The WAND™ MicroAccess Safety Introducer is an integrated sterile, single-use intravascular catheter introducer. It is designed to incorporate a combination of devices into an all-in-one device that provides the clinician with a safe and simple approach to the Modified Seldinger technique, and thereby accelerate the procedure required to place indwelling intravascular catheters. The device includes an Introducer Needle, Guidewire, Dilator, and Introducer Sheath in a single integrated device, and incorporates a safety mechanism to guard against accidental needlestick.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the WAND™ MicroAccess Safety Introducer:

It's important to note that this 510(k) summary is for a medical device, specifically a catheter introducer, not an AI/ML-based diagnostic device. Therefore, many of the requested categories (like MRMC studies, AI effect size, ground truth for training sets, etc.) are not applicable to this type of submission. The performance evaluation for this device focuses on physical and biological characteristics, not diagnostic accuracy.

Acceptance Criteria and Device Performance

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

Based on the provided text, the acceptance criteria are implicitly defined by demonstrating equivalence to predicate devices and meeting established biomechanical and biocompatibility requirements for the intended use. Specific numerical acceptance criteria are not detailed in this summary; rather, it refers to a full application (K081697) for the details.

Acceptance Criterion (Implicit)	Reported Device Performance
Biocompatibility: Device materials are biologically safe for in-body contact.	"A program of design verification testing including biocompatibility testing... has been completed to demonstrate the biological safety... Test results indicate that the device is equivalent to the predicate devices..." (Section 5.6 & 5.8)
Biomechanical Performance: Device meets mechanical requirements for its intended function (e.g., integrity, ease of use, safety mechanism).	"A program of design verification testing including... in vitro bench testing has been completed to demonstrate the... biomechanical performance characteristics... Test results indicate that the device is equivalent to the predicate devices and satisfies mechanical performance requirements for its intended use." (Section 5.6 & 5.8)
Sterility: Device is sterile at the point of use.	"The WAND™ MicroAccess Safety Introducer is provided 'STERILE' by ethylene oxide gas to a sterility assurance level of 10-6." (Section 5.7)
Substantial Equivalence: Device is equivalent in design, function, and indications for use to predicate devices.	"The results of testing demonstrate that the WAND™ MicroAccess Safety Introducer is substantially equivalent to the predicate devices in design, function, and indications for use." (Section 5.8)Predicate devices listed: Arrow International Emergency Infusion Device (K840455), BD Introsyte Precision Introducer (K020834), Stiffer Coaxial Micro-Introducer Set (K071574).

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

Sample Size: Not specified in this summary. The summary refers to the original 510(k) application (K081697) for details on device performance evaluation and testing.
Data Provenance: Not specified, but generally, bench and biocompatibility testing are conducted in laboratories according to established standards.

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. This is a medical device for facilitating catheter placement, not a diagnostic AI/ML device requiring expert interpretation for ground truth establishment. Performance is evaluated through engineering and biological testing, not clinical reads by experts.

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

Not Applicable. This is a medical device, not a diagnostic AI/ML device requiring adjudication of interpretations.

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 a physical medical device, not an AI/ML system, so an MRMC study and AI assistance effect size are irrelevant.

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

Not Applicable. This question typically applies to AI/ML software. The device itself is "standalone" in the sense that its physical functionality is tested, but it's not an algorithm.

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

For biocompatibility: Ground truth is typically based on established biological safety standards, in vitro testing (e.g., cytotoxicity, sensitization, irritation), and in vivo animal studies, rather than expert clinical consensus.
For biomechanical performance: Ground truth is based on engineering specifications, industry standards, and functional testing to ensure the device performs as intended (e.g., strength, integrity, flow rates).

8. The sample size for the training set

Not Applicable. This device does not involve machine learning algorithms that require a "training set."

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

Not Applicable. This device does not involve machine learning algorithms and therefore has no "training set" or associated ground truth establishment.

Summary of Relevant Information from the K090372 Summary:

Device Type: Catheter Introducer (physical medical device).
Performance Evaluation: Focused on biocompatibility, in vitro bench testing for biomechanical performance, and sterility.
Key Conclusion: Substantial equivalence to predicate devices (Arrow International Emergency Infusion Device, BD Introsyte Precision Introducer, Stiffer Coaxial Micro-Introducer Set) in design, function, and indications for use.
Missing Details: Specific test protocols, numerical results, and sample sizes for the performance studies are not included in this summary but are referenced as being in the original 510(k) application K081697.

Summary

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KO90372

510(k) Summary

MAR 3 0 2009

Submitter Information 5.1

A. Company Name:	Access Scientific, Inc.
B. Company Address:	12526 High Bluff Drive, Suite 360San Diego, CA 92130
C. Company Phone:	(858) 259-8333
D. Company Facsimile:	(858) 259-5298
E. Contact Person:	Albert MisajonVice President, Regulatory Affairs andQuality Assuranceamisajon@the-wand.com

5.2 Device Identification

A. Device Trade Name:	The WAND™ MicroAccess Safety Introducer
B. Common Name:	Catheter Introducer
C. Classification Name(s):	Introducer, Catheter
D. Classification Regulation(s):	21 CFR 870.1340
E. Device Class:	Class II
F. Product Code:	DYB
G. Advisory Panel:	Cardiovascular

5.3 Identification of Predicate Devices

The WAND™ MicroAccess Safety Introducer is substantially equivalent to the following ' devices, which are cleared for commercial distribution in the United States:

· Arrow International Emergency Infusion Device distributed under cleared 510(k) Number K840455
BD Introsyte Precision Introducer distributed under cleared 510(k) Number K020834 (Beckton Dickinson Infusion Therapy Systems, Inc.)
· Stiffer Coaxial Micro-Introducer Set distributed under cleared 510(k) Number K071574 (Enpath Medical, Inc.)

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5.4 Device Description

5.5 Indications for Use

The WAND™ MicroAccess Safety Introducer is used to facilitate the placing of an intravascular catheter through the skin into the circulatory system.

Biocompatibility and Performance Testing 5.6

A program of design verification testing including biocompatibility testing and in vitro bench testing has been completed to demonstrate the biological safety and biomechanical performance characteristics of the WAND™ MicroAccess Safety Introducer. Test results indicate that the device is equivalent to the predicate devices and satisfies mechanical performance requirements for its intended use. Refer to the original 510(k) application for the WAND (K081697) for information on device performance evaluation.

5.7 Sterility

The WAND™ MicroAccess Safety Introducer is provided "STERILE" by ethylene oxide gas to a sterility assurance level of 10-.

Conclusions Drawn from Studies 5.8

The results of testing demonstrate that the WAND™ MicroAccess Safety Introducer is substantially equivalent to the predicate devices in design, function, and indications for use. Refer to the original 510(k) application for the WAND (K081697) for the details of the testing.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged in a circular pattern around the eagle. The logo is black and white and appears to be a scanned image.

MAR 3 0 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Access Scientific, Inc. c/o Mr. Albert Misajon VP, Regulatory Affairs Quality Assurance 12526 High Bluff Drive, Suite 360 San Diego, CA 92130

Re: K090372

Trade/Device Name: The WAND MicroAccess safety Introducer Common Name: Introducer, Catheter Regulation Number: 21 CFR 870.1340 Regulatory Class: II Product Code: DYB Dated: February 13, 2009 Received: February 13, 2009

Dear Mr. Misajon:

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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Page 2 - Mr. Albert Misajon

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) 276-0210. 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 Biometrics' (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,

R. Vochner

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

11090372 510(k) Number: To Be Assigned By FDA

Device Name: The WAND™ MicroAccess Safety Introducer

Indications for Use: The WAND™ MicroAccess Safety Introducer is used to facilitate the placing of an intravascular catheter through the skin into the circulatory system.

AND/OR Over-The-Counter Use X Prescription Use (21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duma R. Wulmer
(Division Sign-Off)

Division of Cardiovascular Devi...

510(k) Number_K09037 2

Access Scientific, Inc.

Confidential

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).