(43 days)
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.
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.
The provided document is a 510(k) Premarket Notification for the Cook® Sidearm Core Tissue Biopsy Device/Set. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials with specific acceptance criteria and performance metrics.
Therefore, the document does not contain the detailed information requested regarding acceptance criteria, study design, sample sizes, expert qualifications, or ground truth methodologies as would be found in a study demonstrating novel device performance against predefined metrics.
Here's a breakdown of what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance:
- Missing. The document focuses on demonstrating substantial equivalence to existing predicate devices, not on meeting specific performance acceptance criteria. It claims the device "meets requirements for substantial equivalency according to section 510(k) guidelines" and is "comparable to existing predicate devices in distribution." There are no quantitative performance metrics (e.g., accuracy, sensitivity, specificity, or success rates) or corresponding acceptance criteria presented.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Missing. No test set or clinical study data is presented. The submission relies on a comparison to predicate devices, not on new performance data from a specific test set.
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):
- Missing. No test set or ground truth determination process is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Missing. No test set or adjudication process is described.
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:
- Missing. This device is a mechanical biopsy instrument, not an AI-powered diagnostic tool, so an MRMC study with AI assistance is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Missing. This device is a mechanical biopsy instrument; thus, standalone algorithm performance is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Missing. No ground truth is established as there is no performance study. The device is intended to obtain tissue for histological evaluation (which would then be the ground truth for diagnosis), but its own performance isn't evaluated against a ground truth in this document.
8. The sample size for the training set:
- Missing. There is no training set mentioned, as this is not an AI/machine learning device.
9. How the ground truth for the training set was established:
- Missing. Not applicable.
Summary of Device and Claim:
The Cook® Sidearm Core Tissue Biopsy Device/Set is an automated biopsy instrument designed to obtain multiple core tissue samples from various sites (prostate, kidney, liver, lung, breast, lymph nodes, tumors) for histological evaluation.
The basis for market clearance (510(k) K041544) is substantial equivalence to several predicate devices, including:
- Magnum Biopsy System (K871390) by C.R. Bard, Incorporated
- EMS Biopsy Instrument (K930083) by Engineered Medical Systems
- High Speed Core Cut Biopsy Device (K905556) by BIP USA, Incorporated
- Manan Pro-Mag Automatic Biopsy Device (K914874) by Manan Medical Products, Incorporated
- (Roth) Spiral Rotating Prostatic Biopsy Needle (K863385) by Cook Urological, Incorporated
The document asserts that the Cook® Sidearm Core Tissue Biopsy Device/Set is substantially equivalent due to:
- Similar indications for use.
- Similar technological construction.
- Similar materials (stainless steel, polycarbonate for needles; Ryton, Anodized aluminum, Silicone, Delrin for device).
- Standard manufacturing controls and Quality Assurance Program.
- Similar packaging to currently marketed devices.
The review of this 510(k) submission does not involve the generation or analysis of new clinical performance data specifically demonstrating the Cook® Sidearm Core Tissue Biopsy Device/Set meets predefined acceptance criteria. Instead, it argues that because it is similar to already cleared devices, it is safe and effective for its intended use.
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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.
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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
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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
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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 anautomated biopsy instrument to obtain multiple cores of tissue samplingfrom 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
§ 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.