MARROMAX B ONE MARROW ASPIRATION NEEDLE KIT, MODELS 50083-XX, 50084-XX

K100665 · Needle Tech Products, Inc. · FMF · Jun 24, 2010 · General Hospital

Device Facts

• Record ID: K100665
• Device Name: MARROMAX B ONE MARROW ASPIRATION NEEDLE KIT, MODELS 50083-XX, 50084-XX
• Applicant: Needle Tech Products, Inc.
• Product Code: FMF · General Hospital
• Decision Date: Jun 24, 2010
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.5860
• Device Class: Class 2

Intended Use

The MARROWMAX Bone Marrow Aspiration Needle is a stylet/cannula system to be used to obtain bone marrow and/or autologous blood from patients intraoperatively by use of a syringe.

Device Story

MARROWMAX Bone Marrow Aspiration Needle Kit is a manual stylet/cannula system. Used intraoperatively by clinicians to aspirate bone marrow or autologous blood. Device functions via manual insertion of needle into bone; attachment of syringe to cannula; manual aspiration of biological sample. Provides clinicians with access to bone marrow/blood for diagnostic or therapeutic purposes. No electronic components, software, or automated processing involved.

Clinical Evidence

Bench testing only.

Technological Characteristics

Manual stylet/cannula needle system. Materials and design consistent with standard bone marrow aspiration needles. Non-powered, mechanical device.

Indications for Use

Indicated for patients requiring bone marrow and/or autologous blood aspiration intraoperatively.

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.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

NeedleTech Products, Inc. % Mr. Rick Tripp Director of Product Realization 81 West Street Attleboro, Massachusetts 02703

P

JUN 24 2010

Re: K100665

Trade/Device Name: MARROWMAX Bone Marrow Aspiration Needle Kit Regulation Number: 21 CFR 880.5860 Regulation Name: Piston syringe Regulatory Class: II Product Code: FMF Dated: June 16, 2010 Received: June 18, 2010

Dear Mr. Tripp:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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Page 2 - Mr. Rick Tripp

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson

Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Statement of Indication for Use

Page 1 of 1

K100665 510k Number (if known):

Device Name:

MARROWMAX Bone Marrow Aspiration Needle Kit

Indication for Use:

The MARROWMAX Bone Marrow Aspiration Needle is a stylet/cannula system to be used to obtain bone marrow and/or autologous blood from patients intraoperatively by use of a syringe.

(Please Do not Write Below This Line - Continue On Another Page If Needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription use x

or

Over-the-counter use

(Per 21CFR 801.109)

Neil R.P. Ogden for mxm

Division Sign-Of Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K100665