(173 days)
The K-C Hemostatic Biopsy System is indicated for use endoscopically or percutaneous to retrieve tissue sampling of soft organs/tumors or masses for histological analysis and deliver a hemostatic material to the biopsy site to reduce bleeding from the biopsy site. Soft tissue sampling includes but not limited to organs such as breast, liver, kidney and prostate. It is not intended for use in bone.
The proposed device consists of a mechanism to capture a biopsy sample of soft tissue, soft organs, tumor or masses for histological analysis and a co-axially configured syringe containing a hemostatic agent to be delivered into the biopsy tract upon removal of the biopsy sample.
The provided document is a 510(k) premarket notification for the K-C Hemostatic Biopsy System. It describes the device, its intended use, and its substantial equivalence to previously cleared devices. However, this document does not contain any information regarding specific acceptance criteria for device performance or a study that proves the device meets such criteria.
The document primarily focuses on establishing substantial equivalence based on the technological characteristics, intended use, design, operating principles, and materials being similar to predicate devices. It lists several predicate devices for hemostatic delivery, aspiration, and cutting needles.
Therefore, I cannot provide the requested table and study details based on the information given.
Here's a breakdown of what could not be answered based on the provided text:
- A table of acceptance criteria and the reported device performance: No performance criteria or results are mentioned.
- Sample size used for the test set and the data provenance: No test studies or data are described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment is mentioned for any performance testing.
- Adjudication method for the test set: No test sets are described.
- 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: This device is a biopsy system, not an AI-assisted diagnostic tool. No MRMC study is mentioned.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable for this type of device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): No performance testing requiring ground truth is described.
- The sample size for the training set: Not applicable, as this is not an AI/algorithm-based device in the context of typical training sets.
- How the ground truth for the training set was established: Not applicable.
The submission claims that "All data gathered demonstrate this device as substantially equivalent. No new issues of safety or efficacy have been raised." However, it does not detail what "data gathered" refers to in terms of specific performance metrics or studies. It relies on the assertion of similarity to predicate devices.
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JUL 1 3 2005
Ko50135 1/2
Summary of Safety and Effectiveness Information
Submitter Information:
"
| Submitter's Name: | Bioengineering Consultants Itd. |
|---|---|
| Address: | 801 West Main StreetCharlottesville, VA 22903 |
| Phone Number: | 434-979-4134434-979-5725 fax |
| Contact Person: | William R. Krause |
| Device Name: | |
| Trade Name: | K-C Hemostatic Biopsy System |
| Common/Usual Name: | Biopsy device |
| Classification:Class: | Class II, per CFR Part 876.1075 |
| Name: | Gastroenterology-urology biopsy instrument, needle |
| Product Code | KNW |
| Performance Standards: | The FDA under Section 514 of the Food and Drug andCosmetic Act has not established PerformanceStandards. |
| Indications for Use: | The K-C Hemostatic Biopsy System is indicated for useendoscopically or percutaneous to retrieve tissuesampling of soft organs/tumors or masses forhistological analysis and deliver a hemostatic material tothe biopsy site to reduce bleeding from the biopsy site.Soft tissue sampling includes but not limited to organssuch as breast, liver, kidney and prostate. It is notintended for use in bone. |
| Device Description: | The proposed device consists of a mechanism to capturea biopsy sample of soft tissue, soft organs, tumor ormasses for histological analysis and a co-axiallyconfigured syringe containing a hemostatic agent to bedelivered into the biopsy tract upon removal of thebiopsy sample. |
| Technological Characteristics: | The intended use, design, operating principles andmaterials are similar to devices previously cleared viathe 510(k) process. |
| Substantial Equivalence: | The K-C Hemostatic Biopsy System has been tested andcompared to substantially equivalence, predicativedevices listed below. All data gathered demonstrate this |
| device as substantially equivalent. No new issues ofsafety or efficacy have been raised. |
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12
Hemostatic Delivery Devices: Predicative Devices QuickSeal Arterial Closure System Sub-Q Inc. (San Clemente, CA) FDA # P010049
Aspiration Needles
- Modified MENGHINI Needle for Aspiration Biopsy a. Becton Dickerson and Company(Franklin Lakes, NJ):
- Jamshidi Menghini soft Tissue Biopsy Tray Allegiance b. Healthcare Corporation (McGaw Park, IL)
- Jamshidi Soft Tissue Biopsy Needle/Syringe Baxter ﻥ Healthcare Corp.(Valencia, CA)
Cutting Needles
- Bard Max-Core Disposible Biopsy System a. CR Bard (Murray Hill, NJ)
- Temno Biopsy System b. Cardinal Health Corporation (McGaw Park, IL)
- Coaxial Quick-Core Biopsy Sets c. Cooke Inc. (Bloomington, IN)
- d. ASAP™ Automated Biopsy System Boston Scientific (Watertown, MA)
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. Inside the circle is a stylized image of an eagle with its wings spread. The eagle is facing to the right.
(JUL 1 3 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
William R. Krause, Ph.D. President Bioengineering Consultants, Ltd. 801 West Main Street Charlottesville, Virginia 22903
Re: K050135
Trade/Device Name: K-C Hemostatic Biopsy System Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: II Product Code: FCG Dated: May 4, 2005 Received: May 10, 2005
Dear Dr. Krause:
We have reviewed your Section 510(k) premarket notification of intent to market the device indication we have reviewed your Section 9 ro(x) premeiner is substantially equivalent (for the indications referenced above and nave ucternmed the arrested predicate devices marketed in interstate for use stated in the encrosule) to regarly manated producal Device Ameralments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food. Food commerce prior to May 28, 1970, the enactined with the provisions of the Federal Food, Drug.
devices that have been reclassified in accordance with the provisions of explicat devices that have been reciassified in accordance vitar as proval approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval on o and Cosment Act (Act) that to not require approvial of the general controls provisions of the Act. The .
You may, therefore, market the device, subject to the general contr You may, inerefore, market the device, subject to use gents for annual registration, listing of general controls provisions of the Act merides required in the manage inst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), a If your device is classificul (SCC above) into existing major regulations affecting your device in the subject to such it may be subject to such additional controller Externig may on 800 to 898. In addition, FDA can be found in the Code of Federal Regarations your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA 3 issualled of a complies with other requirements of the Act that FDA has made a determination administered by other Federal agencies. You must of any Federal Statutes and regulations adminities out not limited to: registration and listing (21 comply with an the Act s requirements, me; good manufacturing practice requirements as set CFK Part 807), labeling (21 CFR Part 820); good and forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - William R. Krause, Ph.D.
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ocgin maxeding your mance of your device to a legally premarket notification. "The PDF Imaning of our 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 acvice for your as not 115 . Also, please note the regulation entitled, colliact the Office of Comphalles as (21 the Part 807.97). You may obtain "Misbralloning by relected to premainter to be the Act from the Division of Small other general Information on your responsivensive at its toll-free number (800) 638-204, or Manufacturers, International and Consaint o://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Signature
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
K050135 510(k) Number (if known):
K-C Hemostatic Biopsy System Device Name:
The K-C Hemostatic Biopsy System is indicated for use Indications For Use: Indications For Use: endoscopically or perculaneously to relieve alsous satijsing or other the biopsy site to
masses for histological analysis and deliver a hemostation includes but not limited t masses for histological analysis and dentify includes but not limited to
reduce bleeding from the biopsy site. Soft tissue sampling includes but not integration reduce bleeding from the blopsy site. Soft tissue sampling meaded for use in bone.
organs such as breast, liver, kidney and prostate. It is not intended for use in bone.
× Prescription Use __ (Part 21 CFR 801 Subpart D) AND/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)
RaK
Olvision, E C.J-. Division of General. Restorative and Invital Of Open to a low as a
510(k) Number
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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.