AVD RIGHT RADIAL DRAPE

K131571 · Advanced Vascular Dynamics · KKX · Jan 31, 2014 · General, Plastic Surgery

Device Facts

• Record ID: K131571
• Device Name: AVD RIGHT RADIAL DRAPE
• Applicant: Advanced Vascular Dynamics
• Product Code: KKX · General, Plastic Surgery
• Decision Date: Jan 31, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4370
• Device Class: Class 2

Indications for Use

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 Story

AVD Radial Drapes are single-use, sterile surgical drapes designed for vascular access procedures. The device consists of a fluid-resistant film layer, an absorbent barrier layer, and an adhesive material. The drape features an oval opening surrounded by adhesive tape, allowing clinicians to secure the drape directly over the surgical or vascular puncture site. By isolating the site from microbial and other contamination, the drape provides a sterile field during angiographies and percutaneous interventions. The device is supplied in Left Radial and Right Radial configurations. It is intended for use by medical professionals in clinical settings.

Clinical Evidence

No clinical data. Bench testing only. Testing included biocompatibility (ISO 10993-5:2009, ISO 10993-10:2002), barrier protection (ANSI/AAMI PB70 Level 4), tensile strength (ASTM 5034-09), tear resistance (ASTM D5587-08, WSP 100.2), flammability (16 CFR 1610), and sterilization validation.

Technological Characteristics

Materials: Non-woven rayon absorbent layer, polypropylene adhesive laminating layer, polyester film barrier layer, medical grade double-sided adhesive tapes (PE, LDPE). Barrier Level 4 (ANSI/AAMI PB70). Sterilization: Ethylene Oxide (EO). Form factor: Approx. 38" x 29" with oval access opening.

Indications for Use

Indicated for use by medical professionals as a protective patient covering to isolate surgical incision or vascular puncture sites from microbial contamination during procedures such as angiographies and percutaneous interventions.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• HVO Various Disposable Non-Sterile Drapes (K050508)

Submission Summary (Full Text)

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## 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: [phone]

Fax: [phone]

Matthew Semler, President Contact:

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

| Phone: | [phone] |
|--------|------------------------|
| Fax: | [phone] |
| Email: | [e-mail] |

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:

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.

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### E. Intended Use:

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.

## 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.

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·

| Parameter | AVD Radial Drapes,<br>K131571 (this submission) | Various Disposable Non-<br>Sterile Drapes, K050508 | Substantial<br>Equivalence |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications<br>for Use | Single use sterile devices<br>intended for use by medical<br>professionals as a protective<br>patient covering, such as to<br>isolate a site of surgical incision<br>or vascular puncture from<br>microbial and other<br>contamination. The drapes are<br>attached to the patient in<br>proximity to a vascular puncture<br>site to isolate vascular access<br>punctures from microbial and<br>other contamination during<br>procedures including<br>angiographies and<br>percutaneous interventions. | Disposable, non-sterile<br>drape. Intended to be used<br>by medical professionals<br>as protective coverings,<br>such as a patient covering<br>to isolate a site for surgical<br>incision from<br>contamination. Designed<br>to be repackaged and/or<br>sterilized before use. | Substantially<br>equivalent; the AVD<br>Drapes are designed<br>for use in specific<br>procedures, while the<br>HVO Drapes are for<br>general surgical use.<br>The AVD Drapes are<br>provided sterile as a<br>convenience for the<br>user. |
| Sterility | Sterile (EO) | Non-Sterile<br>Must be sterilized before<br>use (EO) | No adverse effect on<br>S&E the sterile AVD<br>Drapes are a<br>convenience for the<br>user. |
| | | Physical Specifications | |
| Materials | Non-woven rayon absorbent<br>layer<br>Polypropylene adhesive<br>laminating layer<br>Polyester film barrier layer<br>Medical grade double-sided·<br>adhesive tapes (PE, LDPE) | SMS, Micro-embossed<br>LDPE, Clear LDPE,<br>Nonwoven (wetlaid<br>cellulose), Airtex, Sontara,<br>Krayton,<br>Medical Grade Single and<br>Double Coated Tapes,<br>Bridging, Polyfoam,<br>Velcro, Polyester Mesh,<br>Hot Melt, Cold Glue and<br>Coated Medical Grade<br>Liners. | Substantially<br>equivalent; the AVD<br>Drape materials are<br>included in K050508<br>materials list. |
| Size | Approx. 38" ± 1" long by 29"<br>±1" wide | Various | Not a significant<br>difference; the AVD<br>Drape is sized for use<br>in specific procedures. |
| Barrier<br>Protection | Barrier Level 4<br>(ANSI/AAMI PB70) | Not stated | Unknown |
| Resistance<br>to tears | Pass<br>(ASTM D5587-08, WSP 100.2) | Not stated | Unknown |
| Tensile<br>Strength | Pass<br>(ASTM 5034-09) | Not available | Unknown |
| Flammability | Class I (16 CFR 1610 | Not available | Unknown |

| Comparison Table, AVD Radial Drapes vs. HVO Drapes | | | |
|----------------------------------------------------|--|--|--|
| | | | |

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| Parameter | AVD Radial Drapes,<br>K131571 (this submission) | Various Disposable Non-<br>Sterile Drapes, K050508 | Substantial<br>Equivalence |
|-----------------------|-------------------------------------------------|----------------------------------------------------|----------------------------|
| Biocompatibility | | | |
| Cytoxicity | Non-cytotoxic<br>(ISO 10993-5:2009) | Not available | Unknown |
| Skin<br>Sensitization | Non-sensitizing<br>(ISO 10993-10:2002) | Not available | Unknown |
| Skin<br>Irritation | Non-irritating<br>(ISO 10993-10:2002) | Not available | Unknown |
| EO<br>Residuals | Acceptable<br>(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.

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## 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.

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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 [phone] or [phone] 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 [phone] or [phone] 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

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Indications for Use

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

Device Name:

AVD Radial Drapes

Indications for Use:

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.

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