(9 days)
Not Found
No
The summary describes a mechanical biopsy needle and does not mention any software, algorithms, or AI/ML capabilities.
No
The device is described as being used for soft tissue biopsy, which is a diagnostic procedure, not a therapeutic one. It's used to collect tissue for examination, not to treat a condition.
No
The device is described as a biopsy needle used for tissue collection, which is a procedural tool rather than a diagnostic one. While the collected tissue may be used for diagnosis, the device itself performs a biopsy (specimen collection), not a diagnosis.
No
The device description clearly states it is a "Wilson-Cook Modified Ultrasound Biopsy Needle" and is used for "soft tissue biopsy through the accessory channel of an ultrasound endoscope." This describes a physical, hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Used for soft tissue biopsy through the accessory channel of an ultrasound endoscope." This describes a procedure to obtain a tissue sample from a living patient.
- Device Description: The device is a "Modified Ultrasound Biopsy Needle." This is a surgical instrument used to collect a sample from the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens from the human body (like blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device is used to obtain the sample, not to analyze it.
In summary, this device is a tool for collecting a biological sample, which is a step that precedes any potential in vitro diagnostic testing that might be performed on the collected sample.
N/A
Intended Use / Indications for Use
Used for soft tissue biopsy through the accessory channel of an ultrasound endoscope.
Product codes
78 FCG
Device Description
The Wilson-Cook Modified Ultrasound Biopsy Needle is used for soft tissue biopsy through the accessory channel of an ultrasound endoscope. This device is supplied sterile and intended for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Design Control, Risk Analysis, Design Verification activities for the subject of this special 510(k) have been conducted in accordance with all applicable internal procedures. The design control process employed is inclusive of the elements as stipulated by 21 CFR Part 820.30, as applicable to the project. The risk analysis performed identified the risks relative to the performance requirements, as specified by our internal procedure for Risk Analysis. The failure mode, effect of failure, severity, potential cause, rate of occurrence, design control element/production controls to eliminate, the potential to detect and our recommended actions were also documented. During Design Verification, dimensional and functional testing to ensure the performance and design integrity of this product line were conducted. All results obtained during our Design Verification met our predetermined acceptance criteria for this product line.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
OCT 1 9 2001
RE: SPECIAL 510(K): DEVICE MODIFICATION FOR THE WILSON-COOK ULTR BIOPSY NEEDLE
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS l.
Submitted By:
Wilson-Cook Medical Inc. 4900 Bethania Station Road & 5951 Grassy Creek Boulevard Winston-Salem, NC 27105
Device Description:
The Wilson-Cook Modified Ultrasound Biopsy Needle is used for soft tissue biopsy through the accessory channel of an ultrasound endoscope. This device is supplied sterile and intended for single use only.
Trade Name: | Wilson-Cook Ultrasound Biopsy Needle |
---|---|
Common/Usual Name: | Ultrasound Biopsy Needle |
Classification Name/Code: | Set, Biopsy Needle and Needle, GU, 78 FCG |
Classification: | FDA has classified similar devices as Class II, as |
per 21 CFR § 876.1075. This device falls within | |
the purview of the Gastroenterology and Urology | |
Device Panel. | |
Performance Standards: | To the best of our knowledge, performance |
standards for this device do not exist. | |
Intended Use: | Used for soft tissue biopsy through the accessory |
channel of an ultrasound endoscope. |
Predicate Device:
| PREDICATE DEVICE | MANUFACTURER | DOCUMENT CONTROL
NUMBER |
|----------------------------------|--------------------------|----------------------------|
| ProAct Biopsy Needle | ProAct Ltd. | K926559/A |
| Wilson-Cook Ultrasound
Needle | Wilson-Cook Medical Inc. | K934356 |
Substantial Equivalence:
The Wilson-Cook Modified Ultrasound Biopsy Needle is substantially equivalent to the referenced predicate devices with respect to design, materials of construction and intended use.
Biopsy Needle in the side-cutting This device is identical to the ProAct configuration of the needle, as well as the echogenic needle tip. In addition, both of these devices operate in the same manner in order to obtain biopsies.
The modified Ultrasound Biopsy Needle and the predicate Wilson-Cook Ultrasound Needle are both used endoscopically, employing ultrasound technology to quide the needle. The patient-contacting materials of these devices differ slightly, with the sheath of the predicate being polytetrafluoroethylene and the sheath of the modified device being PEEK. In addition, the stylet of the predicate is comprised of ANSI Grade 304 Stainless Steel while the modified device stylet is comprised of Titanium Nickel (Nitinol). Applicable biocompatibility data is included.
1
K06 3356
Page 2 of 2
RE: SPECIAL 510(K): DEVICE MODIFICATION FOR THE WILSON-COOK ULTR BIOPSY NEEDLE
| DEVICE
CHARACTERISTIC | Wilson-Cook Modified
Ultrasound Biopsy
Needle
[Subject of Special
510(k)] | ProAct Biopsy
Needle
(K926559/A) | Predicate
Wilson-Cook
Ultrasound Needle
(K934356) |
|--------------------------|------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Used for soft tissue
biopsy through the
accessory channel of an
ultrasound endoscope. | Used for
percutaneous,
intra-operative, or
through a
laparoscope
biopsies. | Used for aspiration
biopsy to diagnose
and stage GI lesions,
providing sampling
by employing
ultrasound
technology to guide
the needle. |
| Sterility | Sterile, Disposable | Sterile, Disposable | Sterile, Disposable |
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS (continued) l.
Biocompatibility:
Reasonable assurance of biocompatibility for the patient-contacting materials has been established through a history of use in similar patient-contacting medical devices and as applicable biocompatibility test results.
Design Control/Risk Analysis/Design Verification:
Design Control, Risk Analysis, Design Verification activities for the subject of this special 510(k) have been conducted in accordance with all applicable internal procedures. The design control process employed is inclusive of the elements as stipulated by 21 CFR Part 820.30, as applicable to the project. The risk analysis performed identified the risks relative to the performance requirements, as specified by our internal procedure for Risk Analysis. The failure mode, effect of failure, severity, potential cause, rate of occurrence, design control element/production controls to eliminate, the potential to detect and our recommended actions were also documented. During Design Verification, dimensional and functional testing to ensure the performance and design integrity of this product line were conducted. A l l results obtained during our Design Verification met our predetermined acceptance criteria for this product line.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol featuring a staff with two snakes coiled around it. The caduceus is positioned to the right of the text "DEPARTMENT OF HEALTH &" which is arranged in a semi-circular fashion. The text is in all caps.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 9 2001
Re: K013356
Trade/Device Name: Wilson-Cook Ultrasound Biopsy Needle Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: II
Product Code: 78 FCG Dated: September 28, 2001 Received: October 10, 2001
Dear Ms. Posner:
Ms. Margaret J. Posner
Wilson-Cook Medical
GI Endoscopy
Regulatory Affairs Specialist
4900 Bethania Station Road
WINSTON-SALAM NC 27105
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your booker only of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for associated in the encreated of 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 r read of acrease 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.
3
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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this 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 Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Snogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page __ 12__ of ___ 12__
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: ____Wilson-Cook Ultrasound Biopsy Needle
Indications for Use:
Used for soft tissue biopsy through the accessory channel of an ultrasound endoscope.
(Please do not Write Below This Line – Continue on another Page, if Needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use | ✓ | OR | Over-The-Counter |
---|---|---|---|
(Per 21 CFR 801.109) | (Optional Format 1-2-96) |
Nancy C Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number | K013356 |
---|---|
--------------- | --------- |