IMBIBE II SYRINGE

K030208 · Orthovita, Inc. · FMF · Apr 16, 2003 · General Hospital

Device Facts

• Record ID: K030208
• Device Name: IMBIBE II SYRINGE
• Applicant: Orthovita, Inc.
• Product Code: FMF · General Hospital
• Decision Date: Apr 16, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2

Intended Use

The IMBIBE II Syringe is intended for use as a piston syringe for the aspiration of bone marrow, autologous blood, plasma or other blood components. Prior to use, the syringe can be filled with the surgeon's choice of bone void filler (allograft, autograft or synthetic bone graft material). This syringe provides the surgeon with a convenient way to mix blood or marrow with bone void filler (bone graft) and deliver the material to the orthopaedic surgical site.

Device Story

IMBIBE II Syringe is a piston-style delivery device for orthopaedic bone graft materials. Device consists of a calibrated hollow barrel, moveable piston, and Luer-lock nozzles at both distal and proximal ends. Surgeon fills barrel with bone void filler; collects bone marrow or blood via aspiration needle attached to distal Luer-lock using vacuum from secondary syringe at proximal Luer-lock; or fills via proximal port. Device facilitates mixing of graft material with blood/marrow components within the barrel. After mixing, surgeon attaches pushrod to piston, removes distal cap, and extrudes mixture into surgical site. Used in clinical/surgical settings by physicians. Benefits include convenient, integrated mixing and delivery of bone graft composites.

Clinical Evidence

No clinical data. Substantial equivalence is based on design, intended use, and biocompatibility testing of materials (ISO 10993).

Technological Characteristics

Piston syringe; materials include polycarbonate, ABS, silicone, and Dymax UV adhesive 1187-M-T. Features Luer-lock nozzles at distal and proximal ends. Available in 5, 10, 15, and 30 cc volumes. Single-use; sterilized by gamma radiation. No lubricant used.

Indications for Use

Indicated for use in orthopaedic surgical procedures requiring the aspiration of bone marrow, autologous blood, plasma, or other blood components, and the subsequent mixing and delivery of these components with bone void fillers (allograft, autograft, or synthetic bone graft material).

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

• IMBIBE Bone Marrow Aspiration Syringe (K011087)

Submission Summary (Full Text)

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K03020f

IMBIBE II Syringe 510(k) Notification Orthovita, Inc.

APR 1 6 2003

### 510(k) Summary

### IMBIBE II Syringe

| 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 |
| April 2001 | | | |
| Trade Name | Subject Device | | Predicate Device |
| | IMBIBE II Syringe | | IMBIBE Bone Marrow<br>Aspiration Syringe |
| Common Name | Bone Graft/Bone Void Filler<br>Delivery Syringe | | Bone Graft/Bone Void Filler<br>Delivery Syringe |
| Classification Name | Piston Syringe | | Piston Syringe |

### Device Description:

The IMBIBE II Syringe consists of a calibrated hollow barrel and a moveable piston. At the distal end of the syringe, there is a Luer-lock nozzle for fitting the connector (hub) of a single lumen aspiration needle. A Luer-lock nozzle makes a stable connection between the syringe and needle. A threaded screw cap (containing the Luer-lock nozzle) at the distal end of the syringe can be removed to allow the user to fill the syringe with his or her choice of bone void filler. The proximal end of the syringe contains a moveable piston. A Luerlock nozzle is located in the center of the piston. This connector provides a mechanism for either of two actions.

- Fitting the male connector of a vacuum application device, such as a secondary empty I piston syringe.
- . Fitting the male connector of a secondary pre-filled piston syringe containing bone marrow, autologous blood, plasma or other blood components.

Prior to use, the IMBIBE II syringe is filled with the surgeon's choice of bone void filler (allograft, autograft or synthetic bone graft material). Two methods can be used to imbibe the bone void filler with bone marrow or autologous blood. Method I collects blood or marrow by way of a needle attached to the distal Luer-lock and vacuum/aspiration applied by way of a secondary syringe attached to the proximal Luer-lock. Method II fills the IMBIBE II Syringe through the proximal port (Luer-lock) with blood or marrow collected by way of a secondary syringe.

Once the desired volume of blood or marrow has been collected and mixed with the bone void filler, the secondary syringe and/or aspiration needle are removed. A pushrod is

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KOSOLO 8 IMBIBE II Syringe 510(k) Notification Orthovita, Inc.

attached to the piston at the proximal end of the IMBIBE II Syringe by way of the female Luer-lock, the distal cap is unscrewed and the contents of the syringe are delivered to the surgical site by extruding the mixed bone void filler.

#### Intended Use:

The IMBIBE II Syringe is intended for use as a piston syringe for the aspiration of bone marrow, autologous blood, plasma or other blood components. Prior to use, the syringe is filled with the surgeon's choice of bone void filler (allograft, autograft or synthetic bone graft material). This syringe provides the surgeon with a convenient way to mix blood or marrow with bone void filler (bone graft) and deliver the material to the orthopaedic surgical site.

| COMPARISON TO PREDICATE<br>Table I | | |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | IMBIBE 11 Syringe | Predicates IMBIBE Bone<br>Marrow Aspiration<br>Syringe NML1087 |
| Syringe Type | Piston Syringe | Piston Syringe |
| Intended Use | To collect blood<br>components/bone marrow for<br>mixing with bone graft and<br>subsequent delivery to the<br>surgical site. | To collect blood<br>components/bone marrow for<br>mixing with bone graft and<br>subsequent delivery to the<br>surgical site. |
| Principle of Operation | Syringe used to collect<br>blood, marrow Removable cap allows<br>syringe to be filled with graft<br>material Syringe provides for mixing<br>of blood, marrow with graft<br>material Removable screw cap allows<br>for delivery of blood,<br>marrow filled graft to<br>surgical site Luer-lock (nozzle) at the<br>proximal end of the barrel<br>allows connection of a<br>secondary piston syringe. | Syringe used to collect blood,<br>marrow Removable cap allows<br>syringe to be filled with graft<br>material Syringe provides for mixing<br>of blood, marrow with graft<br>material Removable screw cap allows<br>for delivery of blood, marrow<br>filled graft to surgical site |

### Comparison to Predicate:

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K030208f

IMBIBE II Syringe
510(k) Notification
Orthovita, Inc.

| Overall Length | 3.5, 4.6, 3.9, 5.3 inches<br>(respectfully for a 5cc, 10cc, 15cc, 30cc internal volume) | 2.9 inches |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|
| Barrel Diameter | 0.73, 0.73, 1.05, 1.05 inches, OD<br>(respectfully for a 5cc, 10cc, 15cc, 30cc internal volume) | 0.73 inches, OD |
| Tip Type | Gasket | Gasket |
| Volume | 5, 10, 15, 30 cc | 10 cc |
| Nozzle Type | Luer-lock | Luer-lock |
| Barrel Markings | Graduated scale | Graduated scale |
| Lubricant Composition | None | Silicone |
| Lubricant amt/cm² | Not Applicable | 100mg ± 5mg |
| Barrel Transparency | Transparent, no radiopacifiers | Transparent, no radiopacifiers |
| Reuse | Single use only | Single use only |
| Biocompatibility | Established by way of legally marketed device, IMBIBE Bone<br>Marrow Aspiration Syringe, K011087 and ISO 10993 testing of adhesive | Established |
| Materials | Polycarbonate, ABS, Silicone,<br>Dymax UV adhesive 1187-M-T | Polycarbonate, ABS, Silicone |
| Labeling | See Exhibit B. Same as predicate except additional information regarding directions for use. | See Exhibit C |
| Sterility | Sterilized by gamma radiation | Sterilized by gamma radiation |

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and head. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 6 2003

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

Re: K030208

Trade/Device Name: IMBIBE II Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston syringe Regulatory Class: II Product Codes: FMF Dated: January 17, 2003 Received: January 21, 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. Iisting 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 (OS) 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]. Additionally, for questions on the promotion and advertising of your device, 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 may be obtained 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/dsmaldsmamain.html

Sincerely yours,

Miriam C. Provost

tot 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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## INDICATIONS FOR USE STATEMENT

# 510(k) Number:

### Device Name: IMBIBE II Syringe

### Indications For Use:

The IMBIBE II Syringe is intended for use as a piston syringe for the aspiration of bone marrow, autologous blood, plasma or other blood components. Prior to use, the syringe can be filled with the surgeon's choice of bone void filler (allograft, autograft or synthetic bone graft material). This syringe provides the surgeon with a convenient way to mix blood or marrow with bone void filler (bone graft) 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

Miriaml. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K030208

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