(8 days)
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.
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.
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.
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.
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).
Standard Procedure Kits will have an optional fill port cover, inhibiting access to the fill port once the cover is attached.
This document, K033039, is a 510(k) summary for modifications to the McKinley Accufuser, Accufuser Plus & Standard Procedure Kit. It describes changes to an existing device, rather than a new device requiring extensive performance studies. Therefore, much of the requested information regarding acceptance criteria, study designs, sample sizes, and ground truth establishment, which are typical for studies validating AI/ML-based devices or devices requiring clinical performance data, is not present or applicable here.
The core of this submission is to demonstrate "substantial equivalence" of the modified device to a legally marketed predicate device (K023098) by ensuring the modifications do not raise new safety and efficacy concerns.
Here's a breakdown of the available information in response to your request, indicating where information is not applicable (N/A) or not provided in the document:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) for modifications to an existing device, specific quantitative "acceptance criteria" and "reported device performance" in the context of a new efficacy study are not presented in the same way as for a novel device. The primary "acceptance criteria" for this type of submission is demonstrating that the modifications do not negatively impact the safety and effectiveness of the device compared to the predicate.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Modifications do not raise new safety and efficacy concerns. | "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." |
| Modified device is substantially equivalent to the predicate device. | "The Accufuser Plus, and Standard Procedure Kit is substantially equivalent to the named predicate device (K023098)." |
2. Sample Size Used for the Test Set and the Data Provenance
This document does not describe a "test set" in the context of clinical data for performance evaluation. The evaluation is based on engineering and design changes and their impact on the existing device's safety and efficacy.
- Sample size used for the test set: Not applicable (N/A) – No clinical test set described for performance evaluation.
- Data provenance: Not applicable (N/A) – No clinical data in the traditional sense is presented for performance evaluation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable (N/A). This document does not refer to a test set requiring expert-established ground truth for performance evaluation. The "ground truth" here is the established safety and efficacy of the predicate device.
4. Adjudication Method for the Test Set
Not applicable (N/A). No test set requiring expert adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable (N/A). This device is an elastomeric infusion pump system and does not involve AI or human readers in its function.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable (N/A). This device does not involve an algorithm.
7. The Type of Ground Truth Used
The "ground truth" in this context is the established safety and efficacy of the predicate device (K023098). The modifications are assessed against this existing baseline. No new clinical outcomes data or pathology results are explicitly generated to establish a new ground truth for the modified components themselves in this summary.
8. The Sample Size for the Training Set
Not applicable (N/A). There is no "training set" as this is not an AI/ML device or a device requiring a training phase with clinical data.
9. How the Ground Truth for the Training Set Was Established
Not applicable (N/A). There is no "training set" or corresponding ground truth establishment process described in the document.
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Image /page/0/Picture/0 description: The image shows the word "McKinley" in a serif font, with a stylized mountain logo above it. The mountain logo is black and appears to be split into two sections. The logo is simple and geometric, and the text is clean and easy to read.
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.4080 Youngfield StreetWheat Ridge, CO 80033 |
| Phone: | 303-420-9569 |
| Fax: | 303-420-8585 |
| Contact for questions: | Andy Lamborne |
| Trade Name: | Accufuser; Accufuser Plus; StandardProcedure 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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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of a stylized eagle or bird with three human profiles incorporated into its design. The logo is black and white.
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 (301) 594-4618. 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/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
§ 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).