(73 days)
Not Found
No
The summary describes a physical surgical drape and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is a surgical drape used to cover medical equipment, not to treat a disease or condition.
No.
The device is described as a surgical drape used to cover medical equipment, not to diagnose medical conditions.
No
The device description clearly outlines physical components (polyethylene film, polycarbonate, stainless steel pegs, butyl rubber gasket), indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "cover medical equipment in a surgical setting." This is a physical barrier function, not a diagnostic test performed on samples from the human body.
- Device Description: The description details a physical drape made of polyethylene film, polycarbonate, stainless steel, and butyl rubber. It does not mention any reagents, assays, or components used to analyze biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
The device is clearly a surgical accessory designed to maintain a sterile field around equipment during surgery.
N/A
Intended Use / Indications for Use
The Surgical Concept Designs Surgical Drape is an equipment cover used to cover medical equipment in a surgical setting. It is to be used in general surgery.
The Surgical Concept Designs Surgical Drape, Model #01001 is used to cover medical equipment in a surgical setting. It is to be used in general surgery.
Product codes (comma separated list FDA assigned to the subject device)
KKX
Device Description
The Surgical Concept Designs Surgical Drape is a generally tubular sleeve of polyethylene film with an integrated equipment attachment feature at one end made from polycarbonate, with stainless steel pegs and a butyl rubber gasket.
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
Used in general surgery.
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)
Testing has shown that the proposed device meets the applicable requirements of the standards for surgical drapes.
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
Summary of Safety and Effectiveness
AUG - 8 2008
- Submitter: Christopher Scott Surgical Concept Designs 307 Prospect Ave - 2G Hackensack, NJ 07601
- Date Prepared: May 15, 2008
Surgical Concept Designs Surgical Drape Device:
- Classification: 79 KKX - Surgical drape and drape accessories, 21 CFR 878.4370 Class 11
- Predicate Device: Advance Medical Designs Slush Drapes - K053594 Microtek Medical, Inc. Equipment Drapes - K050322
- Device Description: The Surgical Concept Designs Surgical Drape is a generally tubular sleeve of polyethylene film with an integrated equipment attachment feature at one end made from polycarbonate, with stainless steel pegs and a butyl rubber gasket.
- Intended Use: The Surgical Concept Designs Surgical Drape is an equipment cover used to cover medical equipment in a surgical setting. It is to be used in general surgery.
Comparison to Predicates:
The Surgical Concept Designs Surgical Drape consists of a polyethylene drape cut and configured to a specification with an integrated equipment attachment feature. The device is equivalent to the Microtek Medical Equipment Drape and Advance Medical Designs Slush Drapes which are also surgical drapes manufactured from polymer film cut and configured to a specification.
Surgical Concept Designs has determined that any differences in the proposed device will not impact the safety or effectiveness of the surgical drape for its intended use. Testing has shown that the proposed device meets the applicable requirements of the standards for surgical drapes.
1
Image /page/1/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's emblem, which is a stylized caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 8 2008
Mr. Christopher Scott President Surgical Concept Designs 307 Prospect Avenue, Suite 2G Hackensack, New Jersey 07601
Re: K081476
Trade/Device Name: Surgical Concept Designs Surgical Drape Regulation Number: 878.4370 Regulation Name: Surgical drape and drape Accessories Regulatory Class: II Product Code: KKX Dated: July 30, 2008 Received: August 4, 2008
Dear Mr. Scott:
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.
2
Page 2 - Mr. Scott
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 équivalence 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
H.Sommerler. Send und foe. //
Chiu S. Lin. Ph. D Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use Form
510(k) Number (if known):
Device Name: __Surgical Concept Designs Surgical Drape
Indications for Use:
The Surgical Concept Designs Surgical Drape, Model #01001 is used to cover medical equipment in a surgical setting. It is to be used in general surgery.
Prescription Use X (Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANQTHER PAGE IF NEEDED) :
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shule A. Murphy, M.D.
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K08142/
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