(90 days)
This device is intended to be used for taking biopsy sample, must be used on soft tissues and I has device is intended to be about to taming copies to obtain biopsies of various tissues, including those from Breast, Kidney, Liver, Prostate, Lung , Bladder, Thyroid, Abdomen and Pancrease
SecurcutTM Aspiration Biopsy Needle
The provided text describes a 510(k) premarket notification for the "Securcut™ Aspiration Biopsy Needle." This document is not a study report and therefore does not contain the information required to answer the questions about acceptance criteria and device performance evaluation.
Here's why and what information is missing:
- No Acceptance Criteria or Performance Data: The document is a regulatory submission for premarket clearance, primarily focused on establishing substantial equivalence to a predicate device. It briefly mentions the intended use but does not outline specific acceptance criteria (e.g., sensitivity, specificity, accuracy targets) or present any study results demonstrating the device meets such criteria.
- No Study Details: There is no description of any clinical or performance study, nor details about sample sizes, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth establishment, or training set specifics.
Therefore, I cannot provide the requested information based on the given input.
The document states: "We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your beeemined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This indicates that the 510(k) process relied on demonstrating equivalence to an existing device, rather than presenting a performance study with acceptance criteria.
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PREMARKET NOTIFICATION SUBMISSION - 510 (k)
Pag. 35 di 36
KO13071
510 (k) SUMMARY
DEC 1 2 2001
| Applicant | : H.S. Hospital Service S.p.A.Via Naro, 81 - 00040 Pomezia (RM) Italy |
|---|---|
| Contact Person | : MMC International, LLCMr. Lucio Improta10147 Umberland Place - Boca Raton, FL 33428Tel. (561) 477-1671 - Fax. (561) 477-0863e-mail : mmcintern@aol.com |
| Submission Date | : September 03, 2001 |
| Trade Name | : SecurcutTM Aspiration Biopsy Needle |
| Common Name | : Aspiration Biopsy Needle |
| Classification Name | : 876.1075 - Biopsy instrument |
Indication for use :
This device is intended to be used for taking biopsy sample, must be used on soft tissues and I has device is intended to be about to taming copies to obtain biopsies of various tissues, including those from Breast, Kidney, Liver, Prostate, Lung , Bladder, Thyroid, Abdomen and Pancrease
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized symbol that resembles three abstract birds in flight, arranged in a row.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 2 2001
H.S. Hospital Service S.p.A. c/o Mr. Lucio Improta MMC International, LLC 10147 Umberland Place Boca Raton, Florida 33428
Re: K013071
Trade/Device Name: Securcut™ Aspiration Biopsy Needle Regulation Number: 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: II Product Code: FCG Dated: September 3, 2001 Received: September 13, 2001
Dear Mr. Improta:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your beeemined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Amendments, or to oonimoted pror to Trad 20, 20, 2017 )
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 r ou may, dicrosere, mans of the Act include requirements for annual registration, listing of general oonline provision 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 11 70at ab 100 is o 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 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 premaited 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 adultionally 21 211) 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 O wision 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,
Susan Walker
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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 (k)
510 (k) # KO13071
DEVICE NAME
Securcut™ Biopsy Needle
INDICATION FOR USE
This device is intended to be used for taking biopsy sample, must be used on soft tissues and I his device is intended to be used to taxing brops, bann biopsies of various tissues, can be tised in Fraoroscopic, CF and mananegraphias provide, Abdomen and Pancreas
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED PLEASE DO NOT WATE DELOW THIP ENAE CONTINER CONTINER CONTENTIAL CONTENTERS ---------------------------------------------------------------------------------------------------
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Walker
(Division Sign-Off) (Division Bigi-eral, Restorative Divisionrological Devices
510(k) Number K013071
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
§ 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.