(458 days)
Not Found
No
The description focuses on the mechanical and software control of medication delivery based on pre-programmed modes and patient input, with no mention of adaptive learning or data-driven decision-making characteristic of AI/ML.
Yes
The device is indicated for the "controlled delivery of analgesic, sedative, and anesthetic solutions" to relieve pain, induce sedation, or provide anesthesia, which are therapeutic interventions.
No
Explanation: The Ipump is an external infusion pump designed for the controlled delivery of medications, not for diagnosing conditions.
No
The device description explicitly states it is an external infusion pump operating using a linear peristaltic pumping mechanism, a DC motor, and includes hardware components like an air sensor and occlusion detectors. It also mentions power sources (battery/AC adapter) and disposables (tubing sets, reservoir bags). This is clearly a hardware device with integrated software for control.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. They are used outside of the body.
- Ipump Function: The Ipump™ Pain Management System is an infusion pump designed to deliver medications directly into a patient's body through various routes (intravenous, subcutaneous, epidural, regional). It is used on the patient, not for testing samples from the patient.
The description clearly indicates the device's purpose is to administer substances to a patient, which is the function of a therapeutic or drug delivery device, not an IVD.
N/A
Intended Use / Indications for Use
The Ipump™ Pain Management System is indicated 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, and epidural, and for regional (local) analgesia applications.
Product codes
FRN
Device Description
The Ipump™ Pain Management System is an external infusion pump offering three different modalities for the delivery of medications to a patient. The modalities include Patient Controlled Analgesia (PCA) mode, PCA plus basal (continuous) mode, and continuous mode.
PCA mode delivers a bolus of a medication at a fixed rate of 90 mL/hr at patient-controlled time intervals by pressing the PCA button. PCA plus basal (continuous) mode delivers medication at 90 mL/hr during patient-controlled time intervals in conjunction with the desired basal delivery of between 0.1 mL/hr and 19.9 mL/hr between PCA doses. In continuous mode, the pump delivers medication continuously at a rate adjustable between 0.1 mL/hr and 90.0 mL/hr.
The Ipump operates using a linear peristaltic pumping mechanism and a DC motor with either a 9 volt alkaline battery or an AC adapter power source. The pump's features include an air sensor, an upstream occlusion detector and a down stream occlusion detector. The disposables for the Ipump™ Pain Management System consist of numerous custom tubing sets and flexible non-vented reservoir bags of up to 500 ml.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Electrical safety: Ipump was evaluated against the applicable requirements contained within IEC 60601-1 with successful results.
Electromagnetic Compatibility (EMC): The Ipump characteristics were evaluated against the applicable requirements contained within IEC 60601-1-2 second edition, augmented by the IEC 60601-2-24 clause 36 requirements, with sucessful results.
The Ipump performance during environmental testing, such as the The performance characteristics of the Ipump were evaluated against the applicable requirements contained within IEC 60601-2-24 with successful results.
Software testing was performed at the system level, unit level and integration level to demonstrate that the design changes satisfy the various Ipump™ Pain Management System requirements. Regression testing was performed to demonstrate that the design changes have not adversely affected those parts of the system not changed. The data recorded from the software testing has been determined to meet its acceptance criteria.
A comparison of the predicate device with the subject Ipump shows that the same components come into direct and indirect contact with the patient. These components are processed by the same manufacturing methods, and are of the same patient contact duration and material type. Biocompatibility requirements are therefore satisfied.
The data supports the subject Ipump has shown equivalent characteristics in its electrical safety, EMC, environmental, performance, software and biocompatibility testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5725 Infusion pump.
(a)
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.(b)
Classification. Class II (performance standards).
0
KOS2973
.
510(k) SUMMARY
:
JAN 2 5 2007
| Date | 19 October 2005 |
|---|---|
| Owner | Baxter Healthcare Corporation |
| Contact Person | John Manarik |
| 1620 Waukegan Road | |
| McGaw Park, IL 60085 | |
| Manager, Global Regulatory Affairs | |
| Telephone: (847) 473-6294 | |
| Fax: (847) 785-5116 | |
| E-mail: john_manarik@baxter.com | |
| Device name | IpumpTM Pain Management System |
| Common name | External Infusion Pump |
| Classification name | Infusion Pump (21 CFR 880.5725, Product Code 80 FRN) |
| Predicate Device | IpumpTM Pain Management System, K993387 cleared on |
| 01 November 1999 |
:
:
1
Device Description
The Ipump™ Pain Management System is an external infusion pump offering three different modalities for the delivery of medications to a patient. The modalities include Patient Controlled Analgesia (PCA) mode, PCA plus basal (continuous) mode, and continuous mode.
PCA mode delivers a bolus of a medication at a fixed rate of 90 mL/hr at patient-controlled time intervals by pressing the PCA button. PCA plus basal (continuous) mode delivers medication at 90 mL/hr during patient-controlled time intervals in conjunction with the desired basal delivery of between 0.1 mL/hr and 19.9 mL/hr between PCA doses. In continuous mode, the pump delivers medication continuously at a rate adjustable between 0.1 mL/hr and 90.0 mL/hr.
The Ipump operates using a linear peristaltic pumping mechanism and a DC motor with either a 9 volt alkaline battery or an AC adapter power source. The pump's features include an air sensor, an upstream occlusion detector and a down stream occlusion detector. The disposables for the Ipump™ Pain Management System consist of numerous custom tubing sets and flexible non-vented reservoir bags of up to 500 ml.
Statement of Intended Use
The Ipump™ Pain Management System is indicated 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, and epidural, and for regional (local) analgesia applications.
Technological Characteristics
The subject and predicate devices are similar in operating principle, material composition, energy sources, environmental specifications, performance, dimensional specifications and packaging. A summary of the technological characteristics for the subject and predicate devices follows in Table 1.
KoS2973
2
| Functional Features | Predicate Ipump | Subject Ipump |
|---|---|---|
| Power Sources | ||
| 9 volt battery | included | included |
| 100-120 VAC, 60 Hz | included | included |
| 220-240 VAC, 50 Hz | ||
| Key Features: | ||
| Air sensor | included | included |
| Preventative maintenance alert | included | included |
| Multilanguage interface | included | included |
| Detailed history display and printout capability | included | included |
| Ability to transfer data to another Ipump | included | included |
| Upstream and downstream occlusion detectors | included | included |
| Programmable limits for PCA doses | included | included |
| Record Management: | ||
| Tracking of programming, time and history | included | included |
| Data retained in memory after pump is off | included | included |
| Real time clock | included | included |
| Security | ||
| Key only | included | included |
| Code only | included | included |
| Key plus code | included | included |
| Setting up of the Pump | ||
| PCA cord | included | included |
| May be IV pole mounted | included | included |
| Pumping Mechanism: | ||
| DC motor | included | included |
| Linear peristaltic motion | included | included |
| Display Technology | ||
| Liquid crystal display | included | included |
| Keypad | ||
| Keypad with action keys | included | included |
Table 1. Ipump™ Pain Management System Technological Characteristics Comparison
The technological characteristics of the subject Ipump™ Pain Management System do not raise new questions of safety or effectiveness.
Baxter Confidential
20
Ko52973
3
| Assessment of
Non-clinical Data | A summary and assessment of the non-clinical performance data
relied upon to support substantial equivalence follows: |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Electrical safety: Ipump was evaluated against the applicable
requirements contained within IEC 60601-1 with successful results. |
| | Electromagnetic Compatibility (EMC): The Ipump characteristics
were evaluated against the applicable requirements contained within
IEC 60601-1-2 second edition, augmented by the IEC 60601-2-24
clause 36 requirements, with sucessful results. |
| | The Ipump performance during environmental testing, such as the |
| | The performance characteristics of the Ipump were evaluated
against the applicable requirements contained within
IEC 60601-2-24 with successful results. |
| | Software testing was performed at the system level, unit level and
integration level to demonstrate that the design changes satisfy the
various Ipump™ Pain Management System requirements.
Regression testing was performed to demonstrate that the design
changes have not adversely affected those parts of the system not
changed. The data recorded from the software testing has been
determined to meet its acceptance criteria. |
| | A comparison of the predicate device with the subject Ipump shows
that the same components come into direct and indirect contact with
the patient. These components are processed by the same
manufacturing methods, and are of the same patient contact duration
and material type. Biocompatibility requirements are therefore
satisfied. |
| | The data supports the subject Ipump has shown equivalent
characteristics in its electrical safety, EMC, environmental,
performance, software and biocompatibility testing. |
| Conclusion | Baxter Healthcare Corporation concludes that the results obtained
during non-clinical performance testing for Ipump™ Pain
Management System supports a determination of substantial
equivalence. |
:
21
Kos 2973
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The eagle is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES, U.S.A." in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Baxter Healthcare Corporation C/O Ms. Barbara K. Barbeau Senior Director, Global Regulatory Affairs Global Regulatory Affairs 1620 Waukegan Road McGaw Park, Illinois 60085-6730
14 2 5 1007
Re: K052973
Trade/Device Name: Ipump™ Pain Management System Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: November 13, 2006 Received: November 15, 2006
Dear Ms. Barbeau:
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.
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
5
Page 2 -- Ms. Barbeau
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 (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/industry/support/index.html.
Sincerely yours,
Chih-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
6
Indications for Use
510(k) Number (if known): ____ K 052973
Device Name: Jpump™ Pain Management System
Indications For Use:
The Ipump™ Pain Management system is indicated 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, and epidural, and for regional (local) analgesia applications.
Prescription Use X (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)
KoS2973
Baxter Confidential