ACCUFUSER, ACCUFUSER PLUS, STANDARD PROCEDURE KIT, ACCUFUSER INFUSION KIT
Device Facts
| Record ID | K023098 |
|---|---|
| Device Name | ACCUFUSER, ACCUFUSER PLUS, STANDARD PROCEDURE KIT, ACCUFUSER INFUSION KIT |
| Applicant | Mckinley Infuser |
| Product Code | MEB · General Hospital |
| Decision Date | Dec 9, 2002 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.5725 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The Accufuser and Accufuser Plus systems are intended for general infusion use. Routes of infusion include intravenous, percutaneous, subcutaneous, intra-arterial and epidural, and into the intra-operative (soft tissue / body cavity) site. The Accufuser Plus is also intended for patient-controlled infusion using the integrated bolus button. General infusion uses include pain management for preoperative and postoperative and postoperative surgery. The Accufuser and Accufuser Plus systems are also intended 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 may be intraoperative, perineural or percutaneous. The Accufuser/Accufuser Plus system is suitable for use as an ambulatory device and is intended for use in the hospital, home environment or alternative care sites.
Device Story
Elastomeric infusion pump system; utilizes silicone balloon as both fluid reservoir and energy source; provides continuous medication delivery via fixed-rate administration set. Accufuser Plus includes Patient Medication Control Module (PCM) with bolus button for patient-controlled delivery of fixed volumes with defined lockout intervals. Used in hospital, home, or alternative care sites; operated by clinicians or patients. Flow control achieved via glass orifice or PVC tubing. System supports ambulatory use. Output is continuous or intermittent medication infusion; assists in pain management and regional anesthesia. Standard Procedure Kit includes catheters, needles, syringes, and dressings. No electronic components; no fluid runaway risk.
Clinical Evidence
Bench testing only. No clinical data provided. Performance verified through flow rate accuracy testing at various reservoir volumes, operating pressures, and temperature conditions. Materials conform to ISO 10993.
Technological Characteristics
Elastomeric infusion pump; silicone balloon energy source. Flow control via glass orifice or PVC tubing. Materials: PET-G, ABS, polypropylene, silicone, PVC, polycarbonate, cellulose acetate, PTFE, acrylic. DEHP-free, latex-free. 1.2-micron air-eliminating in-line filter. ETO sterilization. Flow rates: 0.5-10.0 ml/hr. Reservoir: 60-550 ml. Bolus: 0.5-2.0 ml. Lockout: 6-60 min.
Indications for Use
Indicated for patients requiring general infusion or regional anesthesia/pain management (preoperative, perioperative, postoperative). Suitable for intravenous, percutaneous, subcutaneous, intra-arterial, epidural, perineural, or intra-operative administration of medications like local anesthetics or narcotics. Applicable for hospital, home, or 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.
Predicate Devices
- Breg Corporation, Pain Care 3000 and 3200, and accessory Kit (K013928)
- Stryker Pain Pump and Accessory Kit (K014091)
- I-Flow, Infusion Pump and Administration Set (K020862)
Reference Devices
- Accufuser and Accufuser Plus (K003915)
Submission Summary (Full Text)
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K0J309f
# Section D
Premarket Notification – 510(k) Summary of Safety and Effectiveness for Accufuser, Accufuser Plus and Standard Procedure Kit
DEC 0 9 2002
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### Premarket Notification - 510(k) Summary of Safety and Effectiveness for Accufuser, Accufuser Plus and Standard Procedure Kit
September 17, 2002 Date Prepared:
Trade Name: Accufuser; Accufuser Plus; Standard Procedure Kit
Common Name: Elastomeric Infusion Pump Kit
Classification Name: Pump, Infusion, Elastomeric
Classification Panel: General Hospital and Personal Use Device
Device Classification Regulation Number: 880.5725, Class II
Panel: 80
Procode: MEB
Existing Device Cleared 510(k): K003915, Accufuser and Accufuser Plus
Predicate devices demonstrating substantial equivalence include the following.
- K013928, Breg Corporation, Pain Care 3000 and 3200, and accessory Kit. .
- K014091, Stryker Pain Pump and Accessory Kit. .
- K020862, I-Flow, Infusion Pump and Administration Set. ●
## Submitted by:
McKinley Infuser, LLC 631 Howard, #202 San Francisco, CA 94105 USA Phone: 415-543-2196 Contact for questions: John Chappell, RAC Establishment Registration Number: 3003468679 Owner/Operator Number: 9047569
This submission is intended to notify the Food and Drug Administration that McKinley Infuser, LLC intends to market a modification to an existing device (K003915) called the Accufuser/Accufuser Plus and Standard Procedure Kit. Modifications to the existing device include two new indications for use, expansion of the bolus delivery range, addition of two bolus lockout times, addition of one reservoir volume size through combining two reservoirs, addition of flow rates for bolus devices and addition of a standard procedure kit.
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The Accufuser/Accufuser Plus system and its predicate device (K020862) are intended for use as follows.
The Accufuser and Accufuser Plus systems are intended for general infusion use. Routes of infusion include intravenous, percutaneous, subcutaneous, intra-arterial and epidural, and into the intra-operative (soft tissue / body cavity) site. The Accufuser Plus is also intended for patient-controlled infusion using the integrated bolus button. General infusion uses include pain management for preoperative, perioperative and postoperative surgery.
The Accufuser and Accufuser Plus systems are also intended 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 may be intraoperative, perineural or percutaneous.
The Accufuser/Accufuser Plus system is suitable for use as an ambulatory device and is intended for use in the hospital. home environment or alternative care sites.
Description of the Accufuser System
The Accufuser/Accufuser Plus system consists of a pump and an integrated administration set. The pump is a continuous silicone balloon type. The pump provides continuous fluid delivery with an attached, fixed rate administration set. The pumps are supplied as fixed flow rates. A silicone balloon is used as both the fluid reservoir of the device and the pressure (energy) source.
The Accufuser/Accufuser Plus pump and administration set are intended for single patient use.
The Accufuser Plus is the Accufuser with the addition of a Patient Medication Control Module (PCM). The PCM allows the patient to administer a bolus of a fixed volume with a fixed lockout (re-fill) time. The PCM in integrated into the administration set with a bolus button that allows the patient controlled administration of medication as needed.
The Standard Procedure Kit is substantially equivalent to the predicate devices. The kit includes various kit components such as catheter, needle, syringe, y adapter, dressing, tape, gauze and carry case.
Device Specifications and Safety Functions
The Accufuser/Accufuser Plus system has fill volumes and flow rates substantially equivalent to the pumps of the named predicate devices.
The Accufuser/Accufuser pumps and the identified predicate device use either a glass orifice or PVC tubing to control the flow rate.
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The Accufuser/Accufuser Plus provides a fixed flow and is not subject to fluid runaway conditions similar to that of some electronic pumps.
All fluid path materials of the Accufuser/Accufuser Plus system are in conformance with ISO 10993 Part 1.
There are currently no approved performance standards established for elastomeric infusion pumps under Section 514 of the Food, Drug and Cosmetic Act.
Packaging is suitable for ETO sterilization.
ETO is the validated sterilization method.
Product Configuration:
- o Reservoir volume range is from 60 ml to 550 ml.
- Flow rate range is 0.5 ml/hr to 10.0 ml/hr. o
- Bolus levels are 0.5 ml, 1.0 ml and 2.0 ml. o
- o Lockout times range from 6 minutes to 60 minutes and include increments of 6, 8, 15, 30 and 60 minutes.
| Materials: | PET-G, ABS, polypropylene, silicone, PVC, polycarbonate,<br>cellulose acetate, PTFE, and acrylic. DEHP-Free.<br>Plasticizer used is TOTM, Tri-Octyl Trimellitate. Latex-<br>Free. |
|------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Filter: | 1.2 Micron, air-eliminating, in-line filter |
| System Accuracy | Reservoir Volume | Accuracy |
|------------------------|----------------------------------------------------------------------------------------------------|---------------------------------------------------------|
| | 60 ml | +/- 10% of nominal flow rate at 95% confidence interval |
| | 100 ml | +/- 10% of nominal flow rate at 95% confidence interval |
| | 275 ml | +/- 15% of nominal flow rate at 95% confidence interval |
| | 550 ml | +/- 15% of nominal flow rate at 95% confidence interval |
| Operating Pressure | 5 to 6 psi | |
| System Residual Volume | < 3 ml (includes tubing and reservoir) | |
| Operating Temperature: | The Accufuser and Accufuser Plus systems are calibrated to deliver solution at the labeled nominal | |
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| | flow rate when the temperature of the infusate in the<br>flow restrictor (distal end) is 32° C / 89.6°F (normal<br>skin temperature). Flow rate increases<br>approximately 1% per 1°F / 0.56°C increase in<br>temperature. |
|------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Fluid Viscosity: | The Accufuser and Accufuser Plus systems are calibrated<br>using 5% Dextrose in Water (D5W) as the infusate. Flow<br>rate increases as fluid viscosity decreases. (E.g., Using<br>sterile water as diluent will increase the flow rate by<br>approximately 10%.) |
| Head Height: | The Accufuser and Accufuser Plus systems are calibrated<br>with zero head height. Increased head height will cause<br>increased flow rate. (E.g., +43 cm / +17" of head height<br>will increase flow rate by approximately 12%.) |
#### Conclusion:
The Accufuser/Accufuser Plus and Standard Procedure Kit does not raise any new safety and efficacy concerns when compared to similar devices already legally marketed. The Accufuser/Accufuser Plus system and accessory Standard Procedure Kit is substantially equivalent to the named predicate devices.
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### DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name encircling a symbol. The symbol features three stylized human profiles facing right, stacked one behind the other. The profiles are rendered in a thick, curved line, giving a sense of depth and unity.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 0 9 2002
Mr. John Chappell Regulatory Affairs McKinley Infuser, LLC 631 Howard Street, Suite 202 San Francisco, California 94105
Re: K023098
Trade/Device Name: Accufuser, Accufuser Plus, Standard Procedure Kit Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: MEB Dated: September 17, 2002 Received: September 18, 2002
Dear Mr. Chappell:
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 mav, 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. Chappell
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 (OS) 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 (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 yours,
Timothy A. Ulatowski
Timothy A. Ulatowski 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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Page 1 of 1
Applicant: McKinley Infuser, LLC
510(k) Number (if known): _| (023099
Device Name: Accufuser, Accufuser Plus, Standard Procedure Kit
Indications for Use:
The Accufuser and Accufuser Plus systems are intended for general infusion use. Routes of infusion include intravenous, percutaneous, subcutaneous, intra-arterial and epidural, and into the intra-operative (soft tissue / body cavity) site. The Accufuser Plus is also intended for patient-controlled infusion using the integrated bolus button. General infusion uses include pain management for preoperative and postoperative and postoperative surgery.
The Accufuser and Accufuser Plus systems are also intended 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 may be intraoperative, perineural or percutaneous.
The Accufuser/Accufuser Plus system is suitable for use as an ambulatory device and is intended for use in the hospital, home environment or alternative care sites.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Williain
(Optional Format 3-10-98)
Division Sian-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number. K933070
