(109 days)
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Not Found
No
The device description and intended use clearly define the device as a surgical drape made of natural/synthetic material for physical protection, with no mention of software, data processing, or AI/ML capabilities.
No
The device is a surgical drape intended to protect from contamination, not to treat a disease or condition.
No
The device is described as a surgical drape intended to protect from contamination during surgical procedures, not to diagnose any condition.
No
The device description explicitly states it is a surgical drape made of natural and/or synthetic material, which are physical components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a surgical drape used to protect patients and personnel from the transfer of microorganisms, body fluids, and particulate material during surgical procedures. This is a physical barrier function.
- Definition of IVD: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Lack of Diagnostic Function: The description of the primaGARD Surgical Drapes does not mention any testing, analysis of biological samples, or diagnostic capabilities. Its function is purely protective and physical.
Therefore, the primaGARD Surgical Drapes fall under the category of a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The primaGARD Surgical Drapes are Nonsterile Surgical Drape, identified in 21 CFR, part 878.4730, as a medical device intended to be used by operating room personnel during surgical procedures to protect both the surgical patients and the operating room personnel from the transfer of microorganisms, body fluids, and particulate material. The drapes are made of natural and/or synthetic material and used as a protective patient covering. One example of use of this drape is to isolate the site of surgical incision from particulate, microbial and other forms of contamination.
Product codes
KKX
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
operating room personnel during surgical procedures
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized representation of a human figure, with three curved lines forming the body and head. The figure is facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 23 2002
Ms. Brenda Lee Manager, Regulatory Affairs & Quality Assurance PrimeLine Medical Products, Incorporated 10707-100" Avenue, Suite 300 Edmonton, Alberta CANADA T5J 3M1
Re: K021864
Trade/Device Name: Primagard Nonsterile Femoral Angiography Drapes (Models PM1-0136, PM1-0119, PM1-0142) Regulation Number: 878.4370 Regulation Name: Surgical Draper and Drape Accessories Regulatory Class: II Product Code: KKX Dated: September 10, 2002 Received: September 11, 2002
Dear Ms. Lee
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.
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Page 2 - Ms. Lee
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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 regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely yours,
Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Statement of Indications for Use
510(k) Number: K 02/ 964
FEMORAL ANGIOGRAPHY
Device Name: PrimeLine Medical Products Inc. primaGARD Surgical Drapes
The primaGARD Surgical Drapes are NoNSterile Surgical Drape, identified in 21 CFR, part 878.4730, as a medical device intended to be used by operating room personnel during surgical procedures to protect both the surgical patients and the operating room personnel from the transfer of microorganisms, body fluids, and particulate material. The drapes are made of natural and/or synthetic material and used as a protective patient covering. One example of use of this drape is to isolate the site of surgical incision from particulate, microbial and other forms of contamination.
Brenda
Brenda Lee
June 5, 2002
Date:
K021864 Premarket Notification (510K Number)
Qiu S. Lin
510(k) Number:
(Division Sign-Off) Division of Anesthesiology, General Hospital. Infection Control, Dental Devic