(70 days)
The Vitage!™ Surgical Hemostat Spray Set is intended for use in the application (by spraying) of the two components of Vitage]™ Surgical Hemostat onto wound surfaces.
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.
The provided text describes the Vitagel™ Surgical Hemostat Spray Set, a device intended for applying Vitagel™ Surgical Hemostat onto wound surfaces. The submission is a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to legally marketed predicate devices, rather than proving efficacy through clinical trials with specific acceptance criteria and performance metrics.
Therefore, the document does not contain the detailed information typically found in studies designed to prove a device meets acceptance criteria for specific performance metrics (like accuracy, sensitivity, specificity, etc., which are common in AI/diagnostic device submissions).
Based on the provided text, here's what can be extracted and what is not available for your requested table and study details:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Comparable performance to predicate devices (Micromedics FibriJet Aerosol Applicator, Baxter Tissomat and Spray Set) for applying two non-homogenous fluids by spraying. | 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 Vitagel™ Spray Set achieves results comparable to those obtained when Vitagel is applied using previously approved methods. |
Missing Information:
- Specific numerical acceptance criteria for performance benchmarks (e.g., spray pattern consistency, droplet size, flow rate, hemostatic efficacy improvements with the spray set vs. other application methods).
- Quantitative reported device performance metrics against those specific criteria.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified for either bench or animal testing.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The document only mentions "Bench testing" and "Animal testing."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This device is a medical accessory for applying another hemostat, not a diagnostic or AI device that requires expert-established ground truth on a test set. The performance data is derived from bench and animal studies to demonstrate comparable application.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. See point 3.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. This device is not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. See point 5.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the animal testing, the "ground truth" would likely be the observed hemostatic results achieved by applying Vitagel™ using the spray set, compared to results obtained when Vitagel™ was applied using "previously approved methods." The nature of this measurement (e.g., time to hemostasis, blood loss, subjective assessment) is not detailed.
8. The sample size for the training set:
- Not Applicable. This is not an AI/machine learning device that uses a training set.
9. How the ground truth for the training set was established:
- Not Applicable. See point 8.
Summary of the Study:
The provided text describes a 510(k) premarket notification for the Vitagel™ Surgical Hemostat Spray Set. The study conducted to support this notification was aimed at demonstrating substantial equivalence to predicate devices, not at establishing novel efficacy or specific performance metrics against clinical endpoints.
The performance data included:
- Bench Testing: Demonstrated "comparable" performance of the Vitagel Spray Set to predicate devices (Micromedics FibriJet Aerosol Applicator and Baxter Tissomat and Spray Set) for applying two non-homogenous fluids by spraying. Details on the specific parameters tested and quantitative results are not provided.
- Animal Testing: Confirmed that applying Vitagel™ using the Vitagel™ Spray Set achieved "results comparable" to those obtained when Vitagel™ was applied using "previously approved methods." Again, specific details on the animal models, the endpoints measured (e.g., hemostasis time, blood loss), and quantitative comparisons are not included in this summary.
This type of submission focuses on demonstrating that the new device does not raise new questions of safety or effectiveness compared to legally marketed devices, rather than providing in-depth clinical trial data with predefined acceptance criteria and performance.
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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. .
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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.
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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.
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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
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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 ____________________________________________________________________________________________________________________________________________________________________
§ 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).