The Stryker Tempest Orthopedic Pump is intended to be used by surgeons in Orthopedic joints, including the knee, shoulder, ankle, elbow, wrist, and temporomandibular joints. It will be used to distend joints. The distension and saline circulation allow better viewing of the joint and tissues, as well as, irrigation of loose debris. The Tempest Orthopedic Pump replaces currently used manual infusion systems, utilizing either a bulb syringe or gravity flow. The Stryker Orthopedic Pump is to be used with Stryker Arthroscopes, and Pressure Sensing Cannula, found substantially equivalent under 510(k) number K771200, Arthroscopes, and K944593, Pressure Sensing Cannula, respectively.
Device Story
Stryker Tempest Orthopedic Pump system; consists of pump console, disposable tube set, and pressure sensing cannula. Used in orthopedic surgery to distend joints and irrigate debris via saline circulation. Replaces manual bulb syringe or gravity flow systems. Operated by surgeons in sterile field using reusable hand control. Pump monitors joint pressure; features automatic motor stop, outflow solenoid valve activation, and audible/visual alarms if pressure exceeds 150 mmHg or if pressure change is not detected within four seconds. Provides controlled joint distension for improved visualization during arthroscopy.
Clinical Evidence
Bench testing only. Validation includes electrical safety (CSA C22.2 No. 125, UL 544), sterilization validation (AAMI ST 27, AAMI ST 32), and biocompatibility testing (USP Intracutaneous, Systemic Toxicity, Maximization, MEM Elution, Hemolysis).
Technological Characteristics
Electrically powered pump console; disposable tube set; pressure sensing cannula. Safety features: over-pressure control (150 mmHg limit), outflow solenoid valve, audible/visual alarms. Sterilization: ETO (AAMI ST 27) and Gamma irradiation (AAMI ST 32). Electrical standards: CSA C22.2 No. 125, UL 544.
Indications for Use
Indicated for surgeons performing orthopedic joint procedures (knee, shoulder, ankle, elbow, wrist, temporomandibular) requiring joint distension and saline irrigation for visualization and debris removal.
Regulatory Classification
Identification
An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.
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JAN 22 1997
K96 3304
2590 Walsh Avenue, Santa Clara, CA 95051
(408)567-9100 FAX (408)567-2507
# SUMMARY OF SAFETY AND EFFECTIVENESS — 510(K) # K963304
| Device Name : | |
| --- | --- |
| Current Classification Name | : Arthroscope and accessories CFR 888.1100 Class II |
| Common and Usual Name | : Arthroscopy Pump |
| Propriety Name | : Stryker Tempest Orthopedic Pump |
| Device Sponsor | : Stryker Endoscopy
2590 Walsh Avenue, Santa Clara, CA 95051
FDA Registration # 2936485 |
| Regulatory Classification | : Class II |
This summary of 510(k) safety and effectiveness being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92.
The Stryker Tempest Orthopedic Pump System, consisting of Pump Console which powers disposable Tube Set, and Pressure Sensing Cannula, 510(k) # K944593, during orthopedic surgery is equivalent in intended use, safety and effectiveness to existing Stryker Infusion Pump, 510(k) # K910858, used in similar applications, by Stryker Corporation.
The disposable tube set utilized in Stryker Tempest Orthopedic Pump, will be provided sterile for single applications. The material of constructions, maximum pressure and flow rate are equivalent to currently marketed products. As proven in Orthopedic applications, these design offer the required precision for controlling the joints distension.
The Tempest Orthopedic Pump technology utilized in this device is equivalent to existing marketed products. Power modality, intended use, methods of sterilization and safety risks are substantially equivalent. The Stryker Tempest Orthopedic Pump is electrically powered and is designed to meet CSA Electromedical Standard Number C22.2 Number 125, and UL 544 Standards.
The disposable tube set ETO sterilization processes are validated per AAMI standard ST 27, to a S.A.L. of $10^{-6}$. Gamma irradiation validation is per AAMI standard ST 32, method 1, section 5.2.3.1., for sterile packaged, single use disposable tube set. The minimum dose for an S.A.L. of $10^{-6}$ is 1.66 Mrads. The biocompatibility testing will include USP Intracutaneous, USP Systemic Toxicity Test, Maximization, USP MEM Elution, and Hemolysis. These validation are equivalent to the existing marketed products.
The Tempest Orthopedic Pump is designed with appropriate safety features for over pressure controls and alarm. First, under normal Run/Stop mode, the pump prevents the pressure sensed at the joint or body cavity from exceeding 150 mmHg. The pump motor will stop, a red light emitting diode illuminates, and outflow solenoid valve opens to relieve excess pressure. Under Lavage mode, any pressure above 150 mmHg for 3 seconds will trigger an uninterrupted audible alarm. Second, if the pump will not function if the pressure does not detect a change in actual pressure within four seconds, the pump motor will stop, followed by an audible alarm. The ONLY way to re-activate the pump is to depress the RUN/STOP switch. Third, the Lavage feature has an over pressure alarm. When using Lavage feature, and joint pressure go above 150 mmHg for 3 seconds, the uninterrupted audible alarm will sound.
A reusable hand control will be offered to allow surgeons to perform surgery in the sterile field.
Overall, the Stryker Tempest Orthopedic Pump System does not raise any new safety and efficacy concerns when compared to Infusion pump. Therefore, the Stryker Pump System is substantially equivalent to Stryker Infusion Pump System.
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**Indications For Use**: The Stryker Tempest Orthopedic Pump is intended to be used by surgeons in Orthopedic joints, including the knee, shoulder, ankle, elbow, wrist, and temporomandibular joints. It will be used to distend joints.
The distension and saline circulation allow better viewing of the joint and tissues, as well as, irrigation of loose debris. The Tempest Orthopedic Pump replaces currently used manual infusion systems, utilizing either a bulb syringe or gravity flow. The Stryker Orthopedic Pump is to be used with Stryker Arthroscopes, and Pressure Sensing Cannula, found substantially equivalent under 510(k) number K771200, Arthroscopes, and K944593, Pressure Sensing Cannula, respectively.
Roy S. Chin
Associate Project Engineer
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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.
