VITAGEL SURGICAL HEMOSTAT SPRAY SET

K052173 · Orthovita, Inc. · FMF · Oct 19, 2005 · General Hospital

Device Facts

• Record ID: K052173
• Device Name: VITAGEL SURGICAL HEMOSTAT SPRAY SET
• Applicant: Orthovita, Inc.
• Product Code: FMF · General Hospital
• Decision Date: Oct 19, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Vitagel Surgical Hemostat Spray Set is a piston syringe-based applicator system. It consists of a spray applicator and filtered tubing. The device connects to a dual-syringe system containing two components of the Vitagel Surgical Hemostat and a medical-grade propellant gas control device. The system aerosolizes the two non-homogenous fluids for application to wound surfaces. Used in clinical settings by healthcare providers to facilitate the application of the hemostat. The device enables controlled delivery of the hemostat to the treatment site, assisting in surgical hemostasis.

Clinical Evidence

Bench testing demonstrated performance comparable to predicate devices. Animal testing confirmed that application of Vitagel using the Spray Set achieved results comparable to previously approved methods. No human clinical trial data provided.

Technological Characteristics

Piston syringe system (Product Code FMF). Components include a spray applicator and filtered tubing. Connects to a dual-syringe system and a medical-grade propellant gas control device. Mechanical aerosolization principle. No software or electronic components.

Indications for Use

Indicated for the application of Vitagel Surgical Hemostat onto wound surfaces. Patient population not specified.

Regulatory Classification

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.

Predicate Devices

• Micromedics FibriJet Aerosol Applicator
• Baxter Tissomat and Spray Set

Submission Summary (Full Text)

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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: [phone] [phone] 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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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 [phone] or [phone] 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 ________________________________________________________________________________________________________________________________________________________________

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