MPS ACACIA MEDFLO ELASTOMERIC PUMP

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

Intended 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.

Predicate Devices

• MedFlo LI and LI-KVO (K011117)
• MPS Acacia Pain Kit (K003476)
• ON-Q, PainBuster, C-Bloc, Eclipse, Easypump, Homepump (K020251)
• 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: [phone]<br>Fax: [phone] |
|-----------------------|-------------------------------------------------------------------------------------------------|
| 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 [phone]. 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 [phone] or [phone] 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

:
200
Stem C)
of Anesthesiology, General Hosp
caon Control, Dental DevicGE
8052451

umber. R05275

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