K052451 · Mps Acacia · MEB · Dec 8, 2005 · General Hospital
Device Facts
Record ID
K052451
Device Name
MPS ACACIA MEDFLO ELASTOMERIC PUMP
Applicant
Mps Acacia
Product Code
MEB · General Hospital
Decision Date
Dec 8, 2005
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 880.5725
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The MPS Acacia MedFlo Elastomeric Pump is indicated for continuous and/or intermittent infusion of medications for general infusion use, including antibiotic delivery, chemotherapy, and pain management. Routes of administration include intravenous, intra-arterial, subcutaneous, intramuscular, and epidural. The keep vein open (KVO) version provides a sufficient flow rate to maintain a patient IV line open (i.e. keep vein open). The MedFlo Elastomeric pump may also include an optional Y-site at the distal end of the administration set to allow piggyback infusions, and an optional bolus mechanism intended for patient controlled infusion. The MPS Acacia MedFlo Elastomeric Pump is also indicated for continuous and/or intermittent delivery of medication, such as local anesthetics or narcotics, to surgical wound sites and/or close proximity to nerves for preoperative, perioperative, and postoperative regional anesthesia and pain management. Routes of administration include intraoperative, perineural, and percutaneous. The MPS Acacia MedFlo Elastomeric Pump is also indicated to significantly decrease narcotic use and pain when used to deliver local anesthetics to surgical wound sites or close proximity to nerves when compared with narcotic only pain management. The MPS Acacia MedFlo Elastomeric Pump is disposable and single use only.
Device Story
Disposable, single-use elastomeric infusion pump; consists of non-latex elastomeric bladder on plastic mandrel; non-DEHP administration tubing; male luer lock; optional accessories include air-eliminating filter, pinch clamp, flow restrictor, Y-site, checkvalve, and bolus mechanism. Operates via elastomeric membrane tension to deliver fluid at controlled rates (0.5 to 10ml/hr) without external power or alarms. Used in clinical settings for medication delivery (antibiotics, chemotherapy, pain management). Clinician-managed; optional bolus mechanism allows patient-controlled infusion. Benefits include controlled medication delivery and potential reduction in narcotic use for regional anesthesia.
Clinical Evidence
No clinical data provided. Substantial equivalence based on technological characteristics and component similarity to predicate devices.
Technological Characteristics
Non-latex elastomeric bladder; plastic mandrel; non-DEHP administration tubing; flow restrictors (fixed/variable); one-way checkvalve; 50-500ml fill volume; 0.5-10ml/hr flow rates. Passive mechanical operation; no electronic components, software, or alarms.
Indications for Use
Indicated for patients requiring continuous or intermittent infusion of medications (antibiotics, chemotherapy, anesthetics, narcotics) for general infusion, regional anesthesia, or pain management. Routes: IV, intra-arterial, subcutaneous, intramuscular, epidural, intraoperative, perineural, percutaneous. Includes KVO functionality for IV line maintenance.
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.
Accufuser, Accufuser Plus, and Standard Procedure Kit (K050770)
Submission Summary (Full Text)
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K052451
## DEC 8 2005
## 510(k) Summary
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| 1. Submitter: | MPS Acacia<br>785 Challenger Street<br>Brea, CA 92821<br>Tel: 714-257-0470<br>Fax: 714-257-0513 |
|-----------------------|-------------------------------------------------------------------------------------------------|
| 2. Contact: | Fergie F. Ferguson, RA/QA Manager<br>MPS Acacia |
| 3. Date prepared: | August 29, 2005 |
| 4. Device trade name: | MedFlo Elastomeric Pump |
| Common name: | Elastomeric Infusion Pump |
| 5. Predicate device: | MedFlo® LI and LI-KVO |
| 510(k) number: | K011117 |
| Marketed by: | MPS Acacia<br>785 Challenger Street<br>Brea, CA 92821 |
| Predicate device: | MPS Acacia Pain Kit |
| 510(k) number: | K003476 |
| Marketed by: | MPS Acacia<br>785 Challenger Street<br>Brea, CA 92821 |
| Predicate device: | ON-Q, PainBuster, C-Bloc, Eclipse, Easypump, Homepump |
| 510(k) number: | K020251 |
| Marketed by: | I-Flow Corporation<br>20202 Windrow Drive<br>Lake Forest, CA 92630 |
| Predicate device: | Accufuser, Accufuser Plus, and Standard Procedure Kit |
| 510(k) number: | K050770 |
| Marketed by: | McKinley Medical, LLC<br>4080 Youngfield Street<br>Wheat Ridge, CO 80033 |
## 6. Description:
The MPS Acacia MedFlo Elastomeric Pump consists of a non-latex elastomeric bladder that is secured onto a plastic mandrel. Secured to the inside of the mandrel is the non-DEHP administration tubing. Secured to the opposite end of the administration tubing is a male luer lock. Standard IV set accessories are integrated in the administration set of the elastomeric pump and may include (dependant on application as determined by the clinician) an air eliminating filter, pinch clamp, flow restrictor (fixed or variable), Y-site, checkvalve, and bolus mechanism. At the inlet port of the mandrel is a one-way checkvalve to allow for the filling of the device while not allowing fluid backup. Encasing the bladder, mandrel and part of the administration tubing is a clear, protective body. The elastomeric pump does not have an alarm function, is non-DEHP and does not contain latex.
The MPS Acacia MedFlo Elastomeric Pump will be available in configurations consisting of 50 to 500ml fill volume, and 0.5 to 10ml per hour flow rates.
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## 510(k) Summarv
A procedure kit may consist of an introducer, tear-away sheath, multi-port catheter, syringe, sterile tape, wound dressing, and sterile gloves (dependent on application as determined by the clinician), and may be included with each MedFlo Elastomeric Pump or sold separately dependent on the clinician's requirements.
- 7. Intended Use:
- 7.1 The MPS Acacia MedFlo Elastomeric Pump is indicated for continuous and/or intermittent infusion of medications for general infusion use, including antibiotic delivery, chemotherapy, and pain management. Routes of administration include intravenous, intra-arterial, subcutaneous, intramuscular, and epidural. The keep vein open (KVO) version provides a sufficient flow rate to maintain a patient IV line open (i.e. keep vein open). The MedFlo Elastomeric pump may also include an optional Ysite at the distal end of the administration set to allow piggyback infusions, and an optional bolus mechanism intended for patient controlled infusion.
- 7.2 The MPS Acacia MedFlo Elastomeric Pump is also indicated for continuous and/or intermittent delivery of medication, such as local anesthetics or narcotics, to surgical wound sites and/or close proximity to nerves for preoperative, perioperative, and postoperative regional anesthesia and pain management. Routes of administration include intraoperative, perineural, and percutaneous.
- 7.3 The MPS Acacia MedFlo Elastomeric Pump is also indicated to significantly decrease narcotic use and pain when used to deliver local anesthetics to surgical wound sites or close proximity to nerves when compared with narcotic only pain management.
- 7.4 The MPS Acacia MedFlo Elastomeric Pump is disposable and single use only.
- 8. Technological comparison to predicate device:
The MPS Acacia MedFlo Elastomeric Pump offers the same technique, usage parameters and intended use to the predicate devices. The elastomeric membrane delivers fuit at a controlled rate and manner the same as the predicate devices.
- ல் Non-clinical test summary:
All components used in the MPS Acacia MedFlo Elastomeric Pump are the same as the components used in the predicate devices from MPS Acacia, 510(k) numbers K003476, and K011117.
- 10. Conclusion:
The MPS Acacia MedFlo Elastomeric Pump is substantially equivalent to the products currently being legally marketed by MPS Acacia, I-Flow Corporation, and McKinley Medical.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is written around the circumference of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 8 2005
Mr. Fergie F. Ferguson Manager MPS Acacia 785 Challenger Street Brea, California 92821
Re: K052451
Trade/Device Name: MedFlo, MedFlo Pain Kit, MedFlo Nerve Block, MedFlo I I and MedFlo Li-KVO Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: MEB Dated: September 6, 2005 Reccived: September 13, 2005
Dear Mr. Ferguson:
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.
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Page 2 - Mr. Ferguson
Please be advised that FDA's issuance of a substantial equivalence determination does not I lease be advisor that I Da determination that your device complies with other requirements mean that 1 27 mas may Federal statutes and regulations administered by other Federal agencies. of the Flor of any I outhal the Act's requirements, including, but not limited to: registration r od intist comply with and may (21 CFR Part 801); good manufacturing practice and ilsting (21 OF Fur over), acceins (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) I mis feter whilanon. The FDA finding of substantial equivalence of your device to a premaired predicate device results in a classification for your device and thus, permits your device to procced to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), If you desite specific at no 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 may overn 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/industry/support/index.html
Sincerely yours,
Sujata y. Michael O md
Chiu Lin, Ph.D. [Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use Statement
1. 1. 1. 1.
Applicant: MPS Acacia
510(k) NUMBER (IF KNOWN): _ KO 5 J. JS J
DEVICE NAME: MedFlo Pain Kit, MedFlo Nerve Block, MedFlo LI and MedFlo LI-KVO INDICATIONS FOR USE:
- 1. The MPS Acacia MedFlo Elastomeric Pump is indicated for continuous and/or intermittent infusion of medications for general infusion use, including antibiotic delivery, chemotherapy, and pain management. Routes of administration include intra-arterial, subcutaneous, intramuscular, and epidural. The keep vein open (KVO) version provides a sufficient flow rate to maintain a patient IV line open (i.e. keep vein open). The MedFlo Elastomeric pump may also include an optional Y-site at the distal end of the administration set to allow piggyback infusions, and an optional bolus mechanism intended for patient controlled infusion.
- 2. The MPS Acacia MedFlo Elastomeric Pump is also indicated for continuous and/or intermittent delivery of medication, such as local anesthetics or narcotics, to surgical wound sites and/or close proximity to nerves for preoperative, perioperative, and postoperative regional anesthesia and pain management. Routes of administration include intraoperative, perineural, and percutaneous.
- 3. The MPS Acacia MedFlo Elastomeric Pump is also indicated to significantly decrease narcotic use and pain when used to deliver local anesthetics to surgical wound sites or close proximity to nerves when compared with narcotic only pain management.
- 4. The MPS Acacia MedFlo Elastomeric Pump is disposable and single use only.
Prescription Use XX (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter-Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)
Shos Q. Rschfurow 12/16/05
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8052451
umber. R05275
Page 1 of 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.
