K982640 · Medex, Inc. · FRN · Apr 6, 1999 · General Hospital
Device Facts
Record ID
K982640
Device Name
MEDEX 3000 SERIES SYRINGE INFUSION PUMP
Applicant
Medex, Inc.
Product Code
FRN · General Hospital
Decision Date
Apr 6, 1999
Decision
ST
Submission Type
Traditional
Regulation
21 CFR 880.5725
Device Class
Class 2
Attributes
Therapeutic, Pediatric
Indications for Use
The Medex 3000 Series Syringe Infusion Pump is intended for use in the administration of fluids requiring precisely controlled infusion rates including blood and blood products, lipids, drugs and other therapeutic fluids via arterial, epidural, intravenous, spinal and subcutaneous routes. The pumps are indicated for use in continuous, volume/time, body weight, custom dilution, intermittent or bolus delivery modes in critical care, anesthesia, neonatal and pediatric applications or other healthcare settings where the use of the pump can be monitored or supervised by a clinician. The Syringe Infusion Pump is not intended for use on the inlet side of extracorporeal membrane oxygenation (ECMO) systems where high negative pressures may occur.
Device Story
Software-driven, microprocessor-controlled electromechanical syringe infusion pump; operates by controlled displacement of syringe plunger. Inputs: user-defined infusion parameters (rate, volume, time, body weight, dilution). Outputs: controlled fluid delivery via sterile administration set. Used in clinical settings (critical care, anesthesia, neonatal/pediatric) under clinician supervision. Features include pre-delivery (loading) bolus and post-occlusion bolus reduction. Healthcare providers use the interface to program delivery modes; device provides precise flow control to improve therapeutic fluid administration accuracy.
Clinical Evidence
Bench testing only. Testing verified flow rate accuracy and confirmed reduction in post-occlusion bolus volume compared to predicate devices.
Technological Characteristics
Microprocessor-controlled electromechanical system. Features: syringe flange sensor, internal battery, delivery databanks. Flow accuracy: +/- 2%. Software-driven control of motor and pumping mechanism. Sterilization: not specified.
Indications for Use
Indicated for administration of fluids (blood, lipids, drugs, antibiotics) via arterial, epidural, intravenous, spinal, or subcutaneous routes in critical care, anesthesia, neonatal, and pediatric settings. Contraindicated for use on the inlet side of ECMO systems.
Regulatory Classification
Identification
An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.
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4/6/99
510 (k) Summarv
K982640
This summary regarding 510(k) safety and effectiveness and being submitted in accordance with the requirements of SMDA 1990 and 21 CFR part 807.92.
# 807.92(a)(1) Submitter's (and Contact) Name, Address, Telephone No., Summary Date
Cathy Chenetski Director, Regulatory Affairs Medex 3637 Lacon Road Hilliard, OH 43026 (614) 529-3932
July 21, 1998
## 807.92(a)(2) Device Name (Including Trade Name), Common Name, Classification Name
| Classification Name: | Syringe Infusion Pump (80 FRN) |
|-----------------------|--------------------------------|
| Common/Usual Name: | Syringe Infusion Pump |
| Trade/Propriety Name: | Not yet determined. |
| Part Number: | Medex 3000 Series |
### 807.92(a)(3) Legally Marketed Predicate Device to Which Equivalence is Claimed
The Medex 3000 Series Syringe Infusion Pump, for purposes as defined under Section 510(k) of the Federal Food. Drug and Cosmetic Act, is substantially equivalent to the Medex 2000 Series Syringe Infusion Pumps K890120, K901755 and K955231 and the Baxter AutoSyringe AS50 Infusion Pump K945942 (SE decision 7/10/95). For simplicity, the Medex 2010i will be used throughout this 510(k) to represent the Medex 2000 Series Syringe Infusion Pumps as the predicate device.
## 807.92(a)(4) Description of the Premarket Notification Device and 807.92 (a) (5) Intended Use
The Syringe Infusion Pump is a software driven, microprocessor controlled, electromechanical system that contains within its case: user interface, power supply, motor, pumping mechanism, and electronic circuits required to effect the controlled infusion of fluids through a syringe and a sterile administration set. The pump operates by controlled displacement of the syringe plunger. Medex currently markets the Medex Medfusion 2000 Series Syringe Infusion Pumps under 510(k) numbers K890120, K901755 and K955231. The Medex 3000 Series Syringe Infusion Pump is the next generation syringe pump which utilizes the same method of delivery and the same basic elements.
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The Medex 3000 Series Syringe Infusion Pump is intended for use in the administration of fluids requiring precisely controlled infusion rates including blood and blood products, lipids, drugs and other therapeutic fluids via arterial, epidural, intravenous, spinal and subcutaneous routes. The pumps are indicated for use in continuous, volume/time, body weight, custom dilution, intermittent or bolus delivery modes in critical care, anesthesia, neonatal and pediatric applications or other healthcare settings where the use of the pump can be monitored or supervised by a clinician.
The Syringe Infusion Pump is not intended for use on the inlet side of extracorporeal membrane oxygenation (ECMO) systems where high negative pressures may occur.
### 807.92 (a) (6) Technical Characteristics Summary
Similarities between the predicate device and the 510(k) device:
- . Both the Medex 3000 Series Syringe Infusion Pump and the predicate devices contain internal batteries and offer delivery databanks.
- . Both the Medex 3000 Series Syringe Infusion Pump and the Baxter AS50 predicate device have a svringe flange sensor and offer a custom dilution mode.
Differences between the predicate device and the 510(k) device:
- The Medex 3000 Series Syringe Infusion Pumps offer pre-delivery (loading) bolus ● and post-occlusion bolus reduction features while the predicate devices do not.
- . The Medex 3000 Series Syringe Infusion Pump offers a +/- 2% flow delivery accuracy rate while the predicate devices offer a +/- 3% flow delivery accuracy rate.
#### 807.92 (b) (1), (b) (3) Performance Testing Assessment
Medex conducted flow rate testing to verify that the 3000 Series Syringe Infusion Pump meets specifications and is therefore equivalent to the predicate devices. Additionally, Medex conducted testing to confirm that the 3000 Series Svringe Infusion Pump delivered a reduction in post-occlusion bolus volume as compared to the predicate device.
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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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other, with flowing lines representing hair or clothing.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 6 1999
Mr. Cathy Chenetski Director, Requlatory Affairs Medex, Incorporated 3637 Lacon Road Hilliard, Ohio 43026
K982640 Re : Medex 3000 Series Syringe Infusion Pump Trade Name: Regulatory Class: II Product Code: FRN Dated: January 29, 1999 February 1, 1999 Received:
Dear Ms. Chenetski:
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 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਜ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation 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.
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Page 2 - Ms. Chenetski
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA described in your sit (i) promatence of your device to a legally marketed predicate device results in a classification for your marice 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) 594-4692. 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 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/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known) _ K 9826 HO
Device Name: Syringe Infusion Pump
Indications for Use:
The Medex 3000 Series Syringe Infusion Pump indications for use are as follows;
- in the administration of fluids requiring precisely controlled infusion rates including . blood or blood products, lipids, drugs, antibiotics and other therapeutic fluids.
- in the following delivery routes: arterial, epidural, intravenous, spinal, and . subcutaneous.
- . in the following delivery modes: continuous, volume/time, mass, body weight, custom dilution, intermittent and bolus.
- in critical care, anesthesia, neonatal and pediatric applications or other healthcare . settings where the use of the Syringe Infusion Pump can be monitored or supervised by a clinician.
- . the Syringe Infusion Pump is contraindicated for use on the inlet side of extracorporeal membrane oxygenation (ECMO) systems where high negative pressures may occur.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Over-The-Counter Use
Patricio Crescente
(Division Sign-Off)
Division of Dental Infection Control,
Devices
X9826040
OR
(Optional Format 1-2-96)
00017
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.
