OPPORTUNITY INC. BONE MARROW BIOPSY AND ASPIRATION TRAY

K971061 · Opportunity, Inc. · LRO · Jun 11, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K971061
• Device Name: OPPORTUNITY INC. BONE MARROW BIOPSY AND ASPIRATION TRAY
• Applicant: Opportunity, Inc.
• Product Code: LRO · General, Plastic Surgery
• Decision Date: Jun 11, 1997
• Decision: SN
• Submission Type: Traditional
• Regulation: 21 CFR 878.4370
• Device Class: Class 2

Intended Use

Opportunity Inc.'s Bone Marrow and Aspiration Tray is intended for use by a licensed professional or other medical personnel as deemed appropriate by the using facility. The intended use of the medical products assembled in these kits will not change from the manufacturers original intended use. This kit is used for performing or assisting in performing bone marrow surgical procedures.

Device Story

Bone Marrow Biopsy and Aspiration Tray is a procedural kit containing various medical components used for bone marrow surgical procedures. The device is intended for use by licensed professionals or medical personnel in a clinical setting. The kit aggregates existing medical devices into a single package to facilitate the procedure. The device does not perform analysis or provide diagnostic output; it serves as a collection of tools for the clinician to perform manual biopsy and aspiration. The kit includes drug components (PVP Iodine Swab Stick and Lidocaine Hydrochloride USP 1%) which are subject to separate regulatory oversight by the Center for Drug Evaluation and Research.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Procedural kit containing various medical components. Includes drug components (PVP Iodine Swab Stick, Lidocaine Hydrochloride USP 1%). No electronic, software, or complex mechanical sensing components.

Indications for Use

Indicated for use by licensed professionals or medical personnel for performing or assisting in bone marrow surgical procedures.

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
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

JUN 11 1997

Mr. James S. Sanders
Sales Manager
Opportunity, Inc.
1200 Old Skokie Road
Highland Park, Illinois 60035-3028

Re: K971061
Trade Name: Bone Marrow Biopsy and Aspiration Tray
Regulatory Class: II
Product Code: LRO
Dated: February 24, 1997
Received: March 24, 1997

Dear Mr. Sanders:

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 of Act. However, you are responsible to determine that the 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 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 equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and

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Page 2 - Mr. James S. Sanders

Drug Administration (FDA) 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 PVP Iodine Swab Stick and Lidocaine Hydrochloride USP 1% 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 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

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K971061/A3

# OPPORTUNITY, INC.

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510(k) Number: K971061

Device Name: Bone Marrow and Aspiration Tray

INDICATIONS FOR USE:

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FDA/CDRH/ODE/DMC

2 JUN 97 14 30

RECEIVED

Opportunity Inc.'s Bone Marrow and Aspiration Tray is intended for use by a licensed

professional or other medical personnel as deemed appropriate by the using facility.

The intended use of the medical products assembled in these kits will not change

from the manufacturers original intended use. This kit is used for performing or assisting

in performing bone marrow surgical procedures.


Prescription Use

(Per 21 CFR 801.109)

1200 Old Skokie Road · Highland Park, IL 60035-3028 · Phone [phone] · Fax [phone]

Toll Free 888.MEDPACK