(182 days)
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.
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.
The provided text describes a medical device called "Gown Back" (a surgeon's vest) and its 510(k) premarket notification. However, it does not contain any information about acceptance criteria or a study proving the device meets them.
The document is a 510(k) summary and the FDA's response letter indicating substantial equivalence to legally marketed predicate devices. This type of submission generally relies on demonstrating that a new device is as safe and effective as a pre-existing legally marketed device, often through comparison of materials, design, and performance data from internal testing or comparison to recognized standards, rather than new clinical trials with acceptance criteria for device performance in human use.
Therefore, I cannot populate the requested table or answer most of the questions because the necessary information is not present in the provided text.
Here's what I can extract from the provided text regarding the device and its claimed performance, even without formal "acceptance criteria" being explicitly stated as such:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Claim | Reported Device Performance | Study Proving Acceptance Criteria Met |
|---|---|---|
| Fluid repellent | Is fluid repellent | Not detailed in the provided text. The submission states it's made of the same fabric and treated with the same fluid repellency treatment as the predicate device (Optima® Surgical Gowns). |
| Single Use | Is Single Use | Not applicable (design feature) |
| Sterile vest | Considered a sterile vest | Not detailed in the provided text. Implied by its intended use over a surgeon's gown where the back needs to be considered sterile. |
| Protection for chest and back | Provides a supplementary layer of protection for the chest and back in light to moderate fluid situations. | Not detailed in the provided text. Implied by its design and comparison to predicate devices. |
Missing Information:
- Sample size used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this is not a diagnostic device or a study involving ground truth in the typical clinical sense.
- Adjudication method for the test set: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
- Standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical garment, not a software algorithm.
- Type of ground truth used: Not applicable in the context of this device. The "ground truth" for substantial equivalence would be the performance of the predicate devices.
- Sample size for the training set: Not applicable for a physical garment.
- How the ground truth for the training set was established: Not applicable.
Summary of available information:
- Device: GOWN BACK (Surgeon's Vest) manufactured by Techstyles, Inc.
- Function: A fluid repellent, single-use vest worn over a surgeon's gown to provide a supplementary layer of protection for the chest and back in light to moderate fluid situations. Intended to be worn when the surgeon's back needs to be considered sterile.
- Comparison Basis: Substantial equivalence claimed based on comparison to Optima® Surgical Gowns (same fabric, same fluid repellency treatment), Orex Surgeon's Vest, and White Knight Surgeon's Vest (functionally the same).
- Regulatory Conclusion: FDA found the device substantially equivalent to pre-amendments devices. This means the FDA agreed it is as safe and effective as the predicate devices. This determination is based on the information provided in the 510(k) submission, which typically includes material safety, biocompatibility, performance testing (e.g., fluid repellency tests against standards), and manufacturing controls. The specific details of these underlying tests are not in the provided summary.
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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 _
§ 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.