(20 days)
No
The device description focuses on the mechanical properties of an elastomeric pump and flow restrictor to control infusion. There is no mention of AI, ML, or any computational algorithms for decision-making or control.
Yes
The device is intended for delivering medication for pain management and regional anesthesia, which are therapeutic interventions.
No
Explanation: The device is intended for general infusion and delivery of medication for pain management, wound care, and regional anesthesia. It is a drug delivery device, not a diagnostic one.
No
The device description clearly outlines physical components like an elastomeric balloon medication reservoir, administration set, flow restrictor, and bolus device, indicating it is a hardware-based medical device.
Based on the provided information, the Accufuser and Accufuser Plus systems are not In Vitro Diagnostic (IVD) devices.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Accufuser Function: The Accufuser and Accufuser Plus systems are designed to infuse medication directly into the body through various routes (intravenous, subcutaneous, etc.). They are drug delivery systems, not diagnostic tools that analyze biological samples.
The intended use and device description clearly indicate that these systems are for administering medication for pain management and regional anesthesia, which is a therapeutic function, not a diagnostic one.
N/A
Intended Use / 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, 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.
The Accufuser and Accufuser Plus systems are intended 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.
Product codes
MEB
Device Description
The Accufuser device consists of an elastomeric balloon medication reservoir with a flow rate-controlling administration set. The pressure that pumps the fluid is derived from the strain energy of the elastomeric membrane that is forced to expand when the pump is filled. The administration set includes a flow restrictor component with controlled internal diameter and length. The flow rate at which medication is dispensed from the system is a function of the pressure applied to the medication and the dimensions of the flow restrictor component. The medication may be dispensed from the system continuously and/or intermittently.
The size of the reservoir and the amount of flow restriction are determined to yield a variety of product codes with differing infusion volumes and flow rates. The physician variety of product on thow rate and reservoir size based on the individual patient needs.
Administration sets may incorporate a bolus feature, which may be used alone or in conjunction with basal (continuous) flow. The bolus device consists of a dosage reservoir that is filled when activated manually. After the bolus device has been rctivated, the bolus volume is infused at a controlled flow rate. The bolus device is integrated into the administration set and allows patient-controlled administration of medication as needed.
A procedure kit option provides various components that facilitate setup and use of the Accufuser system.
The Accufuser system is intended for single patient use.
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
hospital, home environment or alternative care sites.
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
4080 Youngfield Street Wheat Ridge. CO 80033 USA 303.420.3569 Fax: 303 420.8585
Image /page/0/Picture/3 description: The image shows two geometric shapes, one on the left and one on the right, separated by a white space. The shape on the left is a solid black triangle with a flat bottom. The shape on the right is a distorted polygon with a textured, grainy appearance, also in black.
APR 1 4 2005
McKinley San Salar Sales Banks
050770
510(k) Summary
Traditional 510(k) for Modifications to the McKinley Accufuser, Accufuser Plus, and Standard Procedure Kit
| Date Prepared: | March 23, 2005 |
|---|---|
| Submitted by & 510(k) Owner: | McKinley Medical, LLC |
| 4080 Youngfield Street | |
| Wheat Ridge, CO 80033 | |
| 303-420-9569 | |
| Fax: 720-258-0127 | |
| Contact for questions: | Ralph Cooey |
| 303-420-9569 x204 | |
| Fax: 720-258-0127 | |
| rcooey@mckinleymed.com | |
| Establishment Registration: | 1723533 |
| Owner/Operator Number: | 9027257 |
| Trade Name: | Accufuser, Accufuser Plus, and Standard Procedure |
| Kit | |
| Common Name: | Elastomeric Infusion Pump System & Kit |
| Classification Name: | Elastomeric Infusion Pump |
| Classification Panel: | 80 - General Hospital and Personal Use Device |
| Regulation Number: | Class II, 880.5725 |
| Procode: | MEB |
| Original and previously | |
| cleared 510(k)s: | K003915, K023098, K033039 |
1
Summary of Safety and Effectiveness for the Accufuser, Accufuser Plus and Standard Procedure Kit
This submission is intended to notify the Food and Drug Administration that McKinley Medical I.L.C intends to market a modification to an existing device (K033039) called the Accufuser. Accufuser Plus and Standard Procedure Kit.
The modifications to the existing device consist of an addition of an indication for use.
This device was previously cleared per 510(k)s K003915, K023098 and K033039.
Supporting predicate devices demonstrating substantial equivalence is McKinley's beeLINE system & standard procedure kit (K042228) and the I-Flow Elastomeric Pump (K040337).
The cleared indications for use for the Accufuser/Accufuser Plus system are 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.
The added indication for use is as follows:
The Accufuser and Accufuser Plus systems are intended 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.
Summary Description of the Accufuser System
The Accufuser device consists of an elastomeric balloon medication reservoir with a flow rate-controlling administration set. The pressure that pumps the fluid is derived from the strain energy of the elastomeric membrane that is forced to expand when the pump is filled. The administration set includes a flow restrictor component with controlled internal diameter and length. The flow rate at which medication is dispensed from the system is a function of the pressure applied to the medication and the dimensions of the
Traditional 510(k) McKinley Accufuser/ Accufuser Plus Systems
2
flow restrictor component. The medication may be dispensed from the system continuously and/or intermittently.
The size of the reservoir and the amount of flow restriction are determined to yield a rne sties of product codes with differing infusion volumes and flow rates. The physician variety of product on thow rate and reservoir size based on the individual patient needs.
Administration sets may incorporate a bolus feature, which may be used alone or in conjunction with basal (continuous) flow. The bolus device consists of a dosage reservoir that is filled when activated manually. After the bolus device has been rctivated, the bolus volume is infused at a controlled flow rate. The bolus device is integrated into the administration set and allows patient-controlled administration of medication as needed.
A procedure kit option provides various components that facilitate setup and use of the Accufuser system.
The Accufuser system is intended for single patient use.
Conclusion: The modified Accufuser system does not raise any new safety and efficacy concerns when compared to similar devices that are already legally marketed. The Accufuser, Accufuser Plus, and Standard Procedure Kit are substantially equivalent to the named predicate devices.
3
Image /page/3/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird.
APR 1 4 2005
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Ralph D. Cooey Chief Operations Officer McKinley Medical LLC 4080 Youngfield Street Wheat Ridge, Colorado 80033
Re: K050770
Trade/Device Name: Accufuser; Accufuser Plus; Standard Procedure Kits Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: MEB Dated: March 23, 2005 Received: March 25, 2005
Dear Mr. Cooey:
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. Fxisting major regulations affecting your device can be found in the Codc of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
4
Page 2 - Mr. Cooey
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 (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.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
8. Indications for Use Statement
Applicant: McKinley Medical LLC
510(k) Number (if known):
Accufuser; Accufuser Plus; Standard Procedure Kits
Indications for Use:
Device Name:
The Accufuser and Accufuser Plus systems are intended for general infusion use. Routes of infusion include intravenous, percutaneous, subcutaneous, intra-arterial 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.
The Accufuser and Accufuser Plus systems are intended 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.
Prescription Use XX (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
Cinta O. Ramer
Mision Sion-Off) sion of Anesthesiology, General Hospital, Intection Control, Dental Devices
نَدَبَ ( Number:__ K بَدَدَدَ ( ) 2 +
Traditional 510(k) McKinley Accufuser/ Accufuser Plus Systems