(240 days)
Not Found
Not Found
No
The 510(k) summary describes a simple surgical drape and explicitly states "Not Found" for mentions of AI, DNN, or ML, as well as for details related to training/test sets and performance studies typically associated with AI/ML devices.
No
The device is a drape accessory used for protective covering and isolation in surgical settings, not for treating a disease or condition.
No
The device is described as a "drape accessory" intended to be used as a "protective patient covering" to "isolate a site of surgical incision from microbial and other contamination." This function is protective and preventative, not diagnostic.
No
The device description clearly states it is a "drape accessory made of synthetic material," indicating a physical hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to be a protective patient covering during surgery to isolate the surgical site from contamination. This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as a "drape accessory made of synthetic material." This aligns with a physical barrier, not a diagnostic instrument or reagent.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
Based on the provided information, the Securline Operating Room Drape is a medical device used in a surgical setting for patient protection, not for in vitro diagnostic purposes.
N/A
Intended Use / Indications for Use
The Securline Operating Room Drape is a drape accessory made of synthetic material intended to be used as a protective patient covering such as to isolate a site of surgical incision from microbial and other contamination.
Product codes
KKX
Device Description
The Securline Operating Room Drape is a drape accessory made of synthetic material intended to be used as a protective patient covering such as to isolate a site of surgical incision from microbial and other contamination.
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
Operating Room
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)
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
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines representing the wings and a wavy line representing the body.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 4 1999
Mr. Mike J. Caudwell Amba Medical Limited Unit 5, Bonville Trading Estate Bonville Road, Brislington, Bristol United Kingdom BS4 5QH
K990253 Re : Securline Operating Room Camera Drape, Model Trade Name: #3600 Requlatory Class: II Product Code: KKX Dated: January 25, 1999 Received: January 27, 1999
Dear Mr. Caudwell:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਉ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of
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Paqe 2 -Mr. Caudwell
the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA findinq 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4690. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the oriece of compilance and companding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda?gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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PMN 510(k) number: K990253
STATEMENT OF INDICATIONS FOR USE
Device name: 'Securline' Operating Room Camera Drape #3600
Classification name: Drape, surgical 79KKX
The Securline Operating Room Drape is a drape accessory made of synthetic material intended to be used as a protective patient covering such as to isolate a site of surgical incision from microbial and other contamination.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH Office of Device Evaluation(ODE)
Chin S. Lin
(Division Sign-Off) Division of Dental, Infection Contr and Ger 510(k) Nu
Prescription Use_ (Per 21 CFR801.109) OR
Over-The-Counter Use
Contact: Mike Caudwell Tel: 011 44 117 9728888 Fax: 011 44 117 9724863