(70 days)
Not Found
No
The device description and performance studies focus on the mechanical application of a hemostatic agent and do not mention any computational or data-driven processes indicative of AI/ML.
No
The device is described as a "Surgical Hemostat Spray Set" intended for applying a hemostatic agent to wound surfaces, which is a supportive tool rather than a direct therapeutic intervention on the patient.
No
The device is described as a "Surgical Hemostat Spray Set" intended for "application (by spraying) of the two components of Vitage]™ Surgical Hemostat onto wound surfaces." Its function is to aerosolize a substance for application to a treatment site, not to diagnose a condition or illness.
No
The device description clearly outlines physical components (Spray Applicator, Filtered Tubing) and their interaction with other hardware (dual syringe system, propellant gas control device), indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to apply a hemostatic agent (Vitagel) onto wound surfaces. This is a therapeutic application directly on the body, not a diagnostic test performed on samples outside the body.
- Device Description: The device is a spray set for applying a substance to a wound. This aligns with a medical device used for treatment, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition.
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 Vitagel Spray Set Vitagel™ Application System is intended for use in the application (by spraying) of the two components of Vitage]™ Surgical Hemostat onto wound surfaces.
The Vitagel™ Surgical Hemostat Spray Set is intended for use in the application (by spraying) of the two components of Vitagel™ Surgical Hemostat onto wound surfaces.
Product codes (comma separated list FDA assigned to the subject device)
FMF
Device Description
The Vitagel Spray Set consists of a Spray Applicator and Filtered Tubing. The Spray Applicator is connected directly to the joiner of the dual syringe system supplied with the Vitagel preparation and application kit and is connected to a medical grade propellant gas control device via the Filtered Tubing. The Vitagel Spray Set aerosolizes the Vitagel for application to a suitable treatment site as described in the Vitagel instructions for use.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing demonstrates that the Vitagel Spray Set performs in a comparable manner to predicate devices. Animal testing confirms that application of Vitagel using the Vitage! Spray Set achieves results comparable to those obtained when Vitagel is applied using previously approved methods.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Not Found
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).
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
001 9 2005
510(K) SUMMARY FOR ORTHOVITA, INC.'S VITAGEL™ SURGICAL HEMOSTAT SPRAY SET
Submitter's Name, Address, Telephone Number, And Contact Person
Orthovita, Inc. 45 Great Valley Parkway Malvern, PA 19355
Telephone: (610) 407-5251 (610) 640-2603 Facsimile:
Gina M. Nagvajara, Ph.D. Contact:
Date Prepared
August 9, 2005
Name of the Device
Vitagel™ Surgical Hemostat Spray Set
Common or Usual Name
Piston syringe.
Classification Name
Piston syringe (FMF).
Predicate Devices
- Micromedics FibriJet Aerosol Applicator. .
- Baxter Tissomat and Spray Set. .
1
Intended Use
The Vitagel Spray Set Vitagel™ Application System is intended for use in the application (by spraying) of the two components of Vitage]™ Surgical Hemostat onto wound surfaces.
Technological Characteristics
The Vitagel Spray Set consists of a Spray Applicator and Filtered Tubing. The Spray Applicator is connected directly to the joiner of the dual syringe system supplied with the Vitagel preparation and application kit and is connected to a medical grade propellant gas control device via the Filtered Tubing. The Vitagel Spray Set aerosolizes the Vitagel for application to a suitable treatment site as described in the Vitagel instructions for use.
Performance Data
Bench testing demonstrates that the Vitagel Spray Set performs in a comparable manner to predicate devices. Animal testing confirms that application of Vitagel using the Vitage! Spray Set achieves results comparable to those obtained when Vitagel is applied using previously approved methods.
Substantial Equivalence
The Vitagel Spray Set has an intended use substantially similar to both the Micromedics FibriJet and the Baxter Tissomat, namely the application by spraying of two non-homogenous fluids.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes around a staff. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the caduceus.
OCT 1 9 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dr. Gina M. Nagvajara Vice President, US Regulatory Affairs Orthovita. Incorporated 45 Great Valley Parkway Malvern, Pennsylvania 19355
Re: K052173
Trade/Device Name: VITAGEL SURGICAL HEMOSTAT SPRAY SET Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: August 9, 2005 Received: August 10, 2005
Dear Dr. Nagvajara:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Mcdical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). 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 cither class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2 - Dr. Nagvajara
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. of the Act of any I ederal the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 CF (21 (1 ) in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as set form in are quadistion control provisions (Sections 531-542 of the Act); appreadio, the necessed in this letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence m 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), r you desire spleine at ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours,
Sutie J. Michael Davis
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):_K052173
Device Name:_Vitagel™ Surgical Hemostat Spray Set
Indications For Use:
The Vitage!™ Surgical Hemostat Spray Set is intended for use in the application (by The vitage. " Ourgiour Homostal opray of Surgical Hemostat onto wound surfaces.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Cintas V, me
(Division Sign-Off) (Pivision Sign-Om)
Division of Anesthesiology, General Hospital,
Division of Anesthesiology, General Devices Division Control, Dental Devices
510(k) Number ________________________________________________________________________________________________________________________________________________________________
Page 1 of ____________________________________________________________________________________________________________________________________________________________________