(182 days)
Not Found
Not Found
No
The device description and intended use are for a sterile vest, and there is no mention of AI, ML, or any related technologies in the provided text.
No.
The device is a protective garment (vest) intended to be worn over a surgeon's gown to maintain sterility and protect against microorganisms and fluids during surgical procedures. It does not provide any therapeutic benefit or treatment to a patient.
No
The device, a Gown Back, is described as an accessory worn over a surgeon's gown to provide a sterile barrier and protect against the transfer of microorganisms and fluids. It does not collect or analyze data to diagnose medical conditions.
No
The device description clearly states it is a "vest" and a "Gown Back," which are physical, tangible items, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to diagnose, monitor, or screen for health issues.
- Device Function: The description clearly states the device is a "Gown Back" worn over a surgeon's gown. Its purpose is to provide a sterile barrier and protect against the transfer of microorganisms, body fluids, and particulate matter during surgical procedures.
- No Biological Samples: The device does not interact with or analyze any biological samples from a patient.
- No Diagnostic Purpose: The device is a protective garment, not a tool for diagnosing or monitoring a medical condition.
The device falls under the category of a surgical accessory or protective garment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Gown Back is to be worn over a surgeon's gown during procedures and in situation when the surgeon's back needs to be considered sterile. This accessory device is used to protect both operating room personnel and the surgical patient from the transfer of microorganisms, body fluids, and particulate matter.
Product codes
FYA
Device Description
The device is a vest, commonly called a Gown Back, with a front snap opening. The Gown Back is fluid repellent; it is Single Use. The primary intended use for the Gown Back is as a sterile vest to be worn over a surgeon's gown during procedures or in situations when the surgeon's back needs to be considered sterile. It provides a supplementary layer of protection for the chest and back in light to moderate fluid situations. The Gown Back is not a primary protective garment. The vest design does not provide complete coverage, and the fabric is fluid repellent, not a fluid barrier.
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
Surgeons or other members of the surgical team.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Optima® Surgical Gowns, Orex Surgeon's Vest, White Knight Surgeon's Vest
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.
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TECHStules
PREMARKET NOTIFICATION 510(k) SUMMARY (As Required by 21 CFR 807.92(c))
June 30, 1999 Contact Person: Stephanie Howard
Device
Trade name - GOWN BACK Common name - Surgeon's vest or gown back Classification name - Surgical gown - 21 CFR 878.4040
Legally marketed predicate device Optima® Surgical Gowns Orex Surgeon's Vest White Knight Surgeon's Vest
Description and Conclusions
The device is a vest, commonly called a Gown Back, with a front snap opening. The Gown Back is fluid repellent; it is Single Use. The primary intended use for the Gown Back is as a sterile vest to be worn over a surgeon's gown during procedures or in situations when the surgeon's back needs to be considered sterile. It provides a supplementary layer of protection for the chest and back in light to moderate fluid situations. The Gown Back is not a primary protective garment. The vest design does not provide complete coverage, and the fabric is fluid repellent, not a fluid barrier.
Comparison
Optima® Surgical Gowns and Techstyles, Inc. Gown Back are made of the same nonwoven fabric, the same color and have been treated with the same fluid repellency treatment. The Orex Surgeon's Vest and the White Knight Surgeon's Vest are functionally the same as Techstyles, Inc. Gown Back, though they are of different fabrics.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an emblem featuring a stylized caduceus, which is a symbol often associated with healthcare and medicine. The caduceus in the logo is depicted with three intertwined strands.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 0 2000
Ms. Stephanie T. Howard Techstyles, Incorporated 16415 Addison Road, Suite 850 Addison, Texas 75001
K992436 Re: Gown Back, Model 13-403N; 13-404N; 13-405N Trade Name: Regulatory Class: II Product Code: FYA Dated: December 1, 1999 Received: December 6, 1999
Dear Ms. Howard:
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 of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਚ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any
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Page 2 - Ms. Howard
obligation you might have under sections 531 through 542 of obligation you magno maer the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note ene organis on 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. Ulatowski 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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Ver/ 3 – 4/24/96
Applicant: Techstyles, Inc.
510(k) Number (if known):
Device Name: GOWN BACK, Surgeon's Vest - Single Use/Disposable
Indications For Use:
Target population: Surgeons or other members of the surgical team.
The Gown Back is to be worn over a surgeon's gown during procedures and in situation when the surgeon's back needs to be considered sterile. This accessory device is used to protect both operating room personnel and the surgical patient from the transfer of microorganisms, body fluids, and particulate matter.
Concurrence of CDHR, Office of Device Evaluation (ODE)
OVER TINE COUNTER DEVICE
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Confidential
510(k) Number _