K042873 · Animas Corp. · LZG · Dec 10, 2004 · General Hospital
Device Facts
Record ID
K042873
Device Name
ANIMAS MODEL IR1250 INSULIN INFUSION PUMP
Applicant
Animas Corp.
Product Code
LZG · General Hospital
Decision Date
Dec 10, 2004
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 880.5725
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The intended use of the Animas Model IR1250 Insulin Infusion Pump is the same as that of the Series IR1200 Insulin Infusion Pump, namely to provide subcutaneous delivery of insulin at programmable basal and bolus rates for the management of diabetes mellitus in insulin dependent patients. Accessories to the Model IR1250 are the same as the IR1200 and include the Animas IR serial interface adaptor (the "dongle") and the Animas IR1200 Cradle to hold and align the pump while using with Animas ezManager Plus software on a personal computer. As with the IR1200, this connection allows the user and/or the physician to transfer (download) data stored in the pump to the personal computer where it may be displayed, printed, and saved. With the IR1250, this same connection will allow the user the option to program the pump, via a PC using the ezManager Plus software, with selected user pump settings (basal program, bolus limits, etc.) and non-operational, personalized information. Also available to the user, using the IR connection to the PC with ezManager Plus software, will be the ability to upload and/or modify selected food items and related carbohydrate information, for storage in, and reference/use directly from pump memory. This device is intended for home use and is a prescription device.
Device Story
External syringe pump for subcutaneous insulin delivery; manages diabetes mellitus via programmable basal and bolus rates. Operated by patients in home settings; physician-prescribed. Features infrared (IR) interface for data transfer to PC via 'dongle' and cradle; utilizes ezManager Plus software. Enhancements over predicate include increased memory for storing ~500 food items/carbohydrate data, allowing user reference on pump screen to evaluate insulin needs. PC interface enables remote programming of basal settings, bolus limits, and personalized alerts (names/tunes). Provides dosage history, alarms, and self-test capabilities. Benefits include improved management of insulin delivery and personalized therapy adjustments.
Clinical Evidence
No clinical data provided; bench testing only.
Technological Characteristics
External syringe pump; luer-style connection for infusion sets. Infrared (IR) connectivity for PC interface. Software-controlled basal/bolus delivery. Materials and construction identical to predicate IR1200.
Indications for Use
Indicated for insulin-dependent patients with diabetes mellitus requiring continuous subcutaneous insulin infusion for daily management.
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
Animas Model IR1200 Insulin Infusion Pump
Submission Summary (Full Text)
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DEC 1 0 2004
## Section 6 510(k) Summary
- Submitter: Animas Corporation, 200 Lawrence Drive, West Chester, PA 19380
- Contact: Thomas L. Parker, Manager, Requlatory Affairs, Telephone: (484)-568-1257, Fax: (484)-568-1329, Email: thomasp@animascorp.com
- Name of Device: Animas Model IR1250 Insulin Infusion Pump
Predicate Device: Animas Model IR1200 Insulin Infusion Pump
Description of the Modified Device: The Animas Model IR1250 Insulin Infusion Pump is an external syringe pump and delivery system that provides subcutaneous delivery of insulin for patients with diabetes mellitus who would benefit from a continuous insulin infusion process. The Model IR1250 is used with any insulin infusion set which incorporates a luer style connection.
The pump incorporates serial communications via an infrared (IR) interface with accessories which include the Animas IR to RS-232 serial interface adaptor (the "dongle"), the Animas IR1200 cradle to hold the pump and the Animas ezManager Plus software for the user's personal computer. As with the IR1200, this connection allows the user and/or the physician to transfer (download) data stored in the pump to the personal computer where it may be displayed, printed and saved. With the IR1250 this same connection will allow the user to program the pump, via the PC with ezManager Plus software, with selected user pump settings (basal program, bolus limits, etc.) and non-operational, personalized information including user selection of names for basal settings and musical tunes for initial alert/reminder warnings prior to the present pump alert/warning sounds. Also available to the user is the option to use a PC with ezManager Plus software, to upload and/or modify selected food items and related carbohydrate information, for storage in, and reference/use directly from, pump memory.
The pump is intended for multiple years of use. To hold the insulin for subcutaneous delivery, Animas provides sterile, single use, disposable insulin cartridges for use specifically with the IR1200 series pumps.
As with the IR1200, the IR1250 will deliver a prescribed dosage of insulin as a single programmable bolus or at multiple programmable basal rates. The system will also provide set up information, dosage history, alarms, error and warning messages, device status, and self test capabilities.
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Intended Use of the Modified Device: The intended use of the Animas Model IR1250 Insulin Infusion Pump is the same as that of the Series IR1200 Insulin Infusion Pump, namely to provide subcutaneous delivery of insulin at programmable basal and bolus rates for the management of diabetes mellitus in insulin dependent patients.
Accessories to the Model IR1250 are the same as the IR1200 and include the Animas IR serial interface adaptor (the "dongle") and the Animas IR1200 Cradle to hold and align the pump while using with Animas ezManager Plus software on a personal computer. As with the IR1200, this connection allows the user and/or the physician to transfer (download) data stored in the pump to the personal computer where it may be displayed, printed, and saved. With the IR1250, this same connection will allow the user the option to program the pump, via a PC using the ezManager Plus software, with selected user pump settings (basal program, bolus limits, etc.) and non-operational, personalized information. Also available to the user, using the IR connection to the PC with ezManager Plus software, will be the ability to upload and/or modify selected food items and related carbohydrate information, for storage in, and reference/use directly from pump memory.
This device is intended for home use and is a prescription device.
Comparison of the Technological Features of the Modified Device The modified device and the predicate and the Predicate Device: device are identical in terms of design, materials, and construction. The only change made to the IR1200 is increased storage capability, in pump memory, and the minor software modifications which allow the IR1250 pump to receive program instructions from a PC, with ezManager Plus software, and accept into pump storage approximately 500 food items with associated carbohydrate information. This information can be referenced, at any time, on the pump screen, for evaluating insulin needs.
These minor differences between the modified device and the predicate device do not affect the safety or effectiveness of the device's performance.
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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 features a stylized eagle or bird symbol, composed of three curved lines, representing the department's mission of protecting the health of all Americans and providing essential human services. The bird is positioned to the right of a circular seal that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 0 2004
Mr. Thomas L. Parker Manager, Regulatory Affairs Animas Corporation 200 Lawrence Drive West Chester, Pennsylvania 19380
Re: K042873
Ro42073
Trade/Device Name: Animas Model IR1250 Insulin Infusion Pump Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: LZG Dated: October 15, 2004 Received: October 18, 2004
Dear Mr. Parker:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have roviewed your ever hetermined the device is substantially equivalent (for the releicheco above and have attermilosure) 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 Amendinents, or to arrived Cosmetic Act (Act) that do not require approval of a premarket the rederal 1 600; Drug, and Comment , therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provisions of the stration, 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 If your device is classified (boo as a 10) .
(PMA), it may be subject to such additional controls. Existing major regulations affecting (1 Writ), it may of such of Federal Regulations, Title 21, Parts 800 to 898. In your device can or roundsh further announcements concerning your device in the Federal Register.
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## Page 2 - Mr. Parker
Please be advised that FDA's issuance of a substantial equivalence determination does not I lease oc advisod that 1 DTF is lesaultes on that your device complies with other requirements Incall that I DX mas mace a actess and regulations administered by other Federal agencies. or the Act of ally I outers. Including, but not limited to: registration r ou indisting (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice allu listing (21 OF RT rat 807), adoling systems (QS) regulation (21 CFR Part 820); and if requirenches as sol form in are quadiation 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 premainer netirement on 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 desire specific at 100 for your ce 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 maj occare 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,
Susan Runner
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): | K042873 |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Animas Model IR1250 Insulin Infusion Pump |
| Indications For Use: | The Animas Model IR1250 Insulin Infusion Pump is intended to provide subcutaneous delivery of insulin at programmable basal and bolus rates for the daily management of diabetes mellitus in insulin dependent patients. |
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(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)
Cintia Vrance
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control. Dental Devices
Page 1 of _1__
48/2873 510(k) Number:________________________________________________________________________________________________________________________________________________________________
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.
