WORLDWIDE MEDICAL TECHNOLOGIES BONE MARROW BIOPSY PROCEDURE TRAY

K980137 · Worldwide Medical Technologies, LLC · LRO · Jan 30, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K980137
• Device Name: WORLDWIDE MEDICAL TECHNOLOGIES BONE MARROW BIOPSY PROCEDURE TRAY
• Applicant: Worldwide Medical Technologies, LLC
• Product Code: LRO · General, Plastic Surgery
• Decision Date: Jan 30, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4370
• Device Class: Class 2

Intended Use

THE INTENDED USE OF THE WORLDWIDE MEDICAL MODELOW FOR BONE MARROG OF THE BONE MARROW For PATHOLOGICAL IS TO OBTAIN A SAMPLE BIDPSY TRAY EXAMINATION IN THE DIALNOSIS + TREATIMENT OF VARIOUS DISEASES

Device Story

The Worldwide Medical Bone Marrow Biopsy Procedure Tray is a procedural kit used by clinicians to obtain bone marrow samples. The tray contains various medical components necessary for performing a biopsy. The device is used in a clinical setting to facilitate the collection of tissue for pathological examination, aiding in the diagnosis and treatment of diseases. The kit includes drug components (Lidocaine and Povidone-Iodine) which are subject to separate regulatory oversight.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Procedural tray containing medical components and drug components (Lidocaine, Povidone-Iodine). No specific materials, dimensions, or software characteristics described.

Indications for Use

Indicated for patients requiring bone marrow biopsy for pathological examination to assist in the diagnosis and treatment of various diseases.

Regulatory Classification

Identification

A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.

Special Controls

*Classification.* Class II (special controls). The device, when it is an ear, nose, and throat surgical drape, a latex sheet drape with self-retaining finger cot, a disposable urological drape, a Kelly pad, an ophthalmic patient drape, an ophthalmic microscope drape, an internal drape retention ring (wound protector), or a surgical drape that does not include an antimicrobial agent, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 30 1998

Mr. Gary A. Lamoureux · President Worldwide Medical Technologies 125 Main Street North P.O. Box 505 06798-0505 Woodbury, Connecticut

K980137 Re : Worldwide Medical Technologies Bone Marrow Biopsy Procedure Tray Regulatory Class: II Product Code: LRO Dated: January 12, 1998 Received: January 15, 1998

## Dear Mr. Lamoureux:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 (the Act). You may, therefore, market the device, subject to the general controls provisions However, you are responsible to determine that the of Act. medical devices you use as components in the tray have either . been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. 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 (Premarket Approval) 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 895. A substantially

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equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, the Food and Drug Administration (FDA) action. may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

In addition, we have determined that your device kit contains Lidocaine Ampule and Povidone - Iodine Swabsticks which are --------subject to regulation as drugs.

Our substantially equivalent determination does not apply to the drug components of your device. We recommend you first contact the Center for Drug Evaluation and Research before marketing your device with the drug components. For information on applicable Agency requirements for marketing these drugs, we suggest you contact :

Director, Division of Drug Labeling Compliance (HFD-310) Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, Maryland 20857 [phone] ===============================================================================================================================================================

This letter will allow you to begin marketing your device as described in your 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 809 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" (21 CFR 807.97). Other general information on

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your responsibilities under the Act, may be obtained from the Division of Small Manufacturers Assistance at its toll free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name: BONE MARINO BIOPSY PROCEDORI TRAY

## Indications For Use:

THE INTENDED USE OF THE WORLDWIDE MEDICAL MODELOW FOR BONE MARROG OF THE BONE MARROW For PATHOLOGICAL IS TO OBTAIN A SAMPLE BIDPSY TRAY EXAMINATION IN THE DIALNOSIS + TREATIMENT OF VARIOUS DISEASES

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Coucurence of CDRH, Office of Device Evaluation (ODB)

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Prescription Use (Per 21 CFR 801.109)

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Over-The-Counter Use

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