K-C HEMOSTATIC BIOPSY SYSTEM

K050135 · Bioengineering Consultants , Ltd. · FCG · Jul 13, 2005 · Gastroenterology, Urology

Device Facts

• Record ID: K050135
• Device Name: K-C HEMOSTATIC BIOPSY SYSTEM
• Applicant: Bioengineering Consultants , Ltd.
• Product Code: FCG · Gastroenterology, Urology
• Decision Date: Jul 13, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The K-C Hemostatic Biopsy System is indicated for use endoscopically or percutaneously 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 Story

K-C Hemostatic Biopsy System combines soft tissue biopsy mechanism with co-axially configured syringe for hemostatic agent delivery. Device captures tissue sample for histological analysis; upon sample removal, syringe delivers hemostatic agent into biopsy tract to mitigate bleeding. Used by clinicians in endoscopic or percutaneous procedures. Output is tissue sample for pathology and localized hemostasis to improve patient safety by reducing post-biopsy hemorrhage.

Clinical Evidence

No clinical data provided; substantial equivalence supported by bench testing and comparison to predicate devices.

Technological Characteristics

Co-axially configured biopsy needle and syringe system. Manual operation. Materials and design principles consistent with previously cleared biopsy and hemostatic delivery devices.

Indications for Use

Indicated for patients requiring soft tissue biopsy (breast, liver, kidney, prostate) via endoscopic or percutaneous approach for histological analysis, with concurrent delivery of hemostatic material to reduce biopsy site bleeding. Not for use in bone.

Regulatory Classification

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.

Predicate Devices

• QuickSeal Arterial Closure System (P010049)
• Modified MENGHINI Needle for Aspiration Biopsy (Becton Dickerson and Company)
• Jamshidi Menghini soft Tissue Biopsy Tray (Allegiance Healthcare Corporation)
• Jamshidi Soft Tissue Biopsy Needle/Syringe (Baxter Healthcare Corp.)
• Bard Max-Core Disposible Biopsy System (CR Bard)
• Temno Biopsy System (Cardinal Health Corporation)
• Coaxial Quick-Core Biopsy Sets (Cooke Inc.)
• ASAP™ Automated Biopsy System (Boston Scientific)

Submission Summary (Full Text)

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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 Street<br>Charlottesville, VA 22903 |
| Phone Number: | 434-979-4134<br>434-979-5725 fax |
| Contact Person: | William R. Krause |
| Device Name: | |
| Trade Name: | K-C Hemostatic Biopsy System |
| Common/Usual Name: | Biopsy device |
| Classification:<br>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<br>Cosmetic Act has not established Performance<br>Standards. |
| Indications for Use: | The K-C Hemostatic Biopsy System is indicated for use<br>endoscopically or percutaneous to retrieve tissue<br>sampling of soft organs/tumors or masses for<br>histological analysis and deliver a hemostatic material to<br>the biopsy site to reduce bleeding from the biopsy site.<br>Soft tissue sampling includes but not limited to organs<br>such as breast, liver, kidney and prostate. It is not<br>intended for use in bone. |
| Device Description: | The proposed device consists of a mechanism to capture<br>a biopsy sample of soft tissue, soft organs, tumor or<br>masses for histological analysis and a co-axially<br>configured syringe containing a hemostatic agent to be<br>delivered into the biopsy tract upon removal of the<br>biopsy sample. |
| Technological Characteristics: | The intended use, design, operating principles and<br>materials are similar to devices previously cleared via<br>the 510(k) process. |
| Substantial Equivalence: | The K-C Hemostatic Biopsy System has been tested and<br>compared to substantially equivalence, predicative<br>devices listed below. All data gathered demonstrate this |
| | device as substantially equivalent. No new issues of<br>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

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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

k050135

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