(833 days)
Not Found
No
The device description and performance studies focus on mechanical components for spraying fibrin sealant and do not mention any AI/ML capabilities or data processing.
Yes
The device is described as applying fibrin sealant to wound surfaces for uniform coverage, which directly impacts the healing process and is intended for therapeutic benefit.
No
Explanation: The device is intended for the application of fibrin sealant onto wound surfaces, not for diagnosing any medical condition.
No
The device description clearly outlines physical components: a Spray Set (Spray Head, connection tube with sterile filter) and a Tissomat® device (propellant gas control device). These are hardware components, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to apply a fibrin sealant (Tisseel®) onto wound surfaces. This is a therapeutic application, not a diagnostic one.
- Device Description: The device is described as a system for spraying a sealant onto a wound. This aligns with a therapeutic or surgical device, not a device used to test samples from the body.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition.
- Performance Studies: The performance studies focus on the efficacy of applying the sealant (mixing, hemostasis, pressure) and clinical use for wound treatment. These are not studies related to diagnostic accuracy.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to deliver a therapeutic substance to a wound.
N/A
Intended Use / Indications for Use
The Tissomat® and Spray Set are intended for use in the simultaneous application (by spraying) of the two components of Tisseel® Fibrin Sealant onto wound surfaces. The Spray Set is or the two comployed® two-syringe holder and is equipped with a Spray Head and a connection tube which connects the Spray Head to the Tissomat® device, a propellant gas control device.
Product codes
FMF
Device Description
The Spray Set is a sterile, pyrogen-free, single-use device indicated for use in the simultaneous application (by spraying) of the two components of Tisseel® Fibrin Sealant onto wound surfaces. It consists of a Spray Head and connection tube with sterile filter. The Spray Set is attached to the Duploiect® two-syringe holder, a device that has already been cleared by the FDA through Premarket Notification [510(k)]. The connection tube connects the Spray Head to the Tissomat® device, a propellant gas control device.
The Tissomat® device controls and releases propellant gas provided by a propellant gas source (compressed air or nitrogen). The Tissomat® device is indicated for use only with the Spray Set in the simultaneous application (by spraying) of the two components of Tisseel® Fibrin Sealant onto wound surfaces.
The Tissomat® and Spray Set are used for the spraying of wound surfaces, when uniform coverage is essential.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
wound surfaces
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
A study was conducted to compare the degree of mixing of Tisseel® Fibrin Sealant using the Duploject® two-syringe holder with the Tissomat® and Spray Set, versus using the Duploject® two-syringe holder with an application needle. The results show that at least an equal degree of mixing was reached by using the Tissomat® and Spray Set as with using the application needle.
A study was conducted to compare the hemostatic efficacies of Tisseel® Fibrin Sealant using the Duploject® two-syringe holder with Tissomat® and Spray Set, versus using the Duploject® twosyringe holder with an application needle, in a rabbit liver abrasion model. The results show that the efficacy of Tisseel® Fibrin Sealant is equivalent whether the product is applied by spraying or by using an application needle.
A study was conducted to measure the gas pressure at a (simulated) wound surface using the Duploject® two-syringe holder with the Tissomat® and Spray Set. The results demonstrate a recommended maximum pressure of 2 bars (28.5 psi) for the Tissomat® device and a minimum spraying distance of 10 cm.
The Tissomat® and Spray Set was used clinically to treat a pediatric burn victim on an emergency basis. The Tissomat® and Spray Set were used during multiple operative procedures, in conjunction with the Duploject® two-syringe holder, to deliver fibrin sealant for cultured epidermal autograft adherence and hemostasis. There were no adverse events associated with use of the Tissomat® and Spray Set. Additionally, the surgeon reported this device to be an efficacious method of providing optimal coverage of fibrin sealant to the surgical site.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
| JUL | 5 | 2000 |
|---|---|---|
| ----- | --- | ------ |
510(k) Number: K981089 Response to FDA Questions Posed on 17-Dec-1999 Tissomat® and Spray Set BAXTER HEALTHCARE CORPORATION, HYLAND IMMUNO
Page 27
Summary of Safety and Effectiveness for the Tissomat® and Spray Set
Submitter
Baxter Healthcare Corporation Hyland Immuno 550 North Brand Boulevard Glendale, California 91203-1900
Date Summary was Prepared
03-May-2000
Name(s) of the Device
Tissomat® and Spray Set
Identification of Predicate Device(s)
Duploject® Baxter Healthcare Corporation, Hyland Immuno K973510
Description of the Device
The Spray Set is a sterile, pyrogen-free, single-use device indicated for use in the simultaneous application (by spraying) of the two components of Tisseel® Fibrin Sealant onto wound surfaces. It consists of a Spray Head and connection tube with sterile filter. The Spray Set is attached to the Duploiect® two-syringe holder, a device that has already been cleared by the FDA through Premarket Notification [510(k)]. The connection tube connects the Spray Head to the Tissomat® device, a propellant gas control device.
The Tissomat® device controls and releases propellant gas provided by a propellant gas source (compressed air or nitrogen). The Tissomat® device is indicated for use only with the Spray Set in the simultaneous application (by spraying) of the two components of Tisseel® Fibrin Sealant onto wound surfaces.
The Tissomat® and Spray Set are used for the spraying of wound surfaces, when uniform coverage is essential.
1
Intended Use
The Tissomat® and Spray Set are intended for use in the simultaneous application (by spraying) of the two components of Tisseel® Fibrin Sealant onto wound surfaces. The Spray Set is or the two comployed® two-syringe holder and is equipped with a Spray Head and a connection tube which connects the Spray Head to the Tissomat® device, a propellant gas control device.
Comparison of Device Characteristics to Predicate
The Tissomat® and Spray Set are two parts forming a functional unit, which is intended to be used in conjunction with the Duploject® two-syringe holder, the predicate device cleared through Premarket Notification [510(k)] The Spray Set has the same technological characteristics as the Duploject® device. The Tissomat® device controls and releases propellant gas provided by a propellant gas source (compressed air or nitrogen). Use of this pressure regulating technology in this application is supported by performance testing, as described below, and by the fact that this technology has been used in many other surgical applications, e.g., irrigation systems and insufflators.
Performance Testing
A study was conducted to compare the degree of mixing of Tisseel® Fibrin Sealant using the Duploject® two-syringe holder with the Tissomat® and Spray Set, versus using the Duploject® two-syringe holder with an application needle. The results show that at least an equal degree of mixing was reached by using the Tissomat® and Spray Set as with using the application needle.
A study was conducted to compare the hemostatic efficacies of Tisseel® Fibrin Sealant using the Duploject® two-syringe holder with Tissomat® and Spray Set, versus using the Duploject® twosyringe holder with an application needle, in a rabbit liver abrasion model. The results show that the efficacy of Tisseel® Fibrin Sealant is equivalent whether the product is applied by spraying or by using an application needle.
A study was conducted to measure the gas pressure at a (simulated) wound surface using the Duploject® two-syringe holder with the Tissomat® and Spray Set. The results demonstrate a recommended maximum pressure of 2 bars (28.5 psi) for the Tissomat® device and a minimum spraying distance of 10 cm.
The Tissomat® and Spray Set was used clinically to treat a pediatric burn victim on an emergency basis. The Tissomat® and Spray Set were used during multiple operative procedures, in conjunction with the Duploject® two-syringe holder, to deliver fibrin sealant for cultured epidermal autograft adherence and hemostasis. There were no adverse events associated with use of the Tissomat® and Spray Set. Additionally, the surgeon reported this device to be an efficacious method of providing optimal coverage of fibrin sealant to the surgical site.
2
The Tissomat® and Spray Set have been licensed for many years in Europe, Canada, and other countries, and have been successfully used in more than 250,000 applications of fibrin sealant.
Conclusion
The nonclinical testing along with many years of clinical experience demonstrate that the Tissomat® and Spray Set, used in conjunction with the Duploject® two-syringe holder (the predicate), is a safe and efficacious method of delivering Tisseel® Fibrin Sealant and performs according to required specifications (e.g., adequate mixing of the solutions, appropriate regulation of pressure).
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. The text is in all caps and is evenly spaced around the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL- 5 2000
Ms. Arlene Vidor Vice President, Requlatory Affairs North America Baxter Healthcare Corporation Hyland Division 550 North Brand Boulevard Glendale, California 91023
Re : K981089
Trade Name: Tissomat® and Spray Set Requlatory Class: II Product Code: FMF Dated: May 3, 2000 Received: May 4, 2000
Dear Ms. Vidor:
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 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will Failure to comply with the GMP verify such assumptions. 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.
4
Page 2 - Ms. Vidor
This letter will allow you to begin marketing your device as This lecter will arrow you co responsification. The FDA described in your 510\x) prematice of your device to a legally
finding of substantial equivalence of your accidential for your marketed predicate device results in a classification for your marketed predicate device robated and open device to the market.
If you desire specific advice for your device on our labeling II you desire specific additionally 809.10 for in regulation (21 cm Fare 801 and se contact the Office of Compliance at (301) 594-4692. Additionally, for questions on Compilance at (301) 354 ising of your device, please contact the promocion and advertibing or jour 4639. Also, please note the Office Of Compriance as sociation by reference to Che regulation cheritou, (21 CFR 807.97), " Other general premarket notification - (ar oil oil of the Art may be information on your responsible manufacturers Assistance obtained from the bivision or (301) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
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
510(k) Number
Device Name
Tissomat® and Spray Set
Indications for Use
The Tissomat® and Spray Set are intended for use in the simultaneous application (by spraying) of the two components of Tisseel® Fibrin Sealant onto wound surfaces. The Spray Set is or ure the Duploject® two-syringe holder and is equipped with a Spray Head and a connection tube which connects the Spray Head to the Tissomat® device, a propellant gas control device.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (per 21 CFR § 801.109) 12
Over-the Counter Use 0
Brenda Belke
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number K98/089