Who is the manufacturer of DAS MEDICAL EQUIPMENT DRAPES?

Das Medical, LLC filed the 510(k) submission for DAS MEDICAL EQUIPMENT DRAPES (K121436).

What is the FDA product code for DAS MEDICAL EQUIPMENT DRAPES?

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 DAS MEDICAL EQUIPMENT DRAPES?

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

What are the predicate devices for DAS MEDICAL EQUIPMENT DRAPES?

Medline (K032065); Volcano Corporation (K052395).

Who can help prepare an FDA 510(k) submission like DAS MEDICAL EQUIPMENT DRAPES?

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.

DAS MEDICAL EQUIPMENT DRAPES

K121436 · Das Medical, LLC · KKX · Jun 6, 2013 · General, Plastic Surgery

Device Facts

Record ID	K121436
Device Name	DAS MEDICAL EQUIPMENT DRAPES
Applicant	Das Medical, LLC
Product Code	KKX · General, Plastic Surgery
Decision Date	Jun 6, 2013
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4370
Device Class	Class 2

Intended Use

The DAS Medical, LLC equipment drapes are used to cover a variety of equipment in the surgical and clinical areas where protection is necessary to prevent contamination of medical equipment from fluids or other contaminants in the clinical setting. Equipment drapes are non-patient contact.

Device Story

DAS Medical Equipment Drapes are protective covers for surgical and clinical equipment; intended to prevent contamination from fluids/contaminants. Device consists of polyethylene sheets cut to specific shapes for equipment like microscopes, cameras, monitors, tables, robotics, and c-arms. Features include adhesive tape, elastic bands, and hook-and-loop attachments for positioning/securing. Supplied sterile or non-sterile; single-use disposable. Used in surgical/clinical environments; operated by hospital staff. Non-patient contacting. Benefits include maintaining equipment sterility/cleanliness and reducing cross-contamination risk.

Clinical Evidence

Bench testing only. No clinical data. Performance testing included tensile strength (ASTM D882), water resistance/impact penetration (AATCC 42/INDA IST Method 80.3), flammability (16 CFR Part 1610, Class I), and tear resistance (ASTM D1004).

Technological Characteristics

Polyethylene material; non-patient contacting. Features adhesive tape, elastic, and hook-and-loop attachments. Sterilization via EO or Gamma. Flammability Class I per 16 CFR Part 1610. Physical testing per ASTM D882 (tensile), ASTM D1004 (tear), and AATCC 42/INDA IST 80.3 (water resistance).

Indications for Use

Indicated for use in surgical and clinical settings to cover medical equipment (e.g., microscopes, cameras, monitors, tables, robotics, c-arms, x-ray equipment) to prevent contamination from fluids or other contaminants. Non-patient contacting.

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

Medline (K032065)
Volcano Corporation (K052395)

Related Devices

K083234 — KIMBERLY-CLARK KC100 SURGICAL DRAPES, MODEL KC 100, KIMBERLY-CLARK KC100 SURGICAL EQUIPMENT COVERS, MODEL KC 100 · Kimberly-Clark Corp. · Mar 25, 2009
K122000 — HM SURGICAL DRAPES HM SURGICAL EQUIPMENT COVER · Changzhou Holymed Products Co., Ltd. · Dec 12, 2012
K050322 — MICROTEK EQUIPMENT DRAPES · Microtek Medical, Inc. · May 17, 2005
K023540 — SNAP KOVER, MODEL 01-2020; SNAP KAPS, MODEL 03-KP09 · Valumed · Feb 4, 2003
K081476 — SURGICAL CONCEPT DESIGNS POSITIONOR SURGICAL DRAPE · Surgical Concept Designs · Aug 8, 2008

Submission Summary (Full Text)

{0}------------------------------------------------ ## K121 436 #### Attachment 5 ## DAS Medical, LLC Columbus, MS 39701 JUN 0 6 2013 #### 510k Summary 510k Summary for: DAS Medical Equipment Drapes Date Prepared: December 18, 2012 Firm: DAS Medical, LLC 100 Rosecrest Lane Columbus, MS 39701 662-497-2866 510k submitter and Contact: Armond Groves - Managing Partner Owner/OperatorNumber: 10036300 Device Common Name: Equipment drapes Device Trade Name: DAS Medical Equipment drapes Classification Name: Surgical Drapes and Drape Accessory. Regulation number: 878.4370 Classification: II Panel: General and Plastic Surgery Product code: KKX #### Description of device: The DAS Medical, LLC equipment drapes are used to cover a variety of equipment in the surgical setting, as well as other clinical areas where protection is necessary to prevent contamination of medical equipment from fluids or other contaminants. Equipment drapes are supplied non-sterile. The non-sterile version is supplied primarily for repackers and re-labelers. Sterile, disposable, single use applications are supplied to a distributor or directly to the end-user. These devices are specifically designed for a variety of surgical and general hospital equipment, such as microscopes, cameras, monitors, tables, robotics, c-arms and various other x-ray and/or similar equipment. The DAS Medical Equipment Drapes are manufactured with polyethylene cut to form to a specific shape for the equipment they are intended to cover. Adhesive tape, bands; elastic, and hook and loop attachments are applied to the products in specific areas to aid in positioning and securing the product to the equipment. All of these devices are non-patient contacting. These equipment drapes are substantially equivalent to other drapes currently being marketed for the same purpose. {1}------------------------------------------------ ## DAS Medical, LLC Columbus, MS 39701 #### Intended Use/Indications for Use: The DAS Medical, LLC equipment drapes are used to cover a variety of equipment in the surgical and clinical areas where protection is necessary to prevent contamination of medical equipment from fluids or other contaminants in the clinical setting. Equipment drapes are non-patient contact. #### Substantial Equivalency Comparison Chart | Company | DAS Medical, LLC | Medline K032065 | Volcano Corporation K052395 | |----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------| | Design | Equipment Drape - Various designs and sizes | Similarities: Equivalent intended use Differences: Sizes and added options may vary slightly by manufacturer - marketing options. | Similarities: Equivalent intended use Differences: Sizes and added options may vary slightly by manufacturer - marketing options. | | Functionality | The DAS Medical, LLC equipment drapes are used to cover a variety of equipment in the surgical setting, as well as other clinical areas where protection is necessary to prevent contamination of medical equipment from fluids or other contaminants in the clinical setting. Single use device: Non-patient contacting. | Similarities: Equivalent Differences: None | Similarities: Equivalent Differences: None | | Intended Use/Indications for Use | The DAS Medical, LLC equipment drapes are used to cover a variety of equipment in the surgical and clinical areas where protection is necessary to prevent contamination of medical equipment from fluids or other contaminants in the clinical setting. Equipment drapes are non-patient contact. | Similarities: Equivalent Differences: None | Similarities: Equivalent Differences: None | | Sterile/NS | Sterile and Non-sterile | Similarities: Equivalent Differences: None | Similarities: Equivalent Differences: None | | Sterilization | EO/Gamma | Similarities: Equivalent Differences: None | Similarities: Equivalent Differences: None | | Material | Polyethylene | Similarities: Equivalent Differences: Raw material manufacturer/ proprietary blend and weight | Similarities: Equivalent Differences: Raw material manufacturer/ proprietary blend and weight | | Flammability | Class I | Equivalent | Equivalent | | Technological Characteristics | Polyethylene drapes manufactured to cover a variety of equipment to protect from contamination | Similarities: Equivalent Differences: Drapes may vary by additional added features | Similarities: Equivalent Differences: Drapes may vary by additional added features | | Physical Testing | Tensile-ASTM D882 Water Resistance/Impact Penetration-AATCC 42/INDA IST Method 80.3 Flammability-16 CFR, Part 10- Class I Tear Resistance-ASTM D1004 | Similarities: Equivalent Differences: None | Similarities: Equivalent Differences: None | | Labeling | Sterile/Non-sterile, Single Use, Disposable | Similarities: Equivalent Differences: None | Similarities: Equivalent Differences: None | | Instructions for Use | No instructions for use provided. These drapes have generally known usages and instructions. | Similarities: Equivalent Differences: None | Similarities: Equivalent Differences: None | | Performance Data | No additional performance data is necessary. | Similarities: Equivalent Differences: None | Similarities: Equivalent Differences: None | {2}------------------------------------------------ ## DAS Medical, LLC Columbus, MS 39701 #### Summary A comparison of all non-clinical testing data from pre-determined characteristics of these products and materials used in the manufacture of these products was performed. DAS Medical, LLC has determined these products have met the acceptance criteria for {3}------------------------------------------------ ## DAS Medical, LLC Columbus, MS 39701 performance testing including impact penetration, tear strength, tensile strength, and flammability and meet the pre-determined characteristics of the material properties for functionality, safety, and effectiveness for the intended use of the products. DAS Medical, LLC has determined these products are substantially equivalent to the predicate devices stated in this submission. #### Conclusion All information supplied in this Premarket Notification support the determination that this device is substantially equivalent to the predicate devices listed. {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - (USA)" is arranged in a circular fashion around the symbol. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002 June 6, 2013 DAS Medical, LLC C/O Mr. Armond Groves 100 Rosecrest Lane COLUMBUS MS 39701 Re: K121436 > Trade/Device Name: DAS Medical Equipment Drapes Regulation Number: 21 CFR 878.4370 Regulation Name: Equipment Drapes Regulatory Class: Class II Product Code: KKX Dated: May 31, 2013 Received: June 5, 2013 Dear Mr. Groves: 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.10. 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. 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 {5}------------------------------------------------ Page 2 - Mr. Groves 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ResourcesforYou/Industry/default.htm. Sincerely yours, Susan Runner DESIGN Mary S. Runner -S Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital. Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ #### 510(k) Number - K121436 Device Name: DAS Medical Equipment Drapes ## Indications for Use Statement: The DAS Medical, LLC equipment drapes are used to cover a variety of equipment in the surgical and clinical areas where protection is necessary to prevent contamination of medical equipment from fluids or other contaminants in the clinical setting. Equipment drapes are non-patient contact. | Equipment Drapes | Descriptions | Model # | |-------------------|----------------------------------------------|----------| | Microscope Drapes | 48" X 120" (122 X 305 cm) with tape | MD48120T | | | 48" X 120" (122 X 305 cm) with hook and loop | MD48120H | | | 52" X 150" (132 X 381 cm) with tape | MD52150T | | | 52" X 150" (132 X 381 cm) with hook and loop | MD52150H | | | 20" X 64" (51 X 163 cm) with tape | MD2064T | | | 20" X 64" (51 X 163 cm) with hook and loop | MD2064H | | | 41" X 64" (104 X 163 cm) with tape | MD4164T | | | 41" X 64" (104 X 163 cm) with hook and loop | MD2164H | | | 41" X 80" (104 X 203 cm) with tape | MD4180T | | | 41" X 80" (104 X 203 cm) with hook and loop | MD4180H | | | 41" X 105" (104 X 267 cm) with tape | MD41105T | | | 41" X 105" (104 X 267 cm with hook and loop | MD41105H | | | 41" X 120" (104 X 305 cm) with tape | MD41120T | | | 41" X 120" (104 X 305 cm) with hook and loop | MD41120H | | | 48" X 120" (122 X 305 cm) with tape | MD48120T | | | 48" X 120" (122 X 305 cm) with hook and loop | MD48120H | | | 52" X 150" (132 X 381 cm) with tape | MD52150T | | | 52" X 150" (132 X 381 cm) with hook and loop | MD52150H | | | 20" X 64" (51 X 163 cm) with tape | MD2064T | | | 20" X 64" (51 X 163 cm) with hook and loop | MD2064H | | | 46" X 64" (117 X 163 cm) with tape | MD4664T | | | 46" X 64" (117 X 163 cm) with hook and loop | MD4664H | | | 46" X 80" (117 X 203 cm) with tape | MD4680T | | | 46" X 80" (117 X 203 cm) with hook and loop | MD4680H | | | 46" X 105" (117 X 267 cm) with tape | MD46105T | | | 46" X 105" (117 X 267 cm) with hook and loop | MD46105H | | | 46" X 120" (117 X 305 cm) with tape | MD46120T | | | 46" X 120" (117 X 305 cm) with hook and loop | MD46120H | | | 54" X 105" (137 X 267 cm) with tape | MD54105T | | | 54" X 105" (137 X 267 cm) with hook and loop | MD54105H | {7}------------------------------------------------ | Remote Control Cover | 4" X 11" (10 X 28 cm) | RC411 | |----------------------|----------------------------------------------------|----------| | | 7" X 14" (18 X 35 cm) | RC714 | | Keyboard Cover | 30" X 24" (76 X 61 cm) | KC3024 | | Footswitch Cover | 14" X 30" (36 X 76 cm) | FC1430 | | Banded Bags | 20" X 10" (50 X 25 cm) 20" circular, sewn elastic | BB2010 | | | 30" X 15" (76 X 38 cm) 30" circular, sewn elastic | BB3015 | | | 40" X 20" (102 X 51 cm) 40" circular, sewn elastic | BB4020 | | | 50" X 25" (127 X 64 cm) 50" circular, sewn elastic | BB5025 | | | 60" X 30" (152 X 76 cm) 60" circular, sewn elastic | BB6030 | | | 15" X 15" (38 X 38 cm) Rectangular, with tape | BB1515T | | | 30" X 30" (76 X 76 cm) Rectangular, with tape | BB3030T | | | 36" X 30" (91 X 76 cm) Rectangular, with tape | BB3630T | | | 36" X 54" (91 X 137 cm) Rectangular, with tape | BB3654T | | | 40" X 40" (102 X 102 cm) Rectangular, with tape | BB4040T | | Camera Drapes | 7" X 96" (18 X 244 cm) with tape | CD796T | | | 7" X 96" (18 X 244 cm) with hook and loop | CD796H | | | 54" X 150" (137 X 381 cm) with tape | CD54150T | | | 54" X 150" (137 X 381 cm) with hook and loop | CD54150H | | | 5" X 96"(13 X 244 cm) with tape | CD596T | | | 5" X 96"(13 X 244 cm) with hook and loop | CD596H | | | 9" X 96" (23 X 244 cm) with tape | CD996T | | | 9" X 96" (23 X 244 cm) with hook and loop | CD996H | | | 15" X 64" (38 X 163 cm) with tape | CD1564T | | | 15" X 64" (38 X 163 cm) with hook and loop | CD1564H | | Robotic Arm Drapes | 7" X 96" (18 X 244 cm) with tape | RD796T | | | 7" X 96" (18 X 244 cm) with hook and loop | RD796H | | | 5" X 96"(13 X 244 cm) with tape | RD596T | | | 5" X 96"(13 X 244 cm) with hook and loop | RD596H | | | 9" X 96" (23 X 244 cm) with tape | RD996T | | | 9" X 96" (23 X 244 cm) with hook and loop | RD996H | | | 15" X 64" (38 X 163 cm) with tape | RD1564T | All drapes supplied Non-sterile will contain a "NS" after the model number ### PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED ・ Concurrence of CDRH, Office of Device Evaluation (ODE) {8}------------------------------------------------ # Elizabeth ក្រុកខ្មែរ Next 2013.06.06 115:25:55 -04'00' (Division Sign-Off) Division of General and Plastic Surgery Devices 510(k) Number K121436 or Prescription Use (per 21CFR 801.109) Over-The-Counter Use X