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 Description

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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the DAS Medical Equipment Drapes:

Summary of Device and Regulatory Context:

The submission K121436 describes DAS Medical, LLC equipment drapes used to cover various surgical and clinical equipment to prevent contamination. The drapes are made of polyethylene, supplied sterile or non-sterile, and are non-patient contacting. The submission aims to demonstrate substantial equivalence to previously cleared predicate devices (Medline K032065 and Volcano Corporation K052395).

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Test)	Method/Standard	Reported Device Performance
Tensile Strength	ASTM D882	"DAS Medical, LLC has determined these products have met the acceptance criteria for performance testing including... tensile strength..." (Comparison chart states "Similarities: Equivalent; Differences: Raw material manufacturer/proprietary blend and weight" but this refers to the material itself, not the performance test outcome.)
Water Resistance/Impact Penetration	AATCC 42/INDA IST Method 80.3	"DAS Medical, LLC has determined these products have met the acceptance criteria for performance testing including impact penetration..." (Comparison chart states "Similarities: Equivalent; Differences: None" for Physical Testing.)
Flammability	16 CFR, Part 10 - Class I	"DAS Medical, LLC has determined these products have met the acceptance criteria for performance testing including... flammability..." (Comparison chart states "Class I" under Flammability and "Equivalent" when compared to predicates.)
Tear Resistance	ASTM D1004	"DAS Medical, LLC has determined these products have met the acceptance criteria for performance testing including... tear strength..." (Comparison chart states "Similarities: Equivalent; Differences: None" for Physical Testing.)
Functionality, Safety, and Effectiveness	(Implied by intended use)	"DAS Medical, LLC has determined these products... meet the pre-determined characteristics of the material properties for functionality, safety, and effectiveness for the intended use of the products." (The substantial equivalence chart heavily relies on "Similarities: Equivalent" across various characteristics like design, functionality, intended use, sterile/non-sterile, sterilization, and technological characteristics, implying that the predicates have established appropriate levels for these.)
Substantial Equivalence to Predicate Devices	(Overall comparison of characteristics)	"All information supplied in this Premarket Notification support the determination that this device is substantially equivalent to the predicate devices listed." The detailed comparison chart (Table 1) provides line-by-line justification for this claim across design, functionality, intended use, sterile/NS, sterilization, material, flammability, technological characteristics, physical testing, labeling, and instructions for use, mainly identifying "Similarities: Equivalent" or minor "Differences" that do not affect safety or effectiveness.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size for Test Set: The document does not specify the sample size used for the performance tests (Tensile, Water Resistance/Impact, Flammability, Tear Resistance).
Data Provenance: The document does not explicitly state the country of origin of the data or whether the study was retrospective or prospective. It only mentions that DAS Medical, LLC performed the comparison and determined the products met acceptance criteria.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable. This device is a medical drape that relies on physical performance characteristics. It does not involve interpretation of data or images by experts to establish a "ground truth" in the way an AI diagnostic tool would. The ground truth for the physical performance tests would be the measured values from the tests themselves, compared against established standards.

4. Adjudication Method for the Test Set:

Not applicable. As this is not a study requiring human interpretation or consensus for ground truth, there is no adjudication method described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. This is not applicable. The device is equipment drapes, not a diagnostic AI system intended to assist human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Yes, in essence, the performance testing described is a standalone evaluation of the device's physical properties. The tests for tensile strength, water resistance, flammability, and tear resistance are conducted on the material or product itself, without human intervention in its function (beyond conducting the test). The device itself (the drape) does not have an "algorithm" as typically understood in AI-based systems.

7. Type of Ground Truth Used:

The ground truth used for this device's performance is established industry standards and physical material properties. For example:

Tensile strength is compared against the specific requirements of ASTM D882.
Water resistance/impact penetration is compared against AATCC 42/INDA IST Method 80.3.
Flammability is compared against 16 CFR, Part 10 - Class I.
Tear resistance is compared against ASTM D1004.

The "ground truth" for demonstrating substantial equivalence against predicate devices is based on an assessment that the new device shares fundamental scientific technology characteristics and performs at least as safely and effectively as a legally marketed device.

8. Sample Size for the Training Set:

Not applicable. This is not an AI/ML device that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. This is not an AI/ML device that requires a training set or ground truth for training.

Summary

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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:

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DAS Medical, LLC Columbus, MS 39701

Intended Use/Indications for Use:

Substantial Equivalency Comparison Chart

Company	DAS Medical, LLC	MedlineK032065	Volcano CorporationK052395
Design	Equipment Drape - Variousdesigns and sizes	Similarities:Equivalent intendeduseDifferences: Sizesand added optionsmay vary slightly bymanufacturer -marketing options.	Similarities:Equivalent intendeduseDifferences: Sizesand added optionsmay vary slightly bymanufacturer -marketing options.
Functionality	The DAS Medical, LLCequipment drapes are used tocover a variety of equipment inthe surgical setting, as well asother clinical areas whereprotection is necessary toprevent contamination ofmedical equipment from fluidsor other contaminants in theclinical setting. Single usedevice: Non-patient contacting.	Similarities:EquivalentDifferences: None	Similarities:EquivalentDifferences:None
IntendedUse/Indicationsfor Use	The DAS Medical, LLCequipment drapes are used tocover a variety of equipment inthe surgical and clinical areaswhere protection is necessaryto prevent contamination ofmedical equipment from fluidsor other contaminants in theclinical setting. Equipmentdrapes are non-patient contact.	Similarities:EquivalentDifferences:None	Similarities:EquivalentDifferences: None
Sterile/NS	Sterile and Non-sterile	Similarities:EquivalentDifferences:None	Similarities:EquivalentDifferences: None
Sterilization	EO/Gamma	Similarities:EquivalentDifferences: None	Similarities:EquivalentDifferences: None
Material	Polyethylene	Similarities:EquivalentDifferences:Raw materialmanufacturer/proprietary blendand weight	Similarities:EquivalentDifferences: Rawmaterialmanufacturer/proprietary blend andweight
Flammability	Class I	Equivalent	Equivalent
TechnologicalCharacteristics	Polyethylene drapesmanufactured to cover avariety of equipment to protectfrom contamination	Similarities:EquivalentDifferences: Drapesmay vary byadditional addedfeatures	Similarities:EquivalentDifferences: Drapesmay vary byadditional addedfeatures
Physical Testing	Tensile-ASTM D882Water Resistance/ImpactPenetration-AATCC 42/INDAIST Method 80.3Flammability-16 CFR, Part10- Class ITear Resistance-ASTM D1004	Similarities:EquivalentDifferences:None	Similarities:EquivalentDifferences:None
Labeling	Sterile/Non-sterile, Single Use,Disposable	Similarities:EquivalentDifferences: None	Similarities:EquivalentDifferences: None
Instructions forUse	No instructions for useprovided. These drapes havegenerally known usages andinstructions.	Similarities:EquivalentDifferences:None	Similarities:EquivalentDifferences: None
PerformanceData	No additional performancedata is necessary.	Similarities:EquivalentDifferences: None	Similarities:EquivalentDifferences: None

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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

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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.

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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

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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

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510(k) Number - K121436

Device Name: DAS Medical Equipment Drapes

Indications for Use Statement:

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

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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)

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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

Prescription Use
(per 21CFR 801.109)

Over-The-Counter Use X

Regulation Number and Section

§ 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.