(105 days)
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No
The summary describes a biopsy instrument for bone marrow and contains no mention of AI, ML, image processing, or any related concepts.
No
A therapeutic device is used to treat or cure a disease or condition. This device is specified for drawing and explanting bone marrow, which are diagnostic or procedural actions, not therapeutic ones.
Yes
Explanation: The device is described as a biopsy instrument used for drawing osteomedullary substance and for explantation of bone marrow, which are procedures performed to obtain samples for diagnostic purposes.
No
The intended use describes a "biopsy instrument" used for drawing osteomedulary substance and explanting bone marrow, which are physical actions requiring a hardware device. The summary does not mention any software component or function.
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 osteomedulary substance and or for explantation of bone marrow." This describes a procedure performed on the patient to obtain a sample.
- IVD Definition: In vitro diagnostics are tests performed outside the body on samples such as blood, urine, or tissue to detect diseases, conditions, or infections.
This device is a tool used to collect the sample, not to analyze it for diagnostic purposes. Therefore, it falls under the category of a surgical or procedural instrument, not an IVD.
N/A
Intended Use / Indications for Use
This biopsy instrument is used for drawing of osteomedulary substance and or for explantation of bone marrow.
Product codes (comma separated list FDA assigned to the subject device)
KNW
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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
| of the country of
1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 | I PREMARKET NOTIFICATION SUBMISSION - Data: 11-02-2003
510 k | Pag. 32 di 32 |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|----------------|
| | TRAPMATIC SYSTEM® SET | |
MAR - 1 2004 510 (k) SUMMARY
K033616
| > Applicant | : HS Hospital Service S.p.A.
Via Naro,81 – 00040 Pomezia (Rome) Italy |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| > Contact Person | : H-S Medical, Inc.
Mr. Lucio Improta
1200 Clint Moore Rd. Suite # 1
Boca Raton, FL 33487
Tel. (561)443-3321 - Fax. (561)443-3532
e-mail : hsmedicalinc@aol.com |
| > Submission Date | : November 02, 2003 |
| > Trade Name | : TrapMatic System® Set Bone Marrow Biopsy Needle |
| > Common Name | : Bone Marrow Biopsy Needle |
| > Classification
Name | : 876.1075 - Biopsy instrument |
な Indication for use:
This biopsy instrument is used for drawing of osteomedulary substance and or for explantation of bone marrow.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 1 2004
HS Hospital Service S.p.A. c/o Mr. Lucio Improta H-S Medical, Inc. 1200 Clint Moore Road, Suite #1 Boca Raton, Florida 33487
Re: K033616
Trade/Device Name: TrapMatic System® Set Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: II Product Code: KNW Dated: November 2, 2003 Received: December 2, 2003
Dear Mr. Improta:
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 usc 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 10 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 agencics. 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.
2
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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,
uriam C. Provost
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
3
Indications for Use
510(K): 033616
Device Name : TRAPMATIC® SYSTEM SET
Indications for Use :
This biopsy instrument is used for drawing of Osteomedullary substance and or for explantation of bone marrow.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number__Ko 336/k