EXPANDING VASCULAR SHEATH by APPLIED MEDICAL

The Applied Medical Expandable Vascular Sheath is indicated for percutaneous access to the peripheral vascular system and is designed to assist in the placement and removal of catheters.

Device Description

The Expandable Vascular Sheath is a sterile single use sheath intended to facilitate the placement and removal of vascular catheters. It is manufactured from polyester filled with Titanium Oxide and Barium. Its shape provides an optimum means of facilitating and removing catheters. The device is supplied sterile and is packaged individually in a trav sealed with a Tyvek® lid.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the "Applied Medical Expandable Vascular Sheath." It is a traditional medical device, not an AI/ML-driven diagnostic tool. Therefore, much of the requested information (such as acceptance criteria tables, sample sizes for test sets, expert-established ground truth, MRMC studies, standalone algorithm performance, training set details, etc.) is not applicable to this type of submission.

Here's a breakdown of why and what information can be extracted or inferred:

1. A table of acceptance criteria and the reported device performance:

This information is typically found in detailed design verification and validation documents for traditional medical devices. The 510(k) summary only states that "validation and verification activities were formally controlled and addressed by Applied Medical. The activities included the methods, tests used, and acceptance criteria applied." It does not provide the specific numerical acceptance criteria or performance metrics, as this level of detail is usually reserved for internal company documentation rather than the public 510(k) summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not applicable. This device is not an AI/ML diagnostic tool that processes data in the way implied by this question. The testing conducted was "bench top testing" comparing it to a predicate device, and "biocompatibility according to ISO 10993-1 requirements." These tests do not involve "data provenance" or "test sets" in the context of data analysis.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable. There is no mention of "experts" establishing a "ground truth" for a "test set" as would be relevant for an AI/ML diagnostic device. The evaluation of this device would involve engineering and materials science experts for bench testing, and potentially medical professionals for clinical evaluations if they were conducted (but are not detailed in this summary for the 510(k) submission).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. Adjudication methods are typically used in clinical trials or for establishing ground truth in AI/ML studies where there's potential for disagreement among human readers. This concept does not apply to the bench testing described for this device.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is not an AI-assisted device, so an MRMC study comparing human readers with and without AI assistance is irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not applicable in the context of AI/ML. For this device, the "ground truth" would be established by validated test methods (e.g., measuring forces, dimensions, material properties against design specifications, and confirming biocompatibility standards).

8. The sample size for the training set:

Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established:

Not applicable. As above, no training set for this type of device.

Summary of Relevant Information from the Provided Text:

Acceptance Criteria & Performance: The document states that "validation and verification activities were formally controlled and addressed by Applied Medical. The activities included the methods, tests used, and acceptance criteria applied," and that "bench top testing was conducted and comparisons were made to the predicated device." It also mentions that "The materials used in the device are shown to be biocompatible according to ISO 10993-1 requirements." However, specific quantitative acceptance criteria or detailed performance results are not provided in this 510(k) summary. The primary "performance" reported is its substantial equivalence to the predicate device, implying it meets similar performance characteristics.
Study That Proves the Device Meets Acceptance Criteria: The study mentioned is "Bench top testing" comparing the device to its predicate (Applied Medical's Expandable Vascular Sheath approved under 510(k) K963886). Additionally, biocompatibility testing was conducted according to ISO 10993-1 requirements. The design control process, risk analysis, and design verification activities were conducted in accordance with internal Applied Medical procedures, 21 CFR § 820.30, EN 1441 standards, ISO 13485, and AAMI/ISO TIR 14971.

In essence, the document confirms that testing was done to ensure the device performs as intended and is safe, but it does not provide the detailed output of those tests or explicit acceptance criteria values, which are typically proprietary and part of a more extensive submission package to the FDA, not the public summary.

Summary

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K 070865

510(k) SUMMARY

510(k) NUMBER:	Pending	OCT 23 2007
SUBMITTED BY:	Applied Medical22872 Avenida EmpresaRancho Santa Margarita, CA 92688Phone: 949-713-8327Fax: 949-713-8205e-mail: cblake@appliedmed.com
CONTACT PERSON:	Cheryl BlakeVice President, Regulatory Affairs and Quality Systems
DATE OF PREPARATION:	February 14, 2007
NAME OF DEVICE:	Applied Medical Expandable Vascular Sheath
TRADE NAME:	Undetermined so far
COMMON OR USUAL NAME:	Catheter Introducer
CLASSIFICATION NAME:	Catheter Introducer (870.1340)

SUMMARY STATEMENT:

Identification of the legally marketed device: The Applied Medical Expandable Vascular Sheath is substantially equivalent to Applied Medical's Expandable Vascular Sheath approved under 510(k) K963886.

Description: The Expandable Vascular Sheath is a sterile single use sheath intended to facilitate the placement and removal of vascular catheters. It is manufactured from polyester filled with Titanium Oxide and Barium. Its shape provides an optimum means of facilitating and removing catheters. The device is supplied sterile and is packaged individually in a trav sealed with a Tyvek® lid.

Intended Use: The Applied Medical Expandable Vascular 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 device.

Summary of Technological Characteristics: The technological characteristics are the same as or equivalent to the predicate device and introduce no new safety and effectiveness issues

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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 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 performed 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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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 3 2007

Underwriters Laboratories, Inc. c/o Mr. Morten Simon Christensen Staff Engineer & FDA Program Manager 455 E. Trimble Road San Jose, CA 95131-1230

Re: K070865 Expandable Vascular Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: October 3, 2007 Received: October 4, 2007

Dear Mr. Christernsen:

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.

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Page 2 - Mr. Morten Simon Christensen

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 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,

M. A. Willelmsen

Que 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): ____________________________________________________________________________________________________________________________________________________

Device Name: Expandable Vascular Sheath

Indications For Use: The Applied Medical Expandable Vascular Sheath is indicated for percutaneous access to the peripheral vascular 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)

M. L. Hilleboe

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number K070865

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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).