The AVD Left and Right Radial Drapes are single use sterile devices intended for use by medical professionals as a protective patient covering, such as to isolate a site of surgical incision or vascular puncture from microbial and other contamination. The drapes are attached to the patient in proximity to a vascular puncture site to isolate vascular access punctures from microbial and other contamination during procedures including angiographies and percutaneous interventions.

Device Description

The AVD Radial Drapes are composed of a fluid-resistant film layer, an absorbent barrier layer, and an adhesive material that bonds the two layers. The surgical site is accessed through an oval opening in the drape that is surrounded by an adhesive tape to keep the drape in position over the surgical or vascular puncture site. The AVD Drapes are supplied sterile and for single use only. The Drapes are available in both a Left Radial and a Right Radial configuration. They may be sold singly or as part of a procedure pack.

AI/ML Overview

Here's an analysis of the provided 510(k) summary regarding the AVD Radial Drapes, focusing on acceptance criteria and supporting studies:

Acceptance Criteria and Device Performance for AVD Radial Drapes (K131571)

The AVD Radial Drapes are a Class II surgical drape indicated for isolating surgical incision or vascular puncture sites from microbial contamination. The submission primarily relies on demonstrating substantial equivalence to a predicate device (HVO Various Disposable Non-Sterile Drapes, K050508) and performing non-clinical performance testing.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document details various performance tests conducted on the AVD Radial Drapes. The "acceptance criteria" for many of these appear to be "Pass" or "Acceptable" based on adherence to specific standards.

Parameter	Acceptance Criteria (Implicit from Standards)	Reported Device Performance	Comments / Supporting Standard
Barrier Protection	Barrier Level 4 (ANSI/AAMI PB70)	Barrier Level 4	ANSI/AAMI PB70
Resistance to Tears	Pass (ASTM D5587-08, WSP 100.2)	Pass	ASTM D5587-08, WSP 100.2
Tensile Strength	Pass (ASTM 5034-09)	Pass	ASTM 5034-09
Flammability	Class I (16 CFR 1610)	Class I	16 CFR 1610
Cytotoxicity	Non-cytotoxic (ISO 10993-5:2009)	Non-cytotoxic	ISO 10993-5:2009
Skin Sensitization	Non-sensitizing (ISO 10993-10:2002)	Non-sensitizing	ISO 10993-10:2002
Skin Irritation	Non-irritating (ISO 10993-10:2002)	Non-irritating	ISO 10993-10:2002
EO Residuals	Acceptable (ISO 10993-10:2008)	Acceptable	ISO 10993-10:2008
Sterilization Validation	Acceptable (not explicitly stated, but implied by "Sterile (EO)" and "sterilization validation" under non-clinical testing)	Performed and accepted	Implied by non-clinical testing section

Note: For parameters where the predicate device's performance was "Not stated" or "Not available," the AVD Drapes demonstrated performance against recognized standards, contributing to the claim of substantial equivalence. The predicate device was non-sterile, so sterilization validation and EO residuals were not applicable to it.

2. Sample Size and Data Provenance

The document does not specify the sample sizes used for each of the non-clinical tests (e.g., how many drapes were tested for tensile strength or tear resistance). However, these are typically laboratory tests performed on a representative sample of manufactured products.

Test Set Sample Size: Not explicitly stated for any of the non-clinical tests.
Data Provenance: The non-clinical tests were conducted specifically for this submission (prospective testing) and are laboratory-based, without reference to human or animal data for these specific performance metrics. The country of origin of the data is not stated, but the submission is to the US FDA, and the submitter is based in Milwaukie, OR, USA.

3. Number of Experts and Qualifications for Ground Truth

Ground Truth Establishment: Not applicable in the traditional sense for this submission. The "ground truth" for the non-clinical tests is established by the specified international and national standards (e.g., ISO, ASTM, ANSI/AAMI, CFR). These standards define the methodology and acceptance criteria for measuring material properties and performance. There isn't a panel of clinical experts establishing a ground truth for device performance in this context, as it's a materials and functional performance evaluation.

4. Adjudication Method

Adjudication Method: Not applicable. Non-clinical tests follow established, standardized protocols with objective measurements, rather than requiring expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic imaging devices where human readers interpret medical images with and without AI assistance. The AVD Radial Drape is a physical medical device (surgical drape), not a diagnostic imaging AI.

6. Standalone Performance Study

Standalone Performance Study: Yes, in essence, the non-clinical testing described in Section G constitutes standalone performance evaluations for the AVD Radial Drapes against specified standards. The results for parameters like Barrier Protection, Tensile Strength, Tear Resistance, Flammability, and Biocompatibility (cytotoxicity, sensitization, irritation, EO residuals) were obtained directly from testing the AVD Drapes themselves, without human intervention as part of the performance metric. This is "algorithm only" in the sense that the device's inherent physical and biological properties were evaluated.

7. Type of Ground Truth Used

Type of Ground Truth: For the non-clinical tests, the ground truth is established by objective technical standards and regulatory requirements. For example, "Barrier Level 4" is an objective classification defined by ANSI/AAMI PB70, not by expert consensus or clinical outcomes. Similarly, "Non-cytotoxic" is determined by a specific laboratory assay described in ISO 10993-5.

8. Sample Size for the Training Set

Training Set Sample Size: Not applicable. This device is not an AI/ML algorithm that requires a "training set." The performance is based on the physical and chemical properties of the materials and design, evaluated through standard non-clinical tests.

9. How Ground Truth for Training Set was Established

Ground Truth for Training Set: Not applicable, as there is no training set for this device.

Summary

{0}------------------------------------------------

510(k) Summary

This summary of 510(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: K131571

A. Submitter:

Advanced Vascular Dynamics

4252 SE International Way, Suite F .

Milwaukie, OR 97222 USA

Phone: (503) 223-2333

Fax: (503) 223-8585

Matthew Semler, President Contact:

Semler Technologies, Inc., dba Advanced Vascular Dynamics 4252 SE International Way. Suite F Milwaukie, OR 97222 USA

Phone:	(503) 223-2333
Fax:	(503) 223-8585
Email:	msemler@compressar.com

Date Prepared: December 9, 2013

B. Device Names:

Trade Name:	AVD Radial Drapes
Common/Usual Name:	Surgical Drape
Classification Name:	Surgical Drape and Drape Accessories
Classification Regulation:	21 CFR 878.4370, Class II
Product Code:	KKX

B. Predicate Device:

HVO Various Disposable Non-Sterile Drapes (K050508), currently legally distributed by Haywood Vocational Opportunities, Inc.

D. Device Description:

{1}------------------------------------------------

E. Intended Use:

F. Comparison with the Predicate Device:

The AVD Radial Drapes have the same or similar technological specifications and are the same or similar in design, function, performance characteristics, and intended use as the predicate device.

The AVD Radial Drapes and the HVO Drapes are similar in that:

. They have the same intended use;
They have the same or similar physical and mechanical specifications; .
The materials of construction are the same or very similar; ●
Thev have the same principle of operation and performance; �
They both meet applicable performance requirements; .
Thev are both biocompatible. o

The differences between the AVD Radial Drapes and the HVO Drapes are:

The material used in the AVD Drapes are lighter weight than the HVO drape . material;
The layout of the AVD Drapes and dimensions are slightly different from the . HVO Drapes to be specifically suited for vascular access procedures;
The AVD Drapes are provided sterile, while the HVO Drapes are provided . non-sterile.

There are no significant differences between the AVD Drapes and the predicate device that would adversely affect the use of the device, and the differences do not raise any new issues of safety or effectiveness. The comparison table on the following page summarizes the similarities and differences.

{2}------------------------------------------------

Parameter	AVD Radial Drapes,K131571 (this submission)	Various Disposable Non-Sterile Drapes, K050508	SubstantialEquivalence
Indicationsfor Use	Single use sterile devicesintended for use by medicalprofessionals as a protectivepatient covering, such as toisolate a site of surgical incisionor vascular puncture frommicrobial and othercontamination. The drapes areattached to the patient inproximity to a vascular puncturesite to isolate vascular accesspunctures from microbial andother contamination duringprocedures includingangiographies andpercutaneous interventions.	Disposable, non-steriledrape. Intended to be usedby medical professionalsas protective coverings,such as a patient coveringto isolate a site for surgicalincision fromcontamination. Designedto be repackaged and/orsterilized before use.	Substantiallyequivalent; the AVDDrapes are designedfor use in specificprocedures, while theHVO Drapes are forgeneral surgical use.The AVD Drapes areprovided sterile as aconvenience for theuser.
Sterility	Sterile (EO)	Non-SterileMust be sterilized beforeuse (EO)	No adverse effect onS&E the sterile AVDDrapes are aconvenience for theuser.
		Physical Specifications
Materials	Non-woven rayon absorbentlayerPolypropylene adhesivelaminating layerPolyester film barrier layerMedical grade double-sided·adhesive tapes (PE, LDPE)	SMS, Micro-embossedLDPE, Clear LDPE,Nonwoven (wetlaidcellulose), Airtex, Sontara,Krayton,Medical Grade Single andDouble Coated Tapes,Bridging, Polyfoam,Velcro, Polyester Mesh,Hot Melt, Cold Glue andCoated Medical GradeLiners.	Substantiallyequivalent; the AVDDrape materials areincluded in K050508materials list.
Size	Approx. 38" ± 1" long by 29"±1" wide	Various	Not a significantdifference; the AVDDrape is sized for usein specific procedures.
BarrierProtection	Barrier Level 4(ANSI/AAMI PB70)	Not stated	Unknown
Resistanceto tears	Pass(ASTM D5587-08, WSP 100.2)	Not stated	Unknown
TensileStrength	Pass(ASTM 5034-09)	Not available	Unknown
Flammability	Class I (16 CFR 1610	Not available	Unknown

Comparison Table, AVD Radial Drapes vs. HVO Drapes

・

{3}------------------------------------------------

Parameter	AVD Radial Drapes,K131571 (this submission)	Various Disposable Non-Sterile Drapes, K050508	SubstantialEquivalence
Biocompatibility
Cytoxicity	Non-cytotoxic(ISO 10993-5:2009)	Not available	Unknown
SkinSensitization	Non-sensitizing(ISO 10993-10:2002)	Not available	Unknown
SkinIrritation	Non-irritating(ISO 10993-10:2002)	Not available	Unknown
EOResiduals	Acceptable(ISO 10993-10:2008)	Not available	Unknown

G. Non-clinical Testing

In accordance with applicable test standards and methods, non-clinical performance testing of the AVD Radial Drapes consisted of tensile strength, resistance to tearing, resistance to penetration by synthetic blood/liquid barrier protection, biocompatibility (cytotoxicity, irritation, sensitization, EO residuals), sterilization validation, and

flammability testing. Testing specifics are listed in the Comparison Table in Section F above. The Drapes met the stated acceptance criteria for the non-clinical testing.

H. Clinical Testing

Clinical performance is not applicable for this product. Therefore clinical testing is not included in this submission.

1. Conclusions Drawn from Testing

. .

The non-clinical testing results demonstrate that the AVD Drapes are substantially equivalent to the predicate device and do not raise new questions about safety and effectiveness. Testing included biocompatibility testing (cytotoxicity, sensitization, imitation) according to ISO 10993, barrier protection classification according to ANSI/AAMI PB:70, tensile strength, tear resistance, flammability, sterilization validation, and sterilization residuals.

Page 7

{4}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized abstract symbol resembling a bird or a person with outstretched arms. The symbol is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the symbol. The logo is black and white.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 31, 2014

Advanced Vascular Dynamics, Incorporated Mr. Matthew Semler President 4252 SE International Way, Suite F Milwaukie, OR 97222

Re: K131571

Trade/Device Name: AVD Right Radial Drape Regulation Number: 21 CFR 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: KKX Dated: December 9, 2013 Received: December 11, 2013

Dear Mr. Semler:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

{5}------------------------------------------------

Page 2 - Mr. Semler

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Image /page/5/Picture/7 description: The image shows a signature and some text. The text includes "Tejashri Purohit-Sheth, M.D., Clinical Deputy Director, DAGRID, FOR". The signature is illegible. The image is in black and white.

Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Sincerely yours.

Enclosure

{6}------------------------------------------------

Indications for Use

510(k) Number (if known): _ K131571

Device Name:

AVD Radial Drapes

Indications for Use:

Prescription Use _ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elizabeth Claverie -S
2014.01.30T17:27:33-05'00'

Confidential

Regulation Number and Section

§ 878.4370 Surgical drape and drape accessories.

(a)
Identification. A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.(b)
Classification. Class II (special controls). The device, when it is an ear, nose, and throat surgical drape, a latex sheet drape with self-retaining finger cot, a disposable urological drape, a Kelly pad, an ophthalmic patient drape, an ophthalmic microscope drape, an internal drape retention ring (wound protector), or a surgical drape that does not include an antimicrobial agent, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.