(86 days)
No
The device description and performance studies focus on the mechanical mixing and delivery of fibrin sealant and suction capabilities, with no mention of AI or ML.
No.
The device is used for mixing and delivering fibrin sealant, and for suction, rather than directly treating a medical condition itself.
No
The device is described as an applicator for mixing and delivering fibrin sealant and for suctioning debris, not for making a diagnosis. Its function is therapeutic and procedural, not diagnostic.
No
The device description clearly outlines physical components like a main housing, syringe barrel, plunger, mixing chamber, and application lumen, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The primary intended use is for the mixing and delivery of fibrin sealant for medical applications, and secondarily for suction. These are therapeutic and surgical applications, not diagnostic testing performed in vitro (outside the body) on biological samples.
- Device Description: The description focuses on the mechanical aspects of mixing and delivering a substance and providing suction. It does not mention any components or functions related to analyzing biological samples or providing diagnostic information.
- Lack of IVD-related information: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes
- Providing diagnostic information about a patient's health status
- Performance metrics like sensitivity, specificity, AUC, etc., which are common for diagnostic tests.
The device is clearly intended for use in vivo (within the body) during medical procedures, either for applying a therapeutic substance (fibrin sealant) or for removing material.
N/A
Intended Use / Indications for Use
For the mixing, and one-to-one (1:1) delivery, of fibrin sealant for medical applications. It can also be attached to standard hospital wall suction for removal of debris, excess tissue or foreign particles in the wound.
Product codes
FMF
Device Description
The Sealouette™ Fibrin Sealant Applicator is intended for the mixing and delivery of fibrin sealant for medical applications. It can also be attached to standard hospital wall suction for removal of fluid debris, excess tissue or foreign particles in the wound.
The Sealouette™ Fibrin Sealant Applicator consists of the main housing, which holds the dual chamber syringe barrel and a common plunger that provides for the delivery and mixture of equal volumes of the two-part fibrin sealant through a mixing chamber and application lumen.
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)
A battery of non-clinical tests have been performed which demonstrate the functions of the device, and establish equivalence to the predicates in terms of: accuracy and volume of fibrin sealant delivered: the ability of the device to accurately and reproducibly deliver each component of the fibrin sealant at a fixed, predetermined ratio; and the ability of the device to homogeneously mix the components of the fibrin sealant. In addition, tests have been performed to demonstrate the substantial equivalence of the fibrin sealant delivered by the device to that delivered by the predicate in terms of: the time needed for the fibrin sealant to clot and achieve stable physical properties; the physical characteristics and geometry of the clot produced. Testing has demonstrated that the characteristics of the clot are not adversely affected by the delivery device itself or mode of delivery.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Immuno-U.S. Duploject®, BioSurgical Corporation Multi Chamber Suction Syringe
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
K992351
PREMARKET NOTIFICATION
510(k) SUMMARY
(As Required by 21 CFR 807.92)
Submitter Name: BioSurgical Corporation Contact:
Terry E. Laas Executive Vice President and Chief Operating Officer 5990 Stoneridge Drive, Suite 112 Pleasanton, CA 94588 Phone: (925) 734-3009 Fax: (925) 737-1859
Device Name: Sealouette™ Fibrin Sealant Applicator Common/Usual/Classification Name: Piston Syringe Devices to which Substantial Equivalence is Claimed: Immuno-U.S. Duploject® and BioSurgical Corporation Multi Chamber Suction Syringe Description of the Device:
The Sealouette™ Fibrin Sealant Applicator is intended for the mixing and delivery of fibrin sealant for medical applications. It can also be attached to standard hospital wall suction for removal of fluid debris, excess tissue or foreign particles in the wound.
The Sealouette™ Fibrin Sealant Applicator consists of the main housing, which holds the dual chamber syringe barrel and a common plunger that provides for the delivery and mixture of equal volumes of the two-part fibrin sealant through a mixing chamber and application lumen.
Intended Use:
For the mixing, and one-to-one (1:1) delivery, of fibrin sealant for medical applications. It can also be attached to standard hospital wall suction for removal of debris, excess tissue or foreign particles in the wound.
1
Summary of Comparison to Predicates:
The Sealouette™ is substantially equivalent to the Duploject® in intended use, fluid sealant type, design and technological characteristics, components and materials.
The Sealouette™ suction system design is precisely the same as that of the predicate device, BioSurgical's Multi Chamber Suction Syringe cleared under #K964597.
Both the BioSurgical Sealouette™ and the Immuno-U.S. Duploject® are intended for use in the delivery of fibrin sealant. Both devices achieve the delivery of the fibrin sealant by use of a dual-chamber syringe with a mechanical plunger. Both devices incorporate a housing body, syringe, plunger, and applicator tip. Both devices provide intra-device sealant mixing immediately prior to exiting the application lumens: the Sealouette™ using an impingement mixing geometry, the Duploject® using a Y-configuration (see Mixing Design Comparison below). Where the Duploject® uses a blunt needle tip, the Sealouette™ uses a polypropylene cannula.
Discussion of Non-Clinical Tests:
A battery of non-clinical tests have been performed which demonstrate the functions of the device, and establish equivalence to the predicates in terms of: accuracy and volume of fibrin sealant delivered: the ability of the device to accurately and reproducibly deliver each component of the fibrin sealant at a fixed, predetermined ratio; and the ability of the device to homogeneously mix the components of the fibrin sealant. In addition, tests have been performed to demonstrate the substantial equivalence of the fibrin sealant delivered by the device to that delivered by the predicate in terms of: the time needed for the fibrin sealant to clot and achieve stable physical properties; the physical characteristics and geometry of the clot produced. Testing has demonstrated that the characteristics of the clot are not adversely affected by the delivery device itself or mode of delivery.
2
Conclusions Drawn from Non-Clinical Tests:
Islous Drawn is on Non - Smilly equivalent to the Duploject® and the Multi Chamber Suction syringe in terms physical components, technological characteristics, performance, fibrin sealant delivery, and characteristics of the fibrin sealant after delivery.
Terry L. Lass
(Signature)
Terry E. Laas
(Typed Name)
July 12, 1999
(Date)
K992351 (Premarket Notification (510(k))Number)
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a serpent entwined around it, overlaid on three human profiles. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 8 1999
Jeffrey M. Cohen President and Chief Executive Officer BioSurgical Corporation 5990 Stoneridge Drive, Suite 112 Pleasanton, California 94588
Re: K992351
Sealouette™ Fibrin Sealant Applicator Trade Name: Regulatory Class: II Product Code: FMF Dated: July 12, 1999 Received: July 14, 1999
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 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 Regulations, Title 21, Parts 800 to 895. ಗಿ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP 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
4
Page 2 - Mr. Cohen
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.
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) 594-4692. 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,
Timothy A. Ulatowski
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE STATEMENT
510(K) Number (if known): _ | 99 23 S/ _______________________________________________________________________________________________________________________________________
Device Name: Sealouette™ Fibrin Sealant Applicator
Indications For Use
For the mixing, and one-to-one (1:1) delivery, of fibrin sealant for medical applications. It can also be attached to standard hospital wall suction for removal of debris, excess tissue or foreign particles in the wound.
.
Pagc 12
(PLEASE NO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | ✓ | OR Over-The-Counter Use | |
|---|---|---|---|
| ------------------ | -------------------------------------------- | ------------------------- | -- |
(Per 21 CFR 801.109)
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K992351Page 12