(223 days)
Not Applicable
No
The 510(k) summary describes disposable surgical drapes and focuses on their physical properties and sterilization methods. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
The device is a protective covering used in operating rooms to prevent the transfer of fluids, microorganisms, and particulates, not to treat or diagnose a disease or condition.
No
The device, disposable sterile drapes, is used as a protective covering in the operating room. Its function is to prevent the transfer of body fluids, micro-organisms, and particulates, which is a barrier function, not a diagnostic one. Diagnostic devices are typically used to identify or analyze medical conditions.
No
The device is described as disposable sterile drapes, which are physical products used in an operating room. The performance studies and testing methods listed (Hydrostatic Pressure, Tensile Strength, etc.) are related to the physical properties of the material, not software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the drapes are used as a protective covering in the operating room to prevent the transfer of body fluids, micro-organisms, and particulates. This is a physical barrier function, not a diagnostic one.
- Device Description: While "Not Found" is listed, the intended use and performance studies focus on physical properties and barrier function.
- Mentions image processing, AI, DNN, or ML: None of these are mentioned, which are often associated with diagnostic devices that analyze data or images.
- Input Imaging Modality, Anatomical Site, Indicated Patient Age Range: These are listed as "Not Applicable" or "Not Found," further indicating the device doesn't interact with the body in a way typical of diagnostic devices.
- Performance Studies: The performance studies focus on physical properties like water resistance, tensile strength, tear strength, lint, flammability, and biocompatibility. These are relevant to a barrier device, not a diagnostic one.
- Key Metrics: "Not Applicable" is listed for key metrics like Sensitivity, Specificity, PPV, NPV, etc., which are standard metrics for evaluating the performance of diagnostic tests.
In summary, the device's function is to provide a physical barrier during surgery, not to diagnose a condition or analyze a biological sample. This aligns with the definition of a surgical drape, which is a medical device but not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
KKX
Device Description
Not Found
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
Operating room
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)
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.
Tests conducted include:
- AATCC Test Method 127-1998 Water Resistance: Hydrostatic Pressure Test
- AATCC Test Method 42-2000 Water Resistance: Impact Penetration Test
- ASTM - D5034-95(2001) Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test)
- ASTM - D5734-95(2001) Standard Test Method for Tearing Strength of Nonwoven Fabrics by Falling-Pendulum (Elmendorf) Apparatus
- ISO 9073-10:2003 - Textiles -- Test methods for nonwovens -- Part 10: Lint and other particles generation in the dry state
- CPSC CS-191-53 Flammability Test Method (16 CFR 1610) Standard for Flammability of Clothing Textiles
- AAMI / ANSI / ISO 10993-1:2003(E), Biological evaluation of medical devices -- Part 1: Evaluation and testing
- AAMI / ANSI / ISO 10993-5:1999, Biological evaluation of medical devices - Part 5: Tests for In Vitro cytotoxicity
- AAMI / ANSI / ISO 10993-10:2002(E), Biological evaluation of medical devices -- Part 10: Tests for irritation and sensitization
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
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: 619-291-3695 Fax: 619-393-0582 glenfeye@earthlink.net
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
1
4.0 Predicate Devices:
| Candidate | Predicate | Manufacturer | Docket
Number |
|---------------------------|------------------------|--------------------------------------------|------------------|
| Welmed Surgical
Drapes | IMC Surgical
Drapes | International Medsurg
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 | ||
| Surgical | ||
| Drapes | Basic Intended Use | |
| Materials Used | ||
| Configurations/Design | Same as IMC | |
| 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.
2
K 070432
| Standard or Guidance Document | Data Generated | Relevant
Section of
Submission |
|----------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|--------------------------------------|
| AATCC Test Method 127-1998
Water Resistance: Hydrostatic Pressure
Test | Hydrostatic
Pressure - Water
Resistance | 18 |
| AATCC Test Method 42-2000
Water Resistance: Impact Penetration Test | Impact Penetration
- Water Resistance | 18 |
| ASTM - D5034-95(2001) Standard Test
Method for Breaking Strength and
Elongation of Textile Fabrics (Grab Test) | Tensile Strength | 18 |
| ASTM - D5734-95(2001) Standard Test
Method for Tearing Strength of Nonwoven
Fabrics by Falling-Pendulum (Elmendorf)
Apparatus | Elmendorf Tear | 18 |
| ISO 9073-10:2003 - Textiles -- Test
methods for nonwovens -- Part 10: Lint and
other particles generation in the dry state | Gelbo Flex - Lint | 18 |
| CPSC CS-191-53 Flammability Test
Method (16 CFR 1610) Standard for
Flammability of Clothing Textiles | Flammability | 18 |
| AAMI / ANSI / ISO 10993-1:2003(E),
Biological evaluation of medical devices --
Part 1: Evaluation and testing | Biocompatibility
Testing Evaluation | 15 |
| AAMI / ANSI / ISO 10993-5:1999, Biological
evaluation of medical devices - Part 5:
Tests for In Vitro cytotoxicity | Cytotoxicity | 15 |
| AAMI / ANSI / ISO 10993-10:2002(E),
Biological evaluation of medical devices --
Part 10: Tests for irritation and sensitization | Skin Irritation, intra-
cutaneous
reactivity &
sensitization | 15 |
:
·
Test Data Provided in this Submission
:
.
3
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.
4
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 (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 Division 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,
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
5
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
Page 1 of
Page 4 of 4
6
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
| 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