(85 days)
Not Found
No
The document describes a surgical drape, a physical barrier, and makes no mention of software, algorithms, or any technology that would typically incorporate AI/ML.
No
The device is described as a protective covering used to isolate incision sites and protect against contamination during surgical procedures, which is a barrier function, not a therapeutic one.
No
The device is described as a protective covering for surgical procedures, isolating incision sites and protecting against contamination. This function is preventative and protective in nature, not diagnostic.
No
The device description explicitly states it is a "Surgical Drape," which is a physical product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "protective coverings used to isolate incision sites and protect against contamination during surgical procedures." This describes a physical barrier used during surgery, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description reinforces the intended use as a protective covering.
- Lack of IVD Characteristics: The description 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 diagnostic information
Therefore, this device falls under the category of a surgical drape, which is a medical device but not an IVD.
N/A
Intended Use / Indications for Use
International Medsurg Connection's Surgical Drape is intended to be used as protective coverings used to isolate incision sites and protect against contamination during surgical procedures. The intended use is the same as the intended use on IMC surgical drapes sold by International Medsurg Connection, Reference K052169.
This device is intended to be used as protective coverings used to isolate incision sites and protect against contamination during surgical procedures.
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
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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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
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)
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 circular and contains the department's name around the perimeter. Inside the circle is a stylized symbol that represents human services.
Food and Drug.Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002
Mr. Peter Kim Quality Manager International Medsurg Connection 935 North Plum Grove Road, Suite F Schaumburg, Illinois 60173
Re: K100208
Trade/Device Name: IMC-Surgical Drapes - Various Types, Sizes and Configurations Regulation Number: 21 CFR 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: KKX Dated: March 8, 2010 Received: March 23, 2010
APR 2 0 2010
Dear Mr. Peter Kim:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In 1 addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Page 2- Mr. Peter Kim
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Parl 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Susa Power
Author, B.S. Nutrition, R.S.D.
Anthony D. atson, BS, MS, MBA 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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4.0 INTENDED USES / INDICATION:
International Medsurg Connection's Surgical Drape is intended to be used as protective coverings used to isolate incision sites and protect against contamination during surgical procedures. The intended use is the same as the intended use on IMC surgical drapes sold by International Medsurg Connection, Reference K052169.
This submission includes drapes that will be sold both sterile and non-sterile. Non-sterile drapes are to be sold to OEMs for EtO sterilization according to ISO 11135. Sterile drapes are to be sold directly to users according to current sterilization process. Related items are indicated at the table below.
| Category | Device Name | Catalog # | Sterile/Non-sterile |
|---|---|---|---|
| Surgical Drape | Lithotomy Procedure Drape | 21-0043 | Sterile |
| Lithotomy Procedure Drape | 21-0043NS | Non-sterile | |
| PCNL Procedure Drape | 41-0021 | Sterile | |
| PCNL Procedure Drape | 41-0021NS | Non-sterile | |
| GYN Procedure Drape | 61-0071 | Sterile | |
| GYN Procedure Drape | 61-0071NS | Non-sterile |
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ATTACHMENT
Indications for Use
510(k) Number : _ _
Device Name: IMC-Surgical Drapes-various types, sizes and configurations (Spe
Indications For Use: This device is intended to be used as protective coverings used to isolate incision sites and protect against contamination during surgical procedures.
Prescription Use X (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: KIDD208