SYNTHES (USA) BONE MARROW ASPIRATION SYRINGE

K051720 · Synthes (Usa) · FMF · Jul 25, 2005 · General Hospital

Device Facts

• Record ID: K051720
• Device Name: SYNTHES (USA) BONE MARROW ASPIRATION SYRINGE
• Applicant: Synthes (Usa)
• Product Code: FMF · General Hospital
• Decision Date: Jul 25, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2

Intended Use

The Synthes Bone Marrow Aspiration (BMA) Syringe is intended for aspiration of bone marrow, autologous blood, plasma, or other body fluids.

Device Story

Synthes (USA) Bone Marrow Aspiration (BMA) Syringe; manual piston syringe consisting of calibrated hollow barrel and moveable plunger. Distal end features male connector nozzle for attachment to female hub of single lumen needle. Used for aspiration of bone marrow, autologous blood, plasma, or other body fluids. Operated by clinicians in medical settings. Device facilitates fluid withdrawal via manual suction; provides simple, mechanical means for sample collection.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Manual piston syringe; calibrated hollow barrel and moveable plunger; male connector nozzle for needle attachment. Materials and sterilization methods are standard for medical-grade piston syringes.

Indications for Use

Indicated for aspiration of bone marrow, autologous blood, plasma, or other body fluids in patients requiring such procedures.

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

• Merit Medical Systems, Disposable Coronary Control Syringe
• Wright Medical Technologies, Bone Graft Syringe

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters, with a registered trademark symbol to the right of the word. To the left of the word is a circular logo with a design inside. A horizontal line is located underneath the word.

| 3.0 | 510(k) Summary | K051720 | Page 1 of 1 |
|-----|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| | Sponsor: | Synthes (USA)<br>1302 Wrights Lane East<br>West Chester, PA 19380<br>[phone] | |
| | Device Name: | Synthes (USA) Bone Marrow Aspiration (BMA) Syringe | |
| | Classification: | Class II, 21 CFR §888.5860<br>Piston Syringe | |
| | Predicate Device: | Merit Medical Systems, Disposable Coronary Control Syringe<br>Wright Medical Technologies, Bone Graft Syringe | |
| | Device Description: | The syringe consists of a calibrated hollow barrel and a moveable<br>plunger. At the distal end of the syringe there is a male connector<br>nozzle for fitting the female connector (hub) of a single lumen<br>needle. The syringe can be used for withdrawing body fluids. | |
| | Intended Use: | The Synthes Bone Marrow Aspiration (BMA) Syringe is intended<br>for aspiration of bone marrow, autologous blood, plasma, or other<br>body fluids. | |
| | Substantial<br>Equivalence: | Documentation is provided which demonstrates that Synthes Bone<br>Marrow Aspiration (BMA) Syringe is substantially equivalent* to<br>other legally marketed devices. | |
| | | *The term “substantial equivalence” as used in the 510(k)<br>notification is limited to the definition of substantial equivalence<br>found in the Food, Drug and Cosmetic Act, as amended and as<br>applied under 21 CRF 807, Subpart E, under which a device can be<br>marketed without pre-market approval or reclassification;. A<br>determination of substantial equivalency under this notification is<br>not intended to have any bearing whatsoever on the resolution of<br>patent infringement suits or any other patent matters. No<br>statements related to, or in support of substantial equivalence<br>herein shall be construed as an admission against interest under the<br>US Patent Laws or their application by the courts. | |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three wing-like shapes extending upwards. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the emblem.

Public Health Service

JUL 25 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Kathy Anderson Regulatory Affairs Manager Synthes (USA) 1302 Wrights Lane East West Chester, Pennsylvania 19380

Re: K051720

Trade/Device Name: Synthes (USA) Bone Marrow Aspiration (BMA) Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: June 23, 2005 Received: June 27, 2005

Dear Ms. Anderson:

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). and cosmetic rever (10) was 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 r read be action and 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. Kathy Anderson

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/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson, MS Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1

| | Indications for Use |
|--|---------------------|
|--|---------------------|

| 510(k) Number (if known): | KOS 1720 |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Synthes (USA) Bone Marrow Aspiration (BMA) Syringe |
| Indications: | The Synthes Bone Marrow Aspiration (BMA) Syringe is intended for aspiration of bone marrow, autologous blood, plasma, or other body fluids. |

| Prescription Use ____________ X<br>(Per 21 CFR 801 Subpart D) | AND/OR | Over-The-Counter Use ____________<br>(21 CFR 807 Subpart C) |
|---------------------------------------------------------------|--------|-------------------------------------------------------------|
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(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off)

Division of General, Restorative

and Neurological Devices

K051720