IMC SURGICAL DRAPES

K052169 · International Medsurg Connection, Inc. · KKX · Nov 17, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K052169
• Device Name: IMC SURGICAL DRAPES
• Applicant: International Medsurg Connection, Inc.
• Product Code: KKX · General, Plastic Surgery
• Decision Date: Nov 17, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4370
• Device Class: Class 2

Intended Use

International Medsurg Connection's Surgical Drape is intended to be used as Patient protective coverings used to isolate incision sites and protect against contamination during surgical procedures. This device is intended to be used as protective coverings used to isolate incision sites and protect against contamination during surgical procedures. 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 after EtO sterilization validation to ISO 11135.

Device Story

Surgical drapes in various sizes and configurations (table covers, flat sheets, lap, cardiovascular, head/neck, general, cysto, c-section, orthopedic, specialty). Used to isolate incision sites and protect against contamination during surgical procedures. Operated by healthcare professionals in clinical/surgical settings. Drapes provided either sterile or non-sterile; non-sterile units intended for OEM EtO sterilization. Physical barrier function prevents cross-contamination between patient and surgical environment.

Clinical Evidence

Bench testing only. Materials evaluated for cytotoxicity (ISO 10993-5), skin irritation (ISO 10993-10), skin sensitivity (ISO 10993-11), systemic toxicity (ISO 10993-11), flammability (16 CFR 1610), hydrostatic pressure (AATCC 127), impact penetration (AATCC 42), lint (IST 160.1), and tensile strength (ASTM D5034).

Technological Characteristics

Surgical drapes of various configurations. Materials tested per ISO 10993 biocompatibility standards. Physical performance tested per AATCC 127 (hydrostatic pressure), AATCC 42 (impact penetration), IST 160.1 (lint), and ASTM D5034 (tensile strength). Flammability tested per 16 CFR 1610. Sterilization via EtO per ISO 11135.

Indications for Use

Indicated for use as protective coverings to isolate incision sites and protect against contamination during surgical procedures. Applicable to patients undergoing surgical procedures requiring sterile or non-sterile drapes.

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

• IMC Drapes (K050538)

Submission Summary (Full Text)

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#### 10.0 SUMMARY OF THE SAFETY AND EFFECTIVENESS

International Medsurg Connection Surgical Drape

| Manufacturer: | International Medsurg Connection, Inc.<br>935 N Plum Grove Road, Suite F<br>Schaumburg, Illinois 60173-4770 |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory Contact: | Manny Gupta<br>Vice President / General Manager<br>International Medsurg Connection, Inc.<br>935 N Plum Grove Road, Suite F<br>Schaumburg, Illinois 60173-4770 |
| Telephone: | 847-619-9929 |
| Date Summary Prepared | August 5, 2005 |
| Product Trade Name: | IMC Surgical Drapes - Multiple |
| Common Name: | Surgical Drape. |
| Classification: | Class II |
| Predicate: | IMC Drapes, Reference K050538<br>owned by International Medsurg<br>Connection. |
| Description: | Surgical Drapes including various sizes<br>and configurations of table covers, flat<br>drape sheets, Lap drapes,<br>cardiovascular drapes, head & neck<br>drapes, general use drapes, cysto<br>drapes, c-section drapes, orthopedic<br>drapes and specialty drapes. |

#### Intended Use:

International Medsurg Connection's Surgical Drape is intended to be used as Patient protective coverings used to isolate incision sites and protect against contamination during surgical procedures.

#### Substantial Equivalence:

The International Medsurg Connection Surgical Drapes are substantially equivalent to IMC Drapes sold by International Medsurg Connection, Reference K050538.

INTERNATIONAL MEDSURG CONNECTION, INC. 510K NOTIFICATION

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K052169

They provide the following characteristics: Intended use is the same Similar configurations Similar materials

## Summary of testing:

All material used in the fabrication of the IMC Surgical Drapes were evaluated for:

| Test | Standard |
|----------------------|---------------------|
| Cytotoxicity | ISO 10993 - Part 5 |
| Skin Irritation | ISO 10993 - Part 10 |
| Skin Sensitivity | ISO 10993 - Part 11 |
| Systemic Toxicity | ISO 10993 - Part 11 |
| Flammability | 16 CFR Part 1610 |
| Hydrostatic Pressure | AATCC 127 |
| Impact Penetration | AATCC 42 |
| Lint | IST 160.1 |
| Tensile Strength | ASTM D5034 |

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# ATTACHMENT E DRAPES LIST

| Catalog Number | Description |
|-----------------------|----------------------------------------|
| Table Covers | |
| 270-2500 | Mayo Stand Cover |
| 270-2510 | Mayo Stand Cover, X-Large |
| 270-2309 | Table Cover, Reinforced |
| 270-2311 | Table Cover, Reinforced |
| 270-2316 | Table Cover, Reinforced |
| 270-2313 | Table Cover, Heavy Duty with Extension |
| Flat Drape Sheets | |
| 270-2410 | Half Drape |
| 270-2412 | Medium Drape |
| 270-2416 | Three Quarter Drape, Reinforced |
| 270-2417 | Large Drape |
| 270-2419 | Full Drape |
| Lap Drapes | |
| 270-3003 | Laparotomy Drape |
| 270-3008 | Laparotomy Drape (with pouches) |
| 270-3005 | Trans Laparatomy Drape |
| 270-3009 | Ped Laparatomy Drape |
| 270-3103 | Major Abdominal Laparoscopic Drape |
| 270-9101 | Laparoscopy Drape |
| 270-9103 | LAVH Drape |
| 270-3751S | Laparoscopic Perineal Drape |
| Cardiovascular Drapes | |
| 270-4001 | Cardio / CV Drape |
| 270-4006 | CV Split Drape |
| 270-4007 | Bilateral Split Drape |
| Head & Neck Drapes | |
| 270-7001 | EENT Split Drape |
| 270-7002 | Thyroid Drape |
| 270-7003 | Thyroid T-Drape |
| 270-7008 | Head Bar Drape |
| 270-7009 | Head Turban Drape |
| General Use Drapes | |
| 270-2460 | Legging |
| 270-2461 | Legging |
| 270-2405 | Utility Drape |
| 270-2408 | Utility Drape Extra Large |
| 270-4002 | Top Drape |
| 27-4206S | Bottom Drape |
| 27-4207S | Side Drape |
| 270-2498 | Split Drape |
| 270-2600S | Abdominal Drape |
| Cysto Drapes | |
| 270-5090S | Cysto T-Drape |
| 270-5091S | Cysto Drape |
| 270-9001 | Lithotomy Drape |
| 270-9103 | Lithotomy Drape |
| DRAPES LIST | |
| C-Section Drapes | |
| 270-6101 | C-Section Drape |
| 270-6102 | C-Section Drape |
| Orthopedic Drapes | |
| 270-8101 | Arthroscopy Drape |
| 270-8102 | Arthroscopy Drape |
| 270-8002 | Extremity Drape |
| 270-8003 | Extremity Drape |
| 270-8005 | Hand Drape |
| 270-8301 | Ortho Split Drape |
| 270-8004 | Bilaterial Limb Drape |
| 270-8201 | Hip Drape |
| 270-8401S | Shoulder Drape with pouch |
| 270-2499 | U-Drape |
| Specialty Drapes | |
| 270-8412 | Beach Drape |
| 270-2540S | Chest/Breast Drape |
| 270-6003 | Circumcision Drape |

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# ATTACHMENT E DRAPES LIST

:

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Image /page/4/Picture/1 description: The image is a black and white circular seal. The seal features an emblem of a stylized bird with three curved lines representing its wings or body. Encircling the emblem is text that reads "HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in uppercase and appears to be a standard sans-serif font.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 7 2005

Mr. Manny Gupta Vice President/General Manager International Medsurg Connection, Incorporated 935 North Plum Glove Road, Suite F Schaumburg, Illinois 60173-4770

Re: K052169

Trade/Device Name: IMC Surgical Drapes-Various Types, Sizes and Configurations, Per Attached List Regulation Number: 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: KKX Dated: November 8, 2005 Received: November 9, 2005

Dear Mr. Gupta:

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.

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.

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Page 2 - Mr. Gupta

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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (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) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for 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), please contact the Office of Compliance at [phone]. 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 Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Siren Jump

B

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

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### Indications for Use

| 510K Number : | K052169 |
|---------------|---------|
|---------------|---------|

Device name: IMC Surgical Drapes - Various types, sizes and configurations, per attached List.

### Indication For Use:

This device is intended to be used as protective coverings used to isolate incision sites and protect against contamination during surgical procedures.

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 after EtO sterilization validation 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)

Shula H. Murphy, M.D. 1/16/05
(Division Sign-off)

Division of anesthesiology, General Hospital. Infection Control Dental Devices