(259 days)
Not Found
No
The device description and intended use focus on mechanical and fluid dynamics principles for drug delivery, with no mention of AI/ML terms or functionalities.
Yes.
The device is intended for the infusion of local anesthetic for pain relief, which is a therapeutic purpose.
No
Explanation: The device is described as an "Infusion Pump" whose intended use is "for the infusion of a local anesthetic into a surgical site or body cavity, post-operatively, for the relief of pain." This indicates a therapeutic rather than a diagnostic function.
No
The device description clearly outlines physical components such as elastomeric chambers, plastic housing, a one-way check valve, a filter, an outflow chamber, and an internal pressure regulator, indicating it is a hardware device.
Based on the provided information, the Alpha Infusion Pump is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the infusion of a local anesthetic into a surgical site or body cavity for pain relief. This is a therapeutic application, delivering medication directly to a patient's body.
- Device Description: The device description details a pump mechanism for delivering medication. It does not describe any components or processes for analyzing biological samples (like blood, urine, tissue, etc.) outside of the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Alpha Infusion Pump's function is to deliver medication, which is a treatment, not a diagnostic process.
N/A
Intended Use / Indications for Use
The Alpha Infusion Pump is intended for the infusion of a local anesthetic into a surgical site or body cavity, post-operatively. for the relief of pain. Medication is intended to be delivered through a catheter containing a flow restriction element. The Alpha Infusion Pump is intended for use in the hospital or by an ambulatory patient.
Product codes
MEB
Device Description
The Alpha Infusion Pump consists of two elastomeric chambers, which pressurize the medication. These chambers are protected in a plastic housing. A one-way check valve is provided to fill these chambers. Medication delivered from the elastomeric chambers is filtered through a 5-micron filter and held in an outflow chamber. An internal pressure regulator maintains the pressure of the medication in the outflow chamber at 6 psi in order to provide a constant flow rate through each infusion catheter inserted through the septum into the outflow chamber of the pump.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
surgical site or body cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospital or by an ambulatory patient.
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)
Not Found
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
Image /page/0/Picture/0 description: The image shows a logo for "Advanced Infusion". The logo features a stylized letter "A" with an orbit-like shape encircling it. Below the symbol, the words "Advanced" and "Infusion" are printed in a simple, sans-serif font, with "Infusion" in a smaller font size.
466 W. Arrow Hwy. • Unit H • San Dimas, California 91773 909.394.4916 • fax: 909.305.0895 www.advancedinfusion.com
K07,532
510(k) SUMMARY – Safety and Effectiveness
Alpha Infusion Pump
| Owner: | Advanced Infusion, Inc.
920 E. University Drive. Suite D202
Tempe, Arizona 85281
(480) 768-9747
(480) 894-5288 fax | FEB | 19 2008 |
|-----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|---------|
| Contact: | James Christensen
Vice President Operations
(909) 394-4916 | | |
| Date Prepared: | February 12, 2008 | | |
| Trade Name:
Common Name:
Classification Name: | Alpha Infusion Pump
Infusion Pump
Elastomeric Infusion Pump
(21 CFR 880.5725, Product Code MEB) | | |
| Predicate Devices: | K021964 - Alpha Infusion Pump and Catheters
K003915 - Accufuser and Accufuser Plus | | |
| Device Description: | The Alpha Infusion Pump consists of two elastomeric chambers,
which pressurize the medication. These chambers are protected
in a plastic housing. A one-way check valve is provided to fill
these chambers. Medication delivered from the elastomeric
chambers is filtered through a 5-micron filter and held in an
outflow chamber. An internal pressure regulator maintains the
pressure of the medication in the outflow chamber at 6 psi in
order to provide a constant flow rate through each infusion
catheter inserted through the septum into the outflow chamber of
the pump. | | |
| Intended Use: | The Alpha Infusion Pump is intended for the infusion of a local
anesthetic into a surgical site or body cavity, post-operatively. for
the relief of pain. Medication is intended to be delivered through
a catheter containing a flow restriction element. The Alpha
Infusion Pump is intended for use in the hospital or by an
ambulatory patient. | | Page 1 |
1
Image /page/1/Picture/0 description: The image shows a logo with the letter A at the top. A ring encircles the letter A. Below the letter A, the words "Advanced Infusion" are written in a sans-serif font. The word "Advanced" is on the top line, and the word "Infusion" is on the bottom line.
466 W. Arrow Hwy. • Unit H • San Dimas, California 91773 909.394.4916 • fax: 909.305.0895 www.advancedinfusion.com
510(k) SUMMARY – Safety and Effectiveness
| Technological
Comparison: | The elastomeric chamber material for the Alpha Infusion Pump is
being changed from medical grade polyisoprene to medical grade
silicone. The silicone elastomer chosen has substantially the
same material properties as the previous used polyisoprene
elastomer. |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Silicone is already used elsewhere in the pump for the septum, in
the pressure regulator, and in the check valve. Polyisoprene will
no longer be used in the Alpha Infusion Pump. Silicone
elastomer chambers are also used in Accufuser and Accufuser
Plus infusion pumps marketed by McKinley. |
| Conclusion: | The Alpha Infusion Pump with the silicone elastomer chambers
is substantially equivalent to the current Alpha Infusion Pump
with the polyisoprene chambers. |
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure.
Public Health Service
FEB 19 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. James Christensen Vice President Operations Advanced Infusion, Incorporated 466 West Arrow Highway, Unit H San Dimas, California 91773
Re: K071532
Trade/Device Name: Alpha Infusion Pump Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: MEB Dated: February 6, 2008 Received: February 7, 2008
Dear Mr. Christensen:
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.
3
Page 2 - Mr. Christensen
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 practicerequirements 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,
Chiu 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
4
4. INDICATIONS FOR USE
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
The Alpha Infusion Pump is intended for the infusion of a local anesthetic into a surgical site or body cavity, post-operatively, for the relief of pain. Medication is intended to be delivered through a catheter containing a flow restriction element. The Alpha Infusion Pump is intended for use in the hospital or by an ambulatory patient.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (Part 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)
E. R. Ziemer, M.D.
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
Page 1 of ____________________________________________________________________________________________________________________________________________________________________