(173 days)
P010049
P010049
No
The provided text describes a mechanical biopsy system with a hemostatic agent delivery mechanism. There is no mention of AI, ML, image processing, or any data-driven analytical components. The performance studies focus on substantial equivalence to predicate devices, not on the performance of an AI/ML algorithm.
No
The device is primarily intended for tissue sampling (diagnosis) and bleeding reduction at the biopsy site (a procedural aid), not for treating a disease or condition.
No
The device is designed to retrieve tissue samples for histological analysis and deliver a hemostatic material to reduce bleeding. Histological analysis is a diagnostic process, but the device itself is a tool for sample acquisition and bleeding control, not for performing the diagnostic analysis itself.
No
The device description clearly outlines a physical mechanism for tissue sampling and a syringe for delivering a hemostatic agent, indicating it is a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health.
- Device Function: The K-C Hemostatic Biopsy System is used to retrieve tissue samples from the body and deliver a hemostatic material into the body. It is an invasive procedure performed directly on the patient.
- Intended Use: The intended use is to obtain tissue for histological analysis, which is the examination of tissue structure under a microscope. While the analysis of the tissue sample is an in vitro process, the device itself is used for the collection of that sample from within the body.
Therefore, based on the provided information, the K-C Hemostatic Biopsy System is a device used for tissue sampling and hemostasis within the body, not for in vitro diagnostic testing of specimens.
N/A
Intended Use / Indications for Use
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.
Product codes
KNW, FCG
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft organs/tumors or masses such as breast, liver, kidney, prostate. Not intended for use in bone.
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)
P010049
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
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 Street |
| Charlottesville, VA 22903 | |
| Phone Number: | 434-979-4134 |
| 434-979-5725 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 and |
| Cosmetic Act has not established Performance | |
| Standards. | |
| Indications for Use: | 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. | |
| Device Description: | 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. | |
| Technological Characteristics: | The intended use, design, operating principles and |
| materials are similar to devices previously cleared via | |
| the 510(k) process. | |
| Substantial Equivalence: | The K-C Hemostatic Biopsy System has been tested and |
| compared to substantially equivalence, predicative | |
| devices listed below. All data gathered demonstrate this | |
| device as substantially equivalent. No new issues of | |
| safety or efficacy have been raised. |
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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.
3
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
4
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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