The Pro Vision Surgical Helmet System consists of disposable surgical apparel and re-usable headgear, battery holder and battery pack. The Pro Vision Surgical Helmet System is intended to be worn by healthcare workers in the operating room during surgical procedures to protect both the healthcare worker and the surgical patient from the transfer of microorganisms, body fluids and particulate material.

Device Description

The ProVision Surgical Helmet System consists of disposable surgical apparel and re-usable headgear, battery holder and battery pack. The disposable, sterile surgical apparel of the ProVision system include a barrier hood/gown with Hytrel® elastomer, a barrier hood/gown toga with Hytrel, a barrier hood with Hytrel and a paper hood. A molded, polycarbonate face shield is sealed to the hood material. The Hytrel coated material is fluid resistant but vapor transmissive. The gown, toga and hood with Hytrel therefore protect the wearer from fluid borne pathogens, while maintaining "breathability". The barrier hood/gown and barrier hood/gown toga each come in three sizes. The non-sterile, re-usable component of the Pro Vision system is a two piece unit comprised of a helmet and a battery pack. The helmet is a headgear supporting an air delivery system. The air delivery system pulls air from outside the hood or hood/gown, through a filter media, and directs it to the wearer's face/neck area. The air delivery system is powered by a nickel metal hydride battery pack.

AI/ML Overview

The provided text is a 510(k) submission for a surgical helmet system, focusing on its substantial equivalence to existing devices rather than presenting a detailed study with specific acceptance criteria and performance metrics for a novel technology. Therefore, many of the requested categories for a study proving device performance are not applicable or cannot be extracted from this document.

However, I can provide the available information:

Analysis of Acceptance Criteria and Device Performance (Based on provided text)

Category	Acceptance Criteria (Stated or Implied)	Reported Device Performance
Primary Goal of Device	Protection of healthcare worker and surgical patient from transfer of microorganisms, body fluids, and particulate material.	The ProVision Surgical Helmet System is intended for this purpose. The overall statement of "substantial equivalence" implies that its protective capabilities are comparable to the predicate devices.
Fluid Resistance of Hytrel® Material	Pass ASTM standard test ES-21 for resistance to synthetic blood.	"Testing has shown that the Hytrel coated material...passes ASTM standard test ES-21 for resistance to synthetic blood."
Resistance to Bloodborne Pathogens	Pass ASTM standard test ES-22 for resistance to penetration by blood borne pathogens using viral penetration as a test system.	"Testing has shown that the Hytrel coated material...passes ASTM standard test ES-22 for resistance to penetration by blood borne pathogens using viral penetration as a test system."
Breathability	Maintain "breathability" while protecting from fluid borne pathogens (for Hytrel coated material).	"The Hytrel coated material is fluid resistant but vapor transmissive. The gown, toga and hood...therefore protect the wearer from fluid borne pathogens, while maintaining "breathability"." (Implies meeting this, but no specific metric given).
Filtration Efficiency of Air Delivery System	Adequate filtration efficiency (implied, by comparison to predicate device).	"The air delivery system polls air...through a filter media..." and "The adequate filtration efficiency of the ProVision Surgical Helmet System is comparable to that of the DePuy Disposable Filter Hood." (Confirms comparability, but no specific efficiency percentage is given for either device).
Comfort, Compactness, Weight, Cooling, Quietness	Improved over predicate devices (implied design modifications).	"The system has been modified to make it more comfortable and compact, lighter, cooler and quieter while maintaining adequate filtration efficiency..." (States these improvements were achieved, but without specific metrics or comparative data).

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

Not Applicable/Not Provided: The document does not detail a "test set" in the context of a clinical study or a performance study with a specific sample size. The testing mentioned (ASTM ES-21 and ES-22) refers to material property testing, not human subject testing. The provenance of this material testing data (e.g., in-house, third-party lab, country) is not specified.

2. 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: This type of information is relevant for studies involving subjective human assessment (e.g., image interpretation). This submission focuses on material performance and functional equivalence, not human expert evaluations for ground truth.

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

Not Applicable: There is no "test set" requiring adjudication in the context of this submission.

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 is not an AI/diagnostic imaging device, and therefore no MRMC study would be relevant.

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

Not Applicable: This is a physical medical device, not an algorithm, so "standalone performance" in that sense is not relevant. The material tests (ASTM ES-21 and ES-22) could be considered "standalone" tests of the material, but not a software algorithm.

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

Laboratory Standard Tests: For the material properties, the "ground truth" or standard for acceptance was the successful completion of established laboratory tests (ASTM ES-21 for synthetic blood resistance and ASTM ES-22 for viral penetration).
Predicate Device Comparability: For the overall system's effectiveness and safety, the "ground truth" for substantial equivalence was its similarity in design and identical intended use to legally marketed predicate devices, and its comparable "adequate filtration efficiency."

7. The sample size for the training set

Not Applicable: As this is not an AI/machine learning device, there is no concept of a "training set."

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

Not Applicable: As there is no "training set," this question is not relevant.

Summary

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K972832

SUMMARY OF SAFETY AND EFFECTIVENESS

OCT 21 1997

NAME OF FIRM:	DePuy Orthopaedics, Inc.700 Orthopaedic DriveWarsaw, In 46581-0988
510(k) CONTACT:	Cheryl K. HastingsManager, Clinical Affairs
TRADE NAME:	ProVision Surgical Helmet System
CLASSIFICATION:	878.4040 Surgical apparel
DEVICE PRODUCT CODE:	79 FYA
SUBSTANTIALLYEQUIVALENT DEVICES:	⌀ DePuy Sterile View Surgical Exhaust System⌀ Sterile View Disposable Barrier Hood/Gowns⌀ DePuy Disposable Filter/Hood⌀ Stackhouse FreedomAire Surgical Helmet System⌀ Stryker Steri Shield Turbo III

INTENDED USE AND DEVICE DESCRIPTION:

The ProVision Surgical Helmet System consists of disposable surgical apparel and re-usable headgear, battery holder and battery pack. The Pro Vision Surgical Helmet System is intended to be worn by healthcare workers in the operating room during surgical procedures to protect both the healthcare worker and the surgical patient from the transfer of microorganisms, body fluids and particulate material.

The disposable, sterile surgical apparel of the ProVision system include a barrier hood/gown with Hytrel® elastomer, a barrier hood/gown toga with Hytrel, a barrier hood with Hytrel and a paper hood. A molded, polycarbonate face shield is sealed to the hood material. The Hytrel coated material is fluid resistant but vapor transmissive. The gown, toga and hood with Hytrel therefore protect the wearer from fluid borne pathogens, while maintaining "breathability". The barrier hood/gown and barrier hood/gown toga each come in three sizes. Testing has shown that the Hytrel coated material of the barrier hood/gown and barrier hood/gown toga passes ASTM standard test ES-21 for resistance to synthetic blood and ES-22 for resistance to penetration by blood borne pathogens using viral penetration as a test system.

The non-sterile, re-usable component of the Pro Vision system is a two piece unit comprised of a helmet and a battery pack. The helmet is a headgear supporting an air delivery system. The air delivery system pulls air from outside the hood or hood/gown, through a filter media, and directs

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it to the wearer's face/neck area. The air delivery system is powered by a nickel metal hydride battery pack.

BASIS OF SUBSTANTIAL EQUIVALENCE:

The ProVision Surgical Helmet System is similar in design and identical in use to the DePuy Sterile View Surgical Exhaust System combined with the Sterile View Barrier Hood/Gowns. The system has been modified to make it more comfortable and compact, lighter, cooler and quieter while maintaining adequate filtration efficiency of the ProVision Surgical Helmet System is comparable to that of the DePuy Disposable Filter Hood.

The Pro Vision Surgical Helmet System is also similar in design and intended use to the Stackhouse FreedomAire Surgical Helmet System and the Stryker Steri Shield Turbo III.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

OCT 21 1997

Ms. Cheryl K. Hastings Manager, Clinical Affairs DePuy, Incorporated 700 Orthopaedic Drive Warsaw, Indiana 46581-0988

K972832 Re : Provision Surgical Helmet System Trade Name: Requlatory Class: II Product Code: FYA July 29, 1997 Dated: Received: July 30, 1997

Dear Ms. Hastings:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Ms. Hastings

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be -------------------------------------------------------------------------------------------------------------------obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Timothy A. Ulatows Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

. Enclosure

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510(k) Number (if known) Қ972832

ProVision Surgical Helmet System Device Name

Indications for Use:

The Pro Vision Surgical Helmet System consists of disposable surgical apparel and re-usable headgear, battery holder and battery pack. The Pro Vision Surgical Helmet System is intended to be worn by healthcare workers in the operating room during surgical protect both the healthcare worker and the surgical patient from the transfer of microorganisms, body fluids and particulate material.

Concurrence of CDRH, Office of Device Evaluation

Division Sign Off

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital 510(k) Number

Prescription Use OR

(Per 21 CFR 801.109)

Over-The-Counter Use

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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.