(62 days)
No
The 510(k) summary describes a mechanical vascular access device and does not mention any AI/ML components or functionalities.
No
The device is an introducer sheath used to facilitate placing a catheter, which is a procedural aid rather than a therapeutic device itself.
No
The device is an introducer sheath used for facilitating catheter placement, not for diagnosing medical conditions.
No
The device description clearly describes a physical, hardware-based vascular access device (introducer sheath and dilator) and its components. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to "facilitate placing a catheter through the skin into a graft." This describes a procedure performed on the patient's body, not a test performed on a sample taken from the patient.
- Device Description: The description details a "vascular access device" used for inserting a catheter. This is consistent with a device used for a medical procedure, not for analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening based on sample analysis
The device is a tool used to perform a medical procedure, not a test to analyze a sample for diagnostic purposes.
N/A
Intended Use / Indications for Use
The Inner-Lock Introducer Sheath is used to facilitate placing a catheter through the skin into a graft. The dilator is an accessory device which is used by placing it into the sheath to create an occlusion and further provide support to the wall of the indwelling system.
Product codes
DYB
Device Description
The Rex Medical, Inner-Lock Introducer Sheaths, 6F and 7F is a vascular access device consisting of a central lumen, an angled side arm extension and a hemostasis valve. The distal tip contains a retention mechanism that is operated via a control arm on the proximal hub. The device is used in exactly the same manner as the predicate device and other substantially equivalent 510(K) cleared devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
All testing performed on the Inner-Lock Introducer Sheath was derived from the risk assessment which evaluated the effects of the changed materials from the original Inner-Lock Introducer Sheath. Test methodology and acceptance criteria were derived from ISO 11070, Sterile Single-Use Intravascular Catheter Introducers. All materials used in the Inner-Lock Introducer Sheath were tested according to ISO 10993, Biological Evaluation of Medical Devices.
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
AUG 4 - 2005
Image /page/0/Picture/2 description: The image shows the logo for REX MEDICAL. The logo is in black and white. The word "REX MEDICAL" is written in a bold, sans-serif font, with the letters slightly slanted to the right. There is a curved line above and below the word "REX MEDICAL".
1100 East Hector Street, Suite 245, Conshohocken, PA 19428
510(K) SUMMARY
This summary of 5l0(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(k) number is:_K051468
1. Submitter's Identification:
Rex Medical, LP 1100 East Hector Street, Suite 245 Conshohocken, PA 19428
Date Summary Prepared: June 1, 2005
Contact:
Denise Flamer Development Engineer
2. Name of the Device:
Inner-Lock Introducer Sheath
3. Predicate Device Information:
K022170, Rex Medical Inner-Lock Introducer Sheath K042399, Rex Medical Short Introducer Sheath
1
4. Device Description:
The Rex Medical, Inner-Lock Introducer Sheaths, 6F and 7F is a vascular access device consisting of a central lumen, an angled side arm extension and a hemostasis valve. The distal tip contains a retention mechanism that is operated via a control arm on the proximal hub. The device is used in exactly the same manner as the predicate device and other substantially equivalent 510(K) cleared devices.
5. Intended Use:
The Inner-Lock Introducer Sheath is used to facilitate placing a catheter through the skin into a graft. The dilator is an accessory device which is used by placing it into the sheath to create an occlusion and further provide support to the wall of the indwelling system,
6. Comparison to Predicate Device:
Both the Inner-Lock Introducer Sheath and the modified Inner-Lock Introducer Sheath are provided in 6F and 7F sizes. Both consist of a radiopaque distal tip which allows the physician to visually identify the position of the distal tip when located in the graft. A 45° sidearm located on the sheath hub incorporates an extension tube, female luer, and tubing clamp which allow for infusion or aspiration through the sheath as required during a procedure. An integrated hemostasis valve prevents blood loss or air introduction during use. The sheath also contains a retention mechanism for added patient comfort and safety. The retention mechanism allows the distal end of the device to remain securely in the patient, eliminating the need for a suture or adhesive tape. The sheath is packaged with a dilator which allows for easy insertion over a quidewire. The dilator snaps into the sheath hub to increase the ease of insertion into a dialysis graft. Some of the materials used in the device have been changed and the efficiency of the manufacturing process has been improved.
7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence:
All testing performed on the Inner-Lock Introducer Sheath was derived from the risk assessment which evaluated the effects of the changed materials from the original Inner-Lock Introducer Sheath. Test methodology and acceptance criteria were derived from ISO 11070, Sterile Single-Use Intravascular Catheter Introducers. All materials used in the Inner-Lock Introducer Sheath were tested according to ISO 10993, Biological Evaluation of Medical Devices.
2
8. Discussion of Clinical Tests Performed:
Not Applicable
9. Conclusions:
The subject device, Inner-Lock Introducer Sheath, has identical indications for use as the original Rex Medical Inner-Lock Introducer Sheath. The bench testing contained in our submission demonstrates that there are no differences in their technological characteristics, thereby not raising any new issues of safety or effectiveness. Thus, the Inner-Lock Introducer Sheath is substantially equivalent to the predicate devices.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 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" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three distinct lines forming its body and wings. The logo is black and white.
Public Health Service
AUG 4 - 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Rex Medical c/o Ms. Susan D. Goldstein-Falk MDI Consultants, Inc. 55 Northern Boulevard, Suite 200 Great Neck, NY 11021
Re: K051468
Inner-Lock introducer sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: July 6, 2005 Received: July 7, 2005
Dear Ms. Goldstein-Falk:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your beceived the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for associated in the encreated of the enactment date of the Medical Device Amendments, or to eonimores prior to rias 2011-11-11 in accordance with the provisions of the Federal Food, Drug, de nees that 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, diorerore, mains of the Act include requirements for annual registration, listing of general controls proficturing 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 If your device is elabilition to corrols. Existing major regulations affecting your device can may or dayse to daten as a sues as Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
4
Page 2 - Ms. Susan D. Goldstein-Falk
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. 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) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 yours,
Duna R. bohner
- A Bram D. Zuckerman, M.D. Director
Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Exhibit B
510(k) Number (if known): K051468
Device Name: Rex Medical Inner-Lock Introducer Sheath
Indications For Use:
The Inner-Lock Introducer Sheath is used to facilitate placing a catheter through the skin into a graft. The dilator is an accessory device which is used by placing it into the sheath to create an occlusion and further provide support to the wall of the indwelling system.
Prescription Use X (Per 21 CFR 801 Subpart D)
Over-The Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Duna R. Jackson
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number K051408