TRAPSYSTEM SET

K013692 · H.S. Hospital Service S.R.L. · KNW · Feb 5, 2002 · Gastroenterology, Urology

Device Facts

• Record ID: K013692
• Device Name: TRAPSYSTEM SET
• Applicant: H.S. Hospital Service S.R.L.
• Product Code: KNW · Gastroenterology, Urology
• Decision Date: Feb 5, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

Intended Use

This biopsy instrument is intended to be used for drawing osteomedullary substances and or explantation of bone marrow.

Device Story

TrapSystem® Set is a disposable, single-use bone marrow biopsy needle. Device consists of 304 stainless steel cannula, 302 stainless steel stylet, and 302 stainless steel extracting wire. Cannula and stylet are insert-molded into ABS hubs for manual grip. Includes patented stylet for sample trapping within cannula. Used by physicians in clinical settings to perform bone marrow biopsies or extract osteomedullary substances. Physician manually manipulates needle to penetrate bone; extracts sample via cannula/stylet mechanism. Output is a bone marrow or osteomedullary tissue sample for diagnostic evaluation. Device design incorporates features to assist physician in safe operation.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: 304 stainless steel (cannula), 302 stainless steel (stylet, extracting wire), ABS (hubs), polypropylene (protective cover). Manual biopsy needle. Dimensions range from 8G to 13G and 50mm to 150mm lengths. Non-powered, mechanical device.

Indications for Use

Indicated for patients requiring bone marrow biopsy or collection of osteomedullary substance. No specific age or gender restrictions provided.

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.

Predicate Devices

• PRO-B biopsy Needle (K952350)

Submission Summary (Full Text)

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#### 510 (k) SUMMARY

FEB 0 5 2002

| > Applicant | : HS Hospital Service S.p.A.<br>Via Naro,81 – 00040 Pomezia (Rome) Italy |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| > Contact Person | : MMC International, LLC<br>Mr. Lucio Improta<br>10147 Umberland Place – Boca Raton, FL 33428<br>Tel. [phone] - Fax. [phone]<br>e-mail : [e-mail] |
| > Submission Date | : October 27, 2001 |
| > Trade Name | : TrapSystem® Set Bone Marrow Biopsy Needle |
| > Common Name | : Bone Marrow Biopsy Needle |
| > Classification Name | > : 876.1075 - Biopsy instrument |

Indication for use : 彩

This biopsy instrument is used for drawing of osteomedullary substance and or for explantation of bone marrow.

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## SECTION I - PRODUCT NAME/DESCRIPTION

| A. Trade Name | TrapSystem® Set Bone Marrow Biopsy Needle |
|-----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| B. Usual Name | : Bone Marrow Biopsy Needle |
| C. Description | : A disposable single use Biopsy Needle |
| 1. Intended Use | : This biopsy instrument is intended to be used for drawing osteomedullary<br>substances and or explantation of bone marrow. |
| 2. Material | The product consist of a 304 stainless steel cannula and 302 stainless steel<br>stylet.<br>The cannula is inserted molded into an ABS hub that provide a grip for<br>manipulation of the Needle.<br>Inside of the cannula is a stylet made by 302 stainless steel, inserted molded<br>into an ABS hub<br>An additional patented stylet is provided to be used for trapping the sample<br>in the cannula<br>An extracting 302 stainless steel wire with safety grip.<br>The protective cover of cannula is made of polypropilene<br>This type of device is also referred to Promedical Ltd, PRO-B biopsy<br>Needle 510 (k) # K952350<br>We will incorporate all these features into our product, therefore providing<br>the physician with a product that will safety assist them in their operation.<br>A listing of needle dimension is included in Section I - Attachment C |

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Image /page/2/Figure/0 description: The image shows a document excerpt with the title "PREMARKET NOTIFICATION SUBMISSION - 510 (k)". Below the title is the text "TRAPSYSTEM® SET". On the right side of the image, the date "10-27-2001" and page number "10 di 32" are visible.

Section I - Attachment C

# TABLE OF DIMENSION

| Code | Description |
|------------|-------------|
| TRAPJ 1305 | 13G x 50mm |
| TRAPJ 1306 | 13G x 65mm |
| TRAPJ 1310 | 13G x 100mm |
| TRAPJ 1315 | 13G x 150mm |
| TRAPJ 1205 | 12G x 50mm |
| TRAPJ 1210 | 12G x 100mm |
| TRAPJ 1215 | 12G x 150mm |
| TRAPJ 1105 | 11G x 50mm |
| TRAPJ 1110 | 11G x 100mm |
| TRAPJ 1115 | 11G x 150mm |
| TRAPJ 1005 | 10G x 50mm |
| TRAPJ 1010 | 10G x 100mm |
| TRAPJ 1015 | 10G x 150mm |
| TRAPJ 0905 | 9G x 50mm |
| TRAPJ 0910 | 9G x 100mm |
| TRAPJ 0915 | 9G x 150mm |
| TRAPJ 0805 | 8G x 50mm |
| TRAPJ 0810 | 8G x 100mm |
| TRAPJ 0815 | 8G x 150mm |

| 0 | First release | 31/10/2000 |
|----------|---------------|------------|
| Release. | Description | Date |

| Project n° 48 | |
|---------------|--|
|---------------|--|

| Name: | TRAP SYSTEM ^® SET |
|-------|------------------------------|
|-------|------------------------------|

| | Prepared | Approval |
|-----------|------------------------|-------------------|
| Date: | 18/11/1999 | Date: 31/10/2000 |
| Function: | STE | Function: DG |
| | Dip Ing. Mauro Rinaldi | Ing. Dario Giusti |

| Mod.14r0 misure e codici | |
|--------------------------|--|
|--------------------------|--|

K013692

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## FEB 0 5 2002

Lucio Improta MMC International, LLC 10147 Umberland Place Boca Raton, Florida 33428

Re: K013692

Trade Name: TrapSystem® Set Bone Marrow Biopsy Needle Regulation Number: 876.1075 Regulation Name: Gastroenterology/Urology Biopsy Instrument Regulatory Class: II Product Code: KNW Dated: October 27, 2001 Received: November 7, 2001

Dear Mr. Improta:

We have reviewed your Section 510(k) premarket 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 (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 may or subject to deen traderal 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. Lucio Improta

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,

Meriam C. Provost

fav Celia M. 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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| | PREMARKET NOTIFICATION SUBMISSION – 510<br>(k) | Data: 10-27-2001 |
|--|------------------------------------------------|------------------|
| | TRAPSYSTEM® SET | Pag. 12 di 32 |

510 (k) # Ko13692

DEVICE NAME

TrapSystem® Set Bone Marrow Biopsy Needle

#### INDICATION FOR USE

This biopsy instrument is used for drawing of osteomedullary substance and or for explantation of bone marrow

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

### Concurrence of CDRH, Office of Device Evaluation (ODE)

Muriam C. Provost

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

510(k) Number K013692

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use