(259 days)
Not Found
None
No
The summary describes a mechanical biopsy device and explicitly states "Not Found" for mentions of AI, DNN, or ML, as well as for details typically associated with AI/ML development and validation (training/test sets, performance metrics).
No
Explanation: The device is explicitly stated to be "for diagnosis only" and is used to obtain biopsy samples, which are then used to diagnose conditions, not treat them.
Yes
The "Intended Use / Indications for Use" section explicitly states, "the product is for diagnosis only."
No
The device description explicitly states "Vacuum Assisted Spring Loaded Core Biopsy Device," which is a hardware device used for obtaining tissue samples.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue taken from the human body to detect diseases or other conditions. They are used outside of the body (in vitro).
- Device Function: The description clearly states the device is a "Vacuum Assisted Spring Loaded Core Biopsy Device" used to "obtain percutaneous core biopsy samples from soft tissue and tumors." This is a device used within the body to collect a sample.
- Intended Use: The intended use is to obtain samples for diagnosis, not to perform the diagnostic test itself on those samples.
Therefore, this device is a surgical or procedural device used for sample collection, not an IVD.
N/A
Intended Use / Indications for Use
To obtain percutaneous core biopsy samples from soft tissue and tumors of such organs as the liver, spleen, kidney, prostate, and callors on such organs as also earlier, of breast biopsy, the product is for diagnosis only.
Product codes
78 KNW
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue and tumors of such organs as the liver, spleen, kidney, prostate, and breast.
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.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 8 2004
Mr. Joseph L. Mark Vice President Suros Surgical Systems, Inc. 9502 Angola Court, Suite 3 INDIANAPOLIS IN 46268
Re: K034021
Trade/Device Name: Vacuum Assisted Spring Loaded Core Biopsy Device Regulation Number: 21 CFR §876.1075 Regulation Name: Gastroenterology-urology-biopsy instrument Regulatory Class: II Product Code: 78 KNW Dated: July 23, 2004 Received: August 19, 2004
Dear Mr. Mark:
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. 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 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.
1
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin marker of substantial equivalence of your device to a legally premarket nother 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 If you desire specific advice to your do too to the following numbers, based on the regulation number at the top of the letter:
| 8xx. 1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, 101 questions of the promote of the regulation entitled, "Misbranding Other of Compliance at (501) 59