Surgical Procedure Packs are composed of disposable devices intended for professional use in preparing the operating environment with protective coverings and clothes that aid in maintaining cleanliness and limiting risk of contamination during various types of medical and/or dental surgeries.

Device Description

Omnia Surgical Procedure Packs are composed of disposable devices, drapes, and surgical garb intended for professional use in preparing the operating environment with protective coverings that aid in maintaining cleanliness and limiting risk of contamination during various types of medical and/or dental surgeries. The contents of these kits may include:

Surgical Gowns (various models) with or without hand towels ●
Sterile Surgical Drapes (various models) .
Face mask .
Protective caps .
Sheath/Tubing Sleeve .
Surgical aspirator with adaptor .
Surgical Gauze .
Sterile disinfection sponge and/or basin .
Adhesive Film .
Syringe (s) .
Needle(s) .
. Single-use scalpel
Small dental mirror/dental explorer/tweezer .
Bone collector ●
. Saliva ejector
. Irrigation/Infusion line
Stopcock and ramp for infusion .
Waste bag for contaminated material .

AI/ML Overview

The provided document, K110724, describes Omnia Surgical Procedure Packs and their substantial equivalence to a predicate device, rather than presenting a study to prove acceptance criteria for a novel device's performance. The document focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device.

Therefore, many of the requested details about acceptance criteria, study design, ground truth, and reader studies are not applicable or cannot be extracted from this specific 510(k) summary. The summary focuses on comparative data for substantial equivalence, not de novo performance validation against acceptance criteria for a new type of device.

However, I can extract the parts that relate to performance characteristics and the supporting data provided for substantial equivalence.

Acceptance Criteria and Device Performance (Based on Substantial Equivalence to Predicate)

The acceptance criteria for the Omnia Surgical Procedure Packs are implicitly derived from demonstrating substantial equivalence to the predicate device (Surgical Drape Kit, K041080) and conformance to applicable industry standards for its components. The "performance" here is demonstrating that the new device meets or exceeds the predicate's performance and relevant industry benchmarks for its individual components.

Acceptance Criterion (Implicit)	Reported Device Performance by Omnia
Intended Use Equivalence: Prepare operating environment with protective coverings to maintain cleanliness and limit contamination during medical/dental surgeries.	Substantially Equivalent to Predicate: "Omnia believes that the Omnia Surgical Procedure Packs are substantially equivalent to the Surgical Drape Kit manufactured by D.I.R.R.A. srl and cleared via 510(k) # K041080. Both devices consist 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. Both devices also include other surgical devices of general utility during various types of medical and/or dental surgeries." (Page 3)
Biocompatibility: Materials used are safe for patient contact.	Nonclinical Testing: Biocompatibility was assured via nonclinical testing in accordance with ISO 10993. (Page 4)
Sterilization Efficacy & Shelf-Life: Device is sterile and maintains sterility over time.	Validation & Data: Device sterilization is obtained using ethylene oxide. Sterilization processes were validated in accordance with EN 556 and ISO 11135. Shelf-life has been demonstrated to be a minimum of 5 years after sterilization. (Page 4)
Performance of Gowns, Masks, Drapes: Conformance to relevant material and barrier standards.	Non-clinical Performance Data: Non-clinical performance data for the gowns, masks, and drapes demonstrated conformance to applicable standards (ISO 13795 - ASTM 2407-06 - ASTM 1670-08 - ASTM 1671-07). The characteristics of these items have been previously described in K012186 and K020393 (gowns and drapes) and K911334 (masks). (Page 4)
Packaging & Sterilization Method Equivalence: Similar to predicate device.	Substantially Equivalent to Predicate: "the Omnia Procedure Pack and the predicate device are packaged similarly (single pack in medical envelope) and sterilized via the same sterilization method (ETO)." (Page 3)
Kit Contents Equivalence: Generally similar utility and composition as predicate.	Comparison Chart: A table comparing the kit contents confirms general similarity and intended utility. (Page 3)

1. Sample size used for the test set and the data provenance:

Sample Size: Not applicable. This summary does not describe a clinical "test set" in the context of diagnostic accuracy or a specific performance study involving patient data beyond demonstrating material and sterilization properties. The "testing" involved non-clinical evaluations of materials and sterilization processes.
Data Provenance: The non-clinical testing for biocompatibility, sterilization, and individual component performance (gowns, masks, drapes) would have been conducted in a laboratory setting, likely in Italy (the submitter's country). The specific details on where these tests were conducted are not provided. The data is "retrospective" in the sense that it's laboratory test results rather than prospective clinical trials.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This device is a surgical procedure pack, not a diagnostic or AI device requiring expert ground truth for a test set. The validation relies on technical standards (ISO, EN, ASTM) and manufacturing controls.

3. Adjudication method for the test set:

Not applicable for the reasons stated above.

4. 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 not an AI-powered diagnostic tool, nor does it involve human readers in this context. It's a collection of sterile disposable items.

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

Not applicable. This is not an algorithmic device.

6. The type of ground truth used:

Biocompatibility, Sterilization, Component Performance: The "ground truth" for these aspects comes from established international and industry standards (e.g., ISO 10993 for biocompatibility, EN 556 and ISO 11135 for sterilization, ISO 13795, ASTM 2407-06, ASTM 1670-08, ASTM 1671-07 for gowns/masks/drapes). The "truth" is whether the device components meet these predefined performance specifications.

7. The sample size for the training set:

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

8. How the ground truth for the training set was established:

Not applicable.

Summary

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KJ10724

ﻴﺮ .

510(k) Summary

The following 510(k) summary has been prepared pursuant to requirements specified in 21 CFR 807.92.

807.92(a)(1)

Submitter Information

OMNIA SpA Via F. Delnevo 190 43036 - Fidenza (Parma) - Italy

Contact Person(s): Jamie Austin, RAC Regulatory Consultant, Anson Group Phone: (317) 569-9500 x 118 Facsimile: (317) 569-9520

Alexander Keim Telephone: +39.0524.527453 Fax number: +39.0524.525230 e-mail: alex.keim@omniaspa.eu

Date: March 11, 2011

807.92(a)(2)

Trade Name: Omnia Surgical Procedure Packs

Common Name: Surgical Drape Kit

878.4040 Classification Name(s): Surgical Apparel Surgical Devices 878.4370

Device Classification: II

807.92(a)(3)

Predicate Device

K# K041080

Name Surgical Drape Kit Manufacturer D.I.R.R.A. srl

Additional substantial equivalence information is provided below.

Surgical Procedure Packs Traditional 510(k) Omnia, SpA

P. 1/5

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807.92 (a)(4)

Device Description

Surgical Gowns (various models) with or without hand towels ●
Sterile Surgical Drapes (various models) .
Face mask .
Protective caps .
Sheath/Tubing Sleeve .
Surgical aspirator with adaptor .
Surgical Gauze .
Sterile disinfection sponge and/or basin .
Adhesive Film .
Syringe (s) .
Needle(s) .
. Single-use scalpel
Small dental mirror/dental explorer/tweezer .
Bone collector ●
. Saliva ejector
. Irrigation/Infusion line
Stopcock and ramp for infusion .
Waste bag for contaminated material .

Surgical Procedure Packs Traditional 510(k) Omnia, SpA

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807.92(a)(5)

Intended Use(s)

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

Indications for Use

807.92(a)(6)

Summary of Substantial Equivalence

Omnia believes that the Omnia Surgical Procedure Packs are substantially equivalent to the Surgical Drape Kit manufactured by D.I.R.R.A. srl and cleared via 510(k) # K041080. Both devices consist of natural or synthetic materials and are intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial or other contamination. Both devices also include other surgical devices of general utility during various types of medical and/or dental surgeries. Finally, the Omnia Procedure Pack and the predicate device are packaged similarly (single pack in medical envelope) and sterilized via the same sterilization method (ETO).

Surgical Procedure Packs Traditional 510(k) Omnia, SpA

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Trade Name(s)510(k) NumberManufacturer	Omnia Surgical Procedure PacksSurgical Procedure Pack	Predicate Device
NewOmnia SpA	New	Surgical Drape KitK041080D.I.R.R.A. srl
Indications forUse	Omnia Surgical Drape Procedure Packs are composed ofdisposable devices intended for professional use inpreparing the operating environment with protectivecoverings that aid in maintaining cleanliness and limiting riskof contamination during various types of medical and/ordental surgeries.	The D.I.R.R.A. surgical drape device kit is composed ofnatural or synthetic materials and intended to be usedas a protective patient covering, such as to isolate a siteof surgical incision from microbial or othercontamination.
Kit Contents	- Surgical gowns (various models) with or without hand towels- Surgical Drapes- Face mask- Protective caps- Sheath/tubing sleeve- Surgical aspirator with adaptor- Surgical gauze- Disinfection sponge- Basin- Adhesive films- Syringe- Needle- Single-use scalpel- Irrigation/infusion line- Stopcock and ramp for infusion- Waste bag for contaminated materiai- Bone collector- Saliva ejector	- Gown w/ paper towels- Mayo stand cover- Sterile sheet- Patient drape- Transparent drape- Adhesive strip- Tube holder- Cord drape- Suction tubing w/ tip- Flat gauze- Round gauze sponge- Plastic tray- Transparent adhesive film- Connector for suction tubing.- Kit wrapping drape
PackagingSterilization	Single pack (in medical envelope)ETO	Single pack (in medical envelope)ETO

Surgical Procedure Packs Traditional 510(k)
Omnia, SpA

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807.92(b)(1)

Summary of Non-Clinical Data

1. Biocompatibility

Biocompatibility was assured via nonclinical testing in accordance with ISO 10993.

2. Sterilization and Shelf-Life

Device sterilization is obtained using ethylene oxide. Sterilization processes were validated in accordance with EN 556 and ISO 11135. Shelf-life has been demonstrated to be a minimum of 5 years after sterilization.

3. Performance Data

Non-clinical performance data for the gowns, masks, and drapes demonstrated conformance to applicable standards (ISO 13795 -ASTM 2407-06 - ASTM 1670-08 - ASTM 1671-07). The characteristics of these items have been previously described in K012186 and K020393 (gowns and drapes) and K911334 (masks).

Conclusion

Based on the testing described above, Omnia has determined that the Omnia Surgical Procedure Packs are substantially equivalent to the Surgical Drape Kit manufactured by D.I.R.R.A. srl (and cleared via 510(k) # K041080) in terms of technology and indications for use. The materials used are biocompatible, the devices are provided sterile with a shelf life of 5 years, and the specifications of the contents of the kit are in accordance with industry standards.

Surgical Procedure Packs Traditional 510(k) Omnia, SpA

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Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the circumference. Inside the circle is a stylized emblem featuring three angled lines that resemble a bird in flight or a stylized human figure.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

OMINIA, SpA c/o Mr. Jamie L. Austin, RAC Regulatory Consultant The Anson Group 9001 Wesleyan Road. Suite 200 Indianapolis, Indiana 46268

JUN 2 3 2011

Re: K110724

Trade/Device Name: Omnia Surgical Procedure Pack Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel; Surgical Drape and Drape Accessories Regulatory Class: II Product Code: FYA, LRO, KKX & FXX Dated: June 3, 2011 Received: June 7, 2011

Dear Mr. Austin:

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. 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.

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Page 2 -Mr. Austin

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm 115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Susan Roever

Anthony D. Watson, B.S., M.S., M.B.A. 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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07

Indications for Use

510(k) Number (if known): / K110724

Device Name: SURGICAL PROCEDURE PACKS

Indication For Use:

implantology, used by dental professionals Surgical Procedure Packs are kits for oral when performing surgical procedures.

Surgical Procedure Packs are composed of di sposable devices intended for professional use in preparing the operating environment with protective coverings and clothes that aid in maintaining cleanliness and limiting risk of medical and/or dental surgeries.

Over-The-Counter Use Prescription Use X AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elizabeth F. Clavie-Willis

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

510(k) Number: K110724

Surgical Procedure Packs Traditional 510(k) Omnia, SpA

Regulation Number and Section

§ 878.4040 Surgical apparel.

(a)
Identification. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.(b)
Classification. (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.