arthroplasty (Primary and Revision) - Minimally Invasive Knee Orthopedic Procedures - Total or Hemi-Hip Arthroplasty (Primary and Revision) - Minimally Invasive Hip Orthopedic Procedures - Tumor Resection and Bone/Joint Reconstruction - Stabilization or Repair of Pelvic/Femoral Fractures
Device Story
BRIGIT Surgical Device is a computer-controlled, electromechanical, multi-jointed arm used in operating rooms. It assists surgeons by determining reference alignment axes relative to anatomical landmarks, planning instrument positions, and providing stable, accurate mechanical guidance for orthopedic instruments. The device does not contact the patient directly. In 'cooperative mode,' surgeons manually move the arm by grabbing the tip to collect anatomical landmarks. The system calculates guide positioning based on 3D surgical planning parameters and digitized anatomical landmarks. It provides rigid, steady support for tool guides, enhancing accuracy and reproducibility during procedures like arthroplasty, tumor resection, and fracture repair. The surgeon retains manual control of the instruments while the arm maintains the planned orientation.
Clinical Evidence
Bench testing only. No clinical data provided. Performance validation included electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-2), software verification per FDA guidance, and device accuracy/repeatability testing.
Technological Characteristics
Computer-controlled electromechanical multi-jointed arm. Features include cooperative mode for manual positioning and 3D spatial calculation engine. Connectivity/integration supports digitized landmark referencing. Electrical safety per IEC 60601-1; electromagnetic compatibility per IEC 60601-2. Software-controlled guidance system.
Indications for Use
Indicated for patients requiring orthopedic surgery where stereotaxic guidance is appropriate and rigid anatomical structures (e.g., long bones) can be referenced via digitized landmarks. Applicable to total/unicompartmental knee arthroplasty, hip arthroplasty, tumor resection, and fracture stabilization.
Regulatory Classification
Identification
A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.
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### Summary of Safety and Effectiveness
JUL 31 2006
Submitter:
Contact Person:
Date:
Trade Name:
Common Name:
Classification Name and Reference:
Predicate Device:
Zimmer, Inc. P.O. Box 708 Warsaw, IN 46581-0708
Stephen H. McKelvey Manager, Corporate Regulatory Affairs Telephone: (574) 372-4944 Fax: (574) 372-4605
July 26, 2006
BRIGIT Surgical Device
Computer assisted surgical device
Stereotaxic instrument, 21 CFR § 882.4560
Neuromate Stereotactic system, manufactured by Integrated Surgical Systems, Inc., K963256, cleared May 9, 1997.
Navitrack System - S&N Image Free Knee, manufactured by Orthosoft, K043536, cleared January 14, 2005.
Medtronic Stealth Station, manufactured by Medtronic, K050438, cleared June 2, 2005.
Zimmer Ortho Guidance Systems - Knee Instruments, manufactured by Zimmer, Inc., K033011, cleared February 12, 2004.
Zimmer Ortho Guidance Systems - Hip Instruments, manufactured by Zimmer, Inc., K033223, cleared February 18, 2004.
Zimmer Computer Assisted Solutions -Electromagnetic and Imageless Knee Instrumentation, manufactured by Zimmer, Inc., K052425, cleared December 28, 2005.
006
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## Device Description:
BRIGIT Surgical Device is a computer controlled electromechanical multi-jointed arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide to be used by the surgeon to manually guide orthopedic instruments.
BRIGIT Surgical Device assists the surgeon in:
- determining reference alignment axes in " relation to anatomical landmarks,
- planning the position of instruments relative to these axes,
- and providing a stable, accurate and reproducible mechanical guidance of surgical instruments in accordance with said planning, while not directly entering in contact with the patient.
BRIGIT Surgical Device can be shifted into a "cooperative mode" where the surgeon can manually move the arm anywhere in the operating field by simply grabbing the tip. Pinpoint collection of anatomical landmarks is carried out with BRIGIT Surgical Device and its pointing instrument in cooperative mode.
Adequate position of the guide is derived from three-dimensional calculations performed from desired surgical planning parameters and spatial positions of anatomical landmarks.
BRIGIT Surgical Device offers the rigidity essential for accurate and steady support of the guide.
BRIGIT Surgical Device is a computer controlled electromechanical multi-jointed arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide to be used by the surgeon to manually guide orthopedic instruments.
It is indicated for any orthopedic medical condition in which the use of stereotaxic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a long bone, can be
Intended Use:
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060556
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identified relative to digitized landmarks of the anatomy.
Example orthopedic procedures for these instruments include, but are not limited to:
- · Total Knee Arthroplasty (Primary and Revision)
- · Unicompartmental Knee Arthoplasty (Primary and Revision)
- · Minimally Invasive Knee Orthopedic Procedures
- · Total or Hemi-Hip Arthroplasty (Primary and Revision)
- · Minimally Invasive Hip Orthopedic Procedures
- · Tumor Resection and Bone/Joint Reconstruction
- · Stabilization or Repair of Pelvic/Femoral Fractures
The technological characteristics, features, specifications, materials, mode of operation, and intended use of the BRIGIT Surgical Device are substantially equivalent to the predicate devices listed above.
The differences that exist between the devices do not raise new issues of safety or effectiveness regarding the BRIGIT Surgical Device.
Testing was carried out to assure compliance with recognized electrical safety standards: IEC 60601-1 standard for electrical safety and IEC 60601-2 standard for electromagnetic compatibility.
Tests were also carried out to satisfy the requirements of the FDA Guidance for the Content of Premarket Submisions for Software Contained in Medical Devices.
Device accuracy tests were performed to validate the accuracy and repeatability of the device.
Comparison to Predicate Device:
#### Performance Data
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Zimmer, Inc. % Mr. Stephen H. McKelvey Manager, Corporate Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581-0708
Re: K060556
Trade/Device Name: BRIGIT Surgical Device Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HA W Dated: July 6, 2006 Received: July 7. 2006
Dear Mr. McKelvey:
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 such 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.
JUL 3 1 2006
Image /page/3/Picture/11 description: The image shows the logo for the U.S. Department of Health and Human Services (HHS). The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is composed of three parallel lines that curve and flow together. The logo is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA".
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Page 2 – Mr. Stephen H. McKelvey
This letter will allow you to begin marketing your device as described in your Section 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 (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Herbert Lemmerno
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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# Indications for Use
## 510(k) Number (if known): K060556
Device Name:
BRIGIT Surgical Device
### Indications for Use:
BRIGIT Surgical Device is a computer controlled electromechanical multi-jointed arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide to be used by the surgeon to manually guide orthopedic instruments.
It is indicated for any orthopedic medical condition in which the use of stereotaxic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a long bone, can be identified relative to digitized landmarks of the anatomy.
Example orthopedic procedures for these instruments include, but are not limited to:
- · Total Knee Arthroplasty (Primary and Revision)
- · Unicompartmental Knee Arthroplasty (Primary and Revision)
- · Minimally Invasive Knee Orthopedic Procedures
- · Total or Hemi-Hip Arthroplasty (Primary and Revision)
- · Minimally Invasive Hip Orthopedic Procedures
- · Tumor Resection and Bone/Joint Reconstruction
- · Stabilization or Repair of Pelvic/Femoral Fractures
Prescription Use X (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)
Huler Lemur
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
Page 1 of 1
510(k) Number
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.
