← Product Code [FYA](/submissions/SU/subpart-e%E2%80%94surgical-devices/FYA) · K110724
# SURGICAL PROCEDURE PACKS (K110724)
_Omnia Spa · FYA · Jun 23, 2011 · General, Plastic Surgery · SESE_
**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/FYA/K110724
## Device Facts
- **Applicant:** Omnia Spa
- **Product Code:** [FYA](/submissions/SU/subpart-e%E2%80%94surgical-devices/FYA.md)
- **Decision Date:** Jun 23, 2011
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.4040
- **Device Class:** Class 2
- **Review Panel:** General, Plastic Surgery
## Intended Use
Kit for oral implantology, used by dental professionals when performing surgical procedures. 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 Story
Omnia Surgical Procedure Packs are kits containing disposable surgical supplies; contents include surgical gowns, drapes, face masks, caps, tubing sleeves, aspirators, gauze, sponges, basins, adhesive films, syringes, needles, scalpels, dental instruments, bone collectors, saliva ejectors, and infusion lines. Used by dental professionals in clinical settings to prepare the operating environment; provides protective barriers to isolate surgical sites from microbial contamination. Packaged as single units in medical envelopes; sterilized via ethylene oxide (ETO). Benefits include convenience and reduced contamination risk during surgical procedures.
## Clinical Evidence
Bench testing only. Biocompatibility testing performed per ISO 10993. Sterilization validated per EN 556 and ISO 11135. Performance testing for gowns, masks, and drapes demonstrated conformance to ISO 13795, ASTM 2407-06, ASTM 1670-08, and ASTM 1671-07.
## Technological Characteristics
Disposable surgical kit components (gowns, drapes, accessories) made of natural or synthetic materials. Sterilization: Ethylene Oxide (ETO). Shelf-life: 5 years. Conformance to ISO 13795, ASTM 2407-06, ASTM 1670-08, ASTM 1671-07. Biocompatibility per ISO 10993.
## Regulatory 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.
## Special Controls
*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.
## Predicate Devices
- Surgical Drape Kit ([K041080](/device/K041080.md))
## Reference Devices
- [K012186](/device/K012186.md)
- [K020393](/device/K020393.md)
- [K911334](/device/K911334.md)
## Submission Summary (Full Text)
> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
> Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/).
{0}------------------------------------------------
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
{1}------------------------------------------------
# 807.92 (a)(4)
# 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 .
Surgical Procedure Packs Traditional 510(k) Omnia, SpA
{2}------------------------------------------------
# 807.92(a)(5)
#### Intended Use(s)
Kit for oral implantology, used by dental professionals when performing surgical procedures.
#### Indications for Use
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.
# 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
{3}------------------------------------------------
| Trade Name(s)
510(k) Number
Manufacturer | Omnia Surgical Procedure Packs
Surgical Procedure Pack | Predicate Device |
|------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| New
Omnia SpA | New | Surgical Drape Kit
K041080
D.I.R.R.A. srl |
| Indications for
Use | Omnia Surgical Drape Procedure Packs are composed of
disposable devices 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 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. |
| 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 |
| Packaging
Sterilization | Single pack (in medical envelope)
ETO | Single pack (in medical envelope)
ETO |
Surgical Procedure Packs Traditional 510(k)
Omnia, SpA
.
{4}------------------------------------------------
# 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
{5}------------------------------------------------
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.
{6}------------------------------------------------
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
{7}------------------------------------------------
# 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
---
**Source:** [https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/FYA/K110724](https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/FYA/K110724)
**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).
**Cite:** Innolitics at https://innolitics.com