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

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

Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a simple Class I gauze sponge and makes no mention of AI, ML, or any related technologies like image processing or performance metrics typically associated with AI/ML devices.

Therapeutic

No
A gauze is used for wiping, which is a supportive function and does not directly treat a disease or condition.

Diagnostic

No
Explanation: The device is described as a gauze used for wiping blood and fluids, which is a common item for patient care, not for diagnosing conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "Class I gauze sponge," which is a physical, hardware medical device, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use is to "wipe off blood and fluids from a patient's mouth or skin." This is a physical action performed directly on the patient's body surface.
• IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. They are performed outside of the living body.
• Device Description: The device is described as a "Class I gauze sponge." Gauze sponges are physical tools used for cleaning, absorbing, or applying pressure, not for performing diagnostic tests on samples.
• Lack of Diagnostic Elements: There is no mention of any components or processes related to analyzing biological samples, detecting biomarkers, or providing diagnostic information.

The device is a simple medical device used for patient care, not for in vitro diagnostic testing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Product codes (comma separated list FDA assigned to the subject device)

EFQ

Device Description

Class I gauze sponge 79EFQ

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

patient's mouth or skin

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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)

The performance data is shown in Table 1.

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

Regulation Number and Section

N/A

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
---------------------------	---------

Gauze sponges Device Name:

Indications For Use:

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

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

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