(236 days)
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.
The MAXair® Surgical Helmet system consists of disposable surgical apparel and re-usable headgear, battery pack and accessory battery charger. 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 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. The meltblown fabric hood/filter has passed NIOSH testing (TC-21C-0775) for PAPR's and is rated HE (High Efficiency). 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.
The provided text describes a 510(k) premarket notification for the MAXair® Surgical Helmet System, a device intended to protect operating room personnel and patients from the transfer of microorganisms, body fluids, and particulate material.
However, the provided text does not contain a table of acceptance criteria and reported device performance in the typical format of a study summary. Instead, it describes general claims of performance for two key components: the barrier material of the disposable apparel and the meltblown fabric hood/filter.
Therefore, the requested information will be extracted and presented based on the available text, with caveats about missing data.
Here's the analysis of the acceptance criteria and the study as described:
1. Table of Acceptance Criteria and Reported Device Performance
| Device Component | Acceptance Criteria (Implied by Test Passed) | Reported Device Performance |
|---|---|---|
| Barrier Material | Resistance to synthetic blood (ASTM F1670) | Passed ASTM F1670 |
| Barrier Material | Resistance to penetration by bloodborne pathogens using viral penetration (ASTM F1671) | Passed ASTM F1671 |
| Hood/Filter | NIOSH PAPR testing (TC-21C-0775) for Purity/Efficiency | Passed NIOSH testing (TC-21C-0775) and rated HE (High Efficiency) |
Notes on the Table:
- The text states "Testing has shown that the barrier materials pass ASTM standard test F1670... and F1671..." and "The meltblown fabric hood/filter has passed NIOSH testing... and is rated HE." These statements imply that passing these specific tests constitutes meeting the acceptance criteria for those properties.
- No specific numerical performance metrics (e.g., filtration percentage, fluid penetration volume) are provided for these tests; only the "pass" status and the "HE" rating for the filter are mentioned.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the sample size used for the tests mentioned (ASTM F1670, F1671, NIOSH TC-21C-0775).
- Data Provenance: The document does not explicitly state the country of origin of the data or whether the tests were retrospective or prospective. The tests refer to established standards (ASTM, NIOSH), which are generally performed in controlled laboratory settings.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- This information is not applicable in the context of the described testing. The 'ground truth' for these tests (ASTM F1670, F1671, NIOSH TC-21C-0775) is established by the standardized protocols themselves, which define what constitutes a "pass" or "fail" based on physical and biological challenges, not by expert consensus on clinical findings or images.
4. Adjudication Method for the Test Set
- This information is not applicable. The tests described are objective, standardized laboratory tests. There is no human interpretation or adjudication in the sense of concurring on diagnostic findings.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described in this 510(k) summary. This type of study is typically relevant for diagnostic imaging devices where human readers interpret medical images. The MAXair Surgical Helmet System is a protective apparel device.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) was Done
- Yes, the performance described is a standalone performance of the device's components against physical/biological challenges, without human intervention in the loop of decision-making. The tests (ASTM F1670, F1671, NIOSH TC-21C-0775) evaluate the material properties and filtration efficiency of the device components directly.
7. The Type of Ground Truth Used
- The ground truth for the performance claims is based on standardized test methods and protocols. For example:
- ASTM F1670: Resistance of materials used in protective clothing to penetration by synthetic blood.
- ASTM F1671: Resistance of materials used in protective clothing to penetration by bloodborne pathogens using viral penetration.
- NIOSH TC-21C-0775: Specific NIOSH certification for Powered Air-Purifying Respirators (PAPRs), which includes criteria for filtration efficiency.
These are objective, reproducible endpoints determined by the test apparatus and procedures, not by expert consensus, pathology, or outcomes data in a clinical sense.
8. The Sample Size for the Training Set
- This information is not applicable. The device described is a physical protective apparel system, not an AI or machine learning algorithm that requires a "training set."
9. How the Ground Truth for the Training Set was Established
- This information is not applicable for the same reason as point 8.
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
OCT 1 8 2004
| Summary Date: | February 11,2004 | |
|---|---|---|
| Company/Institution:Name and address | Bio-Medical Devices, Inc.17171 Daimler Ave Irvine, Ca 92614949-752-9642 PH 949-752-9658 Fax | |
| Contact Name: | Nick HerbertPresident | 949-752-9642 Ph ext.113949-752-9658 Fax |
| Classification Name: | Surgical Gown | |
| Device Product Code: | 79 FYA | |
| Regulation Number: | 878.4040 | |
| Device Trade Name: | MAXair® Surgical Helmet system | |
| EstablishmentRegistration Number: | 2083467 | |
| Classification: | Class II | |
| Predicate Device: | The predicate device is the Stryker T4 personal protectionsystem (Ref:K993148) | |
| Substantial Equivalence: | The MAXair® Surgical Helmet system is substantiallyequivalent to the Stryker T4 Personal Protection System.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 isComparable to the Stryker Steri-shield system and isadditionally NIOSH approved. | |
| Intended Use and device description: | The MAXair Surgical Helmet system consists of disposablesurgical apparel and re-usable headgear, battery pack andaccessory battery charger. The MAXair Surgical Helmetsystem is intended to be worn by operating room personnelduring surgical procedures to protect both the surgicalpatient and the operating room personnel from transfer of |
microorganisms, body fluids, and particulate material.
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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
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized depiction of an eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
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 (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 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
§ 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.