MAXAIR SURGICAL HELMET SYSTEM

K040485 · Bio-Medical Devices, Inc. · FYA · Oct 18, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K040485
• Device Name: MAXAIR SURGICAL HELMET SYSTEM
• Applicant: Bio-Medical Devices, Inc.
• Product Code: FYA · General, Plastic Surgery
• Decision Date: Oct 18, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

The MAXair Surgical Helmet system is 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. The MAXair Surgical Helmet system consists of disposable surgical apparel and re-usable headgear, battery pack and accessory battery charger.

Device Story

MAXair Surgical Helmet system is a personal protection system for operating room personnel. Components include disposable hood/filter (electrostatically charged meltblown fabric) and barrier toga; re-usable helmet/blower unit; lithium-ion battery pack; battery charger. Blower pulls air through filter media, directing filtered air to user. Barrier materials provide fluid resistance. Used in surgical settings to protect patient and personnel from cross-contamination of pathogens and fluids. Benefits include reduced risk of infection transmission via fluid-borne pathogens and particulates.

Clinical Evidence

Bench testing only. Barrier materials tested for resistance to synthetic blood (ASTM F1670) and resistance to penetration by blood-borne pathogens using viral penetration (ASTM F1671). Meltblown fabric hood/filter passed NIOSH testing (TC-21C-0775) for PAPR and is rated HE (High Efficiency).

Technological Characteristics

System includes electrostatically charged meltblown fabric hood/filter and barrier toga. Re-usable components include helmet/blower and lithium-ion battery. Filtration meets NIOSH HE (High Efficiency) standards. Barrier materials meet ASTM F1670 and F1671 standards. Powered by rechargeable lithium-ion battery.

Indications for Use

Indicated for operating room personnel during surgical procedures to provide protection against transfer of microorganisms, body fluids, and particulate material between the wearer and the patient.

Regulatory Classification

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

• Stryker T4 personal protection system (K993148)

Submission Summary (Full Text)

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## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

## OCT 1 8 2004

| Summary Date: | February 11,2004 | |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|
| Company/Institution:<br>Name and address | Bio-Medical Devices, Inc.<br>17171 Daimler Ave Irvine, Ca 92614<br>949-752-9642 PH 949-752-9658 Fax | |
| Contact Name: | Nick Herbert<br>President | 949-752-9642 Ph ext.113<br>949-752-9658 Fax |
| Classification Name: | Surgical Gown | |
| Device Product Code: | 79 FYA | |
| Regulation Number: | 878.4040 | |
| Device Trade Name: | MAXair® Surgical Helmet system | |
| Establishment<br>Registration Number: | 2083467 | |
| Classification: | Class II | |
| Predicate Device: | The predicate device is the Stryker T4 personal protection<br>system (Ref:K993148) | |
| Substantial Equivalence: | The MAXair® Surgical Helmet system is substantially<br>equivalent to the Stryker T4 Personal Protection System.<br>The intended use is the same Materials are identical Manufacturing process is identical Packaging is identical Sterilization process is identical The design is similar The filtration efficiency of the MAXair surgical system is<br>Comparable to the Stryker Steri-shield system and is<br>additionally NIOSH approved. | |
| Intended Use and device description: | The MAXair Surgical Helmet system consists of disposable<br>surgical apparel and re-usable headgear, battery pack and<br>accessory battery charger. The MAXair Surgical Helmet<br>system is intended to be worn by operating room personnel<br>during surgical procedures to protect both the surgical<br>patient and the operating room personnel from transfer of | |

microorganisms, body fluids, and particulate material.

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K040485

The disposable, sterile surgical apparel of the MAXair system includes an electrostatically charged meltblown fabric hood/filter and a barrier toga. The barrier material is fluid resistant to protect the wearer from fluid borne pathogens. Testing has shown that the barrier materials pass ASTM standard test F1670 for resistance to synthetic blood and F1671 for resistance to penetration by blood borne pathogens using viral penetration (see section J for test results). The meltblown fabric hood/filter has passed NIOSH testing (TC-21C-0775) for PAPR's and is rated HE (High Efficiency) (see section J for test results).

The non-sterile, re-usable component of the Surgical Helmet system is comprised of a self contained Helmet/blower and a battery pack. The helmet has an incorporated headgear and provides air delivery. The air delivery helmet pulls air from outside the hood/filter, through the filter media, and directs it inside to the user. The system is powered by a lithium ion battery pack. The lithium ion battery pack is recharged by an accessory battery charger.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 8 2004

Mr. Nick Herbert President Bio-Medical Devices, Incorporated 17171 Daimler Avenue Irvine, California 92614

Re: K040485

Trade/Device Name: MAXair® Surgical Helmet System Regulation Number: 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FYA Dated: October 8, 2004 Received: October 8, 2004

Dear Mr. Herbert:

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 – Mr. Herbert

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. or the rever 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 (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.

This letter will allow you to begin marketing your device as described in your Section 510(k) I rab rotet 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), nlease contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Runn

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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510(k) Number (if known): K040485

MAXair Surgical Helmet system Device Name:

Indications For Use:

The MAXair Surgical Helmet system is 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. The MAXair Surgical Helmet system consists of disposable surgical apparel and re-usable headgear, battery pack and accessory battery charger.

Prescription Use X (Per 21 CFR 801 subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kein Nuhuy

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

510(k) Number: K040485