(10 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 text describes a 510(k) premarket notification for a medical device called the MedAmicus Axia RSN™, a catheter introducer designed to minimize needle stick injuries. However, the document does not contain the specific information required to complete the requested table and answer the study-related questions for an AI/device performance evaluation.
The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (MedAmicus Axia RSN K020563) and highlights a material change in the new device. The "Summary of Studies" section only states that "Design Verification has been completed to ensure that the modified material does not affect the safety and effectiveness of the device." It refers to a Risk Analysis compliant with EN 1441, but does not provide any performance metrics, acceptance criteria, or details about patient data, experts, or ground truth that would be relevant to an AI-powered diagnostic or assistive technology.
Therefore, I cannot generate the requested table and answers based on the provided input. The document is for a traditional medical device (catheter introducer) and not an AI/software as a medical device (SaMD) that would typically have the kind of studies and performance data you are asking for.
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MedAmicus, Inc.
Confidential
1622689
p.112
510(k) Summary V.
Submitter
MedAmicus, Incorporated 15301 Highway 55 West Minneapolis, MN 55447 Main: 763-15301 Fax: 763-559-0148 email: www.medamicus.com
Date Prepared
August 10, 2002
Trade Name MedAmicus Axia RSN™
Common Name Catheter Introducer
Predicate Device
MedAmicus Axia RSN K020563
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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11022689
p. 212
Intended Use
There are no changes to the Intended Use of the device from the currently approved device.
The MedAmicus Axia RSN™ is intended to minimize needle stick injuries when used for percutaneous introduction of guidewires, or similar devices.
Technological Characteristics
The modified device is technologically equivalent to the currently approved device. 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
Design Verification has been completed to ensure that the modified material does not affect the safety and effectiveness of the device. The Design Verification Testing was completed based on a Risk Analysis per internal procedures that are compliant with EN 1441. The Risk Analysis was completed by comparing the risks associated with the material change to the original risks identified on the approved device.
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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 eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 23 2002.
MedAmicus, Inc. c/o Mr. Karyl Haskell Quality Assurance and Regulatory Affairs Manager 15301 Highway 55 West Minneapolis, MN 55447
Re: K022689
MedAmicus Axia RSN™ Regulation Number: 870.1340 Regulation Name: Catheter introducer Regulatory Class: Class II (two) Product Code: 74 DYB Dated: August 12, 2002 Received: August 13, 2002
Dear Mr. Haskell:
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 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.
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Page 2 - Mr. Karyl Haskell
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. 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,
Elias Mells
for Bram D. Zuckerman, M.D.
Director
Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Confidential
VI. Indications for Use
.
510(k) Number (if known): Not Assigned
Device Name: MedAmicus Axia RSN™
The MedAmicus Axia RSN™ is intended to minimize Indications for Use: 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) |
|---|
| ---------------------- |
| Elias Malles (Division Sign-Off) Division of Cardiovascular and Respiratory Devices | |
|---|---|
| -- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| 8 510(k) Number | K022689 |
|---|---|
| ----------------- | --------- |
§ 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).