(89 days)
This device is to be used for soft tissue biopsy.
Quick-Cut® Automatic Biopsy System
This document is a 510(k) clearance letter from the FDA for a medical device called the "Quick-Cut® Automatic Biopsy System." It states that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed.
Unfortunately, this document does not contain the detailed information requested regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications. This type of information is typically found in the 510(k) submission itself, which is a much more extensive document presented to the FDA for review, rather than in the final clearance letter. The clearance letter is a summary of the FDA's decision based on its review of that submission.
Therefore, I cannot provide the requested table and study details based solely on the provided text.
Here's what I can extract and what is missing:
1. A table of acceptance criteria and the reported device performance
- Not present. The document does not define any specific performance metrics or acceptance criteria for the device, nor does it report any performance data.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not present. The document makes no mention of test sets, sample sizes, or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not present. The document does not discuss ground truth establishment or the involvement of experts in that process.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not present. The document does not describe any adjudication methods.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not present. The document is for a biopsy system, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study related to AI assistance would not be applicable or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not present. This device is a biopsy system, a physical tool, not an algorithm. Standalone performance for an algorithm is not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not present. The document does not describe how ground truth was established for any studies. For a biopsy system, the de facto "ground truth" for its performance would typically be the quality of tissue samples obtained and their subsequent pathological analysis, but this is not discussed in the provided text.
8. The sample size for the training set
- Not present. This device is a biopsy system, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not present. Not applicable for this type of device.
What the document does state:
- Device Name: Quick-Cut® Automatic Biopsy System
- Indications for Use: This device is to be used for soft tissue biopsy.
- Regulatory Class: II
- Product Code: KNW
- Regulatory Decision: Substantially equivalent to devices marketed prior to May 28, 1976. This means the FDA found that the device is as safe and effective as a legally marketed predicate device, and thus does not require a full Premarket Approval (PMA) submission. Substantial equivalence is determined by comparing the new device to a predicate device regarding intended use, technological characteristics, and performance data if needed to demonstrate equivalence. The details of that comparison are what's missing here.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with three curved lines above them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
6 1998 MAY
Mr. Paul L. Hawthorne ·U.S. Representative Gallini U.S. 3991 Glenside Drive, Suite F Richmond, Virginia 23229
Re: K980479 Quick-Cut® Automatic Biopsy System Trade Name: Requlatory Class: II Product Code: KNW Dated: January 28, 1998 February 6, 1998 Received:
Dear Mr. Hawthorne:
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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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. ದ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) 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 In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Register. 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 requlations.
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Page 2 - Mr. Hawthorne
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.
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,
M. Witten, Ph.D., M.D. Celia Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K98047x
:
Page_1_of __1
| 510(k) Number (if known) | Unknown |
|---|---|
| Device Name: | Quick-Cut® Automatic Biopsy System |
| Indications for Use: | This device is to be used for soft tissue biopsy. |
FDA/CDRH/ODE/DMC
6 FEB 98 14 40
RECEIVED
(PLEASE DO NOT WRITE BELOW THIS LINE—CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number
| Prescription Use | X | OR | Over-the-Counter Use |
|---|---|---|---|
| (Per 21 CFR 801.109) |
(Optional Format 1-2-96)
SK-35
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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.