K Number
K052668
Device Name
OR SPECIFIC BIG CASE BACK TABLE COVER
Manufacturer
Date Cleared
2006-07-24

(300 days)

Product Code
Regulation Number
878.4370
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The OR Specific, Inc. Big Case Back Table Cover is a single use, sterile packaged operating room equipment drape that is intended to provide and maintain a barrier against contamination between the OR Specific dual adjustable shelf operating room equipment tables and a variety of surgical and non surgical equipment during various procedures in the clinical and hospital operating room environment. In normal use as directed this product will not make direct contact with a patient. The drape is available 4 models to meet user requirements. | Part Number | Description | |-------------|-------------| | 420HD-S | Big Case Back Table Cover (Heavy Duty) for 6' long Table (Sterile) | | 420-S | Big Case Back Table Cover (Standard) for 6' Long Table (Sterile) | | 419HD-S | Big Case Back Table Cover (Heavy Duty) for 5' Long Table (Sterile) | | 419-S | Big Case Back Table Cover (Standard) for 5' Long Table (Sterile) | Drapes are available in two lengths to fit 5 foot long and 6 foot long OR Specific dual adjustable shelf operating room equipment tables and each length of Drape is available in a Standard and Heavy Duty version differing in the thickness and composition of the poly film fluid barrier material used in the construction of the drape.
Device Description
The OR Specific, Inc. Big Case Back Table Cover is a single use, sterile packaged operating room equipment drape manufactured using poly film and non woven material, separately and in combination designed to protect a variety of Surgical and non Surgical equipment from Contamination during various procedures throughput the clinical and operating room setting. These equipment drapes are specifically designed to fit, attach to and cover the OR Specific Big Case Back Table and function in an identical manner to other equipment drapes currently being marketed for the same intended use. 2 sizes of these covers are available designed to function with 2 different sizes of OR Specific Big Case Back Tables. In addition, the product is offered in either a standard or heavy duty version as follows. | Part Number | Description | |-------------|-------------| | 420HD-S | Big Case Back Table Cover (Heavy Duty) for 6' long Table (Sterile) | | 420-S | Big Case Back Table Cover (Standard) for 6' Long Table (Sterile) | | 419HD-S | Big Case Back Table Cover (Heavy Duty) for 5' Long Table (Sterile) | | 419-S | Big Case Back Table Cover (Standard) for 5' Long Table (Sterile) | The drapes are packaged in heat sealed Medical grade paper and poly film pouches and ETO sterilized for convenient use in the clinical or hospital operating room environment. The OR Specific Big Case Back Table Cover is manufactured from similar materials to the predicate devices and is packaged, sterilized and labeled in a similar manner. In addition, the indications for use are similar or identical to those of the predicate devices.
More Information

K050322, K0302065, K931417

K050322,K0302065,K931417

No
The device description and intended use clearly define it as a physical operating room equipment drape, with no mention of software, data processing, or AI/ML capabilities. The "Mentions AI, DNN, or ML" section also explicitly states "Not Found".

No.
The device is an equipment drape intended to prevent contamination of surgical equipment, not to diagnose, treat, or prevent disease in a patient.

No

This device is an operating room equipment drape intended to provide a barrier against contamination, not to diagnose medical conditions.

No

The device is a physical operating room equipment drape made of poly film and non woven material, not software.

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
  • Device Function: The OR Specific, Inc. Big Case Back Table Cover is an equipment drape. Its purpose is to provide a sterile barrier for surgical equipment on a table in an operating room.
  • Intended Use: The intended use clearly states it's for providing and maintaining a barrier against contamination for equipment and will not make direct contact with a patient. It does not involve testing samples from the human body.

Therefore, the function and intended use of this device do not align with the definition of an In Vitro Diagnostic.

N/A

Intended Use / Indications for Use

The OR Specific, Inc. Big Case Back Table Cover is a single use, sterile packaged operating room equipment drape that is intended to provide and maintain a barrier against contamination between the OR Specific dual adjustable shelf operating room equipment tables and a variety of surgical and non surgical equipment during various procedures in the clinical and hospital operating room environment. In normal use as directed this product will not make direct contact with a patient. The drape is available 4 models to meet user requirements.

Part NumberDescription
420HD-SBig Case Back Table Cover (Heavy Duty) for 6' long Table (Sterile)
420-SBig Case Back Table Cover (Standard) for 6' Long Table (Sterile)
419HD-SBig Case Back Table Cover (Heavy Duty) for 5' Long Table (Sterile)
419-SBig Case Back Table Cover (Standard) for 5' Long Table (Sterile)

Drapes are available in two lengths to fit 5 foot long and 6 foot long OR Specific dual adjustable shelf operating room equipment tables and each length of Drape is available in a Standard and Heavy Duty version differing in the thickness and composition of the poly film fluid barrier material used in the construction of the drape.

Product codes

KKX

Device Description

The OR Specific, Inc. Big Case Back Table Cover is a single use, sterile packaged operating room equipment drape manufactured using poly film and non woven material, separately and in combination designed to protect a variety of Surgical and non Surgical equipment from Contamination during various procedures throughput the clinical and operating room setting. These equipment drapes are specifically designed to fit, attach to and cover the OR Specific Big Case Back Table and function in an identical manner to other equipment drapes currently being marketed for the same intended use.

2 sizes of these covers are available designed to function with 2 different sizes of OR Specific Big Case Back Tables. In addition, the product is offered in either a standard or heavy duty version as follows.

Part NumberDescription
420HD-SBig Case Back Table Cover (Heavy Duty) for 6' long Table (Sterile)
420-SBig Case Back Table Cover (Standard) for 6' Long Table (Sterile)
419HD-SBig Case Back Table Cover (Heavy Duty) for 5' Long Table (Sterile)
419-SBig Case Back Table Cover (Standard) for 5' Long Table (Sterile)

The drapes are packaged in heat sealed Medical grade paper and poly film pouches and ETO sterilized for convenient use in the clinical or hospital operating room environment.

The OR Specific Big Case Back Table Cover is manufactured from similar materials to the predicate devices and is packaged, sterilized and labeled in a similar manner. In addition, the indications for use are similar or identical to those of the predicate devices.

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

clinical and hospital operating room environment.

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)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K050322, K0302065, K931417

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

KOS2668

510K SUMMARY

Sponsor:

OR Specific, Inc. 4651 36th St. #500 Orlando, FL USA

JUL 2 4 2006

Proprietary/Trade Name: OR Specific Big Case Back Table Cover

Common/Usual Name: Equipment Drape

CDRH Product Regulation: Surgical Drape and drape Accessories (21 CFR 878.4370)

Device Class: Class II

Device/Product Code(s): KKX

Intended Use: The OR Specific, Inc. Big Case Back Table Cover is a single use, sterile packaged operating room equipment drape that is intended to provide and maintain a barrier against contamination between the OR Specific dual adjustable shelf operating room equipment tables and a variety of surgical and non surgical equipment during various procedures in the clinical and hospital operating room environment. In normal use as directed this product will not make direct contact with a patient. The drape is available 4 models to meet user requirements.

Part NumberDescription
420HD-SBig Case Back Table Cover (Heavy Duty) for 6' long Table (Sterile)
420-SBig Case Back Table Cover (Standard) for 6' Long Table (Sterile)
419HD-SBig Case Back Table Cover (Heavy Duty) for 5' Long Table (Sterile)
419-SBig Case Back Table Cover (Standard) for 5' Long Table (Sterile)

Drapes are available in two lengths to fit 5 foot long and 6 foot long OR Specific dual adjustable shelf operating room equipment tables and each length of Drape is available in a Standard and Heavy Duty version differing in the thickness and composition of the poly film fluid barrier material used in the construction of the drape.

Device Description: The OR Specific, Inc. Big Case Back Table Cover is a single use, sterile packaged operating room equipment drape manufactured using poly film and non woven material, separately and in combination designed to protect a variety of Surgical and non Surgical equipment from Contamination during various procedures throughput the clinical and operating room setting. These equipment drapes are specifically designed to fit, attach to and cover the OR Specific Big Case Back Table and function in an identical manner to other equipment drapes currently being marketed for the same intended use.

2 sizes of these covers are available designed to function with 2 different sizes of OR Specific Big Case Back Tables. In addition, the product is offered in either a standard or heavy duty version as follows.

Part NumberDescription
420HD-SBig Case Back Table Cover (Heavy Duty) for 6' long Table (Sterile)
420-SBig Case Back Table Cover (Standard) for 6' Long Table (Sterile)
419HD-SBig Case Back Table Cover (Heavy Duty) for 5' Long Table (Sterile)
419-SBig Case Back Table Cover (Standard) for 5' Long Table (Sterile)

1

The drapes are packaged in heat sealed Medical grade paper and poly film pouches and ETO sterilized for convenient use in the clinical or hospital operating room environment.

The OR Specific Big Case Back Table Cover is manufactured from similar materials to the predicate devices and is packaged, sterilized and labeled in a similar manner. In addition, the indications for use are similar or identical to those of the predicate devices.

Potential Risks: The potential risks associated with this device are the same as with any surgical equipment drape. These include, but are not limited to:

Incorrect Application of the Drape to the equipment to be covered Inadvertent contamination by the user during normal use Inadvertent puncture of the cover resulting in contamination during normal use

Legally Marketed Predicate Devices:

Microtek Medical, Inc. Equipment Drapes K050322 Medline Band Bags and Equipment Drapes K0302065 Custom Medical Products Equipment Drapes K931417

2

Image /page/2/Picture/1 description: The image is a seal for the Department of Health and Human Services, USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. In the center of the seal is a stylized symbol that resembles three human profiles facing to the right. The symbol is black and the background is white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Carl Knobloch Official Correspondent OR. Specific, Incorporated 4651 36" Street #500 Orlando, Florida 32811

JUL 2 4 2006

Re: K052668

Trade/Device Name: OR Specific. Inc Big Case Back Table Cover Regulation Number: 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: KKX Dated: July 5, 2006 Received: July 7, 2006

Dear Mr. Knobloch:

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, thereforc, 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. Knobloch

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 (OS) 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 vours.

Chiu 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

INDICATIONS FOR USE

510(k) Number (if known): K052668

Device Name: OR Specific, Inc. Big Case Back Table Cover

Indications for Use: The OR Specific, Inc. Big Case Back Table Cover is a single use, sterile packaged operating room equipment drape that is intended to provide and maintain a barrier against contamination between the OR Specific dual adjustable shelf operating room equipment tables and a variety of surgical and non surgical equipe ont during various procedures in the clinical and hospital non orgion equipment. In normal use as directed this product will not make direct contact with a patient. The drape is available 4 models to meet user requirements.

Part NumberDescription
420HD-SBig Case Back Table Cover (Heavy Duty) for 6' long Table (Sterile)
420-SBig Case Back Table Cover (Standard) for 6' Long Table (Sterile)
419HD-SBig Case Back Table Cover (Heavy Duty) for 5' Long Table (Sterile)
419-SBig Case Back Table Cover (Standard) for 5' Long Table (Sterile)

Drapes are available in two lengths to fit 5 foot long and 6 foot long OR Specific dual adjustable shelf operating room equipment tables and each length of Orcepe is available in a Standard and Heavy Duty version differing in the thickness and composition of the poly film fluid barrier material used in the construction of the drape.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over the Counter Use × (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Shila L. Murphy, R.D. 2/4/06

ion of Anesthesiology, General Hospital,
on Control, Dental Devices

Number K 052 668