(80 days)
Not Found
Not Found
No
The 510(k) summary describes a simple gauze sponge/bandage and explicitly states "Not Found" for mentions of AI, DNN, or ML, and provides no information about training or test sets, which are typical for AI/ML devices.
No.
The device description indicates it is used for cleaning, scrubbing, dressing wounds, and fluid absorption, which are supportive functions rather than direct therapeutic actions. There are also no clinical studies performed.
No
Explanation: The "Intended Use / Indications for Use" section explicitly states that the devices are "intended to be used to clean wounds, to scrub or prepare incision sites, to absorb fluids, and dress wounds." These are therapeutic and supportive functions, not diagnostic ones. There is no mention of identifying or diagnosing a disease or condition.
No
The device description clearly states it consists of physical materials like cotton, rayon, and cellulose, indicating it is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the devices are for "external use only" and are used for cleaning wounds, scrubbing/preparing incision sites, absorbing fluids, and dressing wounds. These are all external applications and do not involve testing samples taken from the body (like blood, urine, tissue, etc.) to diagnose or monitor a medical condition.
- Device Description: The description reinforces the external use and the materials used (cotton, rayon, cellulose) are consistent with wound care products, not diagnostic tests.
- Lack of Diagnostic Function: There is no mention of the device being used to detect, measure, or analyze any substance or characteristic within a biological sample to provide diagnostic information.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely external wound care.
N/A
Intended Use / Indications for Use
These devices are indicated for external use only for cleaning wounds, scrubbing, dressing and fluid absorption.
These devices, both sterile and non sterile, are indicated for external use only and are intended to be used to clean wounds, to scrub or prepare incision sites, to absorb fluids, and dress wounds.
Product codes
79FRO, 79EFQ
Device Description
Furlong Industries' Non-X-Ray Detectable Gauze Sponges/Bandages, both sterile and non sterile, consist of cotton, rayon or rayon/polyester formed material and/or cellulose. This device is for externation of conly for cleaning wounds, scrubbing, dressing and fluid absorption.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
AUG 12 -
Image /page/0/Picture/1 description: The image shows a handwritten string of characters. The characters appear to be a combination of letters and numbers. The string starts with the letter 'K', followed by the number '991757'. The handwriting is somewhat stylized, with some characters slightly distorted.
SUMMARY OF SAFETY AND EFFECTIVENESS
Page 1 of 2
February 19, 1999
- COMPANY INFORMATION: 1. Furlong Industries 311 N. Slusser Street Grayslake, IL 60030 Registration #: Pending (847) 548-6831 Phone: Pete Furlong Contact Name: Contact Title: President
Non-Absorbable Gauze for External Use DEVICE NAME: PROPRIETARY NAME: None Gauze Sponges/Bandages COMMON NAME: CLASS: I 79FRO Dressing PRO CODE: 79EFQ Sponge, Gauze None
PERFORMANCE STANDARDS:
- MANUFACTURING SITE INFORMATION: 3. Furlong Industries 311 N. Slusser Street Grayslake. IL 60030 Phone: 847-548-6831 Contact Person: Pete Furlong
- INTENDED/INDICATIONS FOR USE: 4. These devices are indicated for external use only for cleaning wounds, scrubbing, dressing and fluid absorption.
-
- CLINICAL TESTS: There are no clinical studies that have been performed on these devices, both for the predicate and the new devices.
1
Furlong Industries
311 N. Slusser Spreet .
Pete Furlong, President
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· 7.
- .
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ph. (847) 548-6831 Grayslake, IL 60060
SUMMARY OF SAFETY AND EFFECTIVENESS, continued
Page 2 of 2
TECHNOLOGICAL CHARACTERISTICS:
There are no technological characteristics to the new device.
DESCRIPTION:
Furlong Industries' Non-X-Ray Detectable Gauze Sponges/Bandages, both sterile and non sterile, consist of cotton, rayon or rayon/polyester formed material and/or cellulose. This device is for externation of conly for cleaning wounds, scrubbing, dressing and fluid absorption.
OTHER INFORMATION:
A reasonable search of all information known or otherwise presently available to Furlong Industries has been conducted, Such a search is defined as examining the Medline Databases, Freedom of Information Services, Inc., competitive literature concerning the safety and effectiveness information for gauze sponges.
Gauze sponges/bandages have been utilized for an extensive period of time for wound scrubbing, cleaning and dressing. ・・
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is positioned within a circle that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 12 1999
Mr. Pete Furlong President Furlong Industries 311 North Slusser Street Grayslake, Illinois 60060
Re: K991757
Trade Name: Non-Absorbable Gauze for External Use Regulatory Class: Unclassified Product Code: EFQ Dated: May 18, 1999 Received: May 24, 1999
Dear Mr. Furlong:
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 requirement, 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 devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 -- Mr. Pete Furlong
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.gov/cdrh/dsmamain.html".
Sincerely yours,
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
4
Furlong Industries 311 N. Slusser Street
ete Furlong, President
ph. (847) 548-6831 · Grayslake, IL 60040
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INTENDED USE
Page " of
K99i757
גרמ"גו
510(k) Number (if known); (N/A)
Device Name: Non-Absorbable Gauze for External Use
Indications for Use:
These devices, both sterile and non sterile, are indicated for external use only and are intended to be used to clean wounds, to scrub or prepare incision sites, to absorb fluids, and dress wounds.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) Over-The-Counter Use
(Optional Format 1-2-96)
(Division Sign Off) Division of Genera Devices KGgi7 510(k) Number