The Short 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.

Device Description

The Rex Medical Short Introducer Sheath, offered in both 6F and 7F sizes, is a vascular access device consisting of a central lumen, angled side arm extension. and a hemostasis valve. The device is used under identical indications for use as the predicate device, as well other substantially equivalent 510(K) cleared devices.

AI/ML Overview

The provided document is a 510(k) summary for a medical device called the "Short Introducer Sheath." This type of document is for premarket notification and focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel clinical effectiveness.

Therefore, the document does not contain the kind of detailed information typically found in a clinical study report that rigorously tests acceptance criteria for a new AI or diagnostic device. Specifically, it states "Discussion of Clinical Tests Performed: Not Applicable."

As such, I cannot provide the requested information in the format of a table describing acceptance criteria and device performance based on a study, nor details on sample sizes, ground truth establishment, or multi-reader studies, because these elements are not present in the provided text.

The document discusses non-clinical tests performed to demonstrate substantial equivalence, focusing on material changes from an original device.

Here's a breakdown of what can be extracted or inferred from the document regarding its non-clinical testing and regulatory submission:

Acceptance Criteria and Reported Device Performance: This information is not explicitly detailed in quantifiable terms in the 510(k) summary. It states that "Test methodology and acceptance criteria were derived from ISO 11070, Sterile Single-Use Intravascular Catheter Introducers." The reported performance is that "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." This implies the device met the ISO 11070 criteria, but the specific numerical performance metrics are not given.
Sample Size Used for the Test Set and Data Provenance: Not applicable, as this was non-clinical (bench) testing. The "test set" would refer to the physical units produced for bench testing. The document does not specify the number of units tested, only that testing was "derived from the risk assessment."
Number of Experts Used to Establish Ground Truth and Qualifications: Not applicable, as this was non-clinical (bench) testing.
Adjudication Method for the Test Set: Not applicable, as this was non-clinical (bench) testing.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No, explicitly stated "Not Applicable" for clinical tests.
Standalone (algorithm only without human-in-the-loop performance) study: Not applicable, as this is a physical medical device, not an algorithm, and no clinical studies were performed.
Type of Ground Truth Used: For the non-clinical testing, the "ground truth" would be established by the specifications defined in ISO 11070 for sterile single-use intravascular catheter introducers.
Sample Size for the Training Set: Not applicable, as this is a physical medical device, not an algorithm.
How the Ground Truth for the Training Set Was Established: Not applicable.

In summary: The provided document is a 510(k) summary for a physical medical device, not a diagnostic or AI device. It focuses on demonstrating substantial equivalence to an existing device through non-clinical (bench) testing and explicitly states that clinical tests were "Not Applicable." Therefore, the detailed information requested about acceptance criteria, study design, and ground truth for clinical performance is not available in this text.

Summary

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Image /page/0/Picture/2 description: The image shows the logo for Rex Medical. The logo is in black and white. The word "REX" is in large, bold letters, and the word "MEDICAL" is in smaller, bold letters.

1100 East Hector Street, Suite 245, Conshohocken, PA 19428

510(K) SUMMARY

This summary of 5I0(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: K04 23 9 9

1. Submitter's Identification:

Rex Medical, LP 1100 East Hector Street, Suite 245 Conshohocken, PA 19428

Date Summary Prepared: August 27, 2004

Contact:

Denise Flamer Development Engineer

2. Name of the Device:

Short Introducer Sheath

3. Predicate Device Information:

K#032569, Rex Medical Short Introducer Sheath

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4. Device Description:

5. Intended Use:

6. Comparison to Predicate Device:

Both the Short Introducer Sheath and the modified Short Introducer Sheath are provided in 6F and 7F sizes. Both consist of a radio-opaque distal tip which allows the physician to visually identify the position of the distal tip when located in the graff. 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 is packaged with a dilator which allows for easy insertion over a guidewire. The dilator snaps into the sheath hub to increase the ease of insertion into a dialysis graft. The changes to the device are materials used in the device and improve the efficiency of the manufacturing process.

7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence:

All testing performed on the Short Introducer Sheath was derived from the risk assessment which evaluated the effects of the changed materials from the original Short Introducer Sheath. Test methodology and acceptance criteria were derived from ISO 11070, Sterile Single-Use Intravascular Catheter Introducers. All materials used in the Short Introducer Sheath were tested according to ISO 10993, Biological Evaluation of Medical Devices.

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8. Discussion of Clinical Tests Performed:

Not Applicable

Conclusions: 9.

The subject device, Short Introducer Sheath, has identical indications for use as the original Rex Medical Short 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 Short Introducer Sheath is substantially equivalent to the original Rex Medical Short Introducer Sheath.

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Public Health Service

Image /page/3/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized symbol that resembles a caduceus, which is a symbol often associated with medicine and healthcare. The symbol consists of a staff with two snakes coiled around it and a pair of wings at the top.

DEC 17 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Rex Medical c/o Ms. Susan D. Goldstein-Falk MDI Consultants 55 Northern Blvd., Suite 200 Great Neck, NY 11021

Re: K042399 Short Introducer Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II (two) Product Code: DYB Dated: November 29, 2004 Received: December 3, 2004

Dear Ms. Goldstein-Falk:

We have reviewed your Section 510(k) premarket notification of intent to market the device indicati We have reviewed your Section 910(x) premained institution in the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enclosine) to regally manage in the Medical Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food. Days commerce prior to May 26, 1776, the enactified in accordance with the Federal Food. Drug.
devices that have been reclassified in accordance with the provisions of the PMA devices that have been recuire approval of a premarket approval apploval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval of the You may, therefore, market the device, subject to the general controls provisions of the Act. The You may, ulerefore, market the devices, basyene to annual registration, listing of general controls provisions of the fice 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 II your device is classified (Sec aborto) and Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulation FDA be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may be found in the Ood of I cases on cerning your device in the Federal Register.

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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 (301) 594-4646. 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/dsma/dsmamain.html

Sincerely yours,

Oma R. Vichner

( 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

510(k) Number (if known): K042399

Device Name: Rex Medical Short Introducer Sheath

Indications For Use:

The Short 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 a grant. "The dilation and further provide support to the wall of the indwelling system.

Prescription Use (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)

Duna R. bichsel

(Division Sign-Off) Division of Cardiovascular Devices

: 40/4 Nimber K642399

Regulation Number and Section

§ 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).