(82 days)
Not Found
Not Found
No
The 510(k) summary describes a physical needle for biopsy and aspiration and contains no mention of AI, ML, image processing, or data sets typically associated with AI/ML devices.
No
The device is described as being used for biopsy and aspiration procedures, which are diagnostic rather than therapeutic.
No
The device, a "Gallini Atra-Cut Needle," is described as being used for "fine bone biopsy and aspiration procedures." These procedures are interventional, aiming to collect tissue or fluid, rather than to identify or determine a disease state. While biopsies are often performed to aid in diagnosis, the device itself is a tool for obtaining a sample, not for performing the diagnostic analysis.
No
The device is described as a "Needle," which is a physical hardware component, not software.
Based on the provided information, the Gallini Atra-Cut Needle is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "fine bone biopsy and aspiration procedures." This describes a procedure performed on the body to collect a sample, not a test performed on a sample outside the body to diagnose a condition.
- Device Description: While the description is "Not Found," the name "Needle" strongly suggests a physical instrument used for insertion into the body.
- Lack of IVD Characteristics: The provided information does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a sample (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes)
- Providing diagnostic information based on the analysis of a sample
The Gallini Atra-Cut Needle appears to be a surgical or procedural device used for obtaining a sample, which would then likely be sent to a laboratory for in vitro diagnostic testing. The needle itself is the tool for sample collection, not the diagnostic test itself.
N/A
Intended Use / Indications for Use
The Gallini Atra-Cut Needle is used for fine bone biopsy and aspiration procedures.
Product codes
KNW
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular emblem with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or movement.
Public I lealth Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 9 1099
Mr. Paul L. Hawthornc U.S. Representative Gallini U.S. LLC 3991 Glenside Drive, Suite F Richmond, Virginia 23229
K990645 Re: Trade Name: Gallini Atra-Cut® Needle Regulatory Class: II Product Code: KNW Dated: February 26, 1999 Received: February 26, 1999
Dear Mr. Hawthorne:
We have reviewed your Section 510(k) notification of intent to market the device eefenered con we nave reviewed your Bection 210(x) notistantially equivalent (for the indications for above and we have decements devices marketed in interstate commerce prior to use stated in the cheristics to do roos he Medical Device Amendments, or to devices that May 26, 1970, the enacified in accordance with the provisions of the Federal Food, I rug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls, Cosment Act (ACT). " Tourmay, merciore, manor and the Act include requirements for provisions or alle Act. - ing 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 II your device is classified (soc abone) n.to such additional controls. Existing major (Premarket Approval), it may be subject to satil additions and regulations, Title 21, regulations areeting your device can be reads to mination assumes compliance with the Faris 800 to 695. A substantian J equirement, as set forth in the Quality System current Oooo Manufacturing Praetice requirement regulation (21 CFR Part 820) and that, Regulation (QS) for Modical 727.000. Food and Drug Administration (FDA) will verify through perfoune (Q5) mispectons, the GMP regulation may result in regulations in such assumptions. Thanne to compty with the Orie organing your device in the Federal Register. Please note: this response to your premarket notification submission docs Federal Rogister. Trease note: this response or sections 531 through 542 of the Act for not allect ally obtigation you might have care as a control provisions, or other Federal laws or regulations.
1
Page 2 – Mr. Paul I .. Hawthorne
This letter will allow you to begin marketing your device as described in your 510(k) i his letter will anow you to begin mancemig your antial equivalence of your device to a premarket notification. The FT/A midling of substantial of a more of the may of the 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 If you desire Specific advice in your devices), please contact the Office of and additionally 809.10 for in Vitto diagnous for questions on the promotion and Compliance at (501) 594-4575. Auditionally, 161 Compliance at (301) 594-4639.
advertising of your dcvice, please contact the Office of Compliance at anymorshal Also, please note the regulation entitled, "Misbranding by reference to premarket. Also, please note the regulation onlines, "Mrs.org.network on your responsibilities under the notification" (21 C.F. 807.97). Other general Missimaliantiacturers Assistance at its toll-free Act may be ontained 41 or (301) 443-6597 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
Enclosure
2
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| 510(k) Number (if known) | K99 0645 |
|---|---|
| Device Name: | Atra-Cut® Needle |
| Indications for Use: | The Gallini Atra-Cut Needle is used for fine bone biopsy and |
| aspiration procedures. |
(PLEASE DO NOT WRITE BELOW THIS LINE—CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-the-Counter Use _
picote
(Optional Format 1-2-96)
(Division Sign-Off)
Division of General Restorative Devices K970645
510(k) Number
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