(210 days)
Not Found
Not Found
No
The description focuses on physical barrier properties and an air delivery system, with no mention of AI/ML terms or functionalities.
No.
The device is described as a personal protective system for the surgical team, designed to prevent the transfer of pathogens and debris, not to treat a medical condition or restore a bodily function in a patient.
No
The device is described as a personal protective system designed to provide a barrier against bloodborne pathogens and prevent debris entry into surgical wounds. Its function is protective, not diagnostic.
No
The device description clearly outlines physical components such as drape material, headband, viewing window, air delivery system, fan, and battery pack, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide a physical barrier for personal protection in a surgical environment and to protect the patient from contamination. This is a protective function, not a diagnostic one.
- Device Description: The device is a protective enclosure with an air delivery system. It does not involve the analysis of biological samples (blood, urine, tissue, etc.) which is a core characteristic of IVDs.
- Lack of IVD-related information: There is no mention of analyzing samples, detecting analytes, or providing diagnostic information.
IVDs are devices used to examine specimens taken from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The device is a sterile, single-use, personal protective system designed to provide a barrier between the surgical team and potentially hazardous body fluids that may be present in the operation room environment.
The device is a sterile, single-use, personal protective system designed to provide a barrier between the surgical team and potentially hazardous bloodborne pathogens that may be present in the operation room environment. The device also offers the patient additional protection from potential deep wound infection by preventing skin, hair and other debris entry into the wound from surgical team members
Product codes (comma separated list FDA assigned to the subject device)
FYA
Device Description
The device consists of an enclosure of drape material that is worn by members of a surgical team and is fitted to the head with an adjustable headband. A clear viewing window is provided along with an air delivery system to supply cool air under the enclosure via a fan powered by a battery pack worn on the waistband.
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
Surgical team / operation room environment
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing: Non-clinical testing demonstrated the device performed as well as or better than currently marketed devices. Substantial equivalence was determined based on a comparison of technological characterizes with the predicate device. This comparison included fabric weight, grab strength, grab elongation, trap tear, hydrohead test, spray impact, alcohol (repellency), permeability and static decay.
Clinical Testing: Clinical testing was not used to establish substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
BIOMET
JAN 1 4 2003
SUMMARY OF SAFETY AND EFFECTIVENESS
| Applicant/Sponsor: | Biomet Orthopedics, Inc.
P.O. Box 587
Warsaw, Indiana 46581-0587 |
|----------------------|--------------------------------------------------------------------------|
| Contact Person: | Kacy Arnold, RN. MBA
Telephone: (574) 372-1644
Fax: (574) 372-1683 |
| Proprietary Name: | DHS Disposable Hood System |
| Common Name: | Disposable Surgical Hood |
| Classification Name: | Surgical Apparel (21 CFR 878.4040) |
Legally Marketed Devices to Which Substantial Equivalence is Claimed:
- Stryker Steri-Shield Personal Protection Device .
- DePuy Sterile View Disposable Hood / Gown .
Device Description: The device consists of an enclosure of drape material that is worn by members of a surgical team and is fitted to the head with an adjustable headband. A clear viewing window is provided along with an air delivery system to supply cool air under the enclosure via a fan powered by a battery pack worn on the waistband.
Intended Use: The device is a sterile, sinqle-use, personal protective system designed to provide a barrier between the surgical team and potentially hazardous body fluids that may be present in the operation room environment.
Summary of Technologies: The disposable sterile surgical hood components (materials, design, sizes and indications) are similar or identical to the predicate devices.
Non-Clinical Testing: Non-clinical testing demonstrated the device performed as well as or better than currently marketed devices. Substantial equivalence was determined based on a comparison of technological characterizes with the predicate device. This comparison included fabric weight, grab strength, grab elongation, trap tear, hydrohead test, spray impact, alcohol (repellency), permeability and static decay.
Clinical Testing: Clinical testing was not used to establish substantial equivalence.
MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587
.
SHIPPING ADDRESS 56 E. Bell Drive
Warsaw, IN 46582
E-MAIL biomet@biomet.com
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with three curved lines forming its body and wings. The bird is facing to the right. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 4 2003
Mr. Kacy Arnold Regulatory Affairs Specialist Biomet Orthopedics, Incorporated P.O. Box 587 Warsaw, Indiana 46581-0587
Re: K021992
Trade/Device Name: DHS Disposable Surgical Hood System Regulation Number: 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FYA Dated: January 2, 2003 Received: January 7, 2003
Dear Mr. Arnold:
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 vour 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.
2
Page 2 - Mr. Arnold
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); 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.
This letter will allow you to begin marketing your device as described in your Section. 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 regulation (21 CFR Part 801), 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" (21CFR Part 807.97) you may obtain. Other general information on vour responsibilities under the Act may be obtained 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,
Timothy A. Ulatowski
Timothy A. Ulatowski 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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Page 1 of 1
K021992 510 (k) Number (if known) : __________________________________________________________________________________________________________________________________________________
Device Name: DHS Disposable Hood System
Indications for Use:
The device is a sterile, single-use, personal protective system designed to provide a barrier between the surgical team and potentially hazardous bloodborne pathogens that may be present in the operation room environment. The device also offers the patient additional protection from potential deep wound infection by preventing skin, hair and other debris entry into the wound from surgical team members
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED.)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | |
|---|---|
| (Per 21 CFR 801.109) | |
| ( |
Over-The-Counter-Use (Optional Format 1-2-96)
Anesthesiology, General Hospital Control. Denta
510(k) Number: K021992