MAGNUM CORE TISSUE BIOPSY NEEDLE MODEL MN1820, RP CUTTING NEEDLE MODEL RP-1820, MCN CORE TISSUE BIOPSY NEEDLE MODEL MCN-

K111529 · Insert Molding Solutions, Inc. · KNW · Jul 29, 2011 · Gastroenterology, Urology

Device Facts

• Record ID: K111529
• Device Name: MAGNUM CORE TISSUE BIOPSY NEEDLE MODEL MN1820, RP CUTTING NEEDLE MODEL RP-1820, MCN CORE TISSUE BIOPSY NEEDLE MODEL MCN-
• Applicant: Insert Molding Solutions, Inc.
• Product Code: KNW · Gastroenterology, Urology
• Decision Date: Jul 29, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

Intended Use

The M-CORE disposable biopsy needle is intended for use with the Bard® Magnum® biopsy instrument in obtaining biopsies from soft tissues such as liver, kidney, prostate, breast, spleen, lymph nodes and various soft tissue tumors. The M-CORE needle is not intended for use in bone.

Device Story

M-CORE disposable core biopsy needle; sterile, single-use device; stainless steel cutting cannula and stylet; includes thermoplastic removable spacer for insertion into Bard® Magnum® reusable biopsy instrument. Used by clinicians to obtain soft tissue samples; needle gauges 14-18; lengths 10-25 cm. Operates via manual insertion into reusable instrument; provides tissue core for diagnostic evaluation. Benefits patient by enabling minimally invasive tissue sampling for pathology.

Clinical Evidence

Bench testing only. Performance testing confirmed that the quality of samples obtained with the M-CORE needle is substantially equivalent to the predicate devices.

Technological Characteristics

Materials: 304 stainless steel (cannula/stylet), polycarbonate (hubs), LDPE (sheath), thermoplastic (spacer). Dimensions: 14-18 gauge, 10-25 cm length. Sterilization: Gamma radiation (ISO 11137, VDMax25, SAL 10-6). Mechanical device; no software or electronics.

Indications for Use

Indicated for obtaining soft tissue biopsies (liver, kidney, prostate, breast, spleen, lymph nodes, tumors) using the Bard® Magnum® biopsy instrument. Contraindicated 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

• Riverpoint Medical RP Cutting Needle (K092059)
• C.R. Bard® Aspiration Biopsy System ("Magnum®") (K883469)
• Promex MCN Automated Core Biopsy Device (K994272)

Submission Summary (Full Text)

{0}------------------------------------------------

Insert Molding Solutions, Inc.

K111529

# 510(k) SUMMARY

Date of Preparation: 31 MAY 2011 JUL 2 9 2011

Company/Contact Information: Paul Hendrixson, President Insert Molding Solutions, Inc. 4325 Settingdown Circle, Suite 103 Cumming, GA 30028 Phone: [phone] Fax: [phone] Email: [e-mail] Trade Name M-CORE disposable core biopsy needle Common Name Biopsy Needle

Classification Name Gastroenterology-urology biopsy instrument, needle (21CFR 876.1075, Product Code KNW) Name of Predicate(s) or Legally Marketed Device(s) K092059 - Riverpoint Medical RP Cutting Needle K883469 -C.R. Bard® Aspiration Biopsy System ("Magnum®") K994272- Promex MCN Automated Core Biopsy Device

#### Device Description

The M-CORE disposable core biopsy needle is a sterile, disposable biopsy needle featuring stainless steel cutting cannula and stylet, with sample is a lotenio, disposable biopsy needle leading stames steaturing statiness steat themoplastic removable spacer is provided to allow easy insection of both hubs into a Bard@ Magnum® reusable biopsy instrument. An LDP of the county the neder in both huss in a Barde Magnum® reuseble
available in gauges from 14 ... 18 and longthe forces the needle and packaging from available in gauges from 14 - 18 and lengths from 10 - 25 centimeters.

### Indications for Use

The M-CORE disposable biopsy needle is intended for use with the Bard® Magnum® biopsy instrument in obtaining biopsies from soft issues areas is nicences for as will the barde nagnums biopsy instrument in obtaining
The M-CORE needle is not intended for you in hans The M-CORE needle is not intended for use in bone

#### Substantial Equivalence

The M-CORE disposable biopsy needle has the same intended use as the predicate device(s) and has the same technological characteristics in terms of basic design and materials.

| Characteristic | RP Cutting Needle | Magnum Needle | MCN Needle | M-CORE Needle |
|------------------------------------|--------------------|---------------|---------------------------------------------------------|--------------------------------------------------------|
| Manufacturer | Riverpoint Medical | C.R. Bard | Promex | Insert Molding<br>Solutions |
| 510(k) Number | K092059 | K883469 | K994272 | |
| Cannula and Stylet Material | 304SS | 304SS | 304SS | 304SS |
| Cannula and Stylet Hub<br>Material | Polycarbonate | Polycarbonate | Polycarbonate | Polycarbonate |
| Sheath | LDPE | LDPE | LDPE | LDPE |
| Stylet Sample Notch | 19mm | 19mm | 19mm | 19mm |
| Spacer | Thermoplastic | Thermoplastic | Thermoplastic | Thermoplastic |
| Non-Pyrogenic | Yes | Yes | Yes | Yes, LAL Test |
| Sterile Packaging | Tyvek pouch | Tyvek pouch | Tyvek pouch | Tyvek pouch |
| Sterilization Method | EO, SAL 10-6 | EO, SAL 10-6 | Gamma, 11137,<br>VDMax25,SAL 10-6<br>Dose: 25 - 40 kGy. | Gamma, 11137,<br>VDMax25,SAL 10-6<br>Dose: 25 - 40 kGy |

### Performance Testing Summary

Performance testing confirms that the quality of the samples obtained with the M-CORE disposable core biopsy needle is substantially equivals of the samples obtailed with the M-CORE disposable con biopsy
needle is substantially equivalent to the predicate device(s). See Section 18

4325 Settingdown Circle, Suite 103

Cumming, GA 30028 phone: (678) 965 - 5334 fax: (678) 965 - 5343 www.insertmoldingsolutions.com

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings and tail feathers. The eagle is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a sans-serif font. The text is arranged around the circle, with "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the left side and "USA" on the top right.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Mr. Paul Hendrixson President Insert Molding Solutions, Inc. 4325 Settingdown Circle, Suite 103 CUMMING GA 30028

JUL 2 9 2011

Re: K111529

Trade/Device Name: M-CORE disposable core biopsy needle Regulation Number: 21 CFR\$ 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: II Product Code: KNW Dated: June 27, 2011 Received: June 29, 2011

Dear Mr. Hendrixson:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject 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 that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related

{2}------------------------------------------------

Page 2

adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Hubert Lehman MD

Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

## Enclosure

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for Insert Molding Solutions, Inc. The logo consists of a star with a medical symbol in the center, followed by the company name. The text is in a simple, sans-serif font and is aligned to the right of the star symbol. The logo is simple and professional, and it is likely used to represent the company's brand.

# Indications for Use

K11529

510(k) Number (if known):

M-CORE disposable core biopsy needle

Indications For Use:

Device Name:

The M-CORE disposable biopsy needle is intended for use with the Bard® Magnum® biopsy instrument in obtaining biopsies from soft tissues such as liver, kidney, prostate, breast, spleen, lymph nodes and various soft tissue tumors. The M-CORE needle is not intended for use in bone.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hlenin

(Division/Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K111529

4325 Settingdown Circle, Suite 103

phone: (678) 965 - 5334 fax: (678) 965 - 5343 Cumming, GA 30028 www.insertmoldingsolutions.com

SECTION 4, PAGE 1 of 1