BALDUR NON-STERILE COTTON SPONGES

• K Number: K974347
• Device Name: BALDUR NON-STERILE COTTON SPONGES
• Manufacturer: BALDUR SYSTEMS CORP.
• Date Cleared: 1998-02-10 ( 83 days)
• Product Code: EFQ
• Regulation Number: N/A
• Type: Traditional
• Panel: General & Plastic Surgery
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

A gauze is used to wipe off blood and fluids from a patient's mouth or skin.

Device Description

Class I gauze sponge 79EFQ

AI/ML Overview

The provided text describes a 510(k) summary for the "Baldur" Non-Sterile Cotton Sponges. However, it does not contain the detailed information necessary to answer all parts of your request regarding acceptance criteria and a study proving device performance in the context of an AI/ML device.

This document is for a Class I manual medical device (cotton gauze) and its performance data refers to meeting USP/BP standards for the physical properties of the gauze itself, not a digital device's diagnostic performance. Therefore, many of your questions, especially those related to AI/ML specific studies (MRMC, standalone algorithm performance, ground truth for training/test sets, expert qualifications, etc.), are not applicable to the provided information.

Based only on the provided text, here's what can be extracted:

1. Table of acceptance criteria and the reported device performance:

   Acceptance Criteria	Reported Device Performance
   Compliance with USP/BP standards (for gauze sponges)	"Baldur" gauze sponges meet the USP/BP standards.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Not specified. The document only states "The performance data is shown in Table 1," but Table 1 itself is not provided, nor are details about how the compliance with USP/BP standards was tested (e.g., sample size, test methods).

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. This device is a cotton gauze, not an AI/ML diagnostic tool. Ground truth in the context of expert diagnosis is not relevant here.

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

   • Not applicable.

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/ML device.

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

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

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

   • For a cotton gauze, "ground truth" would likely refer to the physical and chemical properties determined by standard laboratory tests (e.g., absorbency, sterility if applicable, fiber content, etc.) as defined by USP/BP standards. The document only states compliance with these standards, not the specific methods or "ground truth" establishment.

8. The sample size for the training set:

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

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

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

Summary

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Baldur™

FEB 1 0 1998

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3423 Investment Blvd. . Suite 12 . Hayward, CA 94545-3822 Fax: [phone] Phone: [phone]

510 (k) SUMMARY [As required by 807.92(a) } Date of application: November 17, 1997 Applicant's and manufacturers name and street address: Baldur Systems Corporation Applicant's name: 3423 Investment Blvd., Ste. 12 Hayward, CA 94545 Contact person: David Hu, Ph.D., President Telephone and FAX numbers of applicant: Fax: [phone] Tel: [phone] Manufacturer's names: a). Ying Chun Surgical Dressing Factory 28 Koutai Road Taizhou Shi 225300, China Liu, Yu-Lin, General Manager Contact person: Telephone and fax numbers: Tel: [phone] Fax: [phone] b). Kanqlin Healthcare Ltd. Co. # 1. East Economic Development District Taizhou, Jiangsu, China Zhu, Hai-Ling, General Manager Contact person: Telephone and fax number: Tel: [phone] Fax: [phone] "Baldur" Non-Sterile Cotton Sponges Trade name: Common name: Cotton Gauze Classification name: Gauze Sponge (per 21 CFR 880.6250) Legally marketed device: Class I qauze sponqe 79EFQ Description of device: Class I gauze sponge 79EFQ Intended use of device: A gauze is used to wipe off blood and fluids from the patient's mouth or skin. Technological Characteristics: "Baldur" gauze sponges meet the USP/BP standards. Performance data: The performance data is shown in Table 1.

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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 eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 0 1998

David Hu. Ph.D. President Baldur Systems Corporation 3423 Investment Boulevard, Suite 12 Hayward, California 94545-3822

K974347 Trade Name: "Baldur" Non-Sterile Cotton Sponges Regulatory Class: Unclassified Product Code: EFQ Dated: November 17, 1997 Received: November 19, 1997

Dear Dr. Hu:

Re:

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 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 (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. A substantially equivalent determination assumes compliance with the .... current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (OS) 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 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 obligation you might have under sections 531 through 542 of the Act for

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Page 2 - Dr. Hu

devices under 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 regulation (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,

C. Colin McWhirter, Ph.D., M.D.

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):	K974347
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Gauze sponges Device Name:

Indications For Use:

A gauze is used to wipe off blood and fluids from a patient's mouth or skin.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K974347

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

Regulation Number and Section

N/A