(88 days)
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Not Found
No
The summary describes a simple surgical sponge for absorbing fluids and contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
The device is described as a "Rand Surgical Sponge" intended to "absorb excess body fluids or exudate" from wounds or burns. This is a general-purpose medical product used for absorption and wound management, not for treating a disease or condition in a therapeutic manner.
No
Explanation: The device is described as a "Rand Surgical Sponge" intended to "absorb excess body fluids or exudate" from wounds or burns. This function is for direct treatment or management of the wound, not for diagnosing a medical condition.
No
The device description clearly states "Rand Surgical Sponge," which is a physical, hardware-based 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 is to be placed directly on a wound or burn to absorb excess body fluids or exudate. This is a topical application and involves interacting directly with the patient's body, not analyzing samples in vitro (outside the body).
- Device Description: A "Rand Surgical Sponge" is a physical material used for absorption and wound care.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), using reagents, or providing diagnostic information about a patient's health status.
IVDs are devices used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
Intended to be placed directly on wound or burn in absorb excess body fluids or exudate.
Product codes
EFQ
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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N/A
0
Image /page/0/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 tail feathers, representing the department's commitment to health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Duane Tracy Vice President Rand Scientific Corporation Trans Air 4135 Northgate Boulevard, Suite 9 Sacramento, California 95834
JUN 27 1997
Re: K971178 Trade Name: Rand Surgical Sponge Regulatory Class: I Product Code: EFQ Dated: March27, 1997 Received: March 31, 1997
Dear Mr. Tracy:
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 (OS) 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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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 (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,
Enclosure
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
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Cage _________________________________________________________________________________________________________________________________________________________________________
510(k) Nurnber (if known): ... K971178
Rand Surgical Sponge Device Name __
Indications for Use
Intended to be placed directly on wound or burn in absort excess body fiuids or exudale
IPLEASE DO NOT WRITE BELOW THIS LIGHTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |||||
|---|---|---|---|---|---|
| Restorative Devices | K971178 | ||||
| Prescription Use | |||||
| (Per 21 CFR 801.109) | X | OR | Over-The-Counter Use | ||
| (Optional Format 1-2-96) |