K042228 · Mckinley, Inc. · FRN · Nov 8, 2004 · General Hospital
Device Facts
Record ID
K042228
Device Name
BEELINE MOTIV, PROPOLIS, PCA
Applicant
Mckinley, Inc.
Product Code
FRN · General Hospital
Decision Date
Nov 8, 2004
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 880.5725
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The Beeline system is intended for continuous and/or intermittent infusion of medication for general infusion use, including antibiotic delivery, chemotherapy and pain management. The Beeline system is indicated for intravenous, intra-arterial, enteral, subcutaneous, percutaneous and epidural infusion of medications or fluids requiring continuous and/or intermittent delivery at controlled infusion rates. The Beeline system is suitable for use as an ambulatory device and is intended for use in the hospital, home environment, and alternative care sites. The Beeline system is intended to provide 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. The Beeline system is also intended for patient-controlled infusion using the integrated bolus device. The Beeline system is intended 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.
Device Story
Beeline System is a spring-pressurized ambulatory infusion pump for continuous/intermittent medication delivery. Device consists of spring-loaded piston reservoir and administration set with flow-restricting component. Flow rate determined by spring pressure and restrictor dimensions. Integrated bolus device allows patient-controlled administration of medication doses. Used in hospital, home, and alternative care sites; operated by clinicians or patients. Physician prescribes flow rate and reservoir size based on patient needs. System facilitates regional anesthesia, pain management, antibiotic delivery, and chemotherapy. Benefits include reduced narcotic use when delivering local anesthetics to surgical sites. Single-patient use.
Clinical Evidence
No clinical data provided. Substantial equivalence based on bench testing and design comparison to legally marketed predicate devices.
Technological Characteristics
Spring-pressurized medication reservoir; piston-driven; administration set with flow restrictor (controlled diameter/length). Ambulatory form factor. Single-patient use. No electronic components, software, or external energy source described.
Indications for Use
Indicated for patients requiring continuous or intermittent infusion of medications (antibiotics, chemotherapy, pain management, local anesthetics) via intravenous, intra-arterial, enteral, subcutaneous, percutaneous, or epidural routes. Suitable for regional anesthesia and pain management at surgical wound sites or near nerves. Intended for use in hospital, home, and alternative care settings.
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.
SIMS Deltec CADD-Prizm® Model 6101 Ambulatory Infusion System (K000842)
Submission Summary (Full Text)
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Ko42228
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McKinley Medical 4080 Youngfield Street Wheat Ridge, CO 80033 USA 303.420.9569 303.420.4545 Fax
NOV - 8 2004
## 510(k) Summary of Safety and Effectiveness - Traditional 510(k) for Modifications to the McKinley Beeline System
| Date Prepared: | 3 August 2004 |
|------------------------------------------|----------------------------------------------|
| Contact for questions: | Michelle Pratte |
| Trade Name: | Beeline Motiv, Propolis. PCA |
| Common Name: | Infusion Pump System & Kit |
| Classification Name: | Pump, Infusion |
| Classification Panel: | 80 – General Hospital and Personal Use Devic |
| Regulation Number: | Class II, 880.5725 |
| Procode: | FRN |
| Original and previously cleared 510(k)s: | K990461 and K032642 |
## Summary of Safety and Effectiveness for the Beeline System
Modifications to the existing device consist of an extension of the flow rate range, addition of medication reservoir volumes, addition of an indication for use, addition of bolus capability, and addition of intermittent flow capability.
The previously cleared device demonstrating substantial cquivalence is the McKinley Beeline system (K032642).
Supporting predicate devices also demonstrating substantial equivalence is McKinley's Accufuser, Accufuser Plus & standard procedure kit (K033039), the I-Flow Elastomeric Pump (K040337), the Baxter Colleague Volumetric Pump (K010566), and the SIMS Deltec CADD-Prizm® Model 6101 Ambulatory Infusion System (K000842).
### The Beeline system is intended for use as follows:
- The Beeline system is intended for continuous and/or intermittent infusion of 1. medication for general infusion use, including antibiotic delivery, chemotherapy and pain management. The Beeline system is indicated for intravenous, intraarterial, enteral, subcutaneous, percutaneous and epidural infusion of medications or fluids requiring continuous and/or intermittent delivery at controlled infusion rates. The Beeline system is suitable for use as an ambulatory device and is intended for use in the hospital, home environment, and alternative care sites.
- 2. The Beeline system is intended to provide continuous and/or intermittent delivery of medication (such as local anesthetics or narcotics) to surgical wound sites
Traditional 510(k) McKinley Beeline System
Summary of Safety and Effectiveness, Page I of 2
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and/or close proximity to nerves for preoperative, perioperative and postoperative regional anesthesia and pain management. The Beeline system is also intended for patient-controlled infusion using the integrated bolus device.
- The Beeline system is intended to significantly decrease narcotic use and pain 3. when used to deliver local anesthetics to surgical wound sites or close proximity to nerves when compared with narcotic only pain management.
#### Summary Description of the Beeline System
The Beeline device consists of a spring-pressurized medication reservoir with a flowratecontrolling administration set. A spring applies force against a piston, pressurizing the medication. The administration set includes a flow restrictor component with controlled internal diameter and length. The flow rate at which medication is dispensed from the system is a function of the pressure applied to the medication and the dimensions of the flow restrictor component. The medication may be dispensed from the system continuously and/or intermittently.
The size of the reservoir and the amount of flow restriction are determined to yield a variety of product codes with differing infusion volumes and flow rates. The physician prescribes for a patient a flow rate and reservoir size based on the individual patient needs.
Administration sets may incorporate a bolus feature, which may be used alone or in conjunction with basal (continuous) or KVO (very low) flow. The bolus device consists of a dosage reservoir that is filled when activated manually. After the bolus device has been activated, the bolus volume is infused at a controlled flow rate. The bolus device is integrated into the administration set and allows patient-controlled administration of medication as needed.
A procedure kit option provides various components that facilitate setup and use of the Beeline system.
The Beeline system is intended for single patient use.
Conclusion: The modified Beeline system does not raise any new safety and efficacy concerns when compared to the original device that is already legally marketed. The Beeline system is substantially equivalent to the named predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 8 2004
Ms. Michelle Pratte Project Engineer McKinley Medical 4080 Youngfield Street Wheat Ridge, Colorado 80033
Re: K042228
Trade/Device Name: Beeline Motiv, Propolis, PCA Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: August 3, 2004 Received: August 17, 2004
Dear Ms. Pratte:
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 mendments, 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 approvisions 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 (1 wr 1, it na) 0 casyon in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device ear or roundsh further announcements concerning your device in the Federal Register.
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#### Page 2 - Ms. Pratte
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), rr you acented 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Chyu Lin, Ph.D.
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
Enclosure
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# Indications for Use
510(k) Number (if known): K042228
Device Name: Beeline System
Indications For Use:
- 1. The Beeline system is intended for continuous and/or intermittent infusion of medication for general infusion use, including antibiotic delivery, chemotherapy and pain management. The Beeline system is indicated for intravenous, intra-arterial, enteral, subcutaneous, percutaneous and epidural infusion of medications or fluids requiring continuous and/or intermittent delivery at controlled infusion rates. The Beeline system is suitable for use as an ambulatory device and is intended for use in the hospital, home environment, and alternative care sites.
- 2. The Beeline system is intended to provide 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. The Beeline system is also intended for patientcontrolled infusion using the integrated bolus device.
- 3. The Beeline system is intended 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.
Prescription Use × (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)
Anton Dinn
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
Page 1 of 1
510(k) Number Ko42228
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.
