(143 days)
No
The device is a simple fluid collection drape and the summary contains no mention of AI, ML, or any related technologies.
No
This device is a drape for fluid collection during obstetrics procedures, which is a supportive tool, not a device directly involved in treating a disease or condition.
No
The device is a drape for fluid collection during obstetric procedures. It does not perform any diagnostic function such as detecting, diagnosing, or monitoring a disease or condition. Its purpose is to manage fluid, not to provide diagnostic information.
No
The device is described as a "Fluid Collection Under Buttocks Drape," which is a physical medical device, not software. The performance studies listed are for biological safety testing of a physical material.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for fluid collection during obstetrics procedures by being placed under a patient's buttocks. This is a physical collection of bodily fluids, not an analysis or testing of those fluids to diagnose a condition.
- Device Description: The description is for a "Fluid Collection Under Buttocks Drape," which is a physical barrier and collection tool.
- Lack of IVD Characteristics: The description does not mention any components or processes related to:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting specific substances or markers
- Providing diagnostic information about a patient's health status
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely for physical fluid collection.
N/A
Intended Use / Indications for Use
International Medsurg Connection's Fluid Collection Under Buttocks Drape is intended to be used as Fluid Collection and by placing under a patient's buttocks in obstetrics procedure (with absorbent pad).
Product codes (comma separated list FDA assigned to the subject device)
KKX
Device Description
The International Medsurg Connection Fluid Collection Under Buttocks Drape.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Buttocks
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)
International Medsurg Connection Fluid Collection Under Buttocks Drape were tested for:
- Cytotoxicity (ISO 10993-Part 5)
- Skin Sensitivity (ISO 10993 - Part 10)
- Skin Irritation (ISO 10993 - Part 10)
- Systemic Toxicity (ISO 10993 - Part 11)
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.
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
K04-2893
MAR 1 1 7:005
SUMMARY OF THE SAFETY AND EFFECTIVENESS 10.0
International Medsurg Connection Fluid Collection Under Buttocks Drape
| Manufacturer: | International Medsurg Connection, Inc.
935 N Plum Grove Road, Suite F
Schaumburg, Illinois 60173-4770 |
|-----------------------|-------------------------------------------------------------------------------------------------------------|
| Regulatory Contact: | Teodoro Santiago
TRS Consultant, Inc.
P.O. Box 100624
Cudahy, WI 53110 |
| Telephone: | 414-861-2178 |
| Date Summary Prepared | October 5, 2004 |
| Product Trade Name: | Fluid Collection Under Buttocks Drape |
| Common Name: | Under Buttocks Drape. |
| Classification: | Class II |
| Predicate: | Under Buttocks Drapes, Reference
K845112 owned by Kimberly Clark
Corporation. |
| Description: | The International Medsurg Connection
Fluid Collection Under Buttocks Drape. |
Intended Use:
International Medsurg Connection's Fluid Collection Under Buttocks Drape is intended to be used as Fluid Collection and by placing under a patient's buttocks in obstetrics procedure (with absorbent pad).
Substantial Equivalence:
The International Medsurg Connection Fluid Collection Under Buttocks Drapes are substantially equivalent to the Kimberly Clark Fluid Collection Under Buttocks Drape (catalog number 89414) sold by Kimberly Clark, Reference K842115.
INTERNATIONAL MEDSURG CONNECTION, INC. 510K NOTIFICATION
1
Summary of testing:
International Medsurg Connection Fluid Collection Under Buttocks Drape were tested for:
| Test | Standard |
|---|---|
| Cytotoxicity | ISO 10993-Part 5 |
| Skin Sensitivity | ISO 10993 - Part 10 |
| Skin Irritation | ISO 10993 - Part 10 |
| Systemic Toxicity | ISO 10993 - Part 11 |
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the perimeter. In the center of the seal is a stylized caduceus, which is a symbol of medicine. The caduceus has three lines that represent the three branches of government: the executive, legislative, and judicial branches.
MAR 1 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
International Medsurg Connection, Incorporated C/O Mr. Teodoro Santiago Regulatory Consultant Total Regulatory Systems Consultant, Incorporated P.O. Box 100624 Cudahy, Wisconsin 53110
Re: K042893
Trade/Device Name: International Nedsurg Connection's Fluid Collection Under Buttocks Drape Regulation Number: 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: KKX Dated: February 22, 2005 Received: February 24, 2005
Dear Mr. Santiago:
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 cnactment date of the Mcdical Device Amendie ecomments, 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 the Federal FUGU, ITCag, in Cay, therefore, market the device, subject to the general approvisions 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.
3
Page 2 - Mr. Santiago
Please be advised that FDA's issuance of a substantial equivalence determination does not r lease be act recommation that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. or 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 and fishing (21 CF read on 1), and 100 million (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) Fins reter will and in J . The FDA finding of substantial equivalence of your device to a premarket tication on - - device results in a classification for your device and thus, permits your device to proceed to the market.
If vou desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Inter 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/industry/support/index.html.
Sincerely yours,
Carls
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
4
Indications for Use
510K Number : K042893
Device name: International Medsurg Connection's Fluid Collection Under Buttocks Drape
Indication For Use:
International Medsurg Connection's Fluid Collection Under Buttocks Drape is intended to be used in obstetric procedure to collect fluid and by placing under a patient's buttocks (with absorbent pad).
Prescription Use______________________________________________________________________________________________________________________________________________________________ (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)
Shale A. Murphy, KG
(Division Sign-off)
Division of anesthesiology, General Hospital. Infection Control Dental Devices