(90 days)
Not Found
Not Found
No
The summary describes a mechanical biopsy instrument and contains no mention of AI, ML, or related concepts like image processing or performance metrics typically associated with AI/ML devices.
No
The device is described as an instrument for taking core samples from tissues, which is a diagnostic procedure, not a therapeutic one.
No
The device is described as an instrument to take core samples from tissues which is a step in obtaining samples. However, there is no indication that the device itself performs any diagnostic function on these samples or provides diagnostic information.
No
The device description explicitly states it is an "automatic disposable biopsy instrument," which is a physical hardware device.
Based on the provided information, the Speed-Cut device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Speed-Cut's Function: The description clearly states that the Speed-Cut is a "biopsy instrument designed to take core samples from a variety of soft tissues". This is a device used to obtain a sample from the body, not to test a sample that has already been taken.
The Speed-Cut is a surgical or procedural device used for tissue acquisition, which is a different category of medical device than an IVD.
N/A
Intended Use / Indications for Use
The Speed-Cut® is an automatic disposable biopsy instrument designed to take core samples from a variety of soft tissues including the liver, prostate and kidney.
Product codes
KNW
Device Description
The Speed-Cut® is an automatic disposable biopsy instrument designed to take core samples from a variety of soft tissues including the liver, prostate and kidney.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissues including the liver, prostate and kidney
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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of a human figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 8 1698
Mr. Paul L. Hawthrone ·U.S. Representative Gallini U.S. 3991 Glenside Drive, Suite F Richmond, Virginia 23229
Re: K981301 Trade Name: Speed-Cut® Automatic Biopsy System Regulatory Class: II Product Code: KNW Dated: April 2, 1998 Received: April 9, 1998
Dear Mr. Hawthrone:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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.
1
Page 2 - Mr. Paul L. Hawthrone
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Sincerely yours,
[signature]
Celia M. Witten, Ph.B., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
7/07/98 18:41 FAX 804068 5873
CARPENTER CO. 002
Page 1 of 1
| 510(k) Number (if known) | K981301 |
|---|---|
| Device Name: | Speed-Cut® Automatic Biopsy System |
| Indications for Use: | The Speed-Cut is an automatic disposable biopsy instrument designed to take core samples from a variety of soft tissues including the liver, prostate and kidney. |
(PLEASE DO NOT WRITE BELOW THIS LINE—CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)SCOTT
Division
Division of General Restorative Devices
510(k) Number K981701
Prescription Use
(Per 21 CFR 801.109)
OR
Over-the-Counter Use _
(Optional Format 1-2-96)