MODIFICATION TO: ACCUFUSER, ACCUFUSER PLUS, STANDARD PROCEDURE KITS

K033039 · Mckinley, Inc. · MEB · Oct 7, 2003 · General Hospital

Device Facts

• Record ID: K033039
• Device Name: MODIFICATION TO: ACCUFUSER, ACCUFUSER PLUS, STANDARD PROCEDURE KITS
• Applicant: Mckinley, Inc.
• Product Code: MEB · General Hospital
• Decision Date: Oct 7, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Accufuser and Accufuser Plus are elastomeric infusion pumps designed for continuous or intermittent medication delivery. The system utilizes an elastomeric reservoir to provide pressure for fluid infusion. The Accufuser Plus includes an integrated bolus button for patient-controlled delivery. Modifications include optional multi-port catheters with longer fenestrated lengths, fixed-hub catheters, break-away introducer needles, and fill port covers. The device is used in hospitals, homes, or alternative care sites by clinicians or patients for pain management and regional anesthesia. The system provides controlled medication delivery to surgical sites or near nerves, aiding in postoperative recovery and pain control.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Elastomeric infusion pump; mechanical flow control via reservoir pressure. Accessories include multi-port fenestrated catheters, fixed-hub catheters, break-away introducer needles, and fill port covers. Ambulatory form factor. Non-electronic, non-software device.

Indications for Use

Indicated for patients requiring continuous or intermittent infusion of medications, including local anesthetics or narcotics, for pain management or regional anesthesia in preoperative, perioperative, and postoperative settings. Suitable for intravenous, percutaneous, subcutaneous, intra-arterial, epidural, perineural, and intra-operative administration. Applicable for ambulatory use in 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

• Accufuser/Accufuser Plus system (K023098)

Submission Summary (Full Text)

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K033039

McKinley, Inc. 4080 Youngfield Street Wheat Ridge, CO 80033 USA 303.420.9569 303.420.8585 Fax

OCT = 7 2003

## 510(k) Summary-Special 510(k) for Modifications to the McKinley Accufuser, Accufuser Plus & Standard Procedure Kit

| Date Prepared: | 26 September 2003 |
|-----------------------------|-------------------------------------------------------------------|
| Submitter: | McKinley, Inc.<br>4080 Youngfield Street<br>Wheat Ridge, CO 80033 |
| Phone: | 303-420-9569 |
| Fax: | 303-420-8585 |
| Contact for questions: | Andy Lamborne |
| Trade Name: | Accufuser; Accufuser Plus; Standard<br>Procedure Kit |
| Common Name: | Elastomeric Infusion Pump Kit |
| Classification Name: | Elastomeric Infusion Pump |
| Classification Panel: | General Hospital and Personal Use Device |
| Regulation Number: | Class II, 880.5725 |
| Panel: | 80 |
| Procode: | MEB – Elastomeric Infusion Pump |
| Original cleared 510(k): | K023098 |
| Establishment Registration: | 1723533 |
| Owner/Operator Number: | 9027257 |

## 5. Summary of Safety and Effectiveness of the Accufuser System

- 5.1 This submission is intended to notify the Food and Drug Administration that McKinley, Inc. intends to market a modification to an existing device (K023098) called the Accufuser/Accufuser Plus system. The modification to the existing device is the addition of procedure kits containing different accessories.

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- 5.2 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.

- Summary of the Modification 5.3
- 5.3.1 Standard Procedure Kits will have an optional multi-port catheter with a longer fenestrated length for wetting a larger area. The current kits have a standard epidural catheter with a small number of fenestrations over a short length.
- 5.3.2 Standard Procedure Kits will have an optional fixed-hub catheter. The current kits have catheters that utilize a Tuohy-Borst adapter or alligator clip-style adapter.
- 5.3.3 Standard Procedure Kits will have an optional break-away introducer needle, allowing use of a fixed-hub catheter. The current kits have a non-break-away introducer needle that requires use of a catheter with separate connector (i.e., Tuohy-Borst or alligator clip style adapter).
- 5.3.4 Standard Procedure Kits will have an optional fill port cover, inhibiting access to the fill port once the cover is attached.
- 5.4 Conclusion: The new optional accessories for the Standard Procedure Kit do not raise any new safety and efficacy concerns when compared to the original Accufuser device that is already legally marketed. The Accufuser Plus, and Standard Procedure Kit is substantially equivalent to the named predicate device (K023098).

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 7 2003

Mr. Andrew N. Lamborne Director of Engineering McKinley Medical 4080 Youngfield Street Wheat Ridge, Colorado 80033

Re: K033039

Trade/Device Name: Accufuser, Accufuser Plus, Standard Procedure Kits Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: MEB Dated: September 26, 2003 Received: September 29, 2003

Dear Mr. Lamborne:

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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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 [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 Division 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/dsma/dsmamain.html

Sincerely vours.

Chris L

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

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## 3. Indications for Use Statement

Applicant: McKinley, Inc.

510(k) Number (if known):_ KO33039

Device Name: Accufuser; Accufuser Plus, Standard Procedure Kits

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.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Patricia Cuente

(Optional Format 3-10-98)

510(k) Number: K033039