(300 days)
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. |
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. |
This submission is for a Class II medical device, specifically an operating room equipment drape. As such, the FDA 510(k) summary focuses on demonstrating "substantial equivalence" to predicate devices rather than providing detailed acceptance criteria and study results typical of higher-risk devices or AI/software as a medical device submissions.
Based on the provided text, here's a breakdown:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or performance metrics for the OR Specific Big Case Back Table Cover. Instead, the demonstration of substantial equivalence relies on similarities in:
- Intended Use: "to provide and maintain a barrier against contamination" (identical to predicate devices).
- Materials: "manufactured from similar materials to the predicate devices."
- Packaging, Sterilization, and Labeling: "packaged, sterilized and labeled in a similar manner."
- Function: "function in an identical manner to other equipment drapes currently being marketed for the same intended use."
Therefore, the "reported device performance" is implicitly that it performs equivalently to the listed predicate devices in its barrier function, sterility, and ease of use, as suggested by its substantial equivalence determination.
| Acceptance Criteria Category | Reported Device Performance (as implied by substantial equivalence) |
|---|---|
| Barrier against contamination | Provides and maintains a barrier against contamination, functionally identical to predicate devices. |
| Material composition | Manufactured from similar poly film and non-woven materials as predicate devices. |
| Sterility | ETO sterilized, similar to predicate devices. |
| Packaging | Packaged in heat-sealed medical grade paper and poly film pouches, similar to predicate devices. |
| Labeling | Labeled in a similar manner to predicate devices. |
| Fit and Function | Designed to fit, attach to, and cover OR Specific Big Case Back Tables, functioning identically to other equipment drapes for the same intended use. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document makes no mention of a test set, sample size, or specific performance studies with data provenance. The substantial equivalence determination is based on a comparison to existing predicate devices, implying that the established performance of those predicates serves as the benchmark. This type of submission typically relies on existing knowledge of similar devices, material properties, and manufacturing processes rather than new clinical or performance studies for this device class.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No "ground truth" establishment using experts for a test set is described or required for this type of 510(k) submission for an equipment drape.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set or adjudication method is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a physical sterile drape, not an AI or software device, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. The concept of "ground truth" in the context of diagnostic accuracy, as it applies to AI/software, is not relevant to a sterile equipment drape. The "ground truth" for this device's efficacy is the established performance and safety record of its predicate devices, which are also simple barrier drapes.
8. The sample size for the training set
Not applicable. There is no mention of a training set as this is not an AI/software device.
9. How the ground truth for the training set was established
Not applicable. There is no mention of a training set or ground truth establishment for a training set.
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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 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) |
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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
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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.
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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
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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 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 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
§ 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.