(246 days)
Not Found
No
The device description and performance studies focus on physical properties and barrier function, with no mention of AI/ML or data processing.
No
The device is a protective patient covering (drape) used to isolate a surgical or vascular puncture site from contamination. It does not exert a therapeutic effect on the patient.
No
Explanation: The device is described as a protective patient covering used to isolate a site of surgical incision or vascular puncture from contamination. It is a surgical drape, not a diagnostic tool that identifies or characterizes a disease or condition.
No
The device description clearly states it is composed of physical materials (fluid-resistant film, absorbent barrier, adhesive) and is a sterile, single-use physical drape, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "protective patient covering" to "isolate a site of surgical incision or vascular puncture from microbial and other contamination." This describes a physical barrier used during a medical procedure on the patient's body.
- Device Description: The description details a physical drape with layers and adhesive, designed to be placed on the patient's skin.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health. This device does not interact with or analyze any biological specimens.
- Performance Studies: The performance studies focus on physical properties of the drape (tensile strength, tear resistance, barrier protection) and biocompatibility, not on diagnostic accuracy or analysis of biological samples.
Therefore, the AVD Left and Right Radial Drapes are medical devices used on the patient during a procedure, not IVD devices used to analyze samples from the patient.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
KKX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
site of surgical incision or vascular puncture
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical professionals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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. The Drapes met the stated acceptance criteria for the non-clinical 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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:
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.
1
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.
2
·
| Parameter | AVD Radial Drapes,
K131571 (this submission) | Various Disposable Non-
Sterile Drapes, K050508 | Substantial
Equivalence |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
for Use | 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. | Disposable, non-sterile
drape. Intended to be used
by medical professionals
as protective coverings,
such as a patient covering
to isolate a site for surgical
incision from
contamination. Designed
to be repackaged and/or
sterilized before use. | Substantially
equivalent; the AVD
Drapes are designed
for use in specific
procedures, while the
HVO Drapes are for
general surgical use.
The AVD Drapes are
provided sterile as a
convenience for the
user. |
| Sterility | Sterile (EO) | Non-Sterile
Must be sterilized before
use (EO) | No adverse effect on
S&E the sterile AVD
Drapes are a
convenience for the
user. |
| | | Physical Specifications | |
| Materials | Non-woven rayon absorbent
layer
Polypropylene adhesive
laminating layer
Polyester film barrier layer
Medical grade double-sided·
adhesive tapes (PE, LDPE) | SMS, Micro-embossed
LDPE, Clear LDPE,
Nonwoven (wetlaid
cellulose), Airtex, Sontara,
Krayton,
Medical Grade Single and
Double Coated Tapes,
Bridging, Polyfoam,
Velcro, Polyester Mesh,
Hot Melt, Cold Glue and
Coated Medical Grade
Liners. | Substantially
equivalent; the AVD
Drape materials are
included in K050508
materials list. |
| Size | Approx. 38" ± 1" long by 29"
±1" wide | Various | Not a significant
difference; the AVD
Drape is sized for use
in specific procedures. |
| Barrier
Protection | Barrier Level 4
(ANSI/AAMI PB70) | Not stated | Unknown |
| Resistance
to tears | Pass
(ASTM D5587-08, WSP 100.2) | Not stated | Unknown |
| Tensile
Strength | 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 | Substantial
Equivalence |
|-----------------------|-------------------------------------------------|----------------------------------------------------|----------------------------|
| Biocompatibility | | | |
| Cytoxicity | Non-cytotoxic
(ISO 10993-5:2009) | Not available | Unknown |
| Skin
Sensitization | Non-sensitizing
(ISO 10993-10:2002) | Not available | Unknown |
| Skin
Irritation | Non-irritating
(ISO 10993-10:2002) | Not available | Unknown |
| EO
Residuals | 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:
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