(83 days)
Not Found
No
The description focuses on the physical components and barrier properties of the surgical helmet system, with no mention of AI or ML capabilities.
No
The device is described as a surgical helmet system intended to protect healthcare workers and patients from microorganisms, body fluids, and particulate material, not to treat or diagnose a disease or condition.
No
The device is described as a surgical helmet system designed to protect healthcare workers and patients from microorganisms, not for diagnosing medical conditions.
No
The device description explicitly details physical components including disposable surgical apparel, re-usable headgear, battery holder, and battery pack, indicating it is a hardware-based system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for protecting healthcare workers and patients from the transfer of microorganisms, body fluids, and particulate material during surgical procedures. This is a protective function, not a diagnostic one.
- Device Description: The description details a system of surgical apparel and headgear designed for physical protection and air filtration. There is no mention of analyzing samples from the human body (blood, urine, tissue, etc.) to provide diagnostic information.
- Lack of IVD Characteristics: The description does not include any elements typically associated with IVDs, such as reagents, calibrators, controls, or methods for detecting or measuring substances in biological samples.
- Performance Studies: The performance studies mentioned focus on the barrier properties of the material (resistance to synthetic blood and viral penetration), which are relevant to its protective function, not its diagnostic capability.
In summary, the Pro Vision Surgical Helmet System is a personal protective equipment (PPE) designed for use in a surgical setting, not a device used to perform diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
The ProVision 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.
Product codes
79 FYA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare workers in the operating room
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
SUMMARY OF SAFETY AND EFFECTIVENESS
OCT 21 1997
| NAME OF FIRM: | DePuy Orthopaedics, Inc.
700 Orthopaedic Drive
Warsaw, In 46581-0988 |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) CONTACT: | Cheryl K. Hastings
Manager, Clinical Affairs |
| TRADE NAME: | ProVision Surgical Helmet System |
| CLASSIFICATION: | 878.4040 Surgical apparel |
| DEVICE PRODUCT CODE: | 79 FYA |
| SUBSTANTIALLY
EQUIVALENT 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
000004
1
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
3
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
4
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