IMBIBE BONE MARROW ASPIRATION SYRINGE

K023074 · Orthovita, Inc. · FMF · Mar 11, 2003 · General Hospital

Device Facts

• Record ID: K023074
• Device Name: IMBIBE BONE MARROW ASPIRATION SYRINGE
• Applicant: Orthovita, Inc.
• Product Code: FMF · General Hospital
• Decision Date: Mar 11, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5860
• Device Class: Class 2

Intended Use

The IMBIBE Bone Marrow Aspiration 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 autologous blood or bone marrow with bone void filler (bone graft) and deliver the material to the orthopaedic surgical site.

Device Story

Manual piston syringe used by surgeons in orthopaedic surgical settings. Device consists of calibrated hollow barrel, movable plunger, and luer-lock nozzle. User fills syringe with bone void filler (allograft, autograft, or synthetic) via proximal end or distal nozzle; percutaneously aspirates blood or marrow into barrel; mixes contents; and delivers mixture to surgical site. Device facilitates convenient handling and delivery of bone graft materials. Single-use only.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Piston syringe; materials include polycarbonate, ABS, silicone, and PVC. Features luer-lock nozzle, graduated barrel, and silicone lubricant. Sterilized via gamma radiation. Available in 10cc, 20cc, 30cc, and 60cc volumes with varying barrel lengths and diameters.

Indications for Use

Indicated for aspiration of bone marrow, autologous blood, plasma, or other blood components and delivery of bone void filler (allograft, autograft, or synthetic) to orthopaedic surgical sites.

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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K023014

Imbibe™ Bone Marrow Aspiration Syringe Special 510(k)

MAR 11 2003

## 501(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 | | | |
| Trade Name | Imbibe™ Bone Marrow<br>Aspiration Syringe | Imbibe™ Bone Marrow<br>Aspiration Syringe, K011087 | |
| Common Name | Bone Graft Delivery Syringe | Bone Graft Delivery Syringe | |
| Classification Name | Piston Syringe | Piston Syringe | |

### Device Description:

The syringe consists of a calibrated hollow barrel and a movable plunger. At the distal end of the syringe there is a male connector (nozzle) for fitting the female connector (hub) of a single lumen aspiration needle. A luer-lock nozzle makes a stable connection between the syringe and needle. (Please note that the needle is not the subject of this 510(k).) 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. Alternatively, the plunger can be removed to add bone void filler from the proximal end of the syringe.

After filling the syringe with bone void filler, the user attaches a needle by way of the luer-lock, and percutaneously aspirates blood or marrow into the barrel of the syringe. Once the desired volume of blood or marrow has been collected, the threaded screw cap is removed and the contents of the syringe are delivered to the surgical site.

### Intended Use:

The IMBIBE Bone Marrow Aspiration 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 autologous blood or bone marrow with bone void filler (bone graft) and deliver the material to the orthopaedic surgical site.

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K023.74

Orthovita, Inc. Imbibe™ Bone Marrow Aspiration Syringe Special 510(k)

# COMPARISON TO PREDICATE (Original) SYRINGE

Predicate Syringe, K011087

Modified Syringe

| Syringe Type | Piston Syringe | Piston Syringe |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| Intended Use | To collect blood components/bone marrow<br>for mixing with bone graft and subsequent<br>delivery to the surgical site. | Identical |
| Principle of Operation | Syringe used to collect blood, marrow<br>Removable cap allows syringe to be<br>filled with graft material Syringe provides for mixing of blood,<br>marrow with graft material Removable screw cap allows for<br>delivery of blood, marrow filled graft<br>to surgical site | Identical |
| Barrel Length | 2.93 inches | 2.93, 3.25, 3.47, and 5.23 inches for<br>the 10, 20, 30 and 60cc syringes,<br>respectively |
| Barrel Diameter | 0.728 inches, OD | 0.728, 0.898, 1.038, and 1.186 inches<br>OD for the 10, 20, 30 and 60cc<br>syringes respectively |
| Tip Type | Gasket | Gasket |
| Volume | 10cc | 10cc, 20cc, 30cc, 60cc |
| Nozzle Type | Luer-lock | Luer-lock |
| Barrel Markings | Graduated scale | Graduated scale |
| Lubricant Composition | Silicone | Silicone |
| Lubricant amt/cm² | $100mg \pm 5mg$ | 25 mg maximum for all sizes |
| Barrel Transparency | Transparent, no radiopacifiers | Transparent, no radiopacifiers |
| Reuse | Single use only | Single use only |
| Biocompatibility | Established | Established by way of predicate<br>device, K011087 |
| Materials | Polycarbonate, ABS, Silicone | Polycarbonate, ABS, Silicone, PVC |
| Sterility | gamma radiation | gamma radiation |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three heads, representing the three branches of government. The eagle is enclosed in a circle, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are written around the top of the circle. The logo is simple and recognizable, and it is used to represent the U.S. Department of Health & Human Services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 11 2003

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

Re: K023074

Trade/Device Name: IMBIBE™ Bone Marrow Aspiration Syringe Regulation Number: 880.5860 Regulation Name: Piston syringe Regulatory Class: Class II Product Code: FMF Dated: February 10, 2003 Received: February 11, 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

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Page 2 – Ms. Andreina Ide

(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. 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). 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.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Muriam C. Provost

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. Imbibe™ Bone Marrow Aspiration Syringe Special 510(k)

### INDICATIONS FOR USE STATEMENT

# 510(k) NUMBER (IF KNOWN): [ ¿ 2 ≤ ~14

DEVICE NAME: Imbibe™ Bone Marrow Aspiration Syringe

#### INDICATIONS FOR USE:

The Imbibe Bone Marrow Aspiration 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 autologous blood or bone 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 1X (Per 21 CFR 801.109) OR

Over-The-Counter-Use

Muriam C. Provost

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

510(k) Number K023074