GENERAL SURGERY DRAPES

K070432 · Welmed, Inc. · KKX · Sep 24, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K070432
• Device Name: GENERAL SURGERY DRAPES
• Applicant: Welmed, Inc.
• Product Code: KKX · General, Plastic Surgery
• Decision Date: Sep 24, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4370
• Device Class: Class 2

Indications for Use

Disposable sterile drapes are used in the operating room as a protective covering, for both patient and operating room staff, from the transfer of body fluids, micro-organisms and particulates. Drapes provided as sterile and non-sterile. Non-sterile surgical drapes are to be sold to OEMs for EtO sterilization according to ISO 11135. Sterile Surgical Drapes are to be sold directly to users after EtO sterilization validation to ISO 11135.

Device Story

Welmed Surgical Drapes are disposable, sterile or non-sterile protective coverings used in operating rooms; designed to shield patients and staff from body fluids, microorganisms, and particulates. Drapes are available in various configurations, including flat, general surgery, laparoscopic, laparotomy, breast/chest, thyroid, split, and orthopedic extremity designs. Non-sterile versions are intended for OEM distribution for EtO sterilization; sterile versions are provided directly to clinical users. The device functions as a physical barrier; performance is verified through hydrostatic pressure, impact penetration, tensile strength, tear strength, lint generation, and flammability testing. Biocompatibility is confirmed per ISO 10993 standards.

Clinical Evidence

Bench testing only. No clinical data provided. Performance verified via AATCC 127 (hydrostatic pressure), AATCC 42 (impact penetration), ASTM D5034 (tensile strength), ASTM D5734 (tear strength), ISO 9073-10 (lint generation), and CPSC CS-191-53 (flammability). Biocompatibility testing conducted per ISO 10993-1, -5, and -10, covering cytotoxicity, skin irritation, intracutaneous reactivity, and sensitization.

Technological Characteristics

Nonwoven textile materials. Physical barrier properties verified via hydrostatic pressure and impact penetration testing. Sterilization via EtO per ISO 11135. Biocompatibility compliant with ISO 10993-1, -5, -10. Various dimensions and configurations (fenestrated, split, reinforced).

Indications for Use

Indicated for use as a protective barrier for patients and operating room staff to prevent the transfer of body fluids, microorganisms, and particulates during surgical procedures.

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 Surgical Drapes (K052169)

Submission Summary (Full Text)

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K070432

### Section 5: 510(k) Summary

### 1.0 Submitted By:

Dave Fliss, President Welmed, Inc. 691 Lake Street Grayslake, IL 60030 Establishment Registration Number: 3005841027

Primary Contact: Glen Feye, President Accurate Consultants, Inc. 1340 West Pennsylvania Ave. San Diego, CA 92103 Telephone: [phone] Fax: [phone] [e-mail]

### 2.0 Date Submitted:

February 8, 2007

### 3.0 Device Name(s):

#### 3.1 Proprietary Names

Welmed, Inc. Surgical Drapes

### 3.2 Classification Name

21CFR 878.4370 (Surgical Drapes)

Product code - KKX (Surgical drape and drape accessories)

Welmed, Inc. Section 510(k) Notification Surgical Drapes Welmed+Drapes+510K+Draft+2-8-07

SEP 2 4 2007

Page 5 of 46

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### 4.0 Predicate Devices:

| Candidate | Predicate | Manufacturer | Docket<br>Number |
|---------------------------|------------------------|--------------------------------------------|------------------|
| Welmed Surgical<br>Drapes | IMC Surgical<br>Drapes | International Medsurg<br>Connections, Inc. | K052169 |

#### 5.0 Intended Uses:

# Surgical Drapes:

Disposable sterile drapes are used in the operating room as a protective covering, for both patient and operating room staff, from the transfer of body fluids, micro-organisms and particulates.

Drapes provided as sterile and non-sterile.

Non-sterile surgical drapes are to be sold to OEMs for EtO sterilization according to ISO 11135. Sterile Surgical Drapes are to be sold directly to users after EtO sterilization validation to ISO 11135.

#### 6.0 Comparison to Predicate(s):

The following table shows similarities and differences between the predicate identified in Section 4.0 of this summary.

| Product | Aspect/Characteristic | Comments |
|------------------------------|---------------------------------------------------------------|--------------------------------|
| Welmed<br>Surgical<br>Drapes | Basic Intended Use<br>Materials Used<br>Configurations/Design | Same as IMC<br>Surgical Drapes |

## Similarities to the Predicates

There are no significant differences between the Welmed drapes and their respective predicate product.

### 7.0 Summary of Performance Data:

The information in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to devices already in commercial distribution. Equivalence is demonstrated through intended use, materials, design and testing methods.

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K 070432

| Standard or Guidance Document | Data Generated | Relevant<br>Section of<br>Submission |
|----------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|--------------------------------------|
| AATCC Test Method 127-1998<br>Water Resistance: Hydrostatic Pressure<br>Test | Hydrostatic<br>Pressure - Water<br>Resistance | 18 |
| AATCC Test Method 42-2000<br>Water Resistance: Impact Penetration Test | Impact Penetration<br>- Water Resistance | 18 |
| ASTM - D5034-95(2001) Standard Test<br>Method for Breaking Strength and<br>Elongation of Textile Fabrics (Grab Test) | Tensile Strength | 18 |
| ASTM - D5734-95(2001) Standard Test<br>Method for Tearing Strength of Nonwoven<br>Fabrics by Falling-Pendulum (Elmendorf)<br>Apparatus | Elmendorf Tear | 18 |
| ISO 9073-10:2003 - Textiles -- Test<br>methods for nonwovens -- Part 10: Lint and<br>other particles generation in the dry state | Gelbo Flex - Lint | 18 |
| CPSC CS-191-53 Flammability Test<br>Method (16 CFR 1610) Standard for<br>Flammability of Clothing Textiles | Flammability | 18 |
| AAMI / ANSI / ISO 10993-1:2003(E),<br>Biological evaluation of medical devices --<br>Part 1: Evaluation and testing | Biocompatibility<br>Testing Evaluation | 15 |
| AAMI / ANSI / ISO 10993-5:1999, Biological<br>evaluation of medical devices - Part 5:<br>Tests for In Vitro cytotoxicity | Cytotoxicity | 15 |
| AAMI / ANSI / ISO 10993-10:2002(E),<br>Biological evaluation of medical devices --<br>Part 10: Tests for irritation and sensitization | Skin Irritation, intra-<br>cutaneous<br>reactivity &<br>sensitization | 15 |

:

·

# Test Data Provided in this Submission

:

.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 4 2007

SEP 24 200

Welmed, Incorporated C/O Mr. Glen Feye President Accurate Consultants, Incorporated 1340 West Pennsylvania Avenue San Diego, California 92103

Re: K070432

Trade/Device Name: General Surgical Drapes Sterile and Non-Sterile Regulation Number: 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: KKX Dated: September 4, 2007 Received: September 4, 2007

Dear Mr. Feye:

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. Feye

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 (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.

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 yours,

Cluts

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

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### Section 4: Indications for Use Statements

# Indications for Use

510(k) Number (if known): K 070432

Device Name: Welmed Surgical Drapes

Indications for Use:

Disposable sterile drapes are used in the operating room as a protective covering, for both patient and operating room staff, from the transfer of body fluids, micro-organisms and particulates.

Drapes provided as sterile and non-sterile.

Non-sterile surgical drapes are to be sold to OEMs for EtO sterilization according to ISO 11135. Sterile Surgical Drapes are to be sold directly to users after EtO sterilization validation to ISO 11135.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use X (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Shule H. Murphy K.

Jon Sign-Off) vision of Anesthesiology, General Hospital, Infection Control, Dental Devices

Number: K070432

Welmed, Inc. Section 510(k) Notification Surgical Drapes Welmed+Drapes+510K+Draft+2-8-07

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# Welmed Item #

# Drapes

# K070432

# Flat/Basic Drapes:

| Comments of Acres of Acres of Acres of Acres of Children Comments of Children Comments of | | |
|-------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|--|
| 1220-100 | Drape Sheet 40" x 57" | |
| 1220-110 | Half Drape 40" x 70" | |
| | 1000 100 - 14 11 - 7 14 Th ------ 52 " -- 97" -- 97" -- 97" -- 97" -- 97" -- 97" -- 970 | |

- Medium 3/4 Drape 53" x 77" opens 77" first 1220-120
- Medium 3/4 Drape 53" x 77" Fan-Folded opens 53" first 1220-12OFF

Medium 3/4 Drape 53" x 77" - Reinforced - opens 53" first 1220-125

- Large Drape 70" x 100" 1220-130
- Leggings SIV 11VIS 1220-160
- Clear Leggings 1220-163
- Utility Drape w/tape 14x26 1220-170
- Utility Drape w/tape 20x30 1220-175
- Abdominal Drape, with Tape, 1220-178

## General Surgery Drapes:

| produced the first and the controlled in the contract and any and the comments of the first of the first of the first of the first of the first of the first of the first of t<br>1220-183 | Top Drape 100" x 53" |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| 1220-181 | Bottom Drape 75' x 53" |

- Side Drape 38" x 77" 1220-182
## Laparoscopic Drapes:

| Laparoscopic Drapes. | |
|----------------------|--------------------------------------------------------------------|
| 1220-2110 | Laparotomy Drape, 1 00"x77"x 122", 4x 12" Fenestration |
| 1220-2 120 | Laparotomy Drape, 100"x77"x122", w/two 8"x38" Troughs |
| 1220-2 125 | Pediatric Laparotomy Drape 77" x 121", 14"x4" Fenestration |
| 1220-2 130 | Transverse Lap Drape, 100"x77"x119", 14"x4" Fenestration, with/ABC |

## Laparotomy Drapes:

| 1220-2160 | Laparoscopic/Cholecystectomy Drape 1 00"x77"x 124" |
|-----------|----------------------------------------------------------------------|
| 1220-2170 | Laparoscopic/Cholecystectomy/Endo Drape 98"x77"x 123" |
| 1220-2180 | Laparoscopic Abdominal Drape, 1 00"x76"x 124", 1 2x 13" Fenestration |
| 1220-2190 | Laparoscopy T w/ABC & Fenestration, 97"x38"x97" |

## Breast/Chest Drapes:

Chest / Breast Drape 100"x77"x122" 1220-2152

## Thyroid Drapes:

| 1220-2 140 | Thyroid Drape 77"x124" 5"xS" Diamond Fenestration |
|-------------|--------------------------------------------------------|
| 1220-2 14 1 | Thyroid Drape 100"x77"x124" 5"xS" Diamond Fenestration |

## Split Drapes:

| Split Drapes: | |
|---------------|-----------------------------------------------|
| 1220-1900 | Poly U Drape, 60" x 60", 6" x 21" Slit |
| 1220-1910 | Poly U Drape, 60" x 72", 6" x 21" Slit |
| 1220-1920 | Poly U Drape 60" x 70", 21" x 4" Slit |
| 1220-1905 | Poly U Drape, 60" x 84", 8" x 30" Slit |
| 1220-1925 | Poly U Drape 60" x 81", 31" x 4.5" Slit |
| 1220-19227 | DRAPE U 80"xl 10" PE W/GROIN COVERS |
| 1220-19228 | DRAPE U 80"xl 10" W/TAPE PE |
| 1220-19229 | DRAPE U 77"xl 10" W/TAPE Sontara |
| 1220-1950 | Split Drape 77"x108", 37"x 2.5" Split |
| 1220-1960 | Ortho Split Drape 77"x120", 46"x6" split |
| 1220-5000 | Cysto Drape 64"x38"x 90",w/3"x6" Fenestration |
| 1220-6000 | EENT Drape |

## Orthopedic Drapes

### Extremity Drapes

Universal Extremity Drape 86"x 127" 1220-8410