(43 days)
Not Found
No
The description focuses on the mechanical function and materials of a biopsy device, with no mention of AI, ML, or any computational analysis of data.
No
The device is used to obtain tissue samples for diagnostic evaluation (histological evaluation), not to treat a condition or disease.
No
This device is used to obtain tissue samples for histological evaluation, but it does not perform the evaluation itself. The diagnostic process occurs after the tissue is collected.
No
The device description explicitly details the physical construction materials (Ryton, Anodized aluminum, Silicone, Delrin, Stainless Steel, polycarbonate) of the biopsy device and needles, indicating it is a hardware device.
Based on the provided information, the Cook® Sidearm Core Tissue Biopsy Device/Set is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This typically involves tests performed on blood, urine, tissue samples, etc., in a laboratory setting.
- The Cook® Sidearm Core Tissue Biopsy Device/Set is a tool used to obtain the tissue sample from the body. It is a biopsy instrument used during a medical procedure to collect the specimen. The histological evaluation mentioned in the intended use is the subsequent process performed on the tissue sample, which might involve IVD procedures, but the biopsy device itself is not performing the in vitro diagnostic test.
In summary, the device is a surgical instrument for tissue collection, not a device that performs diagnostic testing on a collected sample.
N/A
Intended Use / Indications for Use
The Cook® Sidearm Core Tissue Biopsy Device/Set is used as an automated biopsy instrument to obtain multiple cores of tissue sampling from sites including, but not limited to the prostate, kidney, liver, lung, breast, lymph nodes, and different tumors for histological evaluation.
Product codes (comma separated list FDA assigned to the subject device)
78 KNW, FCG
Device Description
The Cook® Sidearm Core Tissue Biopsy Device/Set is used as an automated biopsy instrument to obtain multiple core tissue sampling from sites including, but not limited to, the prostate, kidney, liver, lung, breast, lymph nodes and different tumors for histological evaluation. The Cook® Sidearm Core Tissue Biopsy Device/Set allows adjustment for an 18mm or 23mm sample, allows the sample to be easily exposed, is a one-handed operation, and will not fire when the sample size is in the incorrect position. The construction of the Cook® Sidearm Core Tissue Biopsy Device is Ryton, Anodized aluminum, Silicone, Delrin, and Stainless Steel. The construction of the Cook® Sidearm Needles are stainless steel and polycarbonate.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
prostate, kidney, liver, lung, breast, lymph nodes, and different tumors
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K871390, K930083, K905556, K914874, K863385
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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JUL 22 2004
K041544
Page 1 of 2
page 18
510(k) Premarket Notification Cook® Sidearm Corc Tissue Biopsy Device/Sct Cook Urological, Incorporated
Being similar to indications for use and technological construction to other Biopsy Devices, the Cook® Don't Core Tissue Biopsy Device meets requirements for substantial equivalency according to section 510(k) guidelines, justifying for commercial sale.
510(k) SUMMARY I.
Submitted By:
Cindy Rumple Cook Urological, Incorporated 1100 West Morgan Street Spencer, Indiana 47460 (812) 829-4891 December 5, 2003
Device
Trade Name:
Proposed Classification Name:
Cook® Sidearm Core Tissue Biopsy Device/Set
Instrument, Biopsy Class II 78 KNW
Predicate Devices:
The Cook® Sidearm Core Tissue Biopsy Device is comparable to existing predicate devices in distribution including the Magnum Biopsy System (K871390) manufactured by C.R. Bard, Incorporated, the EMS Biopsy Instrument (K930083) manufactured by Engineered Medical Systems, the High Speed Core Cut Biopsy Device (K905556) manufactured by BIP USA, Incorporated, the Manan Pro-Mag Automatic Biopsy Device (K914874) manufactured by Manan Medical Products, Incorporated, and the (Roth) Spiral Rotating Prostatic Biopsy Needle (K863385), manufactured by Cook Urological, Incorporated.
Device Description:
The Cook® Sidearm Core Tissue Biopsy Device/Set is used as an automated biopsy instrument to obtain multiple core tissue sampling from sites including, but not limited to, the prostate, kidney, liver, lung, breast, lymph nodes and different tumors for histological evaluation. The Cook® Sidearm Core Tissue Biopsy Device/Set allows adjustment for an 18mm or 23mm sample, allows the sample to be easily exposed, is a one-handed operation, and will not fire when the sample size is in the incorrect position. The construction of the Cook® Sidearm Core Tissue Biopsy Device is Ryton, Anodized aluminum, Silicone, Delrin, and Stainless Steel. The construction of the Cook® Sidearm Needles are stainless steel and polycarbonate.
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K041544
Page 2 of 2
510(k) Premarket Notification Cook® Sidearm Core Tissue Biopsy Device/Sct Cook Urological, Incorporated
page 19
Biocompatibility
The needles are constructed of stainless steel which is a well known material in the medical community and polycarbonate, which does not come into contact with the patient. The biopsy device does come into contact with the patient; therefore, biocompatibility is not warranted.
Substantial Equivalence:
The device and needles will be manufactured according to specified controls and a Quality Assurance Program. The Cook® Sidearm Core Tissue Biopsy Device/Set will undergo packaging similar to devices currently marketed and distributed by Cook Urological, Incorporated. Being similar with respect to indications for use, materials, and physical construction to predicate devices, this device set meets the requirements for section 510(k) substantial equivalence.
2
Image /page/2/Picture/1 description: The image shows a circular logo with text around the perimeter and a stylized bird in the center. The text is curved to follow the circle's shape, but it is not legible. The bird is composed of three curved lines that suggest wings and a body, giving it a sense of flight or movement. The logo appears to be a simple, symbolic representation, possibly for an organization or brand.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 22 2004
Ms. Cindy Rumple Regulatory Affairs Technical Writer Cook Urological, Incorporated 1100 W. Morgan Street SPENCER IN 47460
Re: K041544
Trade/Device Name: Cook® Sidearm Core Tissue Biopsy Device/Set Regulation Number: 21 CFR §876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: II Product Codes: 78 KNW and FCG Dated: June 4, 2004 Received: June 9, 2004
Dear Ms. Rumple:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave revious your becaused in (d the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreations of the enactment date of the Medical Device Amendments, or to connineres proct to may 20, 1978, ac eccordance with the provisions of the Federal Food, Drug, uce noos that nave boon require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, disreleve, mains of the Act include requirements for annual registration, listing of general controls provisions of ractice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (sec above) into either class II (Special Controls) or class III (PMA), it your device is blassified 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 lease of actived that I Drivision that your device complies with other requirements of the Act that I Dr Has made a sand regulations administered by other Federal agencies. You nust of any Federal statutes and regurements, 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 rord in the quant) - 11
3
This letter will allow you to begin marketing your device as described in your Section 510(k) I his lefter will anow you to begin marrer. It substantial equivalence of your device to a legally premarket notification - The PDA intellight 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 for your don't 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 Adultionally, 101 questions on the prosse note the regulation entitled, "Misbranding Other of Compliance at (301) 59 + 100 (21CFR Part 807.97) you may obtain. Other general by relevence to premarked nonneation (21 ce Act may be obtained from the Division of Small information on your responsional and Consumer Assistance at its toll-free number (800) 638-2041 or Mandiacturers, International and Octoss http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
PREMARKET NOTIFICATION
INDICATIONS FOR USE STATEMENT
| 510(k) Number (if known): | K041544 |
|---|---|
| Device Name: | Cook® Sidearm Core Tissue Biopsy Device/Set (Not Yet Assigned) |
| Indications for Use: | The Cook® Sidearm Core Tissue Biopsy Device/Set is used as an |
| automated biopsy instrument to obtain multiple cores of tissue sampling | |
| from sites including, but not limited to the prostate, kidney, liver, lung, | |
| breast, lymph nodes, and different tumors for histological evaluation. |
Prescription Use_ X (Part 21 CFR 801 Subpart D) OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David K. Hergen
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number