(49 days)
The Polyurethane Infusion Catheters are intended for use with the Alpha Infusion Pump for the infusion of a local anesthetic into a surgical site or body cavity, postoperatively, for the relief of pain. The Polyurethane Infusion Catheters are intended for use in the hospital or by an ambulatory patient.
The Polyurethane Infusion Catheter consists of two design options: Alpha Cath™ open end style catheter: this style catheter consists of a length of tubing which functions as a flow restrictor. The proximal end of the tubing has a stainless needle for insertion into the Alpha Infusion Pump. The distal end of the tubing contains axial slit ports near the distal tip which are designed to infuse medication in case the end of the catheter becomes blocked. Multi Drip® closed end style catheter: this style catheter consists of a length of tubing which functions as a flow restrictor. The proximal end of the tubing has a stainless needle for insertion into the Alpha Infusion Pump. The distal end of the tubing has a series of tiny ports along the distal portion of the catheter which are designed to spread medication along an infusion zone.
The provided FDA 510(k) K061356 for the "Polyurethane Infusion Catheter" does not contain information on acceptance criteria, a specific study proving the device meets acceptance criteria, or any of the detailed analytical performance metrics typically associated with AI/ML device studies. This document is a traditional 510(k) submission for a medical device that predates the widespread adoption and specific regulatory guidance for AI/ML-driven medical devices.
Therefore, most of the requested information regarding acceptance criteria, study design, expert involvement, and AI performance metrics is not applicable or not present in this document.
The primary method of demonstrating safety and effectiveness for this device is substantial equivalence to predicate devices, focusing on material change from PVC to medical-grade polyurethane while maintaining the same intended use.
Here's an explanation based on the provided document:
1. A table of acceptance criteria and the reported device performance
- Not Applicable / Not Provided. This document does not specify quantitative acceptance criteria or performance metrics for the Polyurethane Infusion Catheter in the way an AI/ML device would. The "performance" assessment is qualitative, stating that the device is "substantially equivalent" to existing predicate devices based on its design and material change.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not Applicable / Not Provided. This 510(k) does not describe a clinical performance study with a test set of data. The submission is based on the technological comparison and substantial equivalence to existing devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not Applicable / Not Provided. As no specific performance study or test set is described, there's no mention of experts establishing ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided. No test set or related adjudication method is mentioned.
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 / Not Provided. This is not an AI/ML device, and no MRMC study is described.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable / Not Provided. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable / Not Provided. The concept of "ground truth" as it applies to AI/ML performance evaluation is not relevant to this type of device submission. The device's "truth" is its functional design and material properties, which are compared to legally marketed predicate devices.
8. The sample size for the training set
- Not Applicable / Not Provided. This is not an AI/ML device, and therefore, no training set or machine learning model is utilized.
9. How the ground truth for the training set was established
- Not Applicable / Not Provided. As there is no training set for an AI/ML model, this information is not relevant.
Summary of the K061356 submission:
The submission focuses on a material change for an existing "Infusion Catheter" from PVC to medical-grade polyurethane. The primary argument for market clearance is substantial equivalence to previously cleared predicate devices (K021964, K042246, K003915, K993691). The manufacturer asserts that the new polyurethane catheters are "the same as the current Alpha Cath™ and Multi Drip™ Infusion Catheters except that the catheter material has been changed." The intended use remains identical: "for use with the Alpha Infusion Pump for the infusion of a local anesthetic into a surgical site or body cavity, post-operatively, for the relief of pain."
Safety and effectiveness are presumed based on the predicate devices, with the material change being the primary technical difference addressed by the submission, usually supported by biocompatibility and functional testing data (though specific test results are not detailed in this summary).
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Image /page/0/Picture/1 description: The image shows the logo for Advanced Infusion. The logo features a stylized letter "A" with a circular shape partially surrounding it. Below the "A" is the word "Advanced" in a larger, bolder font, and below that is the word "Infusion" in a smaller font. The logo is in black and white.
920 East University Drive · Suite D202 · Tempe, Arizona 85281 480.768.9747 · fax: 480.894.5288 www.advancedinfusion.com
JUL - 3 2006
510(k) SUMMARY - Safety and Effectiveness
Polyurethane Infusion Catheter
| Owner: |
|---|
| -------- |
Advanced Infusion, Inc. 920 E. University Drive, Suite D202 Tempe, Arizona 85281 (480) 768-9747 (480) 894-5288 fax
Contact:
James Christensen Vice President Operations (909) 394-4916
May 5, 2006
Date Prepared:
Trade Name: Common Name: Classification Name:
Predicate Devices:
Device Description:
Polyurethane Infusion Catheter Infusion Catheter Catheter, Conduction, Anesthetic (21 CFR 868.5120, Product Code BSO)
K021964 - Alpha Infusion Pump and Catheters K042246 - Multi Drip Infusion Catheter K003915 - Accufuser and Accufuser Plus K993691 - ARROWg+ard Blue Plus Antimicrobial Multi Lumen Catheter
The Polyurethane Infusion Catheter consists of two design options:
Alpha Cath™ open end style catheter: this style catheter consists of a length of tubing which functions as a flow restrictor. The proximal end of the tubing has a stainless needle for insertion into the Alpha Infusion Pump. The distal end of the tubing contains axial slit ports near the distal tip which are designed to infuse medication in case the end of the catheter becomes blocked.
Multi Drip® closed end style catheter: this style catheter consists of a length of tubing which functions as a flow restrictor. The proximal end of the tubing has a stainless needle for insertion
Page 1
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Image /page/1/Picture/1 description: The image shows the logo for Advanced Infusion. The logo features a large letter 'A' with a ring orbiting around it. Below the 'A' are the words 'Advanced' and 'Infusion' stacked on top of each other.
920 East University Drive · Suite D202 · Tempe, Arizona 85281 480.768.9747 · fax: 480.894.5288 www.advancedinfusion.com
510(k) SUMMARY - Safety and Effectiveness
into the Alpha Infusion Pump. The distal end of the tubing has a series of tiny ports along the distal portion of the catheter which are designed to spread medication along an infusion zone.
Intended Use:
The Polyurethane Infusion Catheters are intended for use with the Alpha Infusion Pump for the infusion of a local anesthetic into a surgical site or body cavity, post-operatively, for the relief of pain. The Polyurethane Infusion Catheter are intended for use in the hospital or by an ambulatory patient.
Technological Comparison:
The Polyurethane Infusion Catheters are the same as the current Alpha Cath™ and Multi Drip™ Infusion Catheters except that the catheter material has been changed from PVC to medical grade polyurethane.
Conclusion:
The Polyurethane Infusion Catheters are substantially equivalent to the existing Alpha Cath™ and Multi Drip™ Infusion Catheter product lines.
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The text "U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 3 2006
Mr. James Christensen Vice President Operations Advanced Infusion, Incorporated 920 East University Drive, Suite D202 Tempe, Arizona 85281
Re: K061356
Trade/Device Name: Polyurethane Infusion Catheters Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: MEB Dated: May 5. 2006 Received: May 15, 2006
Dear Mr. Christensen:
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 H (PMA), it may be subject to such additional controls. Existing major regulations affecting vour device can be found in the Code of Federal Regulations. Title 21. Parts 800 to 898. In addition. FDA may publish further announcements concerning vour device in the Federal Register.
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Page 2 – Mr. Christensen
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 (240) 276-0115. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CHR 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 vours.
Sulette Y. Michie Crist
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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INDICATIONS FOR USE 4.
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name:
Indications for Use:
The Polyurethane Infusion Catheters are intended for use with the Alpha Infusion Pump for the infusion of a local anesthetic into a surgical site or body cavity, postoperatively, for the relief of pain. The Polyurethane Infusion Catheters are intended for use in the hospital or by an ambulatory patient.
and the same of the same of the same of the same of the same of
Prescription Use______________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (Part 21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Cuturng V. Nutton
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Tot Ane Shesiology, General Dovices n of Ane 3 Toolther Devices
Page I of
KY61356
§ 880.6885 Liquid chemical sterilants/high level disinfectants.
(a)
Identification. A liquid chemical sterilant/high level disinfectant is a germicide that is intended for use as the terminal step in processing critical and semicritical medical devices prior to patient use. Critical devices make contact with normally sterile tissue or body spaces during use. Semicritical devices make contact during use with mucous membranes or nonintact skin.(b)
Classification. Class II (special controls). Guidance on the Content and Format of Premarket Notification (510(k)) Submissions for Liquid Chemical Sterilants/High Level Disinfectants, and user information and training.