(130 days)
Not Found
No
The summary describes a physical medical device (introducer sheath) and its intended use for vascular access. There is no mention of software, algorithms, image processing, AI, ML, or data sets, which are typically associated with AI/ML medical devices.
No.
The device is an introducer sheath for percutaneous access and placement/removal of catheters, not a device that treats a disease or condition.
No
The device, an Introducer Sheath, is indicated for percutaneous access to the peripheral vascular and assists in the placement and removal of catheters. It does not perform any diagnostic function such as identifying, confirming, or monitoring a disease or condition.
No
The device description explicitly states it is manufactured from polyurethane and stainless steel, indicating it is a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "percutaneous access to the peripheral vascular Sheath and is designed to assist in the placement and removal of catheters." This describes a device used in vivo (within the body) for a procedural purpose, not for testing samples in vitro (outside the body).
- Device Description: The description details a physical sheath made of polyurethane and stainless steel, used for facilitating access and placement/removal of catheters. This aligns with an in vivo medical device.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing biological samples (blood, urine, tissue, etc.).
- Detecting or measuring substances in samples.
- Providing information for diagnosis, monitoring, or treatment decisions based on sample analysis.
- Reagents, calibrators, or controls typically associated with IVD tests.
The device is clearly intended for direct use within the patient's vascular system during a medical procedure.
N/A
Intended Use / Indications for Use
The Applied Medical Intravascular Access Introducer Sheath is indicated for percutaneous access to the peripheral vascular Sheath and is designed to assist in the placement and removal of catheters.
Product codes
DYB
Device Description
The Intravascular Access Introducer Sheath is a sterile single use Sheath intended Decerption placement and removal of vascular catheters, it is manufactured from polyurethane (pellethane) and stainless steel. Its shape provides an optimum means of facilitating and (penouiners) and re man pouch.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vascular Sheath
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Non-clinical Testing: Bench top testing was conducted and comparisons were made to the predicated device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
KD41506
OCT 1 5 2004 510(k) SUMMARY
| 510(k) NUMBER: | |
|---|---|
| SUBMITTED BY: | Applied Medical Resources Corporation |
| 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: | June 4, 2004 |
| NAME OF DEVICE: | Applied Medical Intravascular Access Introducer Sheath |
| 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 Suture Clinch is substantially equivalent to the Applied Medical Catheter Introducer Sheath under Applied Medical's previous 510(k) filing number K890766 and Johnson & Johnson Cordis Avanti+ Introducer Set.
Description: The Intravascular Access Introducer Sheath is a sterile single use Sheath intended Decerption placement and removal of vascular catheters, it is manufactured from polyurethane (pellethane) and stainless steel. Its shape provides an optimum means of facilitating and (penouiners) and re man pouch.
Intended Use: The Applied Medical Intravascular Access Introducer Sheath is indicated for Intended Use. The Applied interest vascular Sheath 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 device.
1
Summary of Technological Characteristics: The Technological characteristics are the same as or equivalent to the predicated device and introduce no new safety and effectiveness issues when or equivalent in processal material used in the clinch is shown to be biocompatible according to ISO 10993-1 requirements.
Design Control / Risk Analysis/Design Verification: Design control, risk analysis and design Design Court of I Last rizes whiect 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 9001/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.
2
Image /page/2/Picture/13 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 15 2004
Applied Medical Resources Corporation c/o Ms. Cheryl Blake Vice President, Regulatory Affairs and Quality Systems 22872 Avenida Empresa Rancho Santa Margarita, CA 92688
K041506 Re:
K041500
Trade/Device Name: Applied Medical Intravascular Access Introducer Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter introducer Regulatory Class: Class II Product Code: DYB Dated: September 25, 2004 Received: September 30, 2004
Dear Ms. Blake:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your beeemined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass stated in the encreating of the enactment date of the Medical Device Amendments, or to conninered pror co ria) 2011-12-11 in accordance with the provisions of the Federal Food, Drug, de vices mat have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, mererory mains 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
3
Page 2 - Ms. Cheryl Blake
rage = = = = = = = = = = = = = = = = = = = = = = = forth in the quality systems (QS) regulation (21 CFR 1 at 620); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Sectio product radiation control provisions (Sections 33 -342 of the first (Section S10(K)
This letter will allow you to begin marketing your device of your device to a legal This letter will allow you to begin marketing your device of your device to a legally
premarket notification. The FDA finding of substantial equivalence of your device to a l premarket notification. The FDA finding of substantial equivalite of 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
ntitled, If you desire specific advice for your device on on 1805mile the regulation entitled,
contact the Office of Compliance at (240) 276-0120. Also, please note the regulation of contact the Office of Compliance at (240) 2/0-0120. THBO, PR Part 807.97). You may obtain
"Misbranding by reference to premarket notification" (21CFR Part 807.97). You may "Misbranding by reference to premarket nouthication " (21 cm the Division of Small
other general information on your responsibilities under the Act from the Division of Small other general information on your responsionities uner and the more of the more (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its toll-free man.ht Manufacturers, International and Consumer Assistance at its towards.
(301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Duna R. bochner
E
B
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and
Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): ___K041506
Device Name:__Intravascular Access Introducer Sheath
Indications For Use: The Applied Medical Intravascular Access Introducer Sheath is
t Sheath is and the secure assess to the poripheral vascular Sheath and is designed to Indications For Use: The Applied Medical Intravasoular Sheath and is designed to
indicated for percutaneous access to the peripheral vascular Sheath and is designed to
r an indicated for peroutanosus as a moval 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)
R. Lachner
(Division Sign-Off) (Division of Cardiovascular Devices
510(K) Number_KO(K) Number_KO
Page 1 of ____________________________________________________________________________________________________________________________________________________________________