(105 days)
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Not Found
No
The document describes various types of biopsy needles and their intended uses, with no mention of AI, ML, image processing, or any computational analysis of data.
No
The device is a biopsy needle, used for obtaining tissue samples for diagnosis, not for treating a condition.
Yes
Explanation: The device is a biopsy needle, which is used to obtain tissue samples for diagnostic evaluation. Although the needle itself doesn't provide a diagnosis, it's an essential tool in the diagnostic process.
No
The device description is not found, but the intended use clearly describes various types of biopsy needles, which are physical medical devices, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that these are biopsy needles used to obtain tissue samples from various parts of the body (soft tissues, bone marrow).
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. The device itself is the tool for collecting the sample, not for performing the diagnostic test on the sample.
The diagnostic testing would happen after the tissue sample is obtained using these needles, in a laboratory setting using other IVD devices or methods.
N/A
Intended Use / Indications for Use
MEDEASY, UNIVERSAL DUO, VELOX, VELOX 2, UNIVERSAL PLUS, UNIVERSAL, LUX, LUX 2, FACILE, CAESAR biopsy needle is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, breast, spleen, lymph nodes and various soft tissue masses. It is not intended for use in bone biopsy
NEO OXUS, HEMAX biopsy needle must be used for bone marrow aspiration and the posterior iliac crest biopsy
PERFECTUS, HANDLEX biopsy needle must be used for bone marrow aspiration from sternum or litac crest
HEPAX biopsy needle is intended for use in obtaining histological biopsies of soft tissues. It is not intended for use in bone biopsy.
FNA (Chiba(Quincke/Turner/Westcott/Fransen) biopsy needles is intended for use in obtaining biopsies from soft tissues such as thyroid, liver, breast, spleen, abdomen, pancreas, lungs, lymph nodes and various soft tissue masses. It is not intended for use in bone biopsy.
Product codes
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
soft tissues such as liver, kidney, prostate, breast, spleen, lymph nodes and various soft tissue masses, posterior iliac crest, sternum, thyroid, abdomen, pancreas, lungs
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
October 18, 2018
Medax S.r.l. Unipersonale % Serena Coronati Official Correspondent Coronati Consulting srl Via Luigi Gavioli, 3 I-41307 Mirandola, 41037 Italy
Re: K181803
Trade/Device Name: Medax Biopsy Systems III Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-Urology Biopsy Instrument Regulatory Class: Class II Product Code: KNW Dated: October 10, 2018 Received: October 15, 2018
Dear Serena Coronati:
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 use 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 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Lona H. Chen -S 2018.10.18 13:00:36 -04'00'
for
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K181803
Device Name Medax Biopsy System III
Indications for Use (Describe)
MEDEASY, UNIVERSAL DUO, VELOX, VELOX 2, UNIVERSAL PLUS, UNIVERSAL, LUX, LUX 2, FACILE, CAESAR biopsy needle is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, breast, spleen, lymph nodes and various soft tissue masses. It is not intended for use in bone biopsy
NEO OXUS, HEMAX biopsy needle must be used for bone marrow aspiration and the posterior iliac crest biopsy
PERFECTUS, HANDLEX biopsy needle must be used for bone marrow aspiration from sternum or litac crest
HEPAX biopsy needle is intended for use in obtaining histological biopsies of soft tissues. It is not intended for use in bone biopsy.
FNA (Chiba(Quincke/Turner/Westcott/Fransen) biopsy needles is intended for use in obtaining biopsies from soft tissues such as thyroid, liver, breast, spleen, abdomen, pancreas, lungs, lymph nodes and various soft tissue masses. It is not intended for use in bone biopsy.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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