VITOSS-FILLED CARTRIDGE

K032130 · Orthovita, Inc. · MQV · Nov 5, 2003 · Orthopedic

Device Facts

• Record ID: K032130
• Device Name: VITOSS-FILLED CARTRIDGE
• Applicant: Orthovita, Inc.
• Product Code: MQV · Orthopedic
• Decision Date: Nov 5, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

VITOSS® Scaffold Synthetic Cancellous Bone Void Filler is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. VITOSS Scaffold is indicated for use in the treatment of surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. VITOSS should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously. VITOSS Scaffold is intended to be packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis) and may be combined with autogenous blood and/or bone marrow. Following placement in the bony void or gap, the calcium phosphate scaffold resorbs and is replaced with bone during the healing process. The VITOSS-Filled Cartridge is intended for use as a piston syringe system for the aspiration of autogenous blood and/or bone marrow. This Cartridge provides the surgeon with a convenient way to mix autologous blood or bone marrow with Vitoss Scaffold® and deliver the material to the orthopaedic surgical site.

Device Story

Vitoss-Filled Cartridge is a convenience kit combining Vitoss Scaffold (synthetic cancellous bone void filler) and Imbibe II Syringe. Kit includes pre-filled syringe, secondary 30cc Merit Piston Syringe, and vacuum line adapter. Used in orthopedic surgical settings by surgeons. Device functions as a piston syringe system to aspirate autogenous blood or bone marrow; allows mixing of biological fluids with scaffold material within the cartridge; facilitates delivery of mixture to surgical site. Scaffold resorbs and is replaced by bone during healing. No changes to individual components compared to predicates.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on the combination of legally marketed predicate devices with no changes to their design or intended use.

Technological Characteristics

Kit consists of a synthetic calcium phosphate scaffold and a piston syringe delivery system. Materials and design are identical to previously cleared predicates (K994337, K030208). Includes vacuum line adapter for aspiration. Non-electronic, mechanical device.

Indications for Use

Indicated for patients with surgically created osseous defects or traumatic bone injuries requiring a bone void filler in the extremities, spine, or pelvis. Contraindicated for large defects that would not heal spontaneously or defects intrinsic to bony structure stability.

Regulatory Classification

Identification

A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.

Special Controls

*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.

Predicate Devices

• Vitoss Scaffold (K994337)
• Imbibe II Syringe (K030208)

Reference Devices

• Merit Piston Syringe (K875196)

Submission Summary (Full Text)

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K032130

Orthovita, Inc. Vitoss-Filled Cartridge Special 510(k)

# 510(k) Summary

| Submitted by | Address | Telephone | Contact Person |
|---------------------|----------------------------------------------------------|------------------------------------------------------------|-----------------------------------------------------|
| OrthoVita, Inc. | 45 Great Valley Parkway<br>Malvern, PA 19355 | [phone] | Andreina Ide<br>Sr. Director, Regulatory<br>Affairs |
| September 2002 | Subject Device | Predicate Device | |
| Trade Name | Vitoss-Filled Cartridge | Vitoss Scaffold, K994337 and<br>Imbibe II Syringe, K030208 | |
| Common Name | Kit: Bone Void Filler and<br>Bone Graft Delivery Syringe | Bone Void Filler and<br>Bone Graft Delivery Syringe | |
| Classification Name | Bone Void Filler and Piston<br>Syringe | Bone Void Filler and Piston<br>Syringe | |

### Device Description:

The Vitoss-Filled Cartridge is a device that combines two Orthovita products, Vitoss Scaffold Synthetic Cancellous Bone Void Filler (K994337) and the Imbibe II Syringe (K030208) into a kit configuration. The convenience kit provides the Imbibe II Syringe loaded (filled) with Vitoss Scaffold and an empty 30cc secondary syringe (Merit Piston Syringe. K875196). An adapter valve, which can be connected to the vacuum line in the surgical suite, is also provided. The surgeon can use either the secondary syringe or the vacuum line adapter to aspirate blood or marrow into the Vitoss-Filled Cartridge.

### Intended Use:

VITOSS® Scaffold Synthetic Cancellous Bone Void Filler is intended only for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. VITOSS Scaffold is indicated for use in the treatment of surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. VITOSS should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously.

VITOSS Scaffold is intended to be packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). Following placement in the bony void or gap, the calcium phosphate scaffold resorbs and is replaced with bone during the healing process.

The Cartridge, containing Vitoss Scaffold, is intended for use as a piston syringe for the aspiration of bone marrow, autologous blood, plasma or other blood components. The cartridge provides the surgeon with a convenient way to mix autologous blood or bone marrow with Vitoss Scaffold Bone Void Filler and deliver the material to the orthopaedic surgical site.

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## Comparison to Predicate:

The Vitoss-Filled Cartridge claims substantial equivalence to the Vitoss Scaffold Synthetic Cancellous Bone Void Filler (K994337) and the Imbibe II Syringe (K030208), cleared December 14, 2000 and April 16, 2003 respectively.

The Vitoss-Filled Cartridge is a device that combines Vitoss Scaffold (K994337) and the Imbibe II Syringe (K030208) into a convenience kit whereby the Imbibe II Syringe is loaded (filled) with Vitoss Scaffold. No changes have been made to the Vitoss Scaffold or the Imbibe II Syringe.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three wavy lines representing the branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 5 2003

Ms. Andreina Ide Sr. Director, Regulatory Affairs Orthovita, Inc. 45 Great Valley Parkway Malvern, PA 19355

Re: K032130

Trade Name: Vitoss Scaffold Synthetic Cancellous Bone Void Filler Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: October 23, 2003 Received: October 27, 2003

Dear Ms. Ide:

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 Medical 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 either 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.

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. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050

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Page 2 - Ms. Andreina Ide

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 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 regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation 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 Division 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/dsma/dsmamain.html

Sincerely yours.

Sincerery, yours,

Mark A. Milken

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Orthovita, Inc. Vitoss-Filled Cartridge Special 510(k), K032130

#### INDICATIONS FOR USE STATEMENT October 30, 2003

## 510(k) NUMBER (IF KNOWN): K032130

DEVICE NAME: Vitoss-Filled Cartridge

#### INDICATIONS FOR USE:

VITOSS® Scaffold Synthetic Cancellous Bone Void Filler is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. VITOSS Scaffold is indicated for use in the treatment of surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. VITOSS should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously.

VITOSS Scaffold is intended to be packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis) and may be combined with autogenous blood and/or bone marrow. Following placement in the bony void or gap, the calcium phosphate scaffold resorbs and is replaced with bone during the healing process.

The VITOSS-Filled Cartridge is intended for use as a piston syringe system for the aspiration of autogenous blood and/or bone marrow. This Cartridge provides the surgeon with a convenient way to mix autologous blood or bone marrow with Vitoss Scaffold® and deliver the material to the orthopaedic surgical site.

#### PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR Over-The-Counter-Use
(Division Sign-Off

Division of General, Restorative and Neurological Devices

510(k) Number K 032130