(97 days)
Not Found
No
The 510(k) summary describes a surgical drape, a physical barrier, and makes no mention of AI, ML, image processing, or any software-driven analytical capabilities. The predicate device is also a surgical drape.
No
The device is described as a protective covering for isolating incision sites and protecting against contamination during surgical procedures, which serves a preventative and protective function rather than a therapeutic one.
No.
Explanation: The device is described as a protective covering for isolating incision sites and protecting against contamination during surgical procedures. Diagnostic devices are used to identify or characterize diseases or conditions, which is not the stated purpose of this device.
No
The device description clearly identifies it as a "Surgical Drape," which is a physical, non-software medical device. The intended use also describes a physical barrier.
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 a surgical procedure on a patient's body.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a person's health. They are used outside the body (in vitro).
- Lack of IVD Characteristics: The description doesn't mention any analysis of biological samples, diagnostic testing, or any function related to determining a medical condition or state of health through laboratory analysis.
Therefore, the device described is a surgical drape, which is a medical device used for infection control during surgery, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
International Medsurg Connection's Surgical Drape is intended to be used miomational moded goverings used to isolate incision sites and protect against contamination during surgical procedures.
Product codes
KKX
Device Description
International Medsurg Connection Surgical Drape.
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
Not Found
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)
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
JUN 7 - 2005
SUMMARY OF THE SAFETY AND EFFECTIVENESS 10.0
International Medsurg Connection Surgical Drape
| Manufacturer: | International Medsurg Connection, Inc.
935 N Plum Grove Road, Suite F
Schaumburg, Illinois 60173-4770 |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory Contact: | Manny Gupta
Vice President / General Manager
International Medsurg Connection, Inc.
935 N Plum Grove Road, Suite F
Schaumburg, Illinois 60173-4770 |
| Telephone: | 847-619-9929 |
| Date Summary Prepared: | February 18, 2005 |
| Product Trade Name: | Angiography & Cardiovascular Drapes |
| Common Name: | Surgical Drape. |
| Classification: | Class II |
| Predicate: | Surgical Drapes, Reference K030365 owned
by DeRoyal Industries. |
| Description: | International Medsurg Connection
Surgical Drape. |
Intended Use:
International Medsurg Connection's Surgical Drape is intended to be used miomational moded goverings used to isolate incision sites and protect against contamination during surgical procedures.
Substantial Equivalence:
The International Medsurg Connection Surgical Drapes are substantially The Intomational Mousang Surgical Drape sold by DeRoyal Industries, Reference K030365.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it. The symbol is positioned to the right of the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA", which is arranged in a circular fashion around the symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 7 - 2005
Mr. Manny Gupta Vice President/General Manager International Medsurg Connection, Incorporation 935 N. Plum Glove Road, Suite F Schaumburg, Illinois 60173-4770
Re: K050538
Ro20250
Trade/Device Name: IMC Angiography & Cardiovascular Drapes Regulation Number: 21 CFR 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: KKX Dated: April 25, 2005 Received: April 28, 2005
Dear Mr. Gupta:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becalen by 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 interstate conmisered proces that have been reclassified in accordance with the provisions of Allendinents, of to devrees mat neve obct (Act) that do not require approval of a premarket the rouch i vou, Drug, and Ocentras, therefore, market the device, subject to the general approval application (1 the Act. The general controls provisions of the Act include controls provinces of the Frida. Iisting 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 (FMA), It may be subject to back adamf Federal Regulations, Title 21, Parts 800 to 898. In your device can oc found in the South nownerments concerning your device in the Federal Register.
2
Page 2 - Mr. Gupta
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA S Issualled of a substant newices with other requirements
mean that FDA has made a determination that your device complies with other Federal acce mean that FDA has made a deceminations administered by other Federal agencies.
of the Act or any Federal statutes and regulations administed to registration of the Act of any rederal statues and reguirements . including, but not limited to: registration .
You must comply with all the Act's requirements . . . . . . . . . . . . . . You must comply with an the Act 3 require.com 801); good manufacturing practice
and listing (21 CFR Part 807); labeling (21 CFR Part 801); gEP Part 830); and i and listing (21 CFR Fall 807), labeling (21 CFR Party of (21 CFR Part 820); and if requirements as set form in the quality systems (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) I his letter will anow you to begin mading of substantial equivalence of your device to a premarket notification. The I DA miding of sabstains of 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), If you desire specific advice for your de rooms of the more and the regulation prease contact the Office of Comphanes are 210 - 11 - 1 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtail other general miorination of en your and Consumer Assistance at its toll-free Divisor (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Suyite Michael Omd.
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
3
Indications for Use
510K Number : K050538
Device name: IMC Angiography & Cardiovascular Drapes
Indication For Use:
This device is intended to be used as protective coverings used to isolate i ris device is intended to be ass a as a mamination during surgical procedures.
This submission includes drapes that will be sold both sterile and non-sterile. This submission moduces that this for EtO sterilization according to ISO Nor-stente drapes are to be sold directly to users after EtO sterilization, validated to ISO 11135.
Prescription Use X (Partb21 CFR 801 Subpart D) AND/OR
Over-The counter Use (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)
Suer Runnebaum
(Division Sign-off) Division of anesthesiology, General Hospital. Infection Control Dental Devices
(Division Sign-Off) (Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number:________________________________________________________________________________________________________________________________________________________________