(278 days)
The Applied Medical Intravascular Access Introducer Sheath is indicated for percutaneous access to the peripheral vasular system and is designed to assist in the placement and removal of catheters.
The Intravascular Access Introducer Sheath is a sterile single use Sheath intended to facilitate the placement and removal of vascular catheters, it is manufactured from polvurethane (pellethane) and stainless steel. Its shape provides an optimum means of facilitating and removing catheters. The device is supplied sterile and are packaged individually in a tray sealed with a Tyvek® lid
This 510(k) summary (K063650) describes an application for an intravascular access introducer sheath. The document does not contain the kind of information typically associated with studies demonstrating the performance of AI-powered medical devices. Instead, it focuses on demonstrating substantial equivalence to predicate devices for a traditional, non-software medical product.
Therefore, I cannot provide the requested information about acceptance criteria and a study proving device performance in the context of AI/software device evaluation. The provided text discusses:
- Substantial Equivalence: The primary goal of this 510(k) is to show that the Applied Medical Intravascular Introducer System is substantially equivalent to previously cleared Applied Medical products (K041506, K890766) and the Johnson & Johnson Cordis Avanti+ Introducer Set.
- Device Description and Intended Use: It describes the physical characteristics and the intended clinical application of the sheath.
- Non-clinical Testing: Mentions "Bench top testing was conducted and comparisons were made to the predicated devices." This is typical for physical medical devices to ensure they meet basic functional and safety requirements, often comparing physical properties like tensile strength, flow rates, or insertion forces. It does not refer to clinical studies or performance against a ground truth as would be relevant for an AI/software device.
- Biocompatibility: States that materials are biocompatible according to ISO 10993-1.
- Design Controls and Risk Analysis: Discusses adherence to regulatory standards (21 CFR § 820.30, EN 1441, ISO 13485, AAMI/ISO TIR 14971) for design, risk, validation, and verification.
In summary, the provided document is for a traditional medical device (an introducer sheath) and does not involve AI or software components requiring the types of studies or performance metrics you've asked for (e.g., sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance).
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510(k) SUMMARY
510(k) NUMBER: PENDING
- Applied Medical Resources Corporation SUBMITTED BY: 22872 Avenida Empresa Rancho Santa Margarita, CA 92688 Phone: 949-713-8327 Fax: 949-713-8205 e-mail: cblake@appliedmed.com
CONTACT PERSON: Cheryl Blake Vice President, Regulatory Affairs and Quality
Systems
DATE OF PREPARATION: March 18, 2006
Applied Medical Intravascular Access Introducer Sheath NAME OF DEVICE:
TRADE NAME: Not Determined
COMMON OR USUAL NAME: Catheter Introducer
CLASSIFICATION NAME: Catheter Introducer (870.1340)
SUMMARY STATEMENT:
Identification of the legally marketed: The Applied Medical Intravascular Introducer System is substantially equivalent to the Applied Medical Catheter Introducer Sheath under Applied Medical's previous 510(k) filing numbers K041506 and K890766 and Johnson & Johnson Cordis Avanti+ Introducer Set.
Description: The Intravascular Access Introducer Sheath is a sterile single use Sheath intended to facilitate the placement and removal of vascular catheters, it is manufactured from polvurethane (pellethane) and stainless steel. Its shape provides an optimum means of facilitating and removing catheters. The device is supplied sterile and are packaged individually in a tray sealed with a Tyvek® lid
Intended Use: The Applied Medical Intravascular Access Introducer Sheath is indicated for percutaneous access to the peripheral vascular system and is designed to assist in the placement and removal of catheters.
Non-clinical Testing: Bench top testing was conducted and comparisons were made to the predicated devices.
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Summary of Technological Characteristics: The Technological characteristics are the same as or equivalent to the predicated devices and introduce no new safety and effectiveness issues when used as instructed. The materials used in the device are shown to be biocompatible according to ISO 10993-1 requirements.
Design Control / Risk Analysis/Design Verification: Design control, risk analysis and design verification activities for the subject of this Special 510(k) have been conducted in accordance with all applicable internal Applied Medical Procedures. The design control process employed is inclusive of the elements stipulated by 21 CFR § 820.30. The risk analysis preformed identified the risks relative to the performance requirements, as specified by Applied Medical internal procedures for risk analysis. The Design Risk Assessment Profile was conducted in accordance to Applied Medical internal Stand Operating Procedures, EN 1441 standards, ISO 13485, AAMI/ISO TIR 14971, and 21 CFR § 820.30, validation and verification activities addressed the profile. Based on the risk analysis, validation and verification activities were formally controlled and addressed by Applied Medical, the activities included the methods, tests used, and acceptance criteria applied.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is depicted in a simple, black-and-white design, and the text is in a clear, sans-serif font.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Cheryl Blake Vice President of Regulatory Affairs and Quality Systems Applied Medical Resources Corp. 22872 Avenida Empresa Rancho Santa Margarita, CA 92688
SEP 1 2 2007
K063658 Trade/Device Name: Applied Medical Intravascular Catheter Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: August 1, 2007 Received: August 16, 2007
Dear Ms. Blake:
Re:
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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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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Bram D. Zuckerman, M.D.
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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Indications for Use
KO6365B 510(k) Number (if known):_
Device Name: Intravascular Access System
Indications For Use: The Applied Medical Intravascular Access Introducer Sheath is indicated for percutaneous access to the peripheral vasular system and is designed to assist in the placement and removal of catheters.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
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archavasculur Deputas
§ 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).