BONE MARROW ASPIRATION NEEDLE, MODEL BMB1110J, BONE MARROW HARVEST NEEDLE, MODEL BMHN1104VX, & BONE MARROW BIOPSY NEEDL

K020867 · Worldwide Medical Technologies, LLC · KNW · May 20, 2002 · Gastroenterology, Urology

Device Facts

• Record ID: K020867
• Device Name: BONE MARROW ASPIRATION NEEDLE, MODEL BMB1110J, BONE MARROW HARVEST NEEDLE, MODEL BMHN1104VX, & BONE MARROW BIOPSY NEEDL
• Applicant: Worldwide Medical Technologies, LLC
• Product Code: KNW · Gastroenterology, Urology
• Decision Date: May 20, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

Intended Use

The intended use of the Worldwide Medical Technologies Bone Marrow Aspiration/Core Needle is to obtain samples of aspirates and bone marrow for cytologic and histologic examination in the diagnosis and treatment of various diseases. The samples are typically taken by percutanious puncture of the posterior iliac crest of the pelvic bone.

Device Story

AspirCore is a bone marrow aspiration and core biopsy needle. Device facilitates percutaneous puncture of the posterior iliac crest to collect bone marrow aspirate and core tissue samples. Samples are used by clinicians for cytologic and histologic examination to aid in disease diagnosis and treatment. Device is used in clinical settings by healthcare professionals.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Gastroenterology-urology biopsy instrument; percutaneous needle design; manual operation.

Indications for Use

Indicated for patients requiring bone marrow aspiration or core biopsy for cytologic and histologic examination to diagnose or treat disease. Samples obtained via percutaneous puncture of the posterior iliac crest.

Regulatory Classification

Identification

A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Submission Summary (Full Text)

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MAY 2 0 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Gary Lamoureux President Worldwide Medical Technologies 426 Main Street North, P.O. Box 505 Woodbury, CT 06798-0505

Re: K020867

Trade/Device Name: Worldwide Medical Technologies AspirCore Regulation Number: 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: II Product Code: KNW Dated: February 22, 2002 Received: March 18, 2002

Dear Mr. Lamoureux:

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 - Mr. Gary Lamoureux

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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). 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/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

for Celia 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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## EXHIBIT 1

K020867 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Worldwide Medical Technologies AspirCore

Indications For Use:

The intended use of the Worldwide Medical Technologies Bone Marrow Aspiration/Core Needle is to obtain samples of aspirates and bone marrow for cytologic and histologic examination in the diagnosis and treatment of various diseases. The samples are typically taken by percutanious puncture of the posterior iliac crest of the pelvic bone.

Miriam C. Provost

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

510(k) Number K020867

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR

Over-The-Counter Use ___________