The D.I.R.R.A. surgical drape device kit is composed of natural or synthetic materials and intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial or other contamination.

Device Description

The DIRRA surgical drape device kit is composed of natural or synthetic materials and intended to be used as protective patient covering, such as to isolate a site of surgical incision from microbial or other contamination. The DIRRA surgical drape device kit is to be used by medical and dental professionals when performing surgical procedures.

The DIRRA surqical drape device kit consists of the following components: Gown w/ paper towel (2), Mayo stand cover (1), Sterile sheet (1), Patient drape (1), Transparent drape (1), Adhesive strip (4), Tube holder (1), Cord drape (2), Suction tubing w/tip (1), Flat gauze (20), Round gauze sponge (5), Plastic tray (1), Transparent adhesive film (3), Connector for suction tubing (1), Kit wrapping drape (1).

All the components are wrapped in the DIRRA surgical drape device kit wrapping drape which is closed with a label.

The final measurement of the kit (not enveloped) is approximately cm.30x30x10. The kit is then enveloped in sequence and in accordance with the instructions for use. The pack is then inserted in the Sterilization plastic/tyvek pouch and the pouch is sealed. 2 Kits are put into one cardboard box along with instructions for use,. The box is then closed and sterilized by Bioster. A sterilization batch number is applied on the box after the sterilization process has been completed.

AI/ML Overview

The provided document (K041080) is a 510(k) summary for a Surgical Drape Kit. It is a premarket notification for a medical device seeking clearance from the FDA by demonstrating substantial equivalence to a legally marketed predicate device.

For such a device (Class II, Surgical Drape and Drape Accessories, Product Code: LRO), direct performance studies to establish detailed acceptance criteria and prove performance as one would for a diagnostic or AI-driven device are typically not required in the same manner. The basis of clearance is substantial equivalence to a predicate device, meaning it has the same intended use and similar technological characteristics, and any differences do not affect safety or effectiveness.

Therefore, the detailed information requested regarding acceptance criteria, study design (sample sizes, experts, adjudication, MRMC, standalone performance), and ground truth establishment is not applicable to this type of 510(k) submission for a surgical drape kit.

Here's how to address each point based on the information provided in this 510(k) summary:

1. A table of acceptance criteria and the reported device performance

The document explicitly states: "The determination of substantial equivalence is not based on an assessment of performance data." (Section: Comparison to predicate devices). Therefore, there are no specific performance acceptance criteria or reported device performance metrics in the format typically seen for a diagnostic device validation. The "acceptance criteria" here relate to demonstrating substantial equivalence to the predicate device in terms of intended use, technological characteristics (materials, sterility, dimensions), and showing that any differences do not raise new questions of safety or effectiveness.

Acceptance Criteria	Reported Device Performance
Intended Use: Kit for oral implantology, used by dental professionals when performing surgical procedures. Intended as a protective patient covering to isolate a surgical incision site from microbial or other contamination.	Meets: Same indications for use as predicate device (Custom Surgical Pack - distributed by Nobelbiocare and Produced by Maxxim).
Technological Characteristics: Materials, sterility, dimensions.	Meets: "almost the same components, with the same technological characteristics (materials, sterility, dimensions)" as the predicate device.
Safety and Effectiveness: Differences from predicate device should not affect safety and effectiveness.	Meets: "differences... should not affect the safety and effectiveness." (Note: this is a claim made in the submission, not a conclusion from performance data).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. No performance data or test set was used for this 510(k) clearance, as explicitly stated that the determination of substantial equivalence is not based on an assessment of performance data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No test set or ground truth was established for this submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No test set requiring adjudication was used.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a surgical drape kit, not an AI-driven diagnostic or assistive device that would involve human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a surgical drape kit, not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. No ground truth was established as performance data was not used for the determination of substantial equivalence. The "ground truth" for this submission would essentially be the predicate device's established safety and effectiveness, to which the new device is compared.

8. The sample size for the training set

Not applicable. This device is a physical product (surgical drape kit), not a machine learning model that requires a training set.

9. How the ground truth for the training set was established

Not applicable. As there is no training set for a physical surgical drape kit, no ground truth needed to be established for it.

Summary

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K041080

Image /page/0/Picture/1 description: The image shows a heavily redacted document. The visible text includes "510(k)" and "Integration 2". Most of the text is obscured by a thick black bar, making it unreadable. The document appears to be related to a legal or regulatory matter, given the reference to "510(k)".

section 10: 510(K) SUMMARY

NOV 3 0 2004

510(K) Summary of Safety and effectiveness

Trade name:	Surgical Drape Kit - D.I.R.R.A. srl
Common name:	Surgical Drape Kit
Classification name:	878.4370 Surgical Drape and Drape Accessories
Official contact:	D.I.R.R.A. SRL S.r.l.Via Guido Rossa 26I-46019 – Viadana (Mantova) – Italycontact person: Mrs Elisabetta Bacchitelephone: +39 0375 785829fax number: +39 0375 780133e-mail: matteo@dirra.it
Date prepared:	Jul 20th, 2004 / Rev. 2 Oct 26th.2004

Predicate devices - 510(K) Nr: K934688:

The Surgical Drape Kit - produced by D.I.R.R.A. srl, is substantially equivalent to: Custom Surgical Pack - distributed by Nobelbiocare and Produced by Maxxim under the previous name of Sterile Design Inc.

Intended use:

kit for oral implantology, used by dental professionals when performing surgical procedures

Indications for Use:

Comparison to predicate devices (501(k) number K934688):

These devices have the same indications for use (kit for oral implantology), and almost the same components, with the same technological characteristics (materials, sterility, dimensions).

differences between D.I.R.R.A. srl - Surgical Drape Kit and the predicate device should not affect the safety and effectiveness (The determination of substantial equivalence is not based on an assessment of performance data.).

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Device Description

Component	Pieces	Regulatory Clearance Status	Manufacturer
Gown w/ paper towel	2	K012186	Master & Frank Surgical
Mayo stand cover	1	n/a	/
Sterile sheet	1	K020393	Master & Frank Surgical
Patient drape	1	K020393	Master & Frank Surgical
Transparent drape	1	n/a	/
Adhesive strip	4	n/a	/
Tube holder	1	n/a	/
Cord drape	2	n/a	/
Suction tubing w/tip	1	n/a	/
Flat gauze	20	n/a	/
Round gauze sponge	5	n/a	/
Plastic tray	1	n/a	/
Transparent adhesive film	3	n/a	/
Connector for suction tubing	1	n/a	/
Kit wrapping drape	1	n/a	/

The DIRRA surqical drape device kit consists of the following components:

All the components are wrapped in the DIRRA surgical drape device kit wrapping drape which is closed with a label.

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5100kr. 1041080 Int

Following is a further description of the DIRRA surgical kit components:

Gown w/ paper towel

The gown Nr.1 is a Surqical gown in Non Woven PGI water repellent. blue color. This fabric has a high tensile strength and toughness that is also soft, drapeable and easy to work with. In addition, a high fluid and particulate barrier is complimented by excellent breathability while preventing strike-through of fluid and bacteria to meet the need of a wide variety of applications. A paper towel is packaged with the gown and is composed of 100% cellulose;

The gown size is L and this is the only one size provided in the kit. The gown measures are reported in the technical sheet Nr. 1, located on page of this response.

There are no reinforced areas in the gown. The internal code is 12.D1111.00.

The material used for the gown is Non Woven PGI6920 is a spunlaced fabric of 5% Woodpulp and 45% polyester staple fibres. The fabric consists of tightly interlaced fibres which do not allow bacteria to penetrate but do let air circulate freely, are soft, drapable and show good dry and wet strength. There are 2 gowns in 1 kit.

The gown is made for a single-use only. It also prevents cross-contamination in the operating theatre by its single-use (disposable).

Mayo stand cover

The Mayo stand cover Nr.2 compound by two layers, one absorbent and one waterproof, for protection of the Mayo table in the operating theatre. The type of material is Absorbent layer (High absorbent Non Woven color blue) and Waterproof layer (Polyethylene tubular color blue). The mayo cover size is cm. 80 x 140. It is intended to be used to cover the medical table and to maintain the sterile field as well as an aid in the clean up of equipment after surgery. There is 1 Mayo stand cover in the Kit. This cover is not intended to be used as patient drape and has no patient contact. The internal code is 12.A1003.00.

Sterile sheet

The sterile sheet Nr.3 is made of Non Woven PGI6920 water repellent. This fabric has a high tensile strength and toughness that is also soft, drapeable and easy to work with. In addition, a high fluid and particulate barrier is complimented by excellent breathability while preventing strike-through of fluid and bacteria to meet the need of a wide variety of applications The color is blue and the measurement is 100x100cm (square shape). It is intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. There is 1 sterile sheet in the Kit. The internal code is 10.A1701.00.

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510(k): 1041080 Integration 2

Patient drape

The patient drape (split drape) Nr.4 is made of Non Woven PGI6920 water repellent fabric. This fabric has a high tensile strength and toughness that is also soft, drapeable and easy to work with. In addition, a high fluid and particulate barrier is complimented by excellent breathability while preventing strike-through of fluid and bacteria to meet the need of a wide variety of applications. It is intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. There is 1 patient drape, containing a hole, in the Kit. The internal code is 10.T1762.00.

Transparent drape

The transparent drape Nr.5 is composed of Polyethylene and is used to reduce cross contamination risk. It measures 50x40 cm. It is intended to cover the medical table or equipment in order to maintain the sterile field and as an aid in the clean up of equipment after surgery. This cover is not intended to be used as a patient drape and has no patient contact. The internal code is 12.A1003.00. There is 1 transparent drape in the Kit.

The drape has an adhesive strip applied on the short side (cm.40x4).

Adhesive strip

The Adhesive strip Nr.6 is composed of a non woven fabric and medical adhesive for fixation on human skin. It is a device intended to be placed on the skin to attach a surgical drape.

The measures are: cm. 15x2,5, the color is white. There are 4 strips in the Kit; the internal code is 30.A0063.00

Tube holder

The Tube holder Nr.7 is a non woven fabric water repellent SMS, blue color. The measurements are cm 11cm.(width)x12cm.(base) and the shape is that of a semicircle with three holes. It is used as a drape accessory to hold tubes that may be necessary during the operating procedure. It is affixed to the drape via an adhesive strip for fixation (14.5x2 cm.) applied on the base which protrudes 2.5cm, There is 1 tube holder in the Kit. The internal code is 10.A0037.00.

Cord drape

The Cord drape Nr.8 is a plastic transparent cover for protection of the power cord, motor and the contra angle. It is intended to be used to cover the medical table or equipment in order to maintain the sterile field and as an aid in the clean up of equipment after surgery.

It is composed of Polyethylene in a tubular fashion with a diameter of 7cm.and length of 140 cm. and wrapped around a carton used to assist in keeping the cord from becoming entangled. It also has 2 elastic bands (latex free). There are 2 cord drapes in the Kit. The internal code is: 20.U0007.00.

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510(k): 1041080 Integration 2

Suction tubing w/tip

The Suction tube, with cannula Nr.9, is used for surgical suctioning of blood and secretion. It is not an invasive device and it is used only inside the mouth. It is composed of a suction tube, a cannula for suction, and connector for suction tubing. It is intended to be used in an oral cavity evacuator. The suction tube is transparent and composed of PVC. Its measurements are:

Lenath: 2450 mm ± 70,00 mm.

Inner Diameter : 6,25 mm. ± 0,1 mm.

Outer Diameter : 8,80 mm ± 0,1 mm.

The cannula is transparent, made of PVC and the measures are:

Length: 155 mm ± 0,5 mm.

Inner Diameter : 2,6 mm. ± 0,1 mm.

Outer Diameter : 4,6 mm ± 0,1 mm.

There is 1 suction tube in the Kit. The internal code is: 30.F5151.00

Flat gauze

The Flat gauze Nr.10 is a gauze composed of 100% cotton for use in wound cleaning, prepping, scrubbing, packing, or dressing situations. Its measurements are cm. 7.5 x 7.5.

Edges are folded, not cut to reduce threads and lint loss. There are 20 Flat gauzes in the kit.

The internal code is 20.A0100.00.

Round gauze sponge

The round Gauze Sponge Nr.11 is composed of 100% cotton that offers uses for wound cleaning, scrubbing, or dressing situations. It measures ø 5 cm, and the color is white. There are 5 round gauzes in the Kit. The internal code is 30.V0013.00.

Plastic trav

The plastic tray Nr.12 is composed of Polyethylene, in a "U" shape and the measurements are: Length 250 mm. Width 135 mm. Depth 350 mm. It is intended to be held by a dental handpiece and used to apply the polishing agent during prophylaxis. There is 1 plastic tray in the Kit. The internal code is 30.V0013.00.

Transparent adhesive film

The transparent adhesive film Nr.13 is a Polyethylene Adhesive Plastic film and is used to reduce the cross contamination risk. The measurements are: 200x200 mm. The adhesive (applied all along 1 of the surfaces) is acrylic in solution. It is intended to be used to cover the medical table or equipment in order to maintain the sterile field and as an aid in the clean up of equipment after surgery. This cover is not intended to be used as a patient drape and has no patient contact. There are 3 Transparent adhesive films in the Kit. The internal code is 30.V0020.00.

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Connector for suction tubing

The connector for the suction tube Nr. 14 is made of PVC and the measurements are:

Length: 5,8cm.

Max Diameter: 10mm

It is composed of 5 different sectors with different diameters (1 sector of 10mm, 2 sectors of 7mm and 2 sectors of 6,4 mm).There is 1 connector for suction tubing in the Kit. The internal code is: 30.Z1070.00

Kit wrapping drape

The kit wrapping drape Nr.15 is an instrument Table drape made of non woven absorbent material and a polyethylene plastic film. The drape measures cm. 160 x 190 cm., the color of both material is blue and it is intended to be used to cover the medical table or equipment in order to maintain the sterile field and as an aid in the clean up of equipment after surgery. Their cover is not intended to be used as a patient drape and has no patient contact. There is 1 Kit wrapping drape in the Kit. The internal code is 30.A1006.00.

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Image /page/6/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol is a stylized representation of a human figure embracing a globe, signifying the department's mission to protect the health of all Americans and provide essential human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 3 0 2004

Mrs. Elisabetta Bacchi D.I.R.R.A. s.r.l Via Guido Rossa 26 -- Zona Ind. Gerbolina I-46019 Viadana (Mantova) ITALY

Re: K041080

Trade/Device Name: Surgical Drape Kit Regulation Number: 21 CFR 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: LRO Dated: November 5, 2004 Received: November 5, 2004

Dear Mrs. Bacchi:

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 - Mrs. Bacchi

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 (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/dsma/dsmamain.html

Sincerely yours,

Susan Quares

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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Indications for Use

510(k) Number (if known): K041080

Device Name: Surgical Drape Kit

Indications for Use: The D.I.R.R.A. surgical drape device kit is composed of natural or synthetic materials and intended to be used as a protective patient covering, such as isolate a site of surgical incision from microbial or other contamination.

Prescription Use Over-The-Counter × Use - AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Russo

Page 1of 1

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

VOUL () 8 510(k) Number

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.