K031566 · Baxter Healthcare Corp · MEA · Aug 19, 2003 · General Hospital
Device Facts
Record ID
K031566
Device Name
SYNDEO PCA SYRINGE PUMP, MODEL 2L3113
Applicant
Baxter Healthcare Corp
Product Code
MEA · General Hospital
Decision Date
Aug 19, 2003
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 880.5725
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The Syndeo PCA Syringe Pump is designed for the controlled delivery (continuous, intermittent, and continuous plus intermittent) of analgesic, sedative, and anesthetic solutions through clinically acceptable routes of administration including intravenous, subcutaneous, spinal (or intrathecal), epidural (or subarachnoid), and for regional anesthesia applications. The Syndeo PCA Syringe Pump is appropriate for use in hospital or alternate medical site environments, but it is not intended for use in homecare settings. The Syndeo PCA Syringe Pump is not indicated for use with blood or blood products.
Device Story
Syndeo PCA Syringe Pump delivers analgesic, sedative, and anesthetic solutions via continuous, intermittent, or continuous-plus-intermittent infusion. Device accepts 60 mL plastic or 50 mL prefilled syringes; includes locking cover and patient-controlled bolus button. Operated by clinicians in hospital or alternate medical sites; not for home use. Microprocessor-controlled system features color touch-screen GUI for programming. Sensors monitor syringe loading and door closure for safety. Device supports wireless communication with infrared printers or Palm OS-compatible computing tools. Powered by 4 D-size alkaline batteries or optional AC rechargeable pack. Output allows clinicians to manage patient pain regimens; provides controlled medication delivery to improve patient comfort.
Clinical Evidence
No clinical data provided; bench testing only.
Technological Characteristics
Microprocessor-controlled syringe infusion pump. Materials: plastic syringes. Energy: 4 D-size alkaline batteries or optional AC rechargeable pack. Interface: color touch-screen GUI. Connectivity: wireless (infrared/Palm OS compatible). Safety features: sensors for syringe loading and door closure.
Indications for Use
Indicated for patients requiring controlled delivery of analgesic, sedative, and anesthetic solutions via intravenous, subcutaneous, spinal, epidural, or regional anesthesia routes in hospital or alternate medical site environments. Not for homecare use. Not for use with blood or blood products.
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.
Predicate Devices
PCA II Syringe Infusion Pump
Ipump Pain Management System
Submission Summary (Full Text)
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K03/566
# 510(k) Summary of Safety and Effectiveness
## Submitted by:
Jennifer M. Paine Manager, Requlatory Affairs Baxter Healthcare Corporation Medication Delivery Rte. 120 and Wilson Road Round Lake, IL 60073
### Name/Classification of Device:
Infusion Pump/ Class II, 80MEA - 21 CFR 880.5725
#### Trade Name:
Syndeo PCA Syringe Pump
### Predicate Devices:
PCA II Syringe Infusion Pump Ipump Pain Management System
### Statement of Intended Use:
The Syndeo PCA Syringe Pump is designed for the controlled delivery (continuous, intermittent, and continuous plus intermittent) of analgesic, sedative, and anesthetic solutions through clinically acceptable routes of administration including intravenous, subcutaneous, spinal (or intrathecal), epidural (or subarachnoid), and for regional anesthesia applications.
The Syndeo PCA Syringe Pump is appropriate for use in hospital or alternate medical site environments, but it is not intended for use in homecare settings.
The Syndeo PCA Syringe Pump is not indicated for use with blood or blood products.
#### Device Description:
The Syndeo PCA Syringe Pump consists of a syringe infusion pump with locking cover, and a PCA button for delivery of bolus doses of medication upon request. The pump accommodates 60 mL plastic syringes or 50 mL prefilled syringes. The pump can communicate with wireless accessories such as commercially available infrared printers or computing tools with device communications that are compatible with the Palm Operating System.
The Syndeo pump is capable of continuous, intermittent, or continuous plus intermittent infusion of small volumes of medications, following standard patientrequest PCA regimens. The pump operates on 4 D-size alkaline batteries or the
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optional AC rechargeable pack. The pump uses microprocessor electronics for control of all functions. A large, color touch-screen display provides a userfriendly graphic user interface (GUI), and simple programming steps that lead the operator through programming. As an added safety feature, the pump employs a variety of sensors to ensure appropriate syringe loading and door closure prior to allowing initiation of infusion.
# Summary of Technological Characteristics of New Device to Predicate Devices:
The new and predicate devices have similar materials and basic design. The new device uses a touchscreen, color display and wireless communications technology.
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Image /page/2/Picture/1 description: The image shows a circular seal with the words "U.S. Health & Human Services USA" around the edge. Inside the circle is a stylized eagle-like symbol with three curved lines representing the body and wings. The image is in black and white and appears to be a scan or photocopy due to the slightly blurred text and the presence of some artifacts.
#### Public Health Service
AUG 1 9 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Jennifer M. Paine Manager, Regulatory Affairs Baxter Healthcare Corporation 7511 114" Avenue North Largo, Florida 33773
Re: K031566
Trade/Device Name: Syndeo PCA Syringe Pump Regulation Number: 880. 5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: MEA Dated: May 16, 2003 Received: May 19, 2003
## Dear Ms. Paine:
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, an 1 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. Iisting 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.
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# Page 2 - Ms. Paine
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. 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 (301) 594-4618 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely Yours,
fiscing the first of the many of the successfully be
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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# Indications for Use Statement
510(k) Number (if known):
Syndeo PCA Syringe Pump Device Name:
Indications For Use:
The Syndeo PCA Syringe Pump is designed for the controlled delivery (continuous, intermittent, and continuous plus intermittent) of analgesic, sedative, and anesthetic solutions through clinically acceptable routes of administration including intravenous, subcutaneous, spinal (or intrathecal), epidural (or subarachnoid), and for regional anesthesia applications.
The Syndeo PCA Syringe Pump is appropriate for use in hospital or alternate medical site environments, but it is not intended for use in homecare settings.
The Syndeo PCA Syringe Pump is not indicated for use with blood or blood products.
# (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR Counter Use _
Over-the-
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
Paltare Cuccente
Division of Anesthesiology, General Hospital. Infection Control. Den
510(k) Number: K031564
SYNDEO 510(K) -- INDICATIONS FOR USE
BAXTER CONFIDENTIAL
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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.
