(8 days)
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No
The document describes modifications to an existing infusion pump system, focusing on accessories like catheters and introducer needles. There is no mention of AI or ML in the intended use, device description, or any other section.
Yes
The device is intended for pain management and delivery of medication, which are therapeutic uses.
No
Explanation: The device is an infusion system designed for the delivery of medication for pain management and regional anesthesia, not for diagnosing medical conditions.
No
The device description explicitly details modifications to physical components (catheters, introducer needles, fill port cover) of an existing infusion system, indicating it is a hardware-based device with physical accessories, not software only.
Based on the provided text, the Accufuser and Accufuser Plus systems are not IVD (In Vitro Diagnostic) devices.
Here's why:
- Intended Use: The intended use clearly describes the delivery of medication and fluids into the body (intravenous, subcutaneous, intra-arterial, epidural, surgical wound sites, etc.). This is an in vivo application, meaning it's used within a living organism.
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, tissue) taken from the body to provide information about a person's health. The Accufuser systems do not perform this function.
- Device Description: The device description focuses on the mechanics of infusion and the accessories used for delivery into the body. There is no mention of analyzing biological samples.
Therefore, the Accufuser and Accufuser Plus systems are medical devices for infusion, but they do not fit the definition of an In Vitro Diagnostic device.
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.
Product codes (comma separated list FDA assigned to the subject device)
MEB
Device Description
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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
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 Street | |
| Wheat Ridge, CO 80033 | |
| Phone: | 303-420-9569 |
| Fax: | 303-420-8585 |
| Contact for questions: | Andy Lamborne |
| Trade Name: | Accufuser; Accufuser Plus; Standard |
| 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.
1
- 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