(45 days)
Not Found
Not Found
No
The summary describes a mechanical biopsy needle and does not mention any software, image processing, or AI/ML terms.
No
The device is used for soft tissue biopsy, which is a diagnostic procedure, not a therapeutic one. It is used to collect tissue for examination, not to treat a condition.
Yes
The device is used for soft tissue biopsy, which involves collecting tissue samples to diagnose diseases.
No
The device description clearly states it is a physical biopsy needle constructed of stainless steel and polycarbonate, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body (in vitro).
- Device Function: The Quick-Core™ Biopsy Needle is a tool used to obtain a tissue sample from the body. It is a surgical instrument used in vivo (within the body) to collect the sample. It does not perform any diagnostic testing on the sample itself.
The description clearly states its purpose is for "soft tissue biopsy," which is the process of removing tissue for examination, not the examination itself.
N/A
Intended Use / Indications for Use
Used for soft tissue biopsy. Supplied sterile in peel-open packages. Intended for single procedure use.
Product codes
74DQT, KNW
Device Description
The Quick-Core™ Biopsy Needle is used for soft tissue biopsy procedures. The device will be constructed of stainless steel and polycarbonate in 14, 15, 16, 18, 19 and 20 gauge and 6, 9, 15, 20 and 48 cm lengths. It will be supplied sterile, intended for onetime use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
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
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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
510(k) Premarket Notification Biopsy Needle
COOK INCORPORATED
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ATTACHMENT 5
SMDA SUMMARY
.
1
Safety and Effectiveness Information 0
| Submitted By: | April Lavender, RAC |
|---|---|
| Vice President, Regulatory Affairs | |
| COOK INCORPORATED | |
| 925 South Curry Pike | |
| P.O. Box 489 | |
| Bloomington, IN 47402 | |
| (812) 339-2235 |
Device:
Trade Name: Proposed Classification Name: Quick-Core™ Biopsy Needle Gastroenterology-Urology Biopsy Instruments 21 CFR Part 876.1075 (74DQT)
Predicate Devices:
The Quick-Core™ Biopsy Needle has the same intended use, materials of construction, and technological characteristics as the ProAct Biopsy Needle for soft tissue biopsy procedures.
Device Description:
The Quick-Core™ Biopsy Needle is used for soft tissue biopsy procedures. The device will be constructed of stainless steel and polycarbonate in 14, 15, 16, 18, 19 and 20 gauge and 6, 9, 15, 20 and 48 cm lengths. It will be supplied sterile, intended for onetime use.
Substantial Equivalence:
This device will be manufactured according to specified process controls and a Quality Assurance Program. This device will undergo packaging similar to the devices currently marketed and distributed by COOK INCORPORATED. This device will undergo sterilization similar to the devices currently marketed and distributed.
2
Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three overlapping wing shapes, suggesting movement or flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle, with the words evenly spaced to follow the curve of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 3 1997
Ms. April Lavender, RAC Vice President Regulatory Affairs Cook Inc. 925 South Curry Pike, PO Box 489 Bloomington, Indiana 47402
Re: K973565
Trade Name: Ouick-Core™ Biopsy Needle Regulatory Class: II Product Code: KNW Dated: October 9, 1997 Received: October 14, 1997
Dear Ms. Lavender:
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 requirements , 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 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
3
Page 2 - Ms. April Lavender, RAC
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.
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,
Celia M. Witten, Ph.D., M.D.
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
4
510(k) Premarket Notification Biopsy Needle COOK INCORPORATED
510(k) Number (if known): K9723565
Device Name:
Quick-Core™ Biopsy Needle
Indications for Use:
Used for soft tissue biopsy. Supplied sterile in peel-open packages. Intended for single procedure use.
(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
(Division Sign-Off)
Division of General Restorative Devices K973565
510(k) Number