Who is the manufacturer of IMC SURGICAL DRAPE?

International Medsurg Connection filed the 510(k) submission for IMC SURGICAL DRAPE (K100991).

What is the FDA product code for IMC SURGICAL DRAPE?

KKX. It is classified under 21 CFR 878.4370 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for IMC SURGICAL DRAPE?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like IMC SURGICAL DRAPE?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

IMC SURGICAL DRAPE

Q: What are the predicate devices for IMC SURGICAL DRAPE?

3M Steri-Drape (K031287); Medline Blockade and Resistat Non-Sterile Surgical Gowns and Surgical Drapes (K003755).

K100991 · International Medsurg Connection · KKX · Oct 5, 2010 · General, Plastic Surgery

Device Facts

Record ID	K100991
Device Name	IMC SURGICAL DRAPE
Applicant	International Medsurg Connection
Product Code	KKX · General, Plastic Surgery
Decision Date	Oct 5, 2010
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4370
Device Class	Class 2

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

Device Story

IMC Surgical Drape consists of patient protective coverings designed to isolate surgical incision sites and prevent contamination. Devices feature an integrated latex-free rubber finger cot and a fluid collection bag. Available in multiple configurations (Bladder Suspension, GYN, TUR) with varying dimensions and aperture sizes. Used in clinical surgical environments by healthcare professionals. Drapes are provided either sterile or non-sterile (for OEM EO sterilization). Functionality relies on physical barrier properties to maintain a sterile field during procedures.

Clinical Evidence

Bench testing only. Performance characteristics evaluated against ISO and ASTM standards: Flammability (16 CFR Part 1610, Class I), Hydrostatic Pressure (AATCC 127-2008), Impact Penetration (AATCC 42-2007), Linting (ISO 9073-10), and Tensile Testing (ASTM D5034-2009). All results met intended use requirements and were comparable to predicate devices.

Technological Characteristics

Materials tested per ISO 10993-5, 10993-10, and 10993-11. Features include non-latex rubber finger cot and fluid collection bag. Sterilization via Ethylene Oxide (EO) per ANSI/AMMI/ISO 11135. Mechanical properties verified via ASTM D5034-2009 and AATCC standards.

Indications for Use

Indicated for use as protective surgical drapes to isolate incision sites and prevent contamination during surgical procedures, including bladder suspension, GYN, and TUR procedures. Suitable for use in clinical surgical settings.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

3M Steri-Drape (K031287)
Medline Blockade and Resistat Non-Sterile Surgical Gowns and Surgical Drapes (K003755)

Related Devices

K100208 — IMC SURGICAL DRAPE · International Medsurg Connection · Apr 20, 2010
K052169 — IMC SURGICAL DRAPES · International Medsurg Connection, Inc. · Nov 17, 2005
K042131 — PROMEDICAL SURGICAL DRAPES · Promedical Products Co., Ltd. · Dec 10, 2004
K061422 — SURGICAL DRAPES · Austin Medical, Inc. · Sep 25, 2006
K980210 — VARIOUS SURGICAL OR PATIENT DRAPES · Gel-Lite, LLC · May 15, 1998

Submission Summary (Full Text)

{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)