(90 days)
The MedAmicus Axia RSN™ is intended to minimize needle stick injuries when used for percutaneous introduction of guidewires or other devices.
The MedAmicus Axia RSN™ is a single use device for percutaneous introduction of guidewires, or similar devices, up to 0.038 inches in diameter. The device is packaged as either sterile single units or as part of a kit. The device is designed with a shield as part of the safety needle mechanism to aid in the prevention of needle stick injuries. The needle of the device is retracted into the shield by pushing the button prior to removal of the device off the guidewire, or other device, and out of the body. After retraction, the shield covers the needle tip. The device is disposed of according to routine procedure in a sharps container.
The provided document is a 510(k) summary for the MedAmicus Axia RSN™ catheter introducer. It does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria.
Here's why and what information is missing based on your request:
Key Takeaway: The document explicitly states: "No new testing was performed for the device as the only change being made is to the Indications for Use. All testing previously summarized in K011085 remains applicable." This means the current submission (K020563) relies on studies conducted for a previous device (K011085) for its safety and effectiveness claims.
Therefore, for your specific questions, the answers are largely "Not applicable" or "Not provided in this document."
Here's a breakdown based on your requested information:
1. A table of acceptance criteria and the reported device performance
- Not provided in this document. The document does not define specific acceptance criteria for performance metrics (e.g., probability of needle stick injury, force required for retraction, number of successful retractions). It focuses on the change in "Indications for Use" for an existing device.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided in this document. Since no new testing was performed, this information would have been part of the previous 510(k) submission (K011085), which is not included here.
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. The device is a physical medical device, not an AI or diagnostic application that typically relies on expert ground truth for evaluating performance. Its "performance" would likely be based on engineering benchmarks, user studies for safety features, and mechanical reliability.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. This is relevant for image-based diagnostic AI, not for a physical medical device like a catheter introducer.
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. This study type is specific to AI-assisted diagnostic tools. The MedAmicus Axia RSN™ is a physical medical device designed to reduce needle stick injuries, not to assist in interpreting diagnostic images.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This question pertains to AI algorithm performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable directly. For a safety needle, "ground truth" would likely relate to objective measurements of safety features (e.g., successful retraction rate, force to retract, accidental stick rate in simulated use). The document does not detail these.
8. The sample size for the training set
- Not applicable. This refers to AI model training data.
9. How the ground truth for the training set was established
- Not applicable. This refers to AI model training data.
In summary: The provided document is a regulatory submission for a change in "Indications for Use" for an already cleared device. It explicitly states that no new testing was performed for this submission. All performance and safety data would be found in the referenced predicate device's 510(k) (K011085). Therefore, the specific details you requested regarding acceptance criteria and performance studies are not present in this document.
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Confidential
KO20563
V. 510(k) Summary
Submitter
MedAmicus, Incorporated 15301 Highway 55 West Minneapolis, MN 55447 Main: 763-15301 Fax: 763-559-0148 email: www.medamicus.com
Date Prepared
February 15, 2002
Trade Name MedAmicus Axia RSN™
TOTAL NITROGEN (N) 15%
Common Name
Catheter Introducer
Predicate Device
MedAmicus Guidewire Introducer Safety Needle, K011085 Boston Scientific Corporation Introducer Sheath and Dilator, K971165
Device Description
The MedAmicus Axia RSN™ is a single use device for percutaneous introduction of guidewires, or similar devices, up to 0.038 inches in diameter. The device is packaged as either sterile single units or as part of a kit. The device is designed with a shield as part of the safety needle mechanism to aid in the prevention of needle stick injuries. The needle of the device is retracted into the shield by pushing the button prior to removal of the device off the guidewire, or other device, and out of the body. After retraction, the shield covers the needle tip. The device is disposed of according to routine procedure in a sharps container.
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Intended Use
The MedAmicus Axia RSN™ is intended to minimize needle stick injuries when used for percutaneous introduction of guidewires, or similar devices.
Technological Characteristics
The device is technologically equivalent to other introducers and safety needles. The safety feature, which forms an integral part of this device, is a retractable needle mechanism that helps to minimize the risk of needle stick injuries.
Summary of Studies
No new testing was performed for the device as the only change being made is to the Indications for Use. All testing previously summarized in K011085 remains applicable.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of an eagle or bird in flight, composed of three curved lines that suggest the shape of a bird's head and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 21 2002
Mr. Dennis S. Madison Vice President, Regulatory Affairs MedAmicus. Inc. 15301 Highway 55 West Minneapolis, MN 55447
K020563 Re:
MedAmicus Axia RSN™M Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter introducer. Regulatory Class: Class II (two) Product Code: 74 DYB Dated: February 18, 2002 Received: February 20, 2002
Dear Mr. Madison:
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.
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
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Page 2 -- Mr. Dennis S. Madison
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 premains 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4586. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 yours,
Dorth Tillh
Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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MedAmicus, Inc.
Indications for Use VI.
510(k) Number (if known): Not Assigned
Device Name: MedAmicus Axia RSNTM
Indications for Use:
The MedAmicus Axia RSN™ is intended to minimize needle stick injuries when used for percutaneous introduction of guidewires or other devices.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_
OR
Over-The-Counter Use_
(Per 21 CFR 801.109)
Division of Cardiovascular & Respiratory Devices
510(k) Number K020563
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).