(90 days)
Not Found
No
The description focuses on the mechanical components and materials of a biopsy needle, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
Explanation: The device is a biopsy instrument used for drawing osteomedullary substance and explantation of bone marrow, which are diagnostic procedures, not therapeutic treatments.
No
The device is described as a biopsy instrument used for drawing osteomedullary substance or explantation of bone marrow. While a biopsy sample can be used for diagnostic purposes downstream, the instrument itself is for collecting the sample, not performing the diagnosis. It's an interventional tool, not a diagnostic one.
No
The device description clearly outlines physical components made of stainless steel and ABS, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for drawing of osteomedullary substance and or for explantation of bone marrow." This describes a procedure to collect a sample from the body.
- Device Description: The device is a "Biopsy Needle" designed for physically extracting tissue.
- Lack of IVD Characteristics: IVD devices are used to examine specimens outside of the body to provide information about a patient's health. This device's purpose is solely to obtain the specimen.
The device is a surgical instrument used for sample collection, not for analyzing the sample itself.
N/A
Intended Use / Indications for Use
This biopsy instrument is used for drawing of osteomedullary substance and or for explantation of bone marrow.
Product codes (comma separated list FDA assigned to the subject device)
KNW
Device Description
A disposable single use Biopsy Needle. The product consist of a 304 stainless steel cannula and 302 stainless steel stylet. The cannula is inserted molded into an ABS hub that provide a grip for manipulation of the Needle. Inside of the cannula is a stylet made by 302 stainless steel, inserted molded into an ABS hub. An additional patented stylet is provided to be used for trapping the sample in the cannula. An extracting 302 stainless steel wire with safety grip. The protective cover of cannula is made of polypropilene
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
osteomedullary substance, bone marrow
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 876.1075 Gastroenterology-urology biopsy instrument.
(a)
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.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
0
510 (k) SUMMARY
FEB 0 5 2002
| > Applicant | : HS Hospital Service S.p.A.
Via Naro,81 – 00040 Pomezia (Rome) Italy |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| > Contact Person | : MMC International, LLC
Mr. Lucio Improta
10147 Umberland Place – Boca Raton, FL 33428
Tel. (561)477-1671 - Fax. (561)477-0863
e-mail : mmcintern@aol.com |
| > 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.
K013692 1/3
1/3
1
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 |
| substances and or explantation of bone marrow. | |
| 2. Material | The product consist of a 304 stainless steel cannula and 302 stainless steel |
| stylet. | |
| The cannula is inserted molded into an ABS hub that provide a grip for | |
| manipulation of the Needle. | |
| Inside of the cannula is a stylet made by 302 stainless steel, inserted molded | |
| into an ABS hub | |
| An additional patented stylet is provided to be used for trapping the sample | |
| in the cannula | |
| An extracting 302 stainless steel wire with safety grip. | |
| The protective cover of cannula is made of polypropilene | |
| This type of device is also referred to Promedical Ltd, PRO-B biopsy | |
| Needle 510 (k) # K952350 | |
| We will incorporate all these features into our product, therefore providing | |
| the physician with a product that will safety assist them in their operation. | |
| A listing of needle dimension is included in Section I - Attachment C |
K013692 2/3
2
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 | |
|---|---|
| -------------------------- | -- |
3/3
3
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.
4
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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
5
| | PREMARKET NOTIFICATION SUBMISSION – 510
(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