(179 days)
No
The document describes a surgical drape, a physical barrier, and does not mention any computational or analytical capabilities that would involve AI or ML.
No
Explanation: The device is described as a "protective covering" used to "isolate incision sites and protect against contamination during surgical procedures." It does not claim to treat, prevent, or diagnose a condition directly.
No
Explanation: The device is described as a protective covering for isolating incision sites and protecting against contamination during surgical procedures. There is no mention of it being used to diagnose conditions or obtain diagnostic information.
No
The device description clearly indicates it is a physical surgical drape with a finger cot, not a software application.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the devices are "protective coverings used to isolate incision sites and protect against contamination during surgical procedures." This describes a physical barrier used during surgery, not a test performed on a sample from the body to diagnose a condition.
- Device Description: The description reinforces this by calling them "patient protective coverings."
- Lack of IVD characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device's function is entirely in vivo (within the body) as a physical barrier during surgery.
N/A
Intended Use / Indications for Use
These devices are intended to be used as protective coverings used to isolate incision sites and protect against contamination during surgical procedures with the additional feature of a finger cot which is latex-free rubber. This submission includes drapes that will be sold both sterile and non-sterile.
Non-sterile drapes are to be sold to OEMs for EO sterilization according to ANSI/AMMII/ISO 11135. Sterile drapes are to be sold directly to users after EO sterilization validation to ANSI/AMMII/ISO 11135
Product codes
KKX
Device Description
The IMC Surgical Drape devices are patient protective coverings used to isolate incision sites and protect against contamination during surgical procedures with the additional feature of a finger cot which is made of non-latex rubber.
The Bladder Suspension Drape, the GYN Drape and the TUR drape have the same features and same materials but have different dimension of drape and aperture.
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
Performance Characteristics:
- Flammability of Clothing Textiles Section 11; Test Method: 16 CFR Part 1610; Result: Class I
- Hydrostatic Pressure Section 12; Test Method: AATCC 127-2008; Result: Meets Intended use
- Impact Penetration Section 13; Test Method: AATCC 42-2007; Result: Meets Intended use
- Determine Lint and Other particles Section 14; Test Method: ISO 9073-10; Result: Meets Intended use
- General Tensile Testing of Fabric Section 15; Test Method: ASTM D5034-2009; Result: Meets Intended use
Key Metrics
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
K100991 510(K) SUMMARY
| Trade Name: | IMC Surgical Drape | |
|---|---|---|
| Common Name: | Surgical Drape | |
| Classification Name: | Surgical Drape and Drape Accessories | |
| (21 CFR subpart E §878.4370) | ||
| Submitter Information: | International Medsurg Connection | |
| 935 N Plum Grove Rd, STE F | ||
| Schaumburg, Illinois 60173 | OCT 5 2010 | |
| Summary Prepared By: | Peter Kim | |
| Quality Manager | ||
| International Medsurg Connection | ||
| 935 N Plum Grove Rd, STE F | ||
| Schaumburg, Illinois 60173 | ||
| Telephone: 847-619-9926 | ||
| Fax: 847-619-9927 | ||
| e-mail: peterkim@intlmedsurg.com | ||
| Date Prepared: | June 7, 2010 | |
| Predicate Devices: | • 3M Steri-Drape™ (K031287) | |
| • Medline (K003755) |
Device Name(s):
IMC Surgical Drape
Classification Panel:
General and Plastic Surgery
Legally Marketed Device Under Which Substantial Equivalence is Being Claimed:
International Medsurg Connections, Inc is claiming substantial equivalence of the IMC Surgical Drape with the currently marketed:
| Description | 510(k) Number | Clearance Date |
|---|---|---|
| 3M Steri-DrapeTM | K031287 | 9/10/2003 |
| Medline BlockadeTM and ResistatTM Non-Sterile | ||
| Surgical Gowns and Surgical Drapes | K003755 | 2/16/2001 |
Device Description
The IMC Surgical Drape devices are patient protective coverings used to isolate incision sites and protect against contamination during surgical procedures with the additional feature of a finger cot which is made of non-latex rubber.
1
K 100991
The Bladder Suspension Drape, the GYN Drape and the TUR drape have the same features and same materials but have different dimension of drape and aperture.
Statement of Intended Use
These devices are intended to be used as protective coverings used to isolate incision sites and protect against contamination during surgical procedures with the additional feature of a finger cot which is latex-free rubber. This submission includes drapes that will be sold both sterile and non-sterile.
Non-sterile drapes are to be sold to OEMs for EO sterilization according to ANSI/AMMI/ISO 11135. Sterile drapes are to be sold directly to users after EO sterilization validation to ANSI/AMMI/ISO 11135
| Catalog Number | Description |
|---|---|
| 31-0051 | Bladder Suspension Drape |
| 31-0051NS | Bladder Suspension Drape |
| 61-0091 | GYN Drape |
| 61-0091NS | G YN Drape |
| 81-0011 | TUR Drape |
| 81-0011NS | TUR Drape |
New Devices as Compared to Marketed Device(s)
The IMC Surgical Drape and the predicate devices (3M Steri Drape TM, and Medline Blockade™ and Resistat™ Non-Sterile Surgical Gowns and Surgical Drapes) to be used as protective coverings used to isolate incision sites and protect against contamination during surgical procedures with the additional feature of a finger cot.
| Feature/
Characteristic | IMC Surgical Drape K100991 | 3M Steri-DrapeTM
K031287
(Predicate) | Medline
K003755
(Predicate) |
|-------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|-----------------------------------|
| Material Composition
Aperture for surgical
site | These materials were tested in
accordance with ISO 10993-
5:2009, 10993-
10:2002/Amd.1:2006, and
10993-11:2006(E) test
methods and were found to be
acceptable for the intended use | Similar | Similar |
| Absorbent Prevention
Fabric | These materials were tested in
accordance with ISO 10993-
5:2009, 10993-
10:2002/Amd.1:2006, and
10993-11:2006(E) test
methods and were found to be | Same | Same |
2
510(h) Summery K100991
| Feature/
Characteristic | IMC Surgical Drape K100991 | 3M Steri-DrapeTM
K031287
(Predicate) | Medline
K003755
(Predicate) |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|-----------------------------------|
| Finger Cot | acceptable for the intended use
These materials were tested in
accordance with ISO 10993-
5:2009, 10993-
10:2002/Amd.1:2006, and
10993-11:2006(E) test
methods and were found to be
acceptable for the intended use | Same | same |
| Color Additive | These materials were tested in
accordance with ISO 10993-
5:2009, 10993-
10:2002/Amd.1:2006, and
10993-11:2006(E) test
methods and were found to be
acceptable for the intended use | Same | Same |
| Design Feature
Finger Cot | Bladder Suspension Drape,
GYN Drape,
TUR Drape | Same | Same |
| Fluid Collection
Bag | Bladder Suspension Drape,
GYN Drape,
TUR Drape | Same | Same |
| Aperture
Bladder
Suspension | 40cm (15.7") x 41cm (16.1") | Similar | Similar |
| GYN | 25cm (9.8") x 25 cm (9.8") | Similar | Similar |
| TUR | 12.5cm (4.9") x 7.5cm (2.95") | Similar | Similar |
Performance Data:
10 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1
ាច្រើន ប្រ
100 million in the state of the states of the states of the states of the states of the states of the states of the states of the states of the states of the states of the st
| Performance
Characteristics | Test Method | IMC Surgical
Drape K100991 | 3M Steri-DrapeTM
K031287
(Predicate) | Medline
K003755
(Predicate) |
|-----------------------------------------------------|------------------|-------------------------------|--------------------------------------------|-----------------------------------|
| Flammability of Clothing
Textiles
Section 11 | 16 CFR Part 1610 | Class I | Same | Same |
| Hydrostatic Pressure
Section 12 | AATCC 127-2008 | Meets Intended
use | Same | Same |
| Impact Penetration
Section 13 | AATCC 42-2007 | Meets Intended
use | Same | Same |
| Determine Lint and Other
particles
Section 14 | ISO 9073-10 | Meets Intended
use | Same | Same |
| General Tensile Testing of
Fabric
Section 15 | ASTM D5034-2009 | Meets Intended
use | Same | Same |
3
Conclusions:
The indications for use, technology, specification, safety of the IMC Surgical Drapes and the two predicate devices K031287 and K003755 are essentially the same. The differences between the drapes are minor and do not raise new issues of safety or effectiveness. Hence, the IMC Surgical Drapes are substantially equivalent to the predicate devices.
4
Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of two main elements: the department's name encircling a symbol. The symbol is a stylized representation of a human figure, with three abstract shapes resembling arms or limbs extending upwards. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
DCT 5 2010
International Medsurg Connection C/O Mr. Peter Kim 935 N. Plum Grove Road, Suite F Schaumberg, Illinois 60173
Re: K100991
Trade/Device Name: IMC Surgical Drape Regulation Number: 21 CFR 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: KKX Dated: September 16, 2010 Received: September 20, 2010
Dear Mr. 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 addition, FDA may publish further announcements concerning your device in the Federal Register.
5
Page 2- Mr. 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 Part 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.
Wh fer
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and dental Devices Office of Device Evaluation Center for Devices and
Radiological Health
Enclosure
6
Indications for Use Form
510(k) Number (if known): K100991
Device Name: IMC Surgical Drape
Indications for Use:
These devices are intended to be used as protective coverings used to isolate incision sites and protect against contamination during surgical procedures with the additional feature of a finger cot which is latex-free rubber. This submission includes drapes that will be sold both sterile and non-sterile.
Non-sterile drapes are to be sold to OEMs for EO sterilization according to ANSIIAMMIIISO 11135. Sterile drapes are to be sold directly to users after EO sterilization validation to ANSIIAMMIIISO 11135
| Catalog Number | Description |
|---|---|
| 31-0051 | Bladder Suspension Drape |
| 31-0051NS | Bladder Suspension Drape |
| 61-0091 | GYN Procedure Drape |
| 61-0091NS | GYN Procedure Drape |
| 81-0011 | TUR Procedure Drape |
| 81-0011NS | TUR Procedure Drape |
Prescription Use AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Elizabeth F. (Laurie) Weller
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
510(k)