NURSES BOUFFANT CAP

• K Number: K965237
• Device Name: NURSES BOUFFANT CAP
• Manufacturer: COPIOUMED INTL., INC.
• Date Cleared: 1997-08-27 ( 239 days)
• Product Code: LYU
• Regulation Number: 878.4040
• Type: Traditional
• Panel: General Hospital
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

This device is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material.

Device Description

CAP, BOUFFANT, NURSES SURGICAL WHITE, BLUE, & GREEN

AI/ML Overview

This looks like a 510(k) clearance letter for a very low-risk device (nurses' bouffant cap) from 1997. It doesn't contain the extensive information you're asking for regarding acceptance criteria or detailed study results because such reports are typically not required for Class I devices cleared through predicate equivalence.

Here's why and what can be extracted:

Why the requested information is absent:

• Device Classification (Class I): Nurses' bouffant caps are classified as Class I devices. These devices are considered to pose the lowest risk to patients and users.
• 510(k) Clearance: For Class I and many Class II devices, the FDA clears them based on "Substantial Equivalence" to a legally marketed predicate device. This means the manufacturer demonstrates that their new device is as safe and effective as a device already on the market.
• Lack of Performance Studies: For low-risk devices like this, the FDA typically does not require comprehensive clinical studies or even extensive bench testing with detailed acceptance criteria and performance metrics. The demonstration of substantial equivalence often relies on:
  • Comparison of technological characteristics (materials, design, intended use).
  • Verification of manufacturing processes to ensure quality and consistency.
  • For something like a cap, basic safety (e.g., non-toxic materials, no sharp edges) and functionality (e.g., stays on, covers hair).

What can be extracted/inferred from the provided text:

1. A table of acceptance criteria and the reported device performance:

   • Acceptance Criteria: Not explicitly stated in the provided documents. For a bouffant cap, criteria would be very basic, likely related to physical integrity, material composition, and fit.
   • Reported Device Performance: Not explicitly stated. The device is intended "to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material." The performance is implicitly assumed to be equivalent to existing predicate bouffant caps.

2. 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. Detailed test sets and data provenance for performance are not typically required for this type of clearance.

3. 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/Not provided. There's no "ground truth" to establish for a device like this in the context of clinical performance.

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

   • Not applicable/Not provided.

5. 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/software device.

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

   • Not applicable. This is not an AI/software device.

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

   • Not applicable. The "ground truth" for a bouffant cap would be its ability to physically contain hair and particulate matter, and its material safety, which are typically assessed through standard material testing and visual inspection, not complex clinical "ground truth."

8. The sample size for the training set:

   • Not applicable/Not provided. There is no AI model or complex algorithm requiring a training set for this device.

9. How the ground truth for the training set was established:

   • Not applicable/Not provided.

Summary based on the provided document:

The document is a 510(k) clearance letter confirming that the "Nurses Bouffant Cap" is substantially equivalent to a predicate device. This clearance is based on the device's classification as a low-risk, Class I device (Product Code: LYU) and the presumption that it meets general controls for manufacturing and labeling. Formal performance studies with detailed acceptance criteria, test sets, or expert ground truths, as would be required for higher-risk or novel devices, are not present in this type of regulatory submission. The "Indications For Use" state the device's purpose: "to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material." This functional intent is the closest equivalent to a performance goal, but no specific performance metrics are provided.

Summary

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Food and Drug Administration. 9200 Corporate Boulevard Rockville MD 20850

AUG 27 1997

Copioumed International, Incorporated C/O Ms. Janna P. Tucker President Janna Tucker & Associates 19001 S. Richfield #185 Green Valley, Arizona 85614

K965237 Re : Nurses Bouffant Cap Trade Name: Regulatory Class: I Product Code: LYU Dated: June 10, 1997 Received: June 16, 1997

Dear Ms. Tucker:

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, Drug, 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 regulations 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 requirements, as set forth in the Quality System Regulation (QS) for Medical General requlation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Reqister. 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. Tucker

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

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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INDICATIONS FOR USE

COPIOUMED INTERNATIONAL, INC

oplicant:

0(k) Number (if known):

evice Name:

CAP, BOUFFANT, NURSES SURGICAL WHITE, BLUE, & GREEN

dications For Use: . . . .

This device is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH Office of Device Evaluation (ODE)

Olin S. Lin

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices

510(k) Number K965237

Prescription Use Per 21 CFR 801.109

OR

Over-The-Counter X

(Optional Format 1-2-96)

HIBIT A
GE 1 of 36 pages

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.