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.

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.

AI/ML Overview

The provided document describes the Sealouette™ Fibrin Sealant Applicator, which is intended for the mixing and delivery of fibrin sealant and can also be used for suction. The acceptance criteria and the study performed are focused on demonstrating substantial equivalence to predicate devices, rather than establishing de novo performance thresholds.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present specific quantitative acceptance criteria with numerical targets. Instead, the "acceptance criteria" are implied by the need to demonstrate substantial equivalence to predicate devices in various functional and performance aspects. The reported device performance is described qualitatively as meeting these equivalency standards.

Acceptance Criteria (Implied by Substantial Equivalence to Predicates)	Reported Device Performance
Accuracy and Volume of Fibrin Sealant Delivered: Ability to accurately and reproducibly deliver each component at a fixed, predetermined ratio.	"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."
Homogeneous Mixing: Ability of the device to homogeneously mix the components of the fibrin sealant.	"and the ability of the device to homogeneously mix the components of the fibrin sealant."
Clotting Time and Stable Physical Properties: 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.	"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;"
Physical Characteristics and Geometry of the Clot: Substantial equivalence regarding the physical characteristics and geometry of the clot produced, ensuring they are not adversely affected by the delivery device or mode.	"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."
Suction System Performance: Equivalence to the predicate BioSurgical Multi Chamber Suction Syringe.	"The Sealouette™ suction system design is precisely the same as that of the predicate device, BioSurgical's Multi Chamber Suction Syringe cleared under #K964597." (Implies equivalent performance for fluid and debris removal.)
Physical Components, Technological Characteristics, and Fibrin Sealant Delivery: Overall equivalence to predicate devices (Duploject® and Multi Chamber Suction Syringe) in these aspects.	"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." (Though misspelled "Islous Drawn is on Non - Smily", the intent is clear: "Conclusions Drawn from Non-Clinical Tests: Is [the device] substantially equivalent to the Duploject® and the Multi Chamber Suction syringe...")

2. Sample Size Used for the Test Set and Data Provenance

The document describes "a battery of non-clinical tests" but does not specify numerical sample sizes for these tests.
The tests are "non-clinical," implying they were conducted in a laboratory or engineering setting, rather than with human subjects or patient data. Therefore, data provenance in terms of country of origin or retrospective/prospective clinical data is not applicable here.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The study described is a non-clinical, performance-based study focused on engineering characteristics of the device (delivery accuracy, mixing, clot formation). There is no mention of experts being used to establish a "ground truth" in the sense of medical diagnosis or interpretation for a test set. The "ground truth" for these engineering tests would typically be established by established measurement standards, reference materials, or predicate device performance.

4. Adjudication Method for the Test Set

Given that this is a non-clinical mechanical/performance study, no adjudication method (like 2+1, 3+1) involving human expert opinions for a diagnostic test set is mentioned or applicable. Results would be based on direct measurements and comparisons to predicate device performance.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was conducted or mentioned. This type of study is typically performed for diagnostic devices where human readers interpret medical images or data, and AI assistance is being evaluated. The Sealouette™ is a delivery and suction device, not a diagnostic one.

6. Standalone Performance Study

The non-clinical tests described are essentially a standalone performance evaluation of the device's engineering characteristics (delivery, mixing, clot formation) and its suction capability, relative to predicate devices. The study aimed to demonstrate the device's inherent functionality without human intervention beyond operating the device. The "algorithm only" concept does not apply here as it's a mechanical device.

7. Type of Ground Truth Used

The "ground truth" for the non-clinical tests would have been established through:

Measurement standards and engineering specifications: For accuracy, volume, and mixing.
Physical and chemical analysis: For characteristics of the fibrin sealant clot (clotting time, physical properties, geometry).
Predicate device performance: The performance of the Immuno-U.S. Duploject® and BioSurgical Corporation Multi Chamber Suction Syringe served as the benchmark for demonstrating substantial equivalence.

8. Sample Size for the Training Set

The document describes non-clinical performance testing and substantial equivalence demonstration, not a machine learning model. Therefore, there is no training set in the context of AI/ML.

9. How the Ground Truth for the Training Set Was Established

As there is no training set for an AI/ML model, this question is not applicable.

Summary

{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:

Intended Use:

{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

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)

Signature

(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K992351Page 12

Regulation Number and Section

§ 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).