(58 days)
Not Found
No
The device is a surgical drape made of standard materials, and the description focuses on its physical properties and intended use as a barrier. There is no mention of any computational or analytical capabilities.
No
The device is a surgical drape intended to provide a protective covering and isolate a surgical site from contamination, not to treat or diagnose a disease or condition.
No
The device described is a surgical drape, which serves as a protective barrier during surgical procedures. It does not perform any diagnostic functions like detecting, monitoring, or identifying a medical condition.
No
The device description clearly states it is made from physical materials (SMS, LDPE, etc.) and is a disposable drape, indicating it is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "protective coverings, such as a patient covering to isolate a site for surgical incision from contamination." This describes a physical barrier used during a surgical procedure.
- Device Description: The description focuses on the materials and physical properties of the surgical drapes, emphasizing their function as a barrier.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. IVDs are designed to analyze biological samples (blood, urine, tissue, etc.).
- Sterilization and Repackaging: The focus on sterilization and repackaging before use further reinforces its role as a physical barrier in a sterile environment, not a diagnostic tool.
In summary, the HVO surgical drapes are a medical device intended for physical protection during surgery, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
HVO surgical drapes are made from natural and synthetic materials intended to be used by medical professionals as protective coverings, such as a patient covering to isolate a site for surgical incision from contamination. They are designed to be repackaged and/or sterilized before use.
This single use product is a disposable non-sterile drape designed to be re-packaged and/or sterilized prior to use. This product may be sterilized using Ethylene Oxide (EO) following the Validation and Routine Control under ANSI/AMMI/ISO 11135. For more information about sterilization of this product, contact HVO, Inc.
Product codes
KKX
Device Description
The proposed HVO, Inc. Various Disposable Non-Sterile Surgical Drapes function in the same manner as predicate devices in that they are intended to be used as protective patient coverings, such as used to isolate a site of surgical incision from microbial and other contamination.
Device Design/ Materials Used/ Physical Properties: The HVO, Inc. Various Disposable Non-Sterile Surgical Drapes are made of materials commonly used for their purpose. The primary material components are 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.
Primarily all of our drapes are offered in the color blue, which is the common color for medical device materials, but some materials are offered in white or with white backing. These materials include Nonwovens, SMS, Airtex, Sontara, Polyfoam, Back Table Covers, Bridging, and LDPE's. All other materials are clear plastics or adhesives, which are not colored, but natural.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
APR 2 7 2005
Haywood Vocational Opportunities, Inc. Various Disposable Non-Sterile Surgical Drapes
510(k) Summary
Summary of the Safety and Effectiveness Information Upon Which An Equivalence Could Be Based
SPONSOR INFORMATION
Haywood Vocational Opportunities, Inc. Name: P.O. Box 7 Address: Hazelwood, N.C. 28738 Telephone: (828) 456-4455 (828) 456-4401 Fax:
DEVICE NAMES
HVO, Inc., Various Disposable Non-Sterile Surgical Drapes Name: Surgical Drapes Common/Usual Name: Classifications Name (if known): Surgical and Drape Accessories Device Names: Table Covers, OB GYN, General Surgery, Orthopedic, ENT and EENT, Drape Sheets, Cystoscopy, Craniotomy, Angiography, Fluid Pouches, and Instrument Covers.
PREDICATE OR LEGALLY MARKETED DEVICES
There are several predicate devices currently on the market that have similar function and are made from same or similar materials.
DEVICE DESCRIPTION
The proposed HVO, Inc. Various Disposable Non-Sterile Surgical Drapes function in the same manner as predicate devices in that they are intended to be used as protective patient coverings, such as used to isolate a site of surgical incision from microbial and other contamination.
Device Design/ Materials Used/ Physical Properties: The HVO, Inc. Various Disposable Non-Sterile Surgical Drapes are made of materials commonly used for their purpose. The primary material components are 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.
Primarily all of our drapes are offered in the color blue, which is the common color for medical device materials, but some materials are offered in white or with white backing. These materials include Nonwovens, SMS, Airtex, Sontara, Polyfoam, Back Table Covers, Bridging, and LDPE's. All other materials are clear plastics or adhesives, which are not colored, but natural.
DEVICE INTENDED USE
The HVO, Inc. Various Non-Sterile Surgical Drapes are intended to be used as protective patient covering, such as to isolate surgical incisions from microbial and other contamination. These proposed devices are intended to undergo sterilization by the customer prior to use in the sterile setting. These products can be sterilized by ETO. The products may be sterilized using Ethylene Oxide following the Validation and Routine Control under ANSVAAMI/ISO 11135, see section 12 for more details on sterilization.
1
Haywood Vocational Opportunities, Inc. Various Disposable Non-Sterile Surgical Drapes
510(k) Summary
TECHNOLOGICAL COMPARISON WITH PREDICATE OR LEGALLY MARKETED DEVICE(S)
| Characteristics | HVO, Inc. Devices | Other Devices |
|---|---|---|
| Materials | SMS, Micro-Embossed LDPE, Clear | |
| LDPE, Sontara, Nonwoven, Krayton, | ||
| Airtex, Polyfoam, Medical Grade Single | ||
| And Double Coated Tapes, Velcro, Cold | ||
| Glue, Hot Melt, Bridging, Polyester Mesh | ||
| Coated Medical Grade Liners | Same or similar materials | |
| Absorbency | Absorbent and Non-Absorbent | Same |
| Packaging | Bulk and Single Use | Bulk and Single Use |
| Disposable | Yes | Yes |
| Sterility | Non-Sterile | Non-Sterile and Sterile |
Page 2
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of a caduceus, which is a symbol often associated with healthcare and medicine.
APR 2 7 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Tim Kelley Director of Regulatory Affairs Haywood Vocational Opportunities, Incorporated 56 Scates Street Waynesville, North Carolina 28786
Re: K050508
Trade/Device Name: Various Disposable Non-Sterile Surgical Drapes (Table Covers, OB GYN, General Surgery, Orthopedic, ENT and ENNT, Drape Sheets, Cystoscopy, Craniotomy, Angiography, Fluid Pouches, and Instrument Covers) Regulation Number: 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: KKX Dated: April 19, 2005 Received: April 20, 2005
Dear Mr. Kelley:
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.
3
Page 2 - Mr. Kelley
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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sultie Y. Michie Omd.
Chr. Livia Ph.D.
Chíu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indication for Use
510(k) Number: K050508
Device Name: HVO, Inc. Various Disposable Non-Sterile Surgical Drapes (Table Covers, OB GYN, General Surgery, Orthopedic, ENT and ENNT, Drape Sheets, Cystoscopy, Craniotomy, Angiography, Fluid Pouches, and Instrument Covers).
Indications For Use:
HVO surgical drapes are made from natural and synthetic materials intended to be used by medical professionals as protective coverings, such as a patient covering to isolate a site for surgical incision from contamination. They are designed to be repackaged and/or sterilized before use.
This single use product is a disposable non-sterile drape designed to be re-packaged and/or sterilized prior to use. This product may be sterilized using Ethylene Oxide (EO) following the Validation and Routine Control under ANSI/AMMI/ISO 11135. For more information about sterilization of this product, contact HVO, Inc.
Prescription Use X (Part 21 CFR 801 Subpart D) and/or
Over-The-Counter Use (21 CFR 807 Subpart C)
Laird H. Mingay 13
on Sign-Off) sion Sign-Off)
sion of Anesthesiology, General Hospital, rection Control. Dental Devices
:(k) Number. 4656508