(294 days)
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No
The summary describes a mechanical suction syringe and does not mention any AI or ML components or functionalities.
Yes
The device is described as being used for the application of FDA approved fluids to wounds, delivery of antibiotics, and other wound treatment fluids, and for the removal of fluid debris, excess tissue, or foreign particles in the wound, all of which are therapeutic actions.
No
The device is described for mixing and applying fluids to wounds and removing fluid, debris, and foreign particles. These are therapeutic or maintenance functions, not diagnostic ones.
No
The device description clearly indicates a physical syringe ("Multi Chamber Suction Syringe") and its intended use involves physical manipulation and connection to hospital wall suction, which are hardware components. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as being used for mixing and applying fluids to wounds, delivering antibiotics, and removing fluid debris directly from wounds. This is a direct interaction with the patient's body or the wound itself.
- IVD Definition: In vitro diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition.
- Lack of Specimen Analysis: The description does not mention the device being used to analyze any specimens taken from the body. Its function is focused on direct wound treatment and fluid management.
Therefore, the BioSurgical Corp. Multi Chamber Suction Syringe falls under the category of a surgical or wound care device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The BioSurgical Corp. Multi Chamber Suction Syringe is indicated for the mixing and application of FDA approved fluids to wounds, the delivery of antibiotics, and other wound treatment fluids. It can also be attached to standard hospital wall suction for removal of fluid debris, excess tissue or foreign particles in the wound.
Product codes
FMF
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
standard hospital wall suction
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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§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or other bird.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Jeffrey M. Cohen Founder Biosurqical Corporation 592 Rosso Court Pleasanton, California 94566
SEP - 8 1997
Re : K964597 Biosurqical, Corporation Multi Chamber Trade Name: Suction Syringe Requlatory Class: II Product Code: FMF Dated: June 23, 1997 Received: June 24, 1997
Dear Mr. Cohen:
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 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 Regulation (QS) 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 Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
1
Page 2 - Mr. Cohen
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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://wwwffda.gov/cdrh/dsmamain.html".
Sincerely yours,
Ulatowsk Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/2/Picture/0 description: The image shows the logo for BioSurgical Corporation. The word "Bio" is in white letters inside a black square. To the right of the black square, the word "Surgical" is written in black letters. Below the words "BioSurgical", the word "CORPORATION" is written in smaller, black letters.
BioSurgical Corporation 592 Rosso Court Pleasanton, California 94566
K964597
Phone: 510-484-4230
Fax: 510-484-3037
November 15, 1996
Document Mail Center (HFZ-401) Center for Devices and Radiological Health Food and Drug Administration 9200 Corporate Blvd. Rockville, MD 20850
Indications for Use Statement BioSurgical Corp. Multi Chamber Suction Syringe
The BioSurgical Corp. Multi Chamber Suction Syringe is indicated for the mixing and application of FDA approved fluids to wounds, the delivery of antibiotics, and other wound treatment fluids. It can also be attached to standard hospital wall suction for removal of fluid debris, excess tissue or foreign particles in the wound.
Walter Cohn
Jeffrey M. Cohen Founder
Ferdinand H. Eickemeyer
Gordon H. Epstein, MD Founder
Prescription Use _i/
(Per 21 CFR 801.109)