(47 days)
None
Not Found
No
The device description and intended use clearly describe a simple gauze sponge, with no mention of any software, image processing, or AI/ML terms.
No
The intended use states that the gauze sponges are for external use and applied to an area, generally to cover a wound or absorb fluids, not to treat a disease or condition therapeutically.
No
The device, Markwell Gauze Sponges, is described as nonsterile and for external use, applied to an area and changed when wet. Its intended use is for dressing or absorbing, not for diagnosing a condition or disease.
No
The device description clearly states it is a physical product (gauze sponges) and does not mention any software component.
Based on the provided information, the Markwell Gauze Sponges are not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "external use" and involves applying the gauze pad to an area. This is a physical application to the body, not a test performed on a sample taken from the body.
- Device Description: The description reinforces the external use and the nature of the product as gauze sponges.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting substances, diagnosing conditions, or any other activity typically associated with in vitro diagnostics.
IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. The Markwell Gauze Sponges do not fit this description.
N/A
Intended Use / Indications for Use
Markwell Gauze Sponges are nonsterile and for external use. It is supplied in bulk package (100/200pcs per package). To use it, simply apply the gauze pad to the area and change it when wet, or more often if needed. Markwell Gauze Sponges may be repacked and sterilized by domestic manufacturer. If so, users have to follow the manufacturer's instructions to use it.
Product codes
EFO
Device Description
Not Found
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
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.2740 Surgical sponge scale.
(a)
Identification. A surgical sponge scale is a nonelectrically powered device used to weigh surgical sponges that have been used to absorb blood during surgery so that, by comparison with the known dry weight of the sponges, an estimate may be made of the blood lost by the patient during surgery.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. The device also is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.
0
Image /page/0/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 2 1998
Mr. Sean Wanq ·Vice President Markwell International, Inc. 2550 West Main Street, Suite 212 Alhambra, California 91801
Re: K982260 Trade Name: Markwell Gauze Sponge Requlatory Class: Unclassified Product Code: EFO Dated: June 22, 1998 Received: June 26, 1998
Dear Mr. Wang:
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 requlations 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 requirement, as set forth in the Quality System Requlation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Register. this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
1
Page 2 - Mr. Sean Wang
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 (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.qov/cdrh/dsmamain.html".
Sincerely yours,
Russell U. Sayer
& 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
2
510 (k) NUMBER (IF KNOWN) : K982260 DEVICE NAME: Markwell Gauze Sponge INDICATIONS FOR USE:
Markwell Gauze Sponges are nonsterile and for external use. It is supplied in bulk package (100/200pcs per package). To use it, simply apply the gauze pad to the area and change it when wet, or more often if needed.
年度
.
Markwell Gauze Sponges may be repacked and sterilized by domestic manufacturer. If so, users have to follow the manufacturer's instructions to use it.
Vessell, /. Eugene fr. IZO
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter-Use √
(Optional Format 1-2-96)
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